Valley Medical And Wellness

Summary Statement of Deficiencies D0000 . The Valley Medical and Wellness laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F. R. part 493) upon completion of the recertification survey performed on January 31, 2025. The following standard-level deficiencies were cited: 493.1236 Evaluation of proficiency testing performance 493.1281 Comparison of test results . 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 observation, document review, and interview with laboratory personnel, the laboratory failed to verify the accuracy of two non-regulated Chemistry analytes at least twice annually in 2023 and 2024. Findings are as follows: 1. The laboratory performed high complexity Chemistry testing as confirmed by the General Supervisor 1 (GS1) during a tour of the laboratory at 10:05 AM on 1/31/2025. 2. Three Shimadzu 8060NX LC/MS instruments were observed as present and available for use during the tour. The laboratory performed a pain panel including the following non-regulated analytes: Xylazine p-OH-Xylazine 3. Shimadzu 8060NX LC/MS accuracy verification was required twice annually for non-regulated analytes as established within the GEN SOP Proficiency Testing Policy found in MediaLab software. 4. Accuracy of Xylazine and p-OH-Xylazine testing was verified once in 2023 as found in the CAP Proficiency Testing binder. No other verification documentation was found for these analytes in 2023. No verification documentation was found for Xylazine and p-OH-Xylazine in 2024. 5. The laboratory was unable to provide the missing verification of accuracy documentation upon request. 6. The laboratory 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 -- performed approximately 414,00 Toxicology tests annually as indicated on the Form CMS-116 provided by the laboratory on date of survey. 7. In an interview at 4:30 PM on 1/31/25, GS1 confirmed the above finding. . D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: . Based on observation, record review, and an interview with laboratory personnel, the laboratory failed to document the evaluation of the relationship of test results between three Chemistry instruments at least twice annually in 2023 and 2024. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor 1 (GS1) during a tour of the laboratory at 10:05 AM on 1/31/2025. 2. Three Shimadzu 8060NX LC/MS instruments were observed as present and available for use for Toxicology testing during the tour. 3. A twice-annual process for comparison of test results obtained from different instruments was found in the laboratory's Performing 6-month Instrument Comparability Studies for Analytical Test Systems procedure found in the MediaLab software. 4. Test result comparison documentation for the three Shimadzu 8060NX LC/MS instruments was not found for 2023 and 2024. 5. In a telephone interview with Testing Personnel 16 (TP16), GS1, and the Laboratory Director at 9:03 AM on 2/4/25, TP16 confirmed the test comparisons between the three Shimadzu 8060NX LC/MS instruments had been completed but not documented in 2023 and 2024. . -- 2 of 2 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to ensure Chemistry (Toxicology) proficiency testing was performed consistent with the number of times the laboratory routinely tested patient samples. Findings are as follows: 1. The laboratory performed Toxicology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 10/16/18 at 10:05 a.m. 2. The laboratory performed proficiency testing (PT) for analytes not available through an approved PT provider using 5C Laboratories. 3. Toxicology PT from the 5C Laboratories SK2 December 2017 event was completed by a former testing personnel and Testing Personnel 2 as indicated on laboratory testing forms. 4. In an interview on 10/16/18 at 12:30 p.m., the GS confirmed the PT had been performed by multiple testing personnel and patient specimens would not routinely be handled in this manner. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 on observation and interview with laboratory personnel, the laboratory failed 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 ensure Chemistry (Toxicology) testing materials were not used after the expiration date had been exceeded. Findings are as follows: 1. The laboratory performed Chemistry testing under the subspecialty of Toxicology as confirmed by the General Supervisor (GS) during a tour of the laboratory on 10/16/18 at 10:05 p.m. 2. Review of laboratory reagent records located in the Maintenance, SOP's Training, Supplies manual indicated the Needle Rinse had been used after the solution had expired. See below. Prep date Expiration date Subsequent prep date 01/17/18 02/17/18 04/10/18 3. Laboratory records indicated 16 days of patient specimen testing occurred between 02 /18/18 and 04/09/18. 4. In an interview on 10/16/18 at 1:40 p.m., the GS confirmed the above finding. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to establish a function check procedure and perform functions checks on all ancillary laboratory equipment. Findings are as follows: 1. Pipettors, thermometers, a centrifuge and a digital timer were observed as present and available for use during a tour the laboratory on 010/16/18 at 10:05 a.m. 2. A function check procedure for the pipettors,thermometers, centrifuge and timer was not found in the laboratory's established procedure manuals. Documentation of function checks for this equipment was not found in laboratory records. The laboratory was unable to provide a function check procedure or documentation of function checks performed since May 2017 for the above equipment upon request. 3. A hand written tag on the back of a digital timer with serial number 140653914 indicated the most recent function check had been performed 12/23/14. The original calibration date and expiration date had been removed from the manufacturer's tag. 4. In an interview on 10/16/18, at 1:55 p. m., the General Supervisor confirmed the above finding. -- 2 of 2 --