Epiphany Family Services

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (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: Based on review of reagent package inserts (PI), review of policies and procedures, and interview with the Technical Consultant (TC) on 3/11/26, the laboratory failed to follow manufacturer instructions for 4 of 6 assays performed on urine samples on the Horiba Pentra C400 analyzer. Findings: The laboratory's test menu consists of 6 assays. Review of the reagent PI for each assay revealed the following: 1. The PI titled ABX Pentra Creatinine 120 CP explained the reagent "should be used according to this notice. The manufacturer cannot guarantee its performance if used otherwise." Under the section titled Specimen on page 2, the manufacturer lists sample types, including serum, plasma, and "Fresh centrifuged urine." 2. Three PIs titled DRI Ethyl Alcohol Assay, DRI Opiate Assay, and DRI Cannabinoid Assay each instructed ," Samples within a pH range of 3 to 11 are suitable for testing with this assay." 3. The PIs titled DRI Benzodiazepine Assay and DRI Cocaine Metabolite did not include a statement concerning a suitable pH. Review of the "Patient Test Management and Specimen labeling/handling and retention" policy revealed the following: 1. Absence of steps which include centrifuging urine prior to performing the Creatinine assay. 2. Absence of steps which include obtaining urine pH to determine sample suitability for performing Ethyl Alcohol, Opiate, and Cannabinoid assays. During an interview at approximately 11:45 a.m., the TC confirmed the laboratory does not use a centrifuge 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 -- to process its urine samples. They also confirmed the absence of a method to determine urine pH. The TC said the reagents have been in use since the Horiba Pentra C400 was installed in December 2024. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; This STANDARD is not met as evidenced by: Based on review of reagent package inserts, lack of a centrifuge, lack of pH testing, and interview with the Technical Consultant (TC), the Lab Director failed to ensure personnel are performing the laboratory's test methods as indicated by the manufacturer to obtain reliable results. Findings: 1. Review of reagent package inserts revealed test method steps that were not being performed, including: a. Utilization of fresh centrifuged urine specimens for the Creatinine assay. b. Determination of urine pH to ensure results are within pH range 3 to 11 for Ethyl Alcohol, Opiate, and Cannabinoid assays. 2. During a tour of the laboratory at approximately 11:30 a.m., the surveyor did not observe a centrifuge or any test method to detect urine pH. 3. During an interview at approximately 11:45 a.m., the Technical Consultant (TC) confirmed there was no centrifuge or pH test available for use by testing personnel. See D5411. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of policies and procedures, review of specimen logs, observation, and interview with testing personnel (TP) on 7/16/25, the laboratory failed to follow its policy for storing patient urine specimens prior to analysis on the Horiba Pentra 400. Findings: Review of the "Patient Test Management and Specimen labeling /handling and retention" policy revealed, "... If the specimen will not be tested within two hours it is placed in the refrigerator at 2-8 C for up to 3 days, if testing will be longer than three days the specimen is placed in the freezer at -20 C or colder. ..." Review of 2024 and 2025 specimen logs revealed patient urine specimens were collected and frozen on the same date, then tested on the Horiba Pentra 400 on a future date. For example, on 6/4/25, 13 of 13 patient specimens were collected and frozen, then thawed for "in-house" testing on 6/16/25. During a tour of the lab at approximately 11:30 a.m., the surveyor observed a thermometer in a black freezer indicating a temperature of -10 degrees Celsius (C). There were four empty, unlabeled boxes in the freezer. The freezer did not contain patient specimens at the time of the observation. During interview at approximately 3:40 p.m., TP #1 stated the boxes were used to store patient specimens if they cannot be tested on the date of collection. She stated the boxes sometimes get mixed up and newer specimens are tested before older ones. 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 -- D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on lack of documentation in the Horiba Pentra 400 validation records, review of reagent assay sheets, and interview with the Technical Consultant (TC) on 7/16/25, the laboratory director failed to ensure all instrument validation requirements, specifically specimen stability studies, were met prior to patient testing. Findings: Review of the Horiba Pentra 400 validation records revealed no documentation of specimen stability studies. Review of assay sheets for tests performed on the Horiba Pentra 400, including Creatinine (CREA), Cocaine (COC), Alcohol (ETOH), Opioids (OPI), Tetrahydrocannabinol (THC), and Benzodiazepine (BENZO) revealed 5 of 6 assay sheets contained no information about specimen stability at freezing temperatures. The ABX Pentra Creatinine 120 CP assay sheet stated urine specimens are stable "... At -20 degrees C: 6 months. ..." During an interview at approximately 2: 58 p.m., the TC verified that specimen stability studies were not performed during validation of the Horiba Pentra 400 analyzer. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of personnel records, review of the laboratory's policies and procedures, review of 2021 and 2022 American Proficiency Institute (API) proficiency testing records, and interview with staff 11/9/22, the laboratory failed to ensure that 1 of 2 testing personnel (TP #2) who perform patient testing participated in proficiency testing. Findings: Review of personnel records revealed TP #1 and TP #2 were trained in July 2021 to perform patient urine drug screens on the Easy RA. Review of the laboratory's policy "LABORATORY PROTOCOL - PROFICIENCY TESTING SURVEYS" revealed "... Testing of Proficiencies should be rotated among the testing personnel to assure each TP is competent. ..." Review of 2021 and 2022 API proficiency testing records revealed TP #1 tested all samples for the 2021 Chemistry Miscellaneous 2nd event, the 2022 Chemistry Miscellaneous 1st event, and the 2022 Chemistry Miscellaneous 2nd event. During the exit conference at approximately 1:30 p.m., TP #1, TP #2, and the technical consultant stated that TP #1 and TP #2 would rotate the testing of proficiency samples in 2023. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory procedure and surveyor observation 11/9/22, the laboratory failed to follow the established specimen labeling procedure for 6 of 8 specimens observed in laboratory refrigerator. Findings: Review of laboratory procedure "Specimen Collection" revealed "#5. Place the following information on the collection container's label: Date of collection...Patient's name and second identifier....Collector's initials...". At approximately 12:30 p.m., surveyor observed 8 urine specimens on shelf in laboratory refrigerator. 6 of the 8 labels on the urine specimens failed to include the date of collection: Sample 1 - date of birth (DOB) 9/17 /57, Sample 2 - DOB 10/27/60, Sample 3 -DOB 5/11/89, Sample 4 - DOB 7/18/85, Sample 5 -DOB 5/30/98 and Sample 6 - DOB 11/16/85. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)