Allegheny County Medical Examiners

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 laboratory's Procedure Manual and interview with the Laboratory Manager (LM), the laboratory failed to have a competency assessment (CA) policy for 1 of 2 Clinical Consultants, 8 of 8 Technical Consultants (TC), and 8 of 8 General Supervisors (GS) for their supervisory responsibilities in 2019, 2020, and 2021. Findings include: 1. On the day of survey, 09/14/2021, the LM could not provide a competency assessment policy to assess the competency of the following personnel from 09/14/2019 to the date of survey: - 1 of 2 CC (on CMS 209, listed as personnel #10) - 8 of 8 TS (on CMS 209, listed as personnel #2, #3, #4, #5, #6, #7, #8, and #9) - 8 of 8 GS (on CMS 209, listed as personnel #2, #3, #4, #5, #6, #7, #8, and #9) 2. The LM confirmed the finding above on 09/14/2021 around 14:20 p.m.. B. Based on record review and interview with the Laboratory Manager (LM), the laboratory failed to establish a complete procedure that includes all six components required for competency assessment for 8 of 8 testing personnel (TP) in each testing methodologies for toxicology in 2019, 2020, and 2021. Findings include: 1. On the day of survey, 09/14/2021, record review revealed the laboratory only assessed 1 of the 6 required components required for competency assessment for 8 of 8 TP through external proficiency testing samples for each testing methodologies for toxicology in 2019, 2020, and 2021 2. The LM Confirmed the finding above on 09/14/2021 at 14:20 p.m. 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 D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of calibration records and interview with technical supervisor (TS) #1 the laboratory failed to establish a maintenance protocol to ensure 7 of 7 refrigerator/ freezer Temp-Chex Thermometers were calibrated from 09/2017 to the date of survey. Findings Include: The Temp-Chex Certificate of Accuracy, under Calibration statement, states, "Periodic re-calibration or verification should be scheduled by each laboratory in accordance with its accrediting agency and/or established procedure". The Quality Assurance procedure, under 11. Refrigerator /Freezer, 11.4 "Thermometers, in which temperatures are recorded, will be checked in accordance with the quality manual". 1. On the day of survey, 03/25/2019, the laboratory's, the ACOME Quality Manual: Forensic Laboratory procedure, did not include methods of calibration, nor did the laboratory have documentation for 7 of 7 refrigerator/ freezer Temp-Chex Thermometers in use, where toxicology standards and specimen were stored from 09/19/2017 to 03/25/2019. 2. TS #1 confirmed the findings above on 03/25/2019 around 3:00 pm. 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 --