NIAHO Accreditatin Prgram Accreditatin Prcess Revisin 17 DNV GL Healthcare USA, Inc. 400 Techne Center Drive, Suite 100 Milfrd, Ohi 45150 Phne 513-947-8343 Fax 513-947-1250 Cpyright 2004-2015 Det Nrske Veritas Healthcare, Inc. All Rights Reserved. N claim t U.S. Gvernment wrk. Rev 17 Effective 2015-04-23 Page 1 f 21
DNV GL HEALTHCARE USA, INC. NIAHO ACCREDITATION PROGRAM INTRODUCTION The Natinal Integrated Accreditatin fr Healthcare Organizatins (NIAHO ) is a prgram ffered by DNV GL Healthcare USA, Inc. (DNV GL) and is the first integrated accreditatin prgram fr hspitals in the United States. Integrated Accreditatin utilizes tw r mre independent sets f standards in the same survey prcess t prduce ne set f utcmes. The NIAHO Hspital Accreditatin Prgram integrates ISO 9001 Quality Management System requirements with the Medicare Cnditins f Participatin fr Hspitals (42 C.F.R. 482) r Critical Access Hspitals (42 C.F.R. 485), as applicable (CPs). Healthcare systems that want t participate in the Medicare prgram must be fund t be in cmpliance with the CPs by the Centers fr Medicare and Medicaid Services (CMS). CMS makes that determinatin by its wn survey prcess thrugh state agencies r by accepting the accreditatin f a private natinal accreditatin rganizatin that has been apprved by CMS t deem healthcare rganizatins in cmpliance with the CPs. DNV GL has been apprved by CMS fr deeming authrity t determine healthcare rganizatins in cmpliance with the Cnditins f Participatin fr Hspitals and Critical Access Hspitals (CPs) since September 26, 2008 and December 23, 2010, respectively. Cmpliance with the ISO 9001 standard must ccur within three (3) years after the first deemed NIAHO accreditatin survey. This Accreditatin Prcess addresses healthcare rganizatins that are either applying fr DNV GL Healthcare USA, Inc. accreditatin r are currently accredited by DNV GL. When a healthcare rganizatin has applied fr but nt received DNV GL accreditatin, it is referred t as an Applicant Organizatin. When a healthcare rganizatin is currently accredited by DNV GL, it is referred t as an Accredited Organizatin. ACCREDITATION, MEDICARE DEEMED STATUS, AND ISO COMPLIANCE OR CERTIFICATION TIME FRAMES A Medicare deemed status survey will cnsist f a survey fr cmpliance with the NIAHO accreditatin requirements and cmpliance with r Certificatin t the ISO 9001 Quality Management System within three years f initial NIAHO accreditatin. Cmpliance t ISO 9001 requirements must be dne thrugh DNV GL. Certificatin t ISO 9001 can be achieved either thrugh DNV GL r by anther Accredited Registrar as utlined in NIAHO Requirement QM.1, SR 1-3. Cntinuing NIAHO accreditatin will require a successful annual survey that validates cntinuing cmpliance with NIAHO Requirements as well as cntinued ISO 9001 cmpliance r Certificatin fllwing the ISO 9001 three-year grace perid described in the abve Intrductin. Once ISO 9001 cmpliance r Certificatin is achieved, cntinued cmpliance r Certificatin will depend n annual ISO Peridic Surveys (limited in scpe t full ISO cmpliance r Certificatin Survey) and a full ISO cmpliance r Certificatin Survey dne triennially. The triennial ISO cmpliance r Certificatin Survey as well as the annual ISO Peridic Surveys, dne in intervening years, will take place cncurrently with the annual NIAHO Accreditatin Survey. Rev 17 Effective 2015-04-23 Page 2 f 21
Assuming the Applicant Organizatin elects t btain NIAHO Accreditatin and ISO 9001 cmpliance r Certificatin at the same time, the schedule f Surveys will typically take place accrding t the fllwing schedule: Initial 3 Year Cntract Year One: NIAHO Accreditatin Survey (infrmal ISO 9001 educatin will als take place) Year Tw: NIAHO Accreditatin Survey and ISO 9001 Pre-Assessment Survey Year Three: NIAHO Accreditatin Survey and ISO 9001 Stage One (where is the hspital n their ISO jurney and what is left t be dne) Secnd 3-Year Cntract Year One: NIAHO Accreditatin Survey and ISO 9001 Stage 2 (Certificatin r Cmpliance) Year Tw: NIAHO Accreditatin Survey and ISO Peridic Survey Year Three: NIAHO Accreditatin Survey and ISO 9001 Peridic Survey Third 3-Year and All Subsequent Cntracts Year One: NIAHO Accreditatin Survey and ISO 9001 Re-Certificatin r Cntinued Cmpliance) Year Tw: NIAHO Accreditatin Survey and ISO Peridic Survey Year Three: NIAHO Accreditatin Survey and ISO 9001 Peridic Survey Failure t btain this ISO Cmpliance r Certificatin in this timeframe will result in Accreditatin Jepardy Status fr the Accredited Organizatin. REGULATORY AND POLICY REFERENCE The Medicare Cnditins f Participatin fr hspitals are in 42 CFR Part 482. Survey authrity and cmpliance regulatins can be fund at 42 CFR Part 488 Subpart A. Shuld an individual r entity (hspital) refuse t allw immediate access upn reasnable request t a State Agency, CMS surveyr, r DNV GL Healthcare (DNV GL) staff, the Office f the Inspectr General (OIG) may exclude the hspital frm participatin in all Federal healthcare prgrams in accrdance with 42 CFR 1001.1301. The regulatry authrity fr the phtcpying f recrds and infrmatin during the survey is fund at 42 CFR 489.53(a)(13). The NIAHO Accreditatin Requirements and Interpretive Guidelines, and CMS State Operatins Manual (SOM) prvide the plicies and prcedures regarding NIAHO survey activities. The ISO 9001 (Quality Management System [QMS]) and ISO 14001 (Envirnmental Management System [EMS]) and ISO 19011 (Guidelines fr Quality and/r Envirnmental Management Systems Auditing as well as related NIAHO Requirements and Interpretive Guidelines prvide the basis fr the ISO survey activities Surveyrs assess the rganizatin s cmpliance with the NIAHO Requirements fr all services and lcatins in which the prvider receives reimbursement fr patient care services billed under its Rev 17 Effective 2015-04-23 Page 3 f 21
prvider number. Surveyrs assess the rganizatin s cmpliance with the applicable ISO Standards fr all services and lcatins included in the rganizatin s scpe statement. All hspital surveys are unannunced. DNV GL will nt prvide hspitals with advance ntice f the upcming survey. SURVEYS AND CLASSIFICATIONS Annual NIAHO Accreditatin Survey and ISO 9001 Cmpliance r Certificatin Survey The length f the Accreditatin/Cmpliance/Certificatin Survey and the number f survey team members are determined by the size and cmplexity f the Applicant Organizatin and will be determined in the applicatin prcess. Regardless f the size and cmplexity f the Applicant Organizatin, the team will cnsist f at least tw members, a nurse r physician and a Physical Envirnment Specialist. The fllwing activities apply whether the survey is fr a cmbined ISO and NIAHO r just ISO. In any f these survey scenaris the team shall include at least the fllwing activities: Intrductin t the Applicant Organizatin and discussin with the Applicant Organizatin s leadership, t include executive and medical staff leadership and bard members; Dcument Review (3-6 hurs, depending n size f the Applicant Organizatin); The Team Leader will request that the fllwing dcuments be prduced n later than 3 hurs after the request is made. If available, a hard cpy f the dcuments requested is preferred. Cmputer access is als acceptable. The Team Leader may use a wrksheet t give t the facility fr btaining this infrmatin; Organizatinal Chart Organizatinal chart fr nursing services A map/flr plan, indicating lcatins fr patient care and treatment areas A list f current inpatients with each patient s rm number, age, primary diagnsis, attending physician, admissin date, and ther significant infrmatin as it applies t that patient. Current Surgical Schedule Mst recent ISO certificatin reprt unless prvided by DNV GL Mst recent healthcare accreditatin reprt (if applicable) Bylaws f the Gverning Bdy Minutes f the Gverning Bdy Medical Staff Bylaws, Rules and Regulatins Minutes f the Medical Executive Cmmittee Organizatinal Plan fr Patient Care/Scpe f service fr each department and patient care unit Minutes f the Quality Oversight/Management Review Cmmittee including Perfrmance Imprvement data fr the previus 12 mnths Minutes frm Envirnment f Care/Safety Cmmittee Management plans fr the physical envirnment and annual evaluatins List f cntracted services, cmpanies and individuals- Surveyrs will select a sample fr review Nursing service plan f administrative authrity/delineatin f respnsibilities fr delivery f pt. care Infectin Cntrl Plan with risk assessment/hazard vulnerability analysis List f emplyees including name, title, unit, and hire date List f current patients wh have had restraint r seclusin used during hspitalizatin List f patients discharged with the past 6 mnths wh had restraint r seclusin used vilent r selfdestructive behavir during their hspitalizatin P&P: Autpsies P&P: Bld & Bld Prduct Administratin P&P: Histry and Physical Examinatin P&P: Infrmed Cnsent Rev 17 Effective 2015-04-23 Page 4 f 21
P&P: Medicatin Security P&P: Mderate Sedatin P&P: Patient Assessment (Nursing, respiratry, nutritinal services, etc.) P&P: Pain Management P&P: Patient Care Planning/Interdisciplinary Treatment Plan P&P: Patient Grievance P&P: Prcedural Verificatin Prcess (Practices ensuring the crrect patient, site & prcedure) P&P: Restraint r Seclusin P&P: Verbal/Telephne Orders As applicable, t assess cmpliance with the ISO 9001 requirements the fllwing dcuments will als be incrprated int this review prcess. Cntrl f Dcuments; Cntrl f Recrds; Cntrl f Nn-Cnfrmity; Internal Reviews (Internal Audits); Crrective Actin; Preventive Actin; Quality Manual; Quality Plicy; Quality Objectives; Management Reviews, and Varius plicies and prcedures Leadership Interview fllwing dcument review fr clarificatin f any identified issues; Using Tracer Methdlgy, department/patient unit audits t include staff interviews and pen medical recrd review as apprpriate (bth clinical and supprt departments) 1. The department/units f the rganizatin will be surveyed thrugh the use f tracer methdlgy. Use f tracer methdlgy shall be the means by which the surveyrs will select recrds and then fllw the patient care and ther prcess(es) t verify varius aspects f the rganizatin as they are applied against the NIAHO requirements and ISO 9001 standards and rganizatin plicies. 2. The rganizatin can expect visits t multiple areas f the rganizatin t include, but nt limited t, patient care units, ancillary services, human resurces/persnnel ffice, medical staff ffice, purchasing, bi-med/clinical engineering and/r facilities management. 3. The Tracer methdlgy prcess may identify perfrmance issues as a result f reviewing an individual patient s case, in ne r mre steps in the prcess r perhaps the interfaces between steps that affect the care f the patient/family as well as staff and rganizatin perfrmance. Human Resurces Interview t verify cmpliance with staff requirements Medical Staff credentialing sessin t verify cmpliance with Medical Staff requirements Building Tur (4-12 hurs, dependent n Applicant Organizatin size); Interviews with individuals wh versee cre prcesses (e.g. patient safety and infectin cntrl, etc.) and apprpriate staff if deemed necessary by survey findings; Interviews with leadership, ther management staff, physicians, and bard members Interviews with patients Additinal dcument review if deemed necessary by survey findings; Oral presentatin f Preliminary Findings t Applicant Organizatin Leadership Team. ACCREDITATION AND CERTIFICATION PROCESS The Accreditatin and Certificatin prcess begins when the Applicant Organizatin submits a cmpleted DNV GL Healthcare USA, Inc. Accreditatin Applicatin, t include an ISO 9001 Certificatin Applicatin if DNV GL is t be the ISO Registrar. Upn receipt f a cmpleted Applicatin(s), DNV GL will review the infrmatin and prvide a fee structure based n the Applicant Organizatin s cmplexity and services requested. Rev 17 Effective 2015-04-23 Page 5 f 21
Fr new enrllees in the Medicare prgram and prir t issuance f a qute fr an accreditatin survey, the applicant rganizatin must submit evidence f its 855A cmpleteness ntificatin by CMS. A survey may nly be scheduled if the applicant rganizatin has received their 855A enrllment cmpleteness ntificatin frm CMS. If the Applicant Organizatin requires a Business Assciate Agreement, it must be submitted t DNV GL and executed prir t the n-site survey. DNV GL shall identify a survey team t cnduct the n-site survey and cnfirm acceptable dates when the survey may be cnducted. As the survey is unannunced, the survey team and the dates will NOT be shared with the Applicant Organizatin. Fllwing the n-site accreditatin survey the Applicant Organizatin will be made aware that the next survey (pending clsure f any pen issues) will ccur any time frm the ninth thrugh the twelfth mnth fllwing the initial Accreditatin Survey. The same timeframes will apply fr subsequent NIAHO surveys cnducted by DNV GL. SURVEY LOCATIONS Fr hspitals with either n r a small number f ff-campus prvider-based lcatins, the team will survey all departments, services, and lcatins that bill fr services under the rganizatin s prvider number and included in the scpe statement (as ISO required) and are cnsidered part f the rganizatin. Fr rganizatins with many prvider-based lcatins survey: All hspital departments and services at the primary rganizatin campus and n the campuses f ther remte lcatins f the hspital All satellite lcatins f the hspital All inpatient care lcatins f the hspital All ut-patient surgery lcatins f the hspital All lcatins where cmplex ut-patient care is prvided by the hspital The surveyrs will select a sample f each type f ther services prvided at additinal prvider-based lcatins. CONTRACTED SERVICES On any rganizatin NIAHO survey, cntracted patient care activities r patient services (such as dietary services, treatment services, diagnstic services, etc.) lcated n rganizatin campuses r rganizatin prvider based lcatins shuld be surveyed as part f the rganizatin fr cmpliance with apprpriate requirements. SURVEY TEAM SIZE AND COMPOSITION DNV GL decides the cmpsitin and size f the team. In general, a suggested survey team fr a full survey f a mid-size (200 bed) hspital wuld typically include 3 surveyrs wh will be at the facility fr 2 r mre days. Each hspital survey team will include at least ne RN r Physician with hspital survey experience and a Physical Envirnment Specialist as well as ther surveyrs wh have the training and expertise needed t determine whether the facility is in cmpliance. Survey team size and cmpsitin are nrmally based n the fllwing factrs: Size f the facility t be surveyed, based n average daily census and number f emplyees Cmplexity f services ffered, including utpatient services Type f survey t be cnducted Whether the facility has special care units r ff-site clinics r lcatins; Whether the facility has a histrical pattern f serius deficiencies r cmplaints Prir t the n-site survey, DNV GL shall verify that all members f the survey team have cnfirmed that there is n present cnflict f interest and they have in n manner assisted the Applicant Rev 17 Effective 2015-04-23 Page 6 f 21
Organizatin in preparatin r therwise served in the capacity as a cnsultant r as a frmer r current emplyee f the Applicant Organizatin. In the event a cnflict f interest is apparent r suspected, DNV GL will remve any surveyr and replace that individual with anther surveyr free f any cnflict f interest. TRAINING FOR SURVEYORS Clinical, Physical Envirnment, and Generalist Surveyrs must successfully cmplete the fllwing: The DNV GL NIAHO Surveyr Training The DNV GL Quality Lead Auditr r an equivalent curse accredited by IRCA r RAB-QSA The DNV GL Risk-Based Certificatin methdlgy training Orientatin t DNV GL plicies, prcedures and sftware requirements Additinally, the Physical Envirnment Specialists must successfully cmplete the fllwing: Successful cmpletin f a NFPA (Natinal Fire Prtectin Assciatin) Life Safety Cde training with an additinal fcus n hspital requirements. Alternatively, 5 years r mre f experience within facilities management including safety prgrams, direct invlvement in the envirnment where patient care services are prvided and knwledge f the Life Safety Cde will satisfy this requirement. LEAD SURVEYOR (TEAM LEADER) The survey is cnducted under the leadership f a Lead Surveyr (Team Leader), designated by DNV GL staff. The Lead Surveyr (Team Leader) is respnsible fr assuring that all survey activities are cmpleted within the specified time frames and in a manner cnsistent with this prtcl and ther DNV GL plicies and prcedures. Respnsibilities f the Lead Surveyr (Team Leader) include: Acting as the spkespersn fr the team n site Facilitating management f the survey Encuraging cmmunicatin amng team members Evaluating team prgress and crdinating meetings with team members and hspital staff as needed Crdinating any nging cnferences with rganizatin leadership and prviding feedback, as apprpriate, t rganizatin leadership n the status f the survey Facilitating Opening and Clsing Meetings Crdinatin and preparatin f Preliminary Survey Reprt, with active participatin f all survey team members Submissin f preliminary reprt t DNV GL SURVEY PLAN PREPARATION The bjective f this activity is t analyze infrmatin abut the rganizatin in rder t identify areas f ptential cncern t be investigated during the survey and t determine if thse areas, r any special features f the rganizatin (e.g., prvider-based clinics, remte lcatins, satellites, specialty units, PPS-exempt units, services ffered, scpe statement, etc.) require additinal surveyrs t the team beynd thse assigned based n average daily census, number f emplyees and cmplexity f the rganizatin. Infrmatin btained abut the rganizatin will als allw DNV GL t develp a preliminary survey plan. The type f prvider infrmatin needed includes: Infrmatin frm the prvider file (t be updated annually using the cmpleted rganizatin applicatin) Currently accredited rganizatins will be required t prvide infrmatin t DNV GL by cmpleting an Annual Update t the applicatin. The infrmatin cntained within the Annual Update will identify: Accurate cntact infrmatin fr the rganizatin Names f members f Senir Leadership Rev 17 Effective 2015-04-23 Page 7 f 21
Any ff-site lcatins that have been added since the prir survey Vlume infrmatin frm the prir year f the annual survey Any new services that have been added since the prir survey Any additinal infrmatin available abut the facility (e.g., the hspital s Web site, any media reprts abut the hspital, etc). (If applicable) If applicable review previus survey results fr patterns, number, and nature f deficiencies, as well as the number, frequency, and types f cmplaint investigatins and the findings Any additinal infrmatin available abut the facility (e.g., the hspital s Web site, any media reprts abut the hspital, etc). The annual survey will be unannunced. SURVEY TEAM OFF-SITE SURVEY PREPARATION The survey team shuld prepare fr the survey ffsite by sharing rganizatin pertinent infrmatin s they are ready t begin the survey immediately upn entering the facility. This can best be accmplished electrnically (frm the Lead Surveyr (Team Leader) t ther team members) with a fllw-up cnference call if necessary. The fllwing shuld be included in this preliminary exchange and/r discussin: Organizatin demgraphics & services ffered Layut f facility if available Survey schedule Timing f survey activities, including beginning and ending times Suggested ldging and transprtatin ptins Directins t facility SURVEY TEAM ARRIVAL The entire survey team shuld enter the rganizatin tgether. Upn arrival, surveyrs shall present their identificatin alng with the annuncement letter t the receptinist r ther hspital representative upn entering the building. The Lead Surveyr (Team Leader) will annunce t the CEO r Executive in charge r rganizatin cntact, that a survey is being cnducted. If the CEO (r executive in charge) is nt nsite r available, the Lead Surveyr (Team Leader) will ask that they are ntified that a survey is being cnducted. The Survey Team will nt delay the survey because the CEO r ther hspital staff is/are nt n site r available. OPENING MEETING Explanatin f the purpse, scpe f the survey, and prvide a schedule f survey activities t the rganizatin (the schedule may be adjusted as necessary) Brief explanatin f the survey prcess; Intrductin f survey team members, including any additinal surveyrs wh may jin the team at a later time, the general area that each will be respnsible fr, and the varius dcuments that they may request; Clarificatin f all rganizatin areas and lcatins, departments, and patient care settings under the hspital prvider number and/r scpe statement that will be surveyed, including any cntracted patient care activities r patient services lcated n rganizatin campuses r rganizatin prvider based lcatins Discuss the lcatin (e.g., cnference rm) where the team may meet privately during the survey A telephne and internet cnnectin fr team cmmunicatins (r access t these services if needed), preferably in the team meeting lcatin Rev 17 Effective 2015-04-23 Page 8 f 21
Determine hw the facility will ensure that surveyrs are able t btain the phtcpies f material, recrds, and ther infrmatin as they are needed Obtain the names, lcatins, and telephne numbers f key staff t whm questins shuld be addressed Discuss the apprximate time, lcatin, and pssible attendees f any meetings t be held during the survey. Prpse a preliminary date and time fr the Clsing Meeting. During the Opening Meeting, the Lead Surveyr (Team Leader) will request that the rganizatin prvide the survey team with the dcuments requested fr Dcument Review as listed. The Lead Surveyr (Team Leader) will request that the dcuments be prduced n later than 3 hurs after the request is made. INITIAL ON-SITE SURVEY TEAM MEETING After the cnclusin f the Opening Meeting, the survey team will meet in rder t evaluate infrmatin gathered, and mdify surveyr assignments, as necessary. The surveyrs will nt delay the cntinuatin f the survey prcess waiting fr infrmatin frm the rganizatin, but rather will adjust survey activities as necessary. During the n-site team meeting, team members shuld: Review the scpe f hspital services Identify hspital lcatins t be surveyed, including any ff-site lcatins Adjust surveyr assignments, as necessary, based n infrmatin prvided Discuss issues such as change f wnership, adverse events, cnstructin activities, and disasters, if they have been reprted Make an initial patient sample selectin (The patient list may nt be available immediately after the pening meeting and the team may delay cmpleting the initial patient sample selectin a few hurs as meets the needs f the survey team) PATIENT SAMPLE SIZE AND SELECTION T select the patient sample, the surveyrs will review the patient list prvided and select patients wh represent a crss-sectin f the patient ppulatin and the services prvided. Patient lgs (ER, OB, OR, restraint, etc.) may be used in cnjunctin with the patient list t assure the sample is reflective f the scpe f services prvided by the rganizatin. Whenever pssible and apprpriate, select patients that are in the facility during the time f survey (i.e., pen recrds). Open recrds allw surveyrs t cnduct a patient-fcused survey and enable surveyrs t validate the infrmatin btained thrugh recrd reviews with bservatins and patient and staff interviews. There may be situatins where clsed recrds are needed t supplement the pen recrds reviewed (e.g., t few pen recrds, cmplaint investigatin, etc), surveyrs will use their prfessinal judgment in these situatins and select a sample size that will enable them t make cmpliance determinatins and verify cnsistency. If it is necessary t remve a patient frm the sample during the survey, (e.g., the patient refuses t participate in an interview), the surveyrs will replace the patient with anther wh fits a similar prfile. This will be dne as sn as pssible in the survey. The number f clinical recrds selected fr review will typically be based n the rganizatin s Average Daily Census (ADC). ). A guiding principle when selecting clinical recrds shuld be at least 10% f the ADC but n fewer than 30 inpatient recrds as sufficient t determine cmpliance in mst instances (including surgical r ther specialty hspitals). In a hspital with an ADC f 20 patients r less, the sample shuld nt be fewer than 20 inpatient recrds, prvided that the number f recrds is adequate t determine cmpliance with any given requirement. Within the sample, the surveyrs will select at least ne patient frm each nursing unit (e.g., med/surg, ICU, OB, pediatrics, specialty units, etc). In additin t the inpatient sample, the surveyrs will select a sample f utpatients in rder t determine cmpliance in utpatient departments, Rev 17 Effective 2015-04-23 Page 9 f 21
services, and lcatins. The sample size may be expanded as needed t assess the rganizatin s cmpliance with all applicable requirements and standards. If a cmplaint is being investigated during the survey, the survey team will include patients wh have been identified as part f the cmplaint in the sample. Issues r cncerns identified thrugh cmplaints may be an area f fcus when selecting the patient sample. SURVEYOR INFORMATION GATHERING AND INVESTIGATION The bjective f this activity is t determine the hspital s cmpliance with the requirements thrugh bservatins, interviews, and dcument review. The surveyrs will fcus attentin n actual and ptential patient utcmes, as well as required prcesses. The surveyrs will assess the care and services prvided, including the apprpriateness f the care and services within the cntext f the Requirements. The surveyrs will visit patient care settings, including inpatient units, utpatient clinics, anesthetizing lcatins, emergency departments, imaging, rehabilitatin, remte lcatins, satellites, etc. The surveyrs will bserve the actual prvisin f care and services t patients and the effects f that care, in rder t assess whether the care prvided meets the needs f the individual patient. DURING THE SURVEY Typically the survey team will be accmpanied by assigned rganizatin staff as the survey is cnducted. Hwever the surveyrs have discretin whether t allw, r refuse t allw, rganizatin staff t accmpany the surveyrs during a survey r a selected activity f the survey. Surveyrs will make a decisin whether t allw rganizatin staff t accmpany them based n the circumstances at the time f the survey activity. The survey team will meet at least daily (typically each mrning) with rganizatin leadership in rder t assess the status f the survey, prgress f cmpletin f assigned activities, areas f cncern, and t identify areas fr additinal investigatins. The meetings will include an update by each surveyr that addresses findings and areas f cncern that have been identified. If areas f cncern are identified in the discussin, the survey team and the rganizatin staff will crdinate effrts t btain additinal infrmatin, if apprpriate. The rganizatin staff will have the pprtunity t present additinal infrmatin r t ffer explanatins cncerning identified issues. Survey infrmatin will nt be discussed unless the investigatin prcess and data cllectin fr the specific cncerns is cmpleted. Additinal team meetings can be called at any time during the survey t discuss crucial prblems r issues. Any significant issues r significant adverse events must be brught t the Lead Surveyr s attentin immediately. Althugh nn-cnsultative infrmatin may be prvided upn request, the surveyr is nt a cnsultant. Hwever, it is cmmn t educate the hspital staff n aspects f the requirements and their applicatin t the hspital prcesses. PATIENT CARE REVIEW A cmprehensive review f care and services received by patients in the sample will be part f the survey. A cmprehensive review includes bservatins f care/services prvided t the patient, patient and/r family interview(s), staff interview(s), and medical recrd review. After btaining the patient s permissin, the surveyrs will bserve sample patients receiving treatments (e.g., intravenus therapy, tube feedings, wund dressing changes) and bserve the care prvided in a variety f treatment settings, as necessary, t determine if patient needs are met. Rev 17 Effective 2015-04-23 Page 10 f 21
SURVEYOR ASSESSMENTS The team will bserve the care envirnment t btain infrmatin abut hw the care delivery system wrks and hw the rganizatin s departments wrk tgether t prvide care. Surveyrs will review services prvided, cnduct interviews, and review recrds and plicies/prcedures by statining themselves as physically clse t patient care as pssible. While cmpleting a chart review the surveyr may als bserve patient care, the envirnment, staff interactins with patients, safety hazards, infectin cntrl practices, r any ther activity that affects patient care r staff perfrmance. During the survey, the surveyrs will pay particular attentin t the fllwing: Patient care, including treatments and therapies in all patient care settings; Staff member activities, equipment, dcumentatin, building structure, sunds and smells; Peple, care, activities, prcesses, dcumentatin, plicies, equipment, etc., that are present that shuld nt be present as well as thse that are nt present that shuld be present; Integratin f all services t determine that the facility is functining as ne integrated whle Whether quality imprvement is a rganizatin-wide activity, incrprating every service and activity f the rganizatin Whether every rganizatin department and activity reprts t and receives reprts frm the rganizatin s quality management versight, facilitating the rganizatin-wide quality management system. Awareness and the effectiveness f the hspital s quality management system Strage, security and cnfidentiality f medical recrds. Surveyrs will recrd ntes f findings/issues and shuld dcument fr bjective evidence: The date and time f the bservatin(s) Lcatin Patient identifiers Individuals present during the bservatin Activity being bserved (e.g., therapy, treatment mdality, etc). Dcument / Frm names and/r numbers (if applicable) The surveyr will try t have findings verified by the patient, family, facility staff, ther survey team member(s), r by anther mechanism. Fr example, when finding an ut-dated medicatin in the pharmacy, the surveyr will ask the pharmacist t verify that the drug is ut-dated. In additin, a surveyr shuld integrate the data frm bservatins with data gathered thrugh interviews and dcument reviews. INTERVIEWS Interviews prvide a methd t cllect infrmatin, and t verify and validate infrmatin btained thrugh bservatins. Infrmal interviews will be cnducted thrughut the survey. The surveyrs will use the infrmatin btained frm interviews t determine what additinal bservatins, interviews, and recrd reviews are necessary. When cnducting interviews, the surveyrs will d the fllwing: Maintain dcumentatin f each interview cnducted. Dcument the interview date, time, and lcatin; the full name and title f the persn interviewed; and key pints made and/r tpics discussed. T the extent pssible, dcument qutes frm the interviewee. The surveyrs will cnduct patient interviews regarding their knwledge f their plan f care, the implementatin f the plan, and the quality f the services received. Other tpics fr patient r family interviews may include patient rights, advanced directives, and the facility s grievance/cmplaint prcedure. Interviews with patients will be cnducted in private and with the patient s prir permissin. The surveyrs will interview staff t gather infrmatin abut the staff s knwledge f the patient s needs, plan f care, and prgress tward gals. Prblems r cncerns identified during a patient r family interview will be addressed in the staff interview in rder t validate the patient s perceptin r t gather additinal infrmatin. Rev 17 Effective 2015-04-23 Page 11 f 21
Telephne interviews will be cnducted if necessary, but the preference is fr in-persn interviews. The surveyrs will integrate the data frm interviews with data gathered thrugh bservatins and dcument reviews. ORGANIZATION DOCUMENTATION Dcuments reviewed by the survey team during the survey, in additin t the frmal Dcument Review, may be bth written and electrnic and include the fllwing: Patient s clinical recrds t validate infrmatin gained during the interviews as well as fr evidence f advanced directives, discharge planning instructins, patient teaching etc. This review will prvide a brad picture f the patient s care. Plans f care and discharge plans shuld be initiated immediately upn admissin, and be mdified as patient care needs change. As an example, the recrd review fr that patient wh has undergne surgery wuld include a review f the pre-surgical assessment, infrmed cnsent, perative reprt, and pre-, inter-, and pst-perative anesthesia ntes. Althugh team members may have a specific area assigned during the survey, the team will avid duplicatin f effrts during review f medical recrds and each surveyr will typically review the recrd as a whle instead f targeting the assigned area f cncern. Surveyrs shuld use pen patient recrds rather than clsed recrds whenever pssible Clsed medical recrds may be used t determine past practice, and the scpe r frequency f a deficient practice. Clsed recrds shuld als be reviewed t prvide infrmatin abut services that are nt being prvided by the hspital at the time f the survey. (Fr example, if there are n bstetrical patients in the facility at the time f the survey, the surveyrs will review clsed OB recrds t determine care practices, r t evaluate past activities that cannt be evaluated using pen recrds.) In the review f clsed clinical recrds, the surveyrs will review all selected medical recrds fr an integrated plan f care, timelines f implementatin f the plan f care, and the patient respnses t the interventins. Persnnel files t determine if staff members have the apprpriate educatinal and training, pre-emplyment requirements, cmpetency/perfrmance assessments, and are licensed if it is required; Physician and allied health credential files t determine if the facility cmplies with Standards requirements and State law and fllws its wn written plicies fr medical staff privileges and credentialing; Maintenance and calibratin recrds t determine if equipment is peridically attested and/r calibrated t determine if it is in gd wrking rder and if envirnmental requirements have been met Staffing dcuments t determine if adequate numbers f staff are prvided accrding t the number and acuity f patients Plicy and Prcedure Manuals Cntracts, if applicable Organizatin activities minutes as requested ANALYSIS OF FINDINGS The bjectives f this survey team meeting are t integrate findings, review and analyze all infrmatin cllected frm surveyr bservatins, interviews, and recrd reviews, and t determine whether r nt the rganizatin meets the apprpriate requirements. Each team member will review his/her ntes, wrksheets, recrds, bservatins, interviews, and dcument reviews t assure that all investigatins are cmplete and rganized fr presentatin t the team. Based n the team s decisins, additinal activities may need t be initiated. The meeting will include the fllwing: The surveyrs will share their findings, evaluate the evidence, and make team decisins regarding cmpliance with each requirement. Decisins abut deficiencies will be based n input frm the team members but the final decisin shall always be the respnsibility f the Lead Surveyr (Team Leader). The team will dcument their decisins, the substance f the evidence, and the numbers f patients impacted, in rder t identify the extent f any facility Nncnfrmity. Rev 17 Effective 2015-04-23 Page 12 f 21
The team will ensure that their findings are supprted by adequate dcumentatin f surveyr bservatins, interviews and dcument reviews. Any additinal dcumentatin r evidence needed t supprt identified Nncnfrmities shuld be gathered prir t the Clsing Meeting but at a minimum, prir t exiting the hspital. When a deficient practice (Nncnfrmity) is determined t have taken place prir t the survey and the rganizatin states that it has crrected the deficient practice/issue, the survey team will cnsider the fllwing: Is the crrective actin superficial r inadequate, r is the crrective actin adequate and systemic? Has the rganizatin implemented the crrective actin(s)? Has the hspital taken a quality management apprach t the crrective actin t ensure mnitring, tracking and sustainability? The survey team will use their judgment t determine if any crrective actin(s) taken by the rganizatin prir t the survey is sufficient t crrect the Nncnfrmity and t prevent the deficient practice frm cntinuing r recurring. If the deficient practice is crrected prir t the survey, the survey team will nt cite the Nncnfrmity. If a Nncnfrmity with any requirement is nted during the survey, even when the hspital crrects the Nncnfrmity during the survey, the Nncnfrmity shall be cited. CLOSING MEETING The Lead Surveyr (Team Leader) is respnsible fr rganizatin f the presentatin f the clsing meeting. The team determines wh will present the findings. If the team feels it may encunter a prblem during the clsing, they shuld immediately cntact the DNV GL ffice. The facility determines which hspital staff will attend the clsing meeting. The Lead Surveyr (Team Leader) will explain hw the team will cnduct the clsing meeting and any assciated grund rules. Grund rules will include waiting until the surveyr finishes discussing a given deficiency befre accepting cmments frm facility staff. The identity f an individual patient r staff member must nt be revealed in discussing survey results. Identity includes nt just the name f an individual patient r staff member, but als includes any reference by which identity might be deduced The surveyr will present the findings f Nncmpliance r Observatin, explaining why the finding(s) is a vilatin. The surveyr will just present the facts. If immediate jepardy is identified by the team, they will explain the significance and the need fr immediate crrectin. The rganizatin will have an pprtunity t present new infrmatin after the clsing meeting fr cnsideratin after the survey. The team will assure that all findings are discussed at the clsing cnference. If the clsing cnference was audi r vide taped, the Lead Surveyr (Team Leader) must btain a cpy f the tape in its entirety befre leaving the facility. DISCONTINUATION OF THE CLOSING MEETING It is DNV GL s plicy t cnduct a clsing meeting at the cnclusin f each survey. Hwever, there are sme situatins that justify refusal t cntinue r t cnduct a clsing meeting. Fr example: If the prvider is represented by cunsel (all participants in the clsing meeting shuld identify themselves), surveyrs may refuse t cnduct the clsing meeting if the attrney tries t turn it int an evidentiary hearing; r Rev 17 Effective 2015-04-23 Page 13 f 21
If the rganizatin leadership creates an envirnment that is hstile, intimidating, r incnsistent with the infrmal and preliminary nature f a clsing meeting, surveyrs may refuse t cnduct r cntinue the clsing meeting. Under such circumstances, the Lead Surveyr (Team Leader) will stp the clsing meeting and call the DNV GL ffices immediately fr further directin. RECORDING THE CLOSING MEETING If the rganizatin wishes t audi tape the clsing meeting, it must prvide tw tapes and tape recrders, recrding the meeting simultaneusly. The surveyrs shuld take ne f the tapes at the cnclusin f the meeting. Vide taping is als permitted if it is nt disruptive t the meeting, and a cpy is prvided t the Lead Surveyr (Team Leader) at the cnclusin f the meeting. It is at the sle discretin f the surveyr(s) t determine if vide taping is permitted. POST-SURVEY ACTIVITIES A Preliminary Reprt shall be cmpleted by the Survey Team and issued t the accredited rganizatin. DNV GL will frward the final survey reprt t the rganizatin within 10 business days f the last date f the survey. SURVEY FINDING DEFINITIONS: NIAHO Nncnfrmity (NC)- (Categry 1) Objective evidence exists that a requirement has nt been addressed (intent), a practice differs frm the defined system (implementatin), r the system is nt effective (effectiveness). The absence f ne r mre required system elements r a situatin which raises significant dubt that the services will meet specified requirements. A grup f categry 2 nn-cnfrmities indicating inadequate implementatin r effectiveness f the system relevant t the requirement. A categry 2 nn-cnfrmity that is persistent (r nt crrected as agreed by the custmer) shall be up-graded t categry 1, OR a situatin, that, n the basis f available bjective evidence, wuld have the capability t cause patient harm r des nt meet a standard f care. Cnditin Level Finding- A Cnditin Level Finding is a Categry 1 Nncnfrmity in which the custmer is determined t be cmpletely r substantially ut f cmpliance with the requirement. Such finding is made n a case-by-case basis in DNV GL Healthcare USA, Inc. s sle discretin. A Cnditin Level Finding will be identified as a Categry 1 Nncnfrmity- Cnditin Level Finding. All Cnditin Level Findings will require a fllw-up survey prir t the next annual survey. Fr rganizatins as new enrllees in the Medicare Prgram, all Categry 1 Nncnfrmities must be clsed prir t issuance f the accreditatin certificate. If there are any Cnditin Level Categry 1 Nncnfrmities identified, the custmer will be required t cmplete a full re-survey prir t issuance f an accreditatin certificate. Fr all ther, Categry 1 nncnfrmities, a fllw-up survey may be required prir t the next annual survey as specified in 3.5.1 (belw) Nncnfrmity (NC)- (Categry 2) A lapse f either discipline r cntrl during the implementatin f system/prcedural requirements, which des nt indicate a system breakdwn r raise dubt that services will meet requirements. Overall system requirement is defined, implemented and effective. Rev 17 Effective 2015-04-23 Page 14 f 21
As applicable a finding as a Categry 2 nncnfrmity may be: An islated nn-fulfillment f a requirement that is therwise prperly dcumented and implemented, r, Incnsistent practice cmpared t ther areas f the custmer, r, Significant enugh t warrant the custmer t take actin t prevent future ccurrence and/r has the ptential fr becming a Categry 1 nncnfrmity. Custmer Fllw-up Required fr Nncnfrmities A Crrective Actin Plan (CAP) must be delivered t DNV GL Healthcare USA, Inc. within ten (10) calendar days frm date f the written reprt. The CAP must: Identify the rt cause that led t the nncnfrmity; Identify the actins taken t crrect the nncnfrmity in the affected areas and/r prcesses; Identify ther areas and/r prcesses (if applicable) that have the ptential t be affected by the same nncnfrmity; Identify the prcess r system changes that will be made t ensure that the nncnfrmity des nt recur; Identify the timeframe fr the implementatin f the crrective actin measure(s); Identify the time f the persn respnsible fr implementing the crrective actin measure(s) and, Identify the perfrmance measure(s) and/r ther supprting evidence that will be mnitred t ensure the effectiveness f the crrective actin(s) taken. DNV GL Healthcare USA, Inc. fllw-up with Custmer fr Nncnfrmities DNV GL Healthcare USA, Inc. will acknwledge receipt f the CAP and state any deficiencies and additinal requirements with timelines fr submissin OR declare acceptance f the submitted dcumentatin. The custmer is expected t implement crrective actin measure(s) within sixty (60) days. When this is nt feasible DNV GL Healthcare will cnsider and evaluate the circumstances invlved and apprve a suitable timeframe t enable the custmer t implement the crrective actin measure(s). Althugh such instances fr extending the timeframe will be evaluated n a case-by-case basis, it wuld be a rare ccurrence that the extended timeframe fr implementatin f crrective actin measure(s) t exceed six (6) mnths. Fr Categry 1 Nncnfrmities, within sixty (60) days f DNV GL Healthcare USA, Inc. acceptance, the custmer shall submit perfrmance measure(s) data, findings, results f internal reviews (internal audits), r ther supprting dcumentatin, including timelines t verify implementatin f the crrective actin measure(s). If a Categry 1 Nncnfrmity results in a Cnditin Level Finding, a fllw-up survey prir t the next annual survey will als be required t determine cmpliance with the specific Categry 1 Nncnfrmity. Fr Categry 2 Nncnfrmities, if the crrective actin plan(s) requirements are met, validatin f effective implementatin f the agreed crrective actin plan will take place at the next annual survey. DNV GL Healthcare USA, Inc. will respnd t the custmer regarding acceptance f the submitted dcumentatin and identify any deficiencies and additinal requirements with time lines fr submissin. Rev 17 Effective 2015-04-23 Page 15 f 21
Failure t cmply with the requirements f the CAP regarding nncnfrmities may als result in a Cnditin Level Finding. A Cnditin Level Finding culd result in Jepardy Status fr the custmer as described in Fllw-up and Special Surveys (ICP-12-5-i5) and Jepardy Status, Withdrawal f Accreditatin, Disputes and Appeals (ICP-12-6-i4). DNV GL Healthcare USA, Inc., in its sle discretin, shall determine the need fr a fllw-up survey when cmpliance and implementatin cannt be reasnably determined thrugh written dcumentatin f bjective evidence. The scpe and extent f the fllw-up survey will be determined based upn the cmplexity f the nncnfrmity and ne r mre surveyrs will be assigned t the fllw-up survey. When pssible, members f the survey team that cnducted the survey when the nncnfrmity was issued will be assigned. When this is nt feasible, DNV GL Healthcare USA, Inc. will assign a surveyr that is familiar with the prcess and has the qualificatins t validate cmpliance. NOTE- In all cases, when an applicant rganizatin is underging an initial accreditatin as a new enrllee in the Medicare prgram, all Categry 1 nncnfrmities must be remved prir t the awarding f accreditatin. In additin, if any Categry 1 nncnfrmity results in a Categry 1 Nncnfrmity- Cnditin Level Finding, the applicant rganizatin must crrect the Cnditin Level Finding AND the applicant rganizatin will be required t underg anther full hspital re-survey prir t the awarding f accreditatin. NIAHO ACCREDITATION IN JEOPARDY (JEOPARDY STATUS) NIAHO Accreditatin in Jepardy (Jepardy Status) may be invked based n the fllwing: Custmer fails t submit a required Crrective Actin Plan and/r related dcumentatin r if established reasnable timelines in a Crrective Actin Plan are nt met Custmer fails t maintain the ISO quality management system r be certified t ISO 9001 within 3 years f initial DNV GL Healthcare fllwing the first NIAHO deemed survey. Custmer vilates terms f the signed accreditatin agreement, including nn-payment f fees r refusal f access. Failure t respnd adequately t nncnfrmities identified during the accreditatin prcess. Custmer makes false public claims regarding its accreditatin. (e.g., accreditatin is used in a way that is unjustifiable r deceptive in advertising.) Infrmatin frm stakehlders that culd affect the status f accreditatin (e.g., nncmpliance t regulatry/statutry requirements). Individual is delivering patient care r prviding services withut a required valid license r certificatin r registratin; Preventable issues that pse Immediate Jepardy (harm r injury t a patient); r, Nn-cmpliance with statutry and regulatry requirements f state and/r federal law. The requirements that the Accredited Organizatin must meet t be remved frm Jepardy Status and the length f time an Accredited Organizatin may remain in Jepardy Status befre Accreditatin and Certificatin are remved will be utlined fr the Accredited Organizatin in the Jepardy ntificatin. Jepardy Status ntificatin will utline the length f time the Accredited Organizatin may remain in Jepardy Status, but nrmally that timeframe will nt exceed fur (4) mnths. Any extensin shall be based n a prgressing Crrective Actin Plan that has been validated by a Special Survey. FINDINGS AND WRITTEN REPORT DNV GL Healthcare USA, Inc. shall prvide final written reprt(s), NIAHO and/r ISO 9001, t the Applicant Organizatin within ten (10) business days f the survey. The final written reprt(s) will cntain all identified Nncnfrmities as well as Opprtunities fr Imprvement relative t the Rev 17 Effective 2015-04-23 Page 16 f 21
NIAHO requirements and/r ISO standards that were identified by the team during the perfrmance f the survey. Fllwing receipt f the final written reprt(s) the Applicant Organizatin will have ten (10) calendar days frm the date f the Survey reprt t appeal any Nncnfrmity findings relative t either NIAHO requirements r ISO standards. The Applicant Organizatin will submit Crrective Actin Plan(s) t address the nncnfrmities identified and return this t DNV GL Healthcare USA, Inc. If the Crrective Actin Plan(s) are apprved, the reprt f nncnfrmities with the Crrective Actin Plan(s) will be submitted t the Accreditatin Cmmittee. Based n successful survey findings and/r Actin Plan fllw-up as described abve, this will be presented t the Accreditatin Cmmittee fr their decisin regarding the accreditatin status f the applicant rganizatin. If apprved, the Applicant Organizatin will receive a three year DNV GL Healthcare USA, Inc. NIAHO Accreditatin and, if apprpriate, a three year Certificatin r GL Cmpliance fr meeting the ISO 9001 Quality Management System requirements, subject t the apprval f the Certificatin Bdy fr ISO 9001. In rder t maintain accreditatin, the rganizatin will be subject t annual surveys fr assessment f cntinual cmpliance with the NIAHO requirements and cmpliance with crrective actin plan(s) frm the prir survey. APPEALS PROCEDURE Appeals received by DNV GL Healthcare USA, Inc. shall be: Registered in a lg t recrd the prgress t cmpletin; Acknwledged by DNV GL Healthcare USA, Inc. withut undue delay; and, Reviewed and answered. The appeal is nt bund t a particular frm r cntent. Hwever, the appeal shall be submitted in writing stating the basis f the appeal and the relief being requested. The appeal can be faxed, e- mailed r sent by US mail t: Darrel J. Sctt, Executive Vice President, Operatins DNV GL Healthcare USA, Inc. 400 Techne Center Drive, Suite 100 Milfrd, Ohi 45150 Fax: (513) 947-1250 Email: Darrel.Sctt@dnvgl.cm The appellant shall be infrmed f the right t: Appeal t the President f DNV GL Healthcare USA, Inc. if the appellant des nt accept the decisin f the Executive Vice President, Accreditatin. Present its case in writing t the Standards and Appeals Bard. The fllwing applies fr all appeals: All issues cnsidered during an appeal must be raised befre DNV GL Healthcare USA, Inc. s acceptance f the appellant s crrective actin plan. The decisin reached by the Executive Vice President, Operatins r President shall be cmmunicated t the appellant in writing If the appellant still remains dissatisfied with the decisin f the Executive Vice President, Operatins r President, the appellant is entitled t ne (1) appeal t the Standards and Appeals Bard. Any appellant ntice that it will pursue a remedy beynd DNV GL Healthcare USA, Inc. shall be reprted t DNV GL Crprate Legal Affairs thrugh the Executive Vice President, Operatins. Rev 17 Effective 2015-04-23 Page 17 f 21