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621 TENTH STREET

NIAGARA FALLS, NY 14302

PATIENT SAFETY

Tag No.: A0286

Based on document review, medical record review and interview, the facility did not ensure a) Adverse events are thoroughly reviewed and analyzed, b) Performance improvements are implemented and monitored. This has the potential for additional adverse events to occur.

Findings include:

Review of Medical Staff Bylaws dated May 5, 2013 revealed one of the purposes and functions of the medical staff departmental committees is to review New York Patient Occurrence and Tracking System (NYPORTS) events and other event reports.

Review of the Performance Improvement Plan - 2015 revealed that departmental and clinical committee quality improvement activities include evaluating adverse outcomes relative to the committee ' s specialty area/function and making recommendations for corrective actions, as well as participate in root cause analysis and implement corrective actions as required.

Review of the anesthesia record for Patient #1 dated 12/12/14 revealed the patient vomited during anesthesia induction and expired.

Interview with Staff B on 12/16/15 revealed that although a root cause analysis was conducted on the case involving Patient #1, the case was not discussed at the surgical or anesthesia medical staff committees.

Interview with Staff M on 12/16/15 revealed that Staff M did not review Patient #1's medical record despite being a member of the Anesthesia department and a participant on the root cause analysis.

Following the adverse event involving Patient #1 the facility implemented revised guidelines for preoperative fasting and nothing by mouth status with a plan for mandatory education to be provided to all nurses, anesthesiologists and surgeons. Review of inservice education documentation revealed no evidence this education was provided to the surgeons.

MEDICAL RECORD SERVICES

Tag No.: A0450

Based on medical record review and document review, medical records were incomplete for 2 of 17 closed records reviewed.

Findings include:

Review of Bylaws, Rules and Regulations for the Medical Staff dated 2013 revealed the requirement for complete discharge summaries include patient deaths. In addition, a post-operative note is required to be entered on the patient's medical record immediately after a procedure.

Review of the medical record for Patient #1 dated 12/12/14 revealed no discharge summary.

Review of the medical record for Patient # 24 dated 8/24/15 revealed no operative report.

SURGICAL SERVICES

Tag No.: A0940

Based on medical record review, document review and interview, the hospital did not ensure compliance with all aspects of patient safety. This includes the thorough review of all adverse patient events, as well as ensuring compliance with surgical and invasive procedures protocols.

Findings include:

See Tags 286 and 951.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on medical record review, document review and interview, the facility did not ensure staff compliance with the 2006 New York State Surgical and Invasive Procedure Protocol (NYSSIPP) for 5 of 27 patients. This has the potential to result in a wrong patient, wrong procedure or wrong site occurrence.

Findings include:

Review of the NYSSIPP protocol dated 2006 reveals the scheduling of surgical and invasive procedures must include the operative side/laterality, including spelling out "left", "right" and "bilateral". The surgeon must mark the operative site for all procedures involving laterality, paired organs, multiple structures or multiple levels. The marking is to be at or near the incision site so that it will be visible when the patient is draped. A special purpose wristband must be used for patients who refuse marking, neonates or problematic surgical site(s) to mark (e.g. perineum or anus) or when marking can be done only after shaving a patient ' s head prior to a neurosurgical/cranial procedure. The first and last name of the patient, a second identifier, the anatomical site and name of the procedure must be written on the special purpose wristband. Final verification of the site mark must take place during the "time out". The " time out " must be conducted in the location where the procedure will be done, after the patient is prepped and draped and just before starting the procedure. It must involve the entire operative/procedural team, use " active communication " , and be documented.

Review of facility Policy # S -10 - Verification of Patient/Procedure/Site revised 3/15/ revealed the process of site verification shall be followed for all invasive/surgical procedures. All patients having invasive/surgical procedures that involves laterality must have their site marked. If it is technically impossible for the surgical site to be visible, an alternative method should be used, such as a bracelet stating left/right placed on the corresponding arm. Once the patient has been prepped and draped and the site marking is visible, a time-out " or pause will be performed to validate correct patient, correct site, correct procedure, correct position, correct radiological exams and correct implants/instruments.

Review of the surgical booking sheets for Patient #9, date of service 10/28/15 and Patient #26, date of service 12/16/15 revealed the use of the abbreviation "R" and "L" in place of spelling out right and left as required.

Review of the Universal Protocol/Time Out Procedure Record revealed the following:
-Patient #4 underwent a left knee arthroscopy on 12/16/15. The time out procedure record revealed incomplete documentation of the time out with no surgical site marking noted.
-Patient #5 underwent lithotripsy, cystoscopy and right ureteroscopy on 12/14/15. The time out procedure record revealed incomplete documentation of the time out with no surgical site marking noted.
-Patient #19 underwent left ureteroscopy on 11/30/15. The time out procedure record revealed incomplete documentation of the time out with no surgical site marking noted.

Interview with Staff T on 12/16/15 revealed a lack of awareness related to the need for site marking on patients undergoing ureteroscopy.