[Code of Federal Regulations]
[Title 12, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR488.110]
[Page 756-768]
TITLE 42--PUBLIC HEALTH
CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF
HEALTH AND HUMAN SERVICES--(Continued)
PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES--Table of Contents
SUBPART C--SURVEY FORMS AND PROCEDURES
Sec. 488.110 Procedural guidelines.
SNF/ICF Survey Process. The purpose for implementing a new SNF/ICF
survey process is to assess whether the quality of care, as intended by
the law and regulations, and as needed by the resident, is actually
being provided in nursing homes. Although the onsite review procedures
have been changed, facilities must continue to meet all applicable
Conditions/Standards, in order to participate in Medicare/Medicaid
programs. That is, the methods used to
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compile information about compliance with law and regulations are
changed; the law and regulations themselves are not changed. The new
process differs from the traditional process, principally in terms of
its emphasis on resident outcomes. In ascertaining whether residents
grooming and personal hygiene needs are met, for example, surveyors will
no longer routinely evaluate a facility's written policies and
procedures. Instead, surveyors will observe residents in order to make
that determination. In addition, surveyors will confirm, through
interviews with residents and staff, that such needs are indeed met on a
regular basis. In most reviews, then, surveyors will ascertain whether
the facility is actually providing the required and needed care and
services, rather than whether the facility is capable of providing the
care and services.
The Outcome-Oriented Survey Process--Skilled Nursing Facilities (SNFs)
and Intermediate Care Facilities (ICFs)
(a) General.
(b) The Survey Tasks.
(c) Task 1--Entrance Conference.
(d) Task 2--Resident Sample--Selection Methodology.
(e) Task 3--Tour of the Facility.
(f) Task 4--Observation/Interview/Medical Record Review (including
drug regimen review).
(g) Task 5--Drug Pass Observation.
(h) Task 6--Dining Area and Eating Assistance Observation.
(i) Task 7--Forming the Deficiency Statement.
(j) Task 8--Exit Conference.
(k) Plan of Correction.
(l) Followup Surveys.
(m) Role of Surveyor.
(n) Confidentiality and Respect for Resident Privacy.
(o) Team Composition.
(p) Type of Facility-Application of SNF or ICF Regulations.
(q) Use of Part A and Part B of the Survey Report.
(a) General. A complete SNF/ICF facility survey consists of three
components:
Life Safety Code requirements;
Administrative and structural requirements (Part
A of the Survey Report, Form CMS-525); and
Direct resident care requirements (Part B of the
Survey Report, Form CMS-519), along with the related worksheets (CMS-520
through 524).
Use this survey process for all surveys of SNFs and ICFs--whether
freestanding, distinct parts, or dually certified. Do not use this
process for surveys of Intermediate Care Facilities for Mentally
Retarded (ICFs/MR), swing-bed hospitals or skilled nursing sections of
hospitals that are not separately certified as SNF distinct parts. Do
not announce SNF/ICF surveys ahead of time.
(b) The Survey Tasks. Listed below are the survey tasks for easy
reference:
Task 1. Entrance Conference.
Task 2. Resident Sample--Selection Methodology.
Task 3. Tour of the Facility. Resident Needs.
Physical Environment. Meeting with Resident Council Representatives.
Tour Summation and Focus of Remaining Survey Activity.
Task 4. Observation/Interview/Medical Record.
Review of Each Individual in the Resident Sample (including drug regimen
review).
Task 5. Drug Pass Observation.
Task 6. Dining Area and Eating Assistance
Observation.
Task 7. Forming the Deficiency Statement (if
necessary).
Task 8. Exit Conference.
(c) Task 1--Entrance Conference. Perform these activities during the
entrance conference in every certification and recertification survey:
Introduce all members of the team to the facility
staff, if possible, even though the whole team may not be present for
the entire entrance conference. (All surveyors wear identification
tags.)
Explain the SNF/ICF survey process as resident
centered in focus, and outline the basic steps.
Ask the facility for a list showing names of
residents by room number with each of the following care needs/
treatments identified for each resident to whom they apply:
--Decubitus care
--Restraints
--Catheters
--Injections
--Parenteral fluids
--Rehabilitation service
--Colostomy/ileostomy care
--Respiratory care
[[Page 758]]
--Tracheostomy care
--Suctioning
--Tube feeding
Use this list for selecting the resident sample.
Ask the facility to complete page 2 of Form CMS-
519 (Resident Census) as soon as possible, so that the information can
further orient you to the facility's population. In a survey of a SNF
with a distinct part ICF, you may collect two sets of census data.
However, consolidate the information when submitting it to the regional
office. You may modify the Resident Census Form to include the numbers
of licensed and certified beds, if necessary.
Ask the facility to post signs on readily viewed
areas (at least one on each floor) announcing that State surveyors are
in the facility performing an ``inspection,'' and are available to meet
with residents in private. Also indicate the name and telephone number
of the State agency. Hand-printed signs with legible, large letters are
acceptable.
If the facility has a Resident Council, make
mutually agreeable arrangements to meet privately with the president and
officers and other individuals they might invite.
Inform the facility that interviews with
residents and Resident Councils are conducted privately, unless they
independently request otherwise, in order to enhance the development of
rapport as well as to allay any resident anxiety. Tell the facility that
information is gathered from interviews, the tour, observations,
discussions, record review, and facility officials. Point out that the
facility will be given an opportunity to respond to all findings.
(d) Task 2--Resident Sample--Selection Methodology. This methodology
is aimed at formulating a sample that reflects the actual distribution
of care needs/treatments in the facility population.
Primarily performed on a random basis, it also ensures
representation in the sample of certain care needs and treatments that
are assessed during the survey.
(1) Sample Size. Calculate the size of the sample according to the
following guide:
------------------------------------------------------------------------
Number of residents in
Number of residents in facility sample\1\
------------------------------------------------------------------------
0-60 residents......................... 25% of residents (minimum--10).
61-120 residents....................... 20% of residents (minimum--15).
121-200 residents...................... 15% of residents (minimum--24).
201+ residents......................... 10% of residents (minimum--30).
------------------------------------------------------------------------
\1\ Maximum--50.
Note that the calculation is based on the resident census, not beds.
After determining the appropriate sample size, select residents for the
sample in a random manner. You may, for example, select every fifth
resident from the resident census, beginning at a random position on the
list. For surveys of dually certified facilities or distinct part SNFs/
ICFs, first use the combined SNF/ICF population to calculate the size of
the sample, and then select a sample that reflects the proportions of
SNF and ICF residents in the facility's overall population.
(2) Special Care Needs/Treatments. The survey form specifies several
care needs/treatments that must always be reviewed when they apply to
any facility residents. These include:
Decubitus Care
Restraints
Catheters
Injections, Parenteral Fluids, Colostomy/Ileostomy,
Respiratory Care, Tracheostomy Care, Suctioning, Tube Feeding
Rehabilitative Services (physical therapy, speech
pathology and audiology services, occupational therapy)
Due to the relatively low prevalence of these care needs/treatments,
appropriate residents may be either under-
represented or entirely omitted from the sample. Therefore, determine
during the tour how many residents in the random selection fall into
each of these care categories. Then, compare the number of such
residents in the random selection with the total number of residents in
the facility with each specified care need/treatment (based on either
the resident census or other information provided by the facility).
Review no less than 25 percent of the residents in each of these
special care needs/treatments categories. For example, if the facility
has 10 residents with
[[Page 759]]
decubitus ulcers, but only one of these residents is selected randomly,
review two more residents with decubitis ulcers (25% of 10 equals 2.5,
so review a total of 3). Or, if the facility has two residents who
require tube feeding, neither of whom is in the random selection, review
the care of at least one of the these residents. This can be
accomplished in the following manner:
Conduct in-depth reviews of the randomly selected residents and then
perform limited reviews of additional residents as needed to cover the
specified care categories. Such reviews are limited to the care and
services related to the pertinent care areas only, e.g., catheters,
restraints, or colostomy. Utilize those worksheets or portions of
worksheets which are appropriate to the limited review. Refer to the
Care Guidelines, as a resource document, when appropriate.
Always keep in mind that neither the random selection approach nor
the review of residents within the specified care categories precludes
investigation of other resident care situations that you believe might
pose a serious threat to a resident's health or safety. Add to the
sample, as appropriate.
(e) Task 3--Tour of the Facility. (1) Purpose. Conduct the tour in
order to:
Develop an overall picture of the types and
patterns of care delivery present within the facility;
View the physical environment; and
Ascertain whether randomly selected residents are
communicative and willing to be interviewed.
(2) Protocol. You may tour the entire facility as a team or
separately, as long as all areas of the facility are examined by at
least one team member. Success of the latter approach, however, is
largely dependent on open intra-team communication and the ability of
each team member to identify situations for further review by the team
member of the appropriate discipline. You may conduct the tour with or
without facility staff accompanying you, as you prefer. Facilities,
however, vary in staff member availability. Record your notes on the
Tour Notes Worksheet, Form CMS-521.
Allow approximately three hours for the tour. Converse with
residents, family members/significant others (if present), and staff,
asking open-ended questions in order to confirm observations, obtain
additional information, or corroborate information, (e.g., accidents,
odors, apparent inappropriate dress, adequacy and appropriateness of
activities). Converse sufficiently with residents selected for in-depth
review to ascertain whether they are willing to be interviewed and are
communicative. Observe staff interactions with other staff members as
well as with residents for insight into matters such as resident rights
and assignments of staff responsibilities.
Always knock and/or get permission before entering a room or
interrupting privacy. If you wish to inspect a resident's skin, observe
a treatment procedure, or observe a resident who is exposed, courteously
ask permission from the resident if she/he comprehends, or ask
permission from the staff nurse if the resident cannot communicate. Do
not do ``hands-on'' monitoring such as removal of dressings; ask staff
to remove a dressing or handle a resident.
(3) Resident Needs. While touring, focus on the residents' needs--
physical, emotional, psychosocial, or spiritual--and whether those needs
are being met. Refer to the following list as needed:
--Personal hygiene, grooming, and appropriate dress
--Position
--Assistive and other restorative devices
--Rehabilitation issues
--Functional limitations in ADL
--Functional limitations in gait, balance and coordination
--Hydration and nutritional status
--Resident rights
--Activity for time of day (appropriate or inappropriate)
--Emotional status
--Level of orientation
--Awareness of surroundings
--Behaviors
--Cleanliness of immediate environment (wheelchair, bed, bedside table,
etc.)
--Odors
--Adequate clothing and care supplies as well as maintenance and
cleanliness of same
(4) Review of the Physical Environment. As you tour each resident's
room and
[[Page 760]]
auxiliary rooms, also examine them in connection with the physical
environment requirements. You need not document physical environment on
the Tour Notes Worksheet. Instead, you may note any negative findings
directly on the Survey Report Form in the remarks section.
(5) Meeting With Resident Council Representatives. If a facility has
a Resident Council, one or more surveyors meet with the respresentatives
in a private area. Facility staff members do not attend unless
specifically requested by the Council. Explain the purpose of the survey
and briefly outline the steps in the survey process, i.e., entrance
conference * * * exit conference. Indicate your interest in learning
about the strengths of the facility in addition to any complaints or
shortcomings. State that this meeting is one part of the information
gathering; the findings have not yet been completed nor the conclusions
formulated. Explain further, however, that the official survey findings
are usually available within three months after the completion of the
survey, and give the telephone number of the State agency office.
Use this meeting to ascertain strengths and/or problems, if any,
from the consumer's perspective, as well as to develop additional
information about aspects of care and services gleaned during the tour
that were possibly substandard.
Conduct the meeting in a manner that allows for comments about any
aspect of the facility. (See the section on Interview Procedures.) Use
open-ended questions such as:
``What is best about this home?''
``What is worst?''
``What would you like to change?''
In order to get more detail, use questions such as:
``Can you be more specific?''
``Can you give me an example?''
``What can anyone else tell me about this?''
If you wish to obtain information about a topic not raised by the
residents, use an approach like the following:
``Tell me what you think about the food/staff/
cleanliness here.''
``What would make it better?''
``What don't you like? What do you like?''
(6) Tour Summation and Focus of Remaining Survey Activity. When the
tour is completed, review the resident census data provided by the
facility. Determine if the care categories specified in the section on
Resident Sample are sufficiently represented in the random selection,
make adjustments as needed, and complete the listing of residents on the
worksheet labeled ``Residents Selected for In-depth Review'', Form CMS-
520.
Transcribe notes of a negative nature onto the SRF in the
``Remarks'' column under the appropriate rule. Findings from a later
segment in the survey or gathered by another surveyor may combine to
substantiate a deficiency. You need not check ``met'' or ``not met'' at
this point in the survey. Discuss significant impressions/conclusions at
the completion of each subsequent survey task, and transfer any negative
findings onto the Survey Report Form in the Remarks section.
(f) Task 4--Observation/Interview/Medical Record Review (including
drug regimen review). Perform the in-depth review of each individual in
the resident sample in order to ascertain whether the facility is
meeting resident needs. Evaluate specific indicators for each resident,
utilizing the front and back of the ``Observation/Interview/Record
Review (OIRR)'' worksheet, Form CMS-524. You may prefer to perform the
record review first, complete resident/staff/family observations and
interviews, and finally, return to the record for any final unresolved
issues. On the other hand, you may prefer to do the interviews first.
Either method is acceptable. Whenever possible, however, complete one
resident's observation/interview/medical record review and document the
OIRR before moving onto another resident. If because of the facility
layout, it is more efficient to do more than one record review at a
time, limit such record review to two or three residents so your
familiarity with the particular resident and continuity of the OIRR are
not compromised.
(1) Observation. Conduct observations concurrently with interviews
of residents, family/significant others, and
[[Page 761]]
discussions with direct care staff [of the various disciplines involved.
In multi-facility operations, whenever possible, observe staff that is
regularly assigned to the facility in order to gain an understanding of
the care and services usually provided.] Maintain respect for resident
privacy. Minimize disruption of the operations of the facility or
impositions upon any resident as much as possible. Based upon your
observations of the residents' needs, gather information about any of
the following areas, as appropriate:
Bowel and bladder training
Catheter care
Restraints
Injections
Parenteral fluids
Tube feeding/gastrostomy
Colostomy/ileostomy
Respiratory therapy
Tracheostomy care
Suctioning
(2) Interviews. Interview each resident in private unless he/she
independently requests that a facility staff member or other individual
be present. Conduct the in-depth interview in a nonthreatening and
noninvasive fashion so as to decrease anxiety and defensiveness. The
open-ended approach described in the section on the Resident Council is
also appropriate for the in-depth interview. While prolonged time
expenditure is not usually a worthwhile use of resources or the
resident's time, do allow time initially to establish rapport.
At each interview:
Introduce yourself.
Address the resident by name.
Explain in simple terms the reason for your visit
(e.g., to assure that the care and services are adequate and appropriate
for each resident).
Briefly outline the process--entrance conference,
tour, interviews, observations, review of medical records, resident
interviews, and exit conference.
Mention that the selection of a particular
resident for an interview is not meant to imply that his/her care is
substandard or that the facility provides substandard care. Also mention
that most of those interviewed are selected randomly.
Assure that you will strive for anonymity for the
resident and that the interview is used in addition to medical records,
observations, discussions, etc., to capture an accurate picture of the
treatment and care provided by the facility. Explain that the official
findings of the survey are usually available to the public about three
months after completion of the survey, but resident names are not given
to the public.
When residents experience difficulty expressing
themselves:
--Avoid pressuring residents to verbalize
--Accept and respond to all communication
--Ignore mistakes in word choice
--Allow time for recollection of words
--Encourage self-expression through any means available
When interviewing residents with decreased
receptive capacity:
--Speak slowly and distinctly
--Speak at conversational voice level
--Sit within the resident's line of vision
Listen to all resident information/allegations
without judgment. Information gathered subsequently may substantiate
or repudiate an allegation.
The length of the interview varies, depending on the condition and
wishes of the resident and the amount of information supplied. Expect
the average interview, however, to last approximately 15 minutes.
Courteously terminate an interview whenever the resident is unable or
unwilling to continue, or is too confused or disoriented to continue.
Do, however, perform the other activities of this task (observation and
record review). If, in spite of your conversing during the tour, you
find that less than 40 percent of the residents in your sample are
sufficiently alert and willing to be interviewed, try to select
replacements so that a complete OIRR is performed for a group this size,
if possible. There may be situations, however, where the resident
population has a high percentage of confused individuals and this
percentage is not achievable. Expect that the information from confused
individuals can be, but is not necessarily, less
[[Page 762]]
reliable than that from more alert individuals.
Include the following areas in the interview of each resident in the
sample:
Activities of daily living
Grooming/hygiene
Nutrition/dietary
Restorative/rehabilitation care and services
Activities
Social services
Resident rights
Refer to the Care Guidelines ``evaluation factors'' as a resource
for possible elements to consider when focusing on particular aspects of
care and resident needs.
Document information obtained from the interviews/observations on
the OIRR Worksheet. Record in the ``Notes'' section any additional
information you may need in connection with substandard care or
services. Unless the resident specifically requests that he/she be
identified, do not reveal the source of the information gleaned from the
interview.
(3) Medical Record Review. The medical record review is a three-part
process, which involves first reconciling the observation/interview
findings with the record, then reconciling the record against itself,
and lastly performing the drug regimen review.
Document your findings on the OIRR Worksheet, as appropriate, and
summarize on the Survey Report Form the findings that are indicative of
problematic or substandard care. Be alert for repeated similar instances
of substandard care developing as the number of completed OIRR
Worksheets increases.
Note: The problems related to a particular standard or condition
could range from identical (e.g., meals not in accordance with dietary
plan) to different but related (e.g., nursing services--lapse in care
provided to residents with catheters, to residents with contractures, to
residents needing assistance for personal hygiene and residents with
improperly applied restraints).
(i) Reconciling the observation/interview findings with the record.
Determine if:
An assessment has been performed.
A plan with goals has been developed.
The interventions have been carried out.
The resident has been evaluated to determine the
effectiveness of the interventions.
For example, if a resident has developed a decubitus ulcer while in
the facility, record review can validate staff and resident interviews
regarding the facility's attempts at prevention. Use your own judgment;
review as much of the record(s) as necessary to evaluate the care
planning. Note that facilities need not establish specific areas in the
record stating ``Assessment,'' ``Plan,'' ``Intervention,'' or
``Evaluation'' in order for the documentation to be considered adequate.
(ii) Reconciling the record with itself. Determine:
If the resident has been properly assessed for
all his/her needs.
That normal and routine nursing practices such as
periodic weights, temperatures, blood pressures, etc., are performed as
required by the resident's conditions.
(iii) Performing the drug regimen review. The purpose of the drug
regimen review is to determine if the pharmacist has reviewed the drug
regimen on a monthly basis. Follow the procedures in Part One of
Appendix N, Surveyor Procedures for Pharmaceutical Service Requirements
in Long-Term Care Facilities. Fill in the appropriate boxes on the top
left hand corner of the reverse side of the OIRR Worksheet, Form CMS-
524. Appendix N lists many irregularities that can occur. Review at
least six different indicators on each survey. However, the same six
indicators need not be reviewed on every survey.
Note: If you detect irregularities and the documentation
demonstrates that the pharmacist has notified the attending physician,
do not cite a deficiency. Do, however, bring the irregularity to the
attention of the medical director or other facility official, and note
the official's name and date of notification on the Survey Report Form.
(g) Task 5--Drug Pass Observation. The purpose of the drug pass
observation is to observe the actual preparation and administration of
medications to residents. With this approach, there is no doubt that the
errors detected, if any, are errors in drug administration, not
[[Page 763]]
documentation. Follow the procedure in Part Two of Appendix N, Surveyor
Procedures for Pharmaceutical Service Requirements in Long-Term Care
Facilities, and complete the Drug Pass Worksheet, Form CMS-522. Be as
neutral and unobtrusive as possible during the drug pass observation.
Whenever possible, select one surveyor, who is a Registered Nurse or a
pharmacist, to observe the drug pass of approximately 20 residents. In
facilities where fewer than 20 residents are receiving medications,
review as many residents receiving medications as possible. Residents
selected for the in-depth review need not be included in the group
chosen for the drug pass; however, their whole or partial inclusion is
acceptable. In order to get a balanced view of a facility's practices,
observe more than one person administering a drug pass, if feasible.
This might involve observing the morning pass one day in Wing A, for
example, and the morning pass the next day in Wing B.
Transfer findings noted on the ``Drug Pass'' worksheet to the SRF
under the appropriate rule. If your team concludes that the facility's
medication error rate is 5 percent or more, cite the deficiency under
Nursing Services/Administration of Drugs. Report the error rate under
F209. If the deficiency is at the standard level, cite it in Nursing
Services, rather than Pharmacy.
(h) Task 6--Dining Area and Eating Assistance Observation. The
purpose of this task is to ascertain the extent to which the facility
meets dietary needs, particularly for those who require eating
assistance. This task also yields information about staff interaction
with residents, promptness and appropriateness of assistance, adaptive
equipment usage and availability, as well as appropriateness of dress
and hygiene for meals.
For this task, use the worksheet entitled ``Dining Area and Eating
Assistance Observation'' (Form CMS-523). Observe two meals; for a
balanced view, try to observe meals at different times of the day. For
example, try to observe a breakfast and a dinner rather than two
breakfasts. Give particular care to performing observations as
unobtrusively as possible. Chatting with residents and sitting down
nearby may help alleviate resident anxiety over the observation process.
Select a minimum of five residents for each meal observation and
include residents who have their meals in their rooms. Residents
selected for the in-depth review need not be included in the dining and
eating assistance observation; however, their whole or partial inclusion
is acceptable. Ascertain the extent to which the facility assesses,
plans, and evaluates the nutritional care of residents and eating
assistance needs by reviewing the sample of 10 or more residents. If you
are unable to determine whether the facility meets the standards from
the sample reviewed, expand the sample and focus on the specific area(s)
in question, until you can formulate a conclusion about the extent of
compliance. As with the other survey tasks, transfer the findings noted
on the ``Dining & Eating Assistance Observation'' worksheet to the
Survey Report Form.
(i) Task 7--Forming the Deficiency Statement. (1) General. The
Survey Report Form contains information about all of the negative
findings of the survey. Be sure to transfer to the Survey Report Form
data from the tour, drug pass observation, dining area and eating
assistance observation, as well as in-depth review of the sample of
residents. Transfer only those findings which could possibly contribute
to a determination that the facility is deficient in a certain area.
Meet as a group in a pre-exit conference to discuss the findings and
make conclusions about the deficiencies, subject to information provided
by facility officials that may further explain the situation. Review the
summaries/conclusions from each task and decide whether any further
information and/or documentation is necessary to substantiate a
deficiency. As the facility for additional information for clarification
about particular findings, if necessary. Always consider information
provided by the facility. If the facility considers as acceptable,
practices which you believe are not acceptable, ask the facility to
backup its contention with suitable reference material or sources and
submit them for your consideration.
[[Page 764]]
(2) Analysis. Analyze the findings on the Survey Report Form for the
degree of severity, frequency of occurrence and impact on delivery of
care or quality of life. The threshold at which the frequency of
occurrences amounts to a deficiency varies from situation to situation.
One occurrence directly related to a life-threatening or fatal outcome
can be cited as a deficiency. On the other hand, a few sporadic
occurrences may have so slight an impact on delivery of care or quality
of life that they do not warrant a deficiency citation. Review carefully
all the information gathered. What may appear during observation as a
pattern, may or may not be corroborated by records, staff, and
residents. For example, six of the 32 residents in the sample are
dressed in mismatched, poorly buttoned clothes. A few of the six are
wearing slippers without socks. A few others are wearing worn clothes.
Six occurrences might well be indicative of a pattern of susbstandard
care. Close scrutiny of records, discussions with staff, and interviews
reveal, however, that the six residents are participating in dressing
retraining programs. Those residents who are without socks, chose to do
so. The worn clothing items were also chosen--they are favorites.
Combinations of substandard care such as poor grooming of a number
of residents, lack of ambulation of a number of residents, lack of
attention to positioning, poor skin care, etc., can yield a deficiency
in nursing services just as 10 out of 10 residents receiving substandard
care for decubiti yields a deficiency.
(3) Deficiencies Alleged by Staff or Residents. If staff or
residents allege deficiencies, but records, interviews, and observation
fail to confirm the situation, it is unlikely that a deficiency exists.
Care and services that are indeed confirmed by the survey to be in
compliance with the regulatory requirements, but considered deficient by
residents or staff, cannot be cited as deficient for certification
purposes. On the other hand, if an allegation is of a very serious
nature (e.g., resident abuse) and the tools of record review and
observation are not effective because the problem is concealed, obtain
as much information as possible or necessary to ascertain compliance,
and cite accordingly. Residents, family, or former employees may be
helpful for information gathering.
(4) Composing the Deficiency Statement. Write the deficiency
statement in terms specific enough to allow a reasonably knowledgeable
person to understand the aspect(s) of the requirement(s) that is (are)
not met. Do not delve into the facility's policies and procedures to
determine or speculate on the root cause of a deficiency, or sift
through various alternatives in an effort to prescribe an acceptable
remedy. Indicate the data prefix tag and regulatory citation, followed
by a summary of the deficiency and supporting findings using resident
identifiers, not resident names, as in the following example.
F102 SNF 405.1123(b).--Each resident has not had a physician's visit
at least once every 30 days for the first 90 days after admission.
Resident 1602 has not been seen by a physician since she was
admitted 50 days ago. Her condition has deteriorated since that time
(formulation of decubiti, infections).
When the data prefix tag does not repeat the regulations, also
include a short phrase that describes the prefix tag (e.g., F117
decubitus ulcer care). List the data tags in numerical order, whenever
possible.
(j) Task 8--Exit Conference. The purpose of the exit conference is
to inform the facility of survey findings and to arrange for a plan of
correction, if needed. Keep the tone of the exit conference consistent
with the character of the survey process--inspection and enforcement.
Tactful, business-like, professional presentation of the findings is of
paramount importance. Recognize that the facility may wish to respond to
various findings. Although deficiency statements continue to depend, in
part, on surveyor professional judgment, support your conclusions with
resident-specific examples (identifiers other than names) whenever you
can do so without compromising confidentiality. Before formally citing
deficiencies, discuss any allegations or findings that could not be
substantiated during earlier tasks in the process. For example, if
information is gathered that suggests a newly hired
[[Page 765]]
R.N. is not currently licensed, ask the facility officials to present
current licensure information for the nurse in question. Identify
residents when the substandard care is readily observed or discerned
through record review. Ensure that the facility improves the care
provided to all affected residents, not only the identified residents.
Make clear to the facility that during a follow-up visit the surveyors
may review residents other than those with significant problems from the
original sample, in order to see that the facility has corrected the
problems overall. Do not disclose the source of information provided
during interviews, unless the resident has specifically requested you to
inform the facility of his/her comments or complaints. In accordance
with your Agency's policy, present the Statement of Deficiencies, form
CMS-2567, on site or after supervisory review, no later than 10 calendar
days following the survey.
(k) Plan of Correction. Explain to the facility that your role is to
identify care and services which are not consistent with the regulatory
requirements, rather than to ascertain the root causes of deficiencies.
Each facility is expected to review its own care delivery. Subsequent to
the exit conference, each facility is required to submit a plan of
correction that identifies necessary changes in operation that will
assure correction of the cited deficiencies. In reviewing and accepting
a proposed plan of correction, apply these criteria:
Does the facility have a reasonable approach for
correcting the deficiencies?
Is there a high probability that the planned
action will result in compliance?
Is compliance expected timely?
Plans of correction specific to residents identified on the
deficiency statement are acceptable only where the deficiency is
determined to be unique to that resident and not indicative of a
possible systemic problem. For example, as a result of an aide being
absent, two residents are not ambulated three times that day as called
for in their care plans. A plan of correction that says ``Ambulate John
Jones and Mary Smith three times per day,'' is not acceptable. An
acceptable plan of correction would explain changes made to the
facility's staffing and scheduling in order to gurantee that staff is
available to provide all necessary services for all residents.
Acceptance of the plan of correction does not absolve the facility
of the responsibility for compliance should the implementation not
result in correction and compliance. Acceptance indicates the State
agency's acknowledgement that the facility indicated a willingness and
ability to make corrections adequately and timely.
Allow the facility up to 10 days to prepare and submit the plan of
correction to the State agency, however, follow your SA policy if the
timeframe is shorter. Retain the various survey worksheets as well as
the Survey Report Form at the State agency. Forward the deficiency
statement to the CMS regional office.
(l) Follow-up Surveys. The purpose of the follow-up survey is to re-
evaluate the specific types of care or care delivery patterns that were
cited as deficient during the original survey. Ascertain the corrective
status of all deficiencies cited on the CMS-2567. Because this survey
process focuses on the actual provision of care and services, revisits
are almost always necessary to ascertain whether the deficienicies have
indeed been corrected. The nature of the deficiencies dictates the scope
of the follow-up visit. Use as many tasks or portions of the Survey
Report Form(s) as needed to ascertain compliance status. For example,
you need not perform another drug pass if no drug related deficiencies
were cited on the initial survey. Similarly, you need not repeat the
dining area and eating assistance observations if no related problems
were identified. All or some of the aspects of the observation/
interview/medical record review, however, are likely to be appropriate
for the follow-up survey.
When selecting the resident sample for the follow-up, determine the
sample size using the same formula as used earlier in the survey, with
the following exceptions:
The maximum sample size is 30 residents, rather
than 50.
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The minimum sample size of 10 residents does not
apply if only one care category was cited as deficient and the total
number of residents in the facility in that category was less than 10
(e.g., deficiency cited under catheter care and only five residents have
catheters).
Include in the sample those residents who, in your judgment, are
appropriate for reviewing vis-a-vis the cited substandard care. If
possible, include some residents identified as receiving substandard
care during the initial survey. If after completing the follow-up
activities you determine that the cited deficiencies were not corrected,
initiate adverse action procedures, as appropriate.
(m) Role of Surveyor. The survey and certification process is
intended to determine whether providers and suppliers meet program
participation requirements. The primary role of the surveyor, then, is
to assess the quality of care and services and to relate those findings
to statutory and regulatory requirements for program participation.
When you find substandard care or services in the course of a
survey, carefully document your findings. Explain the deficiency in
sufficient detail so that the facility officials understand your
rationale. If the cause of the deficiency is obvious, share the
information with the provider. For example, if you cite a deficiency for
restraints (F118), indicate that restraints were applied backwards on
residents 1621, 1634, 1646, etc.
In those instances where the cause is not obvious, do not delve into
the facility's policies and procedures to determine the root cause of
any deficiency. Do not recommend or prescribe an acceptable remedy. The
provider is responsible for deciding on and implementing the action(s)
necessary for achieving compliance. For the restraint situation in the
example above, you would not ascertain whether the improper application
was due to improper training or lack of training, nor would you attempt
to identify the staff member who applied the restraints. It is the
provider's responsibility to make the necessary changes or corrections
to ensure that the restriants are applied properly.
A secondary role for the surveyor is to provide general consultation
to the provider/consumer community. This includes meeting with provider/
consumer associations and other groups as well as participating in
seminars. It also includes informational activities, whereby you respond
to oral or written inquiries about required outcomes in care and
services.
(n) Confidentiality and Respect for Resident Privacy. Conduct the
survey in a manner that allows for the greatest degree of
confidentiality for residents, particularly regarding the information
gathered during the in-depth interviews. When recording observations
about care and resident conditions, protect the privacy of all
residents. Use a code such as resident identifier number rather than
names on worksheets whenever possible. Never use a resident's name on
the Deficiency Statement, Form CMS-2567. Block out resident names, if
any, from any document that is disclosed to the facility, individual or
organization.
When communicating to the facility about substandard care, fully
identify the resident(s) by name if the situation was identified through
observation or record review. Improperly applied restraints, expired
medication, cold food, gloves not worn for a sterile procedure, and diet
inconsistent with order, are examples of problems which can be
identified to the facility by resident name. Information about injuries
due to broken equipment, prolonged use of restraints, and opened mail is
less likely to be obtained through observation or record review. Do not
reveal the source of information unless actually observed, discovered in
the record review, or requested by the resident or family.
(o) Team Composition. Whenever possible, use the following survey
team model:
SNF/ICF Survey Team Model
In facilities with 200 beds or less, the team size may range from 2
to 4 members. If the team size is:
2 members: The team has at least one RN plus
another RN or a dietitian or a pharmacist.
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3-4 member: In addition to the composition
described above, the team has one or two members of any discipline such
as a social worker, sanitarian, etc.
If the facility has over 200 beds and the survey will last more than
2 days, the team size may be greater than 4 members. Select additional
disciplines as appropriate to the facility's compliance history.
Average onsite time per survey: 60 person hours (Number of surveyors
multiplied by the number of hours on site)
Preferably, team members have gerontological training and
experience. Any member may serve as the team leader, consistent with
State agency procedures. In followup surveys, select disciplines based
on major areas of correction. Include a social worker, for example, if
the survey revealed major psychosocial problems. This model does not
consider integrated survey and Inspection of Care review teams, which
typically would be larger.
(p) Type of Facility--Application of SNF or ICF Regulations. Apply
the regulations to the various types of facilities in the following
manner:
Apply SNF regulations.
Freestanding Skilled Nursing
Facility (SNF)
Apply ICF regulations.
Freestanding Intermediate
Care Facility (ICF)
SNF Apply SNF regulations.
Distinct Part of a Hospital
ICF Apply ICF regulations.
Distinct Part of a Hospital
Dually Apply SNF regulations and 442.346(b).
Certified SNF/ICF
Apply SNF regulations for SNF unit.
Freestanding SNF with ICF Apply ICF regulations for ICF distinct
Distinct Part (Regardless of part.
the proportion of SNF and Apply both SNF and ICF regulations for
ICF beds, the facility type shared services (e.g., dietary).
is determined by the higher If the same deficiency occurs in both the
level of care. Therefore, SNF and ICF components of the facility,
LTC facilities with distinct cite both SNF and ICF regulations.
parts are defined as SNFs If the deficiency occurs in the SNF part
with ICF distinct parts.) only, cite only the SNF regulation.
If the deficiency occurs in the ICF part
only, cite only the ICF regulation.
(q) Use of Part A and Part B of the Survey Report. (1) Use of Part A
(CMS-525).--Use Part A for initial certification surveys only, except
under the following circumstances:
When a terminated facility requests program
participation 60 days or more after termination. Treat this situation as
a request for initial certification and complete Part A of the survey
report in addition to Part B.
If an ICF with a favorable compliance history
requests to covert a number of beds to SNF level, complete both Part A
and Part B for compliance with the SNF requirements. If distinct part
status is at issue, also examine whether it meets the criteria for
certification as a distinct part.
(i) Addendum for Outpatient Physical Therapy (OPT) or Speech
Pathology Services. Use the Outpatient Physical Therapy--Speech
Pathology SRF (CMS-1893) as an addendum to Part A.
(ii) Resurvey of Participating Facilities. Do not use Part A for
resurveys of participating SNFs and ICFs. A determination of compliance,
based on documented examination of the written policies and procedures
and other pertinent documents during the initial survey, establishes the
facility's compliance status with Part A requirements. This does not
preclude citing deficiencies if they pertain to administrative or
structural requirements from Part A that are uncovered incidental to a
Part B survey. As an assurance measure, however, each facility at the
time of recertification must complete an affidavit (on the CMS-1516)
attesting that no substantive changes have occurred that would affect
compliance. Each facility must also agree to notify the State agency
immediately of any upcoming changes in its organization or management
which may affect its compliance status. If a new administrator is unable
to complete the affidavit, proceed with the survey using the Part B form
and worksheets; do not use the Part A form. The survey cannot be
considered complete, however, until the affidavit is signed. If the
facility fails to complete the affidavit, it cannot participate in the
program.
(iii) Substantial Changes in a Facility's Organization and
Management. If you receive such information, review the changes to
ensure compliance with the regulations. Request copies of the
appropriate documents (e.g., written policies and procedures, personnel
qualifications, or agreements) if they were
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not submitted. If the changes have made continued compliance seem
doubtful, determine through a Part B survey whether deficiencies have
resulted. Cite any deficiencies on the CMS-2567 and follow the usual
procedures.
(2) Use of Part B (CMS-519). Use Part B and the worksheets for all
types of SNF and ICF surveys--initials, recertifications, followup,
complaints, etc.
The worksheets are:
CMS-520--Residents Selected for Indepth Review
CMS-521--Tour Notes Worksheet
CMS-522--Drug Pass Worksheet
CMS-523--Dining Area and Eating Assistance Worksheet
CMS-5245--Observation/Interview/Record Review
Worksheet
For complaint investigations, perform a full or partial Part B
survey based on the extent of the allegations. If the complaint alleges
substandard care in a general fashion or in a variety of services and
care areas, perform several tasks or a full Part B survey, as needed. If
the complaint is of a more specific nature, such as an allegation of
improper medications, perform an appropriate partial Part B survey, such
as a drug pass review and a review of selected medical records.