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STATEMENT OF DEACIENCIES AND PLAN OF CORRECTION

(Xl) PROVIOERISUPPUERICUA IDENTIFICATION,NUMBj:R:

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33024-1

STREET ADDRESS, CITY, STATE, ZIP CODE 750 EAST AO~MS STREET SYRACUSE, NY 13210

NAME OF PROVIDER OR SUPPUER

UNIVERSITY HOSPITAL SUN Y HEALTH SCIENCE CI

(X3) DATE SURVEY COMPLETED

(X.4) 10 PREFIX TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL , REGULATORY OR LSC IDENTIFYING INFORMATION)

10 PREFIX TAG

PROVIDER'S PLAN OF CORRECTION . (EACH CORRECTIVE ACTION SHOULD BE CROSS·REFERENCED TO THE APPROPRIATE OEACIENCy)

(XS) COMPLETE CATE

S 000 INITIAL COMMENTS

PFI#0635

OPERATING CERTIFICATE #3301007H

NOTE: THE NEW YORK OFFICIAL COMPILATION OF CODES, RULES AND REGULATIONS .(10NYCRR) DEFICIENCIES BELOW ARE CITED AS A. RESULT OF . COMPLAINT#NY00070525, THE PLAN OF CORRECTION, HOWEVER, MUST RELATE'TO THE CARE OF ALL PATIENTS AND PREVENT SUCH OCCURRENCES IN THE FUTURE, INTENDED COMPLETION DATES AND THE MECHANISM{S) ESTABLISHED TO ASSURE ONGOING COMPLIANCE MU'ST BE INCLUDED,

See Attachmel'1t #11 for the CASE Summaries referenced in'Tag.S393 below,

S 122 405,2 (b) (2) GOVERNING BODY,

Organization and operation. .

(2) The governing body, in order to 'achieve and maintain genenillly accepted stendaros of professtonal practice and patient care services in the hospital, shall establish, cause to impl.ement, maintain and, as necessary, revise its practices, polleles and procedures for the ongoIng evaluation of the services operated or delivered by the hospital and for the identification, assessment and resolution of problems that may develop In the conduct of the hospital.

This Regulation is not met as evidenced by:

Based on findings from document reviews and interviews, 'the Governing Body has failed to ensure patient care is. consistently provided in accordance with generally accepted standards of

sooo

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Office of Health Systems Management J Office of Long Term Care

LABORATORY DIRECTOR'S OR PROVlOERISUPPUER REPRESENTATIVE'S SIGNATURE

TITLE

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STATE FORM Verslon NYS 1111712009 ....

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STREET ADDRESS. CITY. STATE. ZIP CODE 7S0 EAST ADAMS STREET SYRACUSE, NY.13210

STATEMENT OF DeFICIENCIES .AND PLAN OF CORRECTION

(X1) PROVIOERlSUPPLleRlCLlA IDENTIFICATION NUMBER;

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professional practice, and fhat.effeclive

processes are in place to timely identify, address and record physician performance problems and potential infection control concerns in the hospital. The Governing Body has also failed to ensure complete and timely reporting to the Office of Professional Medical Conduct (OPMC) when indicated, and has not provided complete and accurate lnformatlon to hospitals requesting - information during credentiaUng activities for ' medical staff appointments / reappointments, These failures are illustrated In the following occurrences and circumstances:

(X51 COMPLETE OATE

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEF[C[ENCY MUST BE PRECEDEO BY FULL REGULATORY OR LSC [DENnFYING INFORMA1l0N)

S 122 Continued From page 1

• Deficiencies in the Infection Control Department regarding: the risk assessment process it has used todetermine high risk areas in the hospital warranting targeted surveillance, participating in and overseeing all infection control (Ie) survelliance conducted in the hospital, assuring appropriate IC practices in the hospltal, ill.1plementing alilC surveillance planned, and providing annuallC reports that have contributed to ·the hospital's' quality. assurance (QA) ?ctlvities' {See findings in Tags S64,1, S644, S645, S648 and S650);

- Multiple lapses in SUJ:gical Services regarding: performance of a surgical procedure by a neurosurgeon not credentialed to perform the procedure, incomplete History and Physical examinations (H&Ps) for neurosurgical patients, inadequate informed consent documentation relative to vendors in the operating room, failure

[0 PREF[X TAG

PROVIDER'S PLAN OF CORREC1l0N (EACH CORRECTIve ACTION'SHOUUO BE CROSS·REFERENCED TO THE APPROPRIATE DEfiCIENcy)

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STREET ADORESS. CITY. STATE. ZIP CODE 750 EAST ADAMS STREET SYRACUSJ:, NY 1321D

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STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

(X1) PROVlOERISUPPLIERlCliA.

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330241

NAME OF PROViDER OR SUPPLIER

UNIVERSITY HOSPITAL. SUN Y HEAL.TH SCIENCE CI

(X4llb PREFIl'; TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDEm:IFYlNG INFORMATION)

PROVIDER'S PlAN OF CORRECTION [EACH CORRECTIVE AcnON SHOULD BE

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to document a Time Out in every surgical procedure performed, failure to require SUfficient documentation of the use of flash sterilization of instruments and implants in the operating room to enable retrospective tracing, and failure to routinely report Infections of clean surgical cases to the Infection Control Department '(5ee findings in ,Tags S461, 5645,5656,5672,,5673, and S676):

"

- Lapses in credentialing activities regarding

documented evidence that a physician possessed the skills necessary for new privileges granted (See findings in Tag 5267):

- Failures to maintain all required information in physicians' quality assurance files (See findings in Tag 5417);

- Failures to report all occurrences of phYSician misconduct and/or restrictions in physician privileges to OPMC, and to report timely when a report is made (See findings in Tags 5134,5213 and S218);

_ - Failure to provide complete and accurate information to .a hospital that requested information during lts appointment/reappointment process for a physician, who, while on the medical staff at University Hospital, was restricted in his clinical privileges (See findings in Tag S416): and

S 134 405,2 (0) (1) GOVERNING BODY,

Compliance with Federal, State and local laws, ,(1) The hospital shall comply with all applicable Federal, State and local laws, including the New York State Public Health Law, Mental Hygiene law, and the Education Law,

S 134

Office of Health Syslems ManagemBnt I Oftil:e of Long Term Care

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NAME OF PROVIDER OR SUPPLIER

330241

STREET ADDRESS, crrv, STATE, ZIP CODe 75D EAST ADAMS STREET SYRACUSE, NY 13210

UNIVERSITY HOSPITAL SUN Y HEALTH SCIENCE CI

(X4) io PREFIX TAG

SUMMARY STATEMENT OF OEFICIENCIJ;S (J;ACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

S 134 Continued From'page 3

This Regulation is not met as evidenced by:

Based on findings from document reviews and interviews, the hospital has not assured compliance with sections 230 and 2803 of the New York State Public Health Law (PHL). Specifically:

Although Section 230 (11) (a) ofthe PHL requires the chief executive officer (CEO), the chief of the med ical staff and the eIlai rperson of each department in every Article 28 institution to' report to the Board for Professional Medical Conduct any information which reasonably appears to show that a physician is guilty of professional misconduct, as defined in Sections 6530 and 6531 of the New York State Education Law (SEL), in certain instances such information was not reported to OPMC in a timely manner or was

, not reported at all,

Facts and findings include:

-In a 11112/03 letter to all hospital administrators rrom the Commissioner of Health, the administrators were reminded of their legal obligation to report potential cases of professional misconduct by physicians, physician assistants, and residents, as defined in Sections 8530 and 6531 of New York State Education Law (SEL).

-SEL 6530 (32) defines failure " ... to maintain a record for each patient which accurately reflects the evaluation and treatment of the patient.." as professional mlsccnduct.

of Health systems Management I Offi!;ll or Long Term Care

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UNIVERSITY HOSPITAL SUN Y HEALTH SCIENCE C[

STREET ADDRESS. CllY, STATe. ZIP CODE 750 EAST ADAMS STREET SYRACUSE, NY 13210

NAME OF PROVIDER OR SUPPLI ER

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8134

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STREET ADDRESS, CITY, STATE, ZIP CDDE 750 EAST ADAMS STREET SYRACUSE, NY 13210

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL ,REGULATORY OR LSC IDENTIFYING INFORMAllON)

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UNIVERSITY HOSPITALS U NY HEALTH SCIENCE CI

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UNIVERSITY HOSPITAL SUN Y HEALTH SCIENCE CI

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UNIVERSITY HOSPITAL SUN Y HEALTH SCIENC~ CI

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5134 Continued From page 12

51

The hospital shall be managed effectively and efficiently in accordance with hospital bylaws and policies and procedures. The daily management and operational affairs ofthe hospital shall be the responsibility of the chief executive officer.

This Regulation is not met as evidenced by:

Based on findings from document reviews and interviews, the hospltal CEOs have not effectively managed the operational affairs of the hospital, See the numerous violations of regulations in this document pertainfngto lapses in the hospltal's Medical Staff services, SUrgical ~ .. rui, ... ",

Systems Mallagement I OffiCII or Long Term Care

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S 172 C0!1tinued.From peg'e 13

Infection Control Department and Quality Assurance Program. Also see the citations at Tags 8134 and S2.13 regarding failures to report to OPMC.

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL ,REGULATORY OR lSC IDENTIFYING INFORMATION)

S 213 405.3 (e) (1) ADMINISTRATION.

Other reporting requirements.

(1.) The hospital shalt report in writing to the Office of Professional Medical Conduct with a copy to the appropriate area administrator of the department's Office of Health Systems Management within 30 days of the occurrence of denial, suspension, restriction, termination or curtailment of training, employment, association or professional privileges or the denial of certification of completion of training of any physician, registered physician's assistant or registered specialist's assistant licensed/registered by the New York State Department of Education.

This Regulation is not met as, evidenced by:

Based on findings from document reviews and interviews, the hospltal fias not reported

8172

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s

405.3 (e) (1) (~v) ADMINlSTRATlON.

Other reporting requirements.

(1) The hospital shall report In writing to the Office of Professional Medical Conduct with, a copy to the appropriate area administrator of the department's Office of Health Systems Management within 30 days ofthe occurrence of denial, suspension, restriction, terminanon or curtailment of training, employment, association or professional privi leges or the denial of certification of comp lstlon of training of any physician, registered physician's assistant or registered' specialist's as~istant licensed/registered by the New York State . Department of Education for reasons related in any way to any of the following:

(iv) the hospital shail establish policies and . implement procedures to ensure compliance witli these reporting requirements.

This Regulation is not met a!> evidenced by:

Based on findings from document reviews, the hospital's written procedures (contained 'in the

Medical Staff OPMC

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Section 3: Precautionary Measure

1. tn the event that an adverse professional review action against a praclitioner's privileges has not yet been determined to be necessary but there is concern for patient care, a precautionary measure maybe issued. The precautionary measure temporarily prevents the' physician from exercising some or all clinical privileges. The purpose of imposing Ihis precautionary measure' is to permit fiict-finding andlor clinical review of the practlfcner'sperfcrmance to ensure quality of patient care ...

2. The precautionary measure is not deemed a final professional review action but is an interim step in a pro(essional review activity: Since it is not adverse professional review action, the precautionary measure is not itself reportable to

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S 218 Continued From page 16

reporting requirements do not ensure compliance with all reporting requirements outlined in 405.3 (e) (I)-(Hi), as well as those outlined in section 230 of the PHL and, by reference, in section 6530 of the SEL.

Facts and findings Iriclude:

- Regulation 405.3 (el (I) indicates that-any type of restriction, denial or tennination of a licensed/registered physician's privileges (or those of a physician assistant or specialist assistant), for reasons related in any way to alleged incompetence, malpractice, misconduct . or endangerment of patient safety or welfare, is reportable to OPMC within 30 days olthe

occurrence.

- However, per review of the hospital Medical Staff Bylaws, last revised 5119/09, pages 3 and 4 under Article XV in the document contain the followirig language:

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS.REFERENCED TO lHEAPPROPRlATE OEFlCIENCy)

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STATEMENT OF DEFICIENCIES AND PlAN OF CORRECTION

(Xl] PROVlDERlSUPPLlERtCLIA IDENTIFICATION NUM9ER:

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NAME OF PROVIDER· OR SUPPLIER

UNIVERSITY HOSPITAL SUN Y HEALTH SCIENCE C!

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(8) Being a habitual abuser of alcohol. or being dependent on or a habitual user of narcotics. barbiturates, amphetamines, hallucinogens, or . other drugs having similar effects, except for a licensee who is maintained on an approved therapeutic regimen which does not impair the.

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SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION]

S218 Continued From page 17

tile National Practitioner Data Bank or to the Office of Professional Medical Conduct...

3. This is intended to be a temporary "time-auf' and should not be imposed longer than 30 days except under unusual circumstances.

This bylaw provision inappropriately indicates that under certain Circumstances, a restriction in a physician's professional privileges is not reportable to OPMC. Further, the earlier findings in Tag 8134 illustrate examples of use ofthe precautionary measure intervenlion even when problems in the physician's provision of patient care were already clearly established.

- Se_ctlon 230 (11 )fa) of the PHL contains the following language: " .•. the chief executive officer, the chief of the medical staff and the chairperson of each department of every institution which is established pursuant to article twenty-eight of this chapter ... shall ... report to the board (OPMC) any infollTlation ... which reasonably appears to show a licensee is guilty of professional misconduct as defined in sections sixty-five. hundred thirty (6530) and sIxty-five hundred thirty-one (6531) of the education law (SEL~."

- Section 6530 of the SEL includes the following definitions of professional misconduct:

(7) Practicing the profession while Impaired by alcohol, drugs. phyalcal disability, or mental disability; and

PROVIOER'S PLAN OF CORRECTION lEACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED.O THE.APPROPRJATE DEFICIENCy)

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These bylaw provisions inaccurately indicate that . physicians (including residents), physician assistants and specialist assistants who have an impainnent need not-be reported to OPMC.

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICI ENCV MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

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ability to practice, or having a psychiatric condition which impairs the licensee's ability to practice.

- Additionally, in a·11/12/03 letter to all hospital administrators from the Commissioner of Health, the administrators were reminded of their legal obligation to report to OPMC potentjal cases of , professional misconduct by physicians, physician assistants and ~sidents, as defined in Sections 6530 and 6531 of New York State Education Law (SEL). The CommissIoner stated "The obligation 'toreport is not discretionary, it is the law.~'

- However, in non-compliance with the OPMC rep.orting requirements oullined above, the hospital Medical Staff Bylaws, last revised 5/19/09, contain the following statement (on page 2 of "Addendum B: Medical Staff Health Policy"):

"This policy is intended not only to address those professionals known or believed to be impaired, but also to provide a mechanism for early intervention before the impainnent affects patient care and requires reporting to the Office of ProfesSional Medical CondUct ('OPMC')."

Also, pageA of Addendum B contains language indicating that the results of a preliminary investigation may fead the Medical Executive Committee to conclude "2). The professional has an impairment \hat may affect his or her practice, which must be addressed, but which does not reasonably appear to have r~ulted in reportable

misconduct." .

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'STATEMENT OF DEFICIENCIES AND Pl.MII OF CORRECTION

~1l PRO~DeRfflUPPUE~UA IDENTIFICATION NUMBER:

~) MULTlPlE CONSTRUCTION

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B. WlNG _

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330241

NAME OF PRO~DER OR SUPPLIER

UNIVERSITY HOSPITAL SUN Y HEAl. TH SCIENCE CI

~3' DATE SURVEY COMPLETED

(X4) 10 PREFIX TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMf,TlONj

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(X5] COMPlETE DATE;.

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Further, findings in Tag S134 illustrate examples of use of this provision to elect not to report impaired physicians to OPMC pursuant to SEL 6530, m and/or (6).

- Additionally, page 4' of Addendum B contains a statement which indicates that a suspension of priVileges is only 'reportable to OPMC when it lasts more than 30 days.

This infonnation in the bylaws addendum is also inaccurate. As noted at 405,3 (e), a hospital is required to report suspension of a practitioners privileges within 30 days of the occurrence. The regulation does not address an amount of time the suspension must have been in effect prior to

obligation to report. .

,

S 267 405.4'(b) (5) MEDICAL STAFF. OrganizatIon"

(5) Medical staff appointments, and , re-appolntments shall be made in accordance with the privilege review procedures of the hospital's quality assurance committee, as contained In section 405.6 of this Part

This Regulation is not met as evidenced by:

Based on findings from document reviews and interviews, in 1 of 5 physician credentials files reviewed regarding the hospital's recredentialirig process, the file 'lacks documentation indicating

the (MS) verifjedlffm~[~r:ililml~

(PI ' "., ~~. . the skills necessary to

pc, ''''t'', , thl "1 t th rt'",..".."".m:,~=r."'Th

gran ,Ing s new pnvi ege 0 eti!~l'¥"~)\{;~f~~11i'

.Findings include:

- Per revIew of the hospital's '''Medical Staff Bylaws," last revised 3/06/01; under Article III,

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STRJ;1ETADDRESS. CITY. STATE. ZIP CODE 750 EAST ADAMS STREET SYRACUSE,NY 132111

!>lAME OF PROVIDER OR SUPPliER

UNIVERSITY HOSPITAL SUN Y HEALTH SCIENCECI

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FUll REGULATORY OR LSC IDENTIFYING INFORMATION)

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S 267 Continued From page 20

Section 2: Reappointment, it states " ... The Chief of Service shall provide information in writing relative to evaluation of the individual's professional performance, judgment and where appropriate, technical skills ... The Credentials Committee shall review the documents and make appropriate recommendations for reappointment." (It was verified through interview that the terms Chief of Service and Department Chairperson are interchangeable.)

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330241

NAME OF PROVIDER OR SUPPLIER

UNIVERSITY HOSPITALS U NY HEALTH SCIENCE Cl

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.r :

s

The governing body shall establish and maintain a coordinated quality assurance program which integrates the review activities of all hospital services to enhance the quality of patient care and Identify and prevent medical, dental and

podiatric malpractice, .

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NAME OF PROVIDER OR SUPPUER

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S

405.6 (a) (2) (I) QUALITY ASSURANCE PROGRAM.

The quality assurance committee shall:

(2) administer the hospital quality assurance program to assure:

(i) the identification of actual or potentia! problems concerning patient care and clinical performance.

of Health Systams Managllment I Office gf Long Tenn Care

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UNIVERSITY HOSPITALS U NY HEALTH SCIENCE ct

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SUMMARY STATE,.,ENT OF DEFICIENCIES (I;ACH DEFICIENCY MUST BE PRECEDED BY FU~l REGULATORY OR LSC IDENTIFYING INFORMATION)

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S 41 405.6 (b)(7)(iv) QUALITY ASSURANCE PROGRAM. Activities.

The activities of the quality assurance committee shall involve all patient care services and shall include, as a minimum:

(7) the committee shall oversee .and coordinate the following:

(iv) The provision by the hospital, within 45 days, in response to requests from any other hospitai or facility performing credentials review for medical staff appolnfment or reappointment, of information related to the physician'S, dentist's or podiatrist's professional practice within the facility for at least ten years,.

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S41 405.6 (b) (7) (v) QUALITY ASSURANCE PROGRAM. ~ctivities.

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S 417 Continued F~om page 34

The activities of the quality assurance committee shall involve all patient care services-and shall include, as a mrnlmum:

(7) the committee shall oversee and coordinate the following:

. (v) the maintenance of a file on each physician, dentist and podiatrist granted privileges or otherwise associated with the hospital which shall contain the information collected pursuant to subparagraphs (i) through (iii) of this paragraph, to be updated at least on a biennial basis, and all other relevant Information' gathered in accordance with the hospital's quality assurance program and as required by this section .

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SUMMARY STATEMENT OF DEFICIENCIES (EACH DEfICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENcy) .

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. S 417 Continued From page 35.

S 46 405.7 (b) (17) PATIENTS' RIGHTS.

Hospital Responsibilities.

TlJe hospital shail afford to each patient the right to:

(17) the identity of any hospital 'personnel including students that the hospital has . authorized to participate !n the patient's treatment and the right to refuse treatment, examination and/or observation by any personnel.

This Regulation is not met as evidenced by:

Based on findings from document reviews and interview, 12 of 16 MRs reviewed lacked evidence the informed consent precess was complete. Specifically, although each MR contained an intraoperative report indicating a vendor had been present during the patients surgical procedure, the vendor was not listed on the informed consent form signed by the patient prior to the procedure.

Findings include:

-Per review ofthepatients' MRs (Patients H through S), a Clinical Documentation form in each MR (containing documentation of intraoperative. activities) listed the name of a vendor that was in attendance during the patient's operative' procedure:

S417

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NYSDOH Contractor

STREET ADDRESS. crrv, STATE, zip CODE 750 EAST ADAMS STREET SYRACU~E, NY 13210

PRINTED; lJ6/171201 0 FORM APPROVED

STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

(Xt) PROVIDERISUpPLIERlClIA IOE~_TlFICATION NUMBER:

(X2) MULTIPLE CONSTRUCTION ABUILDING

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(X3, DATE SURVEY COMPLETED

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330241

NAME OF PROVIDER OR SUPPUER

UNIVERSITY HOSPITALS UN Y HEALTH SCIENCECI

[X4) 10 PREFIX TAG

SUMMARY STATEMENT OF DEFICIENCISS (EACH DEfiCIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

PROVIDER'S PlAN OF CORRECTION' (EACH CORRECTIVE ACTION SHOULD BE CROSS·REFEREroICED TO THE APPRO PRIATE DEFICIENCy)

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S 461 ·Continued From page.36

form in each of the above patients' MRs,it . . includes the following statements:

"I consent to the presence of additional non-hospital staff during my surgery as directed by my attending surgeon or anesthesiologist. This may include manufacturers or technicians ... List below all Non University hospital personnel

. present in the ORIProCedure Room at the time of surgery/procedure. Inform the patient Ipatient representative about their presence."

However. all 12 consent forms In the MRs of Patients H through Slacked the name and title of the vendor who was documented 'as present during the operative procedure, on each patient's corresponding Clinical Documentation form.

-Per intervieW of the Patient Services Supervisor, OR (PSS), on 6/04/09 the findings above were verified.

S 641 405.11 INFECTION CONTROL.

The hospital shall provide a sanitary environment to avoid sources and transmission of nosocomial Infections and of communicable diseases which may lead to morbidity ormorta[ity in patients and .hospital personnel. The hospital shall establish an effective infection control program for the prevention, control, investigation and reporting of all communicable disease and increased incidence of infections, including nosocomial inrections; consistent with current acceptable . 'standards of p.rofessional practice. The hospital-wide infection control program shall be reviewed as frequently as necessary b).lt not less than once per year, and updated as necessary to promote 'optimal effectiveness,

,

8461

$641

Office of Hoalth'Sys)ems Management I orrICO of long Term Care

STATE-FORM Verslon NYS 11/17/2009

QONB1t

If conUnuaHon shee1 370159

NYSDOH Contractor

STREET ADDRESS. CITY. STATE. ZIP CODE 750 EAST ADAMS STREET SYRAPUSE, NY 13210

PRINTED: 06117/2010 FORM APPROVED

STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

(X1) PROVlOERlSUPPUER/CLIA IDENTIFICATION NUMBER:

(X3) DATE SURVEY COMPLETED

(X2) MUL.:TIPlE CONSTRUCTION A. BUILDING

B.WlNG _

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330241

NAME OF PRoVi DER OR SUPPLIER

UNIVERSITY HOSPITAL SUN Y HEALTH SCIENCE CI .

(X4) 10 PREFIX TAG

SUMMAR,Y STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORV OR LSC IDENTIFYING I~FORMA"ONJ

10 PREFIX TAG

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-RE;FERENCEO TO THE APPROPRIATE DEFICIENCy)

(X5) COMPLETE OATE

, S 641 Continued From page 37

This Regulation is not met as evidenced by:

Based on findings from document reviews and intervlews, the hospltal's infection control program, i.e., its Infection Control Committee (ICC), did not organize and did not implement its surveillance activities in a manner that was consistent with current acceptable standards of pmfesslorial praeflee and that assured effective prevention, control. investigation and reporting of increased incidences of infection. Specifically,

" A) The surveillance plans the ICC developed for, , 2007, 2008 and 2009 (st1ll in draft form as of , 6/1/09) were incomplete, based only on requirements in the OqH's Hospital Acquired Infections Reporting Program and the hospital's accrediting organization's standards, and not also based on a meaningful annual risk assessment As a result, the ICC was net collecting all data necessary to identify problems warranting its attention. Further, the surveillance plans did not establish benchmarks/thresholds for infection

'. control pertormance (See findiogs further below); ,

B) The ICC did not provide guidance to the MS departments in the general surveillance and

mo n itoring of infections, did not provide adequate oversight when these departments identified, ' problems with infections, and did not assure appropriate followup of problems identified (See findings further below);

C) The ICC's survetllance plans for 2007, 2008 and 2009 (still in draft form as of 6/1109) were not completely Implemented (See.findings in Tag 644);

0) The report of the ICC's annual evaluations in 2007 and 2008 did not demonstrate the ICC adequately analyzed data, it had collected in order

Office of Health Systems Management f Offiee of Long Term Care

STATE FORM VersIon NYS 11/1712009

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STATEMeNT OF DEFICIENCIES AND PlAN OF CORRECTION

(XI) PRDVIDERISUPPUeRlCUA IDENTIFICATION NUMBER:

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330241

NAME OF PROVIDER OR SUPPUER

UNlVERSITY HOSPITAL SUN Y HEALTH SCIENCE CI

(X4) 10 PREFIX TAG

Findings regarding (Al above include:

10 PREFIX TAG

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCy)

~ COMPlETE DATE

SUMMARY STATEMENT OF DEFICIENCies (EACH DeFICIENCY MUST BE PRECEDED BY FUll REGULATORV OR LSC IDENTIFYlNG INFORMATION]

S 641 Continued Fro'm page 38

. to identifY increased incidences of nosocomia 1 infections in various service departments of·the hosp!tal (See findings in Tag 644); and

E) The ICC did not requiring the hospital's Surgical Services to report infections of clean s.ur:gical cases (See findings in Tag ·676)

responsible for the "Surveillance and analysis of hospital acquired infections to detect and manage outbreaks and possible sources of infections as directed by the Hospital EpIdemiologist and the Infection Control . Committee,"

-It is generally accepted practice for hospital Infection control programs to utilize a targeted surveillance methodology that is based on findings from an annual. risk assessment.

However, this hospital's annual risk assessment activities did not include analyses of historical data; concerning rates ofvarlous types of infections (e.g" multiple drug resistant organisms, device related infections) and important infection control inteNentions (e.g., hand hygiene, isolation precautions), which were necessary for identifying pa rticular areas of increased risk.

Specifically:

-Per review of the hospital's "Infection Control Risk Plan" for years 2007, 200B and 2009 (draft),

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STATEMENT OF DEFICIENCIES AND PlAN OF CORRECTION

(X1) PROVlDERISUPPLIERICUA IDENTIFICATION NUMBER:

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UNIVERSITY HOSPLTALS UN Y HEALTH SCIENCe CI

(X4)ID PREFIX TAG

-Also, the fact the hospital's tcc'was not· reqUiring the hospital's Surgical Services to report infections of clean surgical cases to its infeelion control officer (see findings in Tag 676) further illustrated the ICC's inadequate surveillance

10

, PREFIX T~G

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIve ACTION SHOULD BE CRoSS·REFERENCED TO THE APPROPRIATE DEFICI ENCYj .

jXS) COMPLETE CATE

SUMMARY STATEMENT OF DEF.ICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

8641 Continued From page 39

each lacked information indicating comparisons were made between current and past rates of device related and surgical site infections, and rates of compliance with varlous infection control interventions, to identify and prioritize areas of risk warranting targeted surveillance i~ the next year. Also, the risk (surveillance) plans for 2007, 2008 and 2009 remained nearly the same each year, further illustrating the fact that annual risk assessments did not forin the basis far targeted surveil lance activities at this hospital.

-Additionally, the hospital's targeted surveiilan~ was based only on requirements set forth in NYS . Public Health Law (PHL) and in its accrediting organization's infection control standards.

For example, per review of the hospital's "Infeclion Control Risk Plan" for years 2007 - 2009, surgical site infection surveillance was targeted to only those procedures required by PHL to be reported to the DOH in the Hospital Acquired infection Reporting Program (i.e., colon surgeries, coronary artery bypass surgeries, and additionally, in 2008, hip replacement surgeries).

Per generally accepted infection control practices, targeted surveillance should periodically include infections in other surgical sites as well. Without periodic collection of data conceming infections in other surgical sites, baseline infection rates cannot be established and compared at various times to identify new areas of risk warranting targeted attention.

S 641

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UNIVERSITY HOSPITALS U N Y HEALTH SC1EN~E CI

(X") 10 PREFIX TAG •

SUMMARY STATEMENT OF OEFlCIEN CIES (IOACH OEFICIENCY MUST BE PRECEDED BY FULL" REGULATORY OR LSC IDENllFYING INfORMATlO~)"

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• PROVIDER'S PlAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFlqIENCy)

(X5) COMPlETE OATE

S 641 Continued From page 40

attention to su rgical sites other than those addressed in PHL."

- Additionally, per review of the "Infeclion Control Risk Pian" for years 2007, 2008 and 2009 (draft), the Infection Control Committee did not document benchmarks I thresholds (using internal and/or national dala) for the infections" and infec1ion control interventions it was monitOring. Lack of benchmarks hampers meaningful evaluations of performanCe and identification of high risk areas warranting targeted surveillance."

Findings regarding (6) above include:

- Per interview with Infection Control Professional (IC?) #1 on 6/1/09, the process for identifying infections was via daily review of positive cultures from the lab, which then went to the Infectious Disease Consultant who determined what activities to pursue. The various Medical Staff (MS) services in th"e hospItal (e.g., orthopedics, neurosurgery) were expe~ed to "monitor their own infection rates. In response to specific questions! ICP #1 indicated that the various.MS services used CDC cntena'to define infections, but also acknowledged "it has not been the standard for the criteria 10 be reviewed and approved" by the ICC.

When asked if the MS services share their infection control data/information with tlJe ICC, ICP #1 indicated It "should be" reported to Infection Conlro1. However, information contained in multIple documents reviewed during the DOH investigation (e.g., the ICC's meeting minutes. and annual evaluation reports) lacked any references to infection control data that was

S 641

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SiATEMENTOF DEFICIENCIES AND PlAN OF CORRECTION

(X1) PROVIDERISUPPLIERICLIA IDENTIFICATION NUMBER:

STREET ADDRESS, CITY, SlAiE, ZIP CODE 750 EAST ADAMS STREET SYRACUSE, NY 13210

NAME OF PROVIDER OR SUPPLIER

UNIVERSITY HOSPITAL SUN Y HEAL Tli SCIENCE CI

(X4)ID PREFIX iAG

SUMMARY SlATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST Be PRECEDED BY FULl. REGULATORY OR LSC lDeNTlFYlN G INFORMATION]

5641 Continued From page 41

collected by the MS services and shared with the ICC.

(X2) MUl.TIPLE CONSiRUCTION A. BUILDING

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STIREET ADDRESS, CIlY, STATE, ZIP CODE 750 EAST ADAMS STREET SYRACUSE, NY 13210

NAME OF PROVIDER OR SUPPUER

UNIVERSITY HOSPITAL SUN Y HEALTH SCIENCE CI

SUMMARY STATEMENT OF DEFICIENCIES (~H DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR lSC IDENTIFYING INFORMATION)

(X4) 10 PREFIX TAG

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(Xt) PROVIDERISUPPUERJClIA IDENTIFICATION NU.MBER:

STREET ADDRESS, CITY, STATE, ZIP CODE 750 EAST ADAMS' STREET SYRACUSE, NY 13210

330241

NAME OF PROVIDER OR SUPPLIER

UNIVERSITY HOSPITAL S u N Y HEALTH SCIENCE CI

(X3) DATE SURVEY COMPLETED

C

SU MMARY STATEMENT OF DEFICIENCIES (EACH DefiCIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMAnON)

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s

405.11 (b) (1) INFECTION CONTROL.

Nosocomial surveillance, prevention and control. The hospital-wide infe~on control program shall include processes deslgned to reduce the risk of endemic and epidemic nosocomial infections and communicable, diseases in patients and hospital personnel. Such processes shall include methods to:

(1) collect and analyze surveillance data. including case findings and identincation of epidemiologically important nosoComial infections and communicable disease.

This Regulation. is not met as evidenced by:

Basep on findings from document reviews and interviews, (A) despite information in the ICC's surveillance plans. for 2007,2008 and 2009

(draft) indicating it would collect and analyze surveillance data concerning hand hygiene and hand hygiene product usage, these plans were not completely implemented. Also, (B) the report of the ICC's annual evaluations in 2007 and 2008 did not demonstrate,the ICC adequately analyzed data it had colleetedln order to identify increased incidences of nosocomial infections in various service departments of the, hospital.

Findings regarding (A) above lnclude:

10 PREFIX TAG

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33D2,U

(X2) MULTIPLE CONSTR\JCTlON

A. BUILDING

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NAME OF PROVIDER OR SUPPLIER

UN~RSITY HOSPITAL SUN Y HEALTH ~CIENCE CI

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SUMMARY STATEMENT OF DEFICIENCIES lEACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR, LSC IDENTIFYING INFORMATION)

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PROVIDER'S PLAN OF CORRECTION [EACH CORRECTIVE ACTlON SHOULD BE CROSS·REFERENCED TO THE APPROPRIATE DEFICIENCy)

(X5) COMPLETE OATE

S 644 Continued From page 44

2009 but pending approval on 6/5/09,and having Identical language), it indicated that evaluation strategies for Drug Resistance Organism Surveillance (MRSA, VRE, C-difficile, and ESBL) would lnclude: review hand hygiene audit data, review resistant rates, track hand hygiene product usage, and monthly review at ICC.

However, per review of the monthly ICC meeting minutes from 4/20108 to 4/17/09, there is no documentation indicating this "monthly 'review at ICC· occurred,

S644

l'HL § 2805·in

observations were currently included in _Iy safety rounds conducted in the hospital~s~b acknowledged there is no documentation of the findings of the hand hygiene, obserVations (to provide a means to track progress or lack thereof in this Important infection control intervention).

FIndings regar(jing (8) above include:

- Per review of the hospital's Infection Control Annual Evaluation report for 2008, it did not include information indicating whether the infection numbers/rates provided represented increases or decreases in the numbers/rates compared to the previous year. For example, regarding central line blood stream infections (CLBSI), numbers of infections were reported for the hospital's various intensive care units for the

past year'(2008); however,information ';

of Haalth Systems Management 1 Office of Lana Term Care

STATE FORM Ve .... !an NYS 11/t7/2009

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STREET ADDRESS, CllY, STATE. ZIP CODE 760 EAST ADAMS STREET SYRACUSE, NY 13210

PRINTED: 06/17/2010 FORM APPROVED

STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

(XlI PROVIDER/SUPPUERlCLIA IDENTIFICATION NUMBER:

(X2) MUL TII~LE CONSTRUCTION A. BUILDING

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UNIVERSITY HOSPITAL SUN Y HEALTH SCIENCE CI .

(X3) DATE SURVEY COMPLETED

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SUMMARY STATEMENT OF DEI'ICIENCII,S (EACH DEFICIEN"CY MUSTBE PRECEDED BY FUlL REGULATO~Y OR LSC IDENTIFYING INFORMATION)

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S 644 Continued From page 45

discussing whether these numbers represented increases or decreases from the year previous was lacking.

further, in this annual evaluatlon report. MRSA rates were reported for the entire hospital, not for individual units in the hospital. This manner of reporting the rates didn't allow for discussion of problem areas in the hospital. While an increased rate in MRSA was reported for the hospital in the third quarter of2008, the report lacked an analysis of the cause of 1he Increased rate.

S 645 405.11 (b) (2) INFECTION CONTROL .

. Nosocomial surveillance, prevention and control. :The hospital-wide infection control program shall include processes designed to reduce the risk of endemic and epidemic nosocomial infections and communicable diseases in patients and hospital personnel. Such processes shall include methods

to: .

(2) prevent or reduce the risk of nosocomial infections.

This Regulation is not met as evidenced by:

Based on findings from document reviews and interviews, relative to the hospital's Surgical Services, excessive use of flash sterilization identified in April 2006 was not adequately addressed. Also, when flash sterilization of implants occurred, documentation of flash sterilizations of implants and instruments was not complete (to assure retrospective tracing of the specific device to the patient involved). Further, the hospital policy requirements in this matter were lneomplete. .

Findings include;

S644

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(X1) PROVIDERlSUPPUERlCUA IDENTlFlCATION NUMBER:

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,

750 EAST ADAMS STREET SYRACUSE, NY 13210

(X3) DATE SURVEY COMPLETED

STREET ADDRESS, CITY. STATS, ZIP CODE

NAME OF PROVIDER OR SUPPLIER

UNIVERSITY HOSPITAL SUN Y HEALTH SCIENCE CI

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SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDEO BY FULL REGULATORY OR LSC IDENTIFYING I NFORMATloN)

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S 645 Continued From page 46

• - Per review of the "Opi:mitive Services Planning Committee Minutes," dated 4f18/06, the minutes contained the statement "Flashing instruments has been a standard practice; the need is known to purchase more instruments in addition to space." The "Operative Services Planning Commiltee Minutes," dated 6/13/06, contained the statement "Established an instrumentation list that we believe will help ass1stin efficiency as it relates to the 'flash' discussion."

However, per revieW of the monthly "Operative Serv1ces Planning Committee Minutes," dated 7118106 and forWard through 5111/09, there was no further mention of the flash sterilization issues, or evidence of ongoing monitoring or analysis of flash sterilization use ..

-Per intervie:w of the Deputy Dire~: _ _

Perioperative Services on 8/13/09,~il!lilted monitoring of-flash sterilization use was just being - implemented (i.e., it was not currently being

done).

-Additionally, per review of the bi-monthly "Infection Control Committee Meeting Minutes" from 8/4/06 forward through 4/17/09, they also lacked mention of any monitoring a r analysis of flash sterilization use.

- During interview with the Patient Services Manager, Neuro/ENT Services, when asked about flash sterilization of instruments and implants, the response was "Instruments are rarely flashed and implants are not supposed to be flashed." Also, during intelViewwith the Manager of Central,Sterile Supply (MeSS) on Sf1I09, When asked the same question, the response was "No, we do not flash. implants."

S645

OffICe of Health Systems Managcmcntl Ol!iee of Long Tenn Care .

STATE FORM . VersiDn NVS 11/1712009

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FUI:ther, per th'e above noted 613{09 review of the Surgical Services' flash sterilization. documentation, for each item flash sterilfzed, documentation describing the device sterilized, the patient involved and the reason for the flash sterilization, was lacking.

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S 645 . Continued Fro.m page 47

However;

-While onsite on 6{01/09, DOH staff requested access to review the surgical services flaSh sterilization logs. Nine large boxes were

delivered to the conference room. On 6103109, a . box and then an envelope in that box were randomly selected - a mechanical printout in the envelope was then reviewed. II was dated 7/1/08 and contained the handwritten word "implants" on it. When the MCSS wawed who the flashed implants were used on,~CIn~ble to tell who the patient was but indicate~alti be able to go to the 0 R database for that date and time to find the surgeries being perfonned and correlate the data to fin d the patient who~ the implants flash sterilized, 'i!!!!!!Wer, wherBIt~eRb went to the OR database~1lI only find documentation indicating the patient involved, not the specific qevice{s) flash sterilized.

- Per review of the "Sterile Processing Manual, . Policy Number: SP S-02'(CM S-15), "last' reviewed 2117/06, it contained 2 sections that addressed flash steriliZation (Steam Sterilization and Flash Sterilization). Regarding flash sterilization specifically, the policy lnstru cted staff . to "sign name on the mechanical printout for verifying parameters" but did not address ''tracking''. documentation requirements regarding the device processed, the patient on whom the item was being used or the reason for tlie flash sterilization.

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UNIVERSI_TY HOSPITAL SUN Y HEALTH SCIENCE CI

s

Tl"lis Regulation Is not met as evidenced by; Based on findings from document reviews. information provided to the University Hospital Governijnce Quality Council & Patient Safety

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

S 645 Contin·ued From page 48.

Per generally accepted practices in flash sterilization, documentation should be recorded and maintained for any item that has been flash sterilized to assure it can be traced to the sterilizer and the patient in an event of a

biological test failure. .

405.11 (d) INFECTION CONTROL.

Integration with the quality assurance program. The professional respo.nsible for the hospital-wide infection control program shall ensure that all . hospital in·fection control activities are integrated with the quality assurance program required by section 405.6 of this Part, including identification, assessment and correction of problems related to infection and communicable disease control.

S645

S 648

10 PREFIX TAG

PROVIDER'S PlAN OF CORRECTION (EACH· CORRECTIVE ACTION SHOULD BECROSS--REFERENCED TO THE APPROPRIATE

DEFICIENCY) •

QDNB11

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STATEMENT OF OEFICIENCIES AND PLAN OF CORRECTION

(Xi) PROVIDERISUPPUERICLIA IDENTlF'lCATlON NUMBER:

STREET ADDRESS. CITY. STATE, ZIP CODE 750 EAST ADAMS STREET SYRACUSE, NY 1~210

330241

NAME OF PROVIDER OR SUPPLIER

UNIVERSITY HOSPITAL SUN Y HEALTH SCIENCE CI

(X4) 10 PREFIX TAG

SUMMARY STATEMENt OF DEFICIENCIES (EACH OEFICIENCY MUST 8E PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

S 648 Continued From page 49 '

- Per review of the. hospital's Infection Control Annual Evaluation reports for 2007 and 2008, they did not include information indicating whether the infection numbers/rates provided represented increases or decreases in the numbers/rates compared to the previous year. Also, themanner of reporting the rates didn't allow for discussion 9f problem areas in the hospital. See the findings in Tag S644.

s

Corrective action plans. The hospital shall be responsible for the implemel]tation of acceptable corrective action plans related to infection control and result1ng from problems identified through quality assurance or regulatory oversight activities, and the professional responsible for the hospital-wide infection Control program shall

report to the chief executive officer progress in correcting identifi~d problems.

5648

$650

(Xl) MULTIPLE CONSTRUCTION A. BUILOING

B.~NG ___

(X5) COIoiFLETE PAn;

of Health Sys!ems Management / OffIce of Long Term

STATE FORM Version NYS 11/1712009

(X3j DATE SURVEY COMPLETED

C

10 PREFIX TAG

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REfERENCED TO THE APPROPRIATE DEFICIENCY)

aONB11.

~continuati.n sheet 5D 0159

NYSDOH Contractor

STREET ADDRESS, CITY, STATE, ZIP CODE 150 EAST ADAMS STREET " SYRACUSE, NY 13210

PRINTED: 06/17/2010 FORM APPROVED

STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

(Xl) PROVlDERlSUPPLIERIC LlA IDENTIFICATION NUMBER:

(X2) MULTIPlE CONSTRUCTION

A. BUiLDING

B. WlNG ------

(X3) DATE SURVEY COMPLETED

C 05/1812010

3302-41

NAME OF PROVIDER OR SUPPLIER

UNIVERSITY HOSPITAL SUN Y HEALTH SCIENCE CI

[X4] 10 PREFIX TAG

. SUMMARY STATEMENT OF DE:F1CIENCIES (EACH DEFICJENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC JDE:NTlFYING INFORMATION]

10 PREFIX TAG

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTNE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCy)

(X5) COtolPLETE DATE

$ 556 Continued From page 50 .

S 656 405.12 SURGICAL SERVICES,

If surgery is provided, the service sha II be provlded in: a manner which protects the health and safety of the patients in accordance with generally accepted standards of medical practice.

This Regulation is not met as evidenced by:

Based on findings from document reviews and interviews, the hospital's surgical services are not conslstanfly provided in a manner that assures protection of -the health, safety and rights of the pat1ents, in accordancewnh generally accepted standards of medical practice. Specifically:

(A) In one instance a surgical procedure was completed by a resident under the supervision of a physician not qualified to perform the procedure (See findings further below);

(8) In another Instance the required time out process for verifying the correct site in a surgical procedure was not documented, despite the hospital's history of having twice signed a Stipulation and Order with the DOH for occurrerices of wrong site surgical procedures (See findings further.beloW);

(C) Signed informed consentforms in pati~nts' MRs lack evidence the patients were informed a vendor would be present in the operating room during their surgical procedure (See findings in Tag 8461); and

(D) The Surgical Services has not routinely reported infections of clean surgical cases to the ICC (See findings in Tag 5676).

Findings pertaining to (A) above include:

5656

$656

Office of HeaHh Sy$tems Mana9~ment I Olfi<:e of Lon" Tenn Care

STATE FORM' Version NYS 11/17/2009

QONB11

II conUl'l\JatiOJl sheel Sf of 59

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STATEMENT OF DEFICIENCIE'S AND PLAN OF CORRECTION

STREET ADDRESS. CITY. STATE, ZlP CODE 750 EAST ADAMS STREEi SYRACUSE, NY ,13210 '

(Xi) PROVIDERlSUPPUERfCUA IDENTIFICATION NUMBER:

330241

~e OF PROVIDER OR SUPPLIER

UNIVERSITY HOSPITAL S \J N .Y HEALTH SCIENCE CI '

(X4) 10 PREFIX TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

S 656 Continued From page 51

The Corisent For Diagnostic, Therapeutic,

Invasive Or form in the MR,

signed by days prior to

hospitalization, ~SI'llhe

"Att~nding Physician or Other Practitioner" and' lists Physlcian~& § R'1i1{!the "Additional Physician ... n

However, the Clinical Documentation form in the MR (which documents intra-operative activities

and infonnation such as the staff involved in the procedure), Physicia~~l.§ S1.21ll9

(X2) ~ULTIPLE CONSTRUCTION A. BUILDING

B.'MNG -:- _

(Xl) DATE SURVEY COMPLETED

c

(XS) COMPLIITE . OJo,TE

01 HeaHh Sys!emsManagement 1 Office of Term Care

STATE FORM Ve~ron NYS 11/1712009

10 PREFIX TAG

PROVIOER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCy)

S656

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STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

(Xi) PROVIOERISUPPUERlCLIA IOENTlFICATION NUMBER:

(X2) MULTIPLE CONSTRUCTION A. BUILDING

B.WlNG _

C .

STREET ADDRESS. crrr, STATE, ZIP CODE 750 EAST ADAMS STREET . SYRACUSe, tjY 13210

NAME OF PR9V10ER OR SUPPLIER

UNIVERSITY HOSPITAL SUN Y HEALTH SCIENCE CI .

(X4}ID PREFIX TAG

8656

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FUll REGULATORY OR LSC IDENTIFYING INF9RMATION)

8656 Continued From page 52 performed on Patient U.

The Consent for Diagnostic, Therapeutic •. Invasive or Surgical Procedure form in the MR.

signed by Patient days prior to

the procedure, lists Physician § 87Wthe

"Attending Phy§lcian or other practitioner" and

lists Physjcjad~8lJ § 87,~the "Additional Physician,"

However, the Clinical Do

Patient~,~2~ § d

day as fiiitlen

ID PREFIX TAG

(X3) DATE SI,JRVEY COMPLETED

PROVIDER'S PlAN OF CORRECTION [EACH CORRECTNE ACTION SHOULD BE CROSS·REFERENCED TO TH E APPROPRIATE DEFICIENCy)

(X5) COMPLETE DATE

of Health Systems Management I Office of Long Term Care

STAtE FORM Vcmlion NYS 11/1,7/2009

....

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STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

~1) PRO~DE~UPPUEWCL~ IDENTIFICATION NUMBER:

STREET ADDRESS. CITY. STATE. Z1P CODE 750 EAST ADAMS STREET SYRACUSE, NY 13210 .

330241

(X2) MULTIPLE CONSTRUcnON A. BUIWING

B.WNG ~ __

(X3) DATE SURVEY COMPLETED

C

NAME OF PRO~DER OR SUPPLIER

UNIVERSITY HOSPITAL SUN Y HEALTH SCIENCE CI

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

lei PREFIX TAG

PROVI DER'S PLAN OF CORRECTION (EACH~ORRECTJVE ACTION SHOULD BE CROSS.REFERENCED TO THE APPROPRIATE DEFlCIENCY)

(X5) COMPLeTE DATE

~4)ID PREfIX TAG

S 656 Continued From page 53 stated he performed,rt~ 87.2(ttof p["@.:i11f1n1!ID ,U'~"~I""'J PhysicianC[oL§!it':dip,)B couple of things."

that during the operative

. Physiciant![I?L§~me into P.atitijg9,;~~(b) room from the other operatin~.~'~M

(Patlen i.2(bli'ocedure) and askeCii5Bf the

::t~u:~_::~~:~~:,~ii!~Imrnm

-During interviews with the Int.edical

Director on 6/3/09 and 8127/09 . ~i1i'rated the

Interview finding above that Patlan ,]qslB'fMI!M.

allow Physrcian!i~ § ffe1ll1b his/her procedure, . 7

also noted that the procedure for Patient~ § J

longer than PhysiciaQ~rg;i. § ~ected and that he ran into difficulty. The Interim Medical DirectDr described followup with Physicienl'fld § S~~rding him doing a procedure he was not credentialed to tl

supervising a resident performing a procedure that you yourself were not credentialed to . undertake."

Findings pertaining to (8) above include;

-Per review of the hospital's policy entitled "Procedure Verification for Perioperatlve Areas,"

in

S656

Management 1 Office of Long: Term Care V.rsion NYS 11/17/2009

STATE FORM

QONB11

If ""nun.Bllan sheet 54 of 59

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STATEMENT OF DEFICIENCIES -, AND PLAN OF CORRECTION

STREET ADDRESS, CITY, STATE, ZIP CODE 7&0 EAST ADAMS STREET' SYRACUSE, NY 13210

(Xi) PROVlDERISUPPUERlCLIA IOEtmFICATION NUMBER:

NAME OF PROVIDER OR SUPPLIER

UNIVERSITY HOSPITAl.S UN Y HEALTH SCIENCE CI

(X3) DATE SURVEY COMPLETED

C

(X4) 10 PREFIX TAG

SUMMARY STATEMENT OF DEFICIENCIES' (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

(X2) MULTIPLE CONSTRUCTION

A. BUILDING

B. W1NG _

(X5) COMPLETE DAT~

5 656 Continued From page 54

contains the fonowing

. ''Verification 5: Pre-Incision 'TIme Out': Final verbal veJjfication oftha procedure and agreement using active verbal communication among all surgical team members ... will occur in ALL cases. This final verification is conducted through a formal 'Time Out' .. .immediately before starting the procedure .... The Circulating Registered Nurse will complete 'Verification Step 5' of the Surgical Verification Checklist n

L ffi.I'AtH~tw,ent a Surgical Im •• nt:"tirln C:hel:;kli:st form in

Patient Ws MR, dated the same day. contained the follOWing statements:

''Verification 5: TIME OUT. Must be conducted in location where procedure will be done, after patient" is prepped and draped and just before starting procedure. Involves entire operative team. All work should cease during 'Time Out' ... The following operative members participates in the 'Time Out"

However, the names and credentials of all staff participating in a "Tlme Out" were not recorded in

the area provided on this form. Also, .

documentation indicating a Time Out occurred was not present elsewhere in the MR.

-Per interview of the PSS on 6/4/09 at 3:00 p.m., the above findings were verified.

NOTE: This one occurrence (in the 10 cases reviewed) is unacceptable' in light of the hospital's history of having signed 2 Stipulation and Orders with the DOH for past occurrences of wrong side

Systems Management / Office of Long Term Care

STATE FORM Version NYS 11{1712009

• 10

PREFIX TAG

PROVIDER'S PlAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCy)

S656

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NYSDOH Contractor

PRINTED: 06/17/2010 FORM APPROVED

STREET ADO RESS, CITY, STATE. ZIP CODE 750 EAST ADAMS STREET SY~CUSE. NY 13210

STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

(X1) PROVUJERlSUPPLIER/CUA IOENTIFICATION NUMBER: .

(X2) MULTIPLE CONSTRUCTION

A. BUILDING

B. WlNG __ ...- _;__

(X3) DATE SURVEY COMPLETEO

C 05/1812010

330241

NAME OF PROVIDER OR SUPPLIER

UNIVERSITY HOSPITAL.S U NY HEALTH SCIENCE CI

(X4) 10 PREFIX TAG

Flndings include:·

ID PREFIX TAG

PROViDER'S PlAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE .CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCy)

(X5) CO"?LETEt DATE

Operation and service delivery.

(2) There shall be a complete-history and physlcal work-up in the-chart of every patient prior to any·surgery except emergency surgery. Each record-shall document a review of the patient's overall condition and health status prior to any surgery including the identification of any potential surgical problems and cardiac problems. If this has been dictated, but not yet recorded in the patient's chart, there shall be a statement to that effect and an admission note in the chart by the practitioner who admitted the patient. Such reports shall be signe9 to attest to the adequacy and currency of.the history and physical or

countersigned by the attending surgeon, prior to ,

surgery.

SUMMARY STATEMENT OF DEFICIeNCIEs (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LBC IDENTIFYING INFORMATION)

S 656 Continued From page 55 surgery.

S 672 405.12 (b) (2) SURGJCAL SERVICES.

This Regulation is not met as evidenced by:

Based on findings from document reviews and interviews, in 2 of 10 MRs. reviewed, the H&P work-ups for patients undergoingif:l!Ji~~f3i1~illirlli[qill procedures were not complete, as required by the MS Bylaws andlorgenerally accepted standards

of practice. Specifically, in 2 MRs reviewed, the written H & Ps for~l'@.¥jiI.~M~ij~hl1lliratients

(Patients X and Y) lacked indication that an assessment of all body systems was performed,

as required by the MS Bylaws and generally accepted standards of practice.

.-Per review of the hospital's MS Bylaws, last revised 6/06105, Bylaw Number. MSB R-10 states: "A complete admission history and physical examination shall be recorded within 24

5656

5672

OffICe of Health Systems Management I Office of Long Term Care

STATE FORM Version NYS 11117/2009

QONe11 '

I, CQIIUf1\Jation sheet 5B ~r 59

"

STR,EET AODRESS, CllY, STATE, ZIP CODE 750 EAST ADAMS STREET SYRACUSE, NY 13210

STATEMENT OF DEFICIENCIES AND PlAN OF CORRECTION

(X 1) PROVIOERISUPPLIERICLIA IDENTIFICATION NUMBER:

(X2) MULTIP~E CONSTRUCTION A. BUILDING

B.WlNG _

PRINTED: 06/1712010 FORM APPROVED

(XJ) DATE SURVEY COMPLETED

C

330241

NAME OF PROVIDER OR SUPPLIER

UNIVERSITY HOSPITAL SUN Y HEALTH SCIENCE CI

(X4)IO PREFIX TAG.

SUMMARY STATEMENT OF DEFICIENCIES '(EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSP IDENTIFYING INFORMATION)

10 PREFIX TAG

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CRQSS-REF,ERENCED TO THE APPROPRIATE , DEFICIENCy)

(X5) COMPlETE DATS

S 672 Continued From page 56

hours of admission. A history and physical examination performed within 7 days prior to inpatient admisslon, or within 30 days prior to outpatient surgery, is acceptable if verified by the attending' physician within 24 hours of admission or prior to surgery. This report shall include all pertinent findings resutting from assessment of all the systems of the body."

-Per the hospital's policy entitled "Procedure Verification for Periop Areas and Non-Operative' Procedures," last revised 10/08, it states:

,"Confirm that relevant docum.entation is available including: A current History and Phyalcal.;"

information on r:l[~rl!icentlv completed surgical procedu and postoperative complications, radiographic

findings and a plan for treatment. The H & P lacked documentation addressing the patient's overall health status and physical examination findings from a review of body systems. .'

-Per MR review, Patlen~~ § tmi'fi>l!.dmitted for.an elective neurosurgical

overall health status and physical examination findings from a review of body, systems. '

-During interview ofthe PSS on 6/4/09, she verified that the above patients' MRs lacked a complete H & P;

5672

Office of long Tenn

Verskln NYS 11~1712009

STATE FORM

WI

aONB11

NY DOH Contractor

STREET ADDRESS. CITY. STATE. ZIP CODE 750 EAST ADAMS STREET SYRACUSE, NY 13210

PRINTED: 06/17/2010 FORM APPROVED

STATEMENT OF DEFICIENCI ES AND PLAN OF CORRECTION.

(Xl) PROVIDERJSUPPUERICLIA IDENTIFICATION NUMBER: ,

(X2) MULTIPLE CONSTRUCTION ABUILDING

B, WlNG --'- __

(X3) DATE SURVEY COMPLETED

C 05118/2010

"

330241

NAME OF PROVIDER OR SUPPLIER

UNIVERSITY HOSPITALS U NY HEALTH SCIENCECI J

(X4)ID PREFIX TAG

SUMMARY STATEMENT OF DEFICIENCIES

(EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) -

10 PREFIX TAG

PROVIDER'S PLAN OF CORRECTION (EACH PORRECTIVE ACTION SHOULD BE CROS5-REFEReNCEO TO THE APPROPRIATE DEFICIENCY)

(XSJ COUPLETE CATE

S 673 Continued From page 57

8673 405.12 (b) (3) SURGICAL SERVICES.

Operation and service delivery.

(3) Informed consent shall be obtainfld from the patient, and a properly executed informed consent form for the operation that includes the .' identification of the practitioner(s) performing the surgical procedure(s) shall be in the patient's, chart before surgery except in emergencies in accordance with section 405.7 of this Part.'

This Regulation is not met as evidenced by:

Based on findings, from document reviews and interviews, the hospital's poliCY on informed consent was not completely implemented in 1 of 10 MRs reviewed (i.e., the informed consent form was signed by Patient W 4 months versus 3 months prior to his/her surgical procedure).

Findings include:

-Per review of the hospital~s policy entitled

. "Informed ConsentlRefusal," last reviewed 4/08, it states: "Co~sents are valid for 90 days ... n.

-Per MR review, tbe Consent for Diagnostic, Therapeutic, Invasive OR Procedure form was/signed by However, performed

-During interview of the PSg on 6/4/09, the , above finding was verified.

S 67 405.12 (b) (6) SURGICAL SERVICES.

Operation and service delivery.

(6) All infections of clean surgical cases shall be' recorded and reported to the Infection control officer. A procedure shall be developed and.

8673

8673

8676

J

Office of Heallh Systems Management I Offi~e of Lony Term Care

STATE FORM, Version NYS 11/1712009

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NYSDOH Contractor

PRIl;lTED: 06/1712010 FORM APPROVED

. STREET ADDRESS, CITY, STATE, ZIP"COOE 750 EAST ADAMS STREET SYRACUSE, NY 13210

STATEMENT OF DEFICIENCIES AND· PLAN OF CORRECTION

(Xl). PROVIDERlSUPPLIERlCLIA IDENTIFICAllON NUMBER:

(X2) MUL llPlE CONSTRUCTION ABUILDING·

B.~NG _

(>:3) DATE SURVEY COMPl.ETED

C 05118/2010

330241

NAME OF PROVIDER OR SUPPLIER

UNIVERSITY HOSPITAL SUN Y HEALTH SCIENCE CI

(X4) 10 PREFIX TAG

-During interview with ICPs #1 and #2 on 6/1/09, they verified the. Surgical Services was not : notifying them when there were infections of. clean surgIcal Cases.

10 PREFIX TAG

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY)

(X5) COMPLETE CATE

SUMMAAY STAlEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

S 676. Continued From page ~8

Implemented for the investigation of such cases.

This Regulation is not met as evidenced by:

Based on findings from document reviews and interviews, the hospital's Surgical Services was

. not notifying the infection control staff of clean surgical infections. (Also; although the Surgical Services was awa~here was a problem with postoperativ~tlfeclions, the ICC was not informed about this problem or involved in its mimagement - See the findings in Tag. 5641.)

Findings include:

.. -Per interview with the Patient Service Manager,. Nauro/ENT Services on 6/1/09 and the DeputY Director of Pe rioperative Services on' 8/13f09 •. the Surgical Services was not reporting to the infection control staff any infections of clean surgical cases.

S676

Office of Health Systems ManagementJ Office of long Tenn Care

STATE FORM Version NYS 11/17120,09

....

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