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Based on review of facility documents and staff (EMP) interview, it was determined the facility failed to ensure the TOSOH Automated Enzyme Immunoassay System AIA-360 laboratory equipment manufacture's recommendations for monthly maintenance was followed in six of six months reviewed (November 2022- April 2023) and the six-month maintenance was followed for one of one six-month period reviewed (November 2022- April 2023).

Findings include:

Review on May 9, 2023, of the TOSOH Automated Enzyme Immunoassay System AIA-360 laboratory equipment manufacturer's Operator's Manual, Revision 14 revealed "3. Monthly Maintenance Procedures 3.1 Updating Calibration Curves The length of validity of the calibration curve varies according to the item; however, most remain valid for 90 days. Assay results will be flagged with the CV flag when a calibration curve has expired. Update calibration curves as necessary. ... 5. Six-month Cycle Maintenance Procedures 5.1 Diluent and Wash Lines It is effective to clean the diluent and wash lines at the same time to clean the diluent and wash solution bottles. Note that it takes an hour. 1) Pour about a liter of purified water and 10 mL of aqueous hypochlorite into a clean reservoir. 2) Remove the tubes from the diluent and wash solution bottles and detach the filters from the tube ends. Put the tube ends into the reservoir prepared at the procedure 1). The procedures 3) - 6) should be performed as quickly as possible not to expose the metallic sensor portion to aqueous hypochlorite for a long time. 3) Perform 3: PRIME SAMPLER DILUENT on the MAINTE screen five times to fill the diluent line with aqueous hypochlorite. Next perform 5: PRIME BF WASHER on the same screen five times to fill the wash line with aqueous hypochlorite. 4) Pour about a liter of purified water into another clean reservoir and put the tube ends into this reservoir. Make sure the metallic sensor portion exposed to aqueous hypochlorite is to be washed well in purified water not to leave hypochlorous acid. 5) Leave them for about five minutes. 6) Perform 3: PRIME SAMPLER DILUENT and 5: PRIME BF WASHER on the MAINTE screen five times each to remove hypochlorous acid from diluent and wash line completely. 7) Prepare the diluent and wash solution in the cleaned diluent and wash solution bottles respectively. Attach new filters to the diluent and wash line tube ends and put them into each bottle. Be sure not to put the tube ends into the wrong bottles. 5.2 Replacing Filters for Diluent and Wash Solution Bottles Make a point of replacing the in-line diluent and wash solution bottle filters on a regular basis. Do this by removing the tubes from the diluent and wash solution bottles, detaching the filters from the tube ends and replacing them with new ones. (Product no. 0018585) 6. If AIA-360 Becomes Dirty Wet a cloth with a neutral detergent; wring well, and wipe down the dirty area of the instrument. If the instrument is very dirty, use a cloth wetted with 70% ethanol or 70% isopropyl alcohol solution. Avoid water or moisture build-up on the surface of the AIA-360 system, as it may cause the metal to rust."

Review on May 9, 2023, of the TOSOH daily, monthly and 6 months maintenance logs from November 2022 through April 2023 performed by laboratory staff revealed there were no monthly and no 6-month maintenance tasks documented.

Interview with EMP3 on May 9, 2023, at 1315 confirmed there were no monthly and no six-month maintenance tasks documented on the log and confirmed these tasks were not documented elsewhere.

1) Based on review of facility documents and staff interview, it was determined the governing body failed to reappoint medical staff every two years in two of seven credential files (CF) reviewed (CF4 and CF7); failed to prevent a physician with expired privileges from practicing in one of seven credential files reviewed (CF4); and failed to verify licensure application information prior to granting privileges in three of seven credential files reviewed (CF4, CF5 and CF7).

Findings include:

Review of the "Bucktail Medical Center Medical Staff Bylaws, Rules and Regulations," last reviewed April 2018 revealed "Article III... Section 5- Terms of Appointment Except as otherwise determined by the Board, all initial appointments to any category of the staff shall be subject to a period of observations. Each initial appointee shall be appointed on a provisional basis for a period of six (6) months. ... Reappointments to any category of the Medical Staff shall be for a period of not more than two (2) years. ... Article IV- PROCEDURE FOR APPOINTMENT AND REAPPOINTMENT ... For purposes of this Section, the term "hospital representative" includes the Board, its Directors and Committees; the Administrator or his designee; the Medical Director and all Medical Staff members, clinical services and committees which have responsibility for collecting or evaluating the applicant's credentials or acting upon his application; and any authorized representative of any of the foregoing. Processing the Application: Applicant's Burden- The applicant shall have the burden of producing adequate information for a proper evaluation of his experience, background, training, demonstrated ability, and physical and mental health status, and/or resolving any doubts about these or any of the other basic qualifications. Verification of Information: The applicant shall deliver a completed application to the Administrator or his/her designee who shall, in timely fashion, seek to collect or verify the references, licensure, and other qualification evidence submitted. The Administrator or his/her designee shall promptly notify the applicant of any problem in obtaining information required, and it shall then be the applicant's obligation to obtain required information. When collection and verification are accomplished, the Administrator or his/her designee shall transmit the applications and all supporting materials to the Medical Director. Service Action: Upon receipt, the Medical Director and Administrator shall review the applications and supporting documentation, and recommendation as to staff appointment, and if appointment is recommended, as to staff category, service affiliation, clinical privileges to be granted, and any special conditions attached to the appointment. The Medical Director will review all information prior to making their recommendation to the Board of Directors. ... Section 3- Reappointment Process Information Form for Reappointment: The Administrator shall, at least six months prior to the expiration date of the present staff appointment of each medical staff member, provide such staff member with an interval information form for use in considering his reappointment. Each staff members who desires reappointment shall, at least ninety (90) days prior to such expiration date, send his interval information form to the Administrator. ..."

Review of the facility's "Required Initial Application Documentation" checklist included the following: Current license, DEA" [Drug Enforcement Agency] "License, Current ACLS" [Advanced Cardiac Life Support] "(if applicable), Current ATLS" [Advanced Trauma Life Support] "(if applicable), Current PALS" [Pediatric Advanced Life Support] "(if applicable), Current CPR" [Cardiopulmonary Resuscitation], "PA" [Pennsylvania] "Criminal Background, FBI" [Federal Bureau of Investigation] "Finger Print, Childline, Curriculum Vitae, Liability Insurance Face sheet ... Three (3) Letters of Reference ... Diplomas, UPIN" [Unique Physician Identifier Number] "numbers, PIN" [Provider Identification Number] "numbers, CAQH" [Council for Affordable Quality Healthcare] "number, Medicare Provider number, Tax ID" [identification] "(if applicable), Taxonomy, Promise ID."

Review of CF4 on May 11, 2023, revealed CF4's privileges were appointed from January 2021 through January 2023. The privileges had expired January 2023. There was no Federal Bureau of Information fingerprint criminal background check information in CF4. CF4 was a physician likely to have contact with children. CF4's application information was not verified prior to granting privileges.

A review on May 11, 2023, of the physician schedules from February- May 2023 included physician of CF4 on the schedule and practicing since January 2023 with expired privileges on February 4-5, 2023, February 11-16, 2023, March 11-17, 2023, April 1-4, 2023, April 15-16, 2023 and May 4-6, 2023.

Review of CF5 on May 11, 2023, revealed the physician was granted privileges from January 2022- January 2024. There was no Pennsylvania Department of Public Welfare Childline criminal background check in CF5. CF5 was a physician likely to have contact with children. CF5's application information was not verified prior to granting privileges.

Review of CF7 on May 11, 2023, revealed CF7's privileges were granted from January 2021 through December 2023. This is 2-year, 11-month appointment. The maximum appointment time allowed was 2 years according to the medical staff bylaws. The National Practitioner Data Bank (NPDB) was last verified on February 10, 2021. The privileges were granted prior to the NPDB being verified on January 27, 2021. CF7's application information was not verified prior to granting privileges.

Interview with EMP2 on May 11, 2023, at 1320 confirmed the findings as above in CF4, CF5 and CF7.

Interview with EMP6 on May 11, 2023, at 1430 confirmed CF4's privileges expired in January 2023 and CF4 had practiced in the hospital on expired privileges.
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2) Based on review of facility policies, facility documents and staff (EMP) interview, it was determined the governing body failed to ensure yearly performance evaluations were completed in two of 14 personnel files reviewed (PF3 and PF12).

Findings include:

Review on May 10, 2023, of facility policy, "Employee Performance Appraisal," last review February 22, 2023, revealed "Policy: To evaluate the employee's job performance on a yearly basis, allowing for the employees to comment on their performance, understanding of the job, suggestions and goals for improvement... New employees will be evaluated after their ninety (90) working day probationary period and thereafter evaluations will be done on a yearly basis. Department Heads will be evaluated after their probationary period, which is 180 working days and thereafter on an annual basis. ..."

Review of personnel file (PF)3 conducted on May 10, 2023 revealed PF3's hire date was in April 2012. There was no documented 2022 performance evaluation.

Review of PF12 conducted on May 11, 2023 revealed PF12's hire date was in April 2018. There was no documented 2022 performance evaluation.

Interview with EMP2 on May 11, 2023, at 0930 confirmed there was no documented 2022 performance evaluation in PF12.

Interview with EMP6 on May 11, 2023, at 1245 confirmed there was no documented 2022 performance evaluation in PF3.

Based on facility documents, medical record (MR) reviews, and employee (EMP) interview, it was determined the facility failed to date and time consent forms for three out of 24 medical records (MR21, MR22, and MR24).

Findings include:

Review on May 11, 2023, of facility policy "Obtaining Informed Consent," last reviewed January 25, 2023, revealed "Policy: Informed consent must be obtained in writing, if possible, or orally from the patient or person responsible for making medical decisions for the patient in the event the patient is incompetent, unconscious or too ill to comprehend or make a decision regarding the proposed treatment/procedure. ..."

Review of MR21 on May 11, 2023, revealed the patient was admitted on December 2, 2022, to a Swing Bed. There was no date or time documented on the consent form.

Interview with EMP5 on May 11, 2023, at 1155 confirmed the findings noted above for MR21. EMP5 confirmed the date and time are to be documented at the time of the signature.

Review of MR22 on May 11, 2023, revealed the patient was admitted on May 5, 2023, to a Swing Bed. There was no date or time documented on the consent form.

Interview with EMP5 on May 11, 2023, at 1215, confirmed the findings noted above for MR22. EMP5 confirmed the date and time are to be documented at the time of the signature.

Review of MR24 on May 11, 2023, revealed the patient was admitted on May 11, 2023, to the Emergency Department. There was no date or time documented on the consent form.

Interview with EMP1 on May 11, 2023, at 1345, confirmed the findings noted above for MR24. EMP1 confirmed the date and time are to be documented at the time of the signature.

Interview with EMP1 on May 11, 2023, at 1350, confirmed the date and time are to be documented at the time of the patient or patient representative signature. EMP1 confirmed the facility consent policy does not note the date and time are to be filled in with the patient or patient representative signature, but that it should be in the policy.

Based on facility documents, medical records (MR), and employee (EMP) interview, it was determined the failed to reconcile facility deaths with the Gift of Life listings, for eight of 19 deaths (MR26, MR28, MR35, MR37, MR38, MR39, MR41, and MR42), and failed to ensure referrals were made to the Gift of Life for three of 19 deaths reviewed (MR35, MR38, and MR39).

Findings include:

Review on May 11, 2023, of facility policy, "Organ Tissue Donation," last reviewed January 25, 2023, revealed "... Procedure: 1. On or before the death of a patient the attending physician or nurse will contact Gift of Life Donor Program to determine the patient's suitability for anatomical donation. All patients must be evaluated for donor suitability by Gift of Life Program prior to the patient's attorney-in-fact or legal next-of-kin being approached about donation. The charge nurse will be responsible for contacting the Gift of Life Donor program. ... 2. Gift of Life Donor Program, in consultation with the patient's attending physician or his/her designee, will make the preliminary determination of suitability for donation. If Gift of Life Donor Program, in consultation with the patient/attending physician or his/her designee determine that donation is not appropriate based on established medical criteria, the Certification of Referral/Request Form shall be completed by the designee and placed with the patient's medical record. ... 3. If Gift of Life Donor Program, in consultation with the patient's attending physician or his/her designee, makes a preliminary determination that the patient may be suitable donor, Bucktail Medical Center shall initiate the process for requesting donation. The actual request will only be made by the Gift of Life Donor Program staff or "Designated Requesters" and will be coordinated by following the steps listed below: a. In those instances where the Charge Nurse received actual notice of opposition for donation from the patient (e.g. notation in an advance directive) attorney-in-fact, as applicable, or legal next-of-kin and the patient was not in possession of a validly executed document, a request will not be made. The Certification of Referral/Request Form will be completed and placed with the patient's medical record. ... 7. Prior to recovery of organs, tissues, or eyes, death must be pronounced and documented on the patient's medical record. In cases of organ recovery, the pronouncement of death using established medical criteria to determine total cessation of all brain function, including the brain stem (brain death), must be documented in the patient's medical record by a licensed, practicing physician according to Bucktail Medical Center procedures prior to surgical recovery. The time of death must be recorded in the patient's medical record and a death certificate completed. ..."

Review on May 11, 2023, of MR26 revealed the patient expired on June 14, 2021, per the facility ' s death summary report. The date of death on the facility ' s certificate of referral/request for anatomical donation form was June 13, 2021. The date of death on the Gift of Life list was June 13, 2021.

Interview with EMP1, on May 11, 2023, at 1410 confirmed the findings noted above for MR26. EMP1 confirmed the facility ' s death summary report, and the Gift of Life list were not reconciled in June 2021.

Review on May 11, 2023, of MR28 revealed the patient expired on October 27, 2021, per the facility ' s death summary report. The patient was not included on the Gift of Life list for October 2021.

Interview with EMP1, on May 11, 2023, at 1415, confirmed the findings noted above for MR28. EMP1 confirmed the facility ' s death summary report and the Gift of Life list were not reconciled in October of 2021.

Review on May 11, 2023, of MR41 revealed the patient ' s death was documented on the Gift of Life list for November 2, 2021. The patient did not appear on the facility ' s death summary report for November 2021.

Interview with EMP1, on May 11, 2023, at 1420, confirmed the findings noted above for MR41. EMP1 confirmed the facility ' s death summary report, and the Gift of Life list were not reconciled in November of 2021.

Review on May 11, 2023, of MR37 revealed the patient expired on March 22, 2022, per the facility ' s death summary report. The facility certificate of referral/request for anatomical donation form had a referral date of March 18, 2022. The patient ' s death was documented on the Gift of Life list as March 18, 2022.

Interview with EMP1, on May 11, 2023, at 1425, confirmed the findings noted above for MR37. EMP1 the certificate of referral/request for anatomical donation form may be filled out and sent to Gift of Life prior to the anticipated death. EMP1 confirmed the facility ' s death summary report, and the Gift of Life list were not reconciled in March of 2022.

Review on May 11, 2023, of MR42 revealed the patient ' s date of death was documented on the Gift of Life list for March 31, 2022. The patient did not appear on the facility ' s death summary report for March 2022.

Interview with EMP1, on May 11, 2023, at 1430 confirmed the findings noted above for MR42. EMP1 confirmed the facility ' s death summary report, and the Gift of Life list were not reconciled in March of 2022.

Review on May 11, 2023, of MR35 revealed the patient expired October 13, 2022. The medical record did not contain the certificate of referral/request for anatomical donation form.

Interview with EMP1, on May 11, 2023, at 1435, confirmed the findings noted above for MR35. EMP1 confirmed the certificate of referral/request for anatomical donation form was to be filled out with every death. EMP1 confirmed facility ' s death summary report and the Gift of Life list were not reconciled in October of 2022.

Review on May 11, 2023, of MR38 revealed the patient expired January 28, 2023. The medical record did not contain the certificate of referral/request for anatomical donation form.

Interview with EMP1 on May 11, 2023, at 1440 confirmed the findings noted above for MR38. EMP1 confirmed the certificate of referral/request for anatomical donation form was to be filled out with every death. EMP1 confirmed facility ' s death summary report and the Gift of Life list were not reconciled in January of 2023.

Review on May 11, 2023, of MR39 revealed the patient expired February 27, 2023. The medical record did not contain the certificate of referral/request for anatomical donation form.

Interview with EMP1 on May 11, 2023, at 1445 confirmed the findings noted above for MR39. EMP1 confirmed the certificate of referral/request for anatomical donation form was to be filled out with every death. EMP1 confirmed facility ' s death summary report and the Gift of Life list were not reconciled in February of 2023.

Based on facility documents, medial records (MR), and employee (EMP) interview, it was determined the facility failed to ensure an activity program was completed and care planned for one of three swing bed patients (MR9).

Findings include:

Review on May 11, 2023, of facility policy "Therapeutic Recreation Programming SBU," last reviewed January 25, 2023, revealed "Policy: Recreational Therapy group programs will be offered to all BMC SBU (swing bed unit) patients unless contraindicated in writing on the chart by the admitting physician. Procedure: A. All new admissions to the BMC SBU will be offered an initial leisure assessment with the TR Director and be encouraged to attend scheduled recreational programs. B. Patients have the option to refuse the initial leisure assessment to focus on their rehabilitation services with proper documentation provided by the TR Director. C. A weekly goal is put into place based on their leisure needs and the TR Director provides weekly documentation for each patient. ..."

Review on May 11, 2023, of MR9 revealed the patient was admitted on March 2, 2023, to the SBU and discharged on March 14, 2023. There was no initial leisure assessment, a weekly note, or the care planned.

Interview with EMP5, on May 11, 2023, at 1130, confirmed the findings noted above for MR9.