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Based on medical record (MR) review, document review, and interview, the facility did not ensure a NYPORTS (New York Patient Occurence Reporting Tracking System) Report and adverse event investigation were completed.

This failure placed all patients at risk for potential repeat adverse events.

Findings include:

The Operating Room (OR) Log, dated 8/1/19, noted Patient #1 had surgery for a "foreign body removal" from the right stump.

Patient #1's MR from a hospital stay on 7/31/19 - 8/16/19 identified this patient had bilateral below-the-knee (BKA) amputations during a previous hospital stay from 9/21/18-3/13/19. The results of a CT scan performed on 8/1/19 identified a "presumed drainage catheter" in the right BKA stump.

The post-operative surgical report, dated 8/2/19, documented that a "catheter" was removed.

The facility policy and procedure (P&P) titled "Incidents," last dated 9/5/19, identified a "retained object that requires return to the operating room" as a "Serious Safety Event" requiring an incident report that must be "promptly reported to the department of Risk Management."

The facility P&P titled "System Wide Process for Reporting of Never (Sentinel) Event and Other Regulatory Adverse Event Reporting", last dated 6/28/18, identified "Unintended retention of a foreign object in a patient after surgery or other invasive procedure" as a "Level 1" serious event requiring a "Root Cause Analysis" (RCA) investigation and is a "NYPORTS" reportable event.

Per interview with Staff M, (Director of Risk Management) on 9/24/19 at 11:00AM, the incident was not reported as a NYPORTS and no RCA was completed.

Based on Medical Record (MR) review and interview, the facility medical staff did not document a note for a procedure performed on a patient.

This failure did not ensure a complete and accurate patient medical record.

Findings include:

Patient #1's MR identified theat on 10/8/18, the patient underwent a right below-the-knee (BKA) amputation and a Jackson-Pratt (JP) drain insertion.

The Nursing Flowsheets, dated 10/14/18, noted that the drain was "removed by surgeon."

This documentation did not identify which surgeon removed the drain. No surgeon / physician note regarding the removal of the drain was found in the medical record.

This finding was confirmed with Staff P (Clinical Educator) on 9/24/19 at 10:30AM.

Based on MR review and interview, in 1 (one) of 1 (one) MR, the surgeon did not ensure an unintended retained foreign body was sent to pathology for inspection.

This failure placed all patients at risk for not having potentially infectious organisms identified.

Findings included:

Patient #1's MR identified that a CT scan performed on 8/1/19 noted a "presumed drainage catheter" in the patient's right BKA (Below-the-Knee Amputation) stump.

The Post-Operative Surgical Report, dated 8/2/19, documented that a "catheter" was removed. No other information was documented regarding the catheter.

Per interview with Staff M (Director of Risk Management) on 9/25/19 at 9:30AM, when asked if the retained catheter should have been sent to Pathology for inspection and evaluation, Staff M responded "I spoke with the Pathologist and he said yes, the catheter that was removed should have been sent to the lab for pathology."

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Based on medical record (MR) review, interview and document review, the facility did not ensure that: (1) In 5 (five) of 5 (five) MRs, Discharge Summaries were completed following the operative procedures; (2) In 7 (seven) of 11 (eleven) personnel files, the vendors had current health assessments; and (3) In 7 (seven) of 9 (nine) personnel files, that vendors completed mandatory education prior to operating room (OR) assignments and patient exposure.

These failures placed all patients at risk for adverse outcomes.

Findings for (1) included:

The facility policy and procedure (P&P) titled, "Rules and Regulations- Medical Staff," last revised 01/17, stated the following: "At the time of discharge, use the 'Discharge Navigator' to complete the medical reconciliation and 'After Visit Summary' which are required to facilitate a discharge."

Review of Patient #14's MR identified the following: This three year old child was an elective same day surgical admission for a Tonsillectomy and Adenoidectomy on 9/24/19. At 8:37AM, the surgical procedure was started. At 9:04AM, the surgical procedure was completed. Staff A (Surgeon) documented the Discharge Summary at 8:31AM, 6 (six) minutes prior to the start of the surgical procedure.

Similar findings of Staff A documenting the Discharge Summaries prior to the surgical procedures were found in MRs for Patient #s: 10, 13, 15 and 16.

Per interview of Staff C (Registered Nurse) on 9/25/19 at 2:30PM, Staff C confirmed these findings.
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Findings for (2) included:

The facility P&P titled "Agency Staff, Vendors, Visiting Residents, Students, Volunteers, Forensic Staff," last revised 5/14/19, stated the following: "A health assessment is required of those workers who will have direct patient exposure."

The OR's Vendor /Technician/Student Sign-In Log, dated 9/20/19, identified that Staff F (Commercial Vendor) was in an OR during a patient's surgical procedure.

Personnel File for Staff F identified that Staff F, a commercial vendor, started working in the OR on 6/2/02, but lacked evidence of a health assessment prior to patient exposure.

The same findings of OR vendors lacking health assessments prior to patient exposure were found in the Personnel Files for Staff D, E, G and H.

The OR's Vendor/Technician/Student Sign-In Log, dated 9/20/19 and 9/23/19, identified that Staff J (Commercial Vendor) was in ORs during patients' surgical procedures.

Personnel File for Staff J identified the health assessment dated 1/29/10, had not been updated within the past 9 years.

The OR's Vendor /Technician/Student Sign-In Log, dated 9/23/19, identified that Staff K (Commercial Vendor) was in an OR during a procedure.

Personnel File for Staff K identified the health assessment dated 06/13, had not been updated within the past 6 years.

Per interview of Staff B (Assistant VP/Vice President Surgical Services) and Staff L (Administration Manager of OR) on 9/24/19 at 9:00AM, Staff B and Staff L both confirmed the vendors have direct patient exposure while in the OR and agreed with the findings.


Findings for (3) included:

The facility P&P titled "Agency Staff, Vendors, Visiting Residents, Students, Volunteers, Forensic Staff," last revised 5/14/19, stated the following: "GSHMC will provide the service provider or individual with basic educational information which may include but not be limited to the topics of fire safety, personal safety, cell phone use, proper attire, hazard communication procedures and infection prevention. The service provider or individual agrees to review this information and educate its employees on these topics prior to their assignment."

Personnel File for Staff I (OR Vendor) identified that Staff I started working as a vendor in the OR on 8/15/16, but lacked evidence that he completed the mandatory programmed instruction prior to assignment.

The same lack of completion of mandatory programmed instruction prior to assignment was found in the Personnel Files for Staff D, H, J, K, N, and O.

Per interview of Staff B and Staff L on 9/24/19 at 9:00 AM, both Staff B and Staff L confirmed these findings.
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Based on medical record (MR) review, interview and document review, in 7 (seven) of 7 (seven) MRs, the facility staff did not ensure a brief operative note was completed following the operative procedures.

This failure placed patients at risk for not receiving continuity of care.

Findings include:

Review of Patient #11's MR identified the following: This five year old child was an elective same day surgical admission for a Tonsillectomy and Adenoidectomy on 9/24/19. At 9:24AM, the surgical procedure was started. At 9:34AM, the surgical procedure was completed. Staff A (Surgeon) documented the Brief Operative Progress Note at 9:18AM, 6 (six) minutes prior to the start of the surgical procedure.

The same findings of Staff A documenting Brief Operative Progress Notes prior to the surgical procedures were found in MRs for Patient #s: 10, 12, 13, 14, 15 and 16.

Per interview of Staff C (Registered Nurse) on 9/25/19 at 2:30PM, Staff C confirmed these findings.

The facility policy and procedure titled "Rules and Regulations- Medical Staff," last revised 01/17, stated the following: "In order to facilitate proper communication, a "Brief Operative Note" must be completed by the surgeon or his designee ... after an operative procedure before the surgeon leaves the recovery area."
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