TMENT OF HEALTH dz HUMAN SERVICES Centers for Medicare dz Medicaid Services 7500 Security Boulevard, Mail Stop (22-21-16 Baltimore, Maryland 212444850 FOR MEDICARE d: SERVECES BF {it {Senior oi Ciinicai Standards and Qaaiityffiarvey d1; Certification Group March 25, 2015 Margaret VanArnringe Executive Vice President for Public Policy and Government Relations The Joint Commission 601 13th Street, NW Suite 560 South Washington5 DC 20005 Dear Ms. VanAmringe: The Centers for Medicare Medicaid Services? technical review team has completed its review of The Joint Commission?s (HUS) February 13, 2015 response to ?ndings related to the survey observation conducted on October 20?24, 20M- at Spring?eld Hospital Center, Sykesville, MD. This survey observation was conducted as part of re-application for CMS approval of its Medicare psirchiatric hospital accreditation program. The survey observation is designed to assess processes and procedures for compieting an accreditation survey as described in TiC?s application, and in accordance with Medicare policy and procedure. aassaerei 'i?iie deeisiea as to whether there is compiianee with a cenditiori oi" partieipatiea9 or condition for coverage depends apart tire mariner arid degree to whicii tire provider or sappiier satisfies tire varioas standards within each caadi?tioama {Zeneera i: Levei at? ?irtation arid, at? Merit-eat Records: isevei at? Eitatien: acknowiedge that provides surveyors with a multitude of resources and has a robust process for the review of surveyor ?ndings and documentation when any of the factors listed in 'i?iC?s response are present and surveys have been flagged for review. However, none of the listed factors would be usequ in identifying cases of potential underwcitation, so we continue to be concerned that TiC?s review process has an inherent bias toward preventing over~citation oaiy. dirtiest item: Please submit an action plan to address the concern related to the routine review of survey reports when the survey report has not been ?agged for review by TiC?s Standards interpretation Group (SIG). if TJC already conducts reviews of survey reports, not ?agged by the iist provided in its response, please provide CMS the percentage of surveys reviewed and the outcome of such reviews. Ms. VanAmringe, page 2 i1? aisit?ication of Medieai Records: "fiC?s response to the issue of falsi?cation of medical records does not fully address the issue identified in our January 21, 2015 correspondence. We do not agree that the definition of falsi?cation, as it relates to application information provided to TIC meets the expectation for complete and accurate documentation within a medical record. The issue identi?ed involved physicians within the organization knowingly and deliberately documenting assessment ?ndings for examinations which physicians admit were not conducted, in order to avoid being cited as de?cient on internal audits. We do not View this as merely an ?unfortunate work-around,? as alleged by TJC 5 response. An accurate medical record is an essential component of providing safe and effective care. if portions of the history physical examination were not medically indicated for a speci?c patient, the hospital should have provided physicians a way to simply identify that component as not applicable. We agree that care or a service that IS not medically indicated should not be provided to patients, but falsi?cation of the patient?s medical record is not an appropriate vehicle for accomplishing this. in addition, TiC?s response indicated that had implied that the facility minimized the seriousness of appropriate documentation. In fact, our letter was referring to the behavior of 'l?lC? surveyors and 1eld Director. Our letter stated: ?By the facility 3 own admission, the surveyor confirmed that medical records were being falsi?ed 1n order to satisfy an internal chart review. This practice is contrary Medicare requirements for medical records and aiso raises questions about the quality of care rendered to the hospital?s patients. However, the surveyors? (and the onsite Field Director?s) response to the facility was the ?all facilities do this?. The comments made by TJC staff minimized the importance of the issue if, in fact, all facilities that is familiar with falsify medical records in this manner, it suggests that THE nas tolerated and allowed to become widespread in its accredited facilities a practice that not only violates Medicare standards but which is also potentially dangerous for patients. Because this survey report also contained other condition? level deficiencies, in accordance with TiCls policy the report received a review from a staff member in. Nevertheless, the citation was not raised to the condition level. Thus, there appears to he a systemic lack of understanding of the seriousness of this de?ciency at several. levels of liC?s organization, making this is of particular concern. diction item: Please submit an action plan to address the education and training of surveyors Sit} personnel and Field Directors and others, if applicable, who conduct survey report reviews for the purposes of assuring that citations are made at the appropriate levei (Le. Condition versus Standard). gangrene it 52: {Zornniianee with Standards: We have continued concern about the survey teamls (and Field Director?s) minimization of the importance of compiiance with accreditation and Medicare standards in comments made to the hospitaiis staff during the survey. Comments such as, ?i know hospitals across the nation. don?t do this?, ?i don?t like this requirement either?, ?All facilities do this?, and ?Things i don?t i tend not to pay attention to?, were made to the facility staff throughout the five-day survey. Additional comments made by the survey team (and Field Director) were included in our originai correspondence. Ms. VanAmringe, page 3 "i?.lC?s response to this issue highlighted the provision of ongoing supervision and evaluation. of performance from experienced Field Directors for all surveyors. However, this is not responsive, given that the cavaiier attitude observed during the survey extended beyond the surveyor to include the hieid Director, CMS is concerned about the training provided to Field Directors. item: We request that Tl submit an action plan to ensure that Field Directors and their supervisors understand the importance of compliance with all accreditation standards and. do not make statements to facilities minimizing the signi?cance of de?cient practices observed. ih?ederai review of accreditation organisationai 'i?he ot? snrvey procedures to those at State survey agencies, ineinding survey frequency, and the ahitity to investigate and respond appropriateiy to conthtatnts against accredited tactiities; Concern it immediate "threat to Life or Safety Situation: We acknowledge that the survey team spent a signi?cant amount of time investigating and discussing the issue of the attempted suicide incident cited in our original letter. We do not agree with the TJC response that addressng only the human factor which had contributed to the near successful suicide attempt itiiti gated the risk of future reoccurrences. We are concerned that TIC would suggest that, because the facility had experienced no reoccurrences between the original event and the survey that this was suf?cient evidence that no ongoing risk to patient safety and, therefore, no immediate threat to life existed at the time of the survey. According to the ii?C response, the facility has yet to address, in a plan of correction, the ligature risks in the bathrooms, related to open plumbing and hinges. in addition, the plan of correction accepted by TEC only addressed the open grab bars in these rest rooms. Based on the evidence provided by TEC, it is position that the ligature risks observed during the survey continue unchecked and uncorrected. This poses an ongoing safety risk to patients. it" he ?ndings observed during the onsite survey, along with the continued unmitigated ligature risks meet TiC?s de?nition of an immediate Threat to Life or Safety (i'ih) and de?nition of an immediate ieopardy We continue to be unclear as to why this issue was not cited as such. This raises serious concerns related to the process utilized by WC and the training of "fit: surveyors as weil as other staff at alt leveis of the organization involved in making the determination regarding the presence of an situation. Aiso, TiC?s response indicated that a follow-up survey had been conducted within 45 days of the October 24, 2m. 4 survey, which means that the foliow-up survey would have been completed on or before December 8, 20M. "the documentation contained in TiC?s response stated: ?The renovations have begun where the most acute patients reside. Enclosing ofgmb bars began in October 2014. the expected completion time for this project; February 20;:i 5 for Solomon Building, when Solomon is completed, enclosing ofgrab bars in the Hitcbman and then onto Mekeldin buildings will be Ms. VanArnringe, page 4i We question how the condition-level. finding related to ligature risks could have been cleared during this follow-?up survey. The initial building being renovated was not expected to be completed before February 2015, with subsequent buildings being addressed after that date. The other liga?un?e risks were not even addressed in the plan of correction. Action item: We request that 'i?iC provide the content of training provided to its surveyors? Field Directors? staff, consultative medical staff and any other decision-making groups, related to identifying an If this training and education does not include the actual process or algorithms used in discussing and making such a determination, please provide this separately. We also request if} policies and surveyor education] guidelines related to the appropriate determination that a facility has corrected issues previously cited as a condition?level ?nding, when conducting a follow-?up survey. Concern 2: Medicai Record and Erodentiahno and Priviiegine Reviews: Although the observed review of credential files during this survey may have been atypical of a TIC hospital survey, CMS is concerned that other such cases could occur. CMS is unclear as to how TIC monitors survey activities in order to assure that an adequate and appropriate representative sample of credential ?les have been reviewed during each survey. Aetion item: We request that WC provide further evidence of how it monitors survey activities to assure that an appropriate number and representative sample of credential file reviews have taken place for each survey. @883 i?nsite observation of accreditation organisation operations; As part of the appiication review process9 the vahdation review processor or the continuing oversight of an accreditation organisatiools perfo:rrnanee9 tilt/i3 they eon-duct an. onsite inspection of the accreditation organisationls operations and offices to verify the organisation?s representations and to assess the organisatiools compiiance with its own policies and procedures. (the oosite inspection may iris-hide9 but is not ihnited toj the review of auditing meetings concerning the accreditation process. the evaluation of survey results or the accreditation decisionnrnahing processg and interviews with the organisationls staff. [it our February 19., 2315 meeting, we discussed the purpose of the CMS observation survey and agreed to the following process during the conduct of the survey observation: a CMS staff will be fully included and have full access to all aspects of the on-site survey activitiesg calls to resource staff, and survey team discussions as weli as direct communication with surveyors as outlined in the regulation above; The if Washington, DC, office or other representative will facilitate CMS staff access to the entire on~site survey process as outlined above a CMS observers as well as any ?fiC observer(s) present will .conduct themselves in a manner to minimize disruptions to the survey teams survey process and the facility; a CMS observers as weii as any observer(s) present will not comment on any aspect of the survey? observations or deficiencies in. the presence of facility staff; a if by the day prior to the end date of the survey it appears that the survey team has not identi?ed a serious deficient practice that a CMS observer has noted, the CMS observer Ms. VanArminge, page 5 may raise this as an area of discussion with the survey team. However? the CMS observer must first provide the survey team with adequate time to identify the area of de?ciency before raising the issue; and, if the survey team fails to identify an situations as applicable, CMS observers may contact the appropriate Regional Of?ce to authorize a complaint investigation. Please submit a written response to these areas of concern by Wednesday, April 15, 2915 if you have any questions regarding this letter please do not hesitate to contact Monda Shaver at (430) 786 3410 or monda. shaver@cms. hhs. gov. SincerelyPatricia Chmielewski Deputy Birector Division of Acute Care Services