Integrated Wellness Md Llc Dba Nava Labs

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of testing records and email communication with the director of laboratory operations (DLO), the laboratory failed to retain instrument data from the immunoassay analyzer for at least two years. Findings: 1. The laboratory used an Access 2 immunoassay system for patient testing. 2. The instrument results for sample ID 33084, which was received on 05/17/2021, were requested during the onsite survey on 04/14/2023 then requested via email on 04/18/2023. 3. In the email response received 05/05/2023 at 6:29 PM, the DLO stated that "We no longer have this data." D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the procedure manual, the manufacturer's instrument brochure, final reports, and instrument printouts from the immunoassay analyzer; interview with Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- the technical consultant and testing personnel; and email communication with the director of laboratory operations, the laboratory failed to provide a client service manual with written instructions for clients to follow when transporting patient specimens (D5311 I) and failed to adhere to defined stability acceptability for multiple analytes and tested specimens beyond stated stability limits (D5311 II). 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 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: I. Based on review of the procedure manual and interview with the testing personnel (TP), the laboratory failed to provide a client service manual with written instructions for clients to follow when transporting patient specimens. Findings: 1. Section 2 of the "Specimen Transportation" stated that "All personnel must be knowledgeable in the proper safety and packaging for specimens transported." Section 7 stated "All staff involved in handling specimens should receive training." The procedure failed to include instructions for proper safety, packaging, and training. 2. The "Specimen Transportation" procedure failed to include instructions for who would be collecting the specimens and when the specimens would be collected and transported. 3. Review of the policies and procedure manuals showed that the laboratory did not have written instructions available to their clients that included specimen storage and preservation, conditions for specimen transportation, specimen processing, specimen acceptability and rejection, specimen referral and how to maintain the patient logbook at the offices. 4. According to the TP, specimens collected on Friday afternoons at the clinic are to be sent to a reference laboratory for testing. When the TP is on vacation the specimens are to be sent to the reference laboratory for testing. The TP confirmed that these instructions are not in the laboratory's policy and procedure manuals. 5. During the survey on 04/14/2023 at 4:40 PM, the TP confirmed that the laboratory did not have written instructions available to their clients for the transportation, and training of the staff involved in the collection of the specimens to be sent to the main laboratory. 43123 II. Based on review of the procedure manual, the manufacturer's instrument brochure, final reports, and instrument printouts from the immunoassay analyzer; interview with the technical consultant (TC) and laboratory director (LD); and email communication with the director of laboratory operations (DLO), the laboratory failed to adhere to defined stability acceptability for multiple analytes and tested specimens beyond stated stability limits. Findings: 1. The TC stated that patient specimens were stored at collection sites, transported, and stored at the laboratory at refrigerated temperatures and that no specimens were frozen. 2. The laboratory's procedure manual stated that the following analytes were stable for 24 hours at refrigerated temperatures (2-8C): vitamin B-12 and prostate-specific antigen (PSA). 3. The laboratory's procedure manual stated that the following analytes were stable for 48 hours at 2-8C: dehydroepiandrosterone sulfate (DHEA-S), estradiol, free thyroxine (free T4), follicle stimulating hormone (FSH), luteinizing hormone (LH), progesterone, prolactin, testosterone, thyroid peroxidase antibody (TPO), thyroid stimulating hormone (TSH), antithyroglobulin antibody (ATA), and severe acute -- 2 of 8 -- respiratory syndrome coronavirus 2 immunoglobulin G (SARS-CoV-2 IgG). 4. The laboratory's procedure manual stated that whole blood for complete blood counts (CBCs) was stable for 72 hours at refrigerated temperatures, however, the manufacturer's instrument specifications brochure stated that sample stability was 48 hours at room temperature for CBCs. 5. A total of six specimen reports were reviewed along with the requisitions and instrument printouts for each specimen. The DLO confirmed the time specimens were collected in an email received on 05/05/2023. For four of the six specimens, results were reported beyond the stated stability for at least one analyte. For one of the six specimens, the date of testing was not known because instrument printouts were missing: a. Sample ID 36334 was collected on 11/17/2021 at 9:52 AM, received on 11/17/2021, and tested on 11/20/2021 beginning at 7:42 PM, about 82 hours after collection. Results were reported for CBC, TSH, free T4, FSH, estradiol, DHEA-S, free testosterone, and vitamin B-12. b. Sample ID 37576 was collected on 01/21/2022 at 10:56 AM, received on 01/21/2022 and tested on 01/25 /2022 beginning at 2:21 PM, about 99.5 hours after collection. Results were reported for TSH, free T4, testosterone, free testosterone, estradiol, FSH, PSA, LH, DHEA-S, vitamin B-12, and SARS-CoV-2 IgG. c. Sample ID 58599 was collected on 10/13 /2022 at 10:42 AM, received on 10/13/2022, and tested on 10/14/2022 at 4:02 PM for vitamin B-12, about 29 hours after collection. Results were reported for vitamin B-12. d. Sample ID 63357 was collected on 03/09/2023 at 10:57 AM, received on 03/09 /2023, and tested on 03/13/2023 beginning at 5:48 PM about 102.5 hours after collection. Results were reported for CBC, TSH, free T4, ATA, TPO, FSH, estradiol, prolactin, DHEA-S, free testosterone, vitamin B-12, and SARS-CoV-2 IgG. e. Sample ID 33084 was collected on 05/17/2021 at 11:11 AM and received on 05/17/2021. The testing date and time is unknown because the instrument printouts were missing (cross-refer to tag D3031). The report was issued on 05/26/2021 and results were reported for CBC, TSH, free T4, ATA, TPO, testosterone, free testosterone, estradiol, FSH, LH, PSA, DHEA-S, prolactin, and vitamin B-12. f. In an email received on 06 /06/2023, the DLO confirmed that results from the CBC analyzer could not be printed. As of 06/06/2023, it was not determined when the CBC results from a., d., and e. listed above were run on the analyzer. 6. During the survey on 04/14/2023 at 4:45 PM, the TC and LD confirmed that patient results were reported for analytes received and tested beyond stability limits. 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: Note: This is a repeat deficiency. The laboratory was cited during the recertification survey for CLIA number 21D2117103 that was completed on 06/10/2021 for not following procedures stated in the Quality Management Plan (QMP) in particularly not performing the "Process Verification" on a quarterly basis. The completion date for implementing the laboratory's