St Bernards Physician Clinics, Inc

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based upon observation and interview the laboratory had fifty blood collection tubes that had past the date of expiration available for use. Findings follow: A) During a tour of the laboratory on 7/22/26 at 03:52 p.m., 50 BD Vacutainer Lithium Heparin 3.0 ml. blood collection tubes ( lot # 5169938, expiration date 2026-06-30) were observed next to the phlebotomy chair in the laboratory. B) In an interview on 7/22/26 at 04:00 p.m., the laboratory staff member (#2 on the form CMS 209) confirmed the tubes identified above were expired and were availble for use. 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 D5779

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: Through a review of the laboratory policy and procedure manual, lack of documentation, and interviews with laboratory staff, it was determined laboratory personnel failed to follow written procedures for verifying alert value results. Survey findings include: A. During a review of the laboratory policies and procedures it was revealed that the "Alert Values" policy states, "All Alert Values should be rechecked before calling the physician. The policy lists alert values for White Blood Cells (WBC) as less than 2.5 and greater than 20.0. B. During a review of the instrument data log for 2020 and 2021, the surveyor identified two patients with alert values as described in the Alert Values policy. One of two samples, with alert values, failed to have documentation that the test was repeated to recheck the results. Patient #2 (as listed on the patient identification worksheet) had a WBC of 21.2 reported on 12/15 /2020. There was no documentation that the test was repeated to verify the results. C. In an interview, 10:40 on 4/30/2021, the technical consultant confirmed the alert value policy had not been followed for the high WBC on 12/15/2020. 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 D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Through a review of the hematology instrument data log, a review of patient medical records and interviews with laboratory staff, it was determined the laboratory failed to ensure positive identification of the patient while performing complete blood counts. Survey findings follow: A. A review of the hematology instrument data log and patient medical records revealed two of five patients reviewed, who had complete blood counts performed in August 2018, had the wrong patient identification number (date of birth) entered into the instrument. Patient #161826, who had a complete blood count performed on 8/1/2018, was identified in the hematology instrument as patient #061526 and patient #102673, who had a complete blood count on 8/2/2018 was identified in the hematology instrument as #10267. B. In an interview at 11:40 on 9/19 /2018, laboratory employee #2 (as listed on the form CMS-209) confirmed that she had entered the patient identifiers wrong when running the samples. 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 --