St Bernards Physician Clinics, Inc

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation of the freezer during the laboratory tour, review of the Abbott i- STAT high sensitivity troponin (hs-Tnl) control package insert, January 2026 to date September 9, 2026 laboratory temperature logs, and patient results and interview with the technical consultant (TC) #1, the laboratory failed to ensure the freezer temperature was maintained as required by the manufacturer for 39 of 252 days. Findings: 1. Observation of the freezer during the laboratory tour showed 1 box of Abbott i-STAT hs-Tnl control level 1 Lot # 551199 exp 07/31/2027 and 1 box of Abbott i-STAT hs-Tnl control level 3 Lot # 571199 exp 07/31/2027 in use. 2. Review of the Abbott i-STAT hs-Tnl control package insert states "Store frozen at less than or equal to -20 degrees Celsius (-4 degrees Fahrenheit) until the expiration date printed on the box and vial labels". 3. Review of laboratory temperature logs showed "lab freezer temperature range less than or equal to -15 degrees Celsius". 4. Review of the laboratory temperature logs showed freezer temperature was not maintained as required by the manufacturer for 39 of 252 days. 5. Review of patient results showed the laboratory performs approximately 112 hs-Tnl patient tests per year. 6. Interview 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 -- with the TC #1 on September 9, 2026 at 10:30 AM confirmed the laboratory failed to ensure the freezer temperature was maintained as required by the manufacturer for 39 days. -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the urinalysis microscopic procedure, observation of the urinalysis centrifuge and interview with the laboratory director, the laboratory failed to follow instructions for urine microscopic testing. Findings: 1. Review of the urinalysis microscopic procedure showed the laboratory must centrifuge urine for urine microscopic exams between 1900-2400 revolutions per minute (RPM). 2. Observation of the urinalysis centrifuge revealed, the centrifuge spins at 3300 RPM. 3. Interview with the laboratory director on November 20, 2018 at 10:00 AM confirmed, the laboratory failed to centrifuge urine at the speed stated in the procedure manual. 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 --