Download PIN Survey Self Assessment 2016 (Word)

CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
This tool has been developed the Montana Rural Healthcare Performance Improvement Network
(PIN) to assist in preparing for a survey. This document refers only to Quality Assurance tags that
are supported by the PIN. This tool will be updated with each revision to the SOM. Tags with the
most recent revisions (April 2015) are noted on the index with an asterisk (*). As of the October
2016 revisions, there have not been updates to QA tags.
For more details on each measure, you may view the CAH State Operations Manual (SOM) at the
following link:
http://www.cms.gov/Regulations-and-guidance/Guidance/Manuals/Downloads/som107ap_w_cah.pdf
INDEX
☐C-151: Compliance with Federal Laws & Regulations ......................................................... 3
☐C-160: Condition of Participation: Status & Location .......................................................... 3
☐C-165: Location Relative to Other Facilities or Necessary Prov. ..................................... 3
Agreements ................................................................................................................................. 4
☐C-195: Agreements for Credentialing & Quality Assurance............................................... 4
☐C-196: Agreements for Cred/Priv of Telemedicine Providers ......................................... 5
☐C-197: Agreements for Cred/Priv of Telemedicine Physicians and Practitioners .... 7
Provider Responsibilities ...................................................................................................... 9
☐C-257: Responsibilities of the MD/DO (b)(1)(i) ..................................................................... 9
☐C-258: Responsibilities of the MD/DO (b)(1) (ii) .................................................................. 9
☐C-259: Responsibilities of the MD/DO (b)(1) (iii) .............................................................. 10
☐C-260*: Responsibilities of the MD/DO (b)(1) (iv) ............................................................ 10
☐C-261*: Responsibilities of the MD/DO (b)(2)..................................................................... 11
☐C-263: PA, NP, and Clinical Nurse Specialist Responsibilities(c)(1)(i) ...................... 12
☐C-264: PA, NP, and Clinical Nurse Specialist Responsibilities(c)(1)(i) ...................... 12
☐C-265: PA, NP, and Clinical Nurse Specialist Responsibilities(c)(2)(i) ...................... 13
☐C-267: PA, NP, and Clinical Nurse Specialist Responsibilities(c)(2)(i) ...................... 13
☐C-268: PA, NP, and Clinical Nurse Specialist Responsibilities(c)(3) ........................... 14
Patient Care Policies ............................................................................................................. 14
☐C-271*: Patient Care Policies (a) ............................................................................................... 14
☐C-272*: Patient Care Policies (a)(2) ......................................................................................... 15
☐C-273*: Patient Care Policies (a)(3)(i) .................................................................................... 16
☐C-274*: Patient Care Policies (a)(3)(ii) ................................................................................... 16
☐C-275*: Patient Care Policies (a)(3)(iii) ................................................................................. 17
☐C-276*: Patient Care Policies (a)(3)(iv).................................................................................. 18
☐C-277*: Patient Care Policies (a)(3)(v) ................................................................................... 22
☐C-278*: Patient Care Policies (a)(3)(vi).................................................................................. 23
1
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
☐C-279*: Patient Care Policies (a)(3)(vii) ................................................................................ 24
Patient Services ...................................................................................................................... 26
☐C-281*: Patient Services ............................................................................................................... 26
☐C-282*: Laboratory Services ....................................................................................................... 27
☐C-283*: Radiology Services.......................................................................................................... 28
☐C-285: Services Provided Through Agreements or Arrangements ............................. 30
Patient Visitation Rights ..................................................................................................... 31
☐C-1000: Patient Visitation Rights (f) ........................................................................................ 31
☐C-1001: Records System ............................................................................................................... 31
☐C-1002: Patient Visitation Rights (f) ........................................................................................ 32
Surgical Services .................................................................................................................... 32
☐C-320: CoP Surgical Services ....................................................................................................... 32
State Exemption ..................................................................................................................... 34
☐C-326: State Exemption ................................................................................................................ 34
Periodic Evaluation & Quality Assurance Review ...................................................... 35
☐C-330: CoP Periodic Evaluation and QA Review ................................................................. 35
☐C-331: Periodic Evaluation (a)(1) ............................................................................................. 35
☐C-332: Periodic Evaluation (a)(1)(i) ........................................................................................ 35
☐C-333: Periodic Evaluation (a)(1)(ii)....................................................................................... 36
☐C-334: Periodic Evaluation (a) ................................................................................................... 36
☐C-335: Periodic Evaluation (a)(2) ............................................................................................. 37
☐C-336: Quality Assurance (b) ...................................................................................................... 37
☐C-337: Quality Assurance (b)(1)................................................................................................ 38
☐C-338: Quality Assurance (b)(2)................................................................................................ 39
☐C-339: Quality Assurance (b)(3)................................................................................................ 40
☐C-340: Quality Assurance (b)(4)................................................................................................ 41
☐C-341: Quality Assurance (b)(5)(i)........................................................................................... 43
☐C-342: Quality Assurance (b)(5)(ii) ......................................................................................... 44
☐C-343: Quality Assurance (b)(5)(iii) ........................................................................................ 45
Organ, Tissue & Eye Procurement ................................................................................... 45
☐C-345: CoP Organ, Tissue, & Eye Procurement.................................................................... 45
Swing-Beds ............................................................................................................................... 47
☐C-350: Special Req. for CAH providers of LTC Services (Swing-Beds) ....................... 47
2
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
C-0151
§485.608(a) Standard: Compliance with Federal Laws and Regulations
Each CAH must be in compliance with applicable Federal laws and regulations related to the health and
safety of patients. This includes other Medicare regulations and Federal laws and regulations not
specifically addressed in the CoPs. State Survey Agencies are expected to assess the CAH’s compliance with
the following Medicare provider agreement regulation provisions when surveying for compliance with
§485.608(a).
C-0160
§485.610(a) Standard: Condition of Participation: Status & Location
(Rev. 84, Issued: 06-07-13, Effective: 06-07-13, Implementation: 06-07-13)
The CAH must meet the location requirements of §485.610(b) and §485.610(c) at the time of the
initial survey. Compliance with these location requirements must be reconfirmed at the time of
every subsequent full survey. If the CAH moves, its eligibility for continued CAH status must be
reassessed in accordance with §485.610(d).
C-0165
§485.610(c) Standard: Location Relative to Other Facilities or Necessary Provider
Certification
(Rev. 84, Issued: 06-07-13, Effective: 06-07-13, Implementation: 06-07-13)
A CAH that can document that it was designated by a State as a necessary provider CAH prior to
January 1, 2006, does not have to meet the location relative to other facilities standard at
§485.610(c). As of January 1, 2006, States do not have the authority to designate any new
necessary provider CAHs. Necessary provider CAHs that were designated prior to that date are
grandfathered by statute, subject to certain conditions if they relocate. ROs and SAs should have
the documentation related to a CAH’s original designation as a necessary provider in the file on
each CAH. If they do not, they should ask the CAH to supply copies of the original necessary
provider designation documents.
Existing CAHs that are not grandfathered necessary provider CAHs must be periodically evaluated
to determine whether there are any more recently certified Medicare-participating hospitals that
are not more than a 35-mile drive, or 15- mile drive, as applicable, from the CAH. In the event that
an existing CAH that is not a grandfathered necessary provider no longer meets the minimum
distance requirement, it is provided the opportunity to avoid termination of its provider
agreement by converting to a certified Medicare hospital after demonstrating compliance with the
hospital CoPs.
3
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
CREDENTIALING AGREEMENTS
C-0195
§485.616(b) Standard: Agreements for Credentialing and Quality Assurance
Each CAH that is a member of a rural health network shall have an agreement with respect to
credentialing and quality assurance with at least- One hospital that is a member of the network;
 One QIO or equivalent entity; or
 One other appropriate and qualified entity identified in the State rural health care plan.
Note: The PIN is identified as such an entity in the State’s rural health plan.
Self-Evaluation:
Comments/Actions
□ Yes □ No Was this a deficiency on your last survey?
□ Yes □ No Does your facility have a written agreement with respect to
credentialing and QA?
_________________________ Where is it?
_________________________ Who is the agreement with
If you are using the PIN to meet this requirement, is your hospital
participating in:
□ Yes □ No
PIN benchmarking or clinical improvement projects?
□ Yes □ No
PIN-sponsored networking meetings?
□ Yes □ No
Other PIN education opportunities?
□ Yes □ No Have you had the PIN conduct an onsite credentials review?
If so, where are the review findings? _________________________
□ Yes □ No Have you addressed them?
4
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
C-0196
§485.616(b) Standard: Agreements for Credentialing & Privileging of Telemedicine
Physicians and Practitioners
A CAH may make arrangements with a distant-site Medicare-participating hospital for the
provision of telemedicine services to the CAH’s patients by physicians or practitioners granted
privileges by the distant-site hospital.
If a CAH enters into an agreement for telemedicine services with a distant-site hospital, the
agreement must be in writing. Furthermore, the written agreement must specify that it is the
responsibility of the distant-site hospital to conduct its credentialing and privileging process for
those of its physicians and practitioners providing telemedicine services such that the distant-site
hospital:
Self-Evaluation:
Comments/Actions
□ Yes □ No Are agreements for telemedicine services in writing for each
distant-site hospital?
□ Yes □ No Do the agreements specify that it is the responsibility of the
distant-site hospital to conduct its own credentialing and
privileging process for physicians and practitioners
providing telemedicine services?
Do the agreements include the following credentialing and privileging
responsibilities of the distance-site hospital:
□ Yes □ No Determines, which categories of practitioners are eligible
candidates for privileges or membership on the distant-site
hospital’s medical staff.
□ Yes □ No Appoints members and grants medical staff privileges after
considering the recommendations of the existing members
of the distant-site hospital’s medical staff.
5
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
□ Yes □ No Assures that the distant-site hospital’s medical staff has
bylaws.
□ Yes □ No Approves the distant-site hospital’s medical staff bylaws and
other medical staff rules and regulations.
□ Yes □ No Ensures that the medical staff is accountable to the distantsite hospital’s governing body for the quality of care
provided to patients.
□ Yes □ No Ensures the criteria for granting medical staff
membership/privileges to an individual are the individual’s
character, competence, training, experience, and judgment.
□ Yes □ No Ensures that under no circumstances is the accordance of
distant-site hospital medical staff membership or privileges
dependent solely upon certification, fellowship or
membership in a specialty body or society.
If your hospital relies on the credentialing and privileging decisions of the
distant-site hospital, does your agreement address the following?
□ Yes □ No Distant-site hospital participates in the Medicare.
□ Yes □ No Distant-site hospital provides a list to the CAH of all
privileged physicians and practitioners covered by the
agreement, including their privileges at the distant- site
hospital.
□ Yes □ No Each physician or practitioner who provides under the
agreement holds a license issued or recognized by the State
where the CAH is located.
□ Yes □ No CAH has evidence that it reviews the telemedicine services
provided to its patients and provides feedback based on this
review to the distant-site hospital for the latter’s use in its
periodic appraisal of each physician and practitioner
providing telemedicine services under the agreement.
6
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
C-0197
§485.616(b) Standard: Agreements for Credentialing & Privileging of Telemedicine
Physicians and Practitioners
(3) The governing body of the CAH must ensure that when telemedicine services are furnished to
the CAH’s patients through an agreement with a distant- site telemedicine entity, the agreement is
written and specifies that the distant-site telemedicine entity is a contractor of services to the CAH
and as such, in accordance with §485.635(c)(4)(ii), furnishes the contracted services in a manner
that enables the CAH to comply with all applicable conditions of participation for the contracted
services, including, but not limited to, the requirements in this section with regard to its physicians
and practitioners providing telemedicine services.
Self-Evaluation:
Comments/Actions
Do you have a written agreement with the distant-site telemedicine entity
that includes requirements and ensures that the contractor fulfills these
requirements?
□ Yes □ No providing medical direction for the CAH
□ Yes □ No provides consultation for health care staff?
□ Yes □ No provides supervision of health care staff?
Does the distant-site telemedicine entity do the minimum:
□ Yes □ No Determine which categories of practitioners are eligible
candidates for medical staff privileges or membership at the
telemedicine entity;
□ Yes □ No Appoint members and grant medical staff privileges after
considering the recommendations of the existing members
of its medical staff;
□ Yes □ No Assure that its medical staff has bylaws;
7
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
□ Yes □ No Approve its medical staff‘s bylaws and other medical staff
rules and regulations;
□ Yes □ No Ensure that the medical staff is accountable to the distantsite telemedicine entity’s governing body for the quality of
care provided to patients;
□ Yes □ No Ensure the criteria for granting distant-site telemedicine
medical staff membership/privileges to an individual are
the individual’s character, competence, training, experience,
and judgment;
□ Yes □ No Ensure that under no circumstances is the accordance of
medical staff membership or privileges dependent solely
upon certification, fellowship or membership in a specialty
body or society.
Does the written agreement include the following:
□ Yes □ No The distant-site telemedicine entity provides to the CAH a
list of all its privileged physicians and practitioners covered
by the agreement, including their privileges at the distantsite telemedicine entity.
□ Yes □ No Each physician or practitioner who provides telemedicine
services to the CAH’s patients under the agreement holds a
license issued or recognized by the State where the CAH is
located.
□ Yes □ No The CAH reviews the performance of the physicians and
practitioners providing telemedicine services to its patients
and provides a written review to the distant-site
telemedicine entity for the latter’s use in its periodic
appraisal of each physician and practitioner providing
telemedicine services under the agreement.
8
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
PROVIDER RESPONSIBILITIES
C-0257
§485.631 (b)(1) Standard: Responsibilities of the Doctor of Medicine or Osteopathy
(i) Provides medical direction for the CAH’s health care activities and consultation for, and medical
supervision of, the health care staff;
Self-Evaluation:
Comments/Actions
Do the medical staff and governing board bylaws indicate a physician is
responsible for:
□ Yes □ No providing medical direction for the CAH
□ Yes □ No provides consultation for health care staff?
□ Yes □ No provides supervision of health care staff?
C-0258
§485.631 (b)(1) Standard: Responsibilities of the Doctor of Medicine or Osteopathy
(ii) In conjunction with the PA(s) and/or NP(s), participates in developing, executing, and
periodically reviewing the CAH’s written policies governing the services it furnishes.
Self-Evaluation:
Comments/Actions
□ Yes □ No
9
Is there documentation that demonstrates a physician has
participated in developing, executing and annually
reviewing the CAH’s medical care policies, procedures,
clinical practice guidelines, etc?
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
C-0259
§485.631 (b)(1) Standard: Responsibilities of the Doctor of Medicine or Osteopathy
(iii) In conjunction with the PA(s) and/or NP(s), periodically reviews the patient records,
provides medical orders, and provides medical services to the patients of the CAH;
Self-Evaluation:
Comments/Actions
Is there documentation that a physician:
□ Yes □ No periodically reviews CAH patient records in conjunction
with staff mid-level practitioners;
□ Yes □ No provides medical orders for CAH patients?
□ Yes □ No provides medical services?
C-0260
§485.631 (b)(1) Standard: Responsibilities of the Doctor of Medicine or Osteopathy
(Rev. 138, Issued: 04-07-15, Effective: 04-07-15)
(iv) The MD or DO periodically reviews and signs the records for all inpatients cared for by NP’s,
clinical nurse specialists, or PA’s.
Note: See the clarification released 6-9-05 from CMS for specific guidelines concerning the
number/percent of midlevel inpatient and outpatients records to be signed by the physician in
Montana CAHs
(v) Periodically reviews and signs a sample of outpatient records of patients cared for by nurse
practitioners, clinical nurse specialists, certified nurse midwives, or physician assistants only to
the extent required under State law where State law requires record reviews or co-signatures, or
both, by a collaborating physician.
Self-Evaluation:
Comments/Actions
□ Yes □ No What sample size does your policy require to have MD/DO
review of outpatient encounters?
□ Yes □ No What time frame does your policy specify for reviews of
outpatient encounters?
10
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
□ Yes □ No How do you ensure your sample is representative of various
non-physician practitioners as well as various types of
outpatient services?
For inpatient records of patients whose care is/was managed by a nonphysician practitioner, is there documentation that a physician has:
□ Yes □ No reviewed and signed all records open at the time of review?
□ Yes □ No reviewed and signed all records closed since last review?
□ Yes □ No has reviewed in the timeframe specified by the CAH’s
policy?
□ Yes □ No reviewed and signed at least 25% of outpatient and 100% of
inpatient records of patients treated by a NP?
□ Yes □ No reviewed and signed at least 25% of outpatient record and
100% of inpatients treated by a CRNA?
C-0261
§485.631 (b)(2) Standard: Responsibilities of the Doctor of Medicine or Osteopathy
(Rev. 138, Issued: 04-07-15, Effective: 04-07-15)
A doctor of medicine or osteopathy is present (being on-site) for sufficient periods of time to
provide the medical direction, medical care services, consultation and supervision for services
provided in the CAH, and is available through direct radio, telephone or electronic communication
for consultation, assistance with medical emergencies or patient referral.
Self-Evaluation:
Comments/Actions
□ Yes □ No Do you have policies and procedures that address minimum
time and frequency of MD/DO presence on-site at CAH?
□ Yes □ No Do policies reflect volume and type of services to determine
there is sufficient MD/DO presence on-site to support these
services?
□ Yes □ No Where and what is the documentation showing a MD/DO is
onsite for frequency and duration specified in CAH polices?
11
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
□ Yes □ No Can you demonstration that a MD/DO is always available by
telecommunications for consultation, et al?
C-0263
§485.631 (c)(1) Standard: Physician Assistant, Nurse Practitioner and Clinical Nurse
Specialist Responsibilities
(i) Participate in the development, execution, and periodic review of the written policies
governing the services the CAH furnishes;
Self-Evaluation:
Comments/Actions
□ No Mid-Levels - N/A
□ Yes □ No Is there documentation that mid-level providers have
participated in the development, execution and annual review of policies,
procedures, clinical practice guidelines, etc, governing CAH medical
services?
C-0264
§485.631 (c)(1) Standard: Physician Assistant, Nurse Practitioner and Clinical Nurse
Specialist Responsibilities
(i) Participate with a doctor of medicine or osteopathy in a periodic review of the patient’s health
records.
Self-Evaluation:
Comments/Actions
□ No Mid-Levels - N/A
□ Yes □ No Is there documentation that the mid-level provider
periodically reviews the records of CAH patients he/she has cared for in
conjunction with the physician supervisor?
12
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
C-0265
§485.631 (c)(2) Standard: Physician Assistant, Nurse Practitioner and Clinical Nurse
Specialist Responsibilities.
Performs the following services to the extent that they are not being performed by a doctor of
medicine or osteopathy:
(i) Provides services in accordance with CAH policies
Self-Evaluation:
Comments/Actions
□ No Mid-Levels - N/A
□ Yes □ No Is there documentation that the mid-level provider
provides services in accordance with CAH policies?
C-0267
§485.631 (c)(2) Standard: Physician Assistant, Nurse Practitioner and Clinical Nurse
Specialist Responsibilities.
Performs the following services to the extent that they are not being performed by a doctor of
medicine or osteopathy:
(i)
Arranges for, or refers patients to, needed services that cannot be furnished at the
CAH, and assures that adequate patient health records are maintained and
transferred as required when patients are referred.
Self-Evaluation:
Comments/Actions
Is there documentation that the mid-level provider provides services in
accordance with CAH policies?
□ No Mid-Levels - N/A
□ Yes □ No arranges for needed services that cannot be furnished at
the CAH?
□ Yes □ No refers patients to needed services that cannot be furnished
at the CAH?
□ Yes □ No Assures that adequate patient records are maintained and
transferred as when required when patients are referred?
13
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
C-0268
§485.631 (c)(3) Standard: Physician Assistant, Nurse Practitioner and Clinical Nurse
Specialist Responsibilities.
Whenever a patient is admitted to the CAH by a NP, PA or clinical nurse specialist, a doctor of
medicine or osteopathy on the staff of the CAH is notified of the admission.
Self-Evaluation:
Comments/Actions
□ No Mid-Levels - N/A
□ Yes □ No Is there documentation that the mid-level notifies a
physician on staff at the CAH of patients who are admitted?
PATIENT CARE POLICIES
C-0271
§485.635 (a) Standard: Patient care policies
(Rev. 138, Issued: 04-07-15, Effective: 04-07-15)
The CAH’s health care services are furnished in accordance with appropriate written policies that
are consistent with applicable State law.
Self-Evaluation:
Comments/Actions
□ Yes □ No Is there written policies covering health care services
furnished in the CAH?
□ Yes □ No Can you ensure your staff is providing services consistent
with the writing policies?
14
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
C-0272
§485.635 (a) Standard: Patient care policies
(Rev. 138, Issued: 04-07-15, Effective: 04-07-15)
(2) The policies are developed with the advice of members of the CAH’s professional healthcare
staff, including one or more doctors of medicine or osteopathy and one or more physician
assistants, nurse practitioners, or clinical nurse specialists, if they are on staff under provisions of
§485.631 (a) (1). Policies are reviewed at least annually by the group described and as necessary
by the CAH. A CAH with no non-physician practitioners on staff is not required to obtain the services
of an outside non-physician practitioner to server on the advisory group.
Self-Evaluation:
Comments/Actions
□ Yes □ No Does your policy advisory group include (required!) (1) at
least one MD/DO (2) one or more PA, NP, or CNP if they are
on staff.
□ Yes □ No Is there documentation of physician involvement with the
policy development group?
□ Yes □ No Can you ensure all staff listed as part of the group has had
the opportunity to express opinions and make
recommendations? They will be interviewed.
□ Yes □ No Is there documentation the advisory group developed
written recommendations on the CAH patient care policies
for consideration by the governing body or responsible
individual?
□ Yes □ No Is there documentation the group reviewed the CAH’s
existing policies at least annually and indicated whether or
not it recommended any changes?
15
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
C-0273
§485.635 (a) Standard: Patient care policies
(Rev. 138, Issued: 04-07-15, Effective: 04-07-15 – grammar change only)
(3)(i) The policies include a description of the services the CAH furnishes, including those
furnished through agreement or arrangement.
Self-Evaluation:
Comments/Actions
□ Yes □ No
Is there a policy describing services the CAH furnishes
directly and those furnished under a contract, informal
agreement or lease arrangement?
□ Yes □ No
Is there evidence that all clinical care service contracts
have been reviewed and approved by both the medical staff
and governing board within the past 12 months?
□ Yes □ No
Is there a current CLIA (Clinical Laboratory Improvement
Act) certificate or waiver on file for all tests and laboratory
services performed?
C-0274
§485.635 (a) Standard: Patient care policies
(Rev. 138, Issued: 04-07-15, Effective: 04-07-15)
(3)(ii) Patient care policies must include policy and procedure for providing emergency services,
addressing all of the requirements at 42 CFR 485.618 (tags C 200-209)
Self-Evaluation:
Comments/Actions
□ Yes □ No Are there policies and procedures demonstrating how the
CAH would meet all of its emergency service requirements
(see tags C-200-209)?
16
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
□ Yes □ No Is there evidence that all emergency care service
policies/procedures have been reviewed and revised as
needed by the required policy development group within
the past 12 months?
□ Yes □ No Can you demonstrate how the CAH provides 24 hour
emergency care to patients?
□ Yes □ No Do you have a list of what equipment, supplies, medications,
blood and blood products are maintained onsite AND which
are readily available for treating emergency cases by
agreement at other facilities?
If yes, where?__________________________________________________
□ Yes □ No Can you indicate what types of personnel are available to
provide emergency services and what are their required
onsite response times?
□ Yes □ No Do policies address how the CAH coordinates with local
EMS?
C-0275
§485.635 (a) Standard: Patient care policies
(Rev. 138, Issued: 04-07-15, Effective: 04-07-15)
(3)(iii) Guidelines for the medical management of health problems that include the conditions
requiring medical consultation and/or referral, the maintenance of health care records, and
procedures for the periodic review and evaluation of the services furnished by the CAH.
Self-Evaluation:
Comments/Actions
□ Yes □ No Do the written policies address circumstances under which
consultation with other CAH professional healthcare staff or
referral outside the CAH should occur?
□ Yes □ No Do the written policies address maintenance of medical
records in a manner consistent with 485.638?
17
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
□ Yes □ No Do the written policies address periodic evaluation of the
CAHs healthcare services in a manner consistent with the
requirements of 485.641?
C-0276
§485.635 (a) Standard: Patient care policies
(Rev. 138, Issued: 04-07-15, Effective: 04-07-15)
(3) (iv) Rules for the storage, handling, dispensation and administration of drugs and biologicals.
There has been a lot of detail, information, and resources added to this tag within the state
operations manual. Please review the SOM for details on the requirements.
The CAH’s written patient care policies must include rules governing pharmacy services within
the CAH. The CAH’s rules may be in the form of pharmacy services policies and procedures. These
CAH rules must address storage, handling, dispensing, and administration of drugs and biologicals
within the CAH. The rules must be in accordance with accepted professional principles of
pharmacy and medication administration practices. Accepted professional principles include
compliance with applicable Federal and State law and adherence to standards or guidelines for
pharmaceutical services and medication administration issued by nationally recognized
professional organizations, including, but not limited to: U.S. Pharmacopeia (http://www.usp.org)
the American Society of Health-System Pharmacists (http://www.ashp.org/), the Institute for Safe
Medication Practices (http://www.ismp.org/default.asp), the National Coordinating Council for
Medication Error Reporting and Prevention (www.nccmerp.org); the Institute for Healthcare
Improvement (http://www.ihi.org/ihi); or the Infusion Nurses Society (http://www.ins1.org).
These rules must provide that...
 Responsibility for pharmacy services
 Storage of drugs and biologicals, including the location of storage areas, medication carts,
and dispensing machines
 Proper environmental conditions
 Security
 Handling drugs and biologicals
 Compounding
 Use of outside compounders (Outsourcing Facilities)
 Use of Compounding Pharmacies
 Dispensing drugs and biologicals
 Administration of drugs and biologicals to patients
 Record keeping for the receipt and disposition of all scheduled drugs
 Ensuring that outdated, mislabeled, or otherwise unusable drugs are not used for patient
care
18
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**

Assessing Adverse Drug Reactions & Medication Administration Errors
Self-Evaluation:
Comments/Actions
□ Yes □ No Can you demonstrate that the CAH adopted pharmacy rules
developed with the advice of the CAHs professional
healthcare staff.
□ Yes □ No Can you demonstrate the CAH identified the qualifications
of the individual designated to be responsible for
developing and implementing rules for the CAHs pharmacy
services in accordance with state and federal law and the
CAHs written policies?
□ Yes □ No Does the CAH have procedures in place to ensure effective
dispensing of medications from the pharmacy in a timely
manner? They surveyor will review medical records for late
administration of prescribed medications and will investigate
if these delays are due to pharmacy dispensing delays. This
may be a good topic to perform a QI project on!
□ Yes □ No Does the CAH use a nationally recognized source of
accepted professional principles of pharmacy practice in
developing policies and procedures?
Source: __________________________________________________________
□ Yes □ No Are drugs and biologicals stored in a secure manner?
□ Yes □ No Are drugs stored in areas not accessible to unauthorized
personnel?
□ Yes □ No When drugs or biologicals are kept in a patient care area
during hours when patient care is not provided, are they
locked up?
□ Yes □ No Can you demonstrate that drug inventory procedures are
effective and result in an accurate inventory and all drugs
are accounted for?
□ Yes □ No Does the CAH have a system that tracks movement of
scheduled drugs from point of entry into the CAH to point of
departure (through administration to the patient,
destruction of drug, or return to manufacturer)?
19
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
□ Yes □ No Does the system provide documentation on scheduled drugs
in a readily retrievable manner to facilitate reconciliation of
receipt and disposition of all scheduled drugs?
□ Yes □ No Can you demonstrate that the CAH is able to and has made
efforts to reconcile and address any discrepancies.
□ Yes □ No Can the CAH demonstrate that only a pharmacist or
authorized personnel (in accordance with State and Federal
law) compound, label and dispense drugs or biologicals
regardless of whether the services are provided by CAH staff
or under agreement?
□ Yes □ No Do the CAH’s pharmacy rules address Automated
Dispensing Cabinets (ADCs) if used with in the CAH?
□ Yes □ No Can the CAH demonstrate that ADCs are being used in a
manner prescribed by the CAHs rules?
□ Yes □ No Can the CAH demonstrate that compounded medications
used and/or dispensed by the hospital are being
compounded consistent with standard operating
procedures and quality assurance practices equivalent to or
more stringent than the standards described in US
Pharmacopeial Convention (USP) <795> and <797>?
□ Yes □ No Can the CAH demonstration that the individual responsible
for the pharmacy service, including compounding policies,
practices and quality assurance within the CAH, and
selecting and overseeing any external sources of
compounded medications, has the expertise to conduct
effective quality oversight consistent with USP <795> and
<797> (or equivalent/more stringent) standards?
□ Yes □ No Are compounded sterile preparations (CSPs) produced in
the CAH?
□ Yes □ No Can the individual responsible for the pharmacy services
explain the risk level(s) of the CSPs being produced in-house
and/or obtained from external sources? Can he or she
demonstrate that the assigned risk levels are consistent
with USP <797> or equivalent/more stringent standards?
20
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
□ Yes □ No Is there evidence that the beyond use dating (BUDs) are
determined consistent with the CAH’s rules, policies and
procedures?
□ Yes □ No Do the CAH policy and procedures demonstrate that CSPs
are packaged in a manner to protect package integrity and
sterility? Requirements with respect to motion, light
exposure, temperature and potentially hazardous contents
Should be addressed?
□ Yes □ No Can the CAH demonstrate a process for ensuring that such
information is effectively conveyed to non-pharmacy health
care personnel and/or to patients/caregivers, if applicable?
□ Yes □ No Can the CAH demonstrate that the policies and procedures
are consistent with or more stringent than the applicable
USP standards?
□ Yes □ No Can it demonstrate that the pharmacy personnel assigned to
determining BUDs when a manufacturer’s instructions are
not available have the expertise and technical support
needed to properly conduct the assessments needed to
make such determinations in a manner consistent with
standards and hospital policies?
□ Yes □ No If the CAH obtains compounded products from an external
source that is not an FDA registered outsourcing facility, can
it demonstrate that it systematically evaluates and monitors
whether these sources adhere to accepted professional
principles for safe compounding?
□ Yes □ No Does the CAH have a process for following up on adverse
drug reactions (ADRs) and errors in medication
administration reported by CAH staff in accordance with
§485.635(a)(3)(v)?
□ Yes □ No Can the CAH demonstrate that any ADRs were assessed,
analyzed and corrective action taken by the CAH
□ Yes □ No Does each patient’s individual drug container bears his/her
full name and strength and quantity of the drug dispensed,
as well as include appropriate accessory and cautionary
statements, expiration date, and, when applicable, a BUD.
21
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
□ Yes □ No Does each floor stock container bears the name and strength
of the drug, lot and control number of equivalent, expiration
date, and, when applicable, a BUD.
C-0277
§485.635 (a) Standard: Patient care policies
(Rev. 138, Issued: 04-07-15, Effective: 04-07-15)
(3) (v) Policies include procedures for reporting adverse drug reactions and errors in the
administration of drugs. There has been a lot of detail, information, resources, Quality
Improvement suggestions added to this tag within the state operations manual. Please
review the SOM for details on the requirements.
Self-Evaluation:
Comments/Actions
□ Yes □ No Are there written procedures for reporting adverse drug
reactions and errors?
□ Yes □ No Is there evidence that these procedures are effectively
implemented?
□ Yes □ No Can the CAH demonstrate that ADRs and medication
administration errors are reported to practitioners in a
timely manner?
□ Yes □ No Can the CAH demonstrate medications administered and/or
drug reactions are promptly recorded in the patient’s
medical record?
□ Yes □ No What training and education has been provided to nurses
on the concepts of medications errors that do and do not
reach the patient and ADRs?
□ Yes □ No Can CAH nursing staff demonstrate their knowledge of the
concepts and the procedures for when a medication error or
ADR occurs?
22
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
□ Yes □ No Can the CAH provide evidence of training staff on reporting
expectations?
□ Yes □ No Does the CAH have a system for reporting/identifying ADRs
and medication administration errors for QA/QI purposes?
□ Yes □ No Is the individual responsible for the QA program able to
demonstrate how the CAH determines if the number of
medication administration errors and ADRs reported is
consistent with the size and scope of services provided by
the CAH?
C-0278
§485.635 (a) Standard: Patient care policies
(Rev. 138, Issued: 04-07-15, Effective: 04-07-15)
(3) (vi) Policies include a system for identifying, reporting, investigating and controlling
infections and communicable diseases of patients and personnel. There has been a lot of detail,
information and resources added to this tag within the state operations manual. Please
review the SOM for details on the requirements.
Self-Evaluation:
Comments/Actions
□ Yes □ No Are there written procedures for identifying the infections
and communicable diseases of patients and personnel?
□ Yes □ No Are there written procedures for reporting the infections
and communicable diseases of patients and personnel?
□ Yes □ No Are there written procedures for investigating the
infections and communicable diseases of patients and
personnel?
□ Yes □ No Are there written procedures for controlling the infections
and communicable diseases of patients and personnel?
23
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
□ Yes □ No Is there a designated qualified individual to be responsible
for the infection control program?
□ Yes □ No Can the responsible individual demonstrate that the CAHs
program adheres to nationally recognized practices or
guidelines?
Practice/Guidelines used:______________________________
□ Yes □ No Is there evidence of the CAH training staff in infection
control practices pertinent to their role?
□ Yes □ No Can the responsible individual demonstrate how staff
compliance with infection control program requirements is
assessed and what corrective actions are taken?
□ Yes □ No Can the responsible individual demonstrate that infection
control incidents, problems, and trends are analyzed and
that corrective actions are taken and further assessed?
*********** Staff will be monitored to determine if:
□ Yes □ No Staff employs safe infection control practices for preparing and
administering medications.
□ Yes □ No Staff employ standard precautions appropriately
□ Yes □ No Staff employ safe infection control practices for preparing
and administering medications?
□ Yes □ No Staff perform active surveillance to identify infections
C-0279
§485.635 (a) Standard: Patient care policies
(Rev. 138, Issued: 04-07-15, Effective: 04-07-15)
(3) (vii) If inpatient services are provided, policies include procedures that ensure that the
nutritional needs of inpatients are met in accordance with recognized dietary practices and the
orders of the practitioner responsible for the care of the patients, and that the requirement of
§483.25(i) of this chapter is met with respect to inpatients receiving post hospital SNF (Swing
bed) care. There has been a lot of detail, information and resources added to this tag within
the state operations manual. Please review the SOM for details on the requirements.
24
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
Self-Evaluation:
Comments/Actions
□ No Inpatients - N/A
Are there written procedures for ensuring the nutritional needs of
inpatients are met:
□ Yes □ No in accordance with recognized dietary practices?
□ Yes □ No with the order of the practitioner responsible for the
care of the patient?
□ Yes □ No Can the CAH demonstrate that the individual responsible for
dietary services is qualified based on education, experience,
specialized training, and, if required by State law, is licensed,
certified, or registered by the State?
□ Yes □ No Can the responsible individual demonstrate how the CAH
uses Dietary Reference Intakes (DRIs) in its menus to meet
the nutritional needs of patients?
□ Yes □ No Do the medical record reflect that patients are assessed
using a screening mechanism for the risk of malnutrition
and nutritional complications?
What mechanism is used: ____________________________________
□ Yes □ No Does the medical record reflect dietary orders in line with
the assessment?
□ Yes □ No Can the CAH demonstrate that dietary intake and nutritional
status is being monitored, as appropriate?
□ Yes □ No Is there documentation of swing bed patients maintaining
acceptable parameters of nutritional status, such as body
weight and protein levels, unless the resident's clinical
condition demonstrates that this is not possible?
□ Yes □ No Can the CAH demonstrate that all inpatient diets are
prescribed by a practitioner(s) responsible for the care of
the patient.
□ Yes □ No If the State and the CAH permit dieticians or other nutrition
professionals to order diets, has the CAH verified that they
meet any requirements for licensure or certification under
State law?
25
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
PATIENT SERVICES
C -0281
§485.635 (b) Standard: Patient Services
(Rev. 138, Issued: 04-07-15, Effective: 04-07-15)
(1) (ii) The CAH furnishes acute care inpatient services. In accordance with §485.620(b), CAHs are
required to have an average annual per acute inpatient length of stay that does not exceed 96 hours.
Accordingly, CAHs are expected to provide less complex inpatient services in order to comply with the
length of stay requirement. Furthermore, for each Medicare beneficiary, the CAH is required in accordance
with Medicare payment law and regulations to have the practitioner who admits the beneficiary as an
inpatient certify that the beneficiary may reasonably be expected to be discharged or transferred to a
hospital within 96 hours after admission to the CAH. However, while it may be true that CAHs generally are
not expected to handle patients requiring complex, specialized inpatient services, such as those services
provided by trauma centers, or cardiac surgery centers, CAHs should be able to handle a range of patient
needs requiring inpatient admission. CMS does not believe it is in the best interest of patients for them to
routinely be transferred to a more distant hospital if instead their care can be provided locally without
compromising quality or the length of stay requirements (78 FR 50749). Accordingly, acute inpatient
services must be furnished to patients who present to the CAH for treatment so long as the CAH has an
available inpatient bed and the treatment required to appropriately care for the patient is within the scope
of services offered by the CAH. There has been a lot of detail, information and resources added
to this tag within the state operations manual. Please review the SOM for details on the
requirements.
Self-Evaluation:
Comments/Actions
There are no specific steps for this tag, however below are items that the
surveyor will investigate. These may be helpful in improvement activities
for appropriate transfers.
** Verify that the CAH is furnishing acute care inpatient services by
reviewing data on the number of patients admitted over the prior year.
** Determine the percentage of ED visits that result in an admission to the
CAH. If fewer than eight percent of ED visits lead to an inpatient admission,
review data on transfers of ED patients, overall staffing, the volume and type
of outpatient services offered, including observation services, and swing bed
services to determine whether there is a reasonably proportionate relationship
among the various services the CAH provides.
26
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
** Review a sample of records of the patients the CAH transferred and
determine if the transfers were appropriate based on the services available at
the CAH.
C-0282
§485.635 (b)(2) Laboratory Services
(Rev. 138, Issued: 04-07-15, Effective: 04-07-15)
The CAH provides basic laboratory services essential to the immediate diagnosis and treatment of the
patient that meet the standards imposed under section 353 of the Public Health Service Act (42 U.S.C.
236a). (See the laboratory requirements specified in part 493 of this chapter.) Laboratory services that
must be provided on-site at the CAH’s main campus are the tests specified in the regulation, which would
be considered the minimum necessary for diagnosis and treatment of a patient: (i) Chemical examination of
urine by stick or tablet method or both (including urine ketones); (ii) Hemoglobin or hematocrit, (iii) Blood
glucose; (iv) Examination of stool specimens for occult blood, (v) Pregnancy tests; and (vi) Primary
culturing for transmittal to a certified laboratory.
These services may be provided by the by the CAH staff or under arrangement or agreement, or through a
combination of CAH staff and a laboratory under arrangement. Laboratory services, whether provided
directly by the CAH or under an arrangement with a laboratory contractor, must have a current Clinical
Laboratory Improvement Act (CLIA) certificate or waiver for all tests performed and meet the laboratory
requirements specified in Part 493 of this chapter.
The laboratory must have written policies and procedures for the collection, preservation, transportation,
receipt, and reporting of tissue specimen results. Patient laboratory results and all other laboratory clinical
patient records are considered patient medical records and the CAH must comply with the requirements of
the clinical records CoP at §485.638(a)(4)(ii).
Self-Evaluation:
Comments/Actions
□ Yes □ No Is there documentation of all laboratory services offered
by the facility and location.
□ Yes □ No Is there a CLIA certificate or waiver, as applicable, for all
laboratory tests performed in the facility?
□ Yes □ No If specimens are referred to another laboratory for testing,
does the facility have documentation that the referral
laboratory is CLIA certified for the appropriate tests?
27
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
□ Yes □ No Are laboratory services that are necessary to support the
emergency services of the CAH identified?
C-0283
§485.635 (b)(3) Radiology Services
(Rev. 138, Issued: 04-07-15, Effective: 04-07-15)
Radiology services furnished by the CAH are provided by personnel qualified under State law, and
do not expose CAH patients or personnel to radiation hazards. There must be written policies that
are developed and approved by the governing body or responsible individual and are consistent
with State law, that designate which personnel are qualified to use the radiological equipment and
administer procedures.
Radiological services furnished by the CAH may be provided by CAH staff or under arrangement.
The CAH must maintain and have available diagnostic radiological services to support the services
the CAH provides to meet the needs of its patients. These services must be available at all times
the CAH provides services, including emergency services. The CAH has the flexibility to choose the
types and complexity of radiologic services offered. They may offer only a minimal set of services
or a more complex range of services (including nuclear medicine).
All radiological services provided by the CAH, including diagnostic, therapeutic, and nuclear
medicine, must be provided in accordance with acceptable standards of practice and must meet
professionally approved standards for safety.
Self-Evaluation:
Comments/Actions
□ Yes □ No Are there written policies that designate which personnel
are qualified to use the radiological equipment, administer
procedures, and which studies require interpretation by a
radiologist.
□ Yes □ No Are these policies developed and approved
by the governing body or responsible
individual?
□ Yes □ No Is there evidence that these policies and procedures are
implemented?
28
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
□ Yes □ No Are there written policies and procedures that ensure
safety from radiation hazards for patients and personnel?
They must address at least the following:
□ Yes □ No Adequate radiation shielding for patients, personnel and
facilities, which includes:
□ Yes □ No (i) Shielding built into the CAH’s physical plant, as
appropriate;
□ Yes □ No (ii) Types of personal protective shielding to be used,
under what circumstances, for patients, including high
risk patients as identified in radiologic services policies
and procedures, and CAH personnel;
□ Yes □ No (iii) Types of containers to be used for various radioactive
materials, if applicable, when stored, in transport, in use,
and when disposed;
□ Yes □ No (iv) Clear signage identifying hazardous radiation areas;
□ Yes □ No Labeling of all radioactive materials, including waste, with
clear identification of all material(s);
□ Yes □ No Transportation of radioactive materials between locations
within the CAH;
□ Yes □ No Security of radioactive materials, including determining
who may have access to radioactive materials and
controlling access to radioactive materials;
□ Yes □ No Periodic testing of equipment for radiation hazards;
□ Yes □ No Periodic checking of staff regularly exposed to radiation
for the level of radiation exposure, via exposure meters or
badge tests;
□ Yes □ No Storage of radio nuclides and radio pharmaceuticals as well
as radioactive waste; and
□ Yes □ No Disposal of radio nuclides, unused radio pharmaceuticals,
and radioactive waste.
29
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
□ Yes □ No Are there written policies and procedures to ensure that
periodic inspections of radiology equipment are
conducted and problems identified are corrected in a
timely manner?
□ Yes □ No Is there a system in place to correct identified problems?
□ Yes □ No Is there evidence of inspections and corrective actions?
□ Yes □ No Is there documentation that periodic tests of radiology
personnel by exposure meters or test badges are
performed?
C-0285
§485.635 (c) Standard: Services Provided Through Agreements or Arrangements
All agreements for providing health care services to the CAH’s patients must be with a provider or
supplier that participates in the Medicare program, except in the case of an agreement with a
distant-site telemedicine entity for the provision of telemedicine services.
Self-Evaluation:
Comments/Actions
□ Yes □ No Is there evidence that the facility has verified that every
entity is under an agreement with Medicare (except
distant-site telemedicine entities under agreement or
arrangement).
30
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
PATIENT VISITATION RIGHTS
C-1000
§485.635 (f) Standard: Patient Visitation Rights
A CAH must have written policies and procedures regarding the visitation rights of patients,
including those setting forth any clinically necessary or reasonable restriction or limitation that
the CAH may need to place on such rights and the reasons for the clinical restriction or limitation.
Self-Evaluation:
Comments/Actions
□ Yes □ No Are there written policies or procedures regarding the
visitation rights of patients?
Do policies address:
□ Yes □ No Inpatient and outpatient;
□ Yes □ No Clear rationale that restrictions are clinically necessary
□ Yes □ No Reasons for restrictions/limitations
□ Yes □ No How CAH staff that will enforce visitation be trained
C-1001
§485.638(a) Standard: Patient Visitation Rights
CAHs are required to inform each patient (or the patient’s support person, where appropriate) of
his/her visitation rights.
Self-Evaluation:
Comments/Actions
□ Yes □ No Is there a written notice of visitation rights made available
for the patient?
Does this notice address the following rights:
□ Yes □ No Consent to receive visitors he or she has designated
□ Yes □ No Receive the visitors he or she has designated
□ Yes □ No Withdraw or deny his/her consent to receive specific
visitors, either orally or in writing.
31
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
□ Yes □ No Is there evidence that provision of the required notice is
documented in the patient’s medical record?
C-1002
§485.635 (f) Standard: Patient Visitation Rights
The CAH’s visitation policies and procedures may not use the race, color, national origin, religion,
sex, gender identity, sexual orientation, or disability of either the patient (or the patient’s support
person, where appropriate) or the patient’s visitors (including individuals seeking to visit the
patient) as a basis for limiting, restricting, or otherwise denying visitation privileges.
Self-Evaluation:
Comments/Actions
□ Yes □ No Is there documentation in the visitation policies and
procedures that the CAH DOES NOT restrict, limit or deny
visitation to individuals on a prohibited basis?
SURGICAL SERVICES
C-0320
§485.639 Condition of Participation: Surgical Services
(Rev. 84, Issued: 06-07-13, Effective: 06-07-13, Implementation: 06-07-13)
If a CAH provides surgical services, surgical procedures must be performed in a safe manner by
qualified practitioners who have been granted clinical privileges by the governing body, or responsible
individual, of the CAH in accordance with the designation requirements under paragraph (a) of this
section.
Self-Evaluation:
Comments/Actions
□ Yes □ No Are there written policies governing surgical care?
□ Yes □ No Do policies contain definition of the scope of surgical
services and are approved by the governing body or
responsible individual?
32
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
Do these policies contain:
□ Yes □ No Aseptic surveillance and practice, including scrub
techniques
□ Yes □ No Identification of infected and non-infected cases
□ Yes □ No Housekeeping requirements/procedures
□ Yes □ No Patient care requirements
o Preoperative work-up
o Patient consents and releases
o Clinical procedures
o Safety practices
o Patient identification procedures
□ Yes □ No Duties of scrub and circulating nurse
□ Yes □ No Safety practices
□ Yes □ No The requirement to conduct surgical counts in accordance
with accepted standards of practice
□ Yes □ No Scheduling of patients for surgery
□ Yes □ No Personnel policies unique to the OR
□ Yes □ No Resuscitative techniques
□ Yes □ No DNR status
□ Yes □ No Care of surgical specimens
□ Yes □ No Malignant hyperthermia
□ Yes □ No Appropriate protocols for all surgical procedures
performed. These may be procedure-specific or general in
nature and will include a list of equipment, materials, and
supplies necessary to properly carry out job assignments.
□ Yes □ No Sterilization and disinfection procedures
□ Yes □ No Acceptable operating room attire
□ Yes □ No Handling infections and biomedical/medical waste
□ Yes □ No Does your facility have an informed consent form?
Does the consent form contain the following requirements?
□ Yes □ No Name of patient, and when appropriate, patient’s legal
guardian;
□ Yes □ No Name of CAH;
□ Yes □ No Name of procedure(s);
□ Yes □ No Name of practitioner(s) performing the procedure(s) or
important aspects of the procedure(s), as well as the
33
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
□ Yes □ No
□ Yes □ No
□ Yes □ No
□ Yes □ No
□ Yes □ No
name(s) and specific significant surgical tasks that will be
conducted by practitioners other than the primary
surgeon/practitioner. (Significant surgical tasks include:
opening and closing, harvesting grafts, dissecting tissue,
removing tissue, implanting devices, altering tissues.);
Signature of patient or legal guardian;
Date and time consent is obtained;
Statement that procedure was explained to patient or
guardian;
Signature of professional person witnessing the consent;
and
Name/signature of person who explained the procedure to
the patient or guardian.
STATE EXEMPTION
C-0326
§485.639 (e) Standard: State Exemption
A CAH may be exempted from the requirement for MD/DO supervision of CRNAs as described in
paragraph (c)(2) of this section, if the State in which the CAH is located submits a letter to CMS signed
by the Governor, following consultation with the State’s Boards of Medicine and Nursing, requesting
exemption from MD/DO supervision for CRNAs. The letter from the Governor must attest that he or
she has consulted with the State Boards of Medicine and Nursing about issues related to access to and
the quality of anesthesia services in the State and has concluded that it is in the best interests of the
State’s citizens to opt-out of the current MD/DO supervision requirement, and that the opt-out is
consistent with State law.
The request for exemption and recognition of State laws and the withdrawal of the request may be
submitted at any time, and are effective upon submission.
34
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
PERIODIC EVALUATION & QUALITY ASSURANCE REVIEW
C-0330
§485.641 Condition of Participation: Period Evaluation and Quality Assurance Review
While conducting the survey, a surveyor may identify a patient care practice or other CAH practice
with which the surveyor is unfamiliar. Health care and CAH practice are continually changing due to
new laws, regulations and standards of practice.
C-0331
§485.641 (a) Standard: Periodic Evaluation
(1) The CAH carries out or arranges for a periodic evaluation of its total program. The evaluation is
done at least once a year and includes review of --Self-Evaluation:
Comments/Actions
□ Yes □ No Are there written procedures for conducting an evaluation
of the facility’s total CAH program?
□ Yes □ No Is there evidence that the evaluation has been conducted
within the past 365 days?
C-0332
§485.641 (a) Standard: Periodic Evaluation
(1)(i) The utilization of CAH services, including at least the number of patients served and the volume
of services;
Self-Evaluation:
Comments/Actions
Is there evidence that the most current evaluation included:
□ Yes □ No the number of patients served
□ Yes □ No the volume of services
35
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
C-0333
§485.641 (a) Standard: Periodic Evaluation
(1)(ii) A representative sample of both active and closed clinical records;
Notes:
 Montana requires 100% review of open and closed PA records, and a representative sample of
FNP records.
 ED patients are considered “outpatient”
Self-Evaluation:
Comments/Actions
Is there evidence that the most current evaluation included:
□ Yes □ No review of at least 10% of inpatient clinical records, active
and closed
□ Yes □ No review of at least 10% of outpatient clinical records, active
and closed
Have you included in your count those records reviewed for...
□ Yes □ No participation in clinical improvement studies
□ Yes □ No participation in CMS performance reporting
□ Yes □ No physician performance evaluation
□ Yes □ No midlevel providers by a supervising physician
□ Yes □ No other facility QI/PI projects
□ Yes □ No medical records completeness, timeliness
□ Yes □ No by medical staff for utilization review, mortality review, etc.
C-0334
§485.641 (a) Standard: Periodic Evaluation
Self-Evaluation:
Comments/Actions
□ Yes □ No Is there evidence that the most current evaluation included
the CAH’s health care policies?
□ Yes □ No Have all of the CAHs health care policies been reviewed and
revised as needed within the past 12 months?
36
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
C-0335
§485.641 (a) Standard: Periodic Evaluation
(2) The purpose of the evaluation is to determine whether the utilization of services was appropriate,
the established policies were followed, and any changes needed.
Self-Evaluation:
Comments/Actions
□ Yes □ No Does the annual evaluation report contain a summary of the
evaluation findings?
Do the findings include:
□ Yes □ No a statement, supported by hard data, that indicates whether
or not the utilization of the CAH’s services in the past 12
months was appropriate, and if not, what action will be
taken to correct this.
□ Yes □ No a statement, supported by hard data, that indicates whether
or not established policies were followed, and if not, what
action will be taken to correct this.
□ Yes □ No a statement, supported by hard data, of any changes that
are needed
□ Yes □ No a statement related to each proposed change indicating
how the impact of proposed changes will be monitored and
evaluated during the next 12 month period.
C-0336
§485.641 (b) Standard: Quality Assurance
The CAH has an effective quality assurance program to evaluate the quality and appropriateness
of the diagnosis and treatment furnished in the CAH and of the treatment outcomes. The program
requires that...
37
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
Self-Evaluation:
Comments/Actions
□ Yes □ No Is there evidence that, over the past 12 months, the QA/PI
program has evaluated the quality of diagnosis and
treatment?
□ Yes □ No Is there evidence that, over the past 12 months, the QA/PI
program has evaluated the appropriateness of diagnosis and
treatment?
□ Yes □ No Is there evidence that the QA/PI program has evaluated
treatment outcomes throughout the past 12 months?
□ Yes □ No Is there evidence from the past 12 months that the CAH’s
Quality Assurance/PI program is effective, ie, over the past
12 months....
Is there evidence that the program included:
□ Yes □ No ongoing monitoring and data collection;
□ Yes □ No problem prevention, identification and data analysis;
□ Yes □ No identification of corrective actions;
□ Yes □ No implementation of corrective actions;
□ Yes □ No evaluation of corrective actions;
□ Yes □ No measures to improve quality on a continuous basis.
C-0337
§485.641 (b) Standard: Quality Assurance
(1)
All patient care services and other services affecting patient health and safety, are evaluated;
Note: The minutes of the QA/PI committee should demonstrate that, over the course of 12 months,
all departments/services in the facility have provided a quality report to the committee within the
time frames outlined by policy.
Also, be sure to integrate the findings and work of organization committees, including the Safety,
Infection Control, P & T, Risk Management, Patient Safety, and others working on patient health
and safety issues.
38
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
Self-Evaluation:
Comments/Actions
□ Yes □ No Is there evidence that, over the past 12 months, the QA/PI
program has evaluated all departments and services within
the facility?
Is there evidence that the dept/service included in its report information
about:
□ Yes □ No its ongoing monitoring and data collection?
□ Yes □ No problem prevention, identification, and data analysis with
the dept/service?
□ Yes □ No identification of corrective actions?
□ Yes □ No implementation of corrective actions?
□ Yes □ No evaluation of corrective actions?
□ Yes □ No measures to improve quality on a continuous basis?
C-0338
§485.641 (b) Standard: Quality Assurance
(2) Nosocomial infections and medication therapy are evaluated;
Self-Evaluation:
Comments/Actions
□ Yes □ No Is there evidence that nosocomial infections are evaluated
as part of the QA/PI Program?
Is there evidence that the infection control program included in its report
information about:
□ Yes □ No its ongoing monitoring and data collection?
□ Yes □ No problem prevention, identification, and data analysis with
the dept/service?
□ Yes □ No identification of corrective actions?
□ Yes □ No implementation of corrective actions?
□ Yes □ No evaluation of corrective actions?
□ Yes □ No measures to improve quality on a continuous basis?
39
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
□ Yes □ No Is there evidence that medication therapy is evaluated as
part of the QA/PI Program
Is there evidence that the medication therapy program included in its
report information about:
□ Yes □ No its ongoing monitoring and data collection?
□ Yes □ No problem prevention, identification, and data analysis with
the dept/service?
□ Yes □ No identification of corrective actions?
□ Yes □ No implementation of corrective actions?
□ Yes □ No evaluation of corrective actions?
□ Yes □ No measures to improve quality on a continuous basis?
C-0339
§485.641 (b) Standard: Quality Assurance
(3) The quality and appropriateness of the diagnosis and treatment furnished by nurse practitioners,
clinical nurse specialists, and physician assistants at the CAH are evaluated by a member of the CAH
staff who is a doctor of medicine or osteopathy or by another doctor of medicine or osteopathy under
contract with the CAH;
Self-Evaluation:
Comments/Actions
□ Do Not Use Mid-Levels, go to Tag C-340
□ Yes □ No Do the medical staff Bylaws, Rules and/or Regulations
require physician review of the care provided by mid-levels
(inpatients and outpatients)?
□ Yes □ No Is the level of review required by the Bylaws consistent
with the requirements of the SOM (see C-0260, % records
reviewed)?
□ Yes □ No Is there evidence that the designated physician supervisor
has reviewed the care of each mid-level provider providing
care?
40
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
□ Yes □ No Is there evidence that the physician and mid-level provider
have participated together in the periodic review of patient
health records (see C-0264) for QI purposes?
□ Yes □ No Is there evidence that the physician-midlevel joint review
has produced opportunities to improve diagnosis and/or
treatment in the past 12 mo?
□ Yes □ No Is there evidence that the physician-midlevel joint review
has produced process or systems improvements in response
to identified opportunities?
□ Yes □ No Is there evidence that the process and/or system
opportunities identified and improvements made were
communicated to other facility medical providers, the QA/PI
program and Board during the past 12 months?
□ Yes □ No Is there evidence that the process and/or system
opportunities identified and improvements made were
communicated to the governing board during the past 12
months?
C-0340
§485.641 (b) Standard: Quality Assurance
(4) The quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine
or osteopathy at the CAH are evaluated by –
(i) One hospital that is a member of the network, when applicable;
(ii) One QIO or equivalent entity; or
(iii)One other appropriate and qualified entity identified in the State rural health care plan...
(iv)In the case of distant-site physicians and practitioners providing telemedicine services to
the CAH’s patients under a written agreement between the CAH and a distant-site hospital,
the distant-site hospital; or
(v) In the case of distant-site physicians and practitioners providing telemedicine services to
the CAH’s patients under a written agreement between the CAH and a distant-site
telemedicine entity, one of the entities listed in paragraphs (b)(4)(i) through (iii)of this
section;
41
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
Self-Evaluation:
Comments/Actions
□ Yes □ No Does the medical staff Bylaws, Rules and/or Regulations
require physician review of the diagnosis and treatment
rendered by all physicians treated by the facility (inpatients
and outpatients)?
□ Yes □ No If the facility has more than one practicing physician on
staff, do the Bylaws require both internal and external
review of the diagnosis and treatment rendered?
□ Yes □ No Is there evidence that the diagnosis and treatment provided
by each staff physician is evaluated?
□ Yes □ No Is there evidence that the diagnosis and treatment provided
by each consulting physician is evaluated?
□ Yes □ No Is there evidence that the reviews encompass the full range
of cases the physician typically sees and treats in the facility
in a year’s time?
□ Yes □ No Is there evidence that the physician reviews have produced
opportunities to improve diagnosis and/or treatment in the
past 12 months?
□ Yes □ No Is there evidence that the physician reviews have produced
process or systems improvements in response to identified
opportunities in the past 12 months?
□ Yes □ No Is there evidence that the process and/or system
opportunities and improvements identified through
physician reviews were communicated to other facility
medical providers and the QA/PI program during the past
12 months?
□ Yes □ No Is there evidence that the process and/or system
opportunities and improvements identified through
physician reviews were communicated to the governing
board during the past 12 months?
42
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
Identify those sources through which you obtain internal physician review
of diagnosis and treatment:
□ other in-house physicians
□ infection control committee
□ P & T committee
□ Patient Safety committee
□ Risk Management committee
□ Quality Committee or projects
□ other __________________
□ Yes □ No Does your program for the review of the quality and
appropriateness of diagnosis and treatment meet the
requirements of this standard?
C-0341
§485.641 (b) Standard: Quality Assurance
(5)(i) The CAH staff considers the findings of the evaluations, including any findings or
recommendations of the QIO, and takes corrective action if necessary.
Self-Evaluation:
Comments/Actions
□ Yes □ No Is there evidence that the CAH staff have considered the
findings of QA/PI evaluations and recommendations,
including those obtained from the QIO?
□ Yes □ No Have opportunities for improvement been identified in any
of these evaluations/recommendations?
□ Yes □ No Has corrective action/improvement been implemented in
response to identified recommendations or opportunities
for improvement?
.
43
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
C-0342
§485.641 (b) Standard: Quality Assurance
(5)(ii) The CAH also takes appropriate remedial action to address deficiencies found through the
quality assurance program.
Self-Evaluation:
Comments/Actions
□ Yes □ No Is there evidence that the CAH staff have integrated the
findings from regulatory survey deficiencies, QIO complaint
investigations, HIPAA complaints, patient complaints,
litigation and other sources with other improvement
opportunities identified through the QA/PI program?
□ Yes □ No Have opportunities for remedial action to correct
deficiencies been identified from any source?
□ Yes □ No Have corrective action/improvement been implemented in
response to identified deficiencies?
□ Yes □ No Is there evidence that corrective actions for identified
deficiencies, from any source, have been evaluated for
effectiveness using objective measures of performance?
□ Yes □ No Is there evidence of ongoing intervention to achieve
correction of identified deficiencies when initial steps do not
achieve the necessary correction or desired result?
44
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
C-0343
§485.641 (b) Standard: Quality Assurance
(5)(iii) The CAH documents the outcome of all remedial actions.
Self-Evaluation:
Comments/Actions
□ Yes □ No Is there objective evidence and analysis that demonstrates
corrective actions for identified deficiencies have corrected
the problem, and that correction has been maintained for at
least one year?
□ Yes □ No Is there evidence that the correction of deficiencies has
been communicated to the governing board?
ORGAN, TISSUE, EYE PROCUREMENT
C-0345
§485.643(a) Condition of Participation: Organ, Tissue & Eye Procurement
§485.643(a) Incorporate an agreement with an OPO designated under part 486 of this chapter, under
which it must notify, in a timely manner, the OPO or a third party designated by the OPO of individuals
whose death is imminent or who have died in the CAH. The OPO determines medical suitability for
organ donation and, in the absence of alternative arrangements by the CAH, the OPO determines
medical suitability for tissue and eye donation, using the definition of potential tissue and eye donor
and the notification protocol developed in consultation with the tissue and eye banks identified by the
CAH for this purpose;
Self-Evaluation:
Comments/Actions
□ Yes □ No Is there a written agreement with an Organ Procurement
Organization?
Who?_______________________________________________________________
45
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
Does the OPO agreement contain, at a minimum, the following:
□ Yes □ No The criteria for referral, including the referral of all
individuals whose death is imminent or who have died in
the CAH;
□ Yes □ No Includes a definition of “imminent death”;
□ Yes □ No Includes a definition of “timely notification”;
□ Yes □ No Addresses the OPO’s responsibility to determine medical
suitability for organ donation;
□ Yes □ No Specifies how the tissue and/or eye bank will be notified
about potential donors using S notification protocols
developed by the OPO in consultation with the CAHdesignated tissue and eye bank(s);
□ Yes □ No Provides for notification of each individual death in a timely
manner to the OPO (or designated third party) in
accordance with the terms of the agreement;
□ Yes □ No Ensures that the designated requestor training program
offered by the OPO has been developed in cooperation with
the tissue bank and eye bank designated by the CAH;
□ Yes □ No Permits the OPO, tissue bank, and eye bank access to the
CAH’S death record information according to a designated
schedule, e.g., monthly or quarterly;
□ Yes □ No Includes that the CAH is not required to perform
credentialing reviews for, or grant privileges to, members
of organ recovery teams as long as the OPO sends only
“qualified, trained individuals” to perform organ recovery;
□ Yes □ No The interventions the CAH will utilize to maintain potential
organ donor patients so that the patient organs remain
viable.
46
(Updated December 2016, Rev. 163, 10-14-2016)
CAH Quality Assurance Survey Readiness Self-Assessment
**For tags supported by the Performance Improvement Network**
SWING-BEDS
C-0350
§485.645 Special Requirements for CAH Providers of Long-Term Care Services (SwingBeds)
A CAH must meet the following requirements in order to be granted an approval from CMS to provide
post-CAH SNF care, as specified in §409.30 of this chapter, and to be paid for SNF-level services, in
accordance with paragraph (c) of this section.
Self-Evaluation:
Comments/Actions
□ Yes □ No Is there evidence that the CAH is substantially in compliance with
§409.30?
47
(Updated December 2016, Rev. 163, 10-14-2016)