Most Frequently Cited
Deficiencies for
Acute Care Hospitals
and ASCs:
HFAP Standards and
Medicare CoPs
Donna Tiberi Blaszczyk, RN,BS,MHA
Karen Y. Beem, MS, RN
Most Frequently Cited
Deficiencies for Acute Care
Hospitals and ASCs:
HFAP Standards and
Medicare CoPs
OBJECTIVES
 Knowledge and Understanding of the top scored HFAP
Hospital standards and Condition of Participation (CoP’s).
 Understanding standard and Condition of Participation
requirement compliance issues.
01.00.08 Categories Eligible for Appointment.
The governing body must determine, in accordance with state law, which
categories of practitioners are eligible candidates for appointment to the
medical staff. §482.12(a) §482.12(a)(1)
 The medical staff must, at a minimum, be composed of physicians who are doctors of
medicine or doctors of osteopathic medicine.
 Healthcare professionals must be legally authorized to practice within the state where
the hospital is located and providing services within their authorized scope of practice
(issues noted during survey is that facilities failed to conduct PSV for license, expired license, no license, functioning
outside scope of practice, practitioners were not eligible candidates for appointment to medical staff or medical staff
privileges)
 The medial staff may include other types of health care professionals such as:
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Doctor of medicine or osteopathic medicine
Doctor of dental surgery or of dental medicine
Doctor of podiatric medicine
Doctor of optometry
A Chiropractor
10.01.04 Dating & Timing of Orders.
The hospital must ensure that all orders, including verbal orders, are
dated, timed, and authenticated promptly. The Merriam-Webster online
dictionary defines “prompt” as performed readily or immediately.
 All verbal orders must dated, timed, and signed promptly- immediately
 Verbal orders must include a read-back and verification process per hospital
policy
 Authentication of a verbal orders may be written, electronic, or faxed
 The prescribing practitioner must verify, sign, date and time verbal orders as
soon as possible after issuing the order, in accordance with hospital policy, and
State and Federal requirements
 Verbal orders whether “telephone” or given “on site” must be authenticated
within state law or hospital policy
11.08.01 Adequate Facilities
The hospital shall maintain adequate facilities for its services
 Designed and maintained in accordance with federal, state, and local
laws, regulations and guidelines (facility layout, toilets, sinks, drinking water
supply, irrigation system’s, etc.).
 Designed and maintained to reflect the scope and complexity of the
services it offers in accordance with accepted standards of practice
(sufficient space to provide care, treatment and services; proper sterilization &
disinfection areas, ASC’s deemed status -separate waiting areas).
15.01.09 Exercise of Patient Rights
Exercise of Patient Rights
(15.01.09 continued)
 The right to the confidentiality of his/her clinical records
 The right to access his/her clinical records information within a
reasonable time frame
 The right to be free from restraints of any form that are not
medically necessary, or used for the purpose of coercion,
discipline, convenience, or retaliation by staff
 The right to be fully informed of and to consent or refuse to
participate in any unusual, experimental or research project
without compromising his/her access to services
 The right to know the professional status of any person
providing his/her care / services
Exercise of Patient Rights
(continued)
 The right to know the reasons for any proposed change in the Professional
Staff responsible for his/her care- staff not wearing ID badges
 The right to know the reasons for his/her transfer either within or outside the
hospital- transfer forms incomplete, patients/families not informed
 The right to know the hospital, other persons, other organizations
relationship(s) of participating in the provision of his/her care(physician
ownership, hospital ownership, etc.)
 The right of access to the cost of care treatment and services, itemized when
possible The right to be informed of the hospital's reimbursement source for his/her
services provided and if any limitations which may be placed upon his/her
care
Exercise of Patient Rights
(15.01.09 continued)
 Informed of the right to have pain treated as effectively as
possible
 Hospital must have written policies and procedures regarding
the visitation rights of patients including those to set forth
clinically necessary or reasonable restrictions/limitations:
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Must be informed of any visitation restrictions or limitations and why
Must be informed to receive visitors- spouse, domestic partners (including same sex),family member of
friend and the right to deny consent at any time
Cannot restrict, limit or otherwise deny visitation privileges based on race, color, national origin, religion,
sex, gender identity, sexual orientation, or disability
Ensure all visitors enjoy full and equal visitation privileges consistent with patient preferences.
 The patient's family has the right of informed consent for
donation of organs and tissues.
15.01.10 Participation in the Plan of Care
The patient has the right to participate in the development and
implementation of his or her plan of care. Hospital are required
to plan the patient’s care, with patient participation, to meet the
patient’s psychological and medical needs.
 Hospitals are missing policies and procedures to address patient and family
participation, or fail to develop and implement policies to address patient or
family participation in care
 Patients/family not informed, advance directives not explained or provided
to patients/family
 Patient/family not kept up to date regarding status of care, treatment or
services
15.01.12 Advance Directives
The patient has the right to formulate advance directives and to have
hospital staff and practitioners who provide care in the hospital comply
with these directives, in accordance with 482.13(b)(3).
(hospitals do not track a patients advance directive in the medical
records, staff unaware of patients advance directives, or simply do not
ask patients about advance directives)
15.01.17 Privacy & Safety: Safe Setting
The patient has the right to receive care in a safe setting.
 Hospital staff should follow current standards of practice for patient environmental
safety, infection control, and security
 Hospitals are missing or do not consistently implement policy and procedures
regarding security access to facility
 Construction sites not secured or protected from patients/staff/visitors
 Hospitals missing infection control plan, have incomplete infection control plans or
the plan is not hospital wide program
 Hospitals have no designated Infection Control Officer or the Infection Control
Officer is not trained, educated or qualified to oversee the IC program
25.01.01 Medication Control & Distribution
In order to provide patient safety, drugs and biologicals
must be controlled and distributed in accordance with
applicable standards of practice consistent with federal and
state law.
 Procedures must be established to prevent unauthorized
usage and distribution
 Provide for an accounting of the receipt and disposition in
accordance with state and Federal law and regulations
25.01.01 Medication Control & Distribution
(continued)
 Pharmacist actively involved and participates with appropriate hospital staff
and committees, to develop and implement guidelines, protocols, policies
and procedures for the provision of pharmaceutical services to ensure
patient safety.
 High-Risk Medications/Patients
 Hospitals should have systems in place to minimize adverse drug events
such as:
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checklists – not available or not used
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dose limits- medication dose limits not identified or established
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pre-printed orders- are out dated, not approved through medical staff, no national
references noted
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special packaging- missing new expiration dates, no identification noted
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special labeling- not implemented
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double-checks- not implemented, or are inconsistent
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guidelines- ISMP or other nationally recognized references used
25.01.01 Medication Control & Distribution
(continued)
“High risk medications” are those medications involved in a high percentage of
medication errors and or critical events and medications that carry a higher risk
for abuse, errors, or other adverse outcomes.
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High risk mediations may vary from hospital to hospital
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Hospitals must review and identify medication inventory to
define their high risk medications
High-risk or high-alert drugs are available from such organizations as
the Institute for Safe Medication Practices (ISMP) and the United
States Pharmacopoeia (USP).
25.01.01 Medication Control & Distribution
(continued)
High-risk drugs may include:
 Investigational drugs- missing policy and procedures
 Controlled medications- not stored correctly, missing sign-out
signatures, poor receipt and storage processes, missing med
counts, etc.
 Medications not on the approved FDA list- no policy
 Medications – narrow therapeutic range meds
 Psychotherapeutic medications and look-alike/ sound-alike
medications- no mechanism to identify these meds to avoid
errors such as, special labels red/orange/special lettering, etc.
 Medications that are new to the market or new to the
hospital- staff education
25.01.01 Medication Control & Distribution
(continued)
 Review of Orders-pharmacist reviews before order is dispensed, except in
emergencies:
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Appropriateness
Therapeutic duplication
Appropriateness of drug, dose, frequency, route,& administration method
Potential interactions
Real or potential allergies or sensitivities
Variation from criteria for use and
Other contraindications
Monitor Medication Effects
Sterile Preparation- not followed
Emergency Medication Kits- not available, missing meds or expired meds
Automated Drug Dispensing Machines- issues with inventory levels
Report Adverse Reactions- not reporting medication adverse events
Medications from Home- missing policy, no process to accept or store home meds
Investigational Medications- no policy or approval, IRB protocol
30.00.09 Standards of Practice
Surgical Service:
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Must be consistent with needs and resources
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Must have policies governing surgical care
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Must be designed to assure the achievement
and maintenance of high standards of medical
practice and patient care
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There is a policy manual governing activities in all
operative/invasive procedure locations
30.00.09 Standards of Practice
(continued)
These standards address, at a minimum to:
 Aseptic and sterile surveillance and practice, including scrub techniques- not
followed, failure to follow hand hygiene
 Identification of infected and non-infected cases- missing or incomplete
tracking mechanism, no f/up and reporting
 Housekeeping requirements/procedures- missing OR cleaning policies
and procedures, P & P not followed- use of wrong cleaning products,
etc.
 Patient care requirements (preoperative work-up, patient consents/releases,
clinical procedures, safety practices, patient identification procedures- no
informed consent process, consents not written in language patient
can understand, missing consents, incorrect consents, missing lab
results, poor two patient identification process, vague surgical site
marking, etc.
30.00.09 Standards of Practice
(continued)
 Duties of scrub and circulating nurse- circulating RN performing other
duties, not always available, scrub nurse competencies missing or
incomplete , first assist RN missing list of approved
privileges/procedures allowed
 DNR status- not addressed , missing or no policy
 Safety practices, including patient identification, site identification,
procedure verification, and surgical counts- poor site marking
procedure, time out not documented/not all staff involved in timeout, surgical count not consistently performed, medication
labeling, using single vial medication on multiple patients, etc.
 The requirement to conduct surgical counts in accordance with accepted
standards of practice- not following policy- also may wish to
consider counting number of staples used in closure
 Scheduling of patients for surgery- over scheduling, delays,
cancellations,
30.00.09 Standards of Practice
(continued)
 Outpatient surgery postoperative care planning and coordination,
and provisions for follow-up care- poor processes, f/up not
consistently implemented
 Personnel policies unique to the OR- missing policies, PPE not
used or used inconsistently, partially compliant/IC – nails, etc.
 Resuscitative techniques- qualified, trained staff equipment,
expired emergency medications, etc.
 Handling infectious, biomedical, and medical waste- not followed,
bagged/stored improperly, not sealed, sharps containers
full/not locked
30.00.09 Standards of Practice
(continued)
 Care of surgical specimens, including collection, labeling, handling,
and processing methods: missing policy for specimen collections
and processing
 Malignant hyperthermia: not following the MH recommended
protocols, insufficient Dantrolene vials (36 vials is noted to
stabilize the patient), no process to screen for MH patient’s or
family history, etc. With new standard should run drill to
determine if mediation is retrievable within 10 minutes
 Appropriate protocols for all surgical procedures performed. These
may be procedure-specific or general in nature, includes required list
of equipment, materials, and supplies necessary to properly proceed
with surgical procedure: missing or expired supplies, not all
equipment available, no biomed equipment checks, expired
meds, insufficient surgical trays, etc.
30.00.09 Standards of Practice
(continued)
 Sterilization and disinfection procedures: policy/procedure manual not
available for staff on sterilization/disinfection process, failure to follow
manufactures recommendation for high level disinfections solutions, high
volume “Flash sterilization”, dirty/clean utility rooms flow allows for cross
contamination, steam sterilizing equipment missing biomed tags, staff
competency missing or incomplete, log data incomplete, spore testing log
results missing or inconsistently documented, policies fail to note national
recommended practices such as the CDC, AORN, etc.
 Acceptable operating room attire: failure to follow OR policy, not wearing
clean OR shoes, surgical caps improperly worn, gel nails, jewelry, masks,
etc.
 Alcohol-based skin preparations in anesthetizing locations must have
appropriate policies and procedures to reduce the associated risk
of fire: missing or no policy, staff education not available
30.00.10 History & Physical
 Prior to surgery or any procedure requiring anesthesia services;
only except in emergency cases.
 Any history and physical conducted more than 30 days prior to
admission is not acceptable and must be repeated. The only
exception is for emergency situations.
(i) A medical history and physical examination must be completed and
documented no more than 30 days before or 24 hours after admission
or registration (common finding, H & P exceeds 30 day time frame).
30.00.10 History & Physical
(continued)
 (ii) An updated examination of the patient, including any changes in the
patient’s condition, must be completed and documented within 24 hours
after admission or registration when the medical history and physical
examination are completed within 30 days before admission or
registration.
(common findings are the H & P update is missing, incomplete,
must state patient examined, no changes noted, approve for
surgery, reviewed changes to H& P & patient approved for
surgery- must be dated, timed and signed by the physician)
HFAP TOP-SCORED
CoPs
Acute Care Hospital
01.00.05 Condition of Participation:
Governing Body
 The hospital must have an effective
governing body legally responsible for
the conduct of the hospital as an
institution.
 If a hospital does not have an organized
governing body, the person(s) legally
responsible for the conduct of the hospital
must carry out the functions specified in
this part that pertain to the governing body.
01.00.05 Condition of Participation:
Governing Body
The hospital must have only one
governing body and this governing body
is responsible for the conduct of the
hospital as an institution.
In the absence of an organized governing
body, there must be written documentation
that identifies the individual or individuals
that are responsible for the conduct of the
hospital operations.
03.04.01 Condition of Participation:
Utilization Review
The hospital must have in effect a utilization review
(UR) plan that provides for review of services
furnished by the institution and by members of the
Medical Staff to patients entitled to benefits under
the Medicare and Medicaid program.
03.04.01 Condition of Participation:
Utilization Review
Common Findings related to UR:
 Facility does not have a UR plan, the plan is incomplete or is not
consistently implemented.
 UR plan does not delineate the responsibilities/authority for those
involved in the performance of UR activities.
 Procedures for review of such as, the medical necessity of admissions,
appropriateness of the setting, medical necessity of extended stays, and
medical necessity of professional services are missing, incomplete or not
performed consistently.
 UR committee minutes are incomplete, missing, do not note members
attendance documentation, missing dates, discussions, missing
names/titles or meetings not convened as stated.
07.00.00 Condition of Participation:
Infection Control
 The hospital must provide a sanitary
environment to avoid sources and
transmission of infections and
communicable diseases.
 There must be an active program for the
prevention, control, and investigation of
infections and communicable diseases.
07.00.00 Condition of Participation:
Infection Control
The hospital infection control program
must be:
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hospital-wide
include all locations
all campuses
all departments
all services
07.00.00 Condition of Participation:
Infection Control
Examples:
 There is no hospital – wide infection control plan developed
 IC Program lacks all required components
 No designated infection control officer (ICO)
 ICO lacks the necessary required training for IC position in order
to implement an effective infection control program
 There is no infection control annual report given to the Board
 IC activities are not included in the QAPI program
 Hand washing surveillance and environmental rounds are not
completed consistently and are not documented
07.00.00 Condition of Participation:
Infection Control
Examples of areas to monitor:
 food storage, preparation areas, serving and dish rooms
 refrigerators, ice machines
 air handlers, autoclave room
 venting systems
 inpatient rooms, treatment areas, labs
 waste handling in surgical areas, supply, storage, equipment
cleaning, etc.
10.00.01 Condition of Participation:
Medical Record Services.
The hospital must have a medical record
service that has administrative responsibility
for medical records.
A medical record must be maintained for
every individual evaluated or treated in the
hospital.
10.00.01 Condition of Participation:
Medical Record Services.
 The Hospital must have one unified medical record
service that has administrative responsibility for all
medical records, both inpatient and outpatient
records.
 The hospital must create and maintain a medical
record for every individual, both inpatient and
outpatient, evaluated or treated in the hospital.
10.00.01 Condition of Participation:
Medical Record Services.
The term “medical records” includes at least:
written documents
computerized electronic information
radiology film and scans
laboratory reports and pathology slides
videos, audio recordings
Other forms of information regarding the condition of a
patient.
11.00.01 Environment.
The hospital must be constructed, arranged,
and maintained to ensure the safety of the
patient, and to provide facilities for diagnosis
and treatment, and for special hospital
services appropriate to the needs of the
community.
11.00.01 Environment.
The hospital’s “Hospital Maintenance” and hospital departments or services
are responsible for the hospital’s buildings and equipment (both hospital
equipment and patient care equipment) must be incorporated into the
hospital’s QAPI program and be in compliance with QAPI requirements.
Environmental findings include:
 Missing documentation for patient or other equipment biomedical
checks
 Off site locations are not included
 Environmental tours not conducted
 Issues reported or observed are not resolved
 Environmental issues not reported to the QAPI committee or other
leadership
12.00.01 Condition of Participation:
Quality Assessment Performance Improvement.
 The hospital must develop, implement, and maintain an effective,
ongoing, hospital-wide, data-driven quality assessment and
performance improvement program.
 The hospital’s governing body must ensure that the program reflects
the complexity of the hospital’s organization and services; involves
all hospital departments and services (including those services
furnished under contract or arrangement); and focuses on indicators
related to improved health outcomes and the prevention and
reduction of medical errors.
 The hospital must maintain and demonstrate evidence of its QAPI
program for review by CMS.
12.00.01 Condition of Participation:
Quality Assessment Performance Improvement.
The quality assessment performance improvement program is found non
compliant due to:
 QAPI is Hospital wide
 QAPI not developed or implemented
 Maintenance not included in QAPI
 Not effectiveness or ongoing
 Not data-driven
 Contract services not included in QAPI
 Improved outcomes not documented
 Reduction of medical errors not addressed, no plan of action
included
 Missing reporting mechanisms
20.00.01 Condition of Participation:
Emergency Services.
The hospital must meet the
emergency needs of patients in
accordance with acceptable
standards of practice.
20.00.01 Condition of Participation:
Emergency Services.
 The facility Written Plan for the provision of care and
services identifies the level of emergency services
provided.
 This usually is patterned after Federal or State guidelines
for "trauma" designations. Facilities which offer specialty
services only, and very small - isolated facilities may opt
to list their level of emergency service as "triage, stabilize
and transport“ providing only very basic levels of
emergency care.
25.00.00 Condition of Participation:
Pharmaceutical Services.
The hospital must have pharmaceutical services
that meet the needs of the patients.
The institution must have a pharmacy directed by
a registered pharmacist or a drug storage area
under competent supervision.
The medical staff is responsible for developing
policies and procedures that minimize drug errors.
This function may be delegated to the hospital’s
organized pharmaceutical service.
30.00.00 Condition of Participation:
Surgical Services
If the hospital provides surgical services, the
services must be well organized and provided in
accordance with acceptable Standards of Practice.
If outpatient surgical services are offered, the
services must be consistent in quality with inpatient
care in accordance with the complexity of services
offered.
ASC
HFAP
TOP-SCORED
HFAP STANDARDS
04.00.06 Program Activities.
The ASC must set priorities for its performance
improvement activities that:
Focus on high-risk, high-volume and problemprone areas. §416.43(c)(1)(i).
Consider incidence, prevalence and severity of
problems in those areas. §416.43(c)(1)(ii)
Affect health outcomes, patient safety and quality
of care.§416.43(c)(1)(iii)
04.00.06 Program Activities.
 ASCs not consistently tracking incidences rates or frequency
at which problems occur in the ASC related to indicators
 ASCs not tracking their severity of problems such as patient
transfers of patients to a hospital, other adverse or
unplanned outcomes fro surgical procedures
 ASCs not conducting evaluations of surgical cases, even
when procedures are low volume cases/incidents.
 ASCs not collecting, analyzing and aggregating data based
on their indicators.
04.00.09 Preventive Strategies.
The ASC must implement preventive
strategies throughout the facility targeting
adverse patient events and ensure that all
staff is familiar with these strategies.
04.00.09 Preventive Strategies
Once an ASC has identified opportunities for
improvement, the ASC must develop specific
changes in its policies, procedures, equipment,
etc., as applicable, to accomplish improvements in
the their identified areas of weakness.
The ASC must implement preventive strategies
designed to reduce the likelihood of adverse
events throughout the ASC.
04.00.09 Preventive Strategies
ASCs found not to be tracking medication
error’s, missed medication error’s, wrong
site surgery, time out not conducted, or not
inclusive of entire surgical team, “missed”
wrong site surgery, adverse events, or
hospital transfers.
Must have processes in place to reduce or
eliminate errors.
04.00.10 Performance Improvement
Projects.
The number and scope of distinct improvement projects
conducted annually must reflect the scope and complexity
of the ASC’s services and Operations.
 Each ASC must undertake one or more specific quality
improvement projects each year
 ASCs do not identify quality improvements projects, may identify
too many projects that are not possible to implement
 Not reflective of service provided
04.00.11
Documentation of Projects.
The ASC must document the projects that are
being conducted. The documentation at a
minimum must include the reason(s) for:
a) implementing the project – type/service
b) description of the projects results- analysis
and outcomes/action plans to correct
05.00.02 Physical Environment.
The ASC must provide a functional and sanitary environment
for the provision of surgical services some examples include:
 Improper lighting equipment, dirty lighting equipment
 Insufficient space to provide care, treatment and serves, space does
not allow for staff to respond to a patient life threating emergency
situation properly
 Exit doors in OR suite
 Open decontamination room connected to OR suite that allows for
steam to enter OR suite
05.01.07 Emergency Equipment.
The ASC medical staff and governing body of the ASC coordinates,
develops, and revises ASC policies and procedures to specify the types of
emergency equipment required for use in the ASC’s operating room.
The equipment must meet the following requirements:
a) Be immediately available for use during emergency situations (equipment is
out for repair, no without backup equipment available, batteries not available)
b) Be appropriate for the facility’s patient population ( either do not have the
needed equipment or equipment is something that has not been use or ever
used)
c) Be maintained by appropriate personnel (missing biomedical or other
services evaluation of equipment, equipment not evaluated be fore use on
patients, missing patient equipment inventory list
12.00.03 Infection Control Program.
The ASC must maintain an ongoing program
designed to prevent, control, and investigate
infections and communicable diseases.
In addition, the infection control and prevention
program must include documentation that the ASC
has considered, selected, and implemented
nationally recognized infection control guidelines.
12.00.03 Infection Control Program.
The program must be:
 Must be under the direction of a designated and qualified professional who has
training in infection control. §416.51(b)(1) (ASCs fail to designate an ICO,
committee, or IC consultant to provide direction and oversight of IC program).
 Must be part of an integral part of the ASC’s Quality Assessment Performance
Improvement program (QAPI) §416.51(b)(2)-(ASCs failure to provide data to the
QAPI program, no designated person to oversee QAPI performance
measures).
 Must be responsible for providing a plan of action for preventing, identifying and
managing infections and communicable diseases and for immediately implementing
corrective and preventive measures that result in improvement.
 (ASCs failure to develop action plan for improvements or to identify and
report to the state).
HFAP
TOP SCORED
ASC CoPs
01.00.02 Governing Body & Management.
Must have a Governing Body that assumes full
legal responsibility for determining, implementing,
and monitoring policies governing the ASC total
operation.
The governing body has oversight and
accountability for the quality assessment and
performance improvement program, ensures that
facility policies and programs are administered so
as to provide quality health care in a safe
environment, and develops and maintains a
disaster preparedness plan.
01.00.02 Governing Body & Management.
The regulation particularly stresses the responsibility of the
governing body for:
Direct oversight of the ASC’s Quality Assessment
Performance Improvement (QAPI) program (see 72
FR 50472, August 31, 2007 and 73 FR 68714,
November 18, 2008).
The quality of the ASC’s healthcare services.
The safety of the ASC’s environment. Development
and maintenance of a disaster preparedness plan.
03.00.02 Surgical Procedures
Performed Safely.
Surgical procedures must be performed in a safe
manner by qualified physicians who have been
granted privileges by the Governing Body of the
ASC in accordance with approved policies and
procedures of the ASC.
03.00.02 Surgical Procedures
Performed Safely.
The ASC’s governing body is responsible for
reviewing the qualifications of all physicians who
have been recommended by qualified medical
personnel and granting surgical privileges as the
governing body determines appropriate
03.00.02 Surgical Procedures
Performed Safely.
 For all cases, the physician must be licensed in the State in which
the ASC is located and practicing. (ASCs fail to PSV license,
license is expired)
 Must function within the scope of his/her license (physician
operate outside approve privileges granted, or not part of
medical training)
 Regulation requires that each physician who performs surgery in the
ASC has been determined qualified and granted privileges for the
specific surgical procedures he/she performs in the ASC (ASCs fail
to document approved privileges for initial, reappointments,
approve all “hospital” privileges, etc.)
04.00.01 Quality Assessment
Performance Improvement.
The ASC must develop, implement and
maintain an ongoing, data-driven Quality
Assessment Performance Improvement
(QAPI) program.
04.00.01 Quality Assessment
Performance Improvement.
 Ongoing: Performance Improvement Program for ASC such as
quality data at regular intervals; analysis of the updated data at
regular intervals; and updated records of actions taken to
address quality problems identified in the analyses, as well as
new data collection to determine if the corrective actions were
effective.
 Data-driven: ASCs must identify in a systematic manner what
data is collected, measurement of various aspects of quality
of care, the frequency of data collection, how the data is
analyzed and evidence that the program used the data
collected to assess quality and stimulate performance
improvement.
06.00.01 Medical Staff Membership &
Clinical Privileges.
 The Medical Staff of the ASC must be accountable to the
Governing Body.
 Governing body must approve bylaws (no documentation
of bylaw requirements).
 A physician owner must nevertheless implement a formal
process for complying with all medical staff regulatory
requirements. (findings are that ASCs have no process in
place or incomplete).
07.00.01 Nursing Services.
 The nursing services of the ASC must be directed and staffed to
assure that the nursing needs of all patients are met
 The ASC must ensure that the nursing service is directed under the
leadership of an RN and must have documentation that it has
designated an RN to direct nursing services (findings show no RN
designated to over see ASCs services)
 There must be sufficient nursing staff with the appropriate
qualifications to assure the nursing needs of all ASC patients are
met (issues with RN qualifications, training, etc.)
12.00.01 Infection Control.
The Ambulatory Surgery Center (ASC)
must maintain an infection control program
that seeks to minimize infections and
communicable diseases.
Your Infection Control plan must consider
your geographic location and patient
population.
12.00.01 Infection Control.
 Provide a functional and sanitary environment for surgical services, to avoid
sources and transmission of infections and communicable diseases
 Based on nationally recognized infection control guidelines
 Be directed by a designated health care professional with training in infection
control
 Be integrated into the ASC’s QAPI program
 Be ongoing
 Must Include actions to prevent, identify and manage infections and
communicable diseases
 Must Include a mechanism to immediately implement corrective actions and
preventive measures that improve the control of infection within the ASC
12.00.01 Infection Control.
ASCs found not in compliance due to the
following:
 Faculties not cleaned or maintained
 Designated staff not qualified or trained to over see IC program
 Missing national recognized guidelines/or outdated
 Missing or no corrective action plans development to address ASC IC
issues identified
 IC plan not included into QAPI
QUESTIONS ????
QUESTIONS?
Please submit questions to:
Donna Tiberi Blaszczyk RN
312-202-8073
Karen Beem RN
312-202-8069