Mobile Physical Medicine & Wellness Pc

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the College of American Pathologists (CAP) Proficiency Testing (PT) records and interview with Testing Personnel #1, the laboratory failed to ensure the Laboratory Director (or designee) signed the attestation statement on four out of four PT events from 2022 to 2024. The findings include: 1. A review of the CAP PT records revealed no signature by the Laboratory Director (or designee) on the attestation statements for the following events: a. 2022 UDS6-B PT Event b. 2023 UDS6-A PT Event c. 2023 UDS6-B PT Event d. 2024 UDS6-A PT Event 2. TP#1 confirmed these findings in an interview on 8-28-2024 at 11:30 AM. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the College of American Pathologists (CAP) Proficiency Testing (PT) records and an interview with Testing Personnel #1 (TP#1), laboratory failed to retain records of evaluation, scores, and reviews of PT events from 2022 through 2024. The findings include: 1. A review of the CAP PT records, revealed the lab Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- failed to retain copies of evaluation, scores, and reviews for the following events: a. 2022 UDS6-B PT Event b. 2023 UDS6-B PT Event c. 2024 UDS6-A PT Event 2. TP#1 confirmed these findings in an interview on 8-28-2024 at 11:30 AM. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the College of American Pathologists (CAP) Proficiency Testing (PT) records and an interview with Testing Personnel #1 (TP#1), the laboratory failed to ensure review of CAP evaluation and scores by the Laboratory Director (or designee) for three out of four PT events from 2022 to 2024. The findings include: 1. A review of the CAP PT revealed no evidence of evaluation, scores, and review by the Laboratory Director (or designee) for the following events: a. 2022 UDS6-B PT b. 2023 UDS6-B PT c. 2024 UDS6-A PT 2. During an interview on 8/28/24 at 12:37 PM, TP#1 stated the CAP website went down and the laboratory was not able to print 2022 UDS6-B, 2023UDS6-B and 2024 UDS6-A. The surveyor confirmed CAP website went down 8/18/24, 10 days prior to survey date. PT reports could have been accessed prior to 8/18/24. 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. (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 observation during the entrance tour, the ImmTox user manual, and an interview with Testing Personnel #1 (TP#1), the laboratory failed to ensure the correct type of water was utilized on the ImmTox analyzer as per manufacturer's instructions. This was noted from the date of the previous survey (9-1-2022) to date of the current survey (8-28-2024). Findings include: 1. During the entrance tour, the surveyor noted distilled water was utilized for the ImmTox analyzer. 2. A review of the ImmTox operator's manual revealed on page 3, "1.a. Fill water tank with de-ionized water." 3. TP#1 confirmed the above findings during an interview on 8-28-2024 at 10:15 AM. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- 2 of 6 -- -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review Urine Drug Screen 6 (UDS6) analyte package inserts, a lack of Calibration Verification (CV) records, and an interview with Testing Personnel #1 (TP#1), it was determined the laboratory failed to perform CV on UDS6 analytes on the ImmTox analyzer at least every six months. The laboratory failed to perform and document four out of four CV's due September 2022 through August 2024. Findings include: 1. A review of the UDS6 analytes package inserts revealed calibration information of less than three standards for each analyte. CLIA regulation requires analytes calibrated with less than three calibrators will require CV performed and documented at least every six months. There was no evidence of CV documentation provided during the survey. 2. TP#1 confirmed these findings during the exit conference on 8-28-2024, at 2:04 PM. D5781

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (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 reviews of installation and validation records for the Immtox analyzer (used for qualitative Urine Drug Screening), laboratory procedures, and interviews with the Testing Personnel, the laboratory failed to ensure the manufacturer's performance specifications for accuracy and precision were verified, and the Laboratory Director/ Technical Consultant's review and approval was documented before patient testing began. This affected one of one new moderate-complexity instruments in the laboratory. The findings include: 1. During a review of the Immtox records, the surveyor asked if validation studies were performed on the Immtox during the installation. The Testing Personnel stated she and another testing personnel (previously employed) had run eleven positive and eleven negative Quality Controls (QC) on 2/9 and 2/10/2021 for a total of 44 determinations, as per the procedures. The surveyor requested the procedures for review. 2. During record reviews with the Testing Personnel on 9/1/2022 at 11:20 AM, the surveyor reviewed "Verification of Accuracy-Qualitative Moderate Complexity Assays", and "Verification of Precision- Qualitative Moderate Complexity Assays". The Testing Personnel then provided the Positive and Negative QC printouts for 2/9 and 2/10/2021, however there was no evidence the raw data had been analyzed and evaluated to confirm the accuracy and precision of the tests, as stated in the manufacturer's performance specifications. The 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 -- validation and installation records further failed to include the Laboratory Director/ Technical Consultant's signature and date indicating his review and approval of the new procedures before patient testing began on 2/19/2021. 3. A review of the procedure, "Verification Protocol for Moderate Qualitative Urine Drug Screening and Validity Assays" revealed: "...3 Validity Study Overview ... 5. The Laboratory Director will review the verification data and determine the acceptability of the test system prior to the laboratory performing any patient testing. ... ...5. Evaluation and Summary of Data A summary of the verification studies and raw data will be sent to the Laboratory Director for review and approval. Each study summary will contain acceptability limits and an evaluation statement indicating whether the limits were met. ...". 4. During the exit interview on 9/1/2022 at 1:00 PM, the Testing Personnel confirmed the laboratory had failed to follow the above procedures when validating the Immtox analyzer. . D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on reviews of installation and validation records for the Immtox analyzer (used for qualitative Urine Drug Screening), laboratory procedures, and interviews with the Testing Personnel, the Laboratory Director failed to ensure the manufacturer's performance specifications for accuracy and precision were verified, with review and approval by the Laboratory Director documented, before patient testing began on 2/19 /2021. This affected one of one new moderate-complexity instruments in the laboratory. The findings include: 1. Refer to D5421. SURVEYOR IS #32558 Licensure and Certification Surveyor -- 2 of 2 --