Mastering the Standards for Survey Success: The 2018 HFAP Quality Review

Masterig the Stadards for Survey Success: The 2018 HFAP Quality Review

FROM THE BOARD CHAIRS As physicia leaders of the HFAP programs, we kow that the laboratories, hospitals, ASCs, ad others that choose HFAP are lookig for a accreditatio experiece fouded i shared commitmet to buildig peoplefocused orgaizatios that also fuctio efficietly, effectively, ad withi a culture of cotiuous improvemet. These goals address ad lik cliical ad busiess operatios. They are iterrelated ad achievable ad this aual report of frequet deficiecies idetified i healthcare orgaizatios ca help. Orgaizatios that strive to master the stadards get the most beefit from their survey experiece. This secod aual HFAP Quality Review is a resource to help your orgaizatio itegrate accreditatio stadards ito daily operatios. Use it to: 1. Gai isight to how HFAP surveyors work. HFAP surveyors are evaluatig compliace with idividual stadards i the cotext of the orgaizatio as a whole. They are iterested i how the elemets of each orgaizatio fit together. This report suggests areas for your focused efforts i preparig for a survey ad demostrates how deficiecies occur whe disparate aspects of a orgaizatio fail to coect. 2. Develop a midset of expertise. Read this report i cojuctio with the relevat HFAP accreditatio maual ad/or your most recet deficiecy report. This will give cofidece that most stadards are easily achievable, ad suggest solutios for those that provide cosistet challeges. If you fid that your orgaizatio s deficiecies alig with the commo citatios, do t reivet the wheel. Cosider that your peers may have foud solutios that will also work for you. Look, too, to HFAP educatioal offerigs (webiars ad semiars) for best practices ad tools. 3. Achieve cotiuous readiess. Assig ad perform ogoig audits of policy, process, delivery, ad quality assessmet. Focus o the feedback loops that esure a cotiuous cycle of improvemet. Each of us is committed to HFAP because of its educatioal philosophy. We believe that accreditatio is ot iteded to be a puitive ordeal but a opportuity to meet regulatory requiremets through cosultatio with experts who care about the success of each orgaizatio they survey. Our goal as a orgaizatio is to poit you toward mastery of the stadards. Jack Egatisky, MD Chairma, AAHHS Lawrece U. Haspel, DO Chairma, BHFA

Itroductio From the c-suite to the custodial staff, a osite survey ca create stress for everyoe i a patiet care orgaizatio. This secod aual HFAP Quality Review is desiged to calm axiety by givig you advatages: Kowledge of the stadards most-frequetly cited as ot compliat. Kowledge of treds i deficiecies to help you avoid the most commo errors. Examples of specific citatios made by HFAP surveyors. Usig the report The Deficiecy Report that you receive after a osite survey idetifies areas of primary focus for your orgaizatio. This documet icludes data from all surveys coducted i 2017; use it as a guidelie for selfassessmet ad to idetify areas of secodary focus whe the data differ from fidigs i your orgaizatio. High-frequecy deficiecies are grouped by the type of facility i which they occur most ofte, but topics related to physical eviromet ad life safety are aggregated to iclude all orgaizatios because they are commoly cited across both ipatiet ad outpatiet settigs. I additio to beig cetral to patiet care as they tie to issues of safety, they are ofte oversee by distict, o-cliical staff. Table of Cotets Laboratory Deficiecies...page 2 Ambulatory Surgery Ceter Deficiecies...page 7 Acute Care Hospital Deficiecies...page 10 Critical Access Hospital Deficiecies...page 16 Physical Eviromet Deficiecies...page 19 Life Safety Code deficiecies i Acute Care Hospitals ad CAHs...page 21 Emergecy Maagemet...page 25 HFAP QUALITY REVIEW 2018 1

Laboratory Deficiecies 35% 30% 25% 20% 15% 10% 5% 0% 02.02.12 04.00.08 06.01.16 06.02.01 06.02.04 06.04.00 06.04.02 06.06.01 06.11.02 06.11.04 07.07.02 07.11.05 Laboratory Persoel Proficiecy Testig Aalytic Systems Routie Chemistry PT Hematology PT For 2017 accreditatio surveys of cliical laboratories, stadards for aalytic systems (chapter six, Accreditatio Requiremets for Cliical Laboratories, December 2015 update) are the most frequetly-cited deficiecies, as show above. The horizotal axis idetifies the specific stadard by umber ad the vertical axis shows the frequecy with which that stadard was cited as a deficiecy. These stadards represet deficiecies cited for more tha te percet of surveys. Additioal detail follows. Laboratory Persoel Overview of the requiremet: Tredig the deficiecies: Examples of surveyor citatios: 02.02.12 Competecy Evaluatio The laboratory s techical supervisor is resposible for evaluatig the competecy of all testig persoel usig six elemets idetified withi the stadard. Deficiecies were cited whe documetatio was missig for oe or more elemet of the stadard. Checkmarks were the oly idicatio of competecy evaluatio i employee records. There was o further documetatio of how skills were assessed. Documetatio of competecy for persoel did ot iclude all six elemets. HFAP QUALITY REVIEW 2018 2

Laboratory Deficiecies Documetatio of assessmet of problem solvig skills was missig for seve testig persoel. Proficiecy Testig Overview of the requiremet: 04.00.08 Attestatio Statemets For Moderate Complexity Testig, the laboratory director or a qualified techical cosultat to whom this resposibility has bee delegated must sig a attestatio that samples for proficiecy testig are itegrated ito the regular workload ad tested usig routie methods. For High Complexity Testig, the laboratory director or a qualified techical supervisor to whom this resposibility has bee delegated must sig a attestatio that samples for proficiecy testig are itegrated ito the regular workload ad tested usig routie methods. Tredig the deficiecies: Examples of surveyor citatios: Deficiecies were cited whe specific testig evets lacked siged attestatio statemets or such statemets were siged by oauthorized idividuals. Issues arise i immuohematology where a pathologist is typically the oly qualified techical supervisor for this high complexity testig. Attestatio statemets are routiely siged by the lab maager but there is o letter of delegatio o file from the lab director. Attestatio statemets are routiely siged by the admiistrative director. Attestatio statemets are missig for: Microbiology, testig evet 2017-1 Mycology, testig evet 2017-2 Chemistry, testig evet 2017-1 Hematology, testig evets 2016-2, 2017-1 Aalytic Systems Overview of the requiremet: Tredig the deficiecies: Examples of surveyor citatios: 06.01.16 Procedure Approval Approval of all laboratory procedures is the resposibility of the lab director. All procedures, icludig mauals, maufacturer s istructios for use ad package iserts must reflect the director s review ad approval, or his/her approved modificatios. Periodic review of all procedures should be performed to esure that they accurately reflect curret lab practice. Most deficiecies idicate the lack of a process for either periodic review of stadig procedures or missig documetatio of approval for chaged procedures. Mauals icluded may chages writte as aotatios or attached without date or sigature. Lab mauals icluded procedures that did ot reflect approval by the curret medical director. Procedures added i Jauary 2017 were usiged as of March 2017. HFAP QUALITY REVIEW 2018 3

Laboratory Deficiecies Aalytic Systems Overview of the requiremet: Tredig the deficiecies: Examples of surveyor citatios: 06.02.01 Essetial Coditios The lab must defie criteria cosistet with maufacturer s istructios for water quality, temperature, humidity, ad protectio of equipmet ad istrumets from electrical fluctuatios that are could adversely affect results. Citatios reflect oe or more missig elemet of the stadard. Lab maager reported i iterview that the same water type should be used for all dilutios ad recostitutios but this was ot icluded i the water quality policy. Neither temperature or humidity were moitored with a certified istrumet. Thermometer ad humidistat were past their certificatio expiratio dates. The lab maager could ot produce a water policy. Aalytic Systems Overview of the requiremet: Tredig the deficiecies: Examples of surveyor citatios: 06.02.04 Reaget Kit Compoets Compoets of reaget kits must be used together ad compoets from kits with differet lot umbers may ot be iterchaged (uless approved by maufacturer). Deficiecies relate to missig policy/procedure to cosistetly address this stadard i some lab departmets. Pathology departmet does ot have a procedure to avoid mixig stai kit compoets. Policy for each kit procedure does ot iclude prohibitio o iterchagig the reaget of differig kit lots. Histology departmet does ot have a procedure prohibitig iterchage of stai kit compoets. Aalytic Systems Overview of the requiremet: Tredig the deficiecies: Examples of surveyor citatios: 06.04.00/06.04.02 Maiteace Checks/Modified System Maiteace Checks The lab must comply with the maufacturer s maiteace recommedatios for each umodified piece of equipmet ad istrumet. Similarly, for equipmet, istrumets, or test systems developed iterally, a maiteace protocol must be established ad followed for performig scheduled prevetive maiteace ad uscheduled repairs whe eeded. Documetatio is required. Deficiecies reflect missig documetatio of prevetive maiteace performed. Daily cleaig ad maiteace o the microtome, embeddig ceter, ad tissue processor are performed but ot logged. No yearly prevetive maiteace occurred for these istrumets per iterview. HFAP QUALITY REVIEW 2018 4

Laboratory Deficiecies No prevetive maiteace o microscopes or cryostat i past two years. Water system mothly saitatio is icosistetly performed by the biomed departmet with documetatio missig for 2 moths i each of 2015, 2016, ad 2017 (as of survey date). No policy for maiteace of cetrifuge timers. Aalytic Systems Overview of the requiremet: Tredig the deficiecies: Examples of surveyor citatios: 06.06.01 Cotrol Procedures CMS permits laboratories to develop ad customize quality cotrol for some testig usig a Idividualized Quality Cotrol Pla (IQCP) comprised of a risk assessmet (RA), a quality cotrol pla (QCP), ad a quality assessmet pla (QA). The RA idetifies the questios to ask, the QCP addresses data collectio ad the QA closes the loop by aalyzig the data to cofirm that quality bechmarks are achieved or to idetify a eed for improvemet. This is a volutary process. If the lab opts NOT to apply IQCPs, the it must perform QC testig procedures as specified by maufacturer s istructio or CLIA requiremets, whichever is more striget. If the laboratory chooses to deviate from the more striget of maufacturer s or CLIA requiremets, the a IQCP icludig all elemets must be developed, implemeted, ad documeted. QC procedures for Oxicom use for oximeter testig were less striget tha the CLIA regulatory requiremet for QC each day of patiet testig but o IQCP had bee developed to modify the CLIA regulatio. Review of the techical procedures for Rapid Strep ad RSV, ad review of the QC/patiet logs revealed that the curretly approved procedure is to perform QC o each ew lot umber ad shipmet of kits, ad every 30 days. For Strep, the 30 day QC was ot performed Jue Nov. 2016. For RSV the 30 day QC was ot performed i Sep., Oct., or Nov. 2016 or Ja. 2017. Laboratory policy ad maufacturer s istructios call for quality cotrol testig o each kit for Rapid Streptococcal Atige but testig practice revealed exteral cotrols were tested oly o every ew lot umber. Aalytic Systems Overview of the requiremet: Tredig the deficiecies: 06.11.02 IQCP Risk Assessmet For each regulatory quality cotrol requiremet that is replaced by a IQCP, a risk assessmet (RA) evaluates potetial failures ad sources of error relatig to specime, test system, reaget, eviromet, ad testig persoel. The RA must ecompass preaalytic, aalytic, ad postaalytic phases. Deficiecies are cited whe multi-site laboratories optig to use a IQCP, base the risk assessmet o a sigle lab locatio, ad whe some test are omitted from the RA. HFAP QUALITY REVIEW 2018 5

Laboratory Deficiecies Examples of surveyor citatios: No documetatio was available to support RA for the followig tests: RSV, Fly A7B, Bactec, C diff, Grp B Strep, MRSA, Crypto/ Gia, EPOC, Istat Tropoi, Microsca, Strep A, Fetal Fibroecti, H pylori, Serum HCG, Moo, TOX drug scree, D-Dimer, BNP, RV, ad Microbiology Media. The IQCP for strep testig at this locatio is based o the hospital s mai lab IQCP ad does ot address potetial failures ad errors specific to this testig site. While reviewig documetatio it was difficult to determie whether all five compoets were icluded i the RA. Twelve tests had o documetatio supportig risk assessmet for the use of a IQCP. Aalytic Systems Overview of the requiremet: Tredig the deficiecies: Examples of surveyor citatios: 06.11.04 IQCP Quality Assessmet The lab establishes ad follows a policy for o-goig review of the IQCP. Collectig data is ot sufficiet for a compliat IQCP. The laboratory must aalyze the data it collects to esure that the QCP is adequate ad effective. While the IQCP writte detail icludes moitorig o a weekly, mothly, ad aual basis, there is o evidece that the data is further evaluated i a QA report. The lab has t icorporated QA i its IQCP. No system has bee established to verify effectiveess of the IQCP writte for serum HCG, Triage Meter, exempt media ad AST/ID. Specialty-Subspecialty Specific (Routie Chemistry) Overview of the requiremet: Requiremet for addressig deficiecies: 07.07.02 Routie Chemistry Proficiecy Testig PT for each aalyte must attai a score of at least 80% for each testig evet. Whe the lab scores uder 80% for a idividual aalyte, it must documet its ivestigatio ad remedial actio. Specialty-Subspecialty Specific (Hematology) Overview of the requiremet: Requiremet for addressig deficiecies: 07.11.05 Hematology Proficiecy Testig PT for each aalyte must attai a score of at least 80% for each testig evet. Whe the lab scores uder 80% for a idividual aalyte, it must documet its ivestigatio ad remedial actio. HFAP QUALITY REVIEW 2018 6

Ambulatory Surgery Ceter Deficiecies 80% 70% 60% 50% 40% 30% 20% 10% 0% 03.00.02 06.00.03 12.00.02 13.00.03 05.00.01 05.00.01 05.01.01 Patiet Care ad Safety Physical Eviromet For 2017 surveys of ASCs, the most frequetly-cited deficiecies fall ito two broad areas: patiet care ad safety ad the eviromet, as show above. The horizotal axis idetifies the specific stadard by umber (see Accreditatio Requiremets for Ambulatory Surgical Ceters, 2017 editio) ad the vertical axis shows the frequecy with which that stadard was cited as a deficiecy. Surgical Services Overview of the requiremet: 03.00.02 Surgical Procedures Performed Safely This CMS Coditio for Coverage requires that surgical procedures are performed by qualified physicias who have bee grated privileges by the goverig body. Tredig the deficiecies: This coditio-level stadard frequetly correlates with 06.00.03 o the ext page. Abset a reappraisal process, it may be that procedures are performed by physicias who do ot have curret peer review ad a applicatio for reappoitmet i their credetialig file. Without this documetatio, it is difficult to be cofirmed as compliat with this stadard. HFAP QUALITY REVIEW 2018 7

Ambulatory Surgery Ceter Deficiecies Examples of surveyor citatios: The last reapplicatio with approval had expired July 2016. The facility was uable to provide documetatio of a reapplicatio request by or a peer review of the physicia. The facility lacked evidece of reappoitmet approval, based o review of goverig body meetig miutes from 2014, 2015, 2016 ad 2017. Durig review of credetialig files ad Goverig Board meetig miutes it was idetified that five of the six providers requirig recredetialig were ot documeted as beig approved or discussed at the Goverig Board meetigs. Medical Staff Overview of the requiremet: Tredig the deficiecies: Examples of surveyor citatios: 06.00.03 Reappraisals Medical staff privileges are grated by the goverig body ad a reappoitmet process is followed at least every 24 moths. This is a time-drive stadard ad deficiecies reflect a failure to develop a o-goig, cyclical process. Iitial appraisals ad reappraisal dates could ot be determied from credetialig files. Credetialig files did ot cotai evidece that the board reviewed ad grated privileges. Oe of two physicias performig procedures did ot have curret privileges. There was o reapplicatio request or peer review o file ad o reappoitmet approval i goverig body miutes from the past four years. Ifectio Cotrol Overview of the requiremet: Tredig the deficiecies: 12.00.02 Saitary Eviromet A fuctioal ad saitary eviromet for surgical services is maitaied to avoid sources ad trasmissio of ifectios ad commuicable diseases. This exteds to all areas of the facility with the expectatio that atioally-recogized ifectio cotrol guidelies are the basis for related policies ad procedures. A sigificat umber of deficiecies related to moitored safety factors (vetilatio, air exchage, temperature ad humidity cotrol) ot beig reported to the Ifectio Cotrol or Quality committee. Other citatios related to work flow (access to o-sterile fuctioal areas through clea storage), housekeepig, coditio of equipmet related to patiet care, ad had hygiee. Examples of surveyor citatios: Had hygiee practice as observed was icosistet with ASC policy. Procedure table frames showed large areas of rust. Visible accumulatios of dust were apparet o exhaust vets i OR ad procedure rooms. Dust ad dead isects were preset o gas valves. HFAP QUALITY REVIEW 2018 8

Ambulatory Surgery Ceter Deficiecies Patiet Admissio, Assessmet, ad Discharge Overview of the requiremet: Tredig the deficiecies: Examples of surveyor citatios: 13.00.03 - Admittig History ad Physical Update The patiet s medical record must iclude documetatio that a pre-surgical assessmet was completed by a physicia with regard to the risk of aesthesia ad the procedure. This assessmet should cosider ay chages i the most recet H&P ad address allergies or reactios to drugs or biologicals. Deficiecies reflected missig elemets. These may be defied withi the stadard, e.g. allergy documetatio, or withi the orgaizatio s policies for aesthesia risk assessmet. No documetatio of allergies oted. H&P performed withi 30 days of admissio ad pre-surgical update was oted i record, but 4 of 5 charts were missig date ad time of update as required by facility policy. Updates were siged off more tha a week after the procedure. For Physical Eviromet deficiecies, see page 19. HFAP QUALITY REVIEW 2018 9

Acute Care Hospital Deficiecies 40% 35% 30% 25% 20% 15% 10% 5% 0% 01.01.23 01.01.22 Admiistrative Oversight 25.01.03 07.01.02 10.01.16 30.00.10 Patiet Care ad Safety 16.01.01 11.00.01-CoP 11.01.02 13.00.01 Physical Plat For 2017 surveys of acute care hospitals, the most frequetly-cited deficiecies fall ito three broad areas: admiistrative oversight, patiet care ad safety, ad the physical plat, as show above. The horizotal axis idetifies the specific stadard by umber (see Accreditatio Requiremets for Acute Care Hospitals, 2017 editio) ad the vertical axis shows the frequecy with which that stadard was cited as a deficiecy. The most frequetly idetified deficiecy (36% of surveys) is a coditio-level fidig for Physical Eviromet. Util CMS issued ew Emergecy Maagemet regulatios (effective November 15, 2017), CMS Coditio of Participatio 482.41 icluded three expectatios to esure the safety of the patiet: (1) Emergecy Maagemet, (2) Physical Eviromet, ad (3) Life Safety. HFAP surveyors cited ocompliace with this CoP as a result of total deficiecies for Chapter 9, Chapter 11, ad Chapter 13. (See pages 19 25 for additioal detail o these related deficiecies.) This failure to meet a CMS Coditio of Participatio will trigger a secod survey evet to isure that the Pla of Correctio submitted by the hospital has bee fully implemeted ad the deficiecy corrected. Specific examples of surveyor fidigs related to deficiecies i admiistrative oversight ad patiet care ad safety stadards are described o the followig pages. HFAP QUALITY REVIEW 2018 10

Acute Care Hospital Deficiecies Admiistratio Overview of the requiremet: 01.01.22 ad 01.01.23 Cotracted Services ad Cotractor Quality Moitorig A hospital s goverig body is resposible for all services provided by the hospital regardless of whether they are provided directly by hospital employees or idirectly through cotractual relatioships (icludig joit vetures ad shared services). Services provided must be assessed to esure that the hospital, as a whole, is i compliace with Coditios of Participatio ad stadards. A aual Quality Pla, approved by the goverig body, icludes performace measures for every hospital departmet ad service, icludig those services furished uder cotract. The goverig body maitais a list of all cotracted services to esure that the quality of these services is subject to the same assessmet as those provided directly by the hospital. Tredig the deficiecies: These closely related stadards are ofte deficiet i tadem. If the overall Quality Pla does ot iclude all services, the omissio will be oted as o-compliace with stadard 01.01.22. If a idividual cotract fails to stipulate performace idicators ad reportig requiremets, this ofte sigals a failure to report quality data to the Quality Committee, ad to commuicate upward to the goverig body. I the evet a facility lacks evidece of moitorig the quality of ay sigle cotracted service, o-compliace will be oted. Coversely, if the goverig body does ot maitai a list of curret cotracts, it is a missed opportuity to questio omitted data. Whe oly oe of these stadards is cited, it is ofte because a lik i the chai of reportig has bee broke. Examples of surveyor citatios: Cotracted services submit quality reports to the Quality Committee, but these are ot advaced to the goverig body for review. Goverig body meetig miutes do ot reflect review of cliical services provided uder cotract. There is o evidece of a system to address the stadard. The hospital is part of a system that provides some services at the corporate level but there is o reportig that allows the hospital goverig body to assess services for quality. Pharmacy Services/ Medicatio Use Overview of the requiremet: 25.01.03 Security of Medicatios All drugs ad biologicals are stored so as to prevet umoitored access by uauthorized idividuals. Areas restricted to authorized persoel oly would geerally be cosidered secure. This icludes areas i which staff are actively providig care to patiets or settig up for procedures prior to a patiet s arrival. HFAP QUALITY REVIEW 2018 11

Acute Care Hospital Deficiecies A uit i which care is active aroud the clock is cosidered secure whe hospital policies limit etry ad exit to appropriate staff, patiets, ad visitors. A uit that is ot curretly i use, e.g., a iactive surgical suite, is ot cosidered secure. Uder this circumstace, the hospital may choose to lock the etire suite, to lock o-mobile carts cotaiig drugs ad biologicals, or to move mobile carts to a locked room. All Schedule II, III, IV, ad V drugs must be kept locked withi a secured area. Patiet self-admiistratio of o-cotrolled drugs ad biologicals must be addressed i hospital policy. Tredig the deficiecies: Most deficiecies result from icosistet adherece to hospital policy for securig medicatios that creates risk of access by uauthorized idividuals. Ofte housekeepig ad egieerig staff have access to secure areas via master keys ad access to Schedule II, III, IV ad V drugs is ot further cotrolled. Whe usig a lock ad key process for crash carts, there is risk of delayed access for patiet care if staff are uable to immediately locate the key to ope the cart. Locatig the crash/mobile/med carts i a visible, staff high traffic area ca be helpful i prevetig uauthorized access. May orgaizatio use plastic umbered lock tags. These plastic tags must themselves be secured ad a crash cart log used to demostrate that carts ad equipmet have bee checked daily (or more frequetly, as per hospital policy). Examples of surveyor citatios: Drugs are delivered from the pharmacy to ope bis i medicatio rooms accessed by o-licesed persoel (housekeepig, patiet care techs). A portable aesthesia carryig case cotaiig succiylcholie, Versed ad fetayl is ot secured or placed i a locked aesthesia cabiet. Hospital policy Access to Medicatio Areas by No-Professioal Persoel idicates restrictios to ursig ad pharmacy staff, but egieerig staff have keyed access. There is o daily accoutig system for what is removed from medicatio ivetory, by whom, for whom. A usecured pediatric resuscitatio medicatio cart was i a ulocked surgical storage room. No-arcotic medicatios are kept i ulocked bis i medicatio rooms to which housekeepig has access. HFAP QUALITY REVIEW 2018 12

Acute Care Hospital Deficiecies Ifectio Cotrol Overview of the requiremet: 07.01.02 Ifectio Prevetio The hospital s ifectio cotrol officer has a system for idetifyig, ivestigatig, reportig, ad prevetig the spread of ifectios. A successful system is most likely a collaborative edeavor that icludes active surveillace of the etire physical facility. Surveyors will assess compliace by combiig documet review with visual ispectio to determie how effectively ifectio prevetio is addressed. Tredig the citatios: Examples of surveyor citatios: Most citatios from 2017 surveys addressed aspects of the facility that idicated a lapse i how a saitary eviromet is assessed ad maitaied. A secod area of cocer reflected iteral policies that were foud to be i coflict. Details matter. The rage of fidigs reflects the scope, focused surveillace, ad level of collaborative egagemet required by the stadard. Rust was observed (o casters, o shelves, o cabiets). Drywall showed water damage, deterioratio, visible dirt, peetratios. Dust was apparet o high surfaces (cabiet tops, overhead bed lights, TV wall mout arms). Patiet care supplies are stored uder the sik. Soiled lies are stored i the surgical hadwashig area. Cardboard shippig boxes i which materials were received are retaied i storage areas. Oe ifectio cotrol policy allows for home laudered scrubs. Aother requires scrub attire to be laudered at the hospital s cotracted ad accredited laudry facility. Jaitor s closet o Med/Surg Uit did ot provide separatio betwee clea supplies destied for patiet care rooms ad dirty items. The clea supply room door auto-closure was ot workig. The room is accessed by a public hallway. The policy o Foley catheter use requires that date of isertio ad idicatio for use be oted. A sticker listig CDC idicatios for use was preset with a physicia sigature ad date rage, but o markig of relevat idicators. HFAP QUALITY REVIEW 2018 13

Acute Care Hospital Deficiecies Medical Records (Health Iformatio) Services Overview of the requiremet: 10.01.16 Iformed Coset All ipatiet ad outpatiet medical records must cotai a properly executed coset form for those treatmets ad procedures that have bee specified (by the medical staff, federal, or state law) to require writte patiet coset. This form icludes, at miimum: 1. Name of hospital at which the procedure/treatmet will take place. 2. The ame of the procedure/treatmet. 3. The ame of the practitioer performig the procedure or admiisterig treatmet. 4. A statemet that the aticipated beefits, risks, ad alterative therapies were explaied. 5. Sigature of the patiet or his/her represetative. 6. Date ad time the coset was siged by the patiet or his/her represetative. 7. Surgeo sigature The hospital must have a policy that describes the iformed coset process. Tredig the deficiecies: Most citatios of this stadard idetify oe or more required elemet that is missig. While coset forms are used i legal proceedigs to protect istitutios (the documetatio of coset), they are, first ad foremost, evidece of a iteractive process that should emphasize iformed a act of itetioal affirmatio o the part of the patiet. To this poit, iformed coset is icluded i additioal locatios i the Coditios of Participatio relatig to patiet rights ad surgical services. To achieve the itet of the stadard, cosets must be writte i simple laguage such that the meaig of the documet is repeatable by the patiet. Because of the large percetage of the populatio with literacy deficits, ad the larger percetage with medical literacy challeges, the patiet s primary laguage ad a 4th grade comprehesio level have bee idetified as the goal for a coset documet that will be easily uderstood. Examples of surveyor citatios: Missig coset for aesthesia. Coset ot writte i simple seteces/at 4th grade level. Coset missig alterative therapies. Coset missig aticipated beefits ad risks. Procedure ame abbreviated ad ot further documeted for easy comprehesio. Date ad time missig. HFAP QUALITY REVIEW 2018 14

Acute Care Hospital Deficiecies Surgical Services Overview of the requiremet: Tredig the deficiecies: Examples of surveyor citatios: 30.00.10 History & Physical Prior to a procedure that requires aesthesia, a history ad physical examiatio must be completed. This ca take place o earlier tha 30 days prior to ad o later tha 24 hours after admissio or registratio, except for emergecies. If the H&P was completed prior to admissio, a update is required withi 24 hours after admissio/ registratio. The stadard is very straightforward i its requiremets. Citatios mostly idicate a failure to perform the required update. A few observatios reflect that updates were performed without a origial, comprehesive H&P to serve as the baselie. Missig dated H&P. Podiatric surgery with o update to H&P. Orthopedic surgery with o update to H&P. H&P completed more tha 30 days before admissio. Two of six records reviewed had o H&P; four of six had o update prior to aesthesia. Nursig Departmet Overview of the requiremet: Tredig the deficiecies: Examples of surveyor citatios: 16.01.01 Preparatio ad Admiistratio of Drugs Drugs ad biologicals must be prepared ad admiistered i accordace with federal ad state laws ad based o orders of a practitioer resposible for the patiet s care or aother practitioer actig withi state law, scope of practice, ad hospital policy. Most of the deficiecies cited reflect discrepacies betwee hospital policy ad observed practice. Hospital policy requires reassessmet of the patiet oe hour post admiistratio of pai medicatio. Records i the CCU reflect a four hour reassessmet; i the ICU, a two hour reassessmet; i the Orthopedic uit, o reassessmet. Hospital policy, Nursig Discretioary Medicatio, is ot cosistet with scope of practice. Subcutaeous ijectio observed without precedig had hygiee. The use of bar code scaers has resulted i a practice of documetig admiistratio of medicatios before the actual admiistratio takes place. The hospital s policy icludes rage orders, as eeded, ad per protocol, puttig urses beyod scope of practice. Hospital s policy o admiistratio of drugs has ot bee reviewed i four years. HFAP QUALITY REVIEW 2018 15

Critical Access Hospital (CAH) Deficiecies 40% 35% 30% 25% 20% 15% 10% 5% 0% 01.03.07 Admiistrative Oversight 06.01.02 Patiet Care ad Safety 03.00.01-CoP 03.05.01 Physical Plat For 2017 surveys of CAHs, the most frequetly-cited deficiecies fall ito three broad areas: admiistrative oversight, patiet care ad safety, ad the physical plat, as show above. The horizotal axis idetifies the specific stadard by umber (see Accreditatio Requiremets for Critical Access Hospitals, 2017 editio) ad the vertical axis shows the frequecy with which that stadard was cited as a deficiecy. The most frequetly idetified deficiecy (39% of surveys) is a coditio-level fidig for Physical Eviromet. (See page 19 for additioal detail o this ad related deficiecies.) This failure to meet a CMS Coditio of Participatio will trigger a secod survey evet to isure that the Pla of Correctio submitted by the hospital has bee fully implemeted ad the deficiecy corrected. Specific examples of surveyor fidigs related to deficiecies i admiistrative oversight ad patiet care ad safety stadards are oted at right. HFAP QUALITY REVIEW 2018 16

Critical Access Hospital (CAH) Deficiecies Compliace with Regulatios Overview of the requiremet: 01.03.07 Distat Site Telemedicie Etity/No-Hospital Based Agreemet The CAH goverig body is resposible for all services provided by the hospital regardless of whether they are provided directly by hospital employees or idirectly through cotractual relatioships (icludig services provided via telemedicie). Services provided must be assessed to esure that the hospital, as a whole, is i compliace with Coditios of Participatio ad stadards. The CAH s goverig body or resposible idividual may choose to rely o the credetialig ad privilegig decisios made by the goverig body of the cotracted distat-site telemedicie etity regardig idividual physicias or practitioers, provided that those decisios maitai the hospital s compliace with CoP ad relevat stadards. The cotracted telemedicie etity provides a curret list of its privileged physicias ad/or practitioers with delieatio of privileges. The idividual physicias or practitioers hold a licese issued or recogized by the State i which the CAH is located. The CAH has evidece of a iteral review process of the telemedicie physicia s or practitioer s performace ad participates i this process by providig iformatio icludig, at a miimum, all adverse evets that result from the telemedicie services provided by the distat-site physicia or practitioer to the CAH s patiets ad all complaits the CAH has received about the distat-site physicia or practitioer. Tredig the deficiecies: Examples of surveyor citatios: This stadard is similar i itet ad fidigs to a frequet deficiecy for acute care hospitals: 01.01.22 (see page 11). Maitaiig a ivetory of all cotracts ad icludig goverig body review o a aual basis ca support compliace with each elemet of the requiremet. Tele-radiology cotract does ot iclude a list of physicias providig iterpretatio services. Telemedicie agreemet has ot bee reviewed i the past three years. The Preparatio & Admiistratio of Medicatios Overview of the requiremet: Tredig the deficiecies: 06.01.02 Medicatio Admiistratio Drugs ad biologicals must be prepared ad admiistered i accordace with federal ad state laws ad based o orders of a practitioer resposible for the patiet s care or aother practitioer actig withi state law, scope of practice, ad hospital policy. Most of the deficiecies cited reflect missig policies or discrepacies betwee hospital policy ad observed practice. HFAP QUALITY REVIEW 2018 17

Critical Access Hospital (CAH) Deficiecies Examples of surveyor citatios: Pharmacy was missig policies o timig of medicatios ad admiistratio ad moitorig of high-alert medicatios icludig IV opioids. I 5 of 7 records reviewed, PRN pai medicatios admiistered did ot iclude a writte iitial or follow-up patiet pai assessmet. OR: A ulabeled syrige of propofol, ketamie, ad fetayl was i the aesthesia area. Oe patiet chart oted a pai score of 9 ad a Norco order to be give for moderate pai breakthrough. Hospital policy idetifies 4-6 as moderate pai, 7-10 as severe. HFAP QUALITY REVIEW 2018 18

Physical Eviromet Deficiecies Coditio for Coverage Coditio of Participatio Overview of the requiremet: Tredig the deficiecies: Examples of surveyor citatios: ASC stadard 05.00.01 Eviromet Acute Care Hospital stadard 11.00.01 Physical Eviromet CAH stadard 03.00.01 Physical Eviromet This stadard is met by compliace with systems for buildig safety, buildig security, hazardous materials ad waste, fire safety, medical equipmet maagemet, ad utility systems maagemet. Issues related to the physical eviromet, icludig Life Safety, that rise to the coditio level will be cited here. The coditio may be cited based o a sigle observatio or o cumulative ocompliace with other stadards i this chapter or uder Life Safety. This coditio ties maagemet of the built eviromet to patiet, staff, ad visitor safety. Whe this CoP is cited, it is usually as a result of cumulative deficiecies i Life Safety ad Emergecy Maagemet stadards. Accumulative effect of system deficiecies icludig: Iterior fiishes, Door Locks, exit Discharge, Fire Rated Barriers, Costructio Type, ad Geerator Ispectio No ivetory of supplies eeded for a emergecy evet; safety policies had ot bee reviewed i 36 moths; eyewash statios missig where caustic materials are hadled; doors with magetic locks did ot comply with Life Safety Code; fire alarm system relays had ot bee tested i 12 moths; o sprikler cotrol valve exercises i 12 moths Doors are locked i path of egress (out of compliace with LSC); fire alarm batteries had ot bee tested i 12 moths; aual fire pump test did ot iclude a simulated power failure; fire hose valves had ot bee ispected quarterly i over a year. Fire alarm ad sprikler systems had ot bee fully tested; aual backflow preveter test was ot completed; 5-year replacemet or testig of pressure gauges had ot bee performed; mothly cotrol valve ad pressure gauge ispectio was ot coducted. The emergecy geerator was ot load tested o a mothly basis. HFAP QUALITY REVIEW 2018 19

Physical Eviromet Deficiecies Eviromet Overview of the requiremet: ASC stadard 05.00.05 Health Care Facilities Code This stadard addresses the 2012 editio of NFPA 99: Health Care Facilities Code that establishes requiremets for a rage of health care buildig systems icludig medical gases, electrical, HVAC, gas equipmet, ad hyperbaric facilities. The stadard also requires a risk assessmet of buildig services, icludig: Gas & Vacuum Systems Electrical Systems HVAC Systems Electrical Equipmet Gas Equipmet Tredig the deficiecies: Examples of surveyor citatios: Each system listed above must be evaluated for its potetial impact should the system fail (risk-assessmet). Based o worst-outcome scearios, the system is categorized i Chapter 4 of NFPA 99-2012 with associated requiremets. No risk assessmet had bee performed for the required systems. Eviromet Overview of the requiremet: Tredig the deficiecies: Examples of surveyor citatios: ASC stadard 05.01.01 Safety from Fire This stadard addresses compliace with the 2012 editio of NFPA 101: Life Safety Code. Buildigs with costructio completed, or plas approved after July 5, 2016 must meet the requiremets of Chapter 20. Buildigs or portios thereof that were approved o or before July 5, 2016, bust meet the requiremets of Chapter 21. Deficiecies related to huma iterferece with protective barriers, deferred maiteace, ad errors i testig frequecy for fire safety equipmet. A fire rated door was held ope with a door stop mouted to the bottom of the door. This was corrected durig survey, but a Pla of Correctio must be submitted ad approved. Multiple usealed peetratios were preset i fire-rated barriers. Fire alarm test reports did ot idicate testig of: iterface relay for elevator recall smoke detector sesitivity sice 2012 (required every five years at miimum) Sprikler system test report missig: evidece of aual cotrol valve exercise evidece of aual backflow preveter test pressure gauge calibratio ad replacemet every five years (last documeted replacemet i 2007) HFAP QUALITY REVIEW 2018 20

Life Safety Code deficiecies i Acute Care Hospitals ad CAHs 80% 70% 60% 50% 40% 30% 30% 10% 0% Acute 13.01.01/13.01.02 CAH 14.01.01/14.01.02 Acute 13.02.01/13.02.02 CAH 14.02.01/14.02.02 Acute 13.03.01 CAH 14.03.01 Acute 13.04.01 CAH 14.04.01 Acute 13.04.09 CAH 14.04.09 Acute 13.06.04 CAH 14.06.04 Note: Life Safety Code deficiecies for ASCs are icluded i the Physical Eviromet sectio, page 19. Meas of Egress Acute Care Hospital stadards 13.01.01/13.01.02 Doors ad Door Locks CAH stadards 14.01.01/14.01.02 Doors ad Door Locks Overview of the requiremet: Tredig the deficiecies: Corridor doors resist the passage of smoke. Corridor doors ad doors to hazardous rooms have positive latchig hardware. Doors i the path of egress may have locks where patiet eeds dictate special protective measures for security. Locks may oly be provided uder the requiremets of NFP 101, sectios18/19.2.2.2.5. These stadards for doors ad locks are ofte cited together ad rage from simple-to-correct issue with doors beig held ope itetioally with a wedge, or iadvertetly made less accessible by beig blocked with clutter or equipmet. HFAP QUALITY REVIEW 2018 21

Life Safety Code deficiecies i Acute Care Hospitals ad CAHs More complex issues relate to either a lack of positive latchig o doors, or the iappropriate use of specific types of locks. Life safety compliace overrides security. For example, do ot istall delayed egress locks i buildigs that are ot fully protected with smoke detectio or compliat fire spriklers. Examples of surveyor citatios: Push buttos to cotrol magetized access cotrol locks are more tha 5 from the door. Delayed egress locks used where there is o smoke detectio or fire sprikler system. Egress door operated by key oly ad ot all staff carry keys. Doors are preveted from opeig 90 degrees by wall-mouted or stored equipmet. Fire Alarm Systems Acute Care Hospital stadards 13.02.01/13.02.02 Istallatio ad Testig CAH stadards 14.02.01/14.02.02 Istallatio ad Testig Overview of the requiremet: Tredig the deficiecies: A fire alarm system must be istalled where required by sectio 18/19.3.4 of NFPA 101 (2012 editio). NFPA 72 (2010 editio) defies the istallatio, testig ad documetatio requiremets. This is aother pair of stadards that are frequetly foud ot compliat i tadem. With regard to istallatio, citatios focused o smoke detectors missig or beig istalled outside prescribed parameters for distace from other system elemets. With regard to testig requiremets, deficiecies ofte poit to the lack of a complete ivetory of relevat devices with testig frequecy oted for each. Examples of surveyor citatios: Fire alarm pull blocked by a rollig file cabiet. Fire alarm visual otificatio device blocked by shelvig. Smoke detector too far from the deck. Iterface testig for fuctioality ot documeted for magetic hold-opes, air hadler shut-dow, smoke dampers, fire pump, kitche hood suppressio system, waterflow switches, etc. Maufacturer s expiratio date for system batteries oted as occurrig before testig, but the testig log idicates all batteries passed. Other documetatio idicated that the expirig batteries had bee replaced a year earlier, but the expiratio dates were ot updated i the ivetory list. HFAP QUALITY REVIEW 2018 22

Life Safety Code deficiecies i Acute Care Hospitals ad CAHs Fire Suppressio Systems Acute Care Hospital stadard 13.03.01 Water-based fire protectio system: Istallatio ad Maiteace CAH stadard 14.03.01 Water-based fire protectio system: Istallatio ad Maiteace Overview of the requiremet: Tredig the deficiecies: Examples of surveyor citatios: Just as requiremets for the istallatio ad maiteace of fire alarm system are specific, so too are the requiremets for fire suppressio. The expectatio is that a NFPA 13 water-based fire protectio system is istalled ad maitaied i accordace with sectio 18.3.5 of NFPA 101 (2012 editio) for ew costructio ad i accordace with sectio 19.3.5 i existig costructio or reovated areas. Deficiecies i meetig this stadard ofte result from failig to coordiate differet aspects of facilities maagemet. Sprikler heads are istalled ad later, sigage ad/or furishigs are added that compromise the ability of the spriklers to fuctio as iteded. Rollig medical records storage is less tha 18 iches from sprikler heads i the medical records room. Exit sig is istalled too close to sprikler heads. Aual ispectio report idicates that 44 sprikler heads were corroded ad required replacemet. At the time of survey, this work had ot bee performed. Life Safety Drawigs Acute Care Hospital stadard 13.06.04 Life Safety Drawigs CAH stadard 14.06.04 Life Safety Drawigs Overview of the requiremet: Tredig the deficiecies: Examples of surveyor citatios: Clear ad accurate drawigs of the facility are critical to support maiteace ad idetificatio of required life safety provisios of the buildig. Drawigs should iclude elemets defied by the stadard ad facility represetatives must be able to iterpret all aspects. Citatios ted to occur either because ot every elemet of the stadard is addressed o the drawigs, or because the use of spaces i practice varies from the idicatio o the drawig. Drawigs did ot iclude required elemets. Soiled utility room was ot oted as a hazardous area. Drawigs did ot idicate the farthest distace to the closest smoke compartmet or exit. No idicatio of suite boudaries. Large space adjacet to the fitess ceter is beig used for storage of patiet files; o idicatio that this is a hazardous area. HFAP QUALITY REVIEW 2018 23

Life Safety Code deficiecies i Acute Care Hospitals ad CAHs Fire Safety Systems Fire Rated Barriers (Acute care Hospitals stadard 13.04.01; CAH stadard Overview of the requiremet: Tredig the deficiecies: Examples of surveyor citatios: Fire rated barriers must be properly rated, free of usealed peetratios ad with appropriately fire-rated opeig protectives. Most deficiecies relate to usealed peetratios i fire-rated wall assemblies. Above the cross-corridor fire doors, peetratios were ot properly fire-stopped. Drywall repairs must be stud to stud. Pipes from the Chiller Room ito the Receivig room were uprotected at wall. Multiple shafts were costructed of less tha oe-hour rated fire barrier assemblies. A two-hour rated fire barrier at buildig separatio had usealed peetratios with greefield coduit passig through. Fire Safety Systems Acute Care Hospital stadard 13.04.09 Ceiligs CAH stadard 14.04.09 Ceiligs Overview of the requiremet: Tredig the deficiecies: Examples of surveyor citatios: Ceiligs are expected to resist the passage of smoke where there is a fire suppressio system preset ad therefore caot have ay missig tiles, cracks or holes exceedig 1/8 ich. Missig or damaged ceilig tiles are the most frequet citatios. Ofte these occur i areas less likely to be oticed without rigorous ispectio of all areas. IT closet is missig ceilig tiles. Jaitor s closet is missig ceilig tiles. Compressor room is missig ceilig tiles. Surgical Sterile Processig Room is missig ceilig tiles. Waitig room light fixture has gap of more tha 1/8 ich. Sprikler head escutcheos missig. Pipig escutcheos had falle leavig gaps of greater tha 1/8 ich. HFAP QUALITY REVIEW 2018 24

Emergecy Maagemet New CMS regulatios for Emergecy Maagemet wet ito effect November 15, 2017. While there were few fidigs with regard to these stadards, the overall topic is importat so we are offerig a few tips based o the relatively few deficiecies idetified. Patiet & Staff Trackig ASC stadard 15.01.02 Acute Care Hospital stadard 09.01.05 CAH stadard 17.01.05 The orgaizatio must have a way to track the staff ad patiets i the orgaizatio s care durig a emergecy. This icludes documetig of the ame ad locatio of a receivig facility or other locatio to which patiets ad/or staff have moved. Shelter i Place ASC stadard 15.01.04 Acute Care Hospital stadard 09.01.07 CAH stadard 17.01.07 For patiets, staff, ad voluteers who remai i the facility durig a emergecy evet, the orgaizatio must have a pla that icludes criteria ad a pla for esurig the safety of idividuals who shelter i place. HFAP QUALITY REVIEW 2018 25

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