[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR488.110]



[Page 673-916]

 

                         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 

 

                  SUBPART C_SURVEY FORMS AND PROCEDURES

 

Sec.  488.110  Procedural guidelines.



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Sec.  488.100  Long term care survey forms, Part A.

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Sec.  488.105  Long term care survey forms, Part B.

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    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



[[Page 768]]



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 769]]



--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



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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



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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



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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 773]]



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 774]]



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 775]]



    (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 776]]



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.



[[Page 777]]



     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.



[[Page 778]]



     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



[[Page 779]]



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.



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