Inspector Information
Laboratory Information
TABLE OF CONTENTS
Inspector
Topic
Page Information
Introduction……………………………………………………………. 4

Inspection Objectives………………………………………………... 5

Standards for Laboratory Accreditation……………………………….. 5

Checklists……………………………………………………………. 5

Commission Philosophies……………………………………………… 8

Peer Review…………………………………………………………… 8

Thoroughness………………………………………………………….. 8

Judgment………………………………………………………….…… 8

Disputes………………………………………………………………... 9

Sexual Harassment…………………………………………………….. 9

Solicitation…………………………………………………………….. 9

Confidentiality…………………………………………………….… 9

…
Conflict of Interest…………………………………………………….. 10

Applying to the CAP Laboratory Accreditation Program……………. 11
Prerequisites…………………………………………………………… 11
Application…………………………………………………………….. 11
Pre-Inspection Phase: Preparation of Application Materials…….…. 13
Inspection
13
Checklists…………………………………………………...
Application Demographics Form………………………………..…….. 13
Supplemental Materials………………………………………………... 14
AABB Coordination…………………………………………………… 14
Returning the Application…………………………………………… 14
Preparing for the Inspection……………………………………………. 15

Inspection Team Leader Assignment………………………………... 15

Inspection Team Leader Qualifications……………………………... 15

Inspector Inspection Packet……………………………………….…… 16

Laboratory Disciplines………………………………………………… 17

Inspection Team……………………………………………………….. 17

Arranging the Inspection Date…………………………………….… 17

Requests for Inspection Delays……………………………………… 18

AABB Coordinated Inspection……………………………………… 18

Unprepared Laboratories………………………………………….…… 18

Conducting the Inspection: Meetings and General Principles……… 20

Meeting with the Laboratory Director…………………………….… 20

Meeting with the Hospital
20

Administrator………………………………
Meeting with a Representative of the Medical Staff………………… 20

Meetings with Direct Healthcare Providers……………………….… 21

Meetings with Clients of Independent Laboratories………………… 21

Inspecting the Laboratory Sections…………………………………….. 22

Laboratory General……………………………………………….…… 22

Conducting the Safety Inspection…………………………………… 25

College of American Pathologists
Laboratory
Information












Laboratory Accreditation Manual
Page 1
Inspector Information
Laboratory Information
Inspector
Topic
Page Information
Hematology and Coagulation………………………………………….. 31

Clinical Chemistry, Special Chemistry, Toxicology………………… 33

Inspecting the Laboratory Sections (Continued)
Urinalysis and Clinical Microscopy…………………………………… 34

Microbiology…………………………………………………………... 36

Transfusion
38

Medicine…………………………………………………..
Immunology and Syphilis Serology……………………………….… 39

Anatomic Pathology…………………………………………………… 39

Cytopathology…………………………………………………….…… 41

Cytogenetics…………………………………………………………… 43

Histocompatibility…………………………………………………… 44

Flow Cytometry……………………………………………………….. 44

Molecular Pathology………………………………………………… 44

Point of Care Testing …………………………………………….…… 44

Inspecting Other Types of Laboratories……………………………….. 46

Special Function
46

Laboratories…………………………………….……
Affiliated Laboratories………………………………………………… 46

System Inspection Option…………………………………………… 46

Satellite Laboratories………………………………………………….. 47

Staff Inspected Laboratories………………………………………… 47

Limited Service Laboratory……………………………………….… 47

The Summation Conference…………………………………………… 49

Pre-Summation Team Meeting……………………………………… 49

Summation Conference……………………………………………… 49

Concluding the Inspection…………………………………………… 50

The Inspection Report…………………………………………………… 52

Inspector’s Summation Report (ISR)………………………………….. 52

Expense Reimbursement………………………………………….…… 52

Continuing Medical Education (CME)……………………………… 52

Return of Inspection Packet…………………………………………… 53

Post-Inspection
54
Phase……………………………………………….……
Laboratory Inspection Packet………………………………………….. 54
Packet Review…………………………………………………….…… 55
Immediate Review Criteria………………………………………….. 55
Accreditation………………………………………………………… 56
Denial/Revocation…………………………………………………… 56
Appeals………………………………………………………………… 56
Post Inspection Critique………………………….……………….…… 57
Maintaining
58
Accreditation……………………………………………….
Proficiency Testing Participation and Satisfactory Performance……. 58
Self-Evaluations……………………………………………………….. 58

Anniversary of Accreditation…………………………….………..… 58
Implications of Accreditation …………………………………….…… 58
College of American Pathologists
Laboratory
Information



















Laboratory Accreditation Manual
Page 2
Inspector Information
Laboratory Information
Inspector
Topic
Page Information
Non-Routine Inspections………………………………………………… 60
Change in Location, Director, or Ownership………………………... 60
Added Discipline………………………………………………….…… 60
Secondary On-Site Inspection…………………………………….…. 60
Complaint Investigation……………………………………………….. 61
Appendix A: CAP Checklist
62
Usage………………………………….……
Appendix B: Guidelines for Determining Test Volume………………… 65
Appendix C: Quality Improvement………………………………………. 66
Appendix D: Sample of Inspection Confirmation Letter to Lab
Director…………………………………………………… 68
Appendix E: Resources………………………………………………….. 70
Appendix F: Site Coordinators
74
Manual…………………………………..
Appendix G: Retention
86
Guidelines………………………………………..
Appendix H: Glossary of Terms…………………………………………. 88
College of American Pathologists
Laboratory
Information





Laboratory Accreditation Manual
Page 3
Inspector Information
Laboratory Information
INTRODUCTION
The College of American Pathologists (CAP) has established and directs four separate
accreditation programs. These programs were created with the primary objective of improving
the quality of clinical laboratory services throughout the United States, through voluntary
participation, professional peer review, education and compliance with established performance
standards. Since their creation, these programs have become widely acknowledged as programs
of excellence. In all, the College accredits over 6,000 laboratories. The Laboratory
Accreditation Program (LAP), for all clinical laboratories, was established in 1961. The Forensic
Urine Drug Testing (FUDT) accreditation program was established in 1988 and the Athletic
Drug Testing Program (ADT), in 1992. The Reproductive Laboratory Program (RLAP), directed
jointly with the American Society of Reproductive Medicine (ASRM), was established in 1993.
The accreditation programs examine all aspects of quality control and quality improvement in the
laboratory, including test methodologies, reagents, control media, equipment, specimen handling,
procedure manuals, test reporting, and internal and external proficiency testing and monitoring,
as well as personnel, safety, and overall management practices that distinguish a quality
laboratory.
Management and operation of the four accreditation programs are the responsibility of the
Commission on Laboratory Accreditation (CLA), except the responsibility for the RLAP is
shared with the ASRM. The CLA is a group of specially qualified pathologists appointed by the
president of the CAP and is composed of a chair, a vice chair, and regional and special
commissioners. The CLA meets three times each year to develop standards, guidelines, and
policies for the LAP, to make accreditation decisions and to consider relevant issues.
Each Regional Commissioner has responsibility for a specific geographic region. The Regional
Commissioners are assisted by Deputy and State Commissioners. Other commissioners oversee
the revision of the inspection Checklists, develop inspector training materials, address state and
federal legislative and regulatory issues, and edit the Laboratory Accreditation Newsletter. In
addition, the Commission uses the expertise of numerous CAP scientific resource committees to
keep the program and its requirements current.
State and Division Commissioners are responsible for identifying and assigning inspectors in
their geographic regions. They must make sure that inspections are conducted on a timely basis
and in accordance with Commission policy. Following the on-site inspections, the Regional
Commissioner, in conjunction with the CAP technical staff, reviews the inspection data and
conducts any follow-up necessary to reach an accreditation decision.
The Laboratory Accreditation Department at the CAP headquarters in Northfield, Illinois is
staffed by technical and administrative personnel who carry out the policies and procedures of
the CLA and handle administrative details of the accreditation process.
College of American Pathologists
Laboratory Accreditation Manual
Page 4
Inspector Information
Laboratory Information
The inspectors who conduct the on-site laboratory inspections are the lifeblood of the program.
Typically, the inspection team leader is a board-certified pathologist who has been trained by
attending an inspector training seminar or evening symposium.
Three documents are fundamental to the inspection process: the Standards for Laboratory
Accreditation, the Checklists, and the Inspector’s Summation Report (ISR). The inspector’s role
is to interpret the Standards, in the spirit of peer review, using the Checklists and ISR. The
inspector collects and records the information upon which the CLA will base the accreditation
decision. The inspection is a peer review educational process designed to achieve improvement
of patient care activities in participating laboratories. During the course of the inspection,
inspectors often will share experiences which will enhance the quality of the laboratory’s service,
and inspection team members find ideas that can be implemented in their own laboratories.
Inspection Objectives:
In the course of an inspection, the inspector should learn to :
1.
Describe how to evaluate the operating practices of a particular laboratory, by reviewing
technical procedures and related materials for quality control and quality improvement.
2.
Use the Standards for Laboratory Accreditation and the Inspection Checklists as tools for
the assessment of unfamiliar laboratory practices for compliance and consistency with
good laboratory practice.
3.
Describe knowledge about new methods and technology or approaches enhanced through
the inspection process.
4.
Explain how interaction with administration, physicians and staff enhanced the
inspector’s knowledge of current management issues and solutions.
Standards for Laboratory Accreditation
The Standards are the basis for the accreditation decision. Each of the four-accreditation
programs has its own Standards. The Standards, which have evolved through years of study and
continuous review by the CLA, are approved by the CAP Board of Governors. The inspector
must be familiar with each standard and its interpretation. A copy of the Standards for
Laboratory Accreditation is included with each inspection packet. The Standards should be
reviewed before the inspection of the laboratory. The inspector is considered the on-site
authority for the interpretation of the Standards.
Checklists
Detailed Checklists were developed, based on the requirements of the Standards. The Checklist
format permits a comprehensive evaluation of a laboratory’s compliance with the Standards.
The Checklists are organized by specific laboratory disciplines and/or important management
operations:
College of American Pathologists
Laboratory Accreditation Manual
Page 5
Inspector Information
Laboratory Information


















Laboratory General
Hematology and Coagulation
Automated/General Chemistry
Urinalysis and Clinical Microscopy
Toxicology
Special Chemistry
Microbiology
Transfusion Medicine
Immunology and Syphilis Serology
Anatomic Pathology
Cytopathology
Cytogenetics
Histocompatibility
Flow Cytometry
Molecular Pathology
Limited Service Laboratory
Blood Gas Laboratory
Point-of-Care Testing
The Checklists are available in hard copy format by calling 800-323-4040, extension 6055 or
847-832-7000, extension 6055 or at the CAP Website (www.cap.org). To download Checklists
from the Web page follow these directions. From the Laboratory Improvement icon, view the
dropdown menu and click on Laboratory Accreditation Program. From the Laboratory
Improvement screen click Download checklists. The download library screen will appear, scroll
until you reach LAP Checklist. Click on LAP Checklists and the list of all Checklists will appear
listing two formats. To obtain a copy of a checklist, click the download format. The HTML
format will allow you to view only. These Checklists are revised periodically and consist of
approximately 3,200 questions, many of which are the same item in each of the section-specific
Checklists. During the inspection, the Checklist questions are used to evaluate whether or not a
laboratory meets the LAP Standards. Each of the questions is uniquely numbered, worded and
designed to produce: a “Yes” response, which means that the lab is compliant; a “No” response,
which means the lab does not comply; or N/A which means that the question does not apply in
this testing situation. Each of the questions bears a designation of Phase I (deficiency) or Phase
II (deficiency).
Phase I deficiencies do not seriously affect the quality of patient care or significantly endanger
the welfare of a laboratory worker. Phase I deficiencies require documented responses.
College of American Pathologists
Laboratory Accreditation Manual
Page 6
Inspector Information
Laboratory Information
Phase II deficiencies are major deficiencies that may seriously affect the quality of patient care or
may affect the health and safety of hospital or laboratory personnel. All Phase II deficiencies
must be corrected and the correction documented to the satisfaction of the CLA before
accreditation will be granted. Correction requires both a plan of action and additional evidence
that the plan has been implemented.
College of American Pathologists
Laboratory Accreditation Manual
Page 7
Inspector Information
COMMISSION PHILOSOPHIES
Peer Review
Purpose: Improve laboratory performance through objective evaluation and constructive
criticism.
The inspector can enhance the spirit of peer review and educational benefit of the inspection
process by keeping in mind the following items:
 Inspectors are representatives of the accreditation program and the CAP; they must strive for
an objective and fair review. There may be more than one way to respond to a requirement
and be in compliance.
 The inspection team leader should be a peer of the medical director and serve as a guest
consultant to the laboratory.
 If a deficiency can be corrected to the inspector’s satisfaction while the inspector is on site,
that deficiency should not be cited in the Inspector’s Summation Report.
 Deficiencies should be presented factually with recommendations for improvement.
 A negative, unduly critical, or punitive attitude should be avoided.
 Deficiencies cited by the inspection team may be challenged. Dialogue between the medical
director and the inspection team leader strengthens the program and can provide insight to
both to the director and the team leader. Such discourse may lead to changes to Checklist
questions or clarification of requirements. The director is encouraged to respond in writing to
the CAP about any disputed citation. Supporting documentation should be included in the
any response. The Regional Commissioner, in conjunction with the entire Commission, will
adjudicate the challenge. An inspector should encourage the appeal process, if necessary, to
avoid conflict at the Summation Conference.
Thoroughness
Participating laboratories expect a thorough, detailed, and fair inspection. All pertinent items in
the Checklist should be considered. Most laboratories spend considerable time and effort
preparing for the inspection; they appreciate and deserve a comprehensive inspection.
Overlooking seemingly minor deficiencies does not do anyone a favor.
Judgment
The Commission relies upon the inspector’s judgment more than any other attribute in the
assessment of a laboratory. This attribute is, however, the most difficult to standardize. There
will be occasions when a conscientious inspector will have difficulty deciding whether a
Checklist item should be answered “Yes” or “No” or N/A. Many of these situations involve
partial compliance with the wording in the question. The inspector must be as detailed as
possible in the description of a deficiency in the Inspector’s Summation Report (ISR). In some
cases, there may be doubt as to whether the item actually applies to the specific laboratory
inspected.
College of American Pathologists
Laboratory Accreditation Manual
Page 8
Inspector Information
Disputes
If a laboratory wishes to challenge a particular citation, it must state its disagreement in the
deficiency response. That response should include documentation that demonstrates that the
laboratory was in compliance before the time of inspection. The Regional Commissioner will
review disputed items and determine if the deficiency can be expunged from the record. The
Laboratory Accreditation staff at the CAP office in Northfield may assist an inspector by
telephone on the inspection day to help resolve questionable citations.
Sexual Harassment
Employees of laboratories inspected by the CAP are entitled to a workplace environment free
from sexual harassment. Prohibited sexual harassment includes any comments, gestures,
innuendo, or physical contact of a sexual nature that create an intimidating, offensive or hostile
environment.
Inspectors on a CAP team, whether team leader or team member, must conduct themselves in a
manner that cannot reasonably be construed as sexual harassment. Team leaders must ensure
that the behavior of team members is consistent with this position; they must intervene actively if
inappropriate conduct is observed.
Inappropriate conduct on the part of team leaders or team members should be reported to the
Director of the Laboratory Accreditation Program at 800-323-4040, extension 7479 or 847-8327489. The CAP does not tolerate sexual harassment. In cases of documented sexual
harassment, the CAP will take appropriate action against the responsible individual.
Solicitation
Inspectors should not in any way solicit either the institution or the laboratory for any purpose.
They should conduct themselves at all times in a manner that cannot reasonably be construed to
be a solicitation. Inspectors should not request any information from the institution or laboratory
regarding fees or other business-related matters that are not related to quality assessment and
quality improvement activities. Moreover, the inspector should not request any information
regarding the director’s contractual relationship with the institution’s administration.
Confidentiality
All inspection findings are confidential. They should not be discussed in any context other than
the inspection itself. Moreover, they should not be disclosed to anyone not associated with the
accreditation process unless appropriate prior documented consent has been obtained.
College of American Pathologists
Laboratory Accreditation Manual
Page 9
Inspector Information
Conflict of Interest
The CLA believes that an inspection performed by a team from a laboratory or institution that
competes with the subject laboratory or institution does not represent a conflict of interest.
Further, the CLA believes that team leaders and inspectors will conduct inspections objectively
and professionally regardless of whether they are in competition with the subject institution. In
this connection, it should be noted that the inspection team does not make the accreditation
decision, and the subject laboratory may challenge any deficiency citation. The Regional
Commissioner resolves any challenge based on documentation provided by the subject
laboratory. Nevertheless, any laboratory can discuss the specifics of a perceived conflict of
interest with the State and/or Regional Commissioner before the inspection. The State or
Regional Commissioner has discretion to make a reassignment if a conflict of interest appears.
College of American Pathologists
Laboratory Accreditation Manual
Page 10
Laboratory Information
APPLYING TO THE CAP
LABORATORY ACCREDITATION PROGRAM
Prerequisites



Laboratories must participate regularly in a CAP-approved proficiency testing (PT) program
for each patient-reportable analyte, whenever an appropriate program is available.
Each separately accredited laboratory must be enrolled in such a program under its own CAP
number. It is preferable that the laboratory has a performance history of one or two
shipments of proficiency testing before an initial inspection.
The CLA requires that each accredited laboratory must provide and/or be responsible for
providing an inspection team of a size and composition similar to that required for its own
inspection. This team (if requested by the Regional, State or Division Commissioner) must
perform at least one inspection during its two-year accreditation cycle.
Application
Once an application request form, along with a non-refundable deposit, is received in the CAP
Northfield office, the necessary application materials will be sent to the applying laboratory. The
deposit is applied toward the first-year accreditation fee.
The application packet contains:
1.
A copy of the Laboratory Accreditation Manual that includes instructions for
the completion of accreditation materials
2.
A checkoff list of materials to be returned
3.
Accreditation Application which includes:
 Addresses
 Laboratory Contacts
 Licensure and Certification
 Release of Data
 Conditions of Accreditation
 Personnel Qualification Form - to be duplicated and completed for each
pathologist, physician, doctoral clinical scientist, consultant and supervisor
 Laboratory Sections to be duplicated and completed for each section of the
laboratory
4.
Master Activity Menu
5.
A complete set of Inspection Checklists
6.
Standards for Laboratory Accreditation
College of American Pathologists
Laboratory Accreditation Manual
Page 11
Laboratory Information

A new applicant to an accreditation program has six months to complete and return the
application materials if its inspection is not coordinated with a CAP-accredited laboratory. A
laboratory whose initial inspection is being coordinated with a CAP-accredited laboratory
will be assigned a due date by which the application materials must be returned to the CAP
Northfield office.

All laboratories within an institution that wish to be CAP accredited and that possess
CLIA numbers different from the main clinical laboratory’s must be accredited
separately. Accreditation is matched one-for-one with CLIA certification. Laboratories
operating under separate CLIA certificates must submit separate deposits and application
request forms.
The Standards for Laboratory Accreditation and the inspection Checklists, as noted earlier, are
available on the Website if the laboratory wishes to review them before applying to the program.
If you do not have access to the Website you may call the Laboratory Accreditation Program at
800-323-4040, extension 6055 or 847-832-7000, extension 6055 to request a copy.
College of American Pathologists
Laboratory Accreditation Manual
Page 12
Laboratory Information
PRE-INSPECTION PHASE:
PREPARATION OF APPLICATION MATERIALS
Inspection Checklists



CAP Checklists are method- or discipline-specific. Checklist usage is determined in the CAP
office from the activity menu completed for each laboratory section. Supervisors should
review their departments using the appropriate discipline-specific Checklist(s). A complete
set of CAP inspection Checklists is included with your application packet. (The Checklists
may be copied for your use, if needed. Checklists should not be returned to the CAP office.)
See Appendix A for a detailed explanation of Checklist usage.
Duplicate Checklists are required in instances where there is more than one discrete
laboratory section, under the operation of different supervisors, performing testing within the
same discipline, (i.e., a separate blood gas laboratory with a different medical or technical
supervisor). The appropriate quantity of each Checklist will be provided to your inspector.
The Commission on Laboratory Accreditation expects that the laboratory will have met the
Standards by the date the application materials are returned to the CAP.
Accreditation Application







The laboratory must complete a Laboratory Section page of the Application for each section
of the laboratory.
The laboratory must complete the Master Activity Menu for all laboratory sections and
physically attach (paper clip or staple) the appropriate pages to each Laboratory Section form.
It may be necessary to copy the selected pages of the Master Activity Menu if testing is
performed in more than one section. The Master Activity Menu is a list of all tests and nontest activities categorized by subdiscipline that could be performed by a laboratory.
The laboratory should provide all information requested, including attachments if necessary.
The laboratory should provide detailed annual test volumes for each discipline with the
laboratory section. (See Appendix B for detailed information on calculation of test volumes.)
The Release of Data and Conditions of Accreditation forms must be signed by the medical
director responsible for the laboratory (MD, PhD, or DO). The director must indicate if the
CAP inspection is to be used for regulatory purposes by checking the appropriate agency on
this form.
If your laboratory is affiliated with other laboratories and you prefer to have a coordinated
inspection, complete the Affiliated Laboratories section of the application.
Personnel Qualification Forms must be submitted for the laboratory directors and
supervisors. Curriculum Vitae are to be submitted for laboratory directors only.
College of American Pathologists
Laboratory Accreditation Manual
Page 13
Laboratory Information
Note: Florida laboratories will receive a blank Clinical Laboratory Personnel Roster. The
laboratory must complete a roster for each laboratory section, including any non-laboratory based
employees performing Point of Care Testing classified by HCFA as moderate or high
complexity. The Personnel Roster may be photocopied if more than one page is needed. The
completed Personnel Roster form must be signed by the preparer and, along with a copy of each
employee’s State of Florida License, must be returned with the application/reapplication packet.
Supplemental Material



A sketch of the laboratory floor plan should submitted on 8½” x 11” paper whenever
possible. Laboratories should not submit blueprints.
An organizational chart for the laboratory should be provided.
Curriculum vitae should be submitted for the laboratory director.
AABB Coordination
Laboratories wishing to have a CAP/AABB coordinated inspection of their transfusion medicine
service must contact the CAP office and the AABB National office as early as possible in the
application process to allow sufficient time for administrative processing. Please refer to the
sections in this manual on “Preparing for the Inspection” for further information on AABB
coordination.
 CAP Central Office - 800-323-4040, option 2 or 847-832-7000,
extension 6055
 AABB National Office - 301-907-6977
Returning the Application
Please retain the inspection Checklists as an educational tool to prepare for the inspection. All
other application materials should be returned to:
LABORATORY ACCREDITATION DEPARTMENT
COLLEGE OF AMERICAN PATHOLOGISTS
325 WAUKEGAN ROAD
NORTHFIELD, ILLINOIS 60093-2750
College of American Pathologists
Laboratory Accreditation Manual
Page 14
Inspector Information
PREPARING FOR THE INSPECTION
Inspection Team Leader Assignment
Inspection team leaders are assigned by the State, Deputy, Divisional or Regional
Commissioner.
The State, Deputy, Divisional or Regional Commissioner:
 Contacts the inspection team leader by telephone or letter.
 Sends a confirmation letter to the inspection team leader and laboratory director.
 Faxes a copy of the Inspector Appointment Form (IAF), providing the inspection team
leader’s name and address, to the CAP Northfield office.
 Handles any potential conflict of interest concerns as soon as possible.
Team Leader qualifications






Board-certified pathologist *
Preferably a CAP fellow
Preferably affiliated with a CAP-accredited laboratory
Trained in the inspection process and preferably has completed the inspector training
seminar, evening symposium, or self-study
Peers of the laboratory director with similar status, type of practice and hospital or lab size
Preferably not a close acquaintance of the laboratory director that will be inspected
* A non-pathologist inspector may serve as a team leader only with the prior agreement of the
laboratory director and under the supervision of a qualified pathologist. A pathologist, board
certified in anatomic pathology, must inspect the anatomic pathology section.
* CAP staff medical technologists perform inspections for certain limited service laboratories.
The Staff Inspector Operations Specialist at the CAP Northfield office makes these assignments.
See “Staff Inspected Labs.”
College of American Pathologists
Laboratory Accreditation Manual
Page 15
Inspector Information
Inspector Inspection Packet
The Inspection Packet, sent to the inspection team leader from the CAP Northfield office,
includes the following materials:










Laboratory Accreditation Manual
Standards for Laboratory Accreditation
Team Member List Form
Claim for Inspector Reimbursement
Continuing Medical Education Evaluation (CME)
Accreditation Unit (AU) Materials
1. Inspector Summation Report (ISR)
2. Accreditation Application
3. Laboratory specific Activity Menu
4. Proficiency Testing Enrollment Letter (if applicable)
5. Organizational structure
6. Laboratory Floor Plan
7. Laboratory Director’s Curriculum Vitae
8. Personnel Qualification Forms for key staff (director, pathologists, consultants,
managers, and supervisors)
9. Previous Inspector’s Summation Report (ISR)
Checklist Selection Report
The Checklist Selection Report will indicate which Checklist(s) will be used in each
laboratory section.
Checklists
Name tags for the team (every team member should wear a nametag while in the host
facility) in an envelope.
Prepaid mailer envelope to return the packet to the CAP after the inspection is
complete. These mailers may only be used within the 48 contiguous states.
Notes: Florida laboratory packets include a Clinical Laboratory Personnel Roster.
During the on-site inspection, the inspector must sign the Personnel Roster, indicating
verification of current State of Florida employee licenses and that the licenses are
displayed. Licenses must also be verified for all non-laboratory based employees who
perform Point of Care Testing classified by HCFA as moderate or high complexity.
Oregon laboratory inspectors should verify the specialty/subspecialties listed by the
laboratory and that the State Certificate is displayed in a prominent place.
State Licensure - Many states license clinical laboratories. The extent to which the CAP
accreditation program is recognized by state governments varies. The College will make
the results of the accreditation decision available to a state agency upon request from the
laboratory director.
College of American Pathologists
Laboratory Accreditation Manual
Page 16
Inspector Information
Laboratory Disciplines
Accreditation by the CAP is limited to those disciplines specifically addressed within the
CAP Laboratory Accreditation Program. ALL services provided by the laboratory as
defined by the CLIA number in the application will be inspected. The College does not
accredit portions of laboratories.
CAP disciplines/subdisciplines and HCFA specialties/subspecialties (when appropriate) will be
determined by the selection of activities from the Master Activity Menu. The accreditation letter
lists only those disciplines that are reviewed at the time of the on-site inspection. Laboratories
that add disciplines after the inspection must notify the College in writing; in some cases
additional inspections may be required. (See the section of this manual titled “Non-Routine
Inspections”.)
Inspection Team
The team leader assembles an inspection team appropriate for the size and scope of the
laboratory. Information regarding the size of the previous inspection team is included in the
packet.
Inspection team members:
 have expertise in their assigned area, enhancing the peer review and education philosophy;
 may include pathology residents, medical technologists, cytotechnologists, clinical scientists,
laboratory supervisors and laboratory managers;
 may be located using the CAP inspector database;
(Lists of trained inspectors may be obtained from the CAP central office by calling 1-800323-4040, extension 6065 or 847-832-7000, extension 6065.)
 are trained in the inspection process by completing a didactic seminar or self-study; and
 should review the inspection process, laboratory packet and reference materials (Laboratory
Accreditation Manual, Standards for Laboratory Accreditation, etc.) before the inspection.
Arranging the Inspection Date
The inspection team leader must:
 contact the laboratory director within two weeks of receiving the Inspectors Inspection
Packet.
 contact all directors, if special function laboratories are to be inspected in conjunction with
the main clinical laboratory, to notify them of the inspection date.
 ensure that the inspection occurs within the 30 days before the laboratory’s accreditation
anniversary date. A mutually acceptable date is preferable; however the inspection is
scheduled at the convenience of the inspector.
 notify the Laboratory Accreditation Program at the CAP Northfield office of the inspection
date by telephone, fax or mail.
 send a courtesy letter to the laboratory director(s) indicating the inspection date, team listing,
special requests (e.g., histology slides for review) and preliminary instructions (see an
example of the letter in Appendix D).
College of American Pathologists
Laboratory Accreditation Manual
Page 17
Inspector Information
Requests for Inspection Delays
The policy of the CLA requires that laboratories performing patient testing be prepared for
inspection at any time. Any problems encountered in scheduling inspections should be brought
to the attention of the State or Regional Commissioner for resolution.
AABB Coordinated Inspection





The laboratory director or supervisor is responsible for contacting the AABB (preferably at
the time of application or reapplication) to request coordination. AABB telephone number:
(301) 907-6977. Additionally, the laboratory director should notify the LAP of the intent to
coordinate the inspection.
The name and telephone number of the CAP team leader will be provided to the AABB
inspector by the CAP upon notification of the AABB inspector assignment.
The Transfusion Medicine Inspection Checklist will be sent to the AABB inspector along
with an Inspector Summation Report (ISR), return instructions, and a return envelope.
The AABB inspector should contact the CAP team leader to see if concurrent inspections are
possible. If possible, the AABB inspector will join the team on the inspection day.
The laboratory director is responsible for contacting the AABB concerning any coordination
arrangements.
If the AABB inspection cannot be concurrent:
 The AABB inspector may schedule a separate inspection of the blood bank and is responsible
for notifying the CAP of the inspection date.
 The inspection date must not precede the CAP anniversary date by more than 30 days.
 Following the AABB inspection, the completed CAP Transfusion Medicine ISR will be
returned to the CAP in the envelope provided.
The CAP team leader should not hold his/her report to await the AABB Inspection report. CAP
office staff is responsible for ensuring that the Transfusion Medicine Checklist report is returned.
Each organization (CAP and AABB) makes separate accreditation decisions and one
organization’s decision does not affect the other’s.
Unprepared Laboratories
Occasionally, during the on-site inspection, an inspector is asked to inspect one or more
laboratories that have not completed application materials before the inspection. Unless an
inspection packet has been completed before the on-site inspection, and received by the inspector
as part of the total inspection package, such laboratories are not inspected.
College of American Pathologists
Laboratory Accreditation Manual
Page 18
Inspector Information
If however, an application has been completed but a specific Checklist is missing from the
packet, the inspector should notify the CAP Northfield office immediately, (a Checklist copy
may sometimes be faxed). The laboratory must be inspected at this time with the abovementioned specific Checklist, if required, in order to prevent an additional inspection visit. This
only pertains to laboratories that are affiliated with the main laboratory, are under the
responsibility of the same director, and have the same CLIA certificate number as the main
laboratory.
Special function laboratories that are under separate administrative and professional direction
(e.g., blood gas laboratory, pediatric hematology laboratory), and have not applied in advance for
inspection will not be inspected. The inspector should inform the director that formal
application must be made through the CAP Northfield office for an inspection to be scheduled at
a later date.
College of American Pathologists
Laboratory Accreditation Manual
Page 19
Inspector Information
CONDUCTING THE INSPECTION:
MEETINGS AND GENERAL PRINCIPLES
Meeting with the Laboratory Director
Purpose: To determine whether or not the laboratory director has sufficient responsibility and
authority for day-to-day operations of the areas inspected, or if the sections function
independently of the designated laboratory director.
The interview should:
 help in evaluating the director’s activities as listed in the Laboratory General Checklist and
the Standards for Laboratory Accreditation.
 review any problems that the inspection experience might serve to resolve (e.g., space
problems, staffing shortages, etc.)
Meeting with the Hospital Administrator
For hospital-based laboratories, the inspector should meet with the hospital administrator.
Approximately 10-15 minutes should be allowed for the meeting.
Purpose: To extend the College’s appreciation for participating in the accreditation program and
to record an evaluation of the pathology service.
The interview should:
 be relevant to the inspection itself and ascertain the hospital’s perception of the laboratory
service.
 address the effectiveness of the working relationship between the laboratory, its director and
the hospital director.
 determine whether the laboratory service meets the expectations of the administration
 communicate potential areas of conflict.
The interview must not include a discussion of financial and/or contractual arrangements.
Meeting with a Representative of the Medical Staff
For laboratories closely associated with organized medical staffs, the inspector should meet with
a representative of the medical staff. The representative should be the Chief of Staff, but may be
any physician who uses the laboratory’s services frequently and is familiar with staff issues.
The inspector should allow for a 10-15 minute discussion.
Purpose: To determine whether the director and the laboratory staff have established an
effective working relationship with the medical staff.
College of American Pathologists
Laboratory Accreditation Manual
Page 20
Inspector Information
The interview should:
 evaluate how effectively the scope, quality, and timelines of the laboratory services meet the
patient care needs of the hospital.
 assess the contribution of the pathologist and laboratory staff to teaching conferences and
meetings.
 determine the cooperation of medical staff and pathologist in problem resolution.
 help judge the medical community’s perception of the pathologist.
Meetings with Direct Healthcare Providers
While not a formal requirement, it may be useful for the inspector to visit direct patient care
areas. If the inspector wishes to do so, this should be requested of the laboratory director before
the inspection date.
Purpose: To determine how the laboratory data and communications are used by medical,
nursing, and clerical staff.
The visit should include:
 observation of phlebotomy by laboratory personnel
 review of laboratory portions of patient charts for clarity of presentation
 through interviews, assessment of laboratory responsiveness to clinical needs
 identification of concerns that can be relayed to the laboratory director
Meetings with Clients of Independent Laboratories
Meetings with administrators or clients during an inspection of an independent laboratory are
not required. The corporate manager of a commercial reference laboratory may be interviewed
as a courtesy.
Purpose: To define the functional relationships described in the organizational plan and
determine if the director meets the qualifications outlined in Standard I.
The interview should:
 provide the inspector with an opportunity to review the requirements for the director (See the
Laboratory General Checklist and the Standards for Laboratory Accreditation.)
 enable the inspector to confirm the functional relationships described in the organizational
plan.
College of American Pathologists
Laboratory Accreditation Manual
Page 21
Inspector Information
INSPECTING THE LABORATORY SECTIONS
Note: Checklists are frequently revised and requirements may change. When information
in this manual is not consistent with the currently published Checklists, the Checklist
information prevails.
Laboratory General
The Laboratory General Checklist covers the laboratory overall and is used with every laboratory
inspection. Issues such as management, personnel, specimen collection, computer function,
inventory control, safety policies, quality improvement (QI), and general quality control (QC)
procedures are included. Many of the items are repeated in the subsequent discipline- or methodspecific sections and are tailored to the special needs of individual departments.
Proficiency Testing: Proficiency testing (PT) is an integral part of the CAP program along with
the on-site inspection and self-evaluation. All labs that are seeking CAP accreditation must
participate in a PT program approved by the Commission on Laboratory Accreditation. (A list of
approved PT programs is included in the application and inspection packets. Any questions may
be directed to the Proficiency Testing Specialist in the CAP Northfield office (800) 323-4040,
extension 7580 or 847-832-7000, extension 7580.)
If PT for an analyte is not commercially available, not graded, or not compatible with all
methods, the laboratory is still required to perform an alternative method of proficiency
evaluation at least every six months. Alternative methods include blind testing of specimens
with known results, exchange of specimens with other laboratories or other equivalent systems
specifically recommended and approved by the laboratory director.
Inspectors should verify the performance of all proficiency testing, including any alternate
methods. There must be documentation of identification and corrective action for any problems
discovered through proficiency testing and documentation that the laboratory director or designee
has reviewed all PT results and evaluations.
Personnel: Randomly selected personnel files should be reviewed to determine whether the
required information (job description, health, continuing education records, etc.) is included. If
the qualifications of a supervisor (chief technologist or department head) are in question,
concerns should be described in the Summation Report. Suggestions related to staffing levels
and pathologist coverage issues should be discussed with the laboratory director before, or in lieu
of, bringing such subjects up in the Summation Conference.
The laboratory director must:
 meet the qualifications found in Standard I.
 be a physician or doctoral scientist.
 have sufficient authority to implement the Standards.
 meet the requirements in Laboratory General Checklist.
College of American Pathologists
Laboratory Accreditation Manual
Page 22
Inspector Information
Note: the director need not personally discharge all responsibilities. Administrative functions
may be delegated to qualified laboratory managers or supervisors. Medical and technical
responsibilities may be delegated to other physicians and qualified laboratory personnel.
Consulting Pathologist
When the director cannot adequately discharge all of the responsibilities appropriate for the
pathology or laboratory service, the services of a qualified consulting pathologist must be
retained. A policy regarding the duties of the consulting pathologist must be in place.
The consulting pathologist must:



provide documentation of activities performed and a documented report with evaluation and
recommendations in writing for each consultation visit.
visit the laboratory as often as required.
serve as a consultant to the medical staff and play an active role in the educational programs
of the laboratory and institution.
Quality Improvement: The laboratory must have a planned and systematic program for the
monitoring and evaluation of the quality and appropriateness of its patient care services, for
resolving identified problems, and for ensuring that the program is implemented throughout all
laboratory sections by the director. (See appendix C for an expanded discussion of quality
improvement.)
Quality Control: The quality control questions are designed to determine whether procedures are
clearly defined, the laboratory director uses the quality control program to evaluate performance,
and corrective actions are taken when necessary. Tolerance limits for procedures must be
defined in the manuals and documented.
Space and Facilities: Deficiencies in space and facilities are considered Phase II if severe
enough that they affect the results of tests or compromise the health and safety of personnel.
Less severe deficiencies are considered Phase I and are itemized to help the director plan for the
future.
Specimen Collection: Instructions must be provided for the collection and handling of specimens
for all tests, both within and outside of the laboratory. If the laboratory accepts specimens
collected by hospital nurses and house officers, a typical nursing station should be checked for
availability of the instructions. In independent laboratories, a copy of the directions provided to
client physicians should be reviewed.
Handwritten Reports: As part of the inspection of individual departments, examples of
completed reports for each format in use should be available for review. Legibility and
completeness of demographic information are key issues.
College of American Pathologists
Laboratory Accreditation Manual
Page 23
Inspector Information
Computer-Generated Reports: The laboratory's computer system should be able to identify each
individual contributing to or editing the printed released result. The data must be secure and the
backup system functional. If reference laboratory data are transcribed, the identity of the original
laboratory must be retained. Electronic signatures are permissible if the pathologist has
personally verified the result.
Review of Results: A routine system must be in operation to detect clerical errors or unusual
laboratory results, and to provide for timely correction of those errors. Computer systems that
report data are not exempt from this review. The review mechanism must be described in the
quality control policies and procedures.
Record Retention: Specimen requisitions (including the patient chart or medical record only if
used as the requisition), patient test results and reports, instrument printouts, accession records,
quality control records, proficiency testing records, and quality improvement records must be
retained for two years. Instrument maintenance records must be retained for the life of the
instrument.
Serum and body fluid specimens (excluding urines) must be retained for 24 hours. Blood films,
permanently stained body fluid slides, and microbiology slides must be retained for 7 days.
Additional detailed requirements or recommendations are found in section-specific Checklists.
Any deficiencies noted by the inspector must be detailed in the ISR.
For data transmitted by computer interface (on-line system), it is not necessary to retain paper
worksheets, printouts, etc., so long as the computer retains the data for at least two years.
Manual entry of patient result data requires that all worksheets, printouts, etc. are retained by the
laboratory for at least two years.
Self-Evaluation Documentation: Laboratories inspected for re-accreditation must have
conducted a self-inspection the previous year. The laboratory director must present
documentation validating the occurrence of the self-inspection. If any Phase II deficiencies were
found, the laboratory must have documentation of the corrective actions that were taken at that
time.
College of American Pathologists
Laboratory Accreditation Manual
Page 24
Inspector Information
Conducting the Safety Inspection
Introduction: Checklist questions are based upon current understanding of hazard control and
common sense. Many items have been included to help the laboratory to comply with federal
regulations. The inspector must be familiar with these regulations to provide proper consultation
to the laboratory and uncover potential violations of regulatory code. It is important that no
instance of non-compliance with such regulations is overlooked during a CAP inspection.
Most safety items are contained in the Laboratory General Checklist. All items are to be
considered when individual departments and specialty sections are inspected and evaluated.
When a team inspects the laboratory, each member of the team must inspect for safety hazards
that portion of the laboratory for which he/she is responsible. Each specialty Checklist also has a
safety question that should be used to help specify the area where attention is needed. The
observations should be detailed in the Inspector’s Summation Report Part B.
General Safety: Safety program policies must be documented. Procedures should be posted or
otherwise available to all employees. Instruction in these safe work practices should be a
documented part of new employee orientation. The inspector should review the documented
safety manual for completeness. Several items should be selected from the safety manual for
interviewing an employee regarding knowledge about safety issues. By law, the laboratory must
report serious accidents and illnesses to the Occupational Safety and Health Administration
(OSHA)1, but all injuries that require medical treatment or time lost from work should be
reviewed as part of the laboratory's QA program. This includes every needlestick requiring
treatment with Immune Serum Globulin or Hepatitis B Immune Globulin. An inspector should
ask about recent injuries or occupational illnesses and review the adequacy of the documented
follow-up.
Fire Protection: National Fire Protection Association (NFPA) documents are used as references
for fire prevention and preparedness questions.
An accredited laboratory must: (1) have an automatic fire extinguishing system; or (2) be
separated from a contiguous inpatient facility by fire-resistant construction that has a minimum
rating of two hours and class B self-closing door assemblies rated at three-quarter hours; or (3) be
located in buildings classified as "business occupancy." In all cases, a fire bell, public address
system, or other alarm system must be audible in all sections. This includes lavatories,
darkrooms, storage areas, and offices. Ask employees if there are areas in which the alarm
system is difficult to hear. If there is any area where the alarm is inaudible cite a deficiency. If
there is any doubt as to the arrangement of the laboratory area or applicability to fire codes, the
inspector should ask to see documentation that the local fire authorities have approved the
current arrangement.
1
29CFR 1904.8
College of American Pathologists
Laboratory Accreditation Manual
Page 25
Inspector Information
Fire drills must be held at a frequency so that all laboratory personnel, from all areas and on all
shifts, participate at least once per year. Drills need not be noisy affairs that disturb patients, nor
empty the laboratory of all employees. Orderly, walk-through drills that involve different groups
of employees at varying times are acceptable.
Class B portable fire extinguishers must be located in all areas where flammable or combustible
liquids are stored or handled. There must be documentation that personnel have been properly
trained in the use of these devices. The inspector should note the details of the fire extinguishing
devices in the ISR if the type of device, or its location, is in question.
Ignitable liquids must be stored properly. Up to two gallons may be stored, per 100 square feet
of space, if contained within flammable liquid storage cans or safety cabinets. Up to one gallon
per 100 square feet may be stored if the material is stored outside of safety cans and cabinets. Up
to four gallons per 100 square feet may be stored in laboratories with sprinkler systems. Safety
cabinets may be unvented or vented to the outdoors. If unvented, the bung caps must be in the
venting ports. If vented to the outdoors, ventilation ducts must be explosion proof.
Electrical Hazards: All laboratory instruments and appliances should be adequately grounded
and checked for current leakage before initial use, after repair or modification, and when a
problem is suspected. Those that are double insulated are exempted. All electrical outlets in
technical work areas should be checked at least annually for ground integrity, and records of
these checks should be maintained. Tasks may be delegated to biomedical and electrical
engineers, however, documentation must be present on inspection day, or a deficiency should be
cited.
Chemical Hazards: The hazards of all dangerous chemicals used in the laboratory must be
contained. The director must have a comprehensive signage and labeling system in use and
applied throughout the laboratory. Each hazardous chemical must be labeled with the type of
hazard and what to do if accidental contact occurs. Any container regardless of size must be
properly labeled. Material safety data sheets (MSDS) must be on file for each hazardous
chemical, and the location of the MSDS file should be conspicuously posted for the employees'
benefit.2 The inspector should select one or two hazardous chemicals found in the laboratory and
question an appropriate employee about the safe work practices that relate to that substance.
2
29 CFR 1910,1200
College of American Pathologists
Laboratory Accreditation Manual
Page 26
Inspector Information
OSHA requires each laboratory to develop a comprehensive, documented Chemical Hygiene
Plan (CHP).3 All chemicals regardless of type of risk, volume, or concentration, must be
included in the CHP. A separate CHP for each chemical is not required, but the pertinent
portions of the CHP should be identified. The plan should define storage requirements, handling
procedures (including requirements for personal protective equipment), location of OSHAapproved MSDS (and other pertinent references), and the medical procedures to be followed if
contact or overexposure occur. Monitoring of vapor levels is required initially and whenever
there is reason to believe that safe levels are routinely exceeded. Indications for monitoring must
be defined in the CHP. The CHP must specify the clinical signs and symptoms or the
environmental conditions (such as a spill) that would indicate that overexposure has occurred.
When such conditions exist, the CHP should describe the medical attention that will be provided.
There should be evidence that the plan is reviewed annually for its effectiveness and that it is part
of new-employee orientation and continuing education programs.
Chemical carcinogens, reproductive toxins, and other severely toxic chemicals are special
concerns. The laboratory must be surveyed annually for the presence of carcinogenic and
potentially carcinogenic chemicals. This includes any chemical for which OSHA has specific
occupational regulations.4 (Formaldehyde, ethylene oxide, benzidine, and benzene are examples
in this group that are reasonably likely to be found in laboratories.) The regulations also apply to
any chemical that is believed to be potentially carcinogenic. For practical purposes, this includes
any substance so identified by the National Toxicology Program or by the International Agency
for Research on Cancer. The director or designee must have gone through this exercise before the
inspection, and a deficiency should be cited if there is no documentation that such a review has
taken place.
Personal protective equipment (PPE) appropriate to each hazardous task must be provided and its
use must be mandated where appropriate. Such items include face shields, aprons, and gloves
constructed of materials appropriate to the type of chemical handled. There should be a safety
shower or other emergency source of water in any area in which quantities of concentrated
caustics are manipulated. Piped eyewash fountains or the equivalent should be present. It is a
deficiency if this equipment is present but access to it is obstructed. Chemical fume control
devices such as hoods must be checked annually for proper function.
3
4
29 CFR 1910,1450
29 CFR 1910,1001-1047
College of American Pathologists
Laboratory Accreditation Manual
Page 27
Inspector Information
OSHA requires all workers to be protected from dangerous levels of vapors and dusts. Regulated
substances are listed in 29 CFR 1910, Subpart Z. Formaldehyde vapor is the most likely air
contaminant to exceed the regulatory threshold in the clinical laboratory. Current OSHA
regulations require vapor levels not to exceed 0.75 ppm (measured as an 8-hour, time-weighted
average [TWA]) and 2.0 ppm (measured as a 15-minute, short-term exposure). OSHA requires
monitoring for formaldehyde vapor wherever formaldehyde is used in the workplace. The
laboratory must have evidence, at the time of the inspection, that formaldehyde vapor levels have
been measured, and that both 8-hour and 15-minute exposures must have been determined. If
each is below the permissible exposure limit and the 8-hour measurement is below 0.5 ppm, no
further monitoring is required if laboratory procedures remain constant. If the 0.5 ppm 8-hour
TWA or the 2.0 ppm 15-minute level is exceeded, however, monitoring must be repeated
semiannually. If either the 0.75 ppm 8-hour TWA or the 2.0 ppm 15-minute level is exceeded,
employees are required to wear respirators.
Accidental skin contact with aqueous formaldehyde must be avoided with the use of proper
clothing and equipment. Inspectors should cite a deficiency if compliance with any of these
requirements is lacking, doubtful, or even unclear.
Warning signs must be posted where significant hazards exist. NFPA 704, the standardized
hazard identification system for fire protection, should be found on access doors to the laboratory
and on the outside of storage closets and cabinets, unless local fire authorities have recommended
otherwise. Reagent vessels containing hazardous substances should be labeled appropriately.
Microbiologic Hazards: A system of universal precautions against the infectious hazards of
blood and body fluids must exist. OSHA requires that all employees whose work involves the
potential for contact with such substances to be properly educated in universal or standard
precautions. Those whose work likely involves contact with body substances must use gloves
and other appropriate personal protective devices. This may include phlebotomist and most
technologist functions. The inspector should cite a deficiency if the use of gloves or any other
item commonly associated with universal precautions is not part of the laboratory's practice.
Glove must fit properly. Cleaning and disinfecting of disposable gloves for reuse is prohibited.
Gloves, aprons, or lab coats and protective eyewear must be provided and are required for those
activities likely to splash the skin. Non-latex or powder free latex gloves are recommended to
prevent hypersensitivity reactions to latex proteins.
College of American Pathologists
Laboratory Accreditation Manual
Page 28
Inspector Information
The laboratory should have developed policies and procedures for assessing the occupational risk
associated with exposure to infectious agents handled in the microbiology laboratory. The four
biosafety levels for working with infectious agents are described in the CDC-NIH guideline
(Biosafety in Microbiological and Biomedical Laboratories, U.S. Dept. of Health and Human
Services, Third Edition, 1993). The laboratory should assess the biosafety level in which it
operates and have policies, procedures, and work practice controls appropriate to that level.
Laboratory procedures should specify additional precautions if the level of hazard is especially
severe. For example, extraordinary precautions must be specified within the procedure manual
for surgical pathology specimens and autopsies on patients with Creutzfeldt – Jakob disease or an
undiagnosed encephalopathy.
A functional biological safety cabinet (BSC) must be in use when culturing mycobacteria, fungi
and viruses. Biosafety in Microbiological and Biomedical Laboratories5 has an extensive
discussion of cabinet types and their requirements. The inspector must answer: "Does the
laboratory have the appropriate equipment in use?" and "Does the equipment function as
intended?" The inspector must cite a deficiency when the equipment is present but not regularly
used by the personnel for the task intended. Each BSC must be certified annually, normally by
an outside vendor because of the specialized equipment required. The inspector should review
the records to ensure that the annual inspection included filter checks, flow rate measurements,
and tests for seam integrity. Filters need not be replaced annually, only as needed (usually every
five years).
Waste Disposal: The method for the disposal of all solid and liquid waste must be in compliance
with applicable local, state, and federal regulations. The laboratory must have documentation of
review of the applicable codes.
Federal regulations for chemical waste disposal vary depending on the regulatory status of the
facility. Every clinical laboratory is a hazardous chemical waste generator, but only those that
are part of a facility that generates more than 100 kg of such waste per month have significant
documentary requirements. Many laboratories will also be classified as "hazardous waste storage
facilities" if waste chemicals remain on site more than 90 days. Others are "hazardous waste
disposal facilities" if they manage the final disposition of those wastes as well. The entire
program must be reviewed annually. There should be an ongoing program for hazardous waste
minimization. The Environmental Protection Agency regulates the disposal of biohazardous
waste such as specimen collection tubes, tissues, and bacteriologic cultures. In general, all such
waste must be either incinerated or disinfected before burial in a sanitary landfill. All sharps,
especially those contaminated with potentially infectious materials, must be properly discarded in
puncture-resistant containers with tightly fitted lids.
5
HHS publication, 1993 stock #017-040-00523-7
College of American Pathologists
Laboratory Accreditation Manual
Page 29
Inspector Information
The inspector should review the laboratory's documented policies and procedures for waste
disposal and cite the laboratory if the manual lacks appropriate detail or omits important items.
Technologists should be questioned regarding the segregation of wastes by hazard class at the
point of generation to determine whether they understand the facility's policy. An inspector
should visit the collection point at which wastes are collected for transportation to an offsite
facility or for final disposition and try to determine the director's understanding of the final
handling of all hazardous wastes. The generator retains "cradle-to-grave" responsibility for any
damage to the environment that follows mismanagement of the facility's waste.
Radioactive Hazards: Laboratories using radionuclides must manage them in a responsible
manner. The inspector should begin this portion of the inspection by review of the radiation
safety manual. The Checklist provides a series of questions against which this manual must be
compared. The Laboratory General Checklist prompts an inspector to review policies and
procedures for radiation safety and to review personnel records for documentation of radiation
exposure when indicated.
The inspector should ask to see the facility’s radiation license. The laboratory may be regulated
under a general license 6 if the facility uses only small amounts of radioactive materials. This is
commonly the case when the only contact with radionuclides is with commercially prepared kits
for radioligand analysis. Alternatively, the facility may hold a specific license granted to it by the
Nuclear Regulatory Commission. A specific license has all the elements of a general license as
well as additional items that have been tailored to the requirements of that facility. The Special
Chemistry Checklist should be used as guide to inspect laboratories using radionuclides. The
Checklist itemizes several questions that commonly apply to facilities with a specific license,
however the inspector should inspect such a facility according to the actual requirements listed
in that specific license.
A specific question in the surgical pathology section of the Anatomic Pathology Checklist
addresses specimens that contain radioactive material.
Disaster Preparedness: The laboratory safety manual must have a section on "Internal and
External Disaster Preparedness." A series of policies and procedures must be available to be
followed in the event of a catastrophe such as fire, flood, electrical outage, or spill of hazardous
volatiles (internal disaster) or a tornado, earthquake, or other mass-casualty situation (external
disaster). The form that this portion of the safety manual takes is unique to each laboratory. The
inspector should not hesitate to cite a deficiency if it is believed that the laboratory's documented
plans are inadequate.
6
10CFR31.11
College of American Pathologists
Laboratory Accreditation Manual
Page 30
Inspector Information
Hematology and Coagulation
Automated Blood Cell Counting: The laboratory must have a documented, detailed procedure
for calibration of automated complete blood count (CBC) instruments, including indications
from the quality control system of when recalibration is needed. Calibration techniques may
include the use of fresh whole blood specimens or stabilized commercial preparations. Value
assignment to calibrators, either by primary reference methods or by verification of
manufacturers' assigned values, is essential to obtaining accurate results. Commercial materials
marketed as controls may lack the careful value assignments of those sold as calibrators. If nonadjustable, precalibrated instruments are used, calibration must be verified with appropriate
control materials.
Procedures for daily quality control may include any combination of the following three
approaches, with tolerance limits defined:
1. Processing of stabilized commercial control materials. Two different concentrations
(preferably normal and high) are required for each 8 hours of patient testing; there is no
requirement for 3 control levels. The laboratory should plot standard Levy-Jennings graphs
with control limits and apply at least some Westgard multi-rule criteria for determining if
results are analytically acceptable. It is important for the laboratory to not confuse package
insert values for expected recovery range with ± 2 S.D. limits based on their own instrument's
between day imprecision. There is no requirement for three control levels, and the use of
dilute low particle concentration controls is discouraged.
2. Retained patient specimens. While traditionally applied to CBC instruments, this approach is
only valid if there are defined limits of numeric agreement for each parameter between
successive samplings.
3. Moving average algorithm for erythrocyte indices and other parameters. The laboratory
should set limits that are sensitive to significant alterations in calibration status, yet
insensitive to minor fluctuations in patient population values.
Fluids used with CBC instruments must be periodically checked for contamination by performing
background counts on the instrument. Since nucleated erythrocytes and blood megakaryocytes
may have an additive effect on the instrument leukocyte count, appropriate count correction
procedures must be present for these constituents. There also must be protocols for common
interferences that may affect the accuracy of CBC data, such as lipemia, in-vitro hemolysis,
microclots, cold agglutinins, rouleaux, etc. Patient results that exceed laboratory defined
reportable limits must be verified (e.g., cytopenic samples should be checked against
hemocytometry or blood film estimates).
College of American Pathologists
Laboratory Accreditation Manual
Page 31
Inspector Information
Automated Differential Counters: Such instruments must be carefully evaluated against
previous patient-testing methods, before being placed in service. Quality control options include
periodic comparisons with manual differentials or processing of commercial control materials
with at least two different classes of leukocytes or WBC surrogates. The laboratory must have
criteria for checking and reviewing leukocyte differential counter data, histograms, and/or blood
smears, which have clinically important results flagged by the automated counter.
Manual Blood Films: There must be documented criteria for review of blood films with
specified abnormalities by the pathologist, supervisor or other technologist qualified in
hematomorphology. The laboratory should have a system that ensures that all personnel report
microscopic morphology in a similar fashion. Suggested methods to accomplish this include:

Circulation of blood films with defined leukocyte differential distributions and specific
qualitative abnormalities of each class of cells, and/or

Multi-headed microscopy, and/or

Use of blood or bone marrow photomicrographs with referee and consensus identifications,
such as those from previous CAP Surveys.
Automated Reticulocytes: For flow cytometric systems not using commercial kits approved by
the FDA, there should be evidence of evaluation of the strength and stability of the fluorescent
dye binding to RNA or DNA-RNA. The laboratory should have precision data for its automated
method, based on analysis of commercial controls or comparison with manual methods.
Documented criteria should be present for identifying samples that may give erroneous results
due to interferences (e.g., Howell-Jolly bodies, nucleated RBCs, basophilic stippling,
macrothrombocytes).
Manual Reticulocytes: To reduce imprecision of microscopic enumeration, the reported
reticulocyte concentration must be based on a minimum sample size of 1,000 red cells. Use of a
Miller disc is not mandatory.
Bone Marrow Preparations: The inspector must review bone marrow slides (routine and
cytochemical stains) to assess technical adequacy. If fixed tissue sections and aspirates are
independently evaluated by different sections of the laboratory, there must be a mechanism to
compare data and interpretations before reports are released by pathologists or qualified
hematologists.
Abnormal Hemoglobin Detection: If the laboratory uses alkaline cellulose acetate or isoelectric
focusing as a separatory technique, all abnormal bands must be verified by solubility testing, acid
agar electrophoresis, and/or HPLC, as appropriate. It is emphasized that solubility ("sickle")
testing alone is not appropriate as a stand-alone test for hemoglobinopathy screening or
evaluation.
College of American Pathologists
Laboratory Accreditation Manual
Page 32
Inspector Information
Coagulation Tests: If the laboratory is located in an acute care hospital, there must be a
sufficient menu of tests for routine and emergency testing to detect, evaluate, and monitor the
progress and therapy of the common disorders of coagulation. The tests should reflect
coagulation factor deficiency, coagulation factor inhibitors, accelerated fibrin(ogen)olysis and the
monitoring of anticoagulant therapy. Patient results should be reported with the accompanying
reference ranges. Appropriate controls (at least two levels) must be performed for all procedures
for each eight hours of patient testing. If factor assays are performed, the inspector should
examine sample assay data to determine that appropriate calibration points and two dilutions of
patient plasma are routinely used.
Clinical Chemistry
The Automated/General Chemistry Checklist is designed for laboratories that are providing
basic chemistry procedures.

The Blood Gas Checklist is used for stand-alone blood gas laboratories that are under a
different director, supervisor, location and/or CLIA number. If blood gases are performed in
the laboratory under the same CLIA number as the main laboratory, with the same laboratory
director and supervisor they may be inspected with the Automated Chemistry Checklist. The
Toxicology Checklist is required for laboratories performing testing for drugs of abuse.
Screening and confirmation procedures are addressed in this Checklist. Note: If the
laboratory is performing urine drug screens they must be inspected with this Checklist
regardless of methodology. The Toxicology Checklist contains sections for legal alcohol
and medicolegal drug-of-abuse testing. This Checklist is used for any non-medical testing
such as pre-employment drug screening, criminal justice system, custody decisions, law
enforcement, and medical examiner/coroner systems. The inspector must use the Checklist,
even if the laboratory is enrolled in the Forensic Urine Drug Testing program, to cover
positive screening results released unconfirmed per client request. The inspector should pay
particular attention to chain of custody documents, security of specimens and access to
forensic data in the laboratory computer system.
 The Special Chemistry Checklist addresses therapeutic drug monitoring regardless of
instrument or method, maternal alpha-fetoprotein testing, cystic fibrosis screening,
immunoassays, electrophoresis and gas, thin layer, and liquid chromatography. The Special
Chemistry Checklist is also used for immunoassay testing, such as for viral markers even if
the testing is done in another department.
The chemistry laboratory is usually the largest department in a full-service laboratory, and its test
repertoire is usually extensive. Time does not permit a detailed review of every procedure,
calibration of every pipette and thermometer, or an extensive review of every quality control
record. The emphasis should be selective, focusing on the areas of both highest and lowest
volume as well as on areas where test results most impact patient care, and on any apparent
problem areas. It is usually more instructive to review the records for 10 tests comprehensively
than to review the records for 50 tests superficially.
College of American Pathologists
Laboratory Accreditation Manual
Page 33
Inspector Information
Review of personnel qualifications, test repertoire and volumes, analytical systems, and quality
improvement/control methods will ensure a well-focused, meaningful inspection It is
imperative that the laboratory be enrolled in all appropriate proficiency testing programs,
including programs that cover infrequently tested analytes.
The proficiency testing program must be well documented and show evidence of appropriate
review, evaluation, and corrective action. It is important to evaluate the quality of data,
especially in view of the usual great quantity. Solicit proof that the system actually results in
useful "real time" data regarding the ongoing validity of the various analytical systems.
Questions regarding the procedure manual, specimen handling, result reporting, and controls and
standards follow. In no area of the clinical chemistry laboratory is the inspector's judgment more
important than in evaluating the adequacy of control specimens (type and frequency) for the
various analytical systems employed by that laboratory. Calibration, calibration verification and
reportable range verification records should be examined closely to ensure the analytical system
stability meets the claims of the instrument/reagent manufacturer. The laboratory must be able to
convincingly demonstrate ongoing system accuracy and stability. This is particularly important if
the laboratory has elected infrequent quality control for certain systems. If available, appropriate
multi-level control specimens must be used at least daily whenever patient specimens are run.
Blood gas analysis requires a minimum of two levels of controls each eight hours of operation.
Subsequent sections of the Checklist deal with such items as pipettes, glassware, instrument
maintenance, thermometers, centrifuges, analytical balances, spectrophotometers, and other basic
analytic systems. Depending on the sophistication and scope of testing of the laboratory, these
areas may or may not require close scrutiny. In general, if a laboratory employs such equipment
as primary analytical techniques, then adequate evaluation is mandatory. When such systems are
maintained for backup purposes and are infrequently employed, then evaluation should be
directed to adequacy of maintenance of the system for such backup purposes. Are policies and
procedures documented and adequate to describe the analytic performance characteristics that
must be present and documented before such a system can be used for patient testing?
The section in the Checklist devoted to Multiple Analysis Automated Instruments and Systems is
brief but important since these analyzers perform the bulk of the testing. The importance of "real
time" quality control with documentation of its appropriate use is especially critical with such
systems. Do the documented standard procedures for the "set up," operation, and control of the
systems provide adequate detail to ensure the integrity of the system?
Urinalysis and Clinical Microscopy
Specimens: Instructions must be provided for patients for proper collection of clean voided
specimens to avoid deterioration of constituents. Specimens must be examined within 1-2 hours
of collection unless properly preserved. Simple refrigeration may not be adequate, as it will not
prevent the lytic effects of low specific gravity on sediment elements and may induce crystal
formation.
College of American Pathologists
Laboratory Accreditation Manual
Page 34
Inspector Information
Manual Tests: Refractometer calibration must be periodically verified with at least two solutions
of known specific gravity. While the definition of a "complete" urinalysis is at the discretion of
the laboratory and dependent upon the population tested, the following chemical constituents are
considered important: glucose, protein, blood or hemoglobin, nitrite, and leukocyte esterase.
There should be documented criteria for when a routine urinalysis does not require sediment
microscopy. As sediment is commonly viewed without stains, microscopes must be in excellent
condition, and with Kohler illumination maintained for bright-field microscopy. Dipstick
findings should be correlated with microscopy. The laboratory should have a system that ensures
that all personnel report microscopy morphology in a similar fashion. Suggested methods to
accomplish this include:

Circulation of preserved urine sediments with defined abnormalities involving leukocytes,
erythrocytes, bacteria, yeast, etc., and/or

Multi-headed microscopy, and/or

Use of urine sediment photomicrographs with referee and consensus identifications, such as
those from former CAP Surveys.
Automated/Semi-automated Tests: There should be documented criteria for identifying urine
samples that may give erroneous results with a dipstick reader. Automated imaging systems
must be carefully compared with manual microscopy before use for patient reporting, and cell
count controls processed on each shift of patient testing.
Body Fluids: The procedure manual must address handling of partially clotted specimens, cell
clumps, or debris noted during hemocytometry or automated counting. For instrument counts,
the laboratory should have documentation of linearity studies and defined limits beyond which
instrument counts are not reliable. Differentials should always be performed on stained
preparations, and use of the cytocentrifuge is strongly recommended. As with blood film
morphology, there should be a system to ensure consistency of morphologic classification when
multiple personnel are responsible for smear examination. A pathologist or other qualified
physician must review body fluid preparations with suspected malignant cells.
Semen Analysis: This new section, introduced in 1999, covers basic semen testing; more
specialized requirements are found in the Reproductive Laboratory Checklist. In addition to the
application of the preceding requirements for Body Fluids, there is an emphasis on issues of
specimen collection, motility/viability assessment, and stained morphology classification.
College of American Pathologists
Laboratory Accreditation Manual
Page 35
Inspector Information
Microbiology
The Microbiology Checklist is divided into 5 subsections: bacteriology, mycobacteriology,
mycology, parasitology, and virology, as well as an initial general section applicable to all
subspecialties. Judgment is required on the part of the inspector to determine whether the level
of service is appropriate to the institution’s needs. Laboratories serving larger institutions will
likely provide all services for the subsections listed above. Smaller laboratories may still meet
the Standards by providing reliable preliminary screening and/or identification and then refer
specimens or cultures for more definitive analysis to a reference laboratory when necessary for
patient management.
Quality Control: This section includes quality control requirements for prepared and purchased
culture media, staining procedures, reagents, antimicrobial susceptibility tests, instruments, and
equipment. For each procedure, medium, reagent, item of equipment, etc. to be monitored, the
control methods should be defined, as well as the frequency of testing, limits for acceptability,
and action to be taken when not acceptable.
The inspector should note the following in regards to commercially prepared culture media:

The laboratory must ensure that all media used, whether purchased or prepared in-house by
the laboratory, are sterile, able to support growth appropriately, and are appropriately reactive
biochemically.
 For laboratories preparing their own media, it will be necessary to maintain stock or reference
organisms and to test the media before, or concurrently, with use. Explicit documentation of
such testing is essential and must be retained for at least two years.
 For prepared, purchased media the laboratory must have explicit documentation that each lot
of purchased medium is tested for sterility, ability to support growth of appropriate
organisms, and biochemical reactivity at the time of preparation, or concurrent with use in the
laboratory.
 Laboratories that rely on manufacturers’ quality control of media should have a copy of the
NCCLS document M-22-A2, Quality Assurance for Commercially Prepared Microbiological
Culture Media. The manufacturer or preparer must supply documentation to the user that its
quality control activities meet the NCCLS guidelines. For each lot, the preparer should
certify that quality control performance was acceptable and a record of the lot numbers for all
media is retained for at least two years. The user laboratory may record that fact in place of
the more detailed documentation of media performance.
 The user must visually examine each shipment for breakage, contamination, appearance, or
evidence of freezing or overheating.
College of American Pathologists
Laboratory Accreditation Manual
Page 36
Inspector Information
 The user must continue to test each lot of chocolate, Thayer-Martin, Martin-Lewis,
Campylobacter, and other media not listed specifically in M22-A2 as being exempt from such
testing, using quality control methods used for media manufactured in-house.
 In addition, each shipment or lot of a commercial identification system must be tested for
appropriate performance.
 The director is responsible for the quality and performance of media and must document all
media failures and the resultant corrective action taken.
 Quality control of antimicrobial susceptibility tests is accomplished by monitoring the
performance of the test system with appropriate reference control organisms. Control
organisms must be run with each new lot or batch of antimicrobials or media, and daily
thereafter. The frequency of test monitoring may be reduced to weekly if satisfactory daily
performance is documented. Whenever weekly tests yield unacceptable results, daily quality
control testing must be performed until the cause of the unacceptable results is determined
and resolution of the problem is documented.
Bacteriology: The inspectors’ discretion is necessary to evaluate a laboratory's protocols for
specimen work-up and identification of organisms and test systems. For example, no specific
requirements are listed for the extent of work-up of specimens such as sputum, urine, stools, and
wounds. Policies should be mutually acceptable to the medical staff and the laboratory.
Selection of antibiotics to be tested and reported with each antimicrobial susceptibility test
requires input from the pharmacy department and the medical staff.
The inspector should assess the adequacy of the blood culture system for detection of
microorganisms for the patient population. The laboratory should keep blood culture statistics to
include the number of true positive cultures and the number of contaminated cultures, as a
monitor of collection techniques in order to maintain a low level of contamination.
Mycobacteriology: The College of American Pathologists supports a policy that encourages
laboratories to use the most rapid and reliable methods available for detection and identification
of mycobacteria, especially M. tuberculosis. This is of particular importance in areas where the
incidence of tuberculosis is increasing. Questions relating to smears, processing, culture media,
identification, and susceptibility testing of mycobacteria are recent additions to the Checklist.
The inspector must assess the relevancy of these questions in view of the above stated incidence
of tuberculosis in the area being served.
Mycology: All staining procedures should be checked and results recorded for each new batch of
preparations, and at least daily against known positive and negative control organisms. For stains
such as Gomori methenamine silver, the slide itself serves as the negative control.
College of American Pathologists
Laboratory Accreditation Manual
Page 37
Inspector Information
Virology: The laboratory must have the appropriate media available for all of the virology
services that are performed in the laboratory. Media for this purpose are listed in the Checklist.
Parasitology: Concentration procedures and permanent stained preparations must be performed
on all stools submitted for parasitological microscopic examination. A microscopic examination
of liquid stools should include a direct wet mount if submitted fresh. Laboratories must have an
ocular micrometer available for determining the size of eggs, larvae, etc., and the micrometer
should be calibrated for the microscope in which it is used. The micrometer does not require
periodic checking if the optical path is unaltered.
Transfusion Medicine
The Transfusion Medicine Checklist is generally consistent with the current edition of the
Standards for Blood Banks and Transfusion Services of the American Association of Blood
Banks (AABB), as both documents represent good practices in this area. However, accreditation
by the AABB and the CAP are separate events. Therefore, if an AABB inspection is performed
simultaneously with a CAP inspection, all questions in the Transfusion Medicine Checklist must
still be addressed.
The emphasis in this section is on proper procedure in specimen handling, preparation, reagents
and controls, maintenance and procedure manuals, maintenance of instruments, and verification
and documentation of reagent performance. Quality control requirements are similar to those in
chemistry and diagnostic immunology, and for those laboratories performing molecular
diagnostic procedures, those Checklist requirements must also be met. For laboratories involved
in transplantation, the personnel and other requirements must meet federal requirements.
Component Accession and Disposition Records: The component records should be traceable
from inventory to disposition. It must be possible to account for every unit in the records,
including quarantine, ultimate disposition, wastage, and incineration. For transfusion services, it
must be possible to identify the patient receiving a given unit.
Technical Procedures: Blood typing and compatibility procedures should be directly observed
by the inspector to see if actual practice corresponds to the procedure manual.
Transfusion and Apheresis: Patient care activities should be observed with particular emphasis
on patient identification and blood component administration procedures. Those off-site
activities that interface directly with the laboratory, such as blood transfusion and maintenance of
remote refrigerators, should be observed as a measure of the effectiveness of laboratory
communication. Transfusion reaction records and similar clinical pathology consultation should
be reviewed carefully.
College of American Pathologists
Laboratory Accreditation Manual
Page 38
Inspector Information
Donor Procedures: If donors are drawn and/or units are processed at the facility, each step
should be evaluated, including the details of the donor interview, phlebotomy, and
storage/release/quarantine procedures. If infectious disease testing is done, the adequacy and
appropriateness of procedures should be reviewed, regardless of where in the facility this is
performed. If the facility is computerized, an evaluation of the adequacy of the procedures,
hardware, and software should be undertaken.
Immunology and Syphilis Serology
Positive and negative controls for qualitative tests must be run at least once on each day of
analysis, based on the manufacturer's recommendations. For quantitative tests, control samples
at more than one level must be run at least once each day of analysis. When results are reported
as “weakly” positive, a weakly positive control should be used.
New kits and reagents must be checked against old reagents to ensure comparable reactivity.
One common method for verification is the processing of matrix control materials used with the
old kit using the new reagents.
Certain immunologic reagent/kit systems include built-in controls. If such controls actually
measure reactivity and involve all components of the system such as antigen, complement and
antibody, external matrix controls may not be required, so long as the procedures are waived or
of moderate complexity under CLIA ’88. However, some systems include built-in controls that
involve only part of the testing process. If for example, the control in such a system produced a
color change without involving an antigen-antibody reaction and an analyte, it would not be an
adequate control of the method and would need to be supplemented with true external matrix
controls. The Checklist provides clarification of when controls must be evaluated.
Anatomic Pathology
The Anatomic Pathology Checklist covers general anatomic pathology, surgical pathology, the
histology laboratory, autopsy pathology, and electron microscopy. Cytopathology is covered by
the Cytopathology Checklist. In keeping with the general approach of the Laboratory
Accreditation Program, the inspector is expected to evaluate all aspects of quality control and
quality improvement in the various sections of anatomic pathology. The inspector will consider
procedural and technical activities (process or quality control), issues related to the professional
role of the pathologist (quality improvement) and an evaluation of the quality of the diagnostic
report (features of both quality control and quality improvement).
Quality Improvement Program: The preamble to this part of the Checklist designates the
activities that must be included. The design of the program is the responsibility of the laboratory
director. While the type of program will vary according to the staff size and the volume and type
of diagnostic material, the basic quality control/quality improvement principles of documented
description, organization, systematic review, documentation and communication must apply.
Practical suggestions for implementing and documenting the program can be found in the CAP
Quality Improvement Manual in Anatomic Pathology (CAP 1996).
College of American Pathologists
Laboratory Accreditation Manual
Page 39
Inspector Information
Quality Control: These questions address issues concerned with collection and accessioning of
specimens, the surgical specimen examination area, and procedures related to surgical specimen
examination. Although not solely a quality control issue, surgical consultation (rapid diagnosis
or frozen section) is addressed in this portion of the Checklist. Review of the quality of surgical
pathology reports is considered in this part as well, and the questions included address the need
for clear and concise gross descriptions that contain adequate information about the lesions
present. The final diagnosis should correlate with the descriptions, provide sufficient
information to contribute to patient management, and be available in a timely fashion. The
laboratory should have a mechanism to correlate the results of specialized studies (e.g., electron
microscopy, immunohistochemistry, nucleic acid probes, and cytogenetics) with the
morphological diagnosis.
Histology: Quality control items include evaluation of procedure manuals, histologic
preparations, special stains, (both histochemical and immunohistochemical), instruments, and
equipment. Questions pertaining to immunohistochemistry are included in this section. The
inspector should be aware that issues related to the use of positive and negative controls are
discussed in an explanatory note.
Safety questions emphasize the adequacy of ventilation in areas of specimen handling and
processing and the handling of infectious tissues and other contaminated materials, including
special precautions related to Creutzfeldt-Jacob disease.
Autopsy Pathology: Items emphasized include timely reporting of both preliminary and final
diagnostic findings, and policies regarding proper conduct of autopsies on patients with known or
suspected infectious diseases. In addition, the important quality assurance role of the autopsy
must be addressed. Quality improvement programs must consider both the quality of the
performance of the autopsy itself and the important role of the autopsy in the enhancement of the
quality of patient care.
Electron Microscopy: The initial part of this section is concerned with quality control issues
such as procedure manuals, specimen collection, specimen preparation, instruments and
equipment, reports, and records. This is followed by a review of the physical facilities and safety
items that pertain specifically to the electron microscopy service.
College of American Pathologists
Laboratory Accreditation Manual
Page 40
Inspector Information
Physical Facility: Special attention should be given to the suitability of space and environment
for microscopic study.
Because the sections of anatomic pathology ultimately deal with subjective, consultative medical
opinion, the inspector should recognize that different laboratories vary in their design and
implementation of overall quality improvement programs. It is important that the inspector not
insist on "my way" but rather make an effort to determine whether the programs and procedures
in place achieve the fundamental goal, to provide the referring physician with an accurate, timely,
and clinically relevant diagnostic report based on the interpretation of optimal technical
preparations.
Cytopathology
The inspector should be a pathologist and/or supervisor-qualified cytotechnologist actively
involved or experienced in the current practice of cytopathology and conversant with
contemporary quality improvement practices, as well as the CLIA '88 regulations pertinent to
cytopathology. In addition to the Checklist, it is helpful for the inspector to review the CAP
Quality Improvement Manual in Anatomic Pathology and the CLIA regulations (e.g., the
CAP/ASCP summary of the Final Rules). The inspector should plan to spend several hours
inspecting the cytopathology section regardless of case volume. The on-site inspection will
require documented review of case (slide) material, direct observation of technical procedures,
and careful review of quality improvement practices. The inspection process should confirm
compliance with each Checklist item pertinent to the laboratory.
Personnel and Screening: The inspector should review the qualifications of the pathologist
director (technical supervisor), supervisor (pathologist or cytotechnologist), and
cytotechnologists, and assess documentation of performance of their respective responsibilities,
as outlined in the Checklist.
The importance of the screening process should be considered. Sufficient qualified personnel
and space should be available to handle the case volume and variety. The inspector should
evaluate whether the facility provides adequate space and a suitable environment for screening.
Although CLIA '88 establishes maximum workload limits, the laboratory director is obligated to
establish individual workloads, as indicated in the Checklist. The inspector should review the
documented workload policy, documentation of the periodic determination of workload for
individuals who screen slides, and the daily documentation of slides screened by each individual.
Procedure Manual: The inspector should observe procedures for specimen accession and
processing, staining, screening, hierarchic review, preparation of reports, and storage and
retrieval of slides. Each of these activities should correspond to the laboratory's documented
procedures. During specimen accession and processing, the adequacy of safety measures should
be evaluated.
College of American Pathologists
Laboratory Accreditation Manual
Page 41
Inspector Information
Criteria should be documented and implemented for rejection of specimens and for classification
of specimens as unsatisfactory, and procedures should address notification of the submitting
physician in these cases. Measures for prevention of cross-contamination of specimens should
be included in processing/staining procedures. Case management procedures should cover the
screening process and specify criteria for rescreening and pathologist review. Documented
policies and procedures must be in place for issuing of reports, including amended reports when
indicated, for ensuring communication of findings to the submitting physician (especially crucial
and complex findings), and retention and retrieval of reports and slides. Cytopathologic findings
should be reported using standard descriptive diagnostic terminology. The use of a "class"
system is insufficient for both negative and abnormal findings.
On-site Case Review: An important component of the inspection of cytology is an on-site review
of actual case (slide) material. The on-site review of cases offers an opportunity for the inspector
to assess the laboratory's overall processes. The inspector should request a selection of
gynecologic, fine needle aspiration and other nongynecologic cases, including negatives and
abnormals. The cases should be selected in advance of the inspection and in a random manner
defined by the team leader. The review should encompass the requisition, laboratory worksheets,
information available to the cytotechnologist and/or pathologist at the time the case was
evaluated (e.g., clinical data, laboratory records of previous or concurrent specimens), the slides,
and the preliminary and final reports of the reviewed cases.
The on-site review is designed for process evaluation, not as a comprehensive rescreening or
assessment of competence. The inspector must complete the slide review chart in the ISR.
If there are believed to be clinically significant diagnostic discrepancies, these should be
discussed by the pathologist inspection team leader with the laboratory director. For the purpose
of this review interpretations may be considered discrepant if they are not in the same series of
the diagnostic menu of the CAP PAP Program (e.g.,“100 series” vs. “200 series”). Cases
considered to be “satisfactory but limited” or ASCUS/AGUS either by the inspector or inspectee
should not be considered in the analysis to determine significant discrepancies because of current
lack of interlaboratory reproducibility of the categories.
Quality Improvement: The facility's QI program should address the validation of both normal
and abnormal diagnoses and the assessment of laboratory and personnel performance.
Quality measures for abnormal findings should include such activities as peer and hierarchic
review, correlation of cytologic findings with histologic and clinical findings, documented
evaluation of significant discrepancies, and appropriate use of intradepartmental and
extradepartmental consultation.
College of American Pathologists
Laboratory Accreditation Manual
Page 42
Inspector Information
Evaluation of the quality of negative findings is more difficult, but is very important in reducing
the likelihood of a false negative report. Routine evaluation of specimen adequacy is essential to
ensure that diagnostic interpretations are not reported on unsatisfactory specimens. Among other
useful techniques are retrospective review of previous material whenever a new significant
abnormality is identified and prospective rescreening of negative cases. At least 10 percent of
gynecologic cases screened as negative by a cytotechnologist must be prospectively rescreened
by an individual qualified to be a cytology supervisor. Rescreened slides must include both
randomly selected and high-risk cases. Rescreening of random negative specimens enables
monitoring of false negative fractions, whereas rescreening of specimens from "high-risk"
patients is more likely to identify abnormalities. The documented rescreening program must
include negative gynecological smears received within five years of a new high-grade
intraepithelial lesion or cancer diagnosis, if applicable.
The inspector should assess the procedures for rescreening and hierarchic review, including
criteria for case selection (e.g., identification of "high risk" and retrospective review specimens)
and provision of feedback to the original screener. The statistical records for gynecologic and
nongynecologic specimens should be reviewed; benchmarking data from CAP interlaboratory
comparison programs are useful in evaluating the laboratory's statistical results.
Educational opportunities should also be appraised. A laboratory that examines gynecologic
specimens must be enrolled in the CAP Interlaboratory Comparison Program in Cervicovaginal
Cytology (PAP) or a CAP approved glass slide program that evaluates the laboratory employee
performance. Other internal or external programs may be utilized to meet further educational
and personnel evaluation needs appropriate to the laboratory's scope of practice.
All quality surveillance activities should be documented, with evidence of review and evaluation.
Findings should be shared with the responsible pathologists and cytotechnologists. Results
should be incorporated into revisions of policies, procedures, and personnel assignments and
workload.
Practical suggestions for implementing and documenting these and other measures can be found
in the CAP Quality Improvement Manual in Anatomic Pathology.
Cytogenetics
Laboratories that provide cytogenetic services should be inspected by a qualified cytogeneticist.
The inspection team leader should consult with the State or Regional Commissioner, if one
cannot be found. The Laboratory Accreditation Department can suggest a cytogeneticist that the
team leader can call to add appropriate expertise to the team.
College of American Pathologists
Laboratory Accreditation Manual
Page 43
Inspector Information
The inspector must review at least 10 completed cases. The slides should be well prepared and
banded. The documented (paper or electronic) trail of an analysis from accession to final report
should be followed to verify its coherence. The final interpretation should be substantiated by
the photographs and other records. Statistically significant cell sample sizes must be used.
Verbal, preliminary reports must be documented on the final report and reports issued
appropriately using the International System for Human Cytogenetic Nomenclature (I.S.C.N.).
Histocompatibility
The emphasis in this section is on proper procedure in specimen handling, and preparation of
reagents and controls with verification and documentation of reagent performance. Quality
control requirements are similar to those in chemistry and diagnostic immunology in regard to
procedure manuals and instrument maintenance. Personnel qualifications must meet federal
requirements relating to transplantation.
It is important that the inspector verify that the laboratory participates in approved proficiency
testing programs.
Flow Cytometry
This Checklist includes DNA content and cell cycle analysis. The laboratory must document the
optical alignment, instrument sensitivity, and run fluorescent beads daily. All reagents must be
used within the manufacturer’s stated expiration date. Regional and State Commissioners and
the Laboratory Accreditation Department have names of individuals who have expertise in this
area who have volunteered as inspectors.
Molecular Pathology
Techniques not requiring amplification may be inspected using other discipline specific
Checklists. Regional and State Commissioners and the Laboratory Accreditation Department
have names of individuals who have expertise in this area who have volunteered as inspectors.
Point of Care Testing
This Checklist is used for inspection of testing that is performed outside the physical facilities of
the clinical laboratory, in non-dedicated space, within an institution (examples are bedside
and/or ward testing). The testing is typically performed by nurses and other personnel without
formal laboratory science backgrounds. The laboratory is encouraged to centralize coordination
of the point of care testing program with laboratory personnel responsible for monitoring of
testing procedures, QC, and the training of the individuals who perform the tests.
Point of Care Testing (POCT) is inspected in conjunction with the inspection of the main clinical
laboratory as an additional Checklist section. However, POCT is inspected as a separate
additional Special Function Laboratory when under a different directorship and CLIA number
than the main laboratory.
College of American Pathologists
Laboratory Accreditation Manual
Page 44
Inspector Information

When POCT records are maintained in a central location under one supervisor, use only one
copy of the Point of Care Checklist and visit a few sites to review compliance.

If POCT records are decentralized, a Checklist for each location must be used and each site
inspected separately. An additional fee is charged for each inspection site.
College of American Pathologists
Laboratory Accreditation Manual
Page 45
Inspector Information
Laboratory Information
INSPECTING OTHER TYPES OF LABORATORIES
Special Function Laboratories





Special function laboratories are administered independently of the main clinical laboratory,
employ few personnel and are dedicated to the performance of a highly select group of
clinical procedures. Examples of Special Function laboratories include blood gases
performed by respiratory therapy and special hematology analyses in pediatrics.
At least two Checklists are required: Laboratory General plus the Checklist
appropriate to the specific function(s). The inspection team leader schedules the
inspection concurrently with the main laboratory inspection and contacts all directors to
notify them of the inspection date.
Special function laboratories may request their own Summation Conference.
The special function laboratory and main laboratory accreditation process and decision are
made independently.
The hospital administrator and client members of the medical staff will be interviewed for
every special function laboratory within a hospital.
Affiliated Laboratories




Affiliated laboratories are located at physically separate sites but are affiliated by
management and/or ownership.
Each site is considered a separate laboratory with separate inspection fees, materials,
Checklists and each site will receive a separate certificate of accreditation.
Examples of affiliated laboratories are: a.) two or more merged hospitals that provide some
services at each site. Often one site is designated as full service and the other is rapid turn
around; b.) a large commercial laboratory that has branches in different geographic locations;
or c.) remote limited service or special function laboratories.
The inspection team leader needs to take into consideration the location of these
laboratories when they are inspected at the same time as a laboratory with which they
are associated, in order to allow time for the inspection and arrange for transportation
if necessary.
System Inspection Option



The system option for laboratory accreditation provides Medical Directors the choice to have
multiple laboratories inspected by one team of inspectors using the same Checklists within a
few days of each other.
This provides the opportunity for coordinated preparation and development of common
strategies to comply with the CAP requirements. This initiative allows key personnel with
responsibilities at multiple sites to participate in onsite inspections.
Laboratories may express an interest in the Systems initiative at any time during the
accreditation cycle, however six months before an accredited laboratory’s anniversary date is
preferred to allow ample time for coordination of multiple laboratories.
College of American Pathologists
Laboratory Accreditation Manual
Page 46
Inspector Information
Laboratory Information

For further information, please contact the Laboratory Accreditation Program at 1-800-3234040, extension 6065, 847-832-7000, extension 6065, or visit our Web Site at www.cap.org.
Satellite Laboratories




Satellite laboratories are usually small branch laboratories that are affiliated with, but not
physically located at the same address as the central laboratory.
In most cases, the services that are provided correspond with the Limited Service Laboratory
Checklist.
Separate fees, inspection materials and Checklists are required.
This inspection can occur concurrent with the main laboratory inspection. The
inspection team leader needs to take into consideration the location of the satellite
laboratories when they are inspected at the same time as a laboratory with which they
are associated, in order to allow time for the inspection and arrange for transportation
if necessary.
Staff Inspected Laboratories


The Laboratory Accreditation Program’s new Expanded Eligibility Criteria were created to
encompass satellite laboratories that previously did not meet the criteria for LAP
accreditation. Under the new criteria, satellite and special function laboratories may now
qualify for CAP accreditation if they are affiliated with a currently accredited laboratory
through either directorship, ownership, or administration, regardless of the distance from the
accredited laboratory. This allows the institution to have consistency in all laboratories. by
using the same accrediting organization.
This program is in keeping with the College’s philosophy of peer review by using CAP
employed Medical Technologists to review affiliated laboratories that are often performing
limited testing and have limited oversight by a pathologist.
Limited Service Laboratory



The Limited Service Checklist is provided as a convenience when inspecting a laboratory or a
laboratory section whose scope of services is confined to a small number of commonly
performed tests covering multiple disciplines. It relieves the inspector of the burden of
completing multiple Checklists during on-site visits to such laboratories.
The Master Activity Menu is divided into a basic list and an extended list of reportable
assays. Limited Service Checklist usage is determined by the selection of Reportable Assays
– Basic List (only) within a subdiscipline. If assays are selected from the basic list and the
extended list of reportable assays the discipline specific Checklist must be used.
The Limited Service Checklist CANNOT be used alone if toxicology, anatomic pathology,
cytopathology, flow cytometry, molecular pathology, histocompatibility, cytogenetics, or
point of care testing are performed.
College of American Pathologists
Laboratory Accreditation Manual
Page 47
Inspector Information
Laboratory Information

No more than two additional discipline-specific Checklists may be used with the Limited
Service Checklist (The Point of Care Checklist is not considered an additional disciplinespecific checklist). If additional discipline-specific Checklists are needed, then only
discipline-specific Checklists will be used, rather than the Limited Service Laboratory
Checklist.
College of American Pathologists
Laboratory Accreditation Manual
Page 48
Laboratory Information
THE SUMMATION CONFERENCE
Pre-Summation Team Meeting





The team leader should check that all appropriate sections and questions are complete, with
the correct deficiency numbers on the pink sheets, and are signed by the individual
inspectors.
Part B of the Inspector’s Summation Report (ISR) lists the Checklist number for the
deficiencies with a brief description of the reason for the deficiencies cited each page of
the pink form. The brief description should provide details on the nature of noncompliance. This is the official record of the inspection and must be readable for
accurate documentation and appropriate follow-up.
Recommendations should be cited separately
The team leader should review all findings privately with members of the inspection team
before the Summation Conference.
Cite the deficiencies in a straightforward manner and relate each to concrete information
gathered during the inspection process.
Summation Conference











Education and peer review are essential parts of this conference.
The findings from the inspection are reviewed with the director, supervisors and as many of
the technical staff as practical.
Invitations can also be extended to administrators and the chief of the medical staff.
The Summation Conference should open with a short review of the objectives of LAP.
The review covers all deficiencies that are listed in Part B of the ISR.
The director should find no surprises in the ISR. Findings should have been discussed with
the laboratory supervisors during the inspection.
If the laboratory can provide adequate documentation to remedy deficiencies before the
inspection concludes, such deficiencies are considered corrected and should not be
reported.
The post-inspection process is reviewed with the conference attendees. The inspection team
leader should remind the laboratory that deficiency responses and documentation of
corrective action must be submitted within 30 days of the inspection date, and that
there will NOT be a formal list of deficiencies sent from the College to initiate corrective
action and responses to the CAP.
Note: Prior to the inspection the laboratory should have received instructions on how to
respond to the inspection report. This information is also available by “Fax on Demand” (1800-323-4040, extension 6027 or 847-832-7000, extension 6027 , request document number
303).
There should be adequate time allowed to present findings and answer questions.
A copy of Part B of the ISR, which consists of the deficiencies and the recommendations is
left with the laboratory director.
College of American Pathologists
Laboratory Accreditation Manual
Page 49
Laboratory Information






Both the laboratory director and the inspection team leader must sign Part B of the
ISR.
The Summation Conference is an appropriate time to discuss improvement of the laboratory
in educational terms. A response and/or corrective action is not required for
recommendations, but should be reviewed as suggested improvements.
Phase I deficiencies require a documented response.
Phase II deficiencies require a documented response along with supporting
documentation.
Any unresolved differences concerning interpretation of standards or Checklists should be
addressed at this time. Unresolved differences should be documented in the ISR and left for
the Regional Commissioner to review.
Unresolved differences should be addressed by the laboratory director in the laboratory’s
documented response, along with supporting documentation demonstrating compliance
before the inspection. The challenged deficiencies are referred to the Regional
Commissioner for possible expungement from the record.
Concluding the Inspection
The Inspector should:
 thank the director for supporting the LAP process;
 recruit any director/pathologists for inspection team leaders and ask permission to forward
names to the Regional Commissioners;
 photocopy each page of the ISR Part B - leave the copy with the laboratory director and
place the original in the packet returned to the CAP;
 return the original ISR, CME, Team Member List Form, and Claim for Inspector
Reimbursement and signed state specific forms immediately in the prepaid UPS mailing
envelope. This mailer can only be used in the 48 contiguous states. Materials from
other inspections (example: foreign countries, Alaska) should be returned to the CAP
by the most reliable service available which is traceable;
 send a post inspection letter thanking the director for the laboratory’s hospitality.
The remaining steps in the accreditation process are performed by the College:
 The evaluation is based on many standards, performance, qualifications of personnel, QI and
QC programs, performance in the surveys program, etc. Using the information provided by
the inspector, the technical specialist evaluates the deficiency response for appropriateness
and completeness and forwards the information to the Regional Commissioner.
 The Regional Commissioner may request additional information or recommend accreditation.
 Accreditation is granted by the Commission on Laboratory Accreditation .
College of American Pathologists
Laboratory Accreditation Manual
Page 50
Laboratory Information

The laboratory then receives an Accreditation Packet by mail. This packet includes:
 Certificate of Accreditation
 Letter of accreditation with disciplines listed
 List of specialties/subspecialties that are accredited
 Final List of Deficiencies
 Press Release
College of American Pathologists
Laboratory Accreditation Manual
Page 51
Laboratory Information
THE INSPECTION REPORT
Inspector’s Summation Report (ISR)

Part A of the ISR is used to report any fundamental disparities between the intent of the
standards and the function of the laboratory or role of the director (this is confidential
information and does not go to the laboratory).
The inspector can write a separate confidential report when warranted, for review only by
the technical specialist, Regional Commissioner, and the next inspector.
The entire Commission reviews a laboratory's inspection report before denial (the
inspector’s confidential comments are pivotal in such decisions).
The ISR should include all correspondence with the laboratory.

Part B of the ISR includes the deficiencies cited and the recommendations from the team.
A copy of Part B of the ISR must be left with the laboratory director

If the inspector realizes something was left out of the ISR, a letter must be written to
CAP Northfield office explaining the addition, and a copy sent to the laboratory
director.
Team Member List Form

Return the team member form to the CAP Northfield office once the inspection has
been completed.
Expense Reimbursement

Return reimbursement expense claims for all team members to the CAP Northfield office
with the inspection packet.
The claim form includes instructions for expenses that are reimbursed, maximum allowable
expenses and receipt requirements.
Continuing Medical Education (CME)
CME forms are provided and may be completed by all team members. (California Medical
Technologists may apply the Summation Conference portion, 1-2 credit hours, toward their
requirements for California state licensure.)
The College of American Pathologists is accredited by the Accreditation Council for Continuing
Medical Education (ACCME) to sponsor continuing medical education for physicians.
College of American Pathologists
Laboratory Accreditation Manual
Page 52
Laboratory Information
The College designates this continuing medical education activity for up to 7 credit hours in
Category 1 of the Physician’s Recognition Award of the American Medical Association and
Category A1 of the Pathology Continuing Medical Education Award. Each physician should
claim only those hours of credit he/she actually spends in the educational activity.
This continuing medical laboratory education activity is recognized by the American Society of
Clinical Pathologists as meeting the criteria for up to 7 credit hours of CLME credit. ASCP
CLME credit hours are acceptable to meet the continuing education requirements for the ASCP
Board of Registry Continuing Competence Recognition Program.
AACC members may include inspection credits hours on their transcripts. Pathologists in
accredited laboratories may claim up to 100 hours of Category A-3 CME credit over a three-year
period towards the Pathology Continuing Medical Education Award.
The CME forms also provide information to help maintain the CAP inspector database.
Return of Inspection Packet

UPS pre-paid envelopes are provided for the return of the inspection report
Return in the folder:
Original Inspector’s Summation Report (ISR)
CME
Claim for Inspector Reimbursement
Team Member List Form
State specific forms, signed (if applicable)


Take the packet to your mail center for inclusion in your institution’s regular UPS pick-up or
delivery (excluding Hawaii, Alaska, or APO). If your institution does not use UPS, the
packet can be taken to a local UPS center, or you may call LAP operations (847-832-7000,
extension 6055 or 800-323-4040, extension 6055) for other options.
Provide an explanatory comment in the ISR if an inappropriate Checklist was present in the
inspection packet
College of American Pathologists
Laboratory Accreditation Manual
Page 53
Laboratory Information
POST INSPECTION PHASE
Laboratory Inspection Packet
Before the onsite inspection the lab will receive:
 detailed instructions for completing its response to any deficiencies cited during the
inspection.
 blank response sheet.
 a blank cover sheet to be signed by the laboratory director and returned with the response.
 Laboratory Specific Activity Menu for the laboratory’s review.
 Checklist Selection Report which will identify the Checklists that will be used at the on-site
inspection.
 Additional copies of the cover sheet and deficiency response sheets are available via the CAP
Fax Service at 800-323-4040, extension 6027 or 847-832-7000, extension 6027 (request
document 303).
The laboratory must return all responses and documentation of corrective action for
deficiencies listed in the ISR within 30 days following the inspection. Laboratories that do not
respond within 30 days will receive a certified reminder letter. Continued failure to respond may
result in recommendation for the denial or revocation of accreditation.
Phase I deficiencies are those that do not seriously affect the quality of patient care or
significantly endanger the welfare of the laboratory worker. Phase I deficiencies require
documented responses.
Phase II deficiencies are major deficiencies that may have a serious effect on the quality of
patient care or may affect the health and safety of hospital or laboratory personnel. All Phase II
deficiencies require a documented response and supporting documentation of corrective action,
that meets with the approval of the Commission on Laboratory Accreditation, before
accreditation is granted.
Examples of supporting documentation include policies and procedures, log sheets with evidence
of use, internal memos, photographs, sketches, purchase orders, and meeting minutes.
Organization of documentation materials should occur in the order the deficiencies were cited.
Each phase II deficiency should have its own supporting documentation. It is recommended that
policy and procedure changes be highlighted.
Laboratories are encouraged to use the most recent edition of each Checklist which is available
via the CAP Web site at www.cap.org. The Web site format includes not only Checklist
questions and explanatory text but also references which may be helpful in determining
corrective action. If you do not have access to the Web site, please call the Laboratory
Accreditation Program at 800-323-4040, extension 6055 or 847-832-7000, extension 6055 to
request a copy.
College of American Pathologists
Laboratory Accreditation Manual
Page 54
Laboratory Information
Packet Review
Upon return of the inspection packet from the inspection team leader to the CAP Northfield
office, an audit of the packet, and review of the ISR is performed by the laboratory accreditation
staff to ensure that the material is complete.
All deficiency responses and documentation of corrective action from the laboratory are
thoroughly reviewed by CAP technical staff.

If the laboratory wishes to challenge a particular citation, it must state in the documented
response what deficiency was cited in error and provide documentation that demonstrates
compliance before the time of inspection. Those deficiencies that have been approved for
removal by the Regional Commissioner will not appear on the final list of deficiencies and
are not part of the permanent laboratory record.
The inspection report is then forwarded to the Regional Commissioner. If the responses
adequately address the deficiencies, the Regional Commissioner will notify the laboratory that
accreditation is recommended.
Upon recommendation of accreditation:


The official accreditation letter is sent to the laboratory director with copies to the
administration where applicable.
The laboratory will receive a press release and a final list of deficiencies.
The laboratory should keep the final list of deficiencies on record for review by other
accrediting agencies (e.g., Joint Commission on Accreditation of Healthcare Organizations).
A copy of the list of deficiencies is included in the next inspection packet.
Immediate Review Criteria
Immediate review criteria flag a laboratory’s record for special follow up by the Regional
Commissioner. This occurs when a laboratory is cited with more than 5 percent of the total
possible Phase II deficiencies.
In the past, laboratories with such large numbers of deficiencies have had difficulty correcting
them within the allotted time. Following the review of these laboratories, the Regional
Commissioners take prompt and appropriate action.
Such action may involve one or more of the following:
 direct communication between the director and Commissioner to determine whether
correction is probable;
 a focused reinspection of the problem areas;
 denial of accreditation.
College of American Pathologists
Laboratory Accreditation Manual
Page 55
Laboratory Information
Accreditation
Accreditation is recommended by the Regional Commissioner and granted by the CLA when the
laboratory has provided acceptable documented responses to Phase I and Phase II deficiencies
and satisfactorily documented correction of all Phase II deficiencies.
Accreditation is valid for two years from the date of the first inspection and is renewable
every two years on the accreditation anniversary date.
Denial or Revocation
Accreditation is denied or revoked when the laboratory fails to correct Phase II deficiencies or
fails to meet the Standards for Laboratory Accreditation or any other requirement for continued
participation in the Laboratory Accreditation Program.
Laboratories with numerous deficiencies that cannot be corrected within a reasonable period of
time may be presented to the entire Commission on Laboratory Accreditation. Only the entire
Commission or executive committee may make the decision to deny or revoke accreditation.
New laboratories trying to achieve accreditation for the first time, if conditions warrant, may be
advised to withdraw and reapply at a later time.
Accredited laboratories formally denied accreditation will receive notification by certified mail.
Any agencies accepting CAP accreditation, such as the Health Care Financing Administration
(HCFA), will be notified.
Appeals
The laboratory may appeal the decision of denial or revocation within sixty days of receiving
documented notice of denial. A request for reconsideration shall not stay the denial of
accreditation. Request for information regarding appeal procedures should be directed to the
Regulatory Analyst in the Northfield office at 800-323-4040, extension 7471 or 847-832-7471.
College of American Pathologists
Laboratory Accreditation Manual
Page 56
Laboratory Information
Post-Inspection Critique
As part of on going quality assurance of the inspection process, the director will be asked to
evaluate the quality of the laboratory’s inspection on the post-inspection critique questionnaire.
The laboratory director and staff may offer comments or suggestions. When the questionnaires
are received in the Northfield office, copies are sent to the Education Commissioner, the
appropriate Regional and State Commissioners and the Director of the Laboratory Accreditation
Program. The inspector may call the State Commissioner for feedback regarding the inspection
critique.
The post-inspection critique provides an evaluation of the following processes:




Prompt processing of the application by the LAP office.
Performance of the inspection in a professional manner that supports the CAP's philosophy of
education and peer review.
Objective assessment by the inspection team in all Checklist areas.
Educational value of the inspection for the laboratory and staff.
College of American Pathologists
Laboratory Accreditation Manual
Page 57
Laboratory Information
MAINTAINING ACCREDITATION
Proficiency Testing Participation and Satisfactory Performance
Exceptions in proficiency testing participation and performance will be brought to the attention
of the accredited laboratory's director. Laboratories must respond in a timely manner (within 19
days) to any exceptions by identifying the cause of the exception and describing the action taken
to correct the exception.
Self-Evaluations
During the second year of the two-year accreditation cycle, laboratories complete a
mandatory self-evaluation. Checklists are sent to the laboratory for completion of the selfinspection. The self-inspection verification form must be returned within 30 days of receiving
the self-evaluation materials. Upon completion of the self-evaluation, the laboratory returns the
self-evaluation verification form, signed by the medical director. The verification form states
that the laboratory will correct all deficiencies cited and that documentation will be kept on file
for review by the next CAP inspection team. The laboratory should keep the self-inspection
Checklists on file for future reference. Failure to perform the self-evaluation is a serious
deficiency and may result in an immediate on-site inspection or denial of accreditation.
Anniversary of Accreditation
Accreditation is maintained on a continuous basis provided that:
 reapplication forms are returned within 35 days of the date sent from the CAP Northfield
office (these forms are automatically sent to the laboratory 150 days before the anniversary
date);
 a self-evaluation is completed in the interim year;
 the laboratory successfully participates in approved proficiency testing programs;
 the College and the Health Care Financing Administration are notified in writing of a change
in the laboratory's director, location, and/or ownership; and
 the laboratory continues to meet all other Standards for Laboratory Accreditation.
The LAP functions on a fixed accreditation cycle. This means that a laboratory will be inspected
within the 30 days before the accreditation anniversary date every two years.
Implications of Accreditation
Certain regulatory agencies and other accrediting programs have officially recognized the value
of the CAP Laboratory Accreditation Program. The director has the option at the time of
application to request that the results of the inspection be shared with the JCAHO or with
selected governmental agencies. All inspection data, however, are confidential unless released
by the director. The choice is voluntary. The regulatory and accrediting agencies that may
receive copies of the inspection are listed in the following section.
College of American Pathologists
Laboratory Accreditation Manual
Page 58
Laboratory Information
Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
Hospitals seeking JCAHO accreditation may choose to accredit the hospital laboratory through
the CAP program. The JCAHO accepts CAP accreditation of hospital laboratories. Generally,
CAP accredited laboratories in JCAHO accredited hospitals will not be surveyed by a JCAHO
laboratory surveyor. During the hospital's survey, however, a physician surveyor will request and
review information on such intradepartmental requirements as safety and monitoring and
evaluation of the quality and appropriateness of patient care. The JCAHO will validate the CAP
inspection process by occasionally sending observers along with CAP inspection teams.
Health Care Financing Administration (HCFA)
The LAP was granted deeming authority as a private accrediting organization under CLIA '88 by
the Health Care Financing Administration (HCFA). This recognition imposes significant
obligations upon the LAP. The fixed accreditation cycle must be adhered to and Checklist
changes have resulted. Within each facility, CLIA certificates and CAP accreditation data must
be concordant, (i.e., one CLIA number corresponds to one CAP number). HCFA validates the
CAP inspection process by sending surveyors to a certain percentage of laboratories,
unannounced, within 60 days of completion of CAP inspections.
State Licensure
States also license clinical laboratories. The extent to which the CAP accreditation program is
recognized by state governments varies. The College will make the results of the accreditation
decision available to a state department of health upon request from the laboratory director.
The inspector can determine the accreditation implications of the current inspection by reviewing
the "Release of Data" form in the packet. The director's signature on the form will indicate
which agencies the laboratory has designated to receive CAP accreditation information.
College of American Pathologists
Laboratory Accreditation Manual
Page 59
Laboratory Information
NON-ROUTINE INSPECTIONS
Change in Location, Director, or Ownership
Accreditation by the CAP does not automatically continue after there is a change in location,
director, or ownership. When there is such a change, the CAP must be notified in writing
within 30 days in order to satisfy CLIA ’88 requirements. Additional information may be
requested from the laboratory.
After reviewing the case, the Regional Commissioner may find that no substantive changes in the
operation of the laboratory have been made and that all the requirements of the Standards for
Laboratory Accreditation are met. In these circumstances, the Commissioner may waive
reinspection and shall notify the College in writing of his or her recommendation. The laboratory
will retain its accreditation until the next regularly scheduled inspection.
An additional inspection, however, may be conducted at the discretion of the Regional
Commissioner. A fee is assessed for this type of inspection. A letter explaining the process and
request for the inspection fee will be sent to the laboratory director. An Inspector’s Summation
Report and the appropriate Checklists are used. The laboratory is required to respond in the
usual manner, as for any inspection, to any deficiencies found during this out-of-cycle inspection.
The inspection response material will be reviewed by the technical specialist or regulatory
analyst and the Regional Commissioner.
Added Discipline
An “added discipline inspection” occurs outside of the regular inspection cycle and is used for
labs that add anatomic pathology and/or cytology testing. The addition of any other
discipline may also require an inspection, at the discretion of the Regional Commissioner. A
fee is always assessed for this type of inspection.
If the laboratory adds a clinical pathology discipline, (e.g., toxicology, cytogenetics, etc.)
additional application materials, a self-evaluation verification form, and a copy of the Checklist
for that discipline will be sent. When returned, these materials will be forwarded to the Regional
Commissioner for review. After reviewing these materials, the Regional Commissioner will
determine if this laboratory section requires an inspection before its next scheduled on-site
inspection. If the laboratory requires an inspection for the new discipline, a fee is charged for
this service. A letter explaining the process and the name of the technical specialist, who will
review the responses, will be sent to the laboratory director. An Inspector’s Summation Report
and Checklist will be used. After response and review by the technical staff and Regional
Commissioner, the discipline will be added and a new accreditation letter will be sent to the
laboratory. However, if the section does not require inspection, an accreditation letter will
automatically be sent after the Regional Commissioner’s review. In this case, no additional fee
involved.
College of American Pathologists
Page 60
Laboratory Accreditation Manual
Laboratory Information
Secondary On-Site Inspection
This inspection occurs within the regular inspection cycle and is conducted after an on-site
inspection. The Regional Commissioner requests a second visit by a specialized team of
inspectors to document correction of selected deficiencies in a specific discipline. This occurs
usually because the deficiencies cited were so profound that paper documentation of corrections
were deemed inadequate by the Regional Commissioner. A fee is always assessed unless the
reason for the inspection is due to an error on the part of the CAP (e.g., inspector missed the
section, or the appropriate Checklist was not supplied to the inspector). A letter explaining the
process and requesting the fee will be sent to the laboratory director. The name of the technical
specialist will be included in the letter for the deficiency response. An ISR and the appropriate
Checklists are used. The inspection response material is reviewed by the technical specialist or
regulatory analyst, and the Regional Commissioner before recommendations for accreditation or
denial are made.
Complaint Investigation
This inspection usually follows the same process as a secondary on-site inspection and can take
place at any time during the accreditation cycle. The Special Commissioner for Complaint
Investigations will request this inspection when there is evidence of non-compliance with the
Standards of Laboratory Accreditation in a currently accredited laboratory. The response
material is reviewed by the regulatory analyst for complaint investigations and the Regional
Commissioner. Fee assessment is on a case-by-case basis. Alternatively, complaint
investigations may be conducted as part of a routine on-site inspection if the timing is
appropriate.
College of American Pathologists
Page 61
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
Appendix A:
CAP Checklist Usage
Laboratory General - Must be completed for all inspections and for each separate laboratory in
the case of multiple-lab inspections.
Hematology and Coagulation - Used for blood and body fluid cell counts and differentials,
coagulation tests, bone marrow, and hemoglobin electrophoresis.
Automated/General Chemistry - Used for common chemistry tests typically performed on
automated instruments, including blood gas and oximetry.
Urinalysis and Clinical Microscopy - Used for automated and semi-automated urinalysis,
dipsticks and dipstick readers, morphology systems, microscopic urinalysis, crystal and
microscopic body fluid analysis, and semen analysis.
Toxicology - Must be used for all screening and/or confirmatory testing for drugs of abuse and
legal alcohols, regardless of methodology. This includes kits such as the Biosite Triage™.
NOTE: Therapeutic drug monitoring (TDM) is covered by the Special Chemistry Checklist.
Special Chemistry - Used for flame photometers, atomic absorption, spectrophotometers,
immunoassays (including enzyme immunoassays (EIA) and radioimmunoassays (RIA)),
electrophoresis, therapeutic drug monitoring (TDM), prenatal screening, alpha-fetoprotein (AFP),
cystic fibrosis screening and NON-toxicological chromatography.
Microbiology - Used for bacteriology, mycobacteriology, mycology, parasitology, and virology,
including DNA probes for identification purposes. NOTE: Any DNA amplification testing such
as PCR or LCR is inspected with the Molecular Pathology Checklist.
Transfusion Medicine - Used for blood and tissue storage, compatibility testing, transfusions,
donor collection, component preparation, and parentage testing.
NOTE: Laboratories limiting their immunohematology testing to ABO, Rh, and antibody
screening are inspected with the Diagnostic Immunology Checklist.
Immunology & Syphilis Serology - Used for serology techniques, fluorescent stains, and direct
antigen detection.
Anatomic Pathology - Used for all surgical pathology, including frozen sections,
histology/histopathology, autopsies, and electron microscopy.
Cytopathology - Used for all cytopathology, cell suspensions, screening, and pathologist
evaluation.
College of American Pathologists
Page 62
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
Cytogenetics - Used for amniotic fluid cell analyses, bone marrow cultures, chorionic villus
studies, Fragile X studies, blood lymphocyte analyses, solid tumors, and non-neoplastic tissue
cultures. NOTE: Biochemical genetics (e.g., amino acids) is covered by the Special Chemistry
Checklist.
Histocompatibility - Used for all transplant tissue compatibility (HLA) studies, including
type/crossmatch and antibody identification. NOTE: If flow cytometry is used for
crossmatching, the Flow Cytometry Checklist must also be used. If molecular techniques are
used for typing, the Molecular Pathology Checklist must also be used.
Flow Cytometry - Used to evaluate flow cytometry assays. Testing covered includes: DNA
analysis, lymphocyte phenotyping, leukemia/ lymphoma immunophenotyping, and flow
cytometry crossmatching for HLA.
Molecular Pathology - Used for molecular techniques for oncology, genetics, HLA/
histocompatibility, parentage, forensic identity, in situ testing, and infectious disease testing
using nucleic amplification such as PCR and LCR.
Limited Service Laboratory - Used for multi-discipline laboratories doing a limited number of
common tests (e.g., outpatient or “STAT” labs). This Checklist is not appropriate for singlediscipline or specialized laboratories; these labs should use instead the appropriate discipline
Checklist(s).
NOTE: The following services are NOT covered by the Limited Service Checklist for the
following disciplines:
 Hematology – bone marrow evaluation
 Coagulation - factor assays
 Urinalysis and Clinical Microscopy - semen analysis beyond sperm count
 Special Chemistry - spectrophotometry, electrophoresis, chromatography, AFP, RIA
 Microbiology - cultures beyond initial plating, mycology other than KOH or wet preps,
mycobacteriology, parasitology other than pinworm preparations, all virology
 Transfusion Medicine - ALL other than ABO/Rh and antibody screening
 Separate discipline specific Checklists are needed for: Toxicology (including drugs of abuse
screening), Anatomic Pathology, Cytopathology, Cytogenetics, Histocompatibility, Flow
Cytometry, Molecular Pathology, and Point-of-Care Testing. Items in these discipline
specific Checklists are not covered in the Limited Service Checklist.
Blood Gas Laboratory - The Blood Gas Checklist is used for stand-alone blood gas laboratories
that are under a different director, supervisor, location and/or CLIA number. If blood gases are
performed in the laboratory under the same CLIA number as the main laboratory, with the same
laboratory director and supervisor, they may be inspected with the Automated Chemistry
Checklist. If blood gases were performed in a different laboratory section with a different
Supervisor, they would be inspected with the Blood Gas Checklist.
College of American Pathologists
Page 63
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
Point of Care Testing - Used for all point of care testing (POCT) done in non-dedicated space
(i.e., with portable instrumentation). NOTE: Dedicated laboratories require either a Limited
Service or additional discipline Checklist. A separate Checklist must be completed for each
POCT location when POCT records are not maintained in a central location.
College of American Pathologists
Page 64
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
Appendix B:
Guidelines for Determining Test Volume










Chemistry profiles: each measured individual test is counted separately.
Complete blood counts (CBCs): each measured individual analyte ordered and reported is
counted separately. WBC differentials count as one test.
Do not count calculations (e.g., A/G ratio, MCH, MCHC, and T7), quality control, quality
assurance and proficiency testing assays.
Urinalysis: macroscopics (dipsticks) are counted as one test for each reagent pad on the strip;
microscopic examinations, each count as one test.
Microbiology: susceptibility testing is counted as one test per group of antibiotics used to
determine sensitivity for one organism. Cultures are counted as one per specimen regardless
of the extent of identification, number of organisms isolated, and number of tests/procedures
required for identification.
Testing for allergens should be counted as one test per individual allergen.
Cytology: each slide (not case) is counted as one test for both Pap smears and nongynecologic cytology.
Histopathology: each block (not slide) is counted as one test. Autopsy services are not
included. For those laboratories that perform special stains on histology slides, the test
volume is determined by adding the number of special stains performed on slides to the total
number of specimen blocks prepared by the laboratory.
Histocompatibility: each HLA typing (including disease associated antigens), HLA antibody
screen, and HLA crossmatch is counted as one test.
Cytogenetics: the number of tests is determined by the number of specimen types processed
on each patient, (i.e., a bone marrow and a venous blood specimen received on one patient is
counted as two tests).
College of American Pathologists
Page 65
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
Appendix C:
Quality Improvement
An Accreditation Viewpoint
Analytic results that are useful in the diagnosis, management, and treatment of disease are
achieved by organizing people, instruments, methodologies, and reagents into a semiautonomous system characterized by procedures and protocols. This system identifies sources of
intralaboratory excellence and includes personnel training, performance standards, maintenance
of equipment and consumables, calibration, quality control, proficiency testing, and
documentation.
One component of quality improvement is the attempt to identify all sources of preanalytic,
analytic, and postanalytic variation that may have an impact upon the provision of high-quality
patient care. This definition includes patient preparation, specimen procurement and handling,
test and method selection, reporting formats, and turnaround time as well as the classical analytic
safeguard customarily referred to as quality or process control.
A second and more subtle aspect of quality improvement attempts to integrate the analytic and
interpretive product of the laboratory with the overall clinical care of the patient and the ultimate
clinical "outcome," realizing that the laboratory result is only a partial "outcome" in the overall
course of patient care.
A universally applicable distinction between quality control and quality improvement does not
exist. Conventionally, quality control (QC) has come to be seen as a component of quality
improvement (QI). QC and QI represent adjacent and, at times, overlapping domains and
dimensions of the quest for the benchmarks of excellence in laboratory medicine: the provision
of useful and correct information in a timely, convenient, and cost-effective manner.
In pursuit of these goals, QC and QI may be contrasted. QC is concerned with process,
procedures, means, and data, while QI is concerned with outcomes, results, ends, and information
content.
QI has always been an implicit component of the LAP process. The emphasis of the program,
however, has been on structure and process "indicators" such as equipment, personnel
qualifications, procedure manuals, quality control protocols, and proficiency testing. The LAP
will increasingly attempt to identify "outcome" related issues.
As of 1999, Laboratory General Checklist contains an expansion of previous material on QI, and
there are now 13 questions:
1. Does the quality improvement (QI) program follow a documented operational plan?
2. Has the QI plan been implemented as designed?
College of American Pathologists
Page 66
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
3. Does the QI program cover all aspects of the laboratory service?
4. Are key indicators of quality monitored and evaluated for improvement opportunities?
5. Are appropriate actions taken whenever opportunities for improvement are identified?
6. Do the QI indicators include measures of preanalytic variables?
7. Do the QI indicators include measures of postanalytic variables?
8. Are graphical tools (charts and graphs) used to effectively communicate quality findings?
9. Is there a systematic program to identify and correct problems that may interfere with patient
care services?
10. Is a physician responsible for ensuring that the QI program is coordinated with others in the
facility (medical, surgical, nursing services, etc.)?
11. Have the referring physicians' and patients' satisfaction with the laboratory service been
measured within the past 2 years?
12. Is the QI program appraised at least annually for effectiveness?
13. Is there evidence that objective measures of the laboratory's quality have shown improvement
in the preceding 2 years?
The Q-PROBES  and Q-TRACKS programs of the CAP may be used as important
components of the laboratory’s QI program. Q-PROBES is a subscription program offering
periodic "off-the-shelf" studies of outcome, process, and structure-oriented quality components
of laboratory practice in the clinical laboratory and anatomic pathology. The program allows a
laboratory to compare its performance with that of a peer group of laboratories. The Q-PROBE
may be integrated into the institutional QI programs as a means to satisfy accreditation
requirements of the College as well as the JCAHO.
Q-TRACKS extends the boundaries of communication and quality improvement directly
impacting patient care. Through a series of long-term monitors, Q-TRACKS examines the
complete testing cycle, from physician order to diagnosis and treatment.
Carefully selected and properly implemented QI programs will help to guarantee the continuing
outstanding performance and dedication to excellence of clinical laboratories accredited by the
CAP.
College of American Pathologists
Page 67
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
Appendix D:
Sample of Inspection Confirmation Letter to Laboratory Director
This letter should be sent to Directors of all labs to be inspected during this inspection
(e.g., separately accredited blood gas or special function labs).
(A copy of the letter should be filed in the inspection packet.)
Dear Doctor (...):
This is to confirm our telephone conversation in which we arranged an inspection of your
laboratory. I plan to arrive at your laboratory on (...) at about (...) and I anticipate that my
inspection will last approximately (...).
Assisting me in this inspection will be the following individuals and the areas they will inspect:
(Insert as applicable e.g., Lab General (Name)
Hematology: (Name)
Chemistry: (Name), etc.)
We would like to meet with you and your staff briefly at the beginning of the visit to review the
general operation of the laboratory and to take a walking tour with the inspection team. Team
members will then go back through each department to meet the respective supervisors and to
inspect the departments one by one. If possible, please provide a work space in an office or
conference room.
(Insert for hospital laboratories) Please arrange for brief appointments of 15 minutes each with
the hospital administrator and a representative of the medical staff. These meetings help
determine whether the laboratory has established an effective working relationship with the
administration and staff. Ideally, the time of these meetings would be about halfway through the
inspection.
The inspection will proceed more efficiently if the laboratory has those items of special interest
readily available. As we go through the Checklists, we will review the following:
1. Laboratory general
a. Organizational plan
b. Personnel policies
c. Quality Improvement plan and records
d. Continuing education records
e. Self-inspection records from last year
f. A copy of those portions of the hospital nursing manual or doctor office directions that
relate to specimen collection and to transfusion of blood
2. Each department
a. Procedure manuals
b. Instrument maintenance records
c. Quality control and proficiency testing records
College of American Pathologists
Page 68
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
3.
4.
5.
6.
7.
d. Safety manual
e. Examples of report forms
Hematology
Example slides of Romanowsky, reticulocyte stains, etc.
Microbiology
Example slides of Gram stain and other stains
Chemistry
Reference thermometers, reference weight standards, and volumetric glassware
Anatomic Pathology
Example slides of all routine and special stains offered
Cytopathology
Example slides, workload records, and rescreening documentation should be available.
We want to complete the inspection by (...) at which time we would like to meet with you and
your staff again for the summation conference. Please invite as many personnel from the
laboratory to this meeting as you deem appropriate. We plan to adjourn by (...).
If you have any suggestions for luncheon arrangements, lodging, travel directions, etc., please let
me know. (Include as appropriate.)
Sincerely,
_______________________________________
College of American Pathologists
Page 69
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
Appendix E:
Resources
LAP Checklists
See appropriate sections of the Laboratory Accreditation Manual that pertain to these items. The
inspection checklists are available on the CAP Web page at www.cap.org. This location
provides the opportunity to view and/or download the checklists currently in use as well as
proposed editions approved by the CAP for future implementation. If you do not have access to
the Web site, please call the Laboratory Accreditation Program at 800-323-4040, extension 6055
or 847-832-7000, extension 6055 to obtain a copy of the checklists.
LAP Inspection Education Seminars and Self-Study Modules
Live education seminars begin with a review of the accreditation process, then delve into
practical material regarding the inspection itself. Included are interactive discipline specific
break-out groups that address unique inspection needs of the individual laboratory sections.
CME and CLME credit is given hour for hour for seminar attendance. For information regarding
seminars near you, call the CAP inspector training coordinator at 800-323-4040, ext. 7207 or
847-832-7207.
The Self-Study modules cover the same material as the live seminars and offer the same CME
and CLME credit opportunities. The Basic Self-Study is available on the CAP’s Website:
(www.cap.org) or you may obtain a hard copy of the Basic Self-Study or selected discipline
specific modules of the Advanced Self-Study by mail from the inspector training coordinator, at
800-323-4040, ext. 7207 or 847-832-7207.
CAP Surveys Program
The CAP Surveys program started in the 1940s with distribution of a limited number of
specimens to a few selected laboratories. Since then, it has been greatly expanded, refined, and
updated annually to meet the ever-expanding needs of laboratory medicine. More than 23,000
laboratories are enrolled in the CAP Surveys Program.
To assist laboratories in selecting CAP Surveys appropriate for their operations, the current CAP
Surveys brochure presents the Surveys available according to laboratory sections as defined by
the College's Laboratory Accreditation Program.
Included in this brochure are:
 Index by analytes/procedures
 Descriptions of individual Surveys
 Reference Materials
 Guidelines for selection of Surveys
 How to complete the Survey order form
 Inquiries concerning CAP Surveys
College of American Pathologists
Page 70
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
Proficiency Testing
Proficiency testing is an integral part of the College’s Laboratory Accreditation Program (LAP)
along with the on-site inspection and self-evaluation. To be accredited by the LAP, a laboratory
must participate in a CAP-approved program appropriate in size and scope of the lab whenever
such programs are available. Lists of approved programs are included in application and
inspection packets and are also available by calling the proficiency testing specialist at (800) 3234040 extension 7580 or 847-832-7580.
The EXCEL® Program
The External Comparative Evaluation for Laboratories (EXCEL) program is designed
specifically for use by physicians' office laboratories or other laboratories performing only
limited and routine procedures.
This program helps monitor the laboratory's internal quality control program by providing
information on its performance and by providing comparison of the procedures with other
laboratories using the same or similar methods.
The flexible format allows subscribers to select EXCEL modules in chemistry, hematology,
coagulation, urinalysis, microbiology, blood bank, and immunology. Specimens have been
designed specifically for the scope of testing performed in office laboratories.
Laboratory Accreditation Newsletter
This newsletter, published several times each year by the College's Commission on Laboratory
Accreditation, is distributed to LAP participants and inspectors to inform them of program
changes and developments. It is incorporated into CAP TODAY and distributed to all CAP
members.
Clinical Laboratory Handbooks for Patient Preparation and Specimen Handling
This series of handbooks provides a comprehensive reference source for patient preparation and
specimen handling of all standard medical procedures, plus commentary on the optimal use of
each test. Topics include special patient preparation, type of specimen preferred, preferred
containers, preferred containers, preservatives, and anticoagulants, storage requirements, clinical
use, and special comments. Tests are cross-referenced.
Fascicle I: Diagnostic Immunology/Serology [CAP Pub. No. BC331]
Fascicle II: Hematology [CAP Pub. No. BC344]
Fascicle III: Microbiology [CAP Pub. No. BC351]
Fascicle IV: Therapeutic Drug Monitoring/Toxicology [CAP Pub. No. BC374]
Fascicle V: Endocrinology/Metabolism [CAP Pub. No. BC359]
Fascicle VI: Chemistry/Clinical Microscopy [CAP Pub. No. BC361]
Fascicle VII: Reference Guide for Diagnostic Molecular Pathology/Flow Cytometry [CAP Pub.
No. BC365]
College of American Pathologists
Page 71
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
Complete set [CAP Pub. No. BC373]
Quality Improvement Manual in Anatomic Pathology
[CAP Pub. No. BC3603]
This publication contains a current compilation of ways pathologists can improve quality in
various areas of anatomic pathology. It also provides guidelines for implementing quality
improvement to surgical pathology practice in complying with guidelines of the CAP, JCAHO,
and regulatory agencies. The 1996 manual was updated to address practice questions,
particularly those with quality implications raised by pathologists since the 1988 edition. It
features an extensively revised chapter on cytopathology. It contains many examples of forms for
documenting quality assurance data.
Autopsy Performance and Reporting
[CAP Pub. No. BC205]
The major sections of this book, written for pathologists performing autopsies on a regular basis,
cover Administration and Preautopsy Considerations; Autopsy Performance; Autopsy Reporting;
and Autopsy Utilization, Quality Assurance, and Reimbursement.
Forensic Urine Drug Testing Accreditation Program
[CAP Pub. No. BC210]
The College of American Pathologists, in consultation with the American Association for
Clinical Chemistry, developed an accreditation program designed specifically for laboratories
engaged in urine drugs-of-abuse testing for nonmedical purposes. The Forensic Urine Drug
Testing (FUDT) Accreditation Program is administered separately. Laboratories must enroll in
and successfully complete three consecutive approved forensic urine drug testing proficiency
testing surveys before receiving an invitation into the program. On-site inspections occur
annually. Laboratories also are expected to perform an interim self-evaluation each year and to
participate successfully in the AACC/CAP Forensic Urine Drug Testing Survey (UDC), or CAP
approved equivalent, on an ongoing basis.
Further information regarding the FUDT Accreditation Program may be obtained from the
following sources:
 Standards for Accreditation of Forensic Urine Drug Testing Labs
 Forensic Urine Drug Testing Checklist
Information regarding enrollment policies and fees may be obtained by contacting the College.
Athletic Drug Testing Accreditation Program
[CAP Pub. No. BC232]
The CAP designed the Athletic Drug Testing (ADT) program for laboratories that perform tests
on samples from collegiate and professional athletes. Steroids and other performance-enhancing
drugs, beta-blockers, and stimulants, as well as drugs of abuse are screened for and confirmed
Information regarding enrollment policies and fees may be obtained by contacting the College.
College of American Pathologists
Page 72
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
Reproductive Laboratory Accreditation Program
[CAP Pub. No. BC233]
The College of American Pathologists and the American Society for Reproductive Medicine
(ASRM), have collaborated to develop a national laboratory accreditation program for
reproductive laboratories. This unique cooperative effort provides an opportunity for laboratory
improvement through voluntary participation, professional peer review, education, and
compliance with established performance standards.
Laboratories performing embryology testing, and andrology laboratories that are performing
2,000 procedures per year with at least one high complexity test, not including semen analysis,
but related to sperm processing, are eligible for the accreditation program.
Inspections occur biannually, and laboratories are also expected to perform an interim selfevaluation each year.
Further information regarding the Reproductive Laboratory Accreditation Program (RLAP) may
be obtained from the following sources:
 Reproductive Laboratory Accreditation Program Standards for Accreditation
 Accreditation Checklist
 Standards and Checklist Questions
Information regarding enrollment policies and fees may be obtained by contacting the College.
Laboratory Instrument Evaluation, Verification, and Maintenance Manual, 1989
[CAP Pub. No. B236]
This manual, currently under revision, provides basic information on instrument selection,
operation, verification, and maintenance. It is also useful for preparing to meet accreditation
standards for the CAP and Joint Commission on Accreditation of Healthcare Organizations
(JCAHO).
College of American Pathologists
Page 73
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
Appendix F:
Site Coordinator’s Manual
COLLEGE OF AMERICAN PATHOLOGISTS
LABORATORY ACCREDITATION PROGRAM
SITE COORDINATORS MANUAL
INTRODUCTION
CAP inspections at a large facility are complex. Team leaders have found that to have one local
contact person with knowledge of all the laboratories is helpful.
Many concerns must be addressed and decisions made before to the inspection.
Careful planning and attention to details on site will make an inspection go smoothly.
Considerations include the following:

How will the team get from its hotel to the lab on time and ready to inspect?

Do we know who the team members are and what sections each individual will inspect?

Are there other laboratories on the same campus that the team will be reviewing on this
trip, and how will those inspections be scheduled?

Does the laboratory have satellite labs at other locations? How will the appropriate team
members get there and return?

Are there any special services the team will need that the lab can supply to make the
experience easier and more efficient?
Such questions cannot be addressed by the CAP Northfield office, or its travel agency, or perhaps
not even by the team leadership. A local laboratory coordinator can be of immeasurable help in
anticipating such issues and preventing complications or delays. This manual was developed for
the Site Coordinator.
No document of this type can anticipate every organizational arrangement. CAP teams are often
assigned to clusters of laboratories in one location to minimize the travel costs of the program.
Many small laboratories may be spread throughout the campus and some of them may reside in
departments other than pathology. The central laboratory may support multiple satellite
laboratories; any that are within 15 miles or 30 minutes driving distance will be assigned to the
team. Sometimes entire groups of partnering hospitals may be inspected at the same time. The
document is meant to be a guideline - a set of suggestions that the Site Coordinator can adapt to
her or his local situation.
College of American Pathologists
Page 74
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
The Commission on Laboratory Accreditation would like to gratefully acknowledge the
following individuals who have assisted in the production of this manual by providing resource
information and participating in review of draft copies:
Beverly Charlton, University of Pittsburgh, Pittsburgh, Pennsylvania
Terry Jo Gile, Barnes-Jewish Hospital, St. Louis, Missouri
Dottie Quinn, Kaiser-Permanente Laboratories, Portland, Oregon
Joyce Wilson, University of Alabama, Birmingham, Alabama
Their expertise and experience have made this manual possible.
College of American Pathologists
Page 75
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
WHAT IS A SITE COORDINATOR (SCO)?
The site coordinator is the individual whom the director has appointed to work directly with the
counterpart on the inspection team. Site Coordinator’s duties typically include scheduling
meeting rooms, arranging key interviews and assisting the team with arranging for any special
needs.
WHAT IS THE ROLE OF THE SITE COORDINATOR?
The role of Site Coordinator is not standardized. The tasks will be dictated by the campus
arrangement and the team preferences. The best way to list the duties of a SCO is to answer the
question, “If I were organizing the team that will inspect our laboratories, what arrangements
would I need?”
The SCO should be available to the team throughout the inspection. Even the best planned
inspections may need last minute arrangements. Flexibility is essential, especially on big,
multidisciplinary campuses. The SCO helps resolve unpredicted situations as they arise.
Experience has shown that the only role the SCO should have during the inspection is to be
present and available to answer the team’s questions.
HOW IS A SITE COORDINATOR IS APPOINTED?
Each laboratory’s reapplication packet is mailed 150 days before the laboratory's accreditation
anniversary date. There is no requirement to have a SCO, but if the decision is made to do so,
the SCO should be appointed as soon as the reapplication arrives, so that the person can begin
planning the process.
Usually the director of the central pathology laboratory appoints the SCO whether the complex of
laboratories is administratively related, or laboratories are located in other departments. It is not
the College’s intention to have the pathology department dominate the inspection but it is hoped
that the entire inspection will proceed more successfully for everyone with one person in charge
of coordination. Pathologists have reported that, by facilitating the inspection, they have
enhanced their reputation for leadership on the campus.
College of American Pathologists
Page 76
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
WHEN DO THE SITE COORDINATOR’S RESPONSIBILITIES BEGIN?
The SCO should begin work before the applications/reapplications are sent to the CAP Central
Office, so that he/she knows the content of the paperwork. The first step is to draw up a list of
all laboratories that will be included in the inspection. Questions regarding inspector assignment
can be answered by the calling the Operations Associate at the Northfield office at (800) 3234040 extension 6055 or 847-832-7000, extension 6055. The SCO should realize that CAP’s list
is only as accurate as the information available at the time that the call was placed. Applications
from special function, satellite, and affiliated labs may be accepted up to 45 days before the main
clinical laboratory’s accreditation anniversary date (or even later with the approval of the
Regional Commissioner and team leader). Once the list is compiled, the SCO may identify
acceptable dates for the inspection by contacting the directors of the other laboratories to
determine their preferences. The inspection must occur in the 30 days before the
accreditation anniversary date of the main laboratory. Offering more inspection date choices
increases the likelihood that a mutually acceptable date will be selected. Potential conflicts such
as vacation schedules, remodeling, and computer installations may be taken into consideration,
but none of these can delay an inspection. The final selection of an inspection date will be at the
convenience of the inspector. The Laboratory Accreditation Program (LAP) operates under the
policy that a laboratory that is sending out results is always ready for an inspection.
REPORTING RELATIONSHIPS
Soon after appointment, the SCO should clarify her or his responsibilities to the facility for this
inspection. Duties will vary by location, the number of labs, and their interrelationships. The
chairman of the department of pathology should empower the SCO to handle as many of the
details of the inspection as possible. Local arrangements can involve many telephone calls and
some negotiation. There may be the need to make quick decisions during the inspection.
COMMUNICATION
Good communication is key to inspection planning. To be effective, the SCO should be
knowledgeable about the team, the facility, and the schedule. Correspondence from the CAP
office and the team leader will be addressed to the laboratory directors. The SCO should obtain
copies of all pertinent correspondence. Any letters that the SCO sends to the CAP Northfield
office or the inspection team should be copied to the appropriate laboratory directors.
The SCO will need the names of each of the team members as well as their credentials and areas
of expertise. The managers and supervisors want to know exactly who will be in their
laboratories. In addition, the team members want to know which employees will be working
with them during the inspection. The inspection packet includes personnel qualifications of the
senior individuals in the lab, but often other laboratory personnel work directly with the
inspectors.
College of American Pathologists
Page 77
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
The SCO should find out who will host the inspector in each special function laboratory. This
person might even be “deputized” by the SCO as “special function laboratory coordinator”. This
is not a formal title but rather a designation to facilitate point to point communication. The
inspection team member can be escorted to the special function lab by this deputy coordinator
and returned to the inspection team’s staging area. How these handoffs are managed can be
coordinated between the SCO and this individual.
LOGISTICS OF SATELLITE LABORATORY INSPECTIONS
Satellite laboratories are off-site facilities that are administrative extensions of the main lab.
Logistics of inspecting these laboratories include transportation for the team to and from the
satellite lab, and the time allocated for this travel. There is no LAP requirement for the host
laboratory to provide local ground transportation, but it is far simpler for the inspection team
when the laboratory chooses to do so. In all cases, the inspection team needs to know in advance
how it will get to and from each of the locations included in the inspection.
When a pathology laboratory supports multiple satellites, centralization of records and
standardization of procedures is common. The SCO should describe the arrangement to the team
well before the inspection. If records are kept in a central location, copies of these records
should be available to the inspection team at the satellite lab on inspection day. Records to
be reviewed include personnel files, employee health records, proficiency test evaluation reports,
and biomedical equipment maintenance records.
HELPING WITH TRAVEL ARRANGEMENTS
For the inspection team: The CAP central office can help the inspection team meet its travel
needs. The travel agency at the College is Direct Travel at (800) 323-4040, extension 7800 or
847-832-7000, extension 7800. Airline tickets can be billed directly to the College. The 7-digit
CAP number of the laboratory to be inspected must be given to the agent when booking travel.
The College encourages early booking to be eligible for favorable rates. If a team member needs
to change his/her ticketing for the return trip, Direct Travel should be contacted as soon as
possible.
The CAP can also facilitate hotel accommodations. The “CAP Large Inspection Team Hotel
Accommodation Request Form” may be used for teams of ten or more. With 4-6 weeks notice,
the meeting planning department at the College can negotiate a master account to cover the room
rates and tax.
College of American Pathologists
Page 78
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
For the Site Coordinator: The SCO should suggest a list of nearby hotels. Team member costs
for meals, ground transportation, and covered incidentals are reimbursed according to the
standard CAP meeting policy.
The SCO should advise the team on the best way to get from the airport to the hotel. Most
“chain” hotels offer free shuttles or can recommend low cost shuttle service. The SCO should
suggest transportation arrangements for the team between the hotel and the lab. There is, of
course, no requirement that the laboratory provide busing, but any help the laboratory can offer
the team will simplify the process and minimize its logistic decisions. With advance notice, the
CAP Northfield office can help arrange direct-billed ground transportation.
MEETINGS AND MEETING ROOMS
Every inspection team needs a home base. The SCO should ensure that the team has a work area
for their use. Team members inspecting large campuses will fan out towards their individual
assignments. The home base is a place to which they can return, and where they can interact
with other team members. There should be a spot in or near this team work area where the
inspection team members can secure personal items such as coats, purses, laptops, and luggage.
If practical, the home base should be near the location of the other meetings. Anyone can
become disorientated in large, unfamiliar surroundings. A home base minimizes this affect. The
SCO should provide the inspectors with a phone number to call if they become lost on campus or
need to contact the team leader with a question. The SCO may consider using a beeper for this
purpose.
Introductions should be the first item of the day. The first meeting of the day is a chance for the
hosting laboratory director to make welcoming remarks and for the inspector to introduce her/his
team. Team members will pair up with the appropriate employees of their initial inspection
assignments. The room for this initial meeting should be large enough to hold all of the
principals and be in close proximity to the laboratory. Many times, a general tour of the
laboratory follows the introductory meeting. Arrange a formal general tour only for the
individual(s) responsible for the Laboratory General Checklist. Those team members who want
to see the whole facility may do so by informal arrangement later in the day (time permitting).
PRIVATE MEETINGS
The inspection team leader is expected to meet with the Hospital Administrator (or
representative) and with the Chief of Staff (or representative). These are brief interviews of
about 15 minutes each. The SCO should schedule these appointments for the team leader and
provide a schedule for this ahead of time. The best time to hold these meetings is usually near the
midpoint of the inspection, after the inspector has started to acquire an impression of the
laboratory.
College of American Pathologists
Page 79
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
THE SUMMATION CONFERENCE
The Summation Conferences take place at the end of the day. The team will meet 30-60 minutes
beforehand in private, for a team pre-summation meeting, to compare notes and prepare for the
Summation Conference. This preliminary conference might be held in the team’s work area.
The Summation Conference is usually held in a large classroom or auditorium. Many people will
probably want to attend, and the team welcomes the participation of all interested parties. The
Summation Conference typically will take 30-60 minutes but because the exact starting time may
be unpredictable, the room should be reserved for as large a block of time as possible.
Large inspections usually involve multiple laboratories. If for example, 10 laboratories are
inspected by the team; covering the deficiencies in all of the labs at one big Summation
Conference may be cumbersome. If the labs span more than one department or employer, a
single-large group summation conference may not be appropriate. Before the inspection, the
SCO should ask each satellite laboratory director if she or he would prefer to have a
separate Summation Conference. Discuss these preferences with the inspector. One solution,
that can work well, is to hold individual summation conferences “on the fly” (i.e., a private
summation conference is held as the inspection of each small laboratory is completed). A group
summation conference may still be organized to allow the discussion of common themes and to
allow laboratorians to ask the questions, to clarify citations, and to challenge deficiency findings.
The inspector for each must sign each individual Checklist page of the ISR for the sections
he/she inspected. The team leader and laboratory director must sign the cover page of the
report. A copy of part B must be left with the director of each laboratory. Remember to
copy both sides of the ISR. Part B of the ISR is the official record of the inspection and
laboratory's primary source of information for the deficiencies that need to be addressed. The
laboratory director is required to respond to the deficiencies written on Part B of the ISR
within 30 days of the inspection. No other report will be sent from the CAP. The laboratory
is encouraged to download the checklists, explanatory text, and references from the CAP web
page at www@cap.org. By using a computer word processing program, the exact wording of
each checklist item can be retrieved from the download along with notes and literature
references.
The inspector must return the completed ISR, CME, Team Member, and Reimbursement forms
in the prepaid mailer as soon as possible after the inspection. A United Parcel Service
Authorized Return Service envelope for prepaid return is included in the inspection packet for
this purpose. If paperwork is completed before the team is ready to leave, the SCO might offer to
arrange for shipping of the sealed envelopes. The Checklists and other application materials
are not returned after the inspection. The inspector may discard them.
College of American Pathologists
Page 80
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
MEALS FOR TEAM MEMBERS
There is neither requirement nor expectation that the laboratory provide food and beverages for
the inspection team. Most laboratories do provide modest fare. Elegant presentations are
inappropriate, and sit-down banquets waste valuable time. The luncheon plans that the
laboratory chooses to make for the team’s comfort should be communicated to the team ahead of
time.
Meals such as breakfast and dinner, are outside of the hours of the inspection, and should be
handled by the team itself. (The SCO might provide a list of suggested restaurants.) The team
would appreciate access to coffee or soft drinks at or near its home base in the laboratory. The
most efficient lunches are cold buffet or box lunches. Team members will want to break away
for lunch at a convenient point, which may vary with assignment. The luncheon room should be
reserved for an extended period to allow individual team members to manage their time most
effectively.
Team members who are working off-site at a satellite locations should be offered similar
hospitality or a list of nearby restaurants.
SUPPLIES AND SERVICES
The inspection team will need some supplies and services while on site. In order to help the
inspection proceed more smoothly, work out with the inspection team, the mechanism for
obtaining the following items before the inspection:
1. Photocopies
The ISR Part B must be copied for the laboratory before the team leaves. Sometimes team
members may ask for copies of procedures, worksheets, or reports. The SCO should inform
the laboratory supervisors concerning the local “ground rules” for photocopying. The
hospitality of even the most generous laboratory can be strained by excessive requests. It is
quite appropriate to ask the inspection team leader to keep photocopying requests modest.
2. Telephone calls
The Laboratory Accreditation Program office can be called during regular business hours,
Monday through Friday 8:30 a.m. to 5:00 p.m. Central time, during the inspection via the
College’s toll-free number (800)323-4040 (option 2 for LAP, then 2 for checklist question
interpretation or 3 for inspections) or 847-832-7000, extension 6065.
College of American Pathologists
Page 81
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
3. Personal protective equipment (PPE)
The SCO should arrange for PPE, if possible, or request the team to bring any items. In most
cases, the only PPE needed will be lab coats and gloves, but arrangements should be made for
additional items as needed. For example, an inspector visiting an autopsy suite during a
postmortem examination should be protected from splashes or spatters of biohazardous fluids
with appropriate gown, gloves, shoe covers, and facial protection.)
College of American Pathologists
Page 82
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
SITE COORDINATOR’S CHECKLIST
Preliminary tasks
Determine functions the lab director has designated for the site coordinator.
Request copies of correspondence from the inspection team for all areas.
Make sure documentation of correction of deficiencies is complete
*
From the last on-site inspection.
*
From the self inspection.
Call the LAP Northfield office for list of all laboratories to be included in the inspection.
Contact the director of each special function laboratory on the campus.
 Offer to coordinate the inspection.
 List any special requests of the inspection team.
Individual Summation Conference Preference
Make a preliminary list of recommended dates for the inspection (must be within the 30 days
before the anniversary date).
Telephone call to Inspector
Introduce yourself and describe your role as Site Coordinator.
Determine who will coordinate the schedule for the team. (Will the Inspector appoint a Team
Coordinator?)
Suggest hotel accommodations.
To be accomplished 6 weeks before the inspection
Check again with CAP to determine whether there have been any late additions to the list of
included laboratories.
Request a list of team members, their credentials, assignments, and special needs from the team
leader.
Ensure that the team has appropriate transportation to and from its hotel.
Remind the team leader, if appropriate, to complete the “Large Inspection Team Hotel
Accommodations” form.
In concert with the team coordinator, schedule interviews with
*
the hospital Administrator.
*
the Chief of Staff.
College of American Pathologists
Page 83
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
Prepare the list of laboratory employees who will be working directly with the inspection team.
Reserve the meeting rooms.
*
*
*
“Home base” or staging area for the team (all day)
Introductory meeting (morning)
Summation conference (afternoon)
Discuss personal protective equipment (PPE) needs with team coordinator.
Provide the team with a list of recommended local restaurants.
To have ready for the inspection
Know where the team will be staying and how they will be getting to and from the airport.
Establish a mechanism to escort the team members to the individual laboratories

For special function labs, determine how inspector will get to the lab
and back

For satellite labs, provide for ground transportation
Provide a quiet room where centralized records will be available throughout the course of the
inspection.
Have PPE available as needed.
Food and drink


Arrange for box lunches or simple buffet for a working lunch.
Have cold drinks or coffee available in or near staging area for the
afternoon.
Provide for prompt photocopying of the ISR Part B following the summation conference.
Post-inspection tasks
Construct and distribute (a) Checklist Commentary(ies) using the question numbers as listed on
the ISR Part B.
Remind everyone that the documented responses, based on the handwritten deficiencies, must be
returned to the CAP Central Office within 30 days of the inspection.
Coordinate the return of deficiency response materials to the CAP Northfield office.
College of American Pathologists
Page 84
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
TO THE LABORATORY DIRECTOR
--Frequently asked questions-What is a “Site Coordinator”?
Every large laboratory or medical center campus is a complex challenge for a CAP inspection
team. Pre-inspection planning can spell the difference between an unsatisfactory or a stimulating
inspection experience. The Site Coordinator works with the inspection team to convey their
needs to the key people in the laboratory. The Site Coordinator makes sure the team is aware of
any special requirements the lab might have. During the inspection, the Site Coordinator should
be available to the team to meet any last-minute needs.
Is a Site Coordinator needed?
An inspection will benefit from a Site Coordinator if the answer is yes to any one of these
questions:




Does the inspection require a team of eight or more members?
Will the inspection team travel from out-of-town and require overnight accommodations?
Is there more than one location to be inspected?
Are there two or more laboratories to be inspected at one location?
Who should coordinate the inspection activities for the laboratory?
The Site Coordinator can be anyone who is willing to work with the team and with the
laboratories, in advance, to plan for a smooth inspection. It will take several telephone calls,
many hours, and attention to detail. With the right coordination and planning, an efficient,
productive inspection will result that will be a positive experience for both the lab and the
inspection team.
What about the other labs affiliated with the laboratory?
If the inspection team will be inspecting other laboratories at the same location, such as a lab in a
sister department, or if the team will travel to a satellite location, the Site Coordinator should
help make the local arrangements. Working with the team leader, the Site Coordinator will help
plan the schedule. The inspectors and the directors of the other laboratories will be grateful for
the effort.
How is the Site Coordinator appointed?
The lab director should tell the inspection team leader who will coordinate the inspection. With
the help of the accompanying manual, the Site Coordinator can take it from there. There is no
CAP requirement for the appointment of a SCO, but many inspections have benefited from the
services of a Site Coordinator.
College of American Pathologists
Page 85
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
Appendix G
Retention of Laboratory Records and Materials
The College of American Pathologists makes the following recommendations for the minimal
requirements for the retention of laboratory records and materials. They meet or exceed the
regulatory requirements specified in the Clinical Laboratory Improvement Amendments of 1988
(CLIA-88). The College of American Pathologists urges laboratories to retain records and/or
materials for a longer period of time than specified when such would be appropriate for
educational or quality improvement needs. Laboratories are encouraged to retain materials for a
longer period of time when patient care needs so warrant. In particular, laboratories should
consider retaining paraffin blocks, tissue slides, and tissue pathology reports for the same period
of time, and possibly longer than the times indicated. Some state regulations may require
retention of records and/or materials for a longer time period than that specified in the CLIA-88
regulations; therefore any applicable state laws should be reviewed carefully when individual
laboratories develop their record retention policies.
MATERIAL/RECORD
PERIOD OF RETENTION
Surgical Pathology
Wet tissue
Paraffin blocks
Slides
Reports
Accession log records
Maintenance records
2 weeks after final report
5 years
10 years
10 years
2 years
2 years
Cytology
Slides (negative-unsatisfactory)
Slides (suspicious-positive)
Fine Needle Aspiration Slides
Reports
Accession log records
Maintenance records
5 years
5 years
10 years
10 years
2 years
2 years
Autopsy Records
Wet tissue
Paraffin blocks
Slides
Reports
Accession log records
Maintenance records
College of American Pathologists
3 months after final report
5 years
10 years
10 years
2 years
2 years
Page 86
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
MATERIAL/RECORD
II.
PERIOD OF RETENTION
Clinical Pathology Records
Patient test records
2 years
Accession records
Quality control records
Instrument maintenance records
Bone marrow reports
2 years
2 years
2 years
10 years
III.
Blood Bank*
All donor and recipient records
Records of employee signatures,
initials, and identification codes
Quality control records
Records of permanently deferred donors
Indefinitely
Indefinitely
5 years
Indefinitely
*These guidelines meet or exceed AABB requirements
IV.
Specimens
Serum/CSF/Body Fluids
24 hours
Specimens from blood bank donors
7 days post transfusion (or 10 days post
and recipients
Peripheral blood smears/body fluids
Bone marrow smears
Permanently stained slides-microbiology
(gram, trichrome, etc.)
crossmatch)
7 days
10 years
7 days
References:
American Association of Blood Banks, 15th Edition of Standards, pg 28 and pp 39-41,
Accreditation Manual for Pathology and Clinical Laboratory Services, Joint Commission on
Accreditation of Health Care Organizations, Code of Federal Regulations, 42 CFR Part 405, et
al.
Revised 9/95
Appendix H:
Glossary of Terms
Accreditation
Accreditation is the determination that a specific AU is meeting program-specific Standards for
Accreditation as defined and published by the CAP.
College of American Pathologists
Page 87
Laboratory Accreditation Manual
Accreditation Cycle
An Accreditation Cycle is the period of time between accreditation decisions. This is a variable
period of time dependent on the program (e.g. LAP, ADT) and the specific Accreditation Unit
(AU). The LAP and RLAP are on a two year cycle. FUDT and ADT programs are on a one year
cycle.
Accreditation Packet
An Accreditation Packet is sent to each AU following a decision to grant accreditation. The
packet contains a Certificate of Accreditation, CAP Letter of Accreditation, Final List of
Deficiencies, and press release.
Accreditation Unit (AU)
Accreditation Unit is defined as the laboratory, department or other organizational unit that is
evaluated and can receive accreditation. While an AU is flexibly defined, it is basically a unique
combination of a laboratory with a director and location and some unique combination of
laboratory disciplines and sub-disciplines within a CAP program (LAP, FUDT, ADT, RLAP).
Activity Menu, Master
The Master Activity Menu is the list of all tests and non-test activities that could be performed by
an AU.
Activity Menu, AU-Specific
An AU-Specific Activity Menu is the list of tests and non-test activities that are specific to an
AU.
ADT
(see Athletic Drug Testing)
Alternate Proficiency Testing (Alt PT)
Alternate Proficiency Testing is proficiency testing provided by a provider other than the CAP.
Alt PT
(See Alternate Proficiency Testing)
Accreditation End Date
The date by which an inspection should occur.
College of American Pathologists
Page 88
Laboratory Accreditation Manual
Application
An Application is a form(s) that a laboratory completes out to initiate the CAP accreditation
processes.
Assigning Commissioner
The assigning commissioner is the commissioner who appoints an inspection team leader and
notifies the CAP of the person assigned.
Athletic Drug Testing (ADT)
ADT is a CAP program for laboratories that perform performance-enhancing drug testing.
AU
(See Accreditation Unit)
AU Specific Activity Menu
(Se Activity Menu, AU Specific)
Change of Discipline Form
The Change of Discipline Form is sent to an AU after it has indicated a change in services that
add an additional discipline. The form is comprised of a list of activities pertinent to the added
discipline. The AU indicates the activities in which it participates so that they may be added to
the AU Specific Activity Menu. The AU also provides information on the volume of testing
performed and supervision of the discipline so that the Regional Commissioner can evaluate
whether the discipline can be added without a non-routine inspection.
CLA
(See Commission of Laboratory Accreditation)
CLIA (Clinical Laboratory Improvement Act) Number
A CLIA Number is an ID number assigned to a lab by HCFA.
Commission on Laboratory Accreditation (CLA)
The CLA is a group of CAP members appointed by the CAP president that determines
accreditation policy. It consists of Regional Commissioners, Special Commissioners and the
Chair.
Commissioner
A Commissioner is a member of the CLA who is responsible for accreditation activities. Titles
include Regional, State, Deputy, Division, and Special Commissioners (Complaint, PT,
Checklist, Toxicology, RLAP, Regulatory, and Education
Denial
Denial is the determination that a lab does not meet the CAP’s accreditation standards.
College of American Pathologists
Page 89
Laboratory Accreditation Manual
Director
A Director is an AU-appointed individual who is responsible for the laboratory. The
accreditation of a laboratory is tied to both the lab itself and the director.
Discipline
A Discipline is a CAP term used to describe related activities that are evaluated for the purpose
of accreditation.
Document Management
Document Management is a subsystem of the LAP system used for the tracking of documents
sent to or received from an AU, inspector, commissioner or other individual or organization.
EE
(See Evaluating Entity)
Expungement
Expungement is the process of eliminating a deficiency because the deficiency should have never
existed.
Final List of Deficiencies
The Final List of Deficiencies is a document included in the Accreditation Packet that lists
deficiencies (if any) that were found during an AU’s accreditation inspection. The Final List of
Deficiencies does not include any deficiencies that were expunged.
Forensic Urine Drug Testing (FUDT)
FUDT is a CAP program that accredits laboratories performing recreational drug testing.
FUDT
(See Forensic Urine Drug Testing)
HCFA
(See Health Care Financing Administration)
Health Care Financing Administration (HCFA)
HCFA is an agency within the U.S. Department of Health and Human Services (DHHS) which
administers Medicaid, Medicare and Child Health Insurance programs and enforces the Clinical
Laboratory Improvement Amendments of 1988 (CLIA 88).
IE
(See Inspection Event)
II
(See Inspection Instance)
College of American Pathologists
Page 90
Laboratory Accreditation Manual
Immediate Review Criteria (IRC) Lab
An IRC Lab is an AU whose deficiency percentage exceeds a pre-determined threshold as
determined by the CLA. These labs will be given a higher priority throughout the accreditation
review process.
Inspection Deficiency
An Inspection Deficiency is a specific area in which an AU is not meeting CAP standards based
on a Checklist question. Deficiencies are currently classified as Phase I (i.e. minor deficiencies)
and Phase II (i.e. severe deficiencies). Phase II deficiencies may be further classified as critical
(i.e. extremely severe) in some programs.
Inspection Deficiency Response
For each deficiency cited, an AU is required to submit an Inspection Deficiency Response within
30 days of the inspection. For Phase I deficiencies, the AU needs to submit a plan of corrective
action. For Phase II deficiencies, the AU needs to submit a plan of corrective action and
supporting documentation showing that steps have been taken to correct the deficiency.
Inspection Event (IE)
An Inspection Event is an identifier used within the CAP to determine appropriate Checklists for
inspections. For every AU cycle, there is one Inspection Event for every Section Unit.
Inspection Instance (II)
An Inspection Instance is a grouping of AUs and SUs for inspection purposes. These events are
not necessarily related; however, they are grouped together for ease of inspection (usually a
single campus or geographic area). This is subject to change for each AU cycle.
Inspection Unit (IU)
An Inspection Unit consists of one or more Accreditation Units for the purpose of inspection.
For purposes of assigning inspectors, an IU consists of one or more AUs that are to be inspected
at the same time by one or more teams. This grouping is more static than an II. An IU is used to
ensure that AUs of similar characteristics inspect each other. An IU is also used to track that an
AU has fulfilled its inspection obligation.
Inspector’s Inspection Packet
The Inspector’s Inspection Packet contains all of the materials necessary to facilitate an on-site
inspection.
Inspector’s Summation Report (ISR)
An Inspector’s Summation Report is a form returned by the Team Leader containing the specific
deficiencies cited during an inspection as well as the inspector’s comments.
Inspector Training Self Study Module
Materials used in a self-paced education program designed to familiarize an individual with the
inspection process.
College of American Pathologists
Page 91
Laboratory Accreditation Manual
IRC Algorithm
(See Immediate Review Criteria Algorithm)
IRC Lab
(See Immediate Review Criteria Lab)
JCAHO
Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
JCAHO is an international accreditation organization that accredits healthcare organizations,
including laboratories.
Laboratory Inspection Packet
The Inspection Packet is a packet of information sent to the laboratory prior to the on-site
inspection that contains AU specific activity menu, response sheets and instructions on how and
when to respond to deficiencies.
List of Deficiencies
A List of Deficiencies is a system-generated listing of the checklist questions (including intent)
which were cited as deficiencies during an inspection of a specific AU.
Master Activity Menu
(See Activity Menu, Master)
No Deficiency Lab
A No Deficiency Lab is an AU for which no deficiencies (Phase I or Phase II) were cited during
an inspection.
Non-Routine Inspection
A Non-Routine Inspection is any inspection that is done outside the two-year accreditation cycle.
Non-routine inspections can be done for a variety of reasons, including a change of director or
adding disciplines.
Proficiency Testing
Proficiency Testing is Proficiency testing is the process in which simulated patient specimens are
analyzed by laboratories; it includes the statistical evaluation of the results from such testing in
order to assess individual laboratory performance when compared with laboratories using similar
methods and reagents or with expected results.
Reapplication
A Reapplication is a form that a laboratory completes prior to a routine inspection to continue
participation in the accreditation program.
Reproductive Lab Accreditation Program (RLAP)
RLAP is the CAP program with the focus of accrediting laboratories that perform andrology and
embryology lab services.
College of American Pathologists
Page 92
Laboratory Accreditation Manual
Reviewing Commissioner
The Reviewing Commissioner is the commissioner who reviews the Inspector’s Summation
Report and decides if accreditation is given.
RLAP
(See Reproductive Lab Accreditation Program)
Scientific Director
A Scientific Director is a lab-appointed director associated with an AU (FUDT only).
Section Unit (SU)
A Section Unit is defined as an operational area, department, or other type of organizational unit
within an AU. A Section Unit normally corresponds to a department within an AU (e.g.
hematology, cytopathology, and immunology). One or more SUs comprise an AU. A supervisor
is responsible for an SU.
Specialty
A Specialty is an Evaluating Entity-defined group of activities that are evaluated for purposes of
certification or licensure. Each Evaluating Entity provides its own definition of specialties in
terms of groups of activities.
Staff Inspector
A Staff Inspector is a CAP employee who conducts inspections.
SU
(See Section Unit)
Subdiscipline
A Subdiscipline is a CAP defined term used to describe related activities that reside under a
particular discipline. In the LAP system, a subdiscipline is a subgroup.
Subspecialty
A Subspecialty is an Evaluating Entity-defined grouping of activities that resides under a
particular specialty.
Supervisor
A Supervisor is a person responsible for the daily activities of a Section Unit.
Target Inspection Date
The date that signifies the end of the 30 day window during which the inspection should occur.
College of American Pathologists
Page 93
Laboratory Accreditation Manual
Termination
Termination refers to the process by which a laboratory’s accreditation is ended. The reasons for
termination include:
1. Denial of an AU’s accreditation after an inspection.
2. Initiation of termination by the AU itself when it no longer wishes to participate in the
Lab Accreditation Program. The AU is responsible for notifying the LAP Staff of its
intention to discontinue coverage under the LAP.
3. Failure to return reapplication materials within a specified time frame. The
termination will occur after reminder options (Additional Documentation) have been
exhausted. Letters will be sent to the AU and the Regional Commissioner stating that
the lab has been terminated because reapplication materials were not received.
4. Joining of two or more AUs which results in the accreditation of a single AU. The
AUs that are no longer effective will be terminated and the other AU’s record will be
updated to reflect all changes due to the merger.
5. Failure to meet the standards.
Test
A Test is an analysis of a human specimen, which typically yields a clinical result.
Volunteer Inspector
A Volunteer Inspector is a person who conducts inspections on a volunteer basis. Inspections
may be on behalf of the Inspection Unit with which he/she is affiliated.
College of American Pathologists
Page 94
Laboratory Accreditation Manual
CAP Commission on Laboratory Accreditation
William B. Hamlin, MD
206-386-2730
Chair, Commission on Laboratory Accreditation
858-554-8166
Southwest Region
Robert R. Rickert, MD
973-322-5763
Vice Chair and Overseas Commissioner
Leonard I. Boral, MD
610-237-4057
Middle Atlantic Region
EUROPE, FAR EAST
DC, DE, MD, NJ
Desiree Carlson, MD
508-941-7322
Northeast Region
Edgar H. Pierce Jr., MD
423-559-6168
Mid Central Region
CT, MA, ME, NH, RI, VT, QUEBEC, MARITIME PROVINCES
IL, KY, TN
Frank R. Rudy, MD
717-782-2677
Middle East Region
Francis E. Sharkey, MD
210-567-4135
Mid-South Region
NY, PA
TX
H. Thomas Norris, MD
352-816-3462
Southeast Region
Gerald Hoeltge, MD
216-444-2830
Inter-Region
CA, HI, NV
NC, SC, VA, WV
Thomas G. Puckett, MD
601-264-3856
Special Commissioner for State and Federal
Legislative and Regulatory Issues
Hans J. Peters, MD
706-327-8593
Gulf Region
AL, FL, GA, CENTRAL AND SOUTH AMERICA, THE
CARRIBBEAN, PUERTO RICO
R. Bruce Williams, MD
318-621-8820
South Central Region
Albert Rabinovitch, MD, PhD
973-283-0393
Checklist Commissioner
Ronald B. Lepoff, MD
303-372-0336
Special Commissioner for Complaint Investigations,
PTES Oversight, and Equivalency Determinations
AR, LA, MS, MO, OK
Thomas Ruhlen, MD
913-791-4362
West Central Region
Thomas Merrick, MD
303-839-6825
Education Commissioner
AZ, CO, KS, NM, UT, WY
Loyd R. Wagner, MD
605-331-7878
North Central Region
Wayne Markus, MD
402-731-4145
Toxicology Commissioner
IA, MN, ND, NE, SD, WI, MANITOBA
Aaron Lupovitch, MD
734-246-6922
Great Lakes Region
IN, MI, OH, ONTARIO
William Byrd, PhD
214-648-2376
Reproductive Laboratory Commissioner
Richard G. Patton, MD
206-386-2730
Northwest Region
P. Ridgway Gilmer, MD
713-432-1322
Editor, Laboratory Accreditation Program Newsletter
AK, ID, MT, OR, WA, BRITISH COLUMBIA, ALBERTA,
SASKATCHEWAN
Robert M. Nakamura, MD
College of American Pathologists
Page 95
Laboratory Accreditation Manual