Punxsutawney Area Hospital

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of competency assessment records and interview with Technical Supervisor (TS) #2, the laboratory failed to perform the competency assessment of 1 of 6 general supervisor (GS) #2 and 1 of 14 testing personnel (TP) #2 for their responsibilities performed in 2023. Findings include: 1. On the day of survey, 08/20 /2024 at 9:03 am, review of competency assessment records revealed the laboratory failed to assess the competency of GS #2 (CMS 209 personnel #2) for their supervisory responsibilities in 2023. 2. Review of records on 08/20/2024 at 9:45 am revealed the laboratory failed to assess the annual competency of TP #2 (CMS 209 personnel #2) who performed testing in microbiology, chemistry, hematology, immunohematology and immunology in 2023. 3. On the days of survey, 08/20/2024 and 08/21/2024, the laboratory could not provide competency assessment records for GS #2 and TP #2 for their responsibilities performed in the laboratory in 2023. 4. TS #2 confirmed the findings above on 08/21/2024 at 11:22am. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Based on review of proficiency testing (PT) records and interview with General Supervisor (GS) #3 (CMS 209 personnel #3), the laboratory failed to establish and maintain the accuracy of its testing procedures twice annually for chemistry and hematology testing performed in 2023 and 2024. Findings Include: 1. On the day of survey, 08/20/2024, review of the laboratory's American Proficiency Institute (API) PT records revealed the laboratory failed to verify the accuracy twice annually for the following tests performed in 2023 and 2024: -Prostate specific antigen (PSA) - Body fluid pH - Sperm morphology - Sperm motility 2. GS #3 confirmed these findings on 8 /20/2024 at 10:00 am. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: A. Based on review of the competency assessment records and interview with the Technical Supervisor (TS)#2, the laboratory failed to perform the competency assessment 1 of 5 Technical Supervisors (TS) (on the CMS 209 form, listed as personnel #2) for their supervisory responsibilities in 2021 and 2022. Findings include: 1. On the day of survey, 02/08/2023 at 09:14 am, the TS#2 could not provide a competency assessment for 1 of 5 TS (CMS 209 TS#2) for their supervisory responsibilities in 2021 and 2022 2. The TS#2 confirmed the finding above on 02/09 /2023 around 01:40 p.m. B. Based on review of competency assessment records and interview with the TS #2, the laboratory failed to perform the competency assessment at least semiannually during the first year of patient testing for 2 of 15 Testing Personnel (TP) from 08/09/2021 to the date of survey . Findings include: 1. On the day of survey, 02/08/2023 at 09:08 am, the TS#2 could not provide semiannual competency assessment records during the first year the following TP who performed high and moderate complexity test in Microbiology, Clinical Chemistry, Hematology, Immunohematology, and Immunology: - TP# 8 (CMS 209 personnel# 9) started on 08 /09/2021. - TP# 10 (CMS 209 personnel #11) started on 09/07/2021. 2. The TS#2 confirmed the finding above on 02/09/2020 around 01:40 p.m. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Laboratory Director (LD), the laboratory failed to verify twice annually the accuracy of Frozen section slide examinations performed from 10/08/2020 through the date of survey. Findings include: 1. On the day of survey, 02/08/2023 at 01:14 pm., the laboratory could not provide documentation of verification of accuracy for Frozen section slide examinations performed from 10/08/2020 to 02/08/2023. 2. The laboratory performed 1 frozen section in 2022. 3. The LD confirmed the findings above on 02/08/2023 around 01:15 pm. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: A. Based on observation of the Immunohematology laboratory and interview with Technical Supervisor (TS) #2, the laboratory failed to establish a segregated area for 4 of 4 blood types in the refrigerator from 10/08/2020 to the day of the survey. Findings include: 1. On the day of survey, 02/09/2022 at 11:11 am, observation of the Immunohematology laboratory revealed that the ABO red blood cell products were together without separation on a shelf inside the refrigerator. The stored blood products did not have a separate area in a way to prevent mix-ups. 2. The laboratory stored the following blood units in the refrigerator: - 6 units of O positives - 3 units of O negatives - 6 units of A positives - 4 units of A negatives - 1 unit of AB positive 3. The laboratory's immunohematology annual test volume in 2022 was 2,697 tests. 4. TS #2 confirmed the findings above on 02/09/2023 around 1:40pm. B. Based on Blood Bank temperature record review and interview with the Technical Supervisor (TS) #2, the laboratory failed to follow policy and document

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on laboratory personnel interview with the Laboratory Supervisor and Laboratory Manager and review of the competency records, the laboratory failed to establish written policies and procedures to assess consultant competency for 1 of 2 Clinical Consultants (CC), 2 of 3 Technical Supervisors (TS), 1of 1 Technical Consultants(TC), and 3 of 4 General Supervisors (GS), from 08/20/2018 through the date of the survey. Findings: 1. The laboratory could not produce written policies and procedures to adequately assess consultant competency from 08/20/2018 through the date of the survey 10/08/2020. 2. The Laboratory Director acted as Clinical Consultant, Technical Supervisor, and general Supervisor, from 05/09/2018, through the date of the survey. 3. Review of the competency records revealed non specific documentation of consultant competency for 3 of 3 consultants from 05/09/2018, through the date of the survey. The documentation provided failed to indicate responsibilities of each consultant position (CC, TC, TS, and GS). 4. During the survey (10:00 10/08/2020), the Laboratory Supervisor confirmed, the above findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)