State Operations Manual Provider Certification

Transcription

1 State Operatins Manual Prvider Certificatin Department f Health and Human Services Health Care Financing Administratin Transmittal N. 10 Date JULY 1999 REVISED MATERIAL REVISED PAGES REPLACED PAGES Chapter 9 List f Exhibits (Cnt.) 9-xiii - 9-xiv (2 pp.) 9-xiii - 9-xiv (2 pp.) Exhibit (1 p.) (2 pp.) Exhibit (2 pp.) -- Exhibit (2 pp.) -- Exhibit (4 pp.) -- Exhibit (4 pp.) -- Exhibit (22 pp.) -- Exhibit (1 p.) -- Appendix P P-1 - P-79 (81 pp.) P-1 - P-56 (56 pp.) Appendix PP PP-47 - PP 52.2 (8 pp.) PP-47 - PP-52 (6 pp.) PP PP (17 pp.) PP PP-124 (6 pp.) PP PP (17 pp.) PP PP-136 (10 pp.) PP PP-164 (10 pp.) PP PP-164 (2 pp.) NEW PROCEDURES -- EFFECTIVE DATE: July 1, 1999 Exhibit 265, Rster/Sample Matrix, HCFA-802, is revised t reflect changes in the survey prcedures, including the use f autmated quality indicatr (QI) reprts. Exhibit 270, QI Reprts, is a set f new autmated facility reprts that survey agencies will generate frm their mainframe cmputer systems fr use in ffsite survey preparatin. Appendix P: Survey Prcedures fr Lng Term Care Facilities, is significantly revised t incrprate the use f QI reprts, t add a new task (5G) and t prvide new investigative prtcls and a new drug review prcess. Appendix PP: Guidance t Surveyrs, is revised t incrprate changes in interpretive guidelines fr abuse, drugs, and sufficient staffing. DISCLAIMER: HCFA-Pub. 7 The revisin date and transmittal number nly apply t the redlined material. All ther material was previusly published in the manual and is nly being reprinted.

2 LIST OF EXHIBITS (Cnt.) 245 CLIA Adverse Actin Extract, HCFA-462A/B Reserved 246 Mdel Letter: Reginal Office Ntifying a State-Operated Labratry f Cited Deficiencies and Requesting a Plan f Crrectin 247 Ntice f (Limitatin r) Revcatin f a Labratry s CLIA Certificate - N Immediate Jepardy 248 Ntice f Prpsed Limitatin, Suspensin, r Revcatin f the CLIA Certificate; Opprtunity fr a Hearing - N Immediate Jepardy 249 Mdel Letter: Send t the Labratry in Cnjunctin With the Ntice f Sanctin, In Order t Officially Infrm the Labratry that the Respnsibility Lies With the Labratry t Achieve Cmpliance, Even if They Have Successfully Cmpleted the Directed Plan f Crrectin 250 Ntice f the Reissuance f a CLIA Certificate In Order t Keep a Labratry Operatinal if it is Due t Expire Prir t the Administrative Hearing 251 Mdel Letter: Offering the Opprtunity fr a Recnsideratin f the Additin f Specialties r Subspecialties by a Labratry is Denied by HCFA 252 Mdel Letter: T Labratry Directr t Accmpany the AQAS Instrument 253 Reserved fr SAQIP 254 Mdel Letter: Ntificatin t Applicant that Medicare General Enrllment Health Care Prvider/Supplier Applicatin Has Been Denied 255A Mdel Letter: Ntificatin f Pending Invluntary Terminatin Based n CHOW Review f the Medicare General Enrllment Health Care Prvider/Supplier Applicatin 255B Mdel Letter - Ntificatin f Invluntary Terminatin Based n CHOW Review f the Medicare General Enrllment Health Care Prvider/Supplier Applicatin 256 Frm HCFA Medicare and Other Federal Health Care Prgram General Enrllment Health Care Prvider/Supplier Applicatin 257 Frm HCFA-855C - Medicare and Other Federal Health Care Prgram Change f Infrmatin Health Care Prvider/Supplier Applicatin 258 Frm HCFA-855R - Medicare and Other Federal Health Care Prgram Individual Reassignment f Benefits Health Care Prvider/Supplier Applicatin 259 Minimum Data Set Autmatin Cntract/Agreement Apprval RO Checklist 260 MDS Key Field Crrectin Frm 261 Privacy Act Statement - Health Care Recrds Rev xiii

3 LIST OF EXHIBITS (Cnt.) 245 CLIA Adverse Actin Extract, HCFA-462A/B Reserved 246 Mdel Letter: Reginal Office Ntifying a State-Operated Labratry f Cited Deficiencies and Requesting a Plan f Crrectin 247 Ntice f (Limitatin r) Revcatin f a Labratry s CLIA Certificate - N Immediate Jepardy 248 Ntice f Prpsed Limitatin, Suspensin, r Revcatin f the CLIA Certificate; Opprtunity fr a Hearing - N Immediate Jepardy 249 Mdel Letter: Send t the Labratry in Cnjunctin With the Ntice f Sanctin, In Order t Officially Infrm the Labratry that the Respnsibility Lies With the Labratry t Achieve Cmpliance, Even if They Have Successfully Cmpleted the Directed Plan f Crrectin 250 Ntice f the Reissuance f a CLIA Certificate In Order t Keep a Labratry Operatinal if it is Due t Expire Prir t the Administrative Hearing 251 Mdel Letter: Offering the Opprtunity fr a Recnsideratin f the Additin f Specialties r Subspecialties by a Labratry is Denied by HCFA 252 Mdel Letter: T Labratry Directr t Accmpany the AQAS Instrument 253 Reserved fr SAQIP 254 Mdel Letter: Ntificatin t Applicant that Medicare General Enrllment Health Care Prvider/Supplier Applicatin Has Been Denied 255A Mdel Letter: Ntificatin f Pending Invluntary Terminatin Based n CHOW Review f the Medicare General Enrllment Health Care Prvider/Supplier Applicatin 255B Mdel Letter - Ntificatin f Invluntary Terminatin Based n CHOW Review f the Medicare General Enrllment Health Care Prvider/Supplier Applicatin 256 Frm HCFA Medicare and Other Federal Health Care Prgram General Enrllment Health Care Prvider/Supplier Applicatin 257 Frm HCFA-855C - Medicare and Other Federal Health Care Prgram Change f Infrmatin Health Care Prvider/Supplier Applicatin 258 Frm HCFA-855R - Medicare and Other Federal Health Care Prgram Individual Reassignment f Benefits Health Care Prvider/Supplier Applicatin 259 Minimum Data Set Autmatin Cntract/Agreement Apprval RO Checklist 260 MDS Key Field Crrectin Frm 261 Privacy Act Statement - Health Care Recrds Rev xiii

4 LIST OF EXHIBITS (Cnt.) 262 Overview f MDS Versin 2.0 Crrectin Plicy fr Lcked Recrds 263 Maximum Time Frames fr MDS Cmpletin, Data Entry, Editing, Lcking and Transmissin 264 HCFA Resident Census and Cnditins f Residents 265 HCFA-802P - Rster/Sample Matrix 266 HCFA-802P - Rster/Sample Matrix Prvider Instructins (use with HCFA Frm 802) ) HCFA-802S - Rster/Sample Matrix Instructins fr Surveyrs (Use with Frm HCFA- 268 Facility Characteristics 269 Resident Level Summary 270 Quality Indicatr Matrix 271 Quality Indicatr Glssary 9-xiv Rev. 10

5 PAGES ARE RESERVED FOR EXHIBITS They are in hard cpy nly Exhibit HCFA-802P - Rster/Sample Matrix Exhibit HCFA-802P - Rster/Sample Matrix Prvider Instructins (use with HCFA Frm 802) Exhibit HCFA-802S - Rster/Sample Matrix Instructins fr Surveyrs (Use with Frm HCFA-802) Exhibit Facility Characteristics Exhibit Resident Level Summary Exhibit Quality Indicatr Matrix Exhibit Quality Indicatr Glssary

6 I. Intrductin APPENDIX P SURVEY PROTOCOL FOR LONG TERM CARE FACILITIES PART I Survey Prcedures fr Lng Term Care Facilities II. III. IV. Survey Tasks Task 1 - Offsite Survey Preparatin Task 2 - Entrance Cnference/Onsite Preparatry Activities Task 3 - Initial Tur Task 4 - Sample Selectin Task 5 - Infrmatin Gathering A - General Observatins f the Facility B - Kitchen/Fd Service Observatin C - Resident Review D - Quality f Life Assessment E - Medicatin Pass F - Quality Assessment and Assurance Review G - Abuse Preventin Review Task 6 - Infrmatin Analysis fr Deficiency Determinatin Task 7 - Exit Cnference The Partial Extended and Extended Survey Writing the Statement f Deficiencies V. Deficiency Categrizatin VI. VII. Pst Survey Revisit (Fllw-up) Abbreviated Standard Surveys A. Cmplaint Investigatins B. Substantial Changes in a Facility's Organizatin and Management VIII. Cnfidentiality and Respect fr Resident Privacy IX. Infrmatin Transfer X. Additinal Prcedures fr Medicare Participating Facilities Rev. 10 P-1

7 Part II Guidance t Surveyrs - Lng Term Care Facilities Clumn I Clumn II Clumn III Tag Number Regulatin Guidance t Surveyrs (Guidelines and Survey Prcedures and Prbes) P-2 Rev. 10

8 I. INTRODUCTION Skilled nursing facilities (SNFs) and nursing facilities (NFs) are required t be in cmpliance with the requirements in 42 CFR Part 483, Subpart B, t receive payment under the Medicare r Medicaid prgrams. T certify a SNF r NF, cmplete at least a: Life Safety Cde (LSC) survey, and Standard Survey, (Frms HCFA-670, 671, 672, 677, and 801 thrugh 807). (See Exhibits 85, 86, and 88 t 95.) D nt annunce SNF/NF surveys t the facility. Cnduct standard surveys and cmplete them n cnsecutive wrkdays, whenever pssible. They may, at yur discretin, be cnducted at any time including weekends, 24 hurs a day. When standard surveys begin at times beynd the business hurs f 8:00 a.m. t 6:00 p.m., r begin n a Saturday r Sunday, the entrance cnference and initial tur shuld be mdified in recgnitin f the residents activity (e.g., sleep, religius services) and types and numbers f staff available upn entry. Use the standard survey prcedure discussed in this sectin fr all standard surveys f SNFs and NFs, whether freestanding, distinct parts, r dually participating. Fr surveys f facilities predminantly serving shrt stay residents, mdificatins f ffsite survey preparatin and sampling prcedures will be necessary. NOTE: D nt use this prcess fr surveys f intermediate care facilities fr the mentally retarded (ICFs/MR), swing-bed hspitals, r skilled nursing sectins f hspitals that are nt separately certified as SNF distinct parts. Survey Prtcls and Interpretive Guidelines fr these surveys are fund in Appendices J (ICFs/MR) and T (Swing-bed hspitals and hspitals with nn-distinct part SNFs). When the surveyr team suspects substandard quality f care (SQC), expand the standard (r abbreviated) survey sample as necessary t determine scpe. (See Task 4, Supplementary Sample, fr further infrmatin). If, at Task 6, the existence f SQC is verified, then infrm the administratr that the facility is in SQC and an extended (r partial extended) survey will be cnducted. A. Surveys.--If in cnducting the infrmatin gathering tasks f the survey yu identify a pssible nncmpliant situatin related t any requirement, investigate the situatin t determine whether the facility is in cmpliance with the requirements. 1. Standard Survey.--A standard survey is cmpsed f Tasks 1-7, and is a resident-centered, utcme-riented inspectin which relies n a case-mix stratified sample f residents t gather infrmatin abut the facility's cmpliance with participatin requirements. Outcmes include bth actual and ptential negative utcmes, as well as failure f a facility t help residents achieve their highest practicable level f well-being. Based n the specific prcedures detailed in this appendix, a standard survey assesses: Cmpliance with residents' rights and quality f life requirements; The accuracy f residents' cmprehensive assessments and the adequacy f care plans based n these assessments; Rev. 10 P-3

9 The quality f care and services furnished, as measured by indicatrs f medical, nursing, rehabilitative care and drug therapy, dietary and nutritin services, activities and scial participatin, sanitatin and infectin cntrl; and The effectiveness f the physical envirnment t empwer residents, accmmdate resident needs, and maintain resident safety, including whether requested rm variances meet health, safety, and quality f life needs fr the affected residents. 2. Extended Survey.--The extended survey is cnducted after substandard quality f care is determined during a standard survey. If, based n perfrming the resident-centered tasks f the standard survey yu make a determinatin that the facility has prvided substandard quality f care in 42 CFR , Resident Behavir and Facility Practices; 42 CFR , Quality f Life; and/r 42 CFR , Quality f Care, then yu must cnduct an extended survey within 14 days after cmpletin f a standard survey. (See Appendix P, Part I, Sectin III, the extended and partial extended survey.) 3. Abbreviated Standard Survey.--This survey fcuses n particular tasks that relate, fr example, t cmplaints received r a change f wnership, management r directr f nursing. The abbreviated standard survey des nt cver all the aspects cvered in the standard survey, but rather cncentrates n a particular area f cncern r cncerns. Fr example, an abbreviated standard survey may be cnducted t substantiate a cmplaint. The survey team can expand the abbreviated standard survey t cver additinal areas, r t a standard survey if, during the abbreviated standard survey, they find evidence that warrants a mre extensive review. 4. Partial Extended Survey.--A partial extended survey is always cnducted after substandard quality f care is fund during an abbreviated standard survey r during a revisit, when substandard quality f care was nt previusly identified. If, based n perfrming the abbreviated standard survey r revisit yu make a determinatin that the facility has prvided substandard quality f care in 42 CFR , Resident Behavir and Facility Practices; 42 CFR , Quality f Life; and/r 42 CFR , Quality f Care, then yu must cnduct a partial extended survey. (See Appendix P, Part I, Sectin III, the extended and partial extended survey.) 5. Pst-Survey Revisit (Fllw-up).--The pst-survey revisit is an n-site visit intended t verify crrectin f deficiencies cited in a prir survey. See 2732 and Appendix P, Part I, Sectin VI. If substandard quality f care is determined during a revisit, cmplete a partial extended survey, if a partial extended r extended survey had nt been cnducted as the result f the prir standard r abbreviated standard survey. B. Initial Certificatin Survey.--In a survey fr initial certificatin f SNFs r NFs, perfrm the tasks f bth the standard and extended surveys. During the initial survey, fcus bth n residents and the structural requirements that relate t qualificatin standards and resident rights ntificatin, whether r nt yu identify prblems during the infrmatin gathering tasks. Gather additinal infrmatin t verify cmpliance with every tag number. Fr example, during an initial survey verify the qualificatins f the scial wrker, dietitian, and activities prfessinal. Als, review the rights ntificatin statements n admissins cntracts. Cmplete the Statement f Deficiencies and Plan f Crrectin (Frm HCFA-2567) in Exhibit 7. C. Specialty Surveyrs.--All members f a survey team need nt be nsite fr the entire survey. Specialty surveyrs participating in surveys (e.g., a pharmacist, physician, r registered P-4 Rev. 10

10 dietitian) may be nsite nly during that prtin f the survey dealing with their area f expertise. Hwever, they must cnduct that prtin while the rest f the team is present. All members f the survey team shuld enter the facility at the same time, if pssible. Befre leaving the facility, at the cmpletin f his/her prtin f the survey, the specialty surveyr must meet with the team r team crdinatr t discuss his/her findings and t prvide supprting dcumentatin. The specialty surveyr shuld als share any infrmatin he/she btained that may be useful t ther team members. If he r she is nt present at the infrmatin analysis fr deficiency determinatin, the specialty surveyr shuld be available by telephne at that time and during the exit cnference. D. Team Cmmunicatin.--Thrughut the survey prcess, the team (including specialty surveyrs nsite at the time) shuld discuss amng themselves, n a daily basis, bservatins made and infrmatin btained in rder t fcus n the cncerns f each team member, t facilitate infrmatin gathering and t facilitate decisin making at the cmpletin f the standard survey. II. THE SURVEY TASKS TASK 1 - OFFSITE SURVEY PREPARATION A. General Objectives.--The bjectives f ffsite survey preparatin are t analyze varius surces f infrmatin available abut the facility in rder t: Identify and pre-select cncerns fr Phase 1 f the survey, based n the Facility Quality Indicatr Prfile (see descriptin belw at B.3.a.). (This pre-selectin is subject t amendment based n the results f the tur.); Pre-select ptential residents fr Phase I f the survey based n the Resident Level Summary (see descriptin belw at B.3.a.) (This pre-selectin is subject t amendment based n the results gathered during the tur, entrance cnference, and facility Rster/Sample Matrix); Nte cncerns based n ther surces f infrmatin listed belw and nte ther ptential residents wh culd be selected fr the sample; and Determine if the areas f ptential cncerns r special features f the facility require the additin t the team f any specialty surveyrs. B. Infrmatin Surces fr Offsite Survey Preparatin.--The fllwing surces f infrmatin (1-8) are used during the ffsite team meeting t fcus the survey. 1. Quality Indicatr (QI) Reprts frm the Standard Analytic Reprting System f the HCFA Natinal Resident Assessment Data Base.--(QIs are t be used as indicatrs f ptential prblems r cncerns that warrant further investigatin. They are nt determinatins f facility cmpliance with the lng term care requirements.) There are three QI reprts which can be dwnladed frm the State data base: Facility Characteristics (Exhibit 268).--Prvides demgraphic infrmatin abut the resident ppulatin (in percentages) fr a selected facility cmpared t all the facilities in the State. This reprt is read left t right. It prvides infrmatin such as gender and age f residents, payment surce, diagnstic characteristics, assessments cmpleted by type, and a summary f the number f assessments cmpleted per mnth. Rev. 10 P-5

11 Facility Quality Indicatr Prfile (Exhibit 268).--Prvides facility status fr each f the MDS-based QIs as cmpared t a peer grup f the facilities in the State. The reprt is read left t right. Listed are the individual QIs (gruped by Dmains). Fr each QI, (reading acrss a rw) are: - The numeratr - the number f residents in the facility wh have the QI cnditin; - The denminatr - the number f residents in the facility wh culd have the QI cnditin; - The facility percentage f residents wh have the QI cnditin; - The State percentage f residents wh have the QI cnditin; - The percentile ranking f the facility n the QI - a descriptr f hw the facility cmpares (ranks) with ther facilities in the state. The higher the percentile rank, the greater ptential there is fr a care cncern in the facility; and - A flag is present in any rw in which the facility flags n an indicatr, which means that facility is at r abve the 90th percentile; r a flag is present in ne f the three sentinel event QI rws if any resident has the cnditin. (See D. belw fr mre infrmatin.) Resident Level Summary (Exhibit 269).--Prvides resident-specific QI infrmatin. This reprt is generated using the mst current MDS recrds in the State data base at the time the reprt was generated, including all residents wh have an MDS in the system. It is used t preselect residents fr the Phase 1 sample wh have cnditins representing the cncerns selected using the Facility Quality Indicatr Prfile. Reading frm left t right, the reprt lists: - Each resident in alphabetical rder; - MDS date and type f assessment: + A = admissin; + Y = any full assessment (annual, significant change, r significant crrectin); + Q = quarterly; + O = ther; and + M, when added t A, Y, Q, r O = als cded as a Medicare assessment. - Clumns which list each QI with subclumns fr high and lw risk; and - The ttal number f QIs flagged fr the resident. A checkmark (T) appears in a QI clumn fr a resident wh has that QI cnditin. If a QI is risk adjusted, this checkmark (T ) is in either the high r lw risk subclumn fr the QI, indicating P-6 Rev. 10

12 whether this resident was at high r lw risk t develp the QI cnditin. This specificatin f high r lw risk can help survey teams t select which residents t review. If the team has selected incntinence as a QI cncern, it may be mst prductive t select residents fr whm incntinence wuld nt have been expected (thse at lw risk). NOTE: Resident-specific infrmatin in the Resident Level Summary must be kept cnfidential accrding t the Privacy Act. The reprt is nly fr the use f the State agency, HCFA representatives, and the facility. 2 The Statement f Deficiencies (HCFA-2567) and Statement f Islated Deficiencies Which Cause N Actual Harm With Only Ptential Fr Minimal Harm (Frm A).-- These statements f deficiencies frm the previus survey shuld be reviewed, alng with the sample resident identifiers list. Review the specific infrmatin under each deficiency and nte any special areas f cncern. Fr example, a deficiency was cited fr cmprehensive care planning last year. Share with the team the specific care planning prblems that were listed as the reasns fr this deficiency. Fr resident-centered requirements, determine if any residents identified in the deficiency might be gd candidates fr the sample. Fr example, a deficiency was cited fr abuse partly based n surveyr bservatin f a staff member striking a resident wh was cmbative. Identify this resident by name and add the name t the Offsite Preparatin Wrksheet. (During the Initial Tur, evaluate this resident fr inclusin in the sample.) 3. OSCAR Reprt 3, Histry Facility Prfile, and OSCAR Reprt 4, Full Facility Prfile frm HCFA's OSCAR Cmputer System.--(Refer t Exhibit 96 fr sample cpies f Reprts 3 and 4.) Reprt 3 cntains the cmpliance histry f the facility ver the past 4 surveys. Use it t determine if the facility has patterns f repeat deficiencies in particular tags r related tags. This reprt als lists the dates f any cmplaint investigatins and Federal mnitring surveys during the 4 year time perid. Reprt 4 cntains infrmatin prvided by the facility during the previus survey n the Resident Census (HCFA-672). This reprt cmpares facility ppulatin characteristics with State, HCFA regin, and natinal averages. 4. Results f Cmplaint Investigatins.--Review infrmatin frm bth cmplaints investigated since the previus standard survey and cmplaints filed with the survey agency, but nt yet investigated. Nte resident and staff names related t the cmplaints and nte patterns f prblems relating t specific wings r shifts. 5. Infrmatin abut Waivers r Variances.--If the facility has, r has requested any staffing waiver r rm variances, nte these fr nsite review. The team will determine nsite if these shuld be granted, cntinued, r revked due t a negative effect n resident care r quality f life. 6. Infrmatin frm the State Ombudsman Office.--Nte any ptential areas f cncern reprted by the mbudsman ffice and nte resident names reprted as ptential sample residents, residents fr clsed recrd review, r family members fr family interviews and the reasns fr their recmmendatin by the mbudsman. 7. Preadmissin Screening and Resident Review Reprts (PASRR).--Sme States may have frmal mechanisms t share with the survey agency the results f PASRR screens fr residents with mental illness r mental retardatin. If this infrmatin is available, evaluate if there are any ptential cncerns and nte names f residents fr pssible inclusin in the sample. Rev. 10 P-7

13 8. Other Pertinent Infrmatin.--At times, the survey agency may be aware f special ptential areas f cncern that were reprted in the news media r thrugh ther surces. Evaluate this infrmatin t determine if there are ptential areas f cncern that shuld be investigated nsite. C. Team Crdinatr Respnsibilities.--The team crdinatr (and/r designee) is respnsible fr cmpleting the fllwing tasks: 1. Cntact the mbudsman ffice in accrdance with the plicy develped between the State survey agency and State mbudsman agency. The purpses f this cntact are t ntify the mbudsman f the prpsed day f entrance int the facility and t btain any infrmatin the mbudsman wishes t share with the survey team. Ask if the mbudsman will be available if residents participating in the grup r individual interviews wish her/him t be present. 2. Obtain all infrmatin surces listed in B. abve fr presentatin at the ffsite team meeting. (See Sectin B. fr descriptive infrmatin abut these reprts.) They are as fllws: NOTE: Quality Indicatr (QI) Reprts: - Facility Characteristics Reprt; - Facility Quality Indicatr Prfile; and - Resident Level Summary; It is imprtant that the QI reprts be generated as clse t the date f survey as pssible, preferably n mre than a few days prir t the survey. Frm HCFA-2567 and Statement f Islated Deficiencies Which Cause N Actual Harm With Only Ptential Fr Minimal Harm; Standard OSCAR Reprt 3 and 4; Results f cmplaint investigatins; Infrmatin abut waivers r variances; Infrmatin frm the State Ombudsman ffice; Preadmissin Screening and Resident Review Reprts; and Other pertinent infrmatin. 3. Cmplete the fllwing additinal duties: Cpy and distribute t the team the facility s flr plan if the team is unfamiliar with the facility s layut; Make extra cpies f the OSCAR Reprts 3 and 4, and the three QI reprts t be given t the facility s administratr; Obtain an extra cpy f the grup interview wrksheet (see HCFA-806B, Exhibit 94) t give t the cuncil president. P-8 Rev. 10

14 SURVEY PROCEDURES FOR LONG TERM CARE FACILITIES If the State des nt use an alternate mechanism t btain the wnership disclsure infrmatin, in accrd with 42 CFR (b) fr Medicare facilities, btain wnership disclsure frms; HCFA-1513 (Exhibit 6), HCFA-855, (Exhibit 256) and/r HCFA- 855C (Exhibit 257). If the facility has already cmpleted a HCFA-855 and n changes have ccurred since that filing, the facility may present a cpy f the previusly filed HCFA-855. If changes have ccurred since filing the HCFA-855, the facility will need t cmplete a new HCFA- 855 r HCFA-855C as directed by 2005 f the State Operatins Manual. If the faciltiy has nt previusly filed a HCFA-855 and has had a change f wnership, a HCFA-855 must be cmpleted. In ther cases (including Medicaid facilities), the facility must cmplete a Frm HCFA D. Offsite Survey Preparatin Team Meeting.--Present cpies f the infrmatin btained t the survey team members fr review at a team meeting ffsite. The team must prepare fr the survey ffsite, s they are ready t begin the Entrance Cnference and Initial Tur immediately after they enter the facility. The team shuld: 1. Review the Facility Characteristics reprt t nte the facility s demgraphics. This reprt can be used t identify whether the facility s ppulatin is unusual (high prevalence f yung r male residents, high prevalence f residents with psychiatric diagnsis, high percentage f significant change assessments, etc.). 2. Use a cpy f the Rster/Sample Matrix (Frm HCFA-802, Exhibit 90) t highlight cncerns the team identifies fr Phase 1 f the survey, and t list residents preselected and the QI cnditins fr which each was selected. Mark the ffsite blck n this frm t distinguish it frm the Phase 1 versin that will be cmpleted in Task 4. Use the Facility Quality Indicatr Prfile t select cncerns based n the fllwing: Any sentinel health event QI that is flagged. A sentinel health event is a QI that represents a significant ccurrence that shuld be selected as a cncern, even if it applies t nly ne r a few residents. The sentinel event QIs are Prevalence f Fecal Impactin, Prevalence f Dehydratin, and Prevalence f Pressure Ulcers (lw risk). This means that if even ne resident has any f these cnditins, this QI will flag and the care area must be selected as a cncern and the resident with the prblem must be selected fr the sample (if there are multiple residents wh flag n a sentinel event QI, it is nt necessary t select all f them); Any ther QI that is flagged (at the 90th percentile); and Any unflagged QI in which the facility is at the 75th percentile r greater. The survey team may als wish t select as cncerns any ther QIs that are f interest t them because they are related t QIs that have been selected, r because their percentile number is extremely lw in cmparisn t the remaining QIs. They may als select ther areas f cncern derived frm surces f infrmatin ther than the QI reprts. 3. Preselect ptential residents fr the Phase 1 sample t represent the cncerns that have been selected, including selecting residents wh have sentinel event QI cnditins (if multiple residents have a sentinel event QI cnditin, it is nt necessary t select all f them). Use Table 1 in this sectin and the number f the ttal resident census t determine the sample size fr the Phase 1 sample. Preselect a few mre residents (three t five) than the actual number that will be required fr the Phase 1 sample t accmmdate the fact that sme residents wh have been preselected may n lnger be at the facility (these residents culd fill Clsed Recrd slts n the sample). In any facility in which the team has nted cncerns with weight lss, dehydratin, and/r pressure sres, select apprximately ½ f the preselected sample as residents wh have ne r mre f these cnditins. Fr the cnditin f hydratin, yu must select a resident wh Rev. 10 P-9

15 SURVEY PROCEDURES FOR LONG TERM CARE FACILITIES has flagged fr the sentinel event QI #15(dehydratin) and yu may select residents with any f the fllwing QI cnditns: #11 - Fecal Impactin; #12 - Urinary tract infectins; #13 - weight lss; #14 - Tube feeding; and #17 - Decline in Activities f Daily Living (ADL s). The best residents t select will be thse wh als have multiple care areas that have been selected as cncerns. In any facility in which these cncerns were nt identified, the team shuld still select sme residents wh have these QI cnditins (if any) n the Resident Level Summary, but this need nt be 50% f the Phase 1 sample size. Fr the remaining half f the Phase 1 preliminary sample, select residents t represent the remaining areas f cncern. NOTE: If there are n ther QIs that have been selected as cncerns, the team may select residents based n ther surces f infrmatin (such as cmplaints, r a reprt frm the mbudsman) r may wait t select the remaining Phase 1 residents based n Initial Tur findings. If the average length f stay fr the facility s ppulatin is less than 14 days, there may be little quality indicatr r resident specific QI infrmatin available. Preselectin f QI based cncerns and/r the full sample may nt be pssible. Selectin f sme r all cncerns and residents may need t be ttally cnducted nsite. The survey team shuld be alert t incnsistencies n the Facility Quality Indicatr Prfile that may indicate facility errr in cmpleting and/r transmitting its Minimum Data Set (MDS) recrds, r a prblem with State s sftware r HCFAs data base. The fllwing are sme pssible indicatrs f data quality prblems: - The denminatr fr QIs that use all residents substantially exceeds r is substantially smaller than the facility bed size; - The number f residents with a QI cnditin (i.e., the numeratr) exceeds the resident ppulatin; r - The numeratr fr a particular QI is zer althugh ther infrmatin surces indicate therwise. Fr example, the QI reprt shws zer residents in restraints, but the mbudsman ntified the team that she/he verified cmplaints abut restraints. The mst cmmn reasn fr this type f incnsistency is incrrect MDS cding by the facility. If these r ther ptential accuracy cncerns are nted, the team shuld add resident assessment accuracy as a cncern fr the survey. NOTE: This review need nt be dne fr shrt-stay facilities, which will ften have unusual values in the numeratr and denminatr, due t rapid turnver f residents. The Facility Quality Indicatr Prfile is generated using the mst current MDS recrds in the State data base at the time the reprt was generated. Hwever, it excludes residents wh have nly an initial MDS recrd in the system. This was dne s that the reprt reflects the care residents have received while residing in the facility, as ppsed t the cnditins f residents at the time f admissin t the facility. The Resident Level Summary is calculated using the mst recently transmitted MDS recrd (e.g., annual, significant change, quarterly, r initial MDS recrd). Yu culd see differences between the Facility Quality Indicatr Prfile and the Resident Level Summary since the facility prfile des nt use the admissin MDS data. Fr example, the Resident Level Summary may indicate a resident had a catheter, but the Facility Quality Indicatr Prfile might shw a 0". This is nt an accuracy prblem, it nly reflects the use f different data t generate each reprt. P-10 Rev. 10

16 SURVEY PROCEDURES FOR LONG TERM CARE FACILITIES 4. Review the OSCAR reprts after the review f the QI reprts t add crrbrative infrmatin t the QI infrmatin (e.g., a pattern f repeat deficiencies in a requirement related t a flagged QI) and/r t pint ut areas f large discrepancies between the QI Facility Quality Indicatr Prfile and the OSCAR Reprts (e.g., the OSCAR 4 reprt lists the facility as having triple the average number f residents in restraints, but the QI reprt shws the facility has less restraints than mst facilities). The team crdinatr may wish t discuss such discrepancies with the administratr n entrance t determine the reasn fr them. Relate infrmatin between Reprts 3 and 4 such as a pattern f repeat deficiencies in range f mtin and a lwer than average percentage f residents receiving rehabilitative services. Als, nte any special resident characteristics nt cntained in the QI reprts. NOTE: Bth the OSCAR reprts and the QI reprts can alert surveyrs t the acuity and characteristics f the facility s residents at the time the infrmatin fr these reprts was determined. This infrmatin may nt represent the current cnditin f residents in the facility at the time f the survey. Keep in mind that the OSCAR infrmatin is apprximately ne year ld, and the QI infrmatin may be frm tw t six mnths ld. Resident characteristics that were reprted by the facility during the last survey may have changed significantly and may be the surce f sme discrepancies between OSCAR and QI infrmatin. 5. Review all ther surces f infrmatin and recrd additinal infrmatin n the Offsite Preparatin Wrksheet (Frm HCFA-801, Exhibit 89), fr example, residents' names fr pssible inclusin in the Phase 2 sample based n nn-qi surces f infrmatin (B. 2 thrugh 8 abve), special features f the facility, r special resident ppulatins. Identify any utstanding cmplaints needing investigatin. At this meeting, establish preliminary surveyr assignments and prjectins f which days team members will enter early and/r stay late t make bservatins f resident care and quality f life. TASK 2 - ENTRANCE CONFERENCE/ONSITE PREPARATORY ACTIVITIES A. Entrance Cnference The team crdinatr infrms the facility's administratr abut the survey and intrduces team members. 2. After the intrductin t the administratr, the ther team members shuld prceed t the Initial Tur (Task 3), while the team crdinatr cnducts the entrance cnference. 3. The team crdinatr shuld: Request a cpy f the actual wrking schedules fr licensed and registered nursing staff fr this time perid by the end f the tur r earlier if pssible. Infrm facility staff that the survey team will be cmmunicating with them thrughut the survey and will ask fr facility assistance when needed. (See 2713A fr further infrmatin abut facility staff accmpanying surveyrs.) Advise them that they have the pprtunity t prvide the team with any infrmatin that wuld clarify an issue brught t their attentin. Explain the survey prcess and answer any questins frm facility staff. Give the administratr cpies f the three QI reprts and the OSCAR 3 and Rev. 10 P-11

17 SURVEY PROCEDURES FOR LONG TERM CARE FACILITIES 4 reprts that are being used fr the survey. Briefly explain these reprts and hw they were used by the survey team in Task 1. If there are discrepancies between the OSCAR infrmatin and the QI Facility Characteristics reprt, ask the administratr r persn designated by the administratr t explain the discrepancies. Ask the administratr t describe any special features f the facility's care and treatment prgrams, rganizatin, and resident case-mix. Fr example, des the facility have a special care unit fr residents with dementia? Are residents with heavy care needs placed in particular units? If s, which nes? Infrm the administratr that there will be interviews with individual residents, grups f residents, family members, friends, and legal representatives, and that these interviews are cnducted privately, unless the interviewees request the presence f a staff member. Ask the administratr t ensure that there are times during the survey when residents can cntact the survey team withut facility staff present and withut having t ask facility staff t leave r t allw access t the team. Ask the administratr t prvide the fllwing infrmatin within ne hur f the cnclusin f the Entrance Cnference (r later at the survey team's ptin): 1. List f key facility persnnel and their lcatins (such as: the administratr; directrs f finance, nursing services, scial services, and activities; dietitian r fd supervisr; rehabilitatin services staff; charge nurses; pharmacy cnsultant; plant engineer; husekeeping supervisr; persns respnsible fr infectin cntrl and quality assurance; health infrmatin management prfessinal; and the medical directr); their rights; 2. A cpy f the written infrmatin that is prvided t residents regarding 3. Meal times, dining lcatins, cpies f all menus, including therapeutic menus, that will be served fr the duratin f the survey; 4. Medicatin pass times (by unit, if variable); 5. List f admissins during the past mnth, and a list f residents transferred r discharged during the past 3 mnths with destinatins; 6. A cpy f the facility's layut, indicating the lcatin f nurses' statins, individual resident rms, and cmmn areas, if nt btained in Task 1; 7. A cpy f the facility admissin cntract(s) fr all residents. (Medicare, Medicaid, ther payment surces); 8. Facility plicies and prcedures t prhibit and investigate allegatins f abuse and the name f a persn the administratr designates t answer questins abut what the facility des t prevent abuse (see Task 5G Abuse Prhibitin Review fr further infrmatin); 9. Evidence that the facility, n a rutine basis, mnitrs accidents and ther incidents, recrds these in the clinical r ther recrd; and has in place a system t prevent and/r minimize further accidents and incidents; NOTE: This evidence, at the discretin f the facility, culd include r be a recrd f accident and incident reprts. P-12 Rev. 10

18 NOTE: 10. The current resident activity schedule/calendar; The facility is nt required by Federal regulatins t maintain this recrd. 11. The names f any residents age 55 and under; and 12. The names f any residents wh cmmunicate with nn-ral cmmunicatin devices, sign language, r wh speak a language ther than the dminant language f the facility. Ask the facility t cmplete the Rster/Sample Matrix (HCFA-802), including all residents n bedhld t the best f their ability by the end f the Initial Tur, r t prvide this infrmatin in sme ther frmat (e.g., cmputer-generated list). NOTE: This is an imprtant surce f resident infrmatin, which is crucial fr the team t have fr their sample selectin meetings. Stress t the facility that this frm shuld be cmpleted first and given t the team crdinatr by the end f the Initial Tur. After the Rster/Sample Matrix is delivered t the team, the facility may make mdificatins fr accuracy r add additinal infrmatin within 24 hurs. Ask the facility t prvide, within 24 hurs f the Entrance Cnference: 1. A cmpleted Lng Term Care Facility Applicatin fr Medicare and Medicaid (HCFA-671), (See Exhibit 85); A Resident Census and Cnditins f Residents (HCFA -672), (See Exhibit 86); and the cmpleted wnership dcument (HCFA-1513, r HCFA-855), if nt btained thrugh ther State mechanisms; 2. A list f Medicare residents wh requested demand bills in the last 6 mnths (SNFs r dually-participating SNF/NFs nly). Als, ask the administratr the fllwing questins: 1. Which, if any, rms have less square ftage than required? D yu have a variance in effect and are yu prepared t cntinue t request a variance fr any such rms? (F458) 2. Which, if any, rms are ccupied by mre than fur residents? D yu have a variance in effect and are yu prepared t cntinue t request a variance fr any such rms? (F457) 3. Is there at least ne windw t the utside in each rm? (F461) 4. Which, if any, bedrms are nt at r abve grund level? (F461) 5. D all bedrms have access t an exit crridr? (F459) 6. What are the prcedures t ensure water is available t essential areas when there is a lss f nrmal supply? (F466) NOTE: If the survey is cmmencing at times beynd the business hurs f 8:00 a.m. t 6:00 p.m., r n a Saturday r Sunday, nce nsite, annunce the survey, ascertain wh is in charge, ask the persn t ntify the administratr that a survey has begun. Mdify the entrance cnference in accrdance with staff available and cmplete the task and the nsite preparatry activity as apprpriate within the cntext f the survey. Rev. 10 P-13

19 B. Onsite Preparatry Activities In areas easily bservable by residents and visitrs, pst (r ask the facility t pst) signs annuncing that yu are perfrming a survey and are available t meet with residents in private. 2. The team crdinatr r designee shuld cntact the resident cuncil president after the Entrance Cnference t intrduce him/herself and t annunce the survey. Prvide the president with a cpy f the grup interview questins. Request the assistance f the president fr arranging the grup interview and t slicit any cmments r cncerns. Ask the cuncil president fr permissin t review cuncil minutes fr the past 3 mnths (see Task 5D, Sectin 3B fr further infrmatin). If there is nt an active resident cuncil, r if the cuncil des nt have fficers, ask fr a list f residents wh attend grup meetings (if any), and select a resident representative t assist in arranging the grup interview. If the mbudsman has indicated interest in attending the grup interview, ask the president if it is all right with the grup that the mbudsman attend the meeting. If the reply is affirmative, ntify the mbudsman f the time/place f the meeting. 3. The team crdinatr, the surveyr assigned t cnduct the grup interview, r a designee shuld arrange fr date, time and private meeting space fr the interview. Advise the facility staff that nn-interviewable residents are nt part f this meeting. (See Task 5D fr further guidance.) TASK 3 - INITIAL TOUR kitchen; A. General Objectives.--The Initial Tur is designed t: Prvide yu with an initial review f the facility, the residents and the staff; Obtain an initial evaluatin f the envirnment f the facility, including the facility Cnfirm r invalidate the preselected cncerns (if any) and add cncerns discvered nsite. B. General Prcedures.--The initial tur is used t gather infrmatin abut cncerns which have been preselected; new cncerns discvered nsite; and whether residents preselected fr the Phase 1 sample ffsite are still present in the facility. In additin, during the tur, attempt t meet and talk with as many residents as pssible in rder t identify ther candidates fr the sample, t get an initial verview f facility care and services, t bserve staff/resident interactins; and t evaluate the impact f the facility envirnment n the residents. The tur als includes a first brief lk at the facility kitchen. Dcument tur infrmatin, n either the Rster/Sample Matrix (HCFA-802), r the Surveyr Ntes Wrksheet (HCFA-807). Dcument any cncerns regarding the general envirnment n the General Observatins f the Facility Wrksheet, (HCFA-803) r Surveyr Ntes Wrksheets, (HCFA-807). (See Task 5A fr further infrmatin.) Surveyrs may als dcument ntes n the facility s Rster/Sample Matrix r ther list f residents prvided by the facility. Dcument any cncerns nted in the brief tur f the facility kitchen n the Kitchen/Fd Service Observatin wrksheet (HCFA-804, Exhibit 92). (See Task 5B fr infrmatin regarding bservatins t make during this brief tur.) C. Prtcl.--Surveyrs shuld tur individually as assigned by the team crdinatr. It is desirable fr team members t have a facility staff persn wh is familiar with the residents P-14 Rev. 10

20 SURVEY PROCEDURES FOR LONG TERM CARE FACILITIES accmpanying them during the tur t answer questins and prvide intrductins t residents r family. Hwever, d nt delay the beginning f the Initial Tur if facility staff are nt available. Begin the tur as sn as pssible after entering the facility. NOTE: When standard surveys begin at times beynd the business hurs f 8:00 a.m. t 6:00 p.m., r begin n a Saturday r Sunday, the initial tur will need t be mdified in recgnitin f the residents activity (e.g., sleep, religius services) and types and numbers f staff available upn entry. The tur may fcus n specific care and quality f life issues such as: restraint use, meal service, use f fam r paper meal service prducts rather than regular dinnerware, adherence t the planned menu; sufficiency f staff; whether enteral/parenteral fluids are being administered as rdered; whether incntinent residents are being checked, tileted, changed; etc. as apprpriate. The tur shuld nt be delayed fr lack f staff t accmpany the surveyr and/r survey team. Phase 1-- Pre-selected Cncerns and Ptential Residents: During the tur, be sure t determine fr each resident pre-selected ffsite fr the Phase 1sample whether the resident is still there. Determine which (if any) f the preselected Phase 1 sample residents are interviewable residents wh can be selected t participate in a Quality f Life Assessment Resident Interview r Grup Interview. (See Task 5D.) This can be accmplished by talking with residents and asking questins. Examples f questins that can be used are: What is yur name? What are yu planning t d tday? NOTE: D nt rely slely n the infrmatin that the facility prvides cncerning which residents are interviewable. The survey team shuld determine the residents wh are able t participate in a Quality f Life Assessment interview. If pssible, determine if there are family members f nn-interviewable residents in the preselected Phase 1 sample wh can be selected fr a Quality f Life Assessment family interview. Als nte ther nn-interviewable residents amng the facility ppulatin whse family members culd be selected fr interviews; Observatins f All Residents During the Tur: Ask staff t identify thse residents wh have n family r significant thers. The team may include ne r mre f these residents in the Phase 2 sample fr investigatin f quality f life issues. Have staff identify newly admitted residents (wh have been admitted within the past 14 days) fr pssible inclusin in the sample fr investigatin f decline r deteriratin that may have ccurred befre all MDS, ther resident assessment infrmatin, and care planning is cmpleted. Have staff identify any residents fr whm transfer r discharge is planned within the next 30 days. Nte residents wh are interviewable r wh have special factrs, as listed in Task 4. When n the Initial Tur, bserve and dcument pssible quality f care and quality f life cncerns in additin t thse preselected ffsite. If bserved cncerns invlve specific residents, nte the resident's name and rm number n the wrksheet, and the date/time when describing the bserved cncern. Include in yur dcumentatin the details f yur bservatin including any effects n the residents invlved. Cnduct a brief initial bservatin f the kitchen. See Task 5B fr further infrmatin. Rev. 10 P-15

21 SURVEY PROCEDURES FOR LONG TERM CARE FACILITIES While n tur, identify the licensed and registered nursing staff wh are currently n duty, and later at the end f the tur, cmpare the bserved staff with the duty rster the facility is t prvide. If there are discrepancies between the duty rster and the staff bserved nsite, ask the persn in charge t explain the discrepancies. (This infrmatin will be used in Task 6 t determine if the facility is cmpliant with the requirements fr licensed and registered nursing staff at 42 CFR (a)(2), F353 and 42 CFR (b)(1), F354.) During the tur fcus n the fllwing: Quality f Life: Resident grming and dress, including apprpriate ftwear; 2. Staff-resident interactin related t residents' dignity; privacy and care needs, including staff availability and respnsiveness t residents' requests fr assistance; 3. The way staff talk t residents, the nature and manner f interactins, and whether residents are spken t when care is given; and 4. Scheduled activities taking place and apprpriateness t the residents. Emtinal and behaviral cnduct f the residents and the reactins and interventins by the staff: Resident behavirs such as crying ut, disrbing, agitatin, rcking, pacing; and 2. The manner in which these behavirs are being addressed by staff, including nature and manner f staff interactins, respnse time, staff availability, and staff means f dealing with residents wh are experiencing catastrphic reactins. (See Abuse Prhibitin Investigative Prtcl in Task 5G fr a definitin f catastrphic reactin.) Care issues, hw care is prvided, and prevalence f special care needs Skin cnditins (such as excessive dryness, wetness); 2. Skin tears, bruising, r evidence f fractures that warrant investigatin; 3. Dehydratin risk factrs including availability f water fr mst residents, and ther indicatrs r factrs such as, the amunt and clr f urine in tubing and cllectin bags, dependence n staff, the presence f strng urinary drs, and resident cmplaints f dry muth and lips; 4. Clinical signs such as edema, emaciatin and cntractures; 5. Functinal risk factrs such as pr psitining and use f physical restraints; 6. Side effects f antipsychtic drug use such as tardive dyskinesia (e.g., lip, tngue r ther invluntary abnrmal mvements); 7. Presence r prevalence (numbers) f infectins including antibitic resistant strains f bacteria (e.g., Methicillin Resistant Staphylcccus Aureus (MRSA), Vancmycin Resistant Entercccus (VRE), Clstridium Difficile (C-Diff) r ther infectins: urinary tract infectins, draining wunds, eye infectins, skin rashes (especially if spreading, undiagnsed, and/r nt respnding t treatment), respiratry infectins, gastrenteritis including diarrhea, etc. P-16 Rev. 10

22 SURVEY PROCEDURES FOR LONG TERM CARE FACILITIES 8. Pressure sres, ld scars frm pressure sres r evidence f surgical repair f pressure sres; 9. Amputatin; 10. Significant weight lss; 11. Feeding tubes and/r imprper psitining while feeding is infusing; and 12. Ventilatrs, xygen, r intravenus therapies. Impact f the facility envirnment and safety issues Infectin cntrl practices (such as handwashing, glve use, and islatin prcedures); 2. Functinal and clean equipment, including kitchen equipment; 3. Presentatin and maintenance f a hmelike and clean envirnment; and 4. Availability, use and maintenance f assistive devices. NOTE: If the initial tur is being cnducted during a mealtime, include an initial brief bservatin f the dining areas. Nte if there are any cncerns with meal service, quality f life, psitining, sufficient space, etc. TASK 4 - SAMPLE SELECTION A. General Objective.--The bjective f this task is t select a case-mix stratified sample (see Special Factrs t Cnsider in Sample Selectin belw fr further infrmatin) f facility residents based n QIs and ther ffsite and nsite surces f infrmatin in rder t assess cmpliance with the resident-centered lng term care requirements. B. General Prcedures.-- The Phase 1 sample is preselected during Task 1, Offsite Survey Preparatin, based n QIs and ther areas f cncern. The preselected sample is reviewed during the sample selectin meeting and residents are retained fr the sample unless they are discharged (sme f these may be selected as clsed recrds, at the team s discretin). Each team member is assigned t review a certain number f residents, cmpleting all facets f review that have been selected including any quality f life assessment prtcls selected fr these residents. The Phase 2 sample is selected nsite, part way thrugh the survey when surveyrs have cllected enugh infrmatin t determine the fcus f the remainder f the survey. The Phase 2 sample residents are selected t represent new cncerns and/r t cntinue further investigatin f Phase 1 cncerns when Phase 1 reviews prved incnclusive r when necessary t determine scpe f a prblem. It is statutrily required that the sample in each facility be case-mix stratified in rder t capture bth interviewable and nn-interviewable residents, and residents frm bth heavy and light care categries. NOTE: If the team is cnducting sample selectin during a meal time, delay r interrupt this task t cnduct brief bservatins f the dining areas. Nte if there are any cncerns with meal service, quality f life, psitining, sufficient space, etc. Rev. 10 P-17