00 SL., mpuunun armani I 3 - II, Ttneecapimr Hin at Providence, RI 02908-5097 1 1 rrv; 711 - November 2, 2009 Timothy J. Babineau, MD Chief Executive Rhode Island Hospital S93 Eddy Street I Providence RI 02903 I Dear Dr. Babineau: I The Department of Health concluded our investigation at Rhode Island Hospital regarding yet another I incident involving a patient receiving a surgical procedure in error. The DeparIment's iindings and Statement of Deliciencies (SOD) are enclosed. Pursuant to the provisions ofthe "Rules and Regulations i for Licensing of Hospitals", the Hospital is required to tile a Plan of Correction with the Department I within (15) days. Also enclosed is an amendment to the Immediate Compliance Order served on the Hospital on 26 October I 2009 and outlining additional conditions I have determined necessary to ensure the ongoing safety for . patients scheduled for surgical procedures at Rhode Island Hospital. The conditions ofthe order are effective forthwith. I Finally, as discussed at our meeting on Wednesday, 28 October 2009, the Hospital's continued failure to eifectively implement policies and practices to ameliorate this particular problem is frustrat.ing and i damages the public's perception of safety and the credibility of RI Hospital's ability to consistently provide for safe surgical procedures. Subsequently, I believe additional sanctions are needed to highlight the critical nature and importance of this issue. The Hospital is issued a REPRIMAND and is assessed a line in the amount of one hundred and fiity thousand dollars The Hospital is hereby required to submit payment of this fine within thirty (3 0) days of the receipt of this letter. Address payment to the State of Rhode Island General Treasurer. If the Hospital is aggrieved by the discipline set forth in this letter, it may request a hearing on these matters within thirty (30) days. If you have any questions in these matters, please contact me at 222-2231 or Michael S. Varadian, Executive Director, Environmental and Health Services Regulations at 222-4727. Thank ypu . I I Gilford, M.D., M.P.H. Director of Health Encl: (1) Statement of Deficiencies (2) Amended Immediate Compliance Order I Cc: Lawrence Auburn, RI Hospital Board Chair George Vecchione, Lifespan CEO Al Vericchia, Lifespan Board Chair I State of Rhode Island and Providence Plantation: I STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS RHODE ISLAND DEPARMENT OF HEALTH DAVID R. GIFFORD, MD, MPH, in his capacity as DIRECTOR IN THE MATTER OF: RHODE ISLAND HOSPITAL LICENSE #: 00121 593 EDDY STREET PROVIDENCE RI 020902 AMENDED IMMEDIATE COMPLIANCE ORDER Now comes the Director of Health of the State of Rhode Island, and pursuant to Rhode Island General Laws, section 23-17-21 makes the following findings: 1) Rhode Island Hospital (hereinafter the "Hospital") is a hospital located on Eddy Street in the City of Providence, County of Providence, State of Rhode Island, which is licensed as a hospital by the Office of Facilities Regulation within the Department of Health of the State of Rhode Island pursuant to section 23-17-1, et seq. of the General Laws of the State of Rhode Island. 2) Pursuant to regulation and as a condition of its license, the Hospital is required to provide care and services in accordance with written policies and procedures pertaining to invasive procedures. The Hospital is further required to comply with all rules and regulations requiring the provision of care and services to all patients in accordance with the prevailing community standard of care and in a manner that maintains the health and safety of individuals, and to ensure that patients do not undergo unnecessary and/or unwanted procedures. 3) Whereas the Hospital in accordance with an Interim Consent Agreement with the Department dated May, 2009 and signed on 6 June 2009, copy attached and made a part hereof (Exhibit A), developed and implemented a comprehensive training initiative with all surgical staff to: Increase physician and staff feedback about the policies and procedures to prevent incorrect surgery or surgical site; ii) Improve near miss reporting from physicians and staff about the policies and procedures to prevent incorrect surgery or surgical site; iii) Ensure staff awareness and competency regarding changes to the policies and procedures; and iv) Improve the time out process; 4) Whereas, a review by the Department of Health, initiated on 22 October 2009, indicates that the Hospital failed to: (i) Fully implement, by 30 July 2009, the Hospital's plan of correction dated 5 June 2009, copy attached and made a part hereof (Exhibit B), regarding the Hospital's plan to include provisions for policy clarification and staff education based on operating room staff recommendations made during staff feedback sessions held during May 2009 and implementation of the Surgical Executive Committee's recommendation regarding surgical team culture and any subsequent changes in policy. (ii) Provide surgery care and services in accordance with written policies and procedures pertaining to time-out procedures and surgical site markings; i) DOH-RIH Immediate Compliance Order -Amended 11-3-09 5) Pending finalization of the Department's review, the Director issued an Immediate Compliance Order dated 26 October 2009, copy attached and made a part hereof (Exhibit C) requiring the Hospital to ensure every surgery at RI Hospital will be observed by a licensed clinical professional, not assigned to the subject surgery team, trained to observe surgical site marking and time out procedures. 6) The Department completed the review on 28 October 2009. The results of this review as set forth in the statement of deficient practice (hereafter "survey"), a copy of which is attached hereto and made part hereof (Exhibit D), indicates that the Hospital failed to provide surgery care and services in accordance with the Hospital's written policies and procedures pertaining to surgical site markings and time-out procedures. 7) Therefore, based on the foregoing, the Director finds that without intervention of the Department of Health and issuance of this Amended Immediate Compliance Order, the health, safety, and welfare of the patients scheduled for surgical services will be in jeopardy. The Rhode Island Hospital is herein ordered to: A) The Hospital is ordered to continue the direct observation of surgical-site marking and time-out procedures for any and all surgeries conducted under the Hospital's license for at least one (1) year and will report to Health quarterly regarding its findings, recommendations for modifications to its policy and procedures, and any variations from Hospital policy and procedures or sooner if it determines immediate changes are warranted. The individuals who are not members of the surgical team shall observe surgical marking and time out procedures for the purpose of compliance and shall point out to the team when the policy is not being followed. The observers are to observe for near misses also and for opportunities to simplify steps in the process. 1) The observers will also share their findings and recommendations with the Hospital's Board of Trusties and the Joint Commission's Center for Transforming Healthcare. 2) The Hospital may petition the Department of Health for relief from section A after one year. This petition must be made in writing and it shall include a substantial showing of compliance with the requirement of section A. Relief from the requirement is at the sole discretion of the Department of Health. B) The Hospital will immediately adopt in policy and practice the Rhode Island Uniform Surgical Safety Checklist and Standard Definition, a copy of which is attached hereto and made part hereof (Exhibit E) and to include; 1) Mandate that the surgeon marks the surgical site in pre-op area with assistance from a 2nd licensed professional; 2) Require that the surgeon incorporate the use of primary source verification (i.e., consent, H&P, radiology report if imaging done) prior to incision, and 3) Develop a comprehensive plan on how the Hospital will continually revise protocols, educate staff, and implement changes based on PSO data, "good-catches", input from clinical consultant(s), and operating room monitors. DOH-RIH Immediate Compliance Order --Amended ll-3-09 i C) The Hospital shall, within twenty-one (21) days, schedule a one (1) day shut down of elective I surgical procedures to conduct a mandatory training/review the RI uniform surgical safety I checklist and standard definition as well as the hospitals site-marking and time-out procedures I with all surgical stat}, to include at least the following: I l) of any ambiguities in the policies as they relate to any surgical specialties or procedures related to surgical-site markings and time-out procedures. D) The Hospital shall with-in forty-live (45) days install audio and video monitoring equipment in i all operating sites for all surgeries to ensure monitoring and reviews for each surgical physician, i to include: 1) an analysis of and recommendations regarding at least the safety of surgical services, implementation of site--marking and time-out procedures, and team dynamics of the surgical team. 2) Patient notice and consent documentation about the audio/video recording in accordance with i existing protections of personal medical information. l. 3) A minimum review of two (2) surgical events per year for each surgical physician. I E) The Hospital is ordered to continue timely implementation of any and all previously ordered or agreed upon conditions and stipulations regarding _the implementation of time-out protocols, surgical site markings, and prevention of incorrect surgery or surgical site unless specific relief is I requested in writing to the Department of Health. I F) Compile a complete a summary ofthe Hospital's incidents involving specific surgical errors between 2005 and the present, and forward this summary to the following (with cc to the Department of Health): 1) 'I`he Joint Commission's Center for Transforming Healthcare, 2) The Centers for Medicare and Medicaid Services 3) The Rhode Island State Medicaid 4) The Residency Review Training Commission Not withstanding existing Consent Agreements and previously established reporting requirements and any further actions or sanctions by the Department, this order remains in eifect until further notice. i David ord, MD, MPH Date I Director, RI Department of Health 1 2 i . nn 000 Fic ion 5 2009 15:1* P-U2 I IT A I *09 {44STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS RHODE ISLAND DEPARMENT OF DAVID R. GIFFORD, MD, MPH, in his capacity as I DIRECTOR I IN THE MATTER OF: RHODE ISLAND HOSPITAL . LICENSE 0012l 593 EDDY STREET PROVIDENCE Rl 020902 INTE. CON AG CLA CATI I i Now comes the Director of Health ofthe Stare of Rhode Island, and pursuant to Rhode Island General Laws, i . section 23-17-2] makes the following findings: i l. Rhode island Hospital (hereinafter the "l-lospltal") is a hospital located on Eddy Street in the City of Providence, County of Providence, State oflthode Island, which is licensed as a hospital by the Oihcc of Facilities Regulation within the Depautment of Health ofthe State ?fRh?d? lal??d to 23- 17-l,e-tseq. oftheGene,ral 2. Pumrant to regulation and as a condition of iLs license, the Hospital is required to provide cane and services in accordance with written policies and procedures pertaining to invasive The Hospital ls required to comply with all rules and regulations requirirg the provision of Cure and . services to all patients in accordance with the prevailing conirnurtity standard of care and in a rnarmer that . maintains the health and safety of individuals, and to ensure that patients do not undergo unnecessary and/or unwanted procedures. 3. A preliminary review by the Department of Health, on 12 May 2009, that Hospital failed to provide surgery care and services in accordance with written policies and procedures pertaining to time out procedures and patient I The Dinector and the Hospital agree, based on this preliminary review, the Hospital will implement the following immediate actions: Rhode Island Hospital agees to: 1- increase physician and staff feedback aboutthe policies and procedures to prevent incorrect surgery or surgical site by implementing the following: I . a Urgently institute a series or i meetings for all nurses, surgeons, and nurse involved ur operating room procedures to actively . solicit input on the weaknesses md opportunities for improvement in the existing policies and procedures dcsignedto prevent incorrect Surgery of 5??gi??l Bm- will be suspended for each surgical discipline at least two to threchours in order to accommodate i these meetings and all meetings will occur within the two weeka- at meetings should specifically include unique situations for which current policies may not bc optimum. including, but not limited to surgeries, midline surgeries that have once the incision is made, and surgeries where site markings are difficult ori}, vagnal or ocular surgeries). b. Provide the Department of Health with a summary report ofthe findings tiom these meetings, i within 15 days ofthe conclusion of the aforementioned stall meetings. including lhel I NIYK s0=9I 000zrS0>>?90 ME REG Jun 5 2009 15:11 P.U3 DOHJKIH Consent 5- Il-09 i n??d io bc made bothto policies md prowdurcs as wall as tha cultun: of physicians, nurses and othnr involved in me operating rooms. 1 c. A plan wuhin the next 45 days for how surgeons, anosthesiologists and nurses will provid: regular md ongoing feedback cm hospital policies and pmcodurcs and that addmsans tgojw 'lh? will improv: the mam cultuxe about collaboration in carrying out hospital and pmwdures. I 2. Improve mm miss xzpm??g from physicists and staff about tho policies and procedures to prevent I incorrect surgery cr surgical site by the following; . a. Complete of ngxecmcm with a Rhodc Island Dcpaxtmoni of Health unified Paticm Safety Organization within the next 30 days, md contract within tho next 60 days, initial: a naar miss reporting puogmm abouuhc hospiinh policies md pnmodurcs fox preventing I incorrect surgsn or surgical site. . b. Immediately submit reports twice to the Depuuncnt oflicalfh on the number of ucar miss repmts regarding procedure that could have impacted - on for correct paticnn cured surgical px0??d?r?. and sate/side. . D?o?1?p plan within 30 days ro uidross neu miss reports, and if revise the applicable policies and pzccodmcs. I d. reports on my changes no relevant policies md procedures Hom either MH I miss reporting or physician md staff within 30 days utter the pim is implemented. I 3. Following of Step I above, ensum mi awareness and competency regarding changes no policies md procedures by implementing the following: - I - A A plan within next 30 days for how surgeons, and nurses will work to develop, implement and stay current with the policies and procedures. b. A plan for continual education nursing and other operating room staff rogardmg I . new or changing policies. I c. An updated plan for ongoing competency assessment regarding policies and procedures. I I 4 Improve the BIDS out process by implementing the following. I Add amber a preoperative history physical for ??rg?ri?5, UT 3 inpatient suxgerlcs, to the timc out checklist to bn reviewed and used for vcrificntifm of I Provide a script for physicians to usc rcguding visudizaiion of nurgical mul?nS(5) . and/or descriptive jncution when no site marking is possible tune cut. I c. a collaborative working gqup including physicians and nurses to review surgery I 2 spccifnc site marking to assure visibility of marking niicr patient draping,. 1 . Nm any further actions cr sanctions by this order remains in effect until further notice. I Entered IH . of May, 2009Dwid ~d d, MD, MPH Dm Timoth J. Babincau., MD, DBI: Department of Health President CEO, Rhode Island Hospital NIYR g1gny;?;0y xy:} Booz/S0/90 - PRINTED: 05/22/2009 Foam Appnoveo Rl De rtnienr of Health A 1 21 WING 0sl1 512009 NAME or pnoviozn on sunnuen srnecr Aponess. crrv, sure, zrr? cope nrrope rn or oerrcrekcras ID pnovroerrs run I Ixsi png.; rucn oerrcrervcv nusr ae rncceoeo ev r=uu. pggpix Acrrorr srrouto ae I cormnri TAG necuuronv on ronINITIAL COMMENTS 0 I A complaint investigation sunrey was conducted at facility State deficiencies were identified. I 160_ ORGANIZATION 8 MANAGEMENT 12.2 160 I Organization The plan to ensure compliance with the 12 2 seen riospnar department and service srrarr I marntarn: Protocol Verification of the Patient's I a) clearly written definitions of its organization, SUIQICBI and I authority, responsrbilrty and relationships; Surgical Site" includes holding a series I bi written patient care policies and of with I and surgeons, anesthesiologists and nurse I c) provision for systematic evaluation of anesthetists and perioperative staff to I programs and services. solicit input on the I I This Requirement is not met as evidenced by: weaknesses and opportunities for I I Based on record review, staff interview, and improvement rn the existing policy. review of hospital policies and procedures, it was Specific information will be requested determined that the hospital failed to ensure situations such as multi-site surgeries I I complrance with the hospital policy and procedure and surgeries where site markings are I I entitled, "Unrversal Protocol Verification of the more difficult or not required at present. 5/29/09 Patients Identity, Surgical Procedure, and I Surgical Site", for 2 of 8 relevant sample patients ln addition, the hospital has initiated an I (Patient ID #1 and ID on-line survey to garner feedback from those who may prefer a more private I are as follows: and anonymous form of providing information. Review of the policy, "Unrversal Protocol Verrlicatron of the Patient's Identity, Surgical A report that encompasses the findings Procedure and Surgical Site", states. of the meetings and the survey will be - submitted to the Rl DOH. 6/15/09 Under Section Ill, Procedure, Item #3d) indudes, under Exceptions to Site Marking: "Surgery conducted through body orrfice". - Under Item Time Out, c) states: "Active 1 participation rs required confirming thatthe site I and side marking is visrble prror to initiating the I procedure Team members will verbally I I acknowledge that the mark is visible after I Emzigiiriiar rw DATE qraormorzv on srcrurune Co 6 gpg] Ifoontrnuntion sheet 10fG ZIIOQI NIVIE 05/22/2009 FORM APPROVED Rl artment ol Health xs one sunvev A NAME or wnovroen on suemren srneer Aooness. ctw. sure. cone RHODE ISLAND HOSPITAL tx., ip or berlcrencies rnovioews rum or connecrrorv urs; peep`; (EACH oerrcrewcv uusr ee eneceoeo ev rut; teach connecnve Acrrou sirouio ee comers me necuuronv on isc CROSSREFERENCED ro THE Awnovnmre uerrcreucvr 160 Continued From page 1 prepping and draping 1 Patient ID #1 was scheduled for elective surgery for right alveolar bone graft from the right Once the input findings have been l?iip_ te the right palate on 5l11[0Q_ The right summarized, the Surgical Executive hip was marked appropriately in the Holding area C0mml?T?8 (SEC) will dlS?U$$ what by the Preoperative Nurse. The patient entered changes need to be made in the policy the Operating Suite. and patient identification was and procedure. The SEC will also performed per hospital policy. with verincation of address improvements that could be patient identity and the scheduled surgical made in the team culture to encourage procedure. including the site and side. The collaboration in carrying out the policy, Surgeon did complete the marking of the surgical including supporting staff to speak up if site by placing initials on the line drawn by the they have concerns that the policy is not Preoperative Nurse on the right hip. The prepping being followed Clarifications to the policy and draprng ol the patient was completed will be made and staff will be educated a to any changes. 7/30/09 On 5/12/09 between 11:00 AM and 2:00 PM. the Surgical Team. including the Surgeon, was interviewed All indicated that the Surgeon did To ensure a more consistent practice not ask for verification of the visibility of the site during the time out process. a script will I marking during the Time Out performed. be developed for the team to use however_ no one in the room during the surgery regarding visualization ofthe site 7/30/09 voiced the breach of hospital policy. marking. Monitoring of compliance with the script will be done by direct In addition. the Surgeon proceeded to make a observation of a sample of cases lh each mark on the lelt side (incorrect side) of the OR beginning 8/30/09 and continuing for patients lace. close to the ear, without making 3 months with further monitoring the team aware This is also not in accordance depending on the results of the first 3 with hospital policy for surgery within orifices months. The surgeon then proceeded to cover this mark with a surgical drape After the stan ofthe I surgery. the Surgical Resident looked over the 5 I Su rgeon's shoulder. and questioned the Surgeon I regarding what side ol the mouth was being worked on It was noted that the Surgeon had md I started to operate on the left palate. rather than I the intended right palate. . Funher interview with the Surgeon indicated that i the left face was marked because the Surgeon I Regulation stare Foam nm ri samnuam sneer 2 or N0l.l.vtl.I.SIN1ltdv Xvil 0tI?91 6002/90/90 PRINTED. 05/22/2009 FORM APPROVED Rl artment of'HeaIth pn; pu; CONSTRUCTION A, surroruc 121 NAME os nnovroen on SUPPLIER STREET ADDRESS. crw. STATE. ZIP CODE RHODE ISLAND HOSPITAL our ro SUMMARY sr/u EMENT or oEI=rcrEucrEs ID praovroews nun or conrtecrrou rxr.; (EHCH DEFIGENCY Musr BE PRECEDED mr Eur; ppm; (EACH conrtEcTrvE MZTION SHOULD BE COMPLETE mq; Recuurronv on IDENTIFYING INFORMATION) TAG cnoss-REF ERENCED ro THE APPROPRIATE oEr=rcrErucvr 160i Continued From page 2 160 "thought" that the left palate was the correct site. The left palate surgery had already been performed by this Surgeon rn November of 2008. The Surgeon felt the need to mark the surgical site because. "No one can see what is being done rn the patient's mouth." The surgeon also stated he had felt the procedure was being rushed. Feeling rushed during procedures was a complaint voiced by other staff members as well. Additionally, when the Surgeon was asked how updates to the Universal Protocol are relayed, the response was that these are typically received from the nurses. There was no evidence that tl?re Surgeon had reviewed the updated policy, and/or had relayed concerns or feedback in regards to his specialty - 2. Patrent ID #3 had scheduled surgery for a left leg and debridement on 5/15/09. During survex/0r observation of the Time Out process at 8 15 AM rn the Hasbro unit operating room, the left leg marking was vrsible after the prepping and draping It was noted, however that the Surgeon not verify with the team that the site mark was during this Trme Out, but instead Stated, at the completion of the Time Out, "Is everyone in agreement'?" This is not rn accordance with the hospital policy to verify visualization of the site marking during the Time Out 2 185l ORGANIZATION 8. MANAGEMENT 13 3 185 Personnel 13 3 Provrsrons shall be made for orientation and ongoing education programs for all - personnel There shall be written evidence that staff demonstrate competencies necessary to I work rn areas and/or with specific patient I populations. Regulation FORM rr?oo tteontlnualrori shoot 3 of 6 HJOWI QTZIWHITOP YV.-I ntist 8002/90/90 . PRINTED. 05l22!2009 . FORM APPROVED I D?gartm_e_gLgj Health . STATEMENT OF pm PROVIOERISUPPLIERICLIA (X2) CONSTRUCTION ln) DATE SURVEY ?r Numan. A. nuitomc 121 WING 05l*l $[2009 wwe or rigcmogon suvnusn smear Aooness, cm, swre, ziv CODE RHODE ISLAND HOSPITAL my rp SUMMARY STATEMENT or oericiencres In vnovioerrs mw or connection ppg.; rucri oericieucv uiusr ne PRECEDED BY FULL pnzrix IEACH ACTDN BE rar; Recsuutonv on i.sc iosmuwnc inronmriouy cnoss-nzrerteraceo T0 me Arwnovnmre MTE 185 Continued From page 3 185 This Requirement is not met as evidenced by: Based on staff interviews, it was determined that I the hospital failed to make provisions for ongoing education for all personnel, that includes written The SEC w?ll?1?v?l?? plan ml new gyidence tha] Staff denyonsuale SUYQCODS, and necessary to work in specific areas andlor with staff will Slay Funenl and specific patient populations, related to the Tne Plan 'nelnee I Universal pmiomi expanding the use of the HospitaI's on- line leaming system, Net Learning, to Findings are as follow; Medical and allied health staff and residents. Employees already have During interviews with the surgical staff on le an? use 5I12I09 and 5I13l09, It was revealed that there 9?'n9 can be are different interpretations of the Universal used te track Penmlpent 'ee"n'n9? 8,30/09 Policy related to verification of the visualization of the site during ina Time out process, when are made l? after the patient is prepped and draped, In . me UP P?ll?Y- Slan- addition. the surgeon indicated that updates to ane$lne$l?l?9l$l$ and nurse the policy are typically received from the nurses, will be '6?Ull'6? l0 rather than through Irasprial initiated methods in the It formal training, memos, etc,). Deeulnentallen Of eelnpelenell will be I placed in the personnel or credentials file Ongoing Although the surgical staff receives orientation to the policy, and must demonstrate competencies M?nn?nn9 let ??"nPeleneY i at that time as part of their core competencies, be d?ne PY dlleel ?l 3 there was no evidence of sample cases in each 0R f<>r 3 competencies for surgical staff when policy funnel m?nll?l'ln9 deP?ndln9 0n ine changeslrevisions are made Staff were Yesulls ef lne 3 i inconsistent relating how policy changeslrevisions I are communicated to them. For example, during I conversations with Circulating Nurses, the Scrub Nurse, Anesthesiologist, CRNA (Certmed Registered Nurse Anesthetists), and Assistant Clinical Manager, and other surgery staff I members (on 5I1 3I09, and subsequent discussions), all provided varied information as to how policy and procedure changes are communicated newsletter, e--maiI, insenrice, I morning meeting, or staff meeting). Several I indicated it was often unclear as to which version iacilrtaes Regulation QTATE FQRM CIW II cl 6. S00l7l NIVII XH PRINTED. 0SI22I2009 - FORM APPROVED Rl artme_n_t_ql Health pu; nunime consmucrron A auitomc 121 osu srzcus NAME QF PROVIDER on suppugn STREET ADDRESS, CITY, STATE. ZIP CODE RHODE ISLAND . Ip suwrmv STATEMENT or oemcreiucies I ID Pnovroen-s Puw or connection uns) oernciencv uusr se Pneceoeo ev mu.- (EACH connective ACTION snouto ee cowtete TAG necuuwonv on Ioemlrvinc Inronwmoup TAG cnossaerenenceo ro APPROPRIATE MTE oerrcrenc I 185 Continued From page 4 185 of the policy is lh effect or most current Many staff felt when concerns are voiced, andlor following surveys conducted by the hospital, they receive little or no feedback The hospital failed to provide evidence that all I staff are aware of changes and I that they are deemed competent related to the ollc chan elrevision. I The nurse who inaccurately documented . th 'd k' 3voI PATIENT senvrces 19.6 Patient care 310 ,:22,ds I I Management being audited for accuracy and . . completeness, with results of 100dsa. of his rar 8H0u"I8l' FESUIIS ran I preval mg below 100%, in which case records will ??mm?mtY Standard ?f . be continued to be monitored until I . This Requirement IS not met as evidenced by compliance is maintained at 100% for a I Based on record review and staff interview, it was month I determined that the hospital failed to provide care I and services to all patients in accordance with the Re__?ducau?n for PACU staff ,8 arding I prevailing community standard of care lor 1 of 8 com leteness of Holm Unit Asgassmem relevant sampled patients (ID Fong was done 5,20,09 Findings are as follows: Staff meeting on more specmc . . . formation related to correct The AORN (Association of perr0perat1ve In . I Registered Nurses), August 2008 issue, Vol 4, documemahcn regarding "lmproving Universal Protocol" . . I and "The New Patient Safety Goal Requirements The summa. semces Fepanmem also for 2009" reveals, under "Preprocedure rarsgoghardltix -iotpre-cp .n Verification Process", that checklists Including 9 assessments must be used to review and verify rcceduk in the Hap LIVE audits of 50 I that relevant documentation is available, and is gases per month are berfmmed on I me on These Patient ID #1 was seen In the Holding area by the audns are ?ng?mg' - Preoperative Nurse prior to a surgical procedure I . The nurse completed the Holding Unit C7 I assessment, documenting under the verili tion acrlitres Regulation BTATE FORM olIl ll eonunuatmn sheet 5 of 6 900Wl NIYR XVII 8002/90/90 05l22I2009 - FORM APPROVED RI Departnient of Health sur EMENT or DEFICIENCIES pm FROVIDERISUPPLIERICLIA rx:) MULTIPLE consrnucrton AND PLAN OF CURRECTION IDENTIFICATION NUMBER A. 121 WING g5)1 $]2009 NAME OF PROVIDER on sur?roLrErt STREET ADDRESS. CITY. STATE. ZIP 000E ET RHODE ISLAND HOSPITAL anu: SUMMARY STATEIIENT OF DEFICIENCIES rp Pnovroerrs PLAN or CORRECTION rw (EACH MUST BE PRECEDED BY FULL (EACH ACTION WOULD BE ??gf#?TE TAG nesuuromr on INFORMATION) TA6 TO THE oEr=tcrENc~n 370I Continued From page 5 370 of the surgical procedure sitelsrde, "Right hip bone gran" However, under nursing notes on the same form, the nurse inaccurately I documented, "Mark on left hip area". I During an interview on 5/13/09 at 9:05 AM with the Preoperative Nurse, it was acknowledged that . the correct hip was marked in the Holding area, but that a documentation error was made when the "mark on Iett hip area" was written I under the nursing note section ofthe Holding Unit Assessment, therefore, documentation was not accurately matched to the patientTacilltles Regulation II ol 5 rnnmi NIYK Nnr.T.vN.T.stN1Imv XY.-I ICFST I $0 14*0 Exhibit STATE OF RHODE ISLAND AND PROVIDENCE RHODE ISLAND DEPARMENT OF HEALTH DAVID R. GIFFORD, MD, MPH, in his capacity as . DIRECTOR IN THE MATTER OF: RHODE ISLAND HOSPITAL LICENSE #:00121 593 EDDY STREET PROVIDENCE RI 020902 . IMMEDIATE LIANCE. ORQER Now comes the Director of Health of the State of Rhode Island, and pursuant to Rhode Island General Laws, section 23-17-21 makes the following Endings: 1) Rhode Island Hospital (hereinalter the "Hospital") is a hospital located on Eddy Street in the City of Providence, County of Providence, State of Rhode Island, which is licensed as a hospital by the Oftice of Facilities Regulation within the Department of Health ofthe State of Rhode Island pursuant to section 23-17-1, et seq. ofthe General Laws ofthe State of Rhode Island. 2) Pursuant to regulation and as a condition of its license, the Hospital is required to provide care and services in accordance with written policies and procedmes pertaining to invasive procedmes. The Hospital is further required to comply with all rules and regulations requiring the provision of care and services to all patients in accordance with the prevailing community standard of care and in a manner that maintains the health and safety of individuals, and to ensure that patients do not undergo . - unnecessary and/or unwanted procedures. 3) Whereas the Hospital in accordance with a Consent Agreement with the Department dated May 19, 2009 developed and impl ented a comprehensive training initiative with all surgical staff to: a) Increase physician and staff feedback about the policies and procedures to prevent incorrect surgery or surgical site; b) Improve near mi reporting fr?om physicians and staff about the policies and procedures to prevent incorrect surgery or surgical site; c) Ensure staff awareness and competency regarding changes to the policies and procedures; and d) Improve the time out process; A preliminary review by the Department of Health, initiated on 22 October 2009, indicates that the Hospital failed to provide surgery care and services in accordance with written policies and procedrues pertaining to time out procedures and smgical site markings. 4. Therefore, based on the foregoing, the Director finds that without intervention ofthe Department of Health and issuance of this Immediate Compliance Order, the health, safety, and welfare ofthe patients scheduled for smgical services may be injeopardy. The Rhode Island Hospital is herein ordered to: 1. Starting Monday, October 26, 2009, every surgery at RI Hospital will be observed by a licensed . clinical professional, not assigned to the ubject smgery team, tr?ained to observe surgical site marking and time out procedures. Not withstanding existing Consent Agreements and any further actions or sanctions by the Department, this orderremains ineffectuntil furthernotice. /e/Lo #7 David ord, MD, MPH Da Director, RI Department of Health Exhibit D RI Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING PRINTED: 10/30/2009 FORM APPROVED (X3) DATE SURVEY COMPLETED ______________________ 121 NAME OF PROVIDER OR SUPPLIER B. WING _____________________________ STREET ADDRESS, CITY, STATE, ZIP CODE C 10/28/2009 RHODE ISLAND HOSPITAL (X4) ID PREFIX TAG 593 EDDY STREET PROVIDENCE, RI 02902 ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETE DATE SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) Z 0 INITIAL COMMENTS Z0 An "Other" State licensure survey was conducted at this facility. State deficiencies were cited. Z 160 ORGANIZATION & MANAGEMENT 12.2 Z 160 Organization 12.2 Each hospital department and service shall maintain: a) clearly written definitions of its organization, authority, responsibility and relationships; b) written patient care policies and procedures; and c) written provision for systematic evaluation of programs and services. This Requirement is not met as evidenced by: Based on record review, staff interview, and review of hospital policies, it was determined that the hospital failed to ensure compliance with the hospital policy entitled, "Universal Protocol Verification of the Patient's Identity, Surgical Procedure and Surgical Site", for patient (ID #1). Findings are as follows: Review of the policy, "Universal Protocol Verification of the Patient's Identity, Surgical Procedure and Surgical Site", states: Under Section III, Procedure, Item #2, Arrival to Preoperative Area, c) states: "In cases where laterality is involved (extremities, head, organs for which there is duplication), the Preoperative RN will use an approved indelible marker to mark the surgical site with a straight line in the Preoperative holding area. This includes procedures involving right/left distinction, multiple structures (such as fingers and toes), or Facilities Regulation TITLE LABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE (X6) DATE STATE FORM 6899 JYYD11 If continuation sheet 1 of 7 PRINTED: 10/30/2009 FORM APPROVED RI Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED ______________________ 121 NAME OF PROVIDER OR SUPPLIER B. WING _____________________________ STREET ADDRESS, CITY, STATE, ZIP CODE C 10/28/2009 RHODE ISLAND HOSPITAL (X4) ID PREFIX TAG 593 EDDY STREET PROVIDENCE, RI 02902 ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETE DATE SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) Z 160 Continued From page 1 Z 160 multiple levels (as in spinal procedures; cervical, thoracic lumbar) and bilateral procedures....". Under Item #5, In Operating Room, e) states: "If the line drawn by the Preoperative RN is not where the intended incision will be, the surgeon's initials will be the official confirmation of the surgical site." Under Item #6, Time Out, g) states: "If two procedures are being done on the same patient, the time out must be done before the first procedure, then before you start the second procedure unless both procedures are done through the same approach/incision and by the same surgeon". 1) Patient ID #1 was scheduled for elective outpatient surgery for right middle trigger finger release and right small finger distal interphalangeal (DIP) fusion on 10/22/09. Although the patient's surgery was to include the right middle and right small fingers, the Preoperative Nurse marked a straight line down the patient's right forearm to the wrist, and documented "marked right hand" under nursing notes on the Holding Unit Assessment. The patient entered the Operating Suite, and patient identification was performed per hospital policy, with verification of patient identity and the scheduled surgical procedure, including the site and side. During interviews on 10/23/09 between approximately 10:00 AM and 10:45 AM, with both the Circulating Nurse and the Anesthesiologist that had participated in the identification process in the OR with this patient, Facilities Regulation STATE FORM 6899 JYYD11 If continuation sheet 2 of 7 PRINTED: 10/30/2009 FORM APPROVED RI Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED ______________________ 121 NAME OF PROVIDER OR SUPPLIER B. WING _____________________________ STREET ADDRESS, CITY, STATE, ZIP CODE C 10/28/2009 RHODE ISLAND HOSPITAL (X4) ID PREFIX TAG 593 EDDY STREET PROVIDENCE, RI 02902 ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETE DATE SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) Z 160 Continued From page 2 Z 160 both indicated that the Surgeon did verify the correct surgical procedures, including the site and side. Although the surgical marking made by the Preoperative Nurse was not where the intended incision would be, the Surgeon did not initial the intended multiple digits to confirm the surgical sites, and indicate where the intended incisions would be, per hospital policy, which states, "If the line drawn by the Preoperative RN is not where the intended incision will be, the surgeon's initials will be the official confirmation of the surgical site." Instead, the Surgeon completed the marking of the surgical site by placing his initials on the (incorrect) line drawn by the Preoperative Nurse on the patient's forearm. Immediately before the start of the first procedure, the Surgeon called for a "Time Out" with the entire Surgical Team. This included confirmation of the correct side/site, and correct procedures. The procedures were reportedly verified with the surgical consent. During interviews with the entire Surgical Team, including the Surgeon, on 10/23/09 between 8:45 AM and 12:30 PM, there were discrepancies noted regarding the side/site and procedure confirmation by the Surgeon during the Time Out. Both the Circulating Nurse and the CRNA (Certified Registered Nurse Anesthetist) indicated that they heard the Surgeon call the correct sides/sites, and procedures during the Time Out. The Scrub Technician stated she could not remember what was said during the Time Out. The Surgical Fellow assisting the Surgeon indicated that he heard the Surgeon say, "right middle trigger finger release and DIP fusion". The Surgeon indicated that he was focused on the middle finger and said "right middle trigger Facilities Regulation STATE FORM 6899 JYYD11 If continuation sheet 3 of 7 PRINTED: 10/30/2009 FORM APPROVED RI Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED ______________________ 121 NAME OF PROVIDER OR SUPPLIER B. WING _____________________________ STREET ADDRESS, CITY, STATE, ZIP CODE C 10/28/2009 RHODE ISLAND HOSPITAL (X4) ID PREFIX TAG 593 EDDY STREET PROVIDENCE, RI 02902 ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETE DATE SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) Z 160 Continued From page 3 Z 160 finger release and DIP fusion". The right middle finger trigger release surgery was completed in the palm area of the right hand. The patient's hand was then turned with the palm down, and the Surgeon and the Surgical Fellow proceeded to perform the DIP fusion on the patient's distal middle right finger, instead of the small finger per the Surgical Consent signed by the patient, the History and Physical, the surgical booking, etc. Additionally, there was no evidence that a Time Out was called by the Surgeon prior to the second incision/procedure, in accordance with hospital policy, which states, "If two procedures are being done on the same patient, the time out must be done before the first procedure, then before you start the second procedure unless both procedures are done through the same approach/incision and by the same surgeon". At the completion of the second procedure, the Surgical Fellow wrapped the hand in a gauze dressing, and the CRNA questioned why the surgery to the small finger had not been initiated. The Surgeon was notified, and after speaking with the patient's contact, proceeded to complete the fusion of the right small finger as had been planned. Again, there was no Time Out, or other acknowledgment by the Surgeon, before the incision on the small finger. During the interview with the Preoperative Nurse, she indicated that she did not mark the patient's digits for the surgery because she did not know where the incision would be made. She indicated that she marks "within" the surgical site, so that she will not be "reprimanded" by the Surgeon. She also indicated that she always marks "for side". Facilities Regulation STATE FORM 6899 JYYD11 If continuation sheet 4 of 7 PRINTED: 10/30/2009 FORM APPROVED RI Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED ______________________ 121 NAME OF PROVIDER OR SUPPLIER B. WING _____________________________ STREET ADDRESS, CITY, STATE, ZIP CODE C 10/28/2009 RHODE ISLAND HOSPITAL (X4) ID PREFIX TAG 593 EDDY STREET PROVIDENCE, RI 02902 ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETE DATE SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) Z 160 Continued From page 4 Z 160 During the interview with the Surgeon, he indicated that after the last wrong side surgery at the hospital, a meeting was held at the ASC (Ambulatory Surgery Center) that had resulted in a discussion with the Surgeons and Nurses, related to the potential for problems with multiple surgeries on digits not marked in advance of the surgery by the nurse. He indicated that there was more concern with the side being marked, and the policy was not addressed at that time. He also indicated that the nurses had indicated that they did not always know where the mark should be placed on the digits for the proposed surgery. Although nurse interview revealed that there was concern that they would be reprimanded by the surgeons for marking within the surgical site, he denied that he would dispute such (accurate) markings of the digits by the Preoperative Nurse. 2) Although the Scrub Technician was aware of the correct procedures to be performed, in accordance with the surgical schedule, she handed the Surgical Fellow instruments, including a screw on a screwdriver, for the middle finger fusion, and did not question the Surgeon or the Surgical Fellow regarding the middle finger fusion. 3) During interview with the Surgical Fellow, he indicated that he had not met the patient in the Holding Area, nor had he had a discussion with the patient prior to surgery, because of the time factor in that this patient was the first case. Also, he had not reviewed the patient's Consent Form, or the History and Physical prior to the surgery, as he normally does. He stated he was aware of the planned surgery per an electronic mailing he had received prior to the surgery, and the Surgeon had updated him on the case at the Facilities Regulation STATE FORM 6899 JYYD11 If continuation sheet 5 of 7 PRINTED: 10/30/2009 FORM APPROVED RI Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED ______________________ 121 NAME OF PROVIDER OR SUPPLIER B. WING _____________________________ STREET ADDRESS, CITY, STATE, ZIP CODE C 10/28/2009 RHODE ISLAND HOSPITAL (X4) ID PREFIX TAG 593 EDDY STREET PROVIDENCE, RI 02902 ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETE DATE SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) Z 160 Continued From page 5 Z 160 scrub sink. 4) There continues to be discrepancy between inpatient and outpatient surgeries. During an interview on 10/23/09, at approximately 1:45 PM, with the Director of PeriOperative Services, she indicated that Outpatient Surgery had not been marking digits per hospital policy. She also indicated that there seems to be misinterpretation of the Time Out policy regarding multiple incisions. 5) In July 2009, all of RI's 13 acute care hospitals reportedly agreed to a statewide, single, safe surgical protocol in order to improve patient safety. This protocol outlines steps within three phases of surgery; before induction of anesthesia, before incision, and before patient leaves operating room. Although the hospital participated in the announcement of this protocol, and other hospitals have implemented the protocol, Rhode Island Hospital failed to implement all steps in all phases of the protocol. Z 370 PATIENT CARE SERVICES 19.6 Patient Care Z 370 Management 19.6 The hospital shall provide care and services to all patients in accordance with the prevailing community standard of care. This Requirement is not met as evidenced by: Based on record review and staff interview, it is determined that the hospital failed to provide care and services to all patients in accordance with the prevailing community standard of care for patient ID #1 related to surgical services. Facilities Regulation STATE FORM 6899 JYYD11 If continuation sheet 6 of 7 PRINTED: 10/30/2009 FORM APPROVED RI Department of Health STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A. BUILDING (X3) DATE SURVEY COMPLETED ______________________ 121 NAME OF PROVIDER OR SUPPLIER B. WING _____________________________ STREET ADDRESS, CITY, STATE, ZIP CODE C 10/28/2009 RHODE ISLAND HOSPITAL (X4) ID PREFIX TAG 593 EDDY STREET PROVIDENCE, RI 02902 ID PREFIX TAG PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETE DATE SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) Z 370 Continued From page 6 Z 370 Findings are as follows:: Refer to Z 160 findings, items 1 - 3. Facilities Regulation STATE FORM 6899 JYYD11 If continuation sheet 7 of 7 Exhibit E RHODE ISLAND SURGICAL SAFETY CHECKLIST All team members have an obligation to verbalize their concerns at any step in the process Before induction of anesthesia Before skin incision Before patient leaves operating room Briefing Process Completion of site marking by surgeon* and second licensed provider Identification f t Id tifi ti of team members and roles b d l Each introduce themselves* Surgeon identifies patient, procedure, site/side, (confirmed with consent by RN) and discusses the plan for surgery* Antibiotic status/glycemic control/ beta-blockers/medications needed on field/irrigation as applicable* Patient position* Equipment/implants required for procedure Patient safety considerations: blood, DVT prophylaxis, allergies, special considerations (hearing deficit, language barrier, friable skin, risk for pressure ulcer, Pacemaker, etc.) Relevant information available: X-rays, PACS up on screen, lab work consent screen work, Are we ready to begin induction? Time-Out Process Initiated by attending surgeon Patient, procedure, site/side identification (confirmed with consent id tifi ti ( fi d ith t by RN/licensed provider) Surgeon's initials on procedure site/side visible after prepping and draping Can we see the marking? Debriefing Process Initiated by attending surgeon prior to leaving the operating room Specimen l b li and d i S i labeling d designation ti Post-op plan of care (ICU bed, ventilator, etc.) Patient temperature Review of what worked well and what could have been done differently Identify any instrument/equipment concerns Identify edits for physician preference card Developed with assistance from the World Health Organization * Joint Commission element of performance Attachment A STANDARDIZED DEFINITIONS FOR RHODE ISLAND UNIFORM SURGICAL PROTOCOL Anesthesia Provider: A certified and credentialed registered nurse anesthetist (CRNA) or anesthesiologist who will actively participate in the time-out. Includes student and gradate registered nurse anesthetists. Briefing: Active communication guided by the appropriate safety checklist to identify team members and confirm patient verification, site and procedure before induction of anesthesia. Debriefing: Active communication guided by the appropriate safety checklist to confirm post-operative plan of care before patient leaves the operating room. Invasive Procedure: Any procedure involving puncture/incision of skin or insertion of an instrument or foreign material into the body, Excluded are IV and foley catheters. Licensed Professional: A licensed health care provider who is involved in the procedure. Pause: During the time-out, other activities are suspended, to the extent possible, without compromising patient safety. Proceduralist: A licensed professional who is credentialed by the hospital to perform scheduled procedure who will initiate the time-out. Physician's Assistant: A physician's assistant (PA) as defined by the Rules & Regulations for licensure by the State that will be assisting with the procedure. Physician Designee: Physician, nurse practitioner, or physician's assistant as designated by the attending physician. Pre-Procedure Area: Pre-operative area/pre-procedure area - located outside the operating room/procedural area where patient will be admitted and prepared for surgery/procedure. Immediate pre-procedure area - location within the operating room/procedural area where patient will await entrance to the operating room/procedural suite. Pre-Procedure Registered Nurse: The registered nurse who is designated as the individual responsible for preparing the patient for surgery or invasive procedure. Procedural Registered Nurse/Circulator: The registered nurse who is responsible for admitting and caring for the patient in the operating room/procedural area throughout the procedure, including the time-out. Time-Out: Active communication guided by the appropriate safety checklist involving the entire procedural team, conducted in the location where the procedure will be done immediately prior to starting the procedure. Multiple Procedures: A time-out is required for each procedure if the surgical team changes and/or there is a change in patient position. Scrub Nurse/Technician: Registered nurse or operating room technician in the scrub role during the surgical/invasive procedure who will actively participate in the time-out. Stop the Line: Any member involved in the procedure can ask for clarification or stop the procedure. Unambiguous marking of surgical site: Site mark must be clearly marked on or as close as possible to the surgical site by the surgeon/proceduralist with initials. If site is unable to be marked, a mechanism is established to verify patient, procedure, and operative site. Developed by the Hospital Association of Rhode Island Surgical Protocol Workgroup