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Tag No.: A0283
Based on document review and interview, the hospital failed to use data collected and take actions for and/or follow up on identified opportunities for improvement related to events within 1 (one) department (surgery) of 1 (one) facility and failed to follow their Quality and Patient Safety Plan for report access to the agency.
Findings include:
1. Review of the Quality and Patient Safety Plan, PolicyStat ID: 9871839, last approved May 30, 2021, indicated the following:
Objectives: To identify and act on opportunities for improvement. To reduce the opportunity for harm and improve safety mechanisms.
Priorities are based on: The opportunities that have been identified based on collection and trending of data for patient populations served.
Authority and Responsibility: The Medical Staff is responsible to the Board of Trustees for maintaining a consistently highest level of quality patient care by: Addressing opportunities to improved patient care processes and cost effectiveness as part of the Quality and Patient Safety Plan.
Organization Integration: Analysis: Analysis is performed when undesirable variation occurs which changes priorities. Analysis is required for the following: Adverse events or patterns of adverse events during moderate or deep sedation and anesthesia. Hazardous conditions. Staffing effectiveness issues.
Confidentiality: Performance Improvement data and reports will be accessible only to those participating in the Quality and Patient Safety Plan, those agencies responsible for ascertaining the existence of an ongoing and effective Quality and Patient Safety Plan and the hospital's attorneys/insurance carrier.
2. Review of facility incident reports indicated the following:
Event 445488: Date: 8/24/22, entered 8/26/22. Department: Surgical Services/OR 4. Description: The anesthesia machine will not release pressure. Anesthesia was unable to safely ventilate patient. MRN: patient P11. Equipment ID (identification): 404086770. Removed from service. Resolution and outcome (R&O): submit to the Patient Safety Organization (PSO). To PSO: 9/20/22. Outcome action taken: This area was blank. Recommendation for system improvement: This area was blank. Resolution comment: This area was blank.
Event 435144: Date: 7/18/22. Department: OR 4. Description: Beach chair head malfunctioned. Once procedure completed and drapes removed, it was noted patients head was out of the holder and under pads. The patient had no support and head was laying on shoulder. R&O: submit to PSO. Outcome action taken: This area was blank. Recommendation for system improvement: This area was blank. Resolution comment: This area was blank.
Event 425443: Date 6/8/22. Department: OR 4. Description: Patient anesthetized for total knee procedure. Minutes later anesthesiologist stated problem with machine, the vaporizer was not working. Patient placed on propofol drip and oxygen administered via ambu bag so anesthesia machine could be switched. Second anesthesia machine working properly. The form lacked indication of the equipment asset identification number (IDN). R&O: submit to PSO. Recommendation for system improvement: This area was blank. Resolution comment: This area was blank.
Event 462112: Date: 11/1/22. Surgical Services. Hip fracture repair. Description: Concern for all surgery patients. I am informed the hospital has only 1-2 OR rooms going when 8 are available. I am informed this is due to inadequate staffing, loss of OR staff, higher pay elsewhere, and canceling travel OR staff due to cost. The hospital must provide better OR availability to surgeons and their patients. I have seen many surgeries delayed for both doctors and patients. I reported this delay as a harm because patient lost and extra day, cost, and increased risk of harm. R&O: submit to PSO. Outcome action taken: This area was blank. Recommendation for system improvement: This area was blank. Resolution comment: This area was blank.
Event 461953: Date 11/1/22. Procedure delay. Description: Patient scheduled for surgery on 11/1/22. Surgery cases taking longer than scheduled and emergency cases moved procedure to late evening. Doctor concerned about staff working 12-18 hours. Moved case to 11/2/22 for staff safety. Patient is elderly and laying in hospital another night with fractured hip.
3. Review of equipment preventive maintenance (PM) and repairs lacked evidence of Biomedical Engineering having performed maintenance following the 8/24/22 event, removed the device from service, and/or completed a final review of the medical equipment issues pertaining to Machine 404086770 identified in event ID 445488 on 8/24/22. The hospital lacked evidence of PM and/or repairs to the beach chair associated with event 435144.
4. Review of Patient Safety Quality Council meeting minutes dated 10/12/22 lacked documentation of evaluation of and/or actions taken for any of the events/incidents.
5. On 11/30/22 beginning at approximately 1:45 PM, A1, Quality Director, when asked for evidence of review/evaluation of event reports/unusual occurrences, indicated a Quality Improvement process was performed and review was sent to the appropriate area/committee for review and those minutes were peer protected and could not be reviewed for this survey. When asked how it could be determined that opportunities for improvement were identified and acted upon, A1 stated that information was peer protected and could not be reviewed by the surveyor.
Tag No.: A0392
Based on document review and interview, it could not be determined that the hospital surgery department ensured for adequate numbers of competent, licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed between the dates of 10/30/22 and 11/5/22.
Findings include:
1. Review of the policy Plan for Provision of Care and the Scope of Services, effective 12/6/2021, indicated the following:
Staffing Plan/Requirements: Registered Nurse (RN) - Perioperative Director; RN/Circulator; RN PACU (Post-Anesthesia Care Unit)/Ambulatory Surgery/Pre-Admission Testing; Clinical Coordinator (RN); Surgical Technologists (ST); Sterile Processing Technicians (SPT). Staffing patterns are flexible, and variable based upon patient care needs. The Perioperative Director ensures the coverage of the schedule and makes daily staffing assignments.
Categories of Departmental Staff and Qualifications: Pre-Operative (Pre-Op), Post-Operative (PACU): Two (2) RN, one competent in Phase I post-anesthesia nursing are in the same unit where the patient is always receiving Phase I level care. Two competent personnel, one of whom is a RN competent in Phase II post anesthesia nursing are in the same unit where the patient is receiving Phase II level of care. Two competent personnel, one of whom is a RN where the patient is receiving Pre-operative and Extended Care level of care. Intraoperative: RN. A circulator may only circulate one case at a time. The need for additional RN and support staff is dependent on the patient acuity and patient census.
2. Review of the One Week Staffing Pattern Worksheet for 10/20/22 through 11/5/22 lacked evidence of patient acuities. Unable to determine adequacy of staffing due to lack of acuity for patient census/cases performed.
3. Review of the surgery staffing schedule for the main OR (Operating Room) for 10/20/22 through 11/5/22 indicated 6 of 12 staff scheduled/working were agency/contract staff [Registered Nurse (RN), N6; RN, N7; RN, N8; Surgical Technician (ST), N9; ST N10; and N17 (classification not provided)].
4. Review of personnel files for N6, N7, N8, N9, N10, and N17 lacked documentation of job/department specific orientation and/or competency observations/evaluations for the contracted/agency staff members.
5. On 11/29/22 beginning at approximately 3:00 PM, A5, Chief Medical Officer (CMO) indicated the hospital surgery department did not have a staffing matrix. A5 indicated that based on types of cases, patient acuity levels, fluctuation in schedules, and surgeon preferences the number of staff needed per day varied. The CMO verified the department did not maintain documentation of surgical patient acuity and/or staffing needs per day/shift/case.
Tag No.: A0438
Based on document review and interview, the hospital failed to ensure for an accurately written medical record by failing to include details of surgical events in the medical records for 2 of 3 patients (P11 and P13) who had an event during surgery.
Findings include:
1. A. Review of the Medical Staff Bylaws, dated/approved/final 11/5/2021, indicated the following; All clinical entries in the patient's medical record (MR), shall be accurately and promptly dated, timed, authenticated and legible.
B. Review of the Event Reporting policy, PolicyStat ID: 10842562, last approved 12/7/21, indicated the following: The fact that an event report has been filed must not be mentioned in the MR. The same facts may be included in the medical record where appropriate.
2. Review of facility incident reports indicated the following:
Event 445488: Date: 8/24/22, entered 8/26/22. Department: Surgical Services/OR 4. Description: The anesthesia machine will not release pressure. Anesthesia was unable to safely ventilate patient. (RE: patient P11).
Event 435144: Date: 7/18/22. Department: OR 4. Description: Beach chair head malfunctioned. Once procedure completed and drapes removed, it was noted patients head was out of the holder and under pads. The patient had no support and head was laying on shoulder. (RE: patient P12)
Event 425443: Date 6/8/22. Department: OR 4. Description: Patient anesthetized for total knee procedure. Minutes later anesthesiologist stated problem with machine, the vaporizer was not working. Patient placed on propofol drip and oxygen administered via ambu bag so anesthesia machine could be switched. Second anesthesia machine working properly. (RE: patient P13)
3. A. The MR of patient P11 indicated the patient had a right total hip arthroplasty on 8/24/22. The MR lacked documentation of complications and/or issues related to the patient and/or equipment.
B. The MR of patient P13 indicated a left total knee arthroplasty was performed on 6/8/22. The MR lacked documentation of complications and/or issues related to the patient and/or equipment.
4. On 11/30/22 beginning at approximately 5:00 PM, A1 verified MR findings for P11, and P13.
Tag No.: A0941
Based on document review and interview, the hospital failed to ensure equipment used in surgical services was maintained in an organized manner for two types of equipment (anesthesia machines and beach chairs).
Findings include:
1. A. Review of the policy Reporting Medical Equipment Incident, PolicyStat ID: 8096738, last approved 8/26/2020, indicated the following:
Procedures: The manager is responsible for the completion of the report and investigation within three days. The Biomedical (biomed) Engineering Department is responsible for final review of the medical equipment issues.
B. Review of the policy titled Equipment Maintenance, PolicyStat ID: 8272583, last approved 7/1/2020, indicated personnel were to place an orange out-of order tag on defective equipment and call biomed or maintenance for repair.
C. Review of the policy titled Criteria for Alternate Operations of Medical Equipment, last approved 1/31/2020, indicated that the hospital uses criteria for the safe operating of medical equipment that will maintain in an alternate method and that documentation of written criteria for these devices will be maintained by the Biomedical Engineering Department and included in the Maintenance Management System.
2. Review of facility incident reports indicated the following:
Event 445488: Date: 8/24/22, entered 8/26/22. Department: Surgical Services/OR 4. Description: The anesthesia machine will not release pressure. Anesthesia was unable to safely ventilate patient. Equipment ID (identification): 404086770. Removed from service. Resolution and outcome (R&O): submit to the Patient Safety Organization (PSO). To PSO: 9/20/22. Outcome action taken: This area was blank. Recommendation for system improvement: This area was blank. Resolution comment: This area was blank.
Event 435144: Date: 7/18/22. Department: OR 4. Description: Beach chair head malfunctioned. Once procedure completed and drapes removed, it was noted patients head was out of the holder and under pads. The patient had no support and head was laying on shoulder. R&O: submit to PSO. Outcome action taken: This area was blank. Recommendation for system improvement: This area was blank. Resolution comment: This area was blank.
3. Review of equipment preventive maintenance and repairs lacked documentation of Biomedical Engineering having performed maintenance, removed the device from service, and/or completed a final review of the medical equipment issues pertaining to Machine 404086770 identified in event ID 445488 on 8/24/22. The hospital lacked documentation of PM and/or repairs for beach chairs.
4. A. On 11/30/22 beginning at approximately 3:30 PM, A1 indicated the biomedical engineers did not have the chairs on an alternate or other PM schedule. A1 verified no PM was performed on surgical beach chairs and the surgery department had 2 beach chairs.
B. On 11/30/22 beginning at approximately 4:45 PM, A15, Biomedical Team Leader verified the department did not have documentation of repair for anesthesia machine related to Event 445488 and/or tracking, trending, and analysis records.