Summary:
Summary Statement of Deficiencies D0000 A validation survey was conducted by the Pennsylvania State Agency at Crozer Chester Med Ctr Blood Gas Lab on 01/30/2025. The laboratory was found out of compliance with the following conditions: 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 493.1409 Condition: Laboratories performing moderate complexity testing: technical consultant. 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: Based on review of the Pennsylvania (PA) clinical laboratory permit, record review, and interview with the Respiratory Therapy Director (RTD), the laboratory director (LD) failed to ensure the laboratory was in compliance with PA Department of Health (DOH) regulatory requirements for notifying the DOH of changes in Directorship and physical facilities of the laboratory from 2020 to day of the survey. Findings Include: 1. On the day of the survey, 01/30/2025 at 09:15 am, review of the Pennsylvania Department of Health Clinical Laboratory Permit revealed Laboratory Director A listed as the current Director and physical address as 15th & Upland Ave Chester, PA 19013. 2. Review of the CMS-116 provided by the laboratory listed the physical address as One Medical Center Boulevard Chester. PA 19013. and new laboratory director, LD B. 3. Review of the CMS-209 provided by the laboratory listed LD B current LD on 01/30/2025. 4. During an interview, 01/30/2025 at 09:20 am, the RTD confirmed the laboratory did not notify the PA DOH of change of Directorship and address change. D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- (c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures, operator manuals, and interview with the Respiratory Therapy Director (RTD), the laboratory failed to have a complete written procedure manual for blood gas testing performed on 2 of 2 Siemens analyzers that met the requirements of 493.1251 from 1/30/2023 to the date of the survey. Findings include: 1. On the day of the survey, 1/30/2025, at 11:30 am, review of the procedure manuals for blood gas testing revealed the operator's manuals were used to perform testing on 2 of 2 Siemens 500 blood gas analyzers from 1/30/2023 to 1/30 /2025. 2. Review of the operator's manual revealed that the test system instructions used failed to include the following requirements of 493.1251 that are specific to the laboratory: - Step by step performance of the procedure including test calculations and interpretation of results - Preparation of slides, solution, calibrators, controls, reagents, stains, and other material used in testing. - Control procedures - Calibration and calibration verification procedures. -