Prism Molecular

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: A. Based on record review and interview with the Laboratory Director (LD), the LD failed to be present for a reasonable period of each working day in each laboratory for which they were director for 7 of 15 months from 07/26/2024 to 11/01/2025 as required by Pennsylvania (PA) state regulations. Findings include: 1. The PA State regulation 5.22 (g) states: "A director shall be present for a reasonable period of each working day in each laboratory for which he is director." 2. On the day of survey, 01 /13/2026 at 1:58 pm, review of the Laboratory Director Visitation Forms revealed the LD failed to visit the laboratory onsite for 7 of 15 months from 07/26/2024 to 11/01 /2025. 3.The LD confirmed the findings above on 01/13/2026 at 2:30 pm. B. Based on review of laboratory records, lack of documentation, and interview with the Laboratory Director (LD), the LD/owner failed to ensure that 1 of 6 laboratory personnel met the minimum experience requirements specified in the Pennsylvania (PA) Clinical Lab Act to perform supervisory responsibilities from 03/18/2024 to the date of the survey. Findings include: 1. On the day of survey, 01/13/2026 at 1:30 pm, review of personnel credentials revealed that TP# 4 obtained a Bachelor of Science degree in Biology in August 2020. 2. Further review of laboratory records revealed that TP #4 reviewed the following documentation: - Quality Assurance Records - Quality Control Records - Temperature Records - Test Logs 3. The laboratory was unable to provide the acceptable documentation of 6 years' experience for TP#4 (CMS 209, dated 01/12/2026) required to perform the duties of a supervisor in the state of Pennsylvania from March 18, 2024, to day of the survey. 4. TP# 4 confirmed the findings above on 01/13/2026 at 02:00 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 2 -- D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on lack of maintenance records, observation and interview with the Laboratory Director (LD), the laboratory failed to perform and document the maintenance and function checks as defined by the manufacturer for 4 of 4 traceable timers for assay procedures, 5 of 5 traceable monitoring hygrometers and 7 of 7 traceable thermometers used to ensure acceptable storage and operating temperatures were met in the Bacteriology/Virology departments from 03/02/2025 to 01/13/2026. Findings include: 1. On the day of the survey, 01/13/2026 at 2:00pm, the laboratory failed to provide documentation of maintenance and function checks performed for the following: in bacteriology/virology departments in 2025 and 2026. - 5 of 5 Room Temperature thermometer (s/n 230428035, 230428032, 230428036, 230428037, 230428034) due 23 Jun 2025 -7 of 7 Refrigerator thermometer (s/n 230429136, 230429119, 230429146, 230429110, 230429138, 230429148, 230249,129) due 26 Jun 2025 - 4 of 4 Traceable timers (s/n 230150483, 230150424, 230150615, 23015483) due 02 Mar 2025 2. The LD confirmed the above findings on 01/13/2026 at 2:30 pm. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the laboratory director (LD), the LD failed to ensure that verification procedures were established and performed to ensure the laboratory information system (LIS) implemented performed acceptably before reporting patient test results from 12/07/2023 to the date of the survey. Findings Include: 1. On the day of survey, 03/18/2024 at 12:15 pm, the laboratory failed to provide a policy and documentation of the verification procedures performed to determine if the LIS performs acceptably before reporting patient test results when the laboratory's EDEN LIS was implemented from 12/07/2023 to 03/18/2024. 2. The LD confirmed the findings above on 03/18/2024 at 01:00 pm. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records, lack of documentation, and interview with testing personnel #1 (TP), the laboratory director (LD) failed to ensure that QC programs were established and maintained to ensure the quality of services Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- provided and to identify failures in quality as they occur for microbiology testing performed on the Thermo Fisher Quant Studio 12K Flex analyzer from 02/02/2024 to the date of the survey. Findings Include: 1. The laboratory's Quality Management and Assessment Plan states, "4.2.6 Quality Standards-Standards and Controls, 4.2.6.7 If control values fall outside of defined parameters, the run is repeated." 2. On the day of the survey, 03/18/2024, the laboratory could not provide documentation for the repeated runs performed when the following control values fell outside of the the laboratory's defined parameters when microbiology testing was performed on 1 of 1 Thermo Fisher Quant Studio 12K Flex analyzer from 02/02/2024 to 03/18/2024: - 02 /02/2024: RPP Viral 2: Positive Control for Paraflu4, RV1, and RV2 - 02/20/2024: RPP Bacterial 1: L. pnuemo - 02/21/2024: RPP Viral 4: EV pan, Paraflu1, Paraflu4 3. TP # 1 confirmed the findings above on 03/18/2024 at 01:00 pm. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the laboratory director (LD), the laboratory director (LD) failed to ensure a QA program was established and maintained to ensure the quality of services provided by the laboratory from 12/07 /2023 to the date of the survey. Findings include: 1. On the date of the survey, 03/18 /2024 at 12:45 pm, the laboratory could not provide a procedure for the periodic QA evaluation performed to assess the laboratory's pre-analytical, analytical, and post- analytical processes from 12/07/2023 to 03/18/2024. 2. The LD confirmed the finding above on 03/18/2024 at 01:00 pm. -- 2 of 2 --