Federal warning letter to Los Angeles County Harbor-UCLA Medical Center 6-10-11

8/2/2019 Federal warning letter to Los Angeles County Harbor-UCLA Medical Center 6-10-11

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DEPARTMENT OF HEALTH & HUMAN SERVICESCENTERS FOR MEDICARE & MEDICAID SERVICES

CONSORTIUM FOR QUALITY IMPROVEMENT AND SURVEY & CERTIFICATION OPERATIONSWESTERN CONSORTIUM - DIVISION OF SURVEY AND CERTIFICATION

LETTER - SENT BY FED EXIMPORTANT NOTICE - PLEASE READ CAREFULLY

June 10,2011

Miguel Ortiz-Marroquin, Chief Executive OfficerLAClHarbor - UCLA Medical Center1000West Carson StreetTorrance, CA 90509

Re: CMS Certification Number (CCN): 05-0376(Previously Medicare Provider Number)Dear Mr. Ortiz-Marroquin:This is to inform you that based on a careful review of the findings of an authorized full healthand Life Safety Code (LSC) Medicare surveys, completed on February 17, 2011 (health) andFebruary 18,2011 (LSC) by the California Department of Public Health (CDPH), the Centers forMedicare and Medicaid Services (CMS) has concluded that LAC/Harbor - UCLA MedicalCenter is not in compliance with the applicable Conditions of Participation for a provider ofhospital services in the Medicare program, established by Title XVIII of the Social Security Act.Accordingly, with this notice we are initiating a process, which could result in terminationof the hospital's Medicare provider agreement on or before September 9, 2011, under 42C.F.R. 489.53.

",. As you are aware, to participate in the Medicare program, a hospital must meet the requirementsin 42 U.S.C. 1395x(e) and be in compliance with each of the applicable regulatory Conditionsof Participation for hospitals at 42 C.F.R. Part 482. Indeed, when LAClHarbor - UCLA MedicalCenter entered into a Medicare provider agreement it specifically undertook to comply withFederal statutes and regulations governing Medicare certified hospitals; see section 1861(e) ofthe Social Security Act, 42 U.S.C. 1395x(e); 42C.F.R. Parts 482 and 488.While Federal law provides that hospitals accredited by the Joint Commission (the JC) aredeemed (with certain exceptions not applicable here) to meet all Medicare Conditions ofParticipation for hospitals (see 42 C.F.R. 488.5), such law also provides a mechanism for CMSto validate (by means of a validation survey) this deemed status. 42 C.F.R. 488.7.

Denver Regional Office1600 Broadway, Suite'700Denver, CO 80202

San Francisco Regional Office90 - 7th Street, Suite 5-300 (5W)San Francisco, CA 94103-6707Seattle Regional Office2201 Sixth Avenue, RX-48Seattle, WA 98121


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Page 2 - LAClHarbor - UCLA Medical Center (June 10,2011 Letter)As a result of a complaint validation survey completed by CDPH on October 8, 2009 CMSconcluded that LAC/Harbor - UCLA Medical Center was not in compliance with the requirementsfor participation as a Medicare provider of hospital services. Specifically, the following two (2)Conditions of Participation were not met:

42 C.F.R. 482.2142 C.F.R. 482.26

Quality Assessment and Performance Improvement Program (QAPI)Radiologic Services

By letter dated September 10, 2010, we informed you that as a consequence of the findings of theOctober 8, 2009 survey, LAClHarbor - UCLA Medical Center's deemed status as a hospitalaccredited by the JC was removed.' 42 C.F.R. 488.7(d). This letter enclosed a Statement ofDeficiencies (Form CMS-2567) detailing the survey findings.Subsequently, you submitted a plan for correcting each of the cited violations and further allegedthat the deficiencies detected by the October 8, 2009 complaint validation survey had beenrectified. Based on your representations in this submission, we authorized CDPH to undertake afull Medicare survey to verify that the hospital had in fact come back into compliance with allConditions of Participation, as alleged. These full health and LSC surveys, which were completedon February 17,2011, demonstrated instead that the hospital remains out of compliance with two(2) Conditions of Participation. Specifically you do not comply with the following:

42 C.F.R. 482.42 Infection Control42 C.F.R. 482.51 Surgical Services

The findings of the February 17, 2011 (health survey) and February 18, 2011 (LSC survey) fullsurveys are set forth in the two enclosed Statements of Deficiencies, Form CMS-2567.We have further determined that the deficiencies identified by the February 17,2011 and February18, 2011 surveys substantially limit the hospital's capacity to render adequate care to patients orare of such character as to adversely affect patient health and safety, thus establishing a basisunder 42 C.F.R. 488.26(b) for concluding that the above-referenced Conditions of Participationwere not met. Because LAClHarbor - UCLA Medical Center is not in compliance with allapplicable Conditions of Participation at 42 C.F.R. Part 482, as determined by the February 17,2011 and February 18, 2011 surveys, we must take steps to terminate the hospital's Medicareprovider agreement. 42 C.F.R. 488.24(b), 488.24(c), 488.26(b), 489.53(a)(1) & (3).

1 This action did not affect the hospital's JC accreditation.


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Page 3 - LAClHarbor - UCLA Medical Center (June 10,2011 Letter)Importantly, termination of LAClHarbor - UCLA Medical Center's provider agreement may stillbe avoided if by June 23, 2011 the hospital submits to this San Francisco office and CDPH,Orange County District Office, credible documentation evidencing correction of the citeddeficiencies and that the hospital is otherwise in compliance with all Conditions of Participationapplicable to hospitals participating in the Medicare program, as set forth at 42 C.F.R. Part 482.At a minimum, such submittal must include documentation detailing the actions taken to remedyeach deficiency cited; address improving the processes that led to the deficiency ; describeprocedures for implementing an acceptable plan of correction; and specify a completion date foreach deficiency cited. All plans of correction must take a QAPI approach and addressimprovements in its systems in order to prevent the likelihood of the deficient practice recurring.The plan must also include the monitoring and tracking procedures to ensure the plan of correctionis effective and to prevent recurrence of the deficiency. The plan must include the title of theperson responsible for implementation. This information is to be entered on the right side of FormCMS-2567, opposite the deficiency and must be signed and dated by the administrator or otherauthorized official. Please note that mere plans of future correction or evidence of progresstoward correction will not be sufficient.If we receive such a submittal by the close of business on June 23, 2011 and if we find that thesubmission constitutes a credible allegation of compliance we will notify you of this finding andauthorize a resurvey of the hospital. If such a follow-up survey confirms that LAClHarbor -UCLA Medical Center is in compliance with all Conditions of Participation, the hospital's deemedstatus will be reinstated. Termination may be imposed prior to September 9, 2011 (in accordancewith notice requirements at 42 C.F.R. 489.53(c)) if a credible allegation is not timely receivedby this office, or if an allegation is submitted that we determine to be unacceptable.

In the event termination does occur, there will be no payment for inpatient services rendered toMedicare beneficiaries admitted on or after the effective date. Payment for those beneficiaries inthe hospital prior to the effective date will be limited to thirty (30) days. See 42 C.F.R. 489.55.Application for Readmission Following Involuntary TerminationOnce terminated, LAC/Harbor - UCLA Medical Center may apply for reinstatement. See 42C.F.R. 489.57. However, a new agreement will not be accepted unless CMS determines that thereason for termination of the previous agreement has been removed and that there is "reasonableassurance" that the hospital can maintain compliance with the applicable Conditions ofParticipation. 42 C.F.R. 489.57(a). Compliance will be verified by on-site surveys conducted atthe beginning and end of a reasonable assurance period determined by CMS. This period will be aminimum of 90 days. Prior to issuance of a new provider agreement the hospital also must fulfill,or make satisfactory arrangements to fulfill, all of the statutory and regulatory responsibilities ofits previous agreement. 42 C.F.R. 489.57(b).


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Page 4 - LAClHarbor - UCLA Medical Center (June 10,2011 Letter)Appeal RightsIf you do not agree with this determination, you may request a hearing before an administrativelaw judge of the Department of Health and Human Services, Departmental Appeals Board, inaccordance with 42 C.F.R. Part 498. Such hearing request must be filed in writing no later thansixty (60) days from receipt of this notice.Such a request may be sent directly (accompanied by a copy of this letter) to:

Departmental Appeals BoardCivil Remedies DivisionAttn: Theodore KimCohen Building, Room 0-644330 Independence Avenue, S.W.Washington, D.C. 20201

With a copy of the hearing request to:Steven D. ChickeringWestern Consortium Survey and Certification OfficerDivision of Survey and CertificationCenters for Medicare and Medicaid Services90 - i Street, Suite 5-300 (5W)San Francisco, CA 94103-6707

Your request must identify the specific issues as well as the findings of fact and conclusions oflaw with which you disagree and explain your basis for contending that the findings andconclusions are incorrect. You will have an opportunity to present evidence and further argumentat an in-person hearing, where you may be represented by counsel. Completion of theadministrative review process established by 42 C.F.R. Part 498 is a prerequisite to obtainingjudicial review.We are coordinating this action with the Medicaid State Agency, which will take similar actionunder Title XIX of the Social Security Act.Copies of this notice are being forwarded to the JC, CDPH - Orange County District Office andState Medicaid.


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Page 5 - LAC/Harbor - UCLA Medical Center (June 10, 2011 Letter)Should you have any questions concerning this matter, please contact Patricia Jung at (415) 744-3753 or Alex Garza at (415) 744-2830.

er, anagerNLTC Survey, Certification & Enforcement BranchDivision of Survey and Certification

Enclosures

cc: TheJCCDPH - Orange County District OfficeTitle XIX - CA

Documents

Federal warning letter to Los Angeles County Harbor-UCLA Medical Center 6-10-11