Elite Primary Care Llc

Summary Statement of Deficiencies D0000 A initial survey was completed on February 12, 2025 at Elite Primary Care. Immediate Jeopardy existed for the following condition level deficiencies: 42 C.F.R. 493.1250 Condition: Analytic Systems 42 C.F.R. 493.1441 Condition: High Complexity Laboratory Director 42 C.F.R. 493.1447 Condition: Technical Supervisor 42 C.F.R. 493.1459 Condition: General Supervisor 42 C.F.R. 493.1409 Condition: Technical Consultant 42 C.F.R. 493.1487 Condition: High Complexity Testing Personnel 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 ARK Ethyl Glucuronide (ETG) assay package insert, the laboratory's performance verification study, a FUO (forensic use only) Assay letter, Emit II Plus specialty drug and the Emit II Plus Oxycodone quality control package inserts, patient test results, and interview with Testing Personnel 1, (TP1) and the Siemens Technical Applications Specialist, the laboratory failed to meet analytic system requirements for toxicology testing from July 2024 through February 2025 as evidenced by: 1. The laboratory failed to accurately perform performance verification to ensure the laboratory could result quantitative test results. Refer to D5421 2. The laboratory failed to accurately perform performance verification to include specificity and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- sensitivity for one forensic use only analyte (ETG). Refer to D5423 3. The laboratory failed to run at least 2 quantitative quality control materials per day of patient testing. Refer to 5447 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 direct observation, review of the laboratory's Sample Collection and Handling Policy, ARK Diagnostics, Inc. ARK Ethyl Glucuronide Assay (EtG) manufacturer's instructions (MI), ARK Diagnostics, Inc. ARK Fentanyl II Assay (Fent) manufacturer's instructions, SYVA EMIT II Plus Amphetamines Assay (Amp) manufacturer's instructions, and interview with Testing Personnel 1 (TP1), the laboratory failed to follow the manufacturer's instructions for specimen storage and testing requirements during July 2024 to February 2025. Findings included: 1. During tour of the laboratory on 02/12/2025 at 10:33 am, observed no centrifuge present. 2. Review of the laboratory's Sample Collection and Handling Policy stated "Samples should be stored at the appropriate temperature and conditions as specified by the protocol." 3. Review of EtG MI and Fent MI indicated urine samples must be stored refrigerated and specimens with high turbidity or visible particulate matter must be centrifuged prior to testing. 4. Review of AMP MI indicated specimens with high turbidity must be centrifuged prior to testing. 5. During interview on 02/12/2025 at 11: 11 am with TP1, they stated samples are stored at room temperature for 1 day before testing, are not checked for turbidity or particulate matter, and that the laboratory does not use a centrifuge. This confirmed the above findings. 6. The laboratory reports an estimated 2000 toxicology tests annually. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 ARK Diagnostics, Inc. ARK Ethyl Glucuronide Assay (EtG) manufacturer's instructions (MI); ARK Diagnostics, Inc. ARK Fentanyl II Assay (Fent) manufacturer's instructions; SYVA EMIT II Plus Amphetamines Assay (Amp) manufacturer's instructions; refrigerator temperature log; Beckman Au480 analyzer operations manual; lack of documentation, and interview with Testing Personnel 1 (TP1); the laboratory failed to record the temperature of the -- 2 of 13 -- storage refrigerator for 15 days in July 2024, and monitor temperature and humidity for Au480 Analyzer room for July 2024 through February 2025. Findings included: 1. During tour of laboratory on 02/12/2025 at 10:33 am, reagents for EtG, Fent, and Amp assays were observed being stored in the refrigerator. 2. Review of Etg, Fent, and Amp MI, revealed the reagents must be stored refrigerated (2 -8Celcius(C)). 3. Review of refrigerator temperature logs revealed no temperature was recorded for 15 of 31 days in July 2024 (July 17 through July 31, 2024). 4. Review of the Au480 Serial Number 2023080781 operators manual stated: a. "When the system is in operation, make sure the following requirements are met: i. The temperature of the installation room is between 18C and 32C ii. The temperature does not fluctuate more than +2C. iii. The humidity is between 20% Relative Humidity (RH) and 80% RH with no condensation." 5. The laboratory was asked to provide documentation of temperature monitoring for Au480 analyzer room. No documentation was provided. 6. Interview on 02/12/2025 at 10:55 am with TP1 indicated temperature and humidity for instrument room was not recorded for July 2024 to February 2025 which confirmed the above findings. 7. The laboratory reports an estimated 2000 toxicology tests annually. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on the laboratory's performance verification study, patient reports, and interview with a Siemens Technical Applications Specialist, the laboratory failed to accurately perform performance verification studies to ensure the laboratory could result quantitative test results for 14 of 14 analytes tested on the Beckman Coulter Au80 chemistry analyzer from July 2024 to February 2025. Findings included: 1. A review of the laboratory's performance verification study completed 12/20/2023, revealed the laboratory failed to ensure the performance specifications for accuracy and precision were completed for quantitative results. 2. A random sampling of patient reports reviewed from February 11, 2025, revealed patient results were given a quantitative value with the following reference range for all analytes tested; Reference Range = -9999999 - 100 3. During a phone interview on 02/12/2025 at 1:25 pm with the Siemens Technical Applications Specialist that performed the performance verification study for the laboratory, they stated, "The study only verified the instrument to report out qualitative results", confirming the above findings. 4. The laboratory reported performing 2000 urine toxicology test annually. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) (b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a -- 3 of 13 -- test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (b)(2)(i) Accuracy. (b)(2)(ii) Precision. (b)(2)(iii) Analytical sensitivity. (b) (2)(iv) Analytical specificity to include interfering substances. (b)(2)(v) Reportable range of test results for the test system. (b)(2)(vi) Reference intervals (normal values). (b)(2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on review of the ARK Ethyl Glucuronide (ETG) assay package insert, the laboratory's performance verification study, a FUO (forensic use only) Assay letter, patient reports, and interview with a Siemens Technical Applications Specialist, the laboratory failed to accurately perform performance verification to include sensitivity and specificity for one forensic use only test on the Beckman Coulter Au80 chemistry analyzer from July 2024 to February 2025. Findings included: 1. A review of the ARK ETG assay package insert stated the assay is for "criminal justice and forensic use only" 2. A Review of the laboratory's performance verification study completed 12 /20/2023, listed only accuracy and precision for qualitative results as performance specifications verified during the performance verification. 3. A review of a letter titled "FUO Assays" sent by Siemens Healthineers, states, "by signing the letter the facility acknowledges and understands the following: 1. [The analyte ETG] is not approved or cleared by the FDA for any purpose: 2. [The analyte ETG] is not intended for any invitro diagnostic treatment purposes ..." The laboratory director signed and dated the acknowledgment letter 11/02/2023. 4. The laboratory reported approximately 2000 ETG patient reports from July 2024 through February 2025. 5. During a phone interview on 02/12/2025 at 1:25 pm with the Siemens Technical Applications Specialist, they stated, "An acknowledgement letter about the FUO assay was sent to the laboratory and was returned signed by the laboratory director.", which confirmed the above findings. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on Emit II Plus specialty drug and the Emit II Plus Oxycodone quality control package inserts, patient test results, and interview with Testing Personnel 1 (TP1), the laboratory failed to run at least 2 quantitative quality control (QC) materials per day of patient testing for 14 of 14 analytes on the Beckman Coulter Au80 chemistry analyzer from July 2024 to February 2025. Findings included: 1. A review of the Emit II Plus specialty drug and the Emit II Plus Oxycodone quality control package inserts revealed the intended use for the quality control material is to provide positive and negative cutoff values. 2. A random sampling of patient reports reviewed from February 11, 2025, revealed patient results were given a quantitative value with the following reference range for all analytes tested; Reference Range = -9999999 - 100 3. An interview on 02/12/2025 at 1:10 pm with TP 1 confirming the above findings. 4. The laboratory reported performing 2000 toxicology test annually. D5781