John Ed Chambers Memorial Hospital

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on observation and interview with laboratory staff, the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 6/19/25 at 9:42am, one (of one) container of Easy Touch Meter Glucose test strips (lot 609204 AmerisourceBergen, expiration date 3/10/25) was observed in the laboratory, available for use beyond the expiraton date. C) In an interview on 6/19 /25 at 9:45am the General Supervisor confirmed that the item, identified above, had exceeded its expiration date and was available for use in the laboratory. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of the manufacturer's instruction, patient test records, and interview with staff the laboratory failed to establish a policy to ensure 2 of 3 patient lactate 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 -- samples were centrifuged within 15 minutes of collection and 1 of 3 patient ammonia samples were centrifuged within 30 minutes of collection from 4/18/25 though 5/18 /25. A) Manufacturer's instructions ("Siemens Dimension Clinical Chemistry System Flex Reagent Cartridges" Lactate, REF DF16, Issue Date 2019-04-01) for the lactate analysis performed in the laboratory, stated:"Blood is best collected without stasis in a container of sodium fluoride/potassium oxalate, followed by immediate chilling of the specimen and separation of the cells within 15 minutes." B) A query of Lactate sample turnaround time records from 4/18/25 though 5/18/25 revealed 2 of 3 samples took longer than 15 minutes from collection to result. Centrifuge times were not documented. C) Manufacturer's instructions ("Siemens Dimension Clinical Chemistry System Flex Reagent Cartridges" Ammonia, REF DF119, Issue Date 2019-04-08) for the ammonia analysis performed in the laboratory, stated:"Samples should be analyzed within 30 minutes of centrifugation." D) A query of Ammonia sample turnaround time records from 4/18/25 though 5/18/25 revealed 1 of 3 samples took longer than 30 minutes from collection to result. Centrifuge times were not documented. E) During interview 6/18/25 at 9:06am, the General Supervisor confirmed that the lab documented collection times and report times; but not centrifuge times. -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Through a review of manufacturer 's package inserts, coagulation reagent rollover studies, instrument printout, and interviews with laboratory staff it was determined the laboratory failed to enter the correct ISI for the current lot of Innovin used for performing Prothrombin Times on the Sysmex CA-600. As evidenced by: A. The laboratory uses the Sysmex CA-600 Coagulation instrument for performing Prothrombin Time coagulation tests and reporting INR (International Normalized Ratio). B. Through a review of the Siemens Innovin (package inserts) it was determined the ISI values are lot specific values that are used, along with the geometric mean normal patient value, in order to calculate the INR reported by the laboratory. C. During a tour of the laboratory on 10/5/2021 at 1030, the surveyor requested an instrument printout of the ISI currently in use with lot #549763. The ISI on the printout from the instrument was 1.00. D. In a review of the package insert for the current lot of Innovin, it was revealed the ISI was listed as 1.01 (not the 1.00 programmed into the instrument). E. The failure to use the correct ISI for the current lot of Innovin has the potential to affect all patient INR results reported. 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 No Tags No deficiency details available. 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 --