Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of College of American Pathologists (CAP) proficiency testing (PT) records and interview with the laboratory manager (LM), the laboratory director (LD) /designee and testing personnel (TP) failed to sign 6 of 12 CAP PT attestation statement documents for chemistry and hematology testing performed in 2021 and 2022. Findings include: 1. The CAP PT Attestation/Use of Other Form states, " The laboratory director and the testing personnel must sign on the result form. Retain a signed copy of this page in your laboratory for your records and inspection purposes." 2. On the day of survey, 09/21/2023 at 10:00 am., review of CAP PT attestation records revealed the following 4 of 14 CAP PT attestation statement documents were not signed by the LD/designee or TP in 2021 and 2022: -2021 Chemistry: Event C - (C1) C Chemistry-General, Limited -2022 Hematology: Events A and B - (FH13) Hematology Automated Differential Series -2022 Chemistry: Event B - (C1) C Chemistry-General, Limited 3. The LM confirmed the findings above on 09/21/2023 at 02:00 p.m. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory manager (LM), the laboratory failed to ensure that the State of Pennsylvania (PA) regulations were met regarding having a supervisor on site during all normal scheduled working hours in which tests were performed in 2022, and 2023. Findings include: 1. The PA regulations (5.23(b)(1) states: "A general supervisor who meets all the requirements of subsection (a)(1), (2) or (3) and is on the laboratory premises during all normal scheduled working hours in which tests are being performed." 2. Review of the application for Exception to Section 5.22 (f) form signed by the laboratory director (LD) on 10/16/2020 states: " the laboratory director will appoint a qualified general supervisor for each laboratory who will be on-site to oversee laboratory operations during all hours in which testing is being performed and who will review quality control records on a weekly basis". 3. On the day of the survey, 09/21/2023 at 10:30 am, review of the laboratory personnel report (PA State) and personnel credentials revealed that the laboratory failed to ensure that the PA regulations were met regarding having a qualified supervisor on site during all hours of patient testing for 24 of 24 months in 2022 and 2023. 4. The LM confirmed the findings above on 09/21 /2023 at 02:00 pm. 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 the laboratory's competency assessment's and interview with the laboratory manager (LM), the laboratory failed to establish and follow a competency assessment procedure to assess the competency of 6 of 6 technical consultants (TC) for their supervisory responsibilities in 2021 and 2022. Findings Include: 1. On the day of the survey, 09/21/2023 at 9:35 am, the laboratory could not provide a competency assessment procedure to assess the competency of the following personnel for their supervisory responsibilities in 2021 and 2022: - 6 of 6 TC (CMS 209 personnel #4, #5, #8, #9, #10, and #11). 2. The laboratory could not provide site specific competency assessment documents for 6 of 6 TC. 3. The LM confirmed the findings above on 09/21/2023 at 2:00 pm. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of College of American Pathologists (CAP) Proficiency testing (PT) records, and interview with the laboratory manager (LM), the laboratory failed to document the evaluation and verification activities performed when the laboratory receives a score of less than 100% for 1 of 3 CAP PT chemistry events in 2022. Findings include: 1. On the day of the survey, 09/21/2023 at 10:16 am, review of CAP PT records revealed the laboratory failed to document the