STATE OF RHODE ISLAND OVIDENCE PLANTATIONS DEPARTME HEALTH Qtiw Safe and Healthy Lives in Safe and Healthy Communities David R. Gifford, MD, MPH Director of Health I November 26, 2007 George A. Vecchione - Interim President and Chief Executive Officer Rhode Island Hospital i 592 Eddy sam Providence, RI 02903 Dear Mr. Vecchione: As you know, on Sunday, 25 November 2007 the Department of Health conducted an on- site complaint investigation at Rhode Island Hospital regarding a patient who received a 1 surgical procedure in error. As a consequence of our findings, enclosed is a Statement of I Deficiencies (SOD). Pursuant to the provisions ofthe "Rules and Regulations for Licensing of Hospita1s", the Hospital is required to file a Plan of Correction with the Department within fifteen (15) days. Also enclosed is an Immediate Compliance Order, the contents of which are effective ronhwim. Lastly, tl1e Hospital is issued a REPRIMAND and is assessed a fine in the amount of fifty - thousand dollars The Hospital is hereby required to submit payment of this fine within thirty (30) days of the receipt of this letter. Ifthe Hospital is aggrieved by the discipline set forth in this paragraph, it may request a hearing on these matters within thirty (30) days. I If you have any questions in these matters, please contact me at 222-2231. Da . Gifford, M.D., M.P.H. I Director of Health 5 I cc: Alfred J. Verrecchia Edward A. Iannuccilli, M.D. CANNON BUILDING, Three Capitol Hill, Providence, Rhode Island 02908-5097 Telephone 401-222-2231, FAX 222-6548 - Web Site: Hearing/Speech Impaired, Dial 7ll or Call I-800-745-5555 PRINTED: 11!26!2007 FORM APPROVED STATEMENT OF ?1zr=iciENciEs - (xs) DATE sunvev com-imo A. auimms s. 121 NAME OF Pnovioen on surmise STREET ADDRESS. cm. zip RHODE ISLAND HOSPITAL (X4) SUMMARY STATEMENT OF DEFICIENCIES |p PLAN OF CORRECTION (xs) (EACH ?Er=iciENcv musr BE ev r=uLL (EACH CORRECTNE Acriou sH0uu> BE couriers mg REGULATORY OR INFORMATION) TAG T0 THE APPROPRIATE MTE ?Ei=iciENcY) - 0 INITIAL COMMENTS 0 A complaint investigation survey was conducted at this facility. 18 ORGANIZATION MANAGEMENT 12.2 160 Organization 12.2 Each hospital department and service shall maintain: a) clearly written dehnitions 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 medi record review, policy and procedure review, and staff interview, it is detemtined that the hospital failed to ensure compliance with the policy and procedure entitled, "Veritication of the Patients Identity, . Procedural Site, and Invasive Procedure Performed Outside the for patient ID 1. Findings include: The policy and procedure, "Veriticatlon of the I Patients Identity, Procedural Site, and Invasive Procedure Performed Outside the states, in part: "The nurse, technologist, or second provider will verify that all appropriate documentation is included inthe medical chart: history physical I or preoperative not for inpatients, sign consent form where applicable, and lab work andlor radiographs." Patient ID #1 had CT ns of the head on and both revealing a left Fadllties Regulation tm MTE LABORATORY ?iREcToR?s OR REr?ResEm?AnvE?s SIGNATURE STATE FORM o? C-mmq ir contlnunllon moat 1 PRINTED: 11.*26r2007 I Foam Appnovao I A. BUILDING a avvme 121 11l25I2007 NAME gp OR guppugg STREET ADDRESS, CITY, STATE, ZIP CODE RHODE ISLAND HOSPITAL (X4) |p SUMMARY STATEMENT OF DEFICIENCIES PROVIDERS PLAN OF CORRECTION pts) PREFIX (EACH naricieucv Musr BE PRECEDED BY FULL pruanx (EACH CORFEGTIVE ACTION SHOULD BE TAG necuulrorzv on Iorzurirvrne INFORMATION) mg cnoss-Raranaucan MTE uarlciaucvi 160 Continued From page 1 160 subdural hematoma. On 11/23/07 a decision was made to perfonn a procedure, and signed consent was obtained from the the patients son, for a "Twist Drill for evacuation of left subdural, possible left Burr Holes, possible craniotomy (Left)". On 11l23I07, the Chief Resident inadvertently initiated the procedure on the patients right side, and after noting the error, completed the procedure on the left side, with good affect. Review ofthe patients medical record revealed no evidence that any staff member present during the procedure verified appropriate documentation in accordance with hospital policy. There is no evidence the patient's history physical, preoperative note, si ned consent form, or CT scans were reviewed prior to procedure initiation, although all such fom1s existed. The hospital Risk Manager stated the nurse was a travel nurse and not familiar with the procedure. 370 PATIENT CARE SERVICES 19.6 tient Care 370 Manmement . 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 Based on medi record review, policy and procedure review, and staff interview, it is detemtined that the hospital failed to provide care and senrices to all patients in accordance with the prevailing community standard of care for patient ID Findings include: Facilities Regulation STATE FORM CTDB11 Irammuurrnn mm 2 ?ra PRINTED: 11/26/2007 FORM APPROVED (X1) PRCVIDERISUPPUERICLIA (x2) consmucrncu W) SURVEY AND PLAN OF CORRECTTON NUMBER: COMPLETED A surunrus B. wwe 121 11/25/2007 ruwrs or Paovrosn on suwuzn STREET ADDRESS. CITY. STATE. ZIP CODE RHODE ISLAND HOSPITAL (X4) lp SUMMARY STATEMENT OF DEFICIENCIES Ip PLAN OF CORRECTION (xs) (EACH Musr as av Fuu. (EACH CORRECTNE Action sH0uL? BE cormsre TAG on IDENTIFYING INFORMATION) Tg; CROSS-REFERENCED TO me APPROPRIATE DATE DEFICIENCY) 370 Continued From page 2 370 Patient ID #1 had CT scans ofthe head on 11/13/07 and 11/20/07, both revealing a left subdural hematoma. On 11/23/07, the Chief Resident inadvertently initiated the procedure on the patients ri ht side (rather than the left side), and after noting the error, completed the procedure on the Ieit side. Refer to findings, 160, Section 12.2, Organization, herein. Regulation STATE FORM c7p311 Ifconrlnutlon Ihlel 3 ol'3 STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS DIRECTOR OF HEALTH OF HEALTH DIVISION OF FACILITIES REGULATION . I IN THE MATTER OF: RHODE ISLAND HOSPITAL - - IMIVIEDIATE COMPLIANCE ORDER Now comes the Director of Health of the State of Rhode Island, and pursuant Rhode Island General Laws, section 23-17-21 makes the following Findings and enters - the following Order: . 1. Rhode Island Hospital (hereinaiter the "Hospita1") is a hospital located on Eddy Street in the City of Providence, County of Providence, State of Rhode Island, which is a 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 ofthe General Laws ofthe State of Rhode Island. 2. Pursuant to regulation and as a condition of its license, the Hospital isrequired 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 commimity standard of care and in a manner that maintains the health and safety of individuals, and to ensure that patients do not undergo urmecessary and/or unwanted . procedures . . . 3. A review by the Department of Health, on 21 February 2007, indicated that the Hospital failed to provide care and services ra accordance with written - policies- and procediues pertaining to invasive procedures, and failed to provide care and services in accordance with the_prevailing community standard of care in a manner that maintains the health and safety of - individuals and services. The hospital further failed to ensure that each - patient receiving neursurgery care does not undergo urmecessary and/or . unwanted procedures. - 4. A review by the Department of Health, on 1 August 2007, indicated the hospital had continued to fail to provide neurosurgery care and services in accordance with written policies and procedures pertaining to invasive . procediues, and continued to fail to provide care and services in accordance . I with the prevailing community standard of care in a manner that maintains the I health and safety of individuals, and continued to fail to ensure that each patient receiving neurosurgery care and services does not undergo - . unnecessary and/or unwanted procedures. i 5. As a consequence of its 1 August 2007 review, the Department of Health issued an Irnrnediate Compliance Order (copy attached and made a part hereof) requiring the Hospital to undertake certain activities. I 6. On 23 November 2007 the Hospital informed the Department of Health that a neurosurgery patient had undergone an unnecessary and unwanted procedure. 1 7. A review by the Department of Health, on 25 November 2007, of a hospital report concerning a patient, and the Hospital's implementation of its adopted policies and procedures regarding the provision of *'bedside" neurosurgical procedures indicates the hospital has continued to fail to provide neurosurge1?y care and services in accordance with written policies and procedures pertaining to invasive procedures, and continued to fail to provide care and - I services in accordance with the prevailing community standard of care in a mamrer that maintains the health and safety of individuals, and continued to fail to ensrue that each patient receiving neurosurgery care and services does_ not undergo unnecessary and/or unwanted procedures. 8. The Director hereby iinds that, based on the continued failure to provide adequate care to patients receiving neurosurgery, the Hospital is not in conformance with the requirements of licensure. - 9. The Director hereby finds that the provision of services in accordance with written policy and procedure and in accordance with the prevailing community standard of care, and ensuring each patient does not undergo unnecessary and/or rmwanted invasive procedures is essential to maintain - each patient's maximum health, safety and welfare. . 10. Therefore, based on the foregoing, the Director iinds that without intervention ofthe of Health issuance of this Immediate Compliance Order, the health, safety and welfare of the patients of the Hospital will be in jeopardy. It is hereby ORDERED: Rhode Island Hospital is ordered to I. Rhode Island Hospital is ordered to assure that an attending physician be in physical attendance throughout the performance of all neurosurgical type procedures in the operating room or elsewhere in the hospital. . I 2. Rhode Island Hospital is ordered to implement forthwith a revised form known as "Procedure Note (Invasive Procedure Outside of the Operating Room". The revised form shall be required to be completed for all invasive procedures performed outside ofthe operating room [Note: See Attachment A . for the minimum list]. The form shall require separate, primary document confirmation of the correct side left versus right) and site ofthe intended procedure, at a minimum, with the relevant imaging or other study that indicated/confirmed the need for the procedure, the appropriately executed patient consent form assenting to the specific procedure, and the patient's . medical record. This form shall require separate completion by the physician and another licensed health professional other than a physician. The Hospital shall revise this form within forty-eight (48) hotus ofthe receipt of this Order and shall file any subsequent revisions of the form with the Department within _48 hours of adoption by the Hospital. . 3. Rhode Island Hospital is ordered to report any variance from the requirements established in the amended "Procedure Note (Invasive Procedure Outside of I tl1e Operating Room" (see above) relating to procedures performed outside the operating room, such as an "emergency" situation, within twenty--four (24) hours to the Department of Health through the "Incidents and Events" notification process. 4. Rhode Island Hospital is ordered to provide, no later than 15 December 2007, to the Department of Health copies of reports hom four consultants to the Hospital, including the "Peri-operative Assessment" and the three reports - hom neurosurgery consultants. 5. Rhode Island Hospital is ordered to prepare a detailed plan to educate physician staff regarding the Hospital's Policies and Procedures for assuring the right procedure at the right site for the right patient. The plan must include a detailed ongoing competency assessment component. The Hospital shall provide the plan no later than 15 December 2007. Until further notice, the Hospital shall provide the Department with quarterly reports regarding the implementation of the plan and the assessment of physician competency regarding the subject policies and procedures.- 6. This Immediate Compliance Order shall be effective immediately upon service. . Entered this 26th da ovember, 2007 By I . . Da . Dire Health, State of Rhode -Island - - Exhibit A - . 1. chesimbe - 2. Thorancentisis - . 3. - Central line placement 4. Arterial line placement 5. Joint Aspiration/inj ections 6. Craniotomy 7. Kidney biopsy 8. Nephrostomy tubes 9. Liunbar Puncture 10. Liver biopsy - - 11. Paracentisis - 12. Needle Aspiration 13. G-tube reinsertion 14. Suprapubic catheter . 15. Tracheostomy 16. Incision Drainage of abscess . CERTIFICATION OF SERVICE A copy of the within Imrnediate Compliance Order was faxed delivered to Kenneth I I Arnold, Esq., Lifespan General Counsel by the undersigned on the 26th day of November, 2007