Gb Diagnostics

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted on August 19, 2024, at GB Diagnostics found the laboratory to be not in compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements, with standard deficiencies cited. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the Clinical Laboratory Improvements Amendments (CLIA) Application for Certification CMS - 116, lack of documentation, and interview with testing personnel (TP1), the laboratory failed to verify the accuracy at least twice annually for 6 of 6 of their non-regulated analytes since last inspection. Findings included: 1. A Review of CMS - 116, the laboratory reported testing the following analytes: - Zonulin - Diamine Oxidase - Histamine - 8 - OhdG - Total Bile Acids - Indican 2. Laboratory was asked to provide documentation they were verifying the accuracy of their analytes at least twice annually. No documentation was provided. 3. An Interview on 08/19/2024 at 11:30 am with TP1, confirmed the above findings. 4. The laboratory reported performing 11,300 chemistry tests annually D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. 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 -- (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 direct observation, review of manufacturer's instructions, refrigerator and freezer temperature logs, and interview with testing personnel (TP1), the laboratory failed to ensure the freezer temperature was within manufacturer's specifications for 4 of 4 of the Elabscience ELISA (enzyme - linked immunosorbent assay) testing plates since last inspected. Findings included: 1. During a tour of the laboratory on 08/19 /2024 at 10:00 am the following ELISA testing plates were observed being stored in the freezer: - 1 package of Elabscience HIS ELISA Plate: Lot WE03ZR44856, Expiration 05/14/2025 - 1 package of Elabscience 8 - OHdG ELISA Plate: Lot WS09D2DB7332 Expiration 06/21/2025 - 1 package of Elabscience Human DOA ELISA Plate: Lot WA0382T27896 Expiration 07/24/2025 - 1 package of Elabscience Human Zonulin ELISA Plate: Lot WA04TJ049152 Expiration 07/24/2025 2. A review of the manufacturer's instruction listed the following temperature requirements for storage: - Elabscience HIS ELISA Plate: Storage at 4 - (-20) C (Celsius) - Elabscience 8 - OHdG ELISA Plate: Storage at 4 - (-20) C - Elabscience Human DOA ELISA Plate: Storage at 4 - (-20) C - Elabscience Human Zonulin ELISA Plate: Storage at 4 - (-20) C 3. A random sampling review of the laboratory's refrigerator and freezer logs in 2024 revealed the following dates room temperature fell out of the manufacturer's specified temperature ranges: - 06/27/2024: Freezer Temperature = - 24 C - 06/28/2024: Freezer Temperature = - 24 C - 06/29/2024: Freezer Temperature = - 22 C - 06/30/2024: Freezer Temperature = - 23 C - 07/19/2024: Freezer Temperature = - 26 C - 07/20/2024: Freezer Temperature = - 27 C - 07/21/2024: Freezer Temperature = - 24 C - 07/22/2024: Freezer Temperature = - 25 C - 07/23 /2024: Freezer Temperature = - 26 C - 08/04/2024: Freezer Temperature = - 22 C - 08 /05/2024: Freezer Temperature = - 22 C 4. An interview on 08/19/2024 at 11:30 am TP1 stated, freezer range is kept below - 20 C, confirming the above finding. 5. The laboratory reported performing 11,300 chemistry tests annually -- 2 of 2 --

Summary Statement of Deficiencies D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on the number and severity of deficiencies cited for services provided in the subspecialty of General Immunology, the laboratory failed to meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. See D5217, D5291, D5391, D5400, D5403, D5423, D5425, D5441, D5447, D5775, D5791, D5805 and D5891 for findings. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on the number and severity of deficiencies cited for services provided in the subspecialty of Routine Chemistry, the laboratory failed to meet the requirements specified in 493.1230 through 493.1256 and 493.1281 through 493.1299. See D5217, D5291, D5391, D5400, D5403, D5423, D5425, D5441, D5447, D5775, D5791, D5805 and D5891 for findings. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 16 -- CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of accuracy verification documentation for review for the laboratory- developed tests (LDT) performed by the laboratory and interview with the technical supervisor, the laboratory failed to verify the accuracy of testing performed under the sub-specialties of general immunology and routine chemistry at least twice annually during 2021 and 2022. Findings include: 1. The laboratory began patient testing using a LDT ELISA (enzyme-linked immunosorbent assay) test method on 6/15/2020 under the sub-specialties of General Immunology and Routine Chemistry, with an approximate annual test volume of 7,190. The laboratory performed and reported approximately 12,112 patient tests between 6/15/2020 and the survey date, 1/10/2023. The laboratory's test methods for the testing performed are not FDA-cleared or approved. 2. The laboratory performs their LDT for the following analytes using the ELISA test method: DAO (Diamine Oxidase), Zonulin Family Peptides (Zonulin FP), Histamine, 8-OHdG, Creatinine, Total Bile Acids (TBA), Indican, IgG FS-88 (88 panel Food Sensitivity test), and Candida (IgG, IgA, IgM). 3. No documentation was presented for review during the survey to indicate the laboratory verified the accuracy of each LDT test referenced above at least twice annually during 2021 and 2022. 4. At 12:59pm on 1/10/2023, the technical supervisor interviewed stated the laboratory never verified the accuracy of their tests from the time the laboratory began patient testing through the date of the survey (1/10/2023). D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of quality assessment (QA) policies and procedures and interview with the technical supervisor, the laboratory failed to establish QA policies and procedures to monitor, assess, and when indicated, correct problems identified in the general laboratory systems. Findings include: 1. No QA documentation was provided for review during the survey conducted on 1/10/2023 to indicate the laboratory established policies and procedures to monitor, assess and, when indicated, correct problems identified in the general laboratory systems. 2. The technical supervisor interviewed on 1/10/2023 at 1:50pm confirmed the laboratory failed to provide documentation of an established QA policy and procedure to monitor, assess and correct problems identified with the general laboratory systems. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems -- 2 of 16 -- identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on lack of quality assessment (QA) policies and procedures and interview with the technical supervisor, the laboratory failed to establish QA policies and procedures to monitor, assess, and when indicated, correct problems identified in the preanalytic systems. Findings include: 1. No QA documentation was provided for review during the survey conducted on 1/10/2023 to indicate the laboratory established policies and procedures to monitor, assess and, when indicated, correct problems identified in the preanalytic systems. 3. The technical supervisor interviewed on 1/10/2023 at 1:50pm confirmed the laboratory failed to provide documentation of an established QA policy and procedure to monitor, assess and correct problems identified with the preanalytic systems. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the number and severity of deficiencies cited for quality practices identified during the survey conducted on January 10, 2023, it was determined that the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283, and failed to monitor the overall quality of the analytic systems and correct problems as specified in 493.1289 for patient testing performed by the laboratory in the sub-specialties of general immunology and routine chemistry. See D5403, D5423, D5425, D5441, D5447, D5775, and D5791 for findings. 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)