Medical Record Services 0432
Must have medical record (MR) services and
have an administrator responsible for MR who
will sample 10% of daily census and at least 30
records
Must keep MR on every patient and have one
unified MR service responsible for all MR, both
inpatient and outpatient
MR includes radiology films and scans,
pathology slides, computerized information, etc.
1
Staffing of Medical Records A-0432
Organization must be appropriate for size and must
employ adequate personnel to ensure prompt
completion, filing, and retrieval
Must have proper education, skills, qualifications and
experience to meet state and federal law
 California law: medical record service must be under the
supervision of a registered records administrator or
accredited records technician
Ensure proper coding and indexing of records
Surveyor will look at job descriptions and staffing
schedules
2
Retention of Record A-0438
MR on each patient
Both inpatients and outpatients
MR must be accurate (contain all orders, test
results, care plans, treatment and response to
treatment), complete, retained and accessible
(accessible 24 hours a day)
Use a system of author identification and protect
security of all records
Protect from fire, water damage and other threats
3
Medical Records
Must be promptly completed and within 30 days
 California law: must be completed within two weeks
after discharge
Kept at least five years (A-0439) in original,
microfilm, computer memory or other electronic
storage
 California law: must keep seven years, longer for minors
Certain medical records must be retained longer if
required by state or federal law (OSHA, EPA,
FDA)
See CHA’s Records Retention Guide
Will request records from 48-60 months ago
4
Retrieval A-0440
Must have a system of coding and indexing that
allows timely retrieval of MR
Must be able to retrieve by diagnosis and
procedure to support medical care studies
 California law: indexed according to patient, disease,
operation, practitioner
MRs must be accessible for departments that
need them, such as the emergency department
5
Confidentiality A-0441 and A-0442
Must have a procedure for ensuring
confidentiality of MR
Copies may be released only to authorized
individuals, or upon written authorization by
proper person, agent under AD, guardian, etc.
Surveyor will ask for policy
Release only for court orders, subpoenas,
in-house education purposes, etc.
6
Content of Records A-0449
Contain records, notes, reports, assessment to:
 Justify admission and continued hospitalization
 Support the diagnosis
 Describe the patient’s progress
 Describe response to medications and to interventions,
care, and treatment
 Records must be promptly filed in chart
7
Legible and Authenticated A-0450 6-5-09
All entries must be legible, complete, dated and
timed
Must be authenticated by the person responsible
for ordering, providing, or evaluating the service
provided
Specify in MS or hospital policy who can make
entries in medical record
Need method to identify author (written signatures,
initials, computer key, or other code) and a list of
written signatures must be available
8
Legible and Authenticated (continued)
Must have P&P if electronic medical record
If non-MD does H&P or documents exams, must
be authenticated
MS R&Rs address countersignature when
required by policy or state law and this is defined
in MS R&Rs
Section on standing orders (preprinted order sets)
 Sign, date, and time the last page
 Include total number of pages such as page 3 of 3
 Initial any changes, additions, or deletions
9
Medical Records A-0450
If rubber stamp used, must have signed
statement that only the individual will use it,
Do not allow rubber stamp instead of signature
or you may not be paid for care
If electronic MR must demonstrate how
alterations are prevented
Can’t use system of auto authentication that says
can not review because not transcribed yet
10
Verbal Orders A-0454 and A-0457
 Verbal order section starting in MS section at Tag
A-0407 is repeated (already discussed)
 All doctors can sign VO for any other doctor on case until
Jan. 2012
 California law: must be prescribing, attending, or covering physician
 Person who takes VO must read it back and write it down with date
and time
 When doctor or LIP authenticates and signs off order, must date and
time it also
 Sign off within 48 hours unless state law specifies specific time
frame, even all lab orders
 Can’t sign off within 30 days unless state law is that specific and not
just records be completed within this time frame
 California law: 48 hours
11
History and Physical A-0458 and A-0461
Repeats same provisions on H&P as in medical
staff section under Tags A-0358 and A-0359
H&P done within 24 hours, not older than 30
days and updated within 24 hours and updated
and on chart before patient goes to surgery
 California law: immediately before or within 24 hours
after admission
PA and NP can do if allowed by hospital and all
state laws allow and physician reviews and
authenticates with date, time, and signature
12
MR Must Contain A-0464 and A-0465
Must have admitting diagnosis in chart (A-0463)
All consults and findings by clinical staff and
others must be documented (A-0464)
Information must be promptly filed in the MR so
staff has access to it (A-0464)
Must document complications and hospital
acquired infections (HAI) and unfavorable
reactions to drugs and anesthesia (A-0465)
13
MR Must Contain A-0464 and A-0465 (continued)
It is important for all practitioners to be aware of
the need to document complications and how to
do this correctly
California law
 Title 22 contains a list of elements that must be
included in MR (see Ch. 14 of CHA’s Consent Manual)
14
Informed Consent A-0466
Interpretive guidelines issued on April 13, 2007,
and minor changes Oct. 17, 2008
Now three separate sections related to informed
consent: in patient rights, medical record and
surgical services tags (some redundancies)
Properly executed informed consent for
procedures and treatments specified by MS
Need list of all surgeries (as defined now by ACS
and AMA) and procedures with yes or no
 Can be grouped, such as “all procedures performed
in OR” rather than listing each procedure
15
Informed Consent MR Mandatory
Minimum elements in an informed consent form:
Name of hospital
Name of procedure or treatment
Name of responsible practitioner who is performing
Statement that benefits, material risks and
alternatives were explained
Signature of patient
Date and time form is signed
16
Medical Records A-0466
CMS has list of optional elements which they call a
“well-designed” consent form
Medical record must contain an informed consent
for procedures and treatments specified as
requiring one. MS bylaws R&Rs, or policies should
address this
Consider state laws requiring informed consent
such as for invasive procedures and any federal
laws such as informed consent for research
 Don’t forget special California requirements:
antipsychotics, pelvic exam under anesthesia, etc. (see
Ch. 4 of CHA’s Consent Manual)
17
Consider List of Procedures
Procedure Name
Requires Informed Consent
Ablations
Yes
Amniocentesis
Yes
Angiogram
Yes
Angiography
Yes
Angioplasties
Yes
Arthrogram
Yes
Arterial Line insertion (performed alone) Yes
Aspiration Cyst (simple/minor)
No
18
Consider List of Procedures (continued)
Procedure Name
Requires Informed Consent
Aspiration Cyst (complex)
Yes
Blood Administration
Yes
Blood Patch
Yes
Bone Marrow Aspiration
Yes
Bone Marrow Biopsy
Yes
Bronchoscopy
Yes
Capsule Endoscopy
Yes
19
Informed Consent List
One hospital (Providence Everett Medical Center)
has its informed consent list on the Internet
It has an excellent list of which procedures need
informed consent
List can be used by others to determine which
procedures they want to have informed consent
1http://www.providence.org/resources/everett/ConsentTrainingBooklet.doc
20
Informed Consent Forms
Need for all surgeries
Exception is emergencies
All inpatients and outpatients
For all procedures specified
Needs to reflect a process
Form must follow policies
Must include state and federal requirements
Must contain minimum requirements (mandatory)
21
Medical Records
Medical record must contain an informed consent
for procedures and treatments specified as
requiring one
Medical staff bylaws should address this
Consider state laws requiring informed consent
(see Ch. 4 of CHA’s Consent Manual)
Consider federal laws such as informed consent
for research
22
Well-Designed (Optional) May Also Include:
Name of the practitioner who conducted the
informed consent discussion with the patient or
the patient’s representative
Date, time, and signature of witness
Indication or listing of the material risks of the
procedure or treatment that were discussed with
the patient or the patient’s representative
23
Well-Designed (Optional) May Also Include: (continued)
Statement, if applicable, that physicians other than
the operating practitioner, including but not limited
to residents, will be performing important tasks
related to the surgery, in accordance with the
hospital’s policies and, in the case of residents,
based on their skill set and under the supervision
of the responsible practitioner
Must inform patient if someone is doing important
parts of the surgery, but having this information in
writing is optional
24
Well-Designed (Optional) May Also Include: (continued)
Statement, if applicable, that qualified medical
practitioner (QMPs) who are not physicians and
who will perform important parts of the surgery or
administration of anesthesia will be performing
only tasks that are within their scope of practice,
as determined under state law and regulation,
and for which they have been granted privileges
by the hospital
Sample forms in CHA’s Consent Manual
25
Survey Procedure
Verify that MS has list of procedures and
treatments that require consent, and that hospital
implements list
Verify that informed consent forms contain the
six mandatory elements
Compare the hospital standard informed consent
form to the P&Ps to make sure consistent
Make sure any state law requirements are
included
26
Chart Must Contain A-0467
Medical record must contain all orders, nursing
notes, reports, medication records, radiology, lab
reports, and vital signs
Orders must be authenticated or signed off
All reports of treatment which include
complications
Any other information used to monitor the
patient’s condition
27
Discharge Summary A-0468
All medical records must have a discharge
summary with outcome of hospitalization
Disposition of the patient
Provisions for follow-up care
Follow-up care includes post-hospital
appointments, how care needs will be met, and
any plans for home health care, LTC, hospice or
assisted living
Can delegate to NP or PA if allowed by state law
(California allows) but physician must
authenticate, date and time it
28
Final Diagnosis A-0469
Every medical record has to have a final
diagnosis
Medical records must be completed within 30
days (same as TJC)
 California law: 2 weeks
Includes inpatient and outpatient charts
29
Pharmaceutical Services A-0490
Hospital must have a pharmacy to meet the
patient’s needs and promote safe medication use
process
Must be directed by registered pharmacist or drug
storage area under constant supervision
MS is responsible for developing P&Ps to minimize
drug error
Function may be delegated to the pharmacy
service
30
Pharmacy A-0490
Provide medication-related information to hospital
personnel
Medication management is important to CMS and
TJC. TJC has a medication management chapter
Contains list of functions of the pharmacist (collect
patient-specific information, monitor effects,
identify goals, implement monitoring plan with
patient, etc.)
Flag new types of mistakes
31
Pharmacy Policies Include:
High alert medication-dosing limits: packaging,
labeling and storage (policy at www.wpsi.org)
and ISMP (Institute for Safe Medication Practice)
and USP have list of high alert medications
Limit number of medication-related devices and
equipment: no more that 2 types of infusion
pumps (A-0490)
Availability of up-to-date medication information
Pharmacist on call if not open 24 hours
32
Pharmacy Policies Include: (continued)
Avoid dangerous abbreviations
All elements of order: dose, strength, route, units, rate,
frequency
Alert system for look alike/sound alike (LASA)
Use of facility approved pre-printed order sheets
whenever possible (remember caution)
“Resume pre-op orders” is prohibited
Voluntary, non-punitive reporting system to monitor and
report adverse drug events
 Remember adverse event reporting, medication error
reporting (see Ch. 20 of CHA’s Consent Manual)
33
Pharmacy Policies Include: (continued)
Preparation, distribution, administration and
disposal of hazardous medications (chemotherapy)
Drug recall
Patient-specific information that should be readily
available (TJC tells you exactly what this is, like
age, sex, allergies, current medications, etc.)
Means to incorporate external alerts and
recommendations from national associations and
government for review and policy revision (TJC,
ISMP, FDA, IHI, AHRQ, Med Watch, NCCMER,
MEDMARX)
34
Pharmacy Policies Include (A-0490): (continued)
Identification of weight-based dosing for pediatric
populations
Requirements for review based on facilitygenerated reports of adverse drug events and PI
activities
Policy to identify potential and actual adverse
drug events (IHI trigger tool, concurrent review,
observe med passes, etc.)
Must periodically review all P&Ps
35
Pharmacy Policies Include: (continued)
Need a multidisciplinary committee - committee
of medicine, nursing, administration, and
pharmacy to develop P&P
MS must develop P&P or have policy that this
function is fulfilled by pharmacy
Surveyors will question staff to determine if they
are familiar with all the medication P&Ps
Need policies to minimize drug error
36
Pharmacy Management A-0491
Pharmacy or drug storage must be administered in
accordance with professional principles (TJC
03.01.01 and problematic standard)
This includes compliance with state laws
(pharmacy laws), and federal regulations (USP
797), standards by nationally recognized
organizations (ASHP, FDA, NIH, USP, ISMP, etc.)
Pharmacy director must review P&P periodically
and revise
37
Pharmacy Management A-0491 (continued)
Drugs stored according to manufacturer’s
instructions
Pharmacy employees provide services within the
scope of their licensure and education
Sufficient pharmacy records to follow flow from
order to dispensing/administration
Maintain control over floor stock
38
Pharmacist A-0491
Ensure drugs are dispensed only by licensed
pharmacist
Must have pharmacist to develop, supervise, and
coordinate activities of pharmacy
Can be part-time, full-time or consulting
Single pharmacist must be responsible for overall
administration of pharmacy
39
Pharmacist A-0491 (continued)
Job description should define development,
supervision, and coordination of all activities
Must be knowledgeable about hospital pharmacy
practice and management
Must have adequate number of personnel to
ensure quality pharmacy service, including
emergency services
Sufficient to provide services 24 hours per day, 7
days a week
40
Pharmacy Delivery of Service A-0500
Keep accurate records of all scheduled drugs
Need policy to minimize drug diversion
Drugs and biologicals must be controlled and
distributed to ensure patient safety
In accordance with state and federal law and
applicable standards of practice
Accounting of the receipt and disposition of drugs
subject to Comprehensive Drug Abuse Prevention
and Control Act of 1970
41
Delivery of Service A-0500
Pharmacist and hospital staff and committee develop
guidelines and P&Ps to ensure control and distribution
of medications and medication devices
 Consider Black Box Warnings
System in place to minimize high alert medications
(double checks, dose limits, pre-printed orders, double
checks, special packaging, etc.)
And on high-risk patients (pediatric, geriatric, renal or
hepatic impairment)
High alert meds may include investigational, controlled
meds, medicines with narrow therapeutic range and
42
sound alike/look alike
Delivery of Service A-0500 (continued)
All medication orders must be reviewed by a
pharmacist before first dose is dispensed
Must review therapeutic appropriateness of
medication regime
Therapeutic duplication
Appropriateness of drug, dose, frequency, route
and method of administration
Real or potential med-med, med-food, med-lab
test, and med-disease interactions
Allergies or sensitivities and variation from
organizational criteria for use
43
Delivery of Service A-0500 (continued)
Sterile products must be prepared and labeled in
suitable environment
Pharmacy should participate in decisions about
emergency medication kits (such as crash carts)
 Medication stored should be consistent with age
group and standards (such as pediatric doses for
pediatric crash cart)
Must have process to report serious adverse drug
reactions to the FDA
44
Delivery of Service A-0500 (continued)
 Policy to address use of medications brought in
 P&P to ensure investigational meds are safely controlled and
administered
 Medications dispensed are retrieved when recalled or
discontinued by manufacturer or FDA (e.g., Vioxx)
 System in place to reconcile medications that are not
administered and that remain in medication drawer when
pharmacy restocks
 Will ask why it was not used?
 Not the same as medication reconciliation as in the TJC
NPSG which all hospitals should still do from a patient safety
perspective
45
Compounding of Drugs A-0501
All compounding, packaging, and disposal of drugs
and biologicals must be under the supervision of
pharmacist
Must be performed as required by state and federal
law
Staff ensures accuracy in medication preparation
Staff uses appropriate technique to avoid
contamination
46
Compounding of Drugs A-0501 (continued)
Use a laminar airflow hood to prepare any IV
admixture, any sterile product made from nonsterile ingredients, or sterile product that will not be
used within 24 hours (see USP 797)
Meds should be dispensed in safe manner and to
meet the needs of the patient
Quantities are minimized to avoid diversion,
dispensed timely, and if feasible in unit dose
All concerns, issues, or questions are clarified with
the individual prescriber before dispensing
47
Locked Storage Areas A-0502
Drugs and biologicals must be kept in a secure and
locked area
Would be considered a secure area if staff actively
providing care but not on a weekend when no one
is around
Schedule II, III, IV, and V must be kept locked
within a secure area (see also A-0503)
Only authorized persons have access to locked
areas
48
Locked Storage Areas A-0502 (continued)
Persons without legal access to drugs and
biologicals cannot have unmonitored access
They cannot have keys to storage rooms, carts,
cabinets or containers with unsecured medications
(housekeeping, maintenance, security)
Critical care and L&D areas staffed and actively
providing care are considered secure
Setting up for patients in OR is considered secure
(such as the anesthesia carts) but after case or
when OR is closed need to lock cart
49
Securing Medications
All controlled substances must be locked
Hospitals have greater flexibility in determining
which non-controlled drugs and biologicals must
be kept locked
Medications should not be stored in areas readily
accessible to unauthorized persons such as in a
private office unless visitors are not allowed
without supervision of staff
P&P needs to address security of any carts
containing drugs
50
Securing Medications (continued)
May allow patients to have access to urgently
needed drugs such as Nitro and inhalers
Need P&P on competence of patient, patient
education and must meet elements in TJC MM
standard on self administration
Measures to secure bedside medications
51
Locked Storage Areas A-0254
Saline flushes need to be secure to prevent
tampering, so under constant supervision or
locked up
If medication cart is in use and unlocked, then
someone with legal access must be close by and
directly monitoring the cart, such as when the
nurse is passing meds
Need policy for safeguarding, transferring and
availability of keys
52
53
ASA Standards, Guidelines, Statements
These are available at the ASA website1
Security of medications in the operating room
1http://www.asahq.org/publicationsAndServices/sgstoc.htm
54
55
Policy and Procedure
CMS states that they expect hospital P&Ps to
address the security and monitoring of any carts
including whether locked or unlocked if they
contain drugs and biologicals
In all patient care areas to ensure safe storage
and patient safety
P&P to keep drugs secure, prevent tampering,
and diversion
56
TJC Self Administered Meds
Self administered medications are safely and
accurately administered
If self administration is allowed, need procedure
to manage, train, supervise, and document
process
TJC MM stands for medication management
standard MM 5.20 or MM.06.01.03
57
TJC Self Administered Meds (continued)
 If non-staff member administers (such as
patient or family), must train and make sure
competent to do so (give info on nature of med,
how to administer, side effects, and how to
monitor effects)
 Patient must be competent before allowed to
self administer (document)
 Mentioned TJC in Federal Register but not
in Interpretive Guidelines
58
Outdated or Mislabeled Drugs A-0505
Outdated, mislabeled or otherwise unusable
drugs and biologicals must not be available for
patient use
Hospital has a system to prevent outdated or
mislabeled drugs
Surveyor will spot check individual drug
containers to make sure have all the required
information including lot and control number,
expiration date, strength, etc.
59
No Pharmacist on Duty A-0506
If no pharmacist on duty, drugs removed from
storage area are allowed only by personnel
designated in policies of MS and pharmacy service
Must be in accordance with state and federal law
Routine access to pharmacy by non-pharmacist
should be minimized and eliminated as much as
possible
E.g., night cabinet for use by nurse supervisor
Need process to get meds to patient if urgent or
emergent need
60
No Pharmacist on Duty A-0506 (continued)
TJC does not allow nurse supervisor in pharmacy
so would need to call the on-call pharmacist
Access is limited to set of medications that has
been approved by the hospital and only trained
prescribers and nurses are permitted access
Quality control procedures are in place like second
check by another or secondary verification like bar
coding
Pharmacist reviews all medications removed and
correlates with order first thing in the morning
61
Medications Errors A-0508
Hospital must monitor, implement, and enforce the
automatic stop order system
Drug errors, adverse drug reaction, and
incompatibilities must be immediately reported to the
attending MD/DO and to the hospital PI program and
to CDPH/patient, if required
Definition of med error or adverse drug event (ADE)
should be broad enough to include NEAR MISSES
Recommend use of definition by National
Coordinating Council medication error reporting and
prevention definition
62
Medications Errors A-0509 (continued)
Hospital must proactively identify med errors and
ADE and cannot rely solely on incident reports
Proactive includes observation of med passes,
concurrent and retrospective review of patient’s
clinical record, adverse drug reaction (ADR)
surveillance, evaluation of high alert drugs and
indicator drugs (Narcan, Romazicon, Benadryl,
Digibind, etc.) or generate a review for potential ADE
Remember FMEA (failure mode and effect analysis)
and IHI adverse event trigger tool is great
63
Abuses and Losses A-0509
Abuses and losses of controlled substances must
be reported to pharmacist and CEO and in
accordance with any state or federal laws
Surveyor will interview pharmacist to determine
their understanding of controlled substances
policies
What is procedure for discovering drug
discrepancies?
64
Drug Interaction Information A-0510
Information on drug interactions and information on
drug side effects, toxicology, dosage, indication for
use and routes of administration must be available
to staff
Texts and other resources must be available for
staff at nursing stations and drug storage areas
Staff development programs on new drugs added
to the formulary and how to resolve drug therapy
problems
65
Formulary A-0511
Formulary system must be established by the MS to
ensure quality pharmaceuticals at reasonable cost
Formulary lists the drugs that are available
Processes to monitor patient responses to newly
added medication
Process to approve and procure meds not on the list
Process to address shortages and outages including
communication with staff, approving substitution and
educating everyone on this, and how to obtain
medications in a disaster
66
Radiology A-0529
 Hospital has radiology services to meet needs
of patients
 Radiology services should be provided in
accordance with accepted standards of practice
 Radiology, especially ionizing procedures, must
be free from hazards for patients and personnel
 Must have policy that provides for safety of both
67
Safety A-0535
 Proper safety precautions maintained against
radiology hazards
 Including shielding for patients and personnel as
well as storage, use, and disposal of radioactive
materials
 Need order of practitioner with privileges or
practitioners outside the hospital who have been
authorized by MS to order as allowed by state law
 Periodic inspection of equipment and fix any hazard
(A-0537)
 Check radiation workers by use of badge tests or
68
exposure meters (A-0538)
Personnel
 Qualified radiologist must supervise ionizing
radiology services
 Must interpret those tests that are determined by
the MS to require a radiologist’s specialized
knowledge
 Written policy approved by MS to designate which
tests require interpretation by radiologist
 If telemedicine is used, radiologist interpreting
must be licensed and meet state law
requirements (state medical board requirements)
(A-0546, see A-0023)
69
Personnel A-0546
Supervision of radiology by radiologist who is
member of the MS. Supervision should include the
following:
 Ensure reports are signed by the practitioner who
interpreted them
 Assign duties to personnel based on their level of
training, experience and licensure
 Enforce infection control standards
 Ensure emergency care if patient experiences
ADR to diagnostic agent
70
Radiology A-0547
 Ensure files, records are kept in secure area and
retrievable, train staff on how to operate
equipment safely
 Written policy, approved by the MS, on who can
use radiology equipment and administer
procedures
 Only qualified personnel may use radiology
equipment
 Surveyor will review personnel folders to make
sure they are qualified as established by the MS
for the tasks they perform
71
Radiology Records
 Radiology records must be maintained for all procedures
performed (A-0553)
 Must contain copies of all reports and printouts and any
films, scans, or other image records
 Must have written P&P to ensure the integrity of
authentication and protect privacy of radiology records –
must be secure and retrievable for five years (seven years
in California, longer for minors)
 Radiologist or other practitioner who performs radiology
services must sign the report of his or her interpretation
 They have to be signed by the one who read and
evaluated the x-ray (not the partner who is reviewing the
dictated report) A-0554
72
Laboratory Services A-0576
 Must have adequate lab services to meet the
needs of the patient
 All lab services provided in any hospital
department must meet these guidelines
 All services must be provided in accordance with
CLIA requirements (Clinical Laboratory
Improvement Amendments) and have CLIA
certificate
 Can provide lab services directly or as contracted
service
73
Lab Services
 All lab services, including contracted services,
must be integrated into hospital-wide PI
 Lab results are considered medical records and
must meet all MR CoPs
 Must have lab services available either directly
or indirectly
 Must meet needs of its patients and in each
location of the hospital
 TJC has lab standards also
74
Emergency Lab-Services Available A-0583
 Must provide emergency lab services 24 hours a
day, 7 days a week – directly or indirectly
(contracted)
 Hospital with multiple campuses must have available
24/7 at each campus
 MS must determine which lab tests will be
immediately available
 Should reflect the scope and complexity of the
hospital’s operations
 Written description of emergency lab services available
 Written description of tests available are provided to MS on
routine and stat basis
75
Tissue Specimens A-0584
 Written instructions for the collection,
preservation, transportation, receipts, and
reporting of tissue specimen results
 MS and pathologist determine when tissue
specimens need macroscopic (gross) and
microscopic examination
 Need written policy on this
 TJC has new chapter in 2009 on transplant
safety and FAQs
76
Blood Banks A-0592
 Potentially infectious blood and blood
components
 This section completely rewritten in 2008, so
have person in charge of P&P in this area and
the lookback program review these changes
 May need to update P&Ps
 TJC has similar sections in transplant safety
chapter starting with TS.01.01.01 through
TS.03.03.01 and PC chapter for blood and blood
components
77
78
Blood and Blood Components
 Potentially HIV and hepatitis C virus (HCV) infectious
blood and blood products are collected from a donor
who tests negative
 If on a later donation, the donor tests positive, then
more specific test or follow-up testing is done as
required by FDA
 If services provided by outside blood collecting
establishment (blood bank) then need agreement to
govern procurement, transfer and availability of blood
and blood products
 Agreement with blood bank must require blood bank
to notify hospital promptly (HIV and HCV)
79
Blood Banks A-0592 (continued)
 Time depends on if tested positive on this unit or
tested negative but on later donation tested positive
 Within 3 calendar days if blood tested is positive later
 Follow-up notification within 45 calendar days after
reactive screening test was positive for additional
tests
 See lookback procedures required by 21 CFR 610.45
et seq. and FDA regulations (see Ch. 20 of CHA’s
Consent Manual)
 Hospital will dispose of any remaining contaminated
blood from donor (TJC PC.05.01.01)
80
Patient Notification
 If administered potentially HIV/HCV infected
blood, hospital must make reasonable attempts to
notify patient over period of 12 weeks unless
patient already notified or unable to be located in
12 weeks
 Records of the source and disposition of all units
of blood and blood components must be kept for
10 years
81
Patient Notification (continued)
 A fully funded plan to transfer these records to
another hospital if the hospital closes (TJC
PC.05.01.05 maintains records on receipt, testing
and disposition of all blood and blood components
and fully funded plan to transfer records to another
organization if hospital ceases operation for any
reason)
 Must have P&P that meets federal and state laws
on notification of patients
82
Patient Notification (continued)
 Must document in MR
 Must conform to confidentiality requirements
 Must have 3 things in the content of the notice:
 Explanation of need for HIV and HCV testing and
counseling
 Enough written or oral information so can make an
informed decision
 List of programs where can get counseled and tested
 If minor or incompetent or deceased, then notify
legal representative
83
Food and Dietetic Services A-0618
 Hospital must have organized dietary services
 Must be directed and staffed by qualified personnel
 If contract with outside company, must have
dietician and maintain minimum standards and
provide for liaison with MS on recommendations on
dietary policies
 Dietary services must be organized to ensure
nutritional needs of the patient are met in
accordance with physician orders and acceptable
standard of practice
84
Dietary A-0618 (continued)
 Availability of diet manual and therapeutic
diet menus
 Frequency of meals served
 System for diet ordering and patient tray delivery
 Accommodation of non-routine occurrences
(parenteral nutrition, tube feeding, TPN,
peripheral parenteral nutrition, early/late trays,
nutritional supplements)
85
Dietary A-0618 (continued)
 Integration of food and dietetic services into
hospital-wide QAPI and infection control
programs
 Guidelines on acceptable hygiene practices of
personnel and kitchen sanitation
 Compliance with state and federal laws
86
Organization A-0620
 Must have full-time director who is responsible
for daily management of dietary services
 Must be granted authority and delegation by the
Board and MS for the operation of dietary
services
 Job description should be position specific and
clearly delineate authority for direction of food
and dietary services
 Includes training programs for dietary staff and
ensuring P&Ps are followed
87
Dietary Policies
 Safety practices for food handling
 Emergency food supplies
 Orientation, work assignment, supervision of work
and personnel performance
 Menu planning
 Purchase of foods and supplies
 Retention of essential records (cost, menus,
training records, QAPI reports)
 Participate in QAPI program
88
Dietitian A-0621
 Qualified dietician must supervise nutritional aspects of
patient care and approve patient menus and nutritional
supplements
 Patient and family dietary counseling
 Perform and document nutritional assessments
 Evaluate patient tolerance to therapeutic diets when
appropriate
 Collaborate with other services (MS, nursing, pharmacy,
social work)
 Maintain data to recommend, prescribe therapeutic diets
89
Personnel A-0622
 Must have administrative and technical personnel
competent in their duties
 Menus must be nutritional, balanced, and meet
special needs of patients
 Screening criteria must be developed to determine
which patients are at risk
 Once patient is identified, nutritional assessment
must be done (TJC PC.01.02.01)
 Patient must be evaluated
90
Nutritional Assessment A-0628
TJC requires assessment to be done within 24 hours
(PC.01.02.03)
 If patient requires artificial nutrition by any means
(tube feeding, TPN)
 If medical or surgical condition interferes with ability
to digest, absorb, or ingest nutrients
 If diagnosis or signs and symptoms indicate a compromised
nutritional status such as anorexia, bulimia, electrolyte
imbalance, dysphagia, malabsorption, ESRD
 If patient’s condition is adversely affected by nutritional intake
(diabetes, CHF, taking certain meds)
91
Therapeutic Diets A-0629
 Therapeutic diets must be prescribed in writing by the
practitioner responsible for patient’s care
 Dietician can make recommendations but diet must be
ordered by doctor
 Document in the MR including information about the
patient’s tolerance
 Evaluate for nutritional adequacy
 Manual must be available for nursing, FS, and medical
staff
 Dieticians can only make recommendations and can’t
92
order
Nutritional Needs A-0630
 Must be met in accordance with recognized
dietary practices
 Follow recommended dietary allowances: current
Recommended Dietary Allowances (RDA) or
Dietary Reference Intake (DRI) of Food and
Nutritional Board of the National Research Council
 “Dietary Guidelines for Americans 2005”1
 Surveyor will ask hospital which national standard
is being used
1www.heathierus.gov/dietaryguidelines
93
Next Sections
 Utilization review
 Infection Control
 Discharge Planning
 Organ and Tissue
 Surgery and Anesthesia
 Nuclear Medicine
 Emergency Services
 Respiratory
 Rehab
94
Utilization Review A-0652
 Hospital must have a UR plan that provides for
review of services furnished by the institution
and the members of the MS to Medicare and
Medicaid beneficiaries
 UR plan should state responsibility and authority
of those involved in the UR process
 Surveyor will make sure activities performed as
in UR plan
 CMS issued UR CoP memo June 22, 2007
95
Two Exceptions
 Hospital has an agreement with the QIO in its
state to assume binding review
 Many hospitals have contract with QIO to review
admissions, quality, appropriateness and diagnostic
information related to Medicare inpatients, will look
to see signed contract
 CMS has determined that the UR procedures
established by the state are superior to the ones
required under this section and state requires
hospital to meet UR requirements for Medicaid
program (there are none approved)
96
Composition of UR Committee A-0654
 Consists of 2 or more practitioners who carry
out UR function
 At least 2 members must be doctors
 The UR committee must be either a staff
committee of the hospital or an outside group
established by the local medical society for
hospitals in that locale and established in a
manner approved by CMS
97
UR Committee A-0654
 A committee may not be conducted by an
individual who has a direct financial interest (such
as an ownership interest) or who was
professionally involved in the care of the patient
whose case is being reviewed
 Surveyor will look to see if the governing board
has delegated UR function to an outside group if
impracticable to have a staff committee
98
Frequency of Review A-0655
 UR plan must provide review for
Medicare/Medicaid (M/M) patients with respect to
medical necessity
 Admissions (before, at, or after admission)
 Duration of stay
 Professional services furnished including drugs
and biologicals
99
Scope of Reviews A-0655
 Reviews may be on a sample basis except for
reviews of cases assumed to be outlier cases
because of extended stay or high costs
 Surveyor will examine UR plan to determine if
medical necessity is reviewed for admission,
duration of stay and services provided
 If IPPS hospital there should be a review of the
duration of stay in cases assumed to be outlier
100
Admissions or Continued Stay
 Determination that admission or continued stay
is not medically necessary is made by one
member of UR committee, if MD concurs with
determination or fails to present his/her views
when afforded the opportunity
 Must be made by two members in all other
cases (A-0656)
101
Admissions or Continued Stay (continued)
 Before determining admission or continued stay
is not medically necessary, UR committee must
consult the MD responsible for the care and
afford opportunity to present views
 Then committee must provide written notification
no later than two days after determination to the
hospital, patient and MD responsible for care
102
Admissions or Continued Stay (continued)
 If attending doctor does not respond or contest the
findings of the committee, the findings are final
 If physician on UR committee finds not medically
necessary, no referral of committee is necessary
and he may notify the attending doctor
 If non-physician makes the determination it must
go to the committee
 A non-physician can not make this final
determination
103
Physical Environment A-0700
 Hospital must be constructed, arranged, and
maintained to ensure the safety of patient
 And to provide diagnosis and treatment and for
services appropriate for the community
 This CoP applies to all locations of the hospital,
all campuses, all satellites
104
Physical Environment
 Hospital’s maintenance department and other
hospital departments responsible for the
buildings and equipment must be incorporated
into the QAPI program
 Must also be in compliance with the QAPI
requirements
 Survey of physical environment should be
conducted by one surveyor
 Life Safety Code (LSC) survey may be
conducted by specially trained surveyor
105
Life Safety Code
 Separate CoP
 Both TJC and CMS using 2000 version
 Hospitals should do review of LSC for gap
analysis
 TJC hospitals will have separate life safety
surveyor and larger hospitals might have one for
two days
 Also TJC surveyors have had training on LSC
106
Buildings A-0701
 Condition of physical plant and overall hospital
environment must be developed and maintained
for the safety and well-being of patients
 Making sure that routine and preventative
maintenance (PM) activities are done, as
manufacturer requires and by state and federal
law
 Conduct ongoing maintenance inspections
 Routine and PM and testing activities should be
incorporated into hospital QAPI plan
107
Buildings A-0701 (continued)
 Includes developing and implementing
emergency preparedness plans and capabilities
 Must coordinate with federal, state, and local
emergency preparedness and health authorities
(CDPH)
 To identify risks for their area (natural disasters,
bio-terrorism threats, disruption of utilities like
water, sewer, electrical, communication, fuel,
nuclear accident)
 Lists 14 things to consider in developing this
108
Buildings
 Transfer of hospital equipment to another facility
 Transfer or discharge of patients to home or other
hospitals
 Security of patients and walk in patients and
supplies from misappropriation
 Pharmacy, food, and other supplies and
equipment that may be needed
 Communication among staff
 Training needed to implement emergency
procedure
109
Emergency Power and Lighting
 Must be emergency power and lighting in OR,
PACU, ED, and stairwells
 All other areas must have emergency supply
source, battery lamps, and flashlights available
 Must comply with 2000 LSC-National Fire
Protection amendment NFPA 101, and NFPA-99
on health care facility for emergency lighting and
emergency power
 Doors with no roller latches need positive latching
110
Emergency Gas and Water
 Must be facilities for emergency gas and water
supply (A-0703)
 Includes making arrangements with local utility
company for emergency sources of gas/water
 One source for information on water is Federal
Emergency Management Agency (FEMA)
 Gas includes propane, natural gas, fuel oil, as well
as gases used such as oxygen, nitrous oxide,
nitrogen
111
Life Safety from Fire A-0709
 Must meet 2000 LSC of the NFPA
 CMS may waive specific provisions, after
consideration by state survey agency, if would
result in unreasonable hardship but only if
waiver will NOT adversely affect the health and
safety of patients
 Must follow state fire and safety code and CMS
may allow surveyor to apply instead of LSC
112
Trash A-0713
 Proper storage and disposal of trash
 Trash includes bio-hazardous waste
 Storage of trash must be in accordance with state
and federal law (EPA, CDC, OSHA, state
environmental health and safety regulations)
 Need policies for storage and disposal of trash
 H2E program – no fee (waste reduction, mercury,
etc.)1
1 www.h2e-online.org
113
Fire Control Plan A-715
 Need fire control plan
 Must contain section on prompt reporting of fires,
extinguishing fires, protection of patients and
guests, evacuation and cooperation with fire
fighting authorities
 Surveyor will review fire plan
 Verify all fires are reported to state officials
 Will interview staff to make sure they know what to
do during a fire
 Amended for alcohol-based hand dispensers
114
Facilities
 Keep written evidence of regular inspections and
approval by state or local fire control agencies
 Maintain adequate facilities for its service –
designed and maintained in accordance with
federal, state, and local laws
 Toilets, sinks, and equipment should be accessible
 Make sure water acceptable for its intended use –
drinking, lab water, irrigation – review water quality
monitoring
115
Ventilation, Light, Temperature
 Proper ventilation in areas using ethylene oxide,
nitrous oxide, gluteraldehydes, or other
hazardous substances
 Temperature controls in pharmacy and food
preparation
 Ventilation where O2 is transferred, in isolation
rooms and lab
 Adequate lighting in patient rooms and food and
medication preparation areas (shown to reduce
medication errors)
116
Ventilation, Light, Temperature (continued)
 Temperature, humidity, and airflow in OR within
acceptable standards to inhibit bacterial growth
 New OR humidity guidelines effective 6/10 (FGI)
 Each OR room should have a separate
temperature control - have temp and humidity
tracking logs
 Incorporate AORN – American Association of
periOperative Registered Nurses and American
Institute of Architects (now Facility Guidelines
Institute) should be incorporated into hospital
policy
117
Infection Control A-0747
 Updated to reflect changing infectious and
communicable disease threats including current
knowledge and best practices
 Very important in today’s healthcare environment
 CDC estimates there are 1.7 million HAIs in
hospitals every year and 99,000 deaths
 New Interpretive Guidelines were 12 pages long
1www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/list.asp
118
Infection Control (continued)
 TJC has chapter on Infection Prevention and
Control
 APIC now uses term “infection preventionists” (IPs)
 Hospital must have sanitary environment to avoid
sources and transmission of infection and
communicable diseases (A-0750)
 Active IC program for prevention, control, and
investigation of infections and communicable
diseases
119
Infection Control (IC) A-0750 (continued)
 Standards apply to all departments of hospitals,
both on and off campus
 Infection prevention must include monitoring of
housekeeping and maintenance including
construction activities
 Areas to monitor include food storage,
preparation, serving and dish rooms,
refrigerators, ice machines, air handlers,
autoclave rooms, venting systems, inpatient
rooms, supply storage and equipment cleaning
120
Infection Control (IC) A-0747 (continued)
 Must meet all standards of care and practice (APIC
(Association for Professionals in Infection Control
and Epidemiology), CDC, SHEA (Society for
Healthcare Epidemiology of America), OSHA, etc.)
 Need to investigate infections and communicable
diseases of inpatients and personnel working in
hospitals, including volunteers
 Must have active surveillance program that includes
specific measures for infection detection, data
collection, analysis monitoring, and evaluations of
preventive interventions
121
Infection Control
 Must have sampling or other mechanism in place to
identify and monitor infections and communicable
diseases
 Infection control must be integrated in PI
 Surveillance activities should be conducted in
accordance with recognized surveillance practices
such as those used by CDC NHSN (National
Healthcare Safety Net)
 California law: SB 158 and SB 1058 regarding
state-mandated infection control practices (see
memo in packets)
122
IC Officer’s Responsibilities
 Many have added these to their job descriptions
 Maintain sanitary hospital environment
(ventilation and water controls, construction –
make sure safe environment, safe air handling in
areas of special ventilations such as the OR and
isolation rooms, techniques for food sanitation,
cleaning and disinfecting surfaces, carpeting and
furniture, how is pest control done, and disposal
of trash along with non-regulated waste)
123
IC Officer’s Responsibilities (continued)
 Develop and implement IC measures (hospital
staff, contract workers, volunteers)
 Mitigation of risks associated with patient
infections present upon admission and risks
contributing to HAI
 Active surveillance
 Monitoring compliance with all P&Ps, protocols
and other infection control program requirements
124
IC Officer’s Responsibilities (continued)
 Program evaluation and revision of the program,
when indicated
 Coordination as required by law with federal,
state, and local emergency preparedness and
health authorities to address communicable
disease threats, bioterrorism and outbreaks
 Complying with the reportable disease
requirements of the local health authority (see
Ch. 20 of CHA’s Consent Manual)
 Make sure IC program is integrated into hospital
wide QAPI
125
Infection Control (IC) A-0749
 Long list of IC policies that hospitals must have
 Maintain a sanitary physical environment
 Hospital staff-related measures (evaluate hospital
staff immunization status for infectious diseases
as per CDC and APIC, screen hospital staff for
infections likely to cause significant infectious
disease to others, policy on when staff are
restricted from working)
126
IC Policies to Include
 New employees and what they need in orientation
(including handwashing)
 P&P to mitigate risk when patient admitted with
infection - must be consistent with the CDC isolation
guidelines, staff knowledge of PPE
 Mitigate risks that cause or contribute to HAI such as
SCIP measures, appropriate hair removal, timely
antibiotics in OR, DC in 24 hours except 48 hours for
cardiac patients, beta blockers during perioperative
periods for select cardiac patients, proper sterilization
of equipment, etc.
127
128
129
Medical Equipment and Supplies Resources
 Multi-Society Guidelines for Reprocessing
Flexible Gastrointestinal Endoscopes by
APIC at
www.apic.org/AM/Template.cfm?Section=Guidelines_and_Stand
ards&template=/CM/ContentDisplay.cfm&section=Topics1&Cont
entID=6381
 Disinfection of Healthcare Equipment chapter
in Guidelines for Disinfection and Sterilization
in Healthcare Facilities Nov 2008 at
www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.
pdf
 Single Use Device Reprocessing at
http://cms.h2e-online.org/ee/waste-reduction/waste-minimization/ 130
IC Policies to Include: (continued)
 Isolation procedures for highly immuno-suppressed
patients (HIV or chemo patients)
 Isolation procedures for trach care, respiratory care,
burns, and other similar situations
 Other HAI risk mitigation includes promotion of hand
hygiene, and measures to prevent organisms that are
antibiotic resistant such as MRSA and VRE
 Things such as central line bundle, VRE bundle or sepsis
bundle, prompt removal of foley catheter
 Disinfectants, antiseptics, and germicides, must be used
in accordance with manufacturer’s instructions
131
IC Policies to Include: (continued)
 Appropriate use of facility and medical equipment
(hepa filters and negative pressure room, UV lights
and other equipment to prevent the spread of
infectious agents)
 Patients, visitors, care givers, and staff must
receive education on infection and communicable
diseases
 There must be an active surveillance system,
method for getting data to determine if there is a
problem
 Policy on getting cultures from patients, etc.
132
Policies and Organization
 Need IC officer and IC committee
 IC officer must develop and implement policies on
control of infection and communicable diseases
 Person must be designated in writing who is
qualified through education and experience
 Lists the responsibilities of this person - consider
putting into job description
133
Log of Infections A-0750
 Must maintain a log related to infections and
communicable diseases, including HAI
 Includes information from patients and staff so need
information from employee health nurse
 Includes employees, contract staff such as agency
nurses, and volunteers
 Includes surgical site infections, patients or staff with
MDROs, patients who meet isolation requirements
 Log can be paper or electronic, TJC IC.01.01.01
134
CEO, CNO, and MS A-0756
 The CEO, CNO, and MS must ensure that there
is a hospital-wide QA and training program that
addresses problems identified by IC officer and
implement a successful corrective action plan in
affected problem areas
 Train staff in problems identified
 Problems must be reported to nursing, MS, and
administration
135
Discharge Planning A-0800
 Must have a discharge planning process that
applies to all patients (inpatients and outpatients)
 P&P must be in writing
 Written discharge planning policy must reveal a
clear process to be followed
 Necessary to prevent readmission
 Surveyor will review patient care plans for
discharge planning interventions
136
Identification of Patients A-0806
Must identify at early stage of hospitalization,
all patients who are likely to suffer adverse
consequences if no discharge planning
 No national tool to do this
 May include factors such as functional status,
cognitive ability and family support
 Patients at high risk should be identified during
screening process
137
Discharge Planning Evaluation
 Hospital must provide a discharge planning evaluation to
patients or upon the request of the physician
 Needs assessment can be formal or informal
 Assess factors, including what the patient will need when
discharged; bio-psychosocial needs and patient and
caregiver’s understanding of discharge needs
 Can be a tool or protocol
 Surveyor will ask how patients are made aware of their right
to request a discharge plan
 Are they given the pamphlet “Important Message from
Medicare?”
138
Discharge Planning Responsibility
 RN, SW, or qualified person must develop and
supervise the development of the evaluation
(A-0807)
 Person who does discharge planning evaluation
must have experience and knowledge of social and
physical factors that affect functional status to meet
patient needs (emphysema -coordinate respiratory
therapy, nursing care, financials for home health)
 Ideally, discharge planning is interdisciplinary
process
139
Evaluation A-0809
 Discharge planning evaluation must include
likelihood of needing post-hospital services and
availability of services
 Keep complete file on community-based services
such as LTC, subacute care, and home care
 Is physical, speech, occupational or respiratory
therapy needed?
 Use QAPI program to determine if discharge
planning process is effective
140
Self Care Evaluation
 Discharge planning evaluation must include whether
patient can perform self care and return to
pre-hospital environment
 Willingness of patient and family to do
 Inform patient of freedom to choose providers for
post-hospital care (A-0823)
 Give list of Medicare-certified HHAs that serve your area (SSA
1861) including ownership information
 Must assess if need hospice and give list of Medicare-certified
hospices and LTC (A-0809)
 Counsel patient and family regarding post-hospital care
(A-0822)
141
Discharge Plan
 If in MCO hospital must indicate which ones have
contract with home health or LTC (A-0825)
 Hospital must now document in the medical record
that the list of home health or LTC facilities was
presented to the patient (A-0827)
 Rewrite your P&P to include this
 Hospital must inform patient of freedom to choose
post-hospital provider (A-0828) and respect their
wishes (A-0829)
 HHA must request to be on the list
142
Timely Discharge Evaluation
 Hospital must complete the evaluation timely so
appropriate arrangements can be made
 Assessment should start soon after admission
 Surveyor will review several patient discharge
plans for appropriate coordination of health and
social resources
 Also need to reassess discharge planning
process on an ongoing basis (A-0843)
143
Transfer or Referral A-0837
 Must transfer or refer patients to appropriate
facilities, agencies, or outpatient services for
follow up care
 Must send along necessary medical records
 Make sure patients get appropriate post-hospital care
 Must document if patient refuses discharge
planning services
 Written authorization before release of information
(unless for treatment or payment)
144
Organ, Tissue, and Eye A-0884
 Hospital must have written P&P to address organ
procurement
 Must have agreement with OPO
 Must timely notify OPO if death is imminent or patient
has died
 OPO to determine medical suitability for organ donation
 Defines what must be in written agreement (definitions,
criteria for referral, access to your death record
information)
 TJC has similar standards in TS or transplant safety
chapter
145
Organ, Tissue, and Eye (continued)
 Board must approve organ procurement policy
 Must integrate into hospital’s PI program
 Surveyor will review written agreement with the
OPO to make sure it has all the required
information
 Check off the long list to ensure all elements are
present
146
Tissue and Eye Bank
 Need an agreement with at least one tissue and
eye bank
 OPO is gatekeeper and notifies the tissue or eye
bank chosen by the hospital
 OPO determines medical suitability
 Don’t need separate agreement with tissue bank
if agreement with OPO to provide tissue and eye
procurement
147
Family Notification
 Once OPO has identified a potential donor, family
must be informed of options
 OPO and hospital will decide how and by whom
the family will be approached
 Have to work cooperatively with the OPO and in
educating staff
 OPO can review death records
148
Organ Donation
 Person to initiate request must be a designated
requestor or authorized representative of tissue or
eye bank
 Designated requestor must have completed
course approved by OPO
 Encourage discretion and sensitivity to the
circumstances, views and beliefs of the families
 Surveyor will review complaint file for relevant
complaints
149
Organ Donation Training
 Patient care staff must be trained on organ
donation issues
 Training program at a minimum should include:
consent process, importance of discretion, role of
designated requestor, transplantation and
donation, QI, and role of OPO
 Train all new employees, when change in P&P,
and when problems identified in QAPI process
150
Organ Donation
 Hospital must cooperate with OPO to review
death records to improve ID of potential donors
 Surveyor will verify P&P that hospital works with
OPO
 Maintain potential donors while necessary testing
and placement of donated organs take place
 Must have P&P to maintain viability of organs
 Ensure patient is declared dead within acceptable
timeframe
151
Organ Transplantation
 Hospital in which organ transplants are
performed must be member of OPTN – Organ
Procurement and Transplantation Network
 Must abide by its rules – 42 USC 274, Section
372 of the Public Health Service Act
 Must provide data to OPTN, Scientific Registry
and OPO
152
Surgical Services A-0940
 If provide surgical services, service must be well
organized
 If outpatient surgery, must be consistent in quality
with inpatient care
 Must follow acceptable standards of practice, AMA,
ACOS, APIC, AORN
 Must be integrated into hospital-wide QAPI
 Will inspect all OR rooms
 Access to OR and PACU must be limited to
authorized personnel
153
What Constitutes Surgery? A-0940
 Use ACS definition now
 Surgery is performed for the purpose of altering
the human body by the incision or destruction of
tissue and is part of the practice of medicine
 No longer used if billed by Medicare as a surgery
 Important in that must have informed consent for
any surgery and anesthesia done by patient
going thru surgery except local and moderate
sedation
154
155
Surgical Services A-0940
 Conform to aseptic and sterile technique
 Appropriate cleaning between cases
 Room is suitable for kind of surgery performed
 Equipment available for rapid and routine
sterilization
 And it is monitored, inspected and maintained by
biomed program
 Temperature and humidity controlled
 ACS and AORN have P&P on many of these
156
Surgery A-0942
 OR must be supervised by experienced RN or
MD/DO
 Must have specialized training in surgery and
management of surgical service operation
 Will review job description
 Nurse ratios must be met
157
Surgical Privileges
 Surgical privileges must be delineated for all
practitioners performing surgery, in accordance
with competence of each practitioner
 Surgery service must maintain roster specifying
surgical privileges
 Privileges must be reviewed every two years
 Current list of surgeons suspended must also be
available
158
Surgical Privileges (continued)
 MS bylaws must have criteria for determining
privileges
 Surgical privileges are granted in accordance
with the competence of each practitioner
 MS appraisal procedure must evaluate each
practitioner’s training, education, experience,
and demonstrated competence
 As established by the QAPI program,
credentialing, adherence to hospital P&P and
laws
159
Surgical Privileges A-0945
 Must specify for each practitioner that performs
surgical tasks including MD, DO, dentists, oral
surgeons, podiatrists
 RNFA, NP, surgical PA
 Must be based on compliance with what they are
allowed to do under state law
 If task requires it to be under supervision of
MD/DO, this means supervising doctor is
present in the same room working with the
patient
160
Surgery Policies A-0951
 Aseptic and sterile surveillance and practice,
including scrub technique
 ID of infected and non-infected cases
 Housekeeping requirements/procedures
 Patient care requirements – pre-op work area patient consents and releases - safety practices
- pt ID process - clinical procedures
161
Surgery Policies A-0951
 Duties of scrub and circulating nurses
 Safety practices
 Surgical counts
 Scheduling of patients for surgery
 Personnel policies in OR
 Resuscitative techniques
 DNR status
 Care of surgical specimens
162
Surgery Policies A-0951 (continued)
 Malignant hyperthermia
 Protocols for all surgical procedures
 Sterilization and disinfection procedures
 Acceptable OR attire
 Handling infectious and biomedical waste
 Outpatient surgery post-op planning
163
Preventing OR Fires A-0951
 Read detailed section on use of alcohol-based
skin prep and how to prevent an OR fire
 AORN has very detailed policy on flammable prep
in the OR and how to prevent fires
 Special precautions developed by NFPA and
incorporated into NPSG by TJC
 ASA has good document on preventing fires in the
OR
 Pennsylvania Patient Safety Authority has great
recommendations
164
H&P A-0952
 See prior sections on H&P
 H&P must be in the chart before the patient goes
to surgery
 Except in emergencies
 P&Ps specify what is an emergency
165
Consent A-0955
 Informed consent is in three sections of the
Interpretive Guidelines and each is different and
not a repeat
 Third section is in the surgery chapter (surgical
services)
 Consent must be in chart before surgery
 Exception for emergencies
166
Informed Consent (continued)
 Recommend anesthesia consent now (A-0955)
 Lists elements for well-designed process, which
are the optional elements
 Mandatory elements were under MR section
 Specifies what must be in the consent policy
 Who can obtain
 Which procedures need consent
167
Informed Consent Policy (continued)
 When is surgery an emergency
 Content of consent form
 Process to obtain consent
 If consent obtained outside hospital how to
get it into medical record
168
Informed Consent A-0955
 Should disclose if residents, RNFA, Surgical PAs,
Cardiovascular Techs are doing significant tasks
 Important surgical tasks include: opening and
closing, dissecting tissue, removing tissue,
harvesting grafts, transplanting tissue,
administering anesthesia, implanting devices and
placing invasive lines
 No requirement to have this in writing
169
Surgery Equipment A-0956
 Call-in system
 Cardiac monitor
 Defibrillator
 Aspirator (suction equipment)
 Trach set (cricothyroidotomy equipment is not a
substitute)
 TJC PC.03.01.01 includes this plus ventilator, and
manual breathing bags
170
PACU A-0957
 Must be adequate provisions for immediate postop care
 Must be in accordance with acceptable standards
of care
 Separate room with limited access
 P&Ps specify transfer requirements to and from
PACU
 PACU assessment includes level of activity,
respiration, BP, LOC, patient color (Aldrete)
 Follow ASPAN standards
171
OR Register A-0958
 Patient’s name, ID number
 Date of surgery
 Total time of surgery
 Name of surgeons, nursing personnel,
anesthesiologist, and assistants
 Type of anesthesia
 Operative findings, pre-op and post-op diagnosis
 Age of patient
 See TJC RC.02.01.03 which are now the same 172
Operative Report A-0959
 Name and ID of patient
 Date and time of surgery
 Name of surgeons, assistants
 Pre-op and post-op diagnosis
 Name of procedure
 Type of anesthesia
173
Operative Report A-0959 (continued)
 Complications and description of techniques
and tissue removed
 Grafts, tissue, devices implanted
 Name and description of significant surgical
tasks done by others (see list-opening, closing,
harvesting grafts, etc.)
174
Anesthesia A-1000
 Must be provided in well organized manner under
qualified doctor
 Optional service
 Must be integrated into hospital QAPI
 MS establishes criteria for director’s qualifications
 Revised Dec. 11, 2009
175
Anesthesia A-1000 (continued)
 Will review job description of director – see
elements
 Wherever anesthesia is done – radiology, OB, OR,
outpatient surgery areas
 State exemption process of MD supervision for
CRNA
 California has opted out
176
Anesthesia A-1000 (continued)
 If hospital provides any degree of anesthesia
service must comply with all CoPs
 Anesthesia involves administration of medication
to produce a blunting or loss of:
 Pain perception (analgesia)
 Voluntary and involuntary movements
 Memory and or consciousness
 Analgesia is the use of medication to provide pain
relief thru blocking pain receptor in peripheral and/
or CNS where patient does not lose consciousness
177
Epidural or Spinal in OB
 The administration of a regional (epidural or
spinal) for the purpose of analgesia during labor
and delivery
 Is not considered anesthesia
 Therefore, it is not subject to the supervision
requirements for CRNA
 Unless subsequent administration of medication
for operative delivery like a C-section then the
anesthesia standards apply
178
Monitored Anesthesia Care (MAC)
 Anesthesia care that includes monitoring of patient
by an anesthesia professional (such as
anesthesiologist or CRNA)
 Include potential to convert to a general or regional
anesthetic
 Deep sedation/analgesia is included in a MAC
 Deep sedation: where drug-induced depression of
consciousness during which patient can not easily
be aroused but responds purposefully following
repeated or painful stimulus
179
Anesthesia Services A-1000
Anesthesia services not subject to anesthesia
administration and supervision requirements:
 Topical or local anesthesia
 Minimal sedation: drug-induced state in which
patient can respond to verbal commands such as
oral medication to decrease anxiety for MRI
 Moderate or conscious sedation: in which
patients respond purposely to verbal commands,
either alone or by light tactile stimulation
180
Anesthesia Services A-1000 (continued)
 Rescue capacity
 Sedation is a continuum so need intervention by one
with expertise in airway management
 Must have procedures in place to rescue patients whose
sedation becomes deeper than initially intended
 Anesthesia services must be under one
anesthesia services department, under direction of
qualified physician no matter where performed
 Operating room, both inpatient and outpatient
 OB, radiology, clinics, ED, psychiatry, endoscopy, etc.
181
Organization and Staffing A-1001
 Anesthesia (general, regional, MAC including deep
sedation) can only be administered by:
 Qualified anesthesiologist or CRNA
 Anesthesiology assistant (AA) under the supervision of
anesthesiologist who is immediately available if needed
(not allowed in California)
 Dentist, oral surgeon, or podiatrist who is qualified to
administer anesthesia under state law
 CMS may not require MD supervision for CRNA in
state that has an exemption1
1
List of 15 state exemptions at www.cms.hhs.gov/CFCsAndCoPs/02_Spotlight.asp Iowa,
Nebraska, Idaho, Minnesota, New Hampshire, New Mexico, Kansas, North Dakota,
Washington, California, Alaska, Oregon, South Dakota, Wisconsin, and Montana.
182
Organization and Staffing A-1001
 Need P&P concerning who may administer topical,
local, minimal sedation and moderate sedation
 Hospital must follow generally accepted standards of
anesthesia care if anyone other than anesthesiologist
or CRNA
 Need policy on supervision also
 CRNA under anesthesiologist supervision if
immediately available and in same operative suite or
same L&D unit and nothing prevents from immediate
hands-on intervention
183
Anesthesia Services and Policies A-1002
 Anesthesia must be consistent with needs of
patients and resources
 P&P must include delineation of pre-anesthesia
and post-anesthesia responsibilities
 Policies include:
 Consent
 Infection control measures
 Safety practices
 Equipment requirements
184
Anesthesia Policies Required (continued)
 Policies required (continued):
 Protocols for life support function such as cardiac
or respiratory emergencies
 Reporting requirements
 Documentation requirements
 Equipment requirements
 Monitoring, inspecting, testing and maintenance
of anesthesia equipment
 Pre- and post- anesthesia responsibilities
185
Pre-anesthesia Assessment A-1003
 Pre-anesthesia evaluation must be performed
within 48 hours prior to the surgery
 Includes inpatient and outpatient procedures
 For regional, general, and MAC
 By person qualified to administer anesthetic (nondelegable)
 Delivery of first dose of medication for inducing
anesthesia marks end of 48-hour time frame
186
Pre-anesthetic Assessment A-1003
 Must include:
 Review of medical history, including anesthesia,
drug, and allergy history
 Interview and examine the patient
 Notation of anesthesia risk (such as ASA level)
 Potential anesthesia problems identification
(including what could be complication or
contraindication like difficult airway, ongoing
infection, or limited intravascular access)
187
Pre-anesthetic Assessment A-1003 (continued)
 Pre-anesthetic assessment to include (continued):
 Patient’s condition prior to induction
 Additional items according to SOP such as stress
tests or additional consultations
 Develop plan of care including type of medication
for induction, maintenance, and post-operative
care
 Discuss risks and benefits of delivery of
anesthesia
188
ASA Physical Status Classification System
 ASA PS I – normal healthy patient
 ASA PS II – patient with mild systemic disease
 ASA PS III – patient with severe systemic disease
 ASA PS IV – patient with severe systemic disease
that is a constant threat to life
 ASA PS V – moribund patient who is not expected
to survive without the operation
 ASA PS VI – declared brain-dead patient whose
organs are being removed for donor purposes
189
Johns Hopkins U School of Medicine
 Risk of surgery is function of several factors
including:
 Procedure invasiveness
 Associated blood loss and fluid shift
 Entry into specific body cavities
 Post-operative anatomic and physiologic alterations and
need for post-operative intensive care monitoring
 Category 1 (i.e., minimal risk, minimally invasive,
with little or no blood loss)
 Category 5 (i.e., major risk, highly invasive, with
blood loss greater than 1,500 ml)
190
Survey Procedure Pre-anesthesia Evaluation
 Surveyor to review sample of inpatient and
outpatient records of patients who had anesthesia
 Make sure pre-anesthesia evaluation done, and
done by one qualified to deliver anesthesia
 Determine the pre-anesthesia evaluation had all the
required elements
 Make sure done within 48 hours before first dose of
medication given for purposes of inducing
anesthesia for the surgery or procedure
191
Pre-anesthesia ASA Guideline
 Pre-anesthesia Evaluation1
 Patient interview to assess medical history,
anesthetic history, medication history
 Appropriate physical examination
 Review of objective diagnostic data (e.g.,
laboratory, ECG, X-ray)
 Assignment of ASA physical status
 Formulation of the anesthetic plan and discussion
of the risks and benefits of the plan with the patient
or the patient’s legal representative
1www.asahq.org/publicationsAndServices/standards/03.pdf
192
193
194
Intra-operative Anesthesia Record A-1004
 Need policies related to the intra-operative
anesthesia
 Need intra-operative anesthesia record for patients
who have general, regional, or MAC
 Intra-operative record must contain the following:
 Name of patient and hospital ID number
 Name of practitioner who administered anesthesia
 Techniques used and patient position, including insertion
of any intravascular or airway devices
195
Intra-operative Anesthesia Record (continued)
 Intra-operative record must contain the following
(continued):
 Name, dosage, route and time of drugs
 Name and amount of IV fluids
 Blood/blood products
 Oxygenation and ventilation parameters
 Time-based documentation of continuous vital signs
 Complications, adverse reactions, problems during
anesthesia with symptom, VS, treatment rendered and
response to treatment
196
197
Post-anesthesia Evaluation A-1005
 Post-anesthesia evaluation for proper anesthesia
service for outpatients
 Including CV status, LOC, any complications
 Follow up care needed or patient instructions given
 In accordance with P&P
 Document in chart within 48 hours for patients
receiving anesthesia services (general, regional,
MAC)
 Including inpatients and outpatients
198
Post-anesthesia Evaluation (continued)
Has to be done only by anesthesia person
(CRNA or anesthesiologist)
48 hours starts at time patient moved into
PACU
Evaluation cannot generally be done at point
of movement to the recovery area since
patient not recovered from anesthesia
For outpatients, must be completed before
discharge
199
Post-anesthesia Assessment to Include
 Respiratory function with respiratory rate, airway
patency and oxygen saturation
 CV function including pulse rate and BP
 Mental status, temperature
 Pain
 Nausea and vomiting
 Post-operative hydration
200
Post-anesthesia ASA Guidelines
 Patient evaluation on admission and discharge from
the post-anesthesia care unit
 A time-based record of vital signs and level of
consciousness
 A time-based record of drugs administered, their
dosage and route of administration
 Type and amounts of intravenous fluids
administered, including blood and blood products
 Any unusual events including post-anesthesia or
post-procedure complications
 Post-anesthesia visits
201
202
American Association of Nurse Anesthetists
 AANA has excellent website1
 Information on how to become a CRNA
 Has position statement on documenting the
standard of care for the anesthesia record
 Sample forms
1www.aana.com/resources.aspx?ucNavMenu_TSMenuTargetID=51
&ucNavMenu_TSMenuTargetType=4&ucNavMenu_TSMenuID=6
&id=713
203
204
205
206
207
208
209
Nuclear Medicine A-1026
 Services must meet needs of patients
 Optional service
 Radioactive material must be prepared,
labeled, used, transported, stored and
disposed of in accordance with acceptable
standards of practice
 Will not discuss but be sure to provide CoP
and Interpretive Guidelines to your director if
you do nuclear medicine
210
Nuclear Medicine
 Hospital must have written safety standards for
radioactive material
 Handling of equipment and material
 Protection of patients and staff from radiation
hazards
 Labeling of materials and waste
 Transportation of same
 Security of radioactive material
 Testing of equipment for radioactive hazards, etc.
211
Equipment and Supplies
 Must be appropriate for types of nuclear
medicine services offered
 Must function in accordance with federal and
state laws governing radiation safety - see 21
CFR Subpart J, Radiological Health
 See 10 CFR Chapter 1, Part 20, US Nuclear
Regulatory Commission Standards for Protection
against Ionizing Radiation
212
Nuclear Med
 Must be maintained in safe operating condition
 Inspected, tested, and calibrated annually by
qualified person
 Sign and date reports of nuclear interpretation,
consults, and procedures
 Keep copies of records for five years
213
Nuclear Med (continued)
 Practitioner who interprets test must sign and
date the test and be approved by MS to interpret
 Must maintain records of the receipt and
distribution of radiopharmaceuticals
 Nuclear med studies must be ordered by
practitioners whose scope of federal or state
licensure allows such referrals and who has staff
privileges to perform
214
Outpatient Services A-1076
 Services must meet the needs of the patient
 Optional service
 Must be in accordance with standards of practice
 Both on and off campus
 Outpatient services must be integrated into
hospital QAPI
 Theme in rest of slides: being involved in PI,
qualified director, follow SOCs, and meet needs of
patients
215
Outpatient Services
 Must be integrated with inpatient services
 Medical records, radiology, lab, anesthesia,
including pain management, diagnostic tests
 Hospital must coordinate the care of the patient
 Make sure pertinent information in medical
record
216
Outpatient Services (continued)
 Assign person responsible for this dept.
 Have appropriate professional and
nonprofessional personnel
 Define in writing the qualifications and
competencies necessary to direct the
department
 Will review P&P to determine person’s
responsibility
217
Emergency Services A-1100
Hospital must meet emergency needs of patients
Medicare does not require a hospital to have an
emergency department
Must follow acceptable standards of practice
Must be integrated into hospital-wide QAPI
Need qualified MS director
218
Emergency Services
 Services must be integrated with other depts in
hospital
 Surgery, lab, medical records, etc.
 Includes hand off communications between
departments
 Immediate availability of services, equipment, and
resources of hospital
 Length of time to transport between departments is
appropriate
219
Emergency Services (continued)
 Other departments must provide emergency
patients the care within safe and appropriate times
 If offer urgent care on premises or in provider
based clinics, must follow these regulations
 Remember there is a separate CoP and
Interpretive Guidelines on EMTALA
 Will review policies, including triage policy
220
Emergency Services (continued)
 Must have appropriate equipment
 Periodic assessments of its needs
 Work with state and feds in emergency
preparedness
 Surveyor will interview staff to see if
knowledgeable about blood, IV fluid, parenteral
administration of electrolytes, injuries to
extremities, CNS and prevention of infection
221
Rehab Services A-1123
 If provide rehab, PT, OT, speech language
pathology, audiology, must be staffed and organized
to ensure safety of patients
 These staff must be qualified as specified by MS and
state law
 Meet standards of:
 American Physical Therapy Association
 American Speech and Hearing Association
 American Occupational Therapy Association
 American College of Physicians
 American Medical Association
222
Rehab Services
 Must be integrated into hospital-wide QAPI
 Must have proper equipment and personnel
 Scope of service should be defined in writing
 Review medical records to verify appropriate
documentation
 Director must be knowledgeable and experienced
and capable
 Will review job description
 Services must be furnished in accordance with
written plan of care
223
Rehab Services (continued)
 Must be given in accordance with order of
practitioner
 Orders must be incorporated in the medical
record
 Plan of care must meet criteria such as based
on assessment, measurable short and long
term goals, updated as needed
224
Respiratory Services A-1151
 Must meet needs of patients
 Acceptable standard of practice
 Appropriate equipment and number of qualified
personnel
 Scope of service should be defined in writing
 Director who is a physician with experience to
supervise service
 List of required written policies
225
Respiratory Policies
 Equipment assembly, operation, PM
 Safety practices including IC for sterile supplies,
biohaz waste, posting of signs and gas line ID
 CPR
 Pulmonary function testing
 Procedure to follow for adverse drug reaction (ADR)
 Therapeutic percussion and vibration
 Bronchopulmonary drainage
226
Respiratory Policies (continued)
 Mechanical ventilation
 Aerosol, humidification, and therapeutic gas
administration
 Storage, access and control of medications
 ABG procedure for analyzing
227
Respiratory Services A-1163 (last CoP)
 If blood gases or other clinical lab tests are
performed in unit, then the applicable lab
standards must be met
 Need order of practitioner
 Will review medical records
 Will review to make sure all required policies and
procedures are written
228
 Statement of Deficiencies and Plan of
corrections
 Based on documentation of surveyor
worksheet or notes and form CMS-2567
229
Condition Level Requirement Noncompliance
230
Websites
 Center for Disease Control (CDC) –
www.cdc.gov
 Food and Drug Administration (FDA) –
www.fda.gov
 Association of periOperative Registered Nurses
(AORN) –
www.aorn.org
 American Institute of Architects (AIA) –
www.aia.org
231
Websites (continued)
 Occupational Safety and Health Administration
(OSHA) –
www.osha.gov
 National Institutes of Health (NIH) –
www.nih.gov
 United States Dept of Agriculture (USDA) –
www.usda.gov
 Emergency Nurses Association ENA –
www.ena.org
232
Websites (continued)
 American College of Emergency Physicians
(ACEP) –
www.acep.org
 Joint Commission (TJC) –
www.JointCommission.org
 Centers for Medicare and Medicaid Services
(CMS) –
www.cms.hhs.gov
 American Association for Respiratory Care
(AARC) –
www.aarc.org
233
Websites (continued)
 American College of Surgeons (ACS) –
www.facs.org
 American Nurses Association ANA –
www.ana.org
 Agency for Healthcare Research and Quality
(AHRQ) –
www.ahrq.gov
 American Hospital Association (AHA) –
www.aha.org
234
Websites (continued)
 CMS Life Safety Code page –
http://new.cms.hhs.gov/CFCsAndCoPs/07_LSC.
asp
 CoPs available in word and PDF –
http://www.access.gpo.gov/nara/cfr/waisidx_04/4
2cfr485_04.html
 American College of Radiology –
www.acr.org
 Federal Emergency Management Agency
(FEMA) –
www.fema.gov
235
Websites (continued)
 Drug Enforcement Administration –
www.dea.gov (copy of controlled substance act)
 US Pharmacopeia –
www.usp.org (USP 797 book for sale)
 National Patient Safety Foundation at the AMA –
www.ama-assn.org/med-sci/npsf/htm
 The Institute for Safe Medication Practices –
www.ismp.org
236
Websites (continued)
 U.S. Pharmacopeia (USP) Convention, Inc. –
www.usp.org
 U.S. Food and Drug Administration MedWatch –
www.fda.gov/medwatch
 Institute for Healthcare Improvement –
www.ihi.org
237
Websites (continued)
 Sentinel event alerts –
www.jointcommission.org
 American Pharmaceutical Association –
www.aphanet.org
 American Society of Heath-System Pharmacists –
www.ashp.org
238
Websites (continued)
 Enhancing Patient Safety and Errors in
Healthcare –
www.mederrors.com
 National Coordinating Council for Medication
Error Reporting and Prevention –
www.nccmerp.org
 FDA's Recalls, Market Withdrawals and Safety
Alerts Page –
www.fda.gov/opacom/7alerts.html
239
Infection Control Websites
 Association for Professionals in Infection Control
and Epidemiology (APIC) infection control
guidelines –
www.apic.org
 Centers for Disease Control and Prevention –
www.cdc.gov
 Occupational Health and Safety Administration
(OSHA) –
www.osha.gov
240
Infection Control Websites (continued)
 The National Institute for Occupational Safety
and Health (NIOSH) –
www.cdc.gov/niosh/homepage.html
 AORN –
www.aorn.org
 Society for Healthcare Epidemiology of America
(SHEA) –
www.shea-online.org
241
Resources
 To obtain a copy of Survey and Certification Memo 9-10
go to the CMS website –
www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/item
detail.asp?filterType=dual,%20date&filterValue=30|d&filte
rByDID=-1&sortByDID=4&sortOrder=ascending&itemID
=CMS1216415&intNumPerPage=10
 To see a copy of the final Interpretive Guidelines issued
on Oct. 17, 2008 for hospitals, Appendix A (the regular
hospital conditions of participation) which is also part of
the State Operations Manual (SOM) go to –
www.cms.hhs.gov/transmittals/downloads/R37SOMA.pdf
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CMS Proposed Telemedicine Standards
Also would amend TJC Contract
Standard in Leadership Chapter
Credentialing and Privileging (C&P)
 Direct care through a telemedical link:
 Standard MS.13.01.01 describes several options for
C&P LIPs who are responsible for the care, treatment,
and services of the patient through a telemedical link
 Interpretive services through a telemedical link:
 EP 9 in this standard describes the circumstances under
which a hospital can accept the C&P decisions of a TJC
ambulatory care hospital for licensed independent
practitioners providing interpretive services through a
telemedical link
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Operations LD.04.03.09 Contract Definition
 Definition of contractual agreement: An agreement
with any organization, group, agency, or individual
for services or personnel to be provided by, to, or
on behalf of the organization
 Such agreements are defined in a contract or in
some other form of written agreement
 Such as a letter of agreement, memorandum of
understanding, contract, contracted services,
contractual services, or written agreement
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Operations Contracts LD.04.03.09
LD Standard: Care and treatment provided
through contractual agreement are provided
safely and effectively
EP1. Clinical leaders and MS have an
opportunity to provide advice about the
sources of clinical services that are to be
provided through contracts
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Operations Contracts LD.04.03.09
 July 15, 2010: TJC manual was to be changed related to
tele-intepretive reading. Hospitals using TJC for deemed
status: use of contract in lieu of credentialing and
privileging is not acceptable (CMS requires full C&P at this
time and different from TJC Standard)
 TJC also issues MS.10.01.01 on telemedicine
 Next CMS proposed in May 26, 2010 Federal Register to
revise CoP for CAH and PPS hospitals
 After CMS proposed changes, TJC delayed its changes
until March 2011
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248
CMS Proposes Changes
 Stay tuned because CMS is now proposing less
burdensome telemedicine credentialing rules
 Would allow hospitals to rely on information
provided from another location to base C&P
decisions regarding physicians and practitioners
who use telemedicine at their facility
 CMS realizes that credentialing process is difficult
for small hospitals that lack resources to conduct
traditional credentialing for physicians that provide
telemedicine services
 Would need to amend MS by-laws
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CMS Proposes Changes
 The new rule would still allow hospitals to use a
third party credentialing verification organization to
compile and verify the credentials of practitioners
applying for privileges
 The hospital's governing body would still be
responsible for making all privileging decisions
 Physician would still need to hold a license in the
state where the hospital receiving the telemedicine
service is located
 Comment period ends July 26, 2010
Source: Federal Register May 26, 2010
www.access.gpo.gov/su_docs/fedreg/a100526c.html
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CMS Telemedicine Privileges Rules
 Hospital A has large group of radiologists who want
to provide teleradiology services to Hospital B, a
small community hospital
 Hospital A must and does participate in Medicare
(can’t rely on information from non-hospital entities)
 The practitioners have privileges at Hospital A and
they give Hospital B a list of the practitioners
privileges from Hospital A
 Each practitioner must hold a state license in the state of
the originating site (Hospital A) and licensed by or
recognized by the state whose patients are receiving the
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service
CMS Telemedicine Privileges Rules
 Hospital A reviews the practitioner’s performance
and sends Hospital B the results to be used in the
periodic performance review of the
practitioners/radiologists
 This information must include any adverse events that
result from the telemedicine services
 Hospital A is required to evaluate the quality and
appropriateness of the diagnosis and treatment furnished
by its own staff to a CAH hospital
 Board is to ensure there is this agreement and that the
agreement says distant hospital (A) is meeting these
requirements
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CMS Telemedicine Privileges Rules
 Hospital A and B need an agreement between
them and this must state that Hospital A (the
distant hospital) has to conduct credentialing of
telemedicine in accordance with CoPs
 No distinction made between teleradiology and
teleinterpretive service
 Board (Hospital B) will grant privileges according to
the MS recommendations which can rely on the
information from Hospital A now (now an option or
can continue traditional method)
 CMS has regulations in both Board and MS sections
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CMS Proposed CoP
Visitation Rights for
Hospitals
Visitation Rights for All Patients
 CMS issues proposed changes to the CAH and
PPS hospital Conditions of Participation (CoPs)
 Published in the June 28, 2010 Federal Register (FR) with
comments until Aug. 27, 2010
 This rule would revise the hospital CoPs to ensure
that patients may designate their visitors, including
same sex domestic partners
 Hospitals will be required to have policies and
procedures (P&P) on visitors/visitation
 P&P must set forth any clinically necessary or
reasonable restrictions or limitations
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256
Visitation Rights for All Patients
 The new proposed six page rule implements an April
15, 2010 Presidential memo1
 The President gave HHS (Health and Human
Services) the task of requiring any hospital that
receives Medicare reimbursement to preserve the
rights of all patients to choose who can visit them
 Patients or their representatives have a right to
designate visitors with visitation privileges that are
no more restrictive than those for immediate family
members
1
http://www.whitehouse.gov/the-press-office/presidential-memorandum257
hospital-visitation
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Visitation Rights for All Patients
 The April 15 memo was entitled “Respecting the
Rights of Hospital Patients to Receive Visitors and
to Designate Surrogate Decision Makers for
Medical Emergencies”
 President says there are few moments in our lives
that call for greater compassion and companionship
that when a loved one is admitted to the hospital
 A widow with no children is denied the support and
comfort of a good friend
 Members of religious organizations unable to make
medical decisions for them (can complete an
advance directive)
259
Visitation Rights for All Patients
 Medical staff may not have best information on H&P
and medications if friends or certain family members
are unable to serve as intermediaries
 Notes that some states have passed laws on this
already
260
California Law: Patients’ Rights
Regarding Visitors
California law effective March 1997:
 Patient with decisionmaking capacity: has right
to designate visitors of his/her choosing, unless
an exception applies
 Patient without decisionmaking capacity: must
consider patient's wishes in determining who
may visit
 Must have a policy describing how patient's wishes
will be considered
 Policy must allow any person living in household to
visit
 Unless an exception applies
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California Law: Patients’ Rights
Regarding Visitors (continued)
 The following persons must be permitted to
visit, unless an exception applies:
 Patient's registered domestic partner (DP)
 Children of the patient's DP
 DP of the patient's parent or child
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California Law: Patients’ Rights
Regarding Visitors (continued)
Exceptions to Visitor Designation:
 Hospital may establish reasonable restrictions,
including hours of visitation and number of visitors
 Hospital may restrict visitation in the following
circumstances:
 No visitors are allowed
 A particular visitor would endanger the health or safety
of a patient, staff, or other visitor
 A particular visitor would significantly disrupt the
hospital's operations
 The patient indicates that he/she no longer wants a
particular visitor
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President’s 3 Mandates
1. Requires Medicare or Medicaid hospital to respect
the rights of patient to designate visitors

Can include designated visitors in advance directive
(AD)

Cannot make visitation rules for non-family visitors more
restrictive than as those for immediate family members

Cannot deny visitation on the basis of race, color,
national origin, sex, sexual orientation, gender or
disability
2. Medicare hospitals must guarantee that all patient
ADs are respected
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Visitation Rights for All Patients
3. President requested HHS give him additional
recommendations within 180 days and actions
HHS can take to address hospital visitation and
medical decision making
 In response, CMS issues a new release on June
23, 20101
 Contains a summary of the issues and information
that are published in the FR on June 28
1http://www.hhs.gov/news/press/2010pres/06/20100623a.html
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266
Visitation Rights for All Patients
 “Every patient deserves the basic right to designate
whom they wish to see while in the hospital.”
 “Today’s proposed rules would ensure that all
patients have equal access to the visitors of their
choosing—whether or not those visitors are, or are
perceived to be, members of a patient’s family.”
—HHS Secretary Kathleen Sebelius
 Aimed at providing equal rights and privileges by
the healthcare system regardless of their personal
and family situation
267
Visitation Rights for All Patients
 Will be included in the CAH and PPS hospital CoP
 All hospitals that accept Medicare payments are
required to follow the CoP with respect to all
patients, and not just Medicare patients (such as
private insurance, no pay, worker compensation
patients, etc.)
 Medicare hospitals comprise about 98% of hospitals
in the US – not VA Hospitals or Shriners since they
don’t receive Medicare payments
268
Visitation Rights for All Patients in a Nutshell
 Hospitals will have to explain to all patients their
right to choose who may visit during their inpatient
stay
 Regardless of whether the visitor is a family member, a
spouse, or a domestic partner (including a same-sex
domestic partner)
 As well as the right to change their mind about who may
visit at any time
 Reasonable or necessary restrictions on visitation
must be in P&Ps
269
Visitation Rights: Federal Register
 June 25 FR discusses the President’s memo
 Some patients are denied most basic of human needs
because their loved ones and close friends do not fit the
traditional concept of family
 Discusses current requirements of the hospital
patients’ rights CoPs
 Inform patient of their patient rights
 Right to have a family member and family doctor notified
or their admission
 Right to make informed decisions about care
270
Visitation Rights for All Patients
 Current CMS patient rights’ (continued):
– Right to participate in plan of care
– Right to file grievance and grievance process
– Right to have AD and have it followed
– Right to privacy
 All hospitals will have to inform patients of their visitation
rights
 This includes the right to decide who may and may not visit
them
 Hospitals may need to have written documentation of
patient representatives such as agents or surrogates
271
Visitation Rights: Federal Register
 Hospitals will want to amend their patient rights
statement to include this information (CHA’s model
will be revised when final CoP is published)
 For example, if patient incompetent then the
guardian or agent steps into the shoes of the patient
 In these cases the authorized representative makes the
decision
 No required written documentation if patient is
competent or has the capacity to speak
272
Visitation Rights: Federal Register
 Can still have restrictions or limitations if based on a
clinical reason, such as infection control issues or
visitation may interfere with the care of other
patients
 Mentions the JAMA article published in 2004 on
Restricting Visitation Hours in ICU: A Time to
Change1
 Restricting hours is neither compassionate nor caring
 Gives history of regulating visitor hours
1http://jama.ama-assn.org/cgi/content/full/292/6/736
273
274
275
Visitation Rights: Federal Register
 IHI challenged a number of hospitals to open their
ICUs by having unrestricted visiting hours
 Several hospitals instituted this and shared what
they learned
 Literature shows presence of family and friends can
reduce physiologic stress and lower BP, heart rate
and intracranial pressure
 Patients should be allowed to determine visiting
hours
276
Visitation Rights: JAMA article
 Article discusses the pros and cons
 Does a review of the literature
 Bottom line is evidence shows the problems of open
visitation are overstated
 Provides support system for patients and families
 Friends and family tend to reassure and soothe the
patients
 Notes that this may not be appropriate for every
patient
277
Visitation Rights: JAMA Article
 Found that open visitation ICU hours did not provide
a barrier to care
 Did not make it more difficult for nurses and doctors
to do their jobs
 Families and friends were a helpful support system
 Helped with patient education
 Gave better feedback then the patient could give
 Okay to stipulate no visitation during procedures or
treatments or emergencies (ACEP and ENA
278
position of family presence during codes)
Visitation Rights: Federal Register
 Current hospice CoP allows visitors at any hour
including small children
 Current LTC CoP allows residents to receive
visitors any time or to withdraw or deny consent to
visits from immediate family members
 Need written P&P on visitation including any
reasonable limitations and if justified
 Each patient must be informed of his or her right to
receive designated visitors, whether friend or family
279
Visitation Rights Federal Register
 Patient has the right to designate a representative
who can act on his or her behalf
 Parents act on behalf of their children (usually, see Ch. 2
of CHA’s Consent Manual for exceptions)
 Advance directive/DPOA
 Note: 2011 TJC Patient Provider Communication
standards and RI.01.0.01 on patient access to chosen
support person
280
Resources
 Rosenberg CE. The Care of Strangers: The Rise of
America's Hospital System. Baltimore, Md: Johns
Hopkins University Press; 1987
 A challenge accepted: open visiting in the ICU at
Geisinger, www.ihi.org
 Marfell JA, Garcia JS. Contracted visiting hours in
the coronary care unit: a patient-centered quality
improvement project. Nurs Clin North Am.
1995;30:87-96 at
www.ncbi.nlm.nih.gov/pubmed/7885927?dopt=Abst
ract
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Resources
 Gurley MJ. Determining ICU visitation hours.
Medsurg Nurs. 1995;4:40-43 at
www.ncbi.nlm.nih.gov/pubmed/7874220?dopt=Abstract
 Krapohl GL. Visiting hours in the adult intensive
care unit: using research to develop a system that
works. Dimens Crit Care Nurs. 1995;14:245-258 at
www.ncbi.nlm.nih.gov/pubmed/7656767?dopt=Abstract
 Simon SK, Phillips K, Badalamenti S, Ohlert J,
Krumberger J. Current practices regarding visitation
policies in critical care units. Am J Crit Care.
1997;6:210-217
http://ajcc.aacnjournals.org/cgi/content/abstract/6/3/210?ijkey=e4ebfadff6
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f205451545c622736f88ef98f36485&keytype2=tf_ipsecsha
http://ccn.aacnjournals.org/cgi/content/full/25/1/72
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Thank you for attending
Please fill out your evaluation.
For questions please contact:
Liz Mekjavich
(916) 552-7500
lmekjavich@calhospital.org
www.calhospital.org
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