Jemin N Gajipara Md Pa

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. 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 surveyor observation, review of American Association of Bioanalysts (AAB) proficiency testing (PT) results in 2023 and 2024, and confirmed in interview, the laboratory director and testing personnel failed to attest to the routine integration of PT samples into the patient workload for three of three in 2023 and two of two performed in 2024. Findings included: 1. During a tour of the laboratory on 06/04 /2024 at 10:00 AM, the surveyor observed one LCMS analyzer (Serial Number: ARZ1610804) and one IR 500 chemistry analyzer (Serial Number: 140302 performing urine drug testing on patient samples. 2. Review of AAB PT results in 2023 and 2024 revealed no attestation signature pages included in the laboratory PT documentation. Further review of PT documentation revealed the following: "Reporting Results ...2. Be sure to keep attestation statements printed from your online reporting form ...The attestation statements must be signed for each analyte by the analyst performing the procedure and kept in your files for inspection purposes. In addition to analysts signatures, the director or director's designee must sign only once for each reporting form." The surveyor requested the above attestation documentation on 06/04/2024 at 11:40 AM, and none was provided. 3. In an interview on 06/04/2024 at 11:45 AM, testing person 1 (TP-1) stated they did not keep the PT attestation pages in 2023 and 2024. This confirmed the laboratory director and testing personnel failed to attest to the routine integration of PT samples into the patient workload for three of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- three in 2023 and two of two performed in 2024. Word Key LCMS- Liquid Chromatography Mass Spectrometry D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on surveyor observation, review of College of American Pathologists (CAP) proficiency testing (PT) results in 2023 and 2024, and confirmed in interview, the laboratory failed to document review of analytes not scored by the proficiency program for one of two in 2023 and one of one performed in 2024. Findings included: 1. During a tour of the laboratory on 06/04/2024 at 10:00 AM, the surveyor observed one AB Sciex LCMS analyzer (Serial Number: ARZ1610804) performing urine drug testing on patient samples. 2. Review of CAP PT records in 2023 and 2024 revealed the following: Drug Monitoring for Pain Management PT (DMPM) I. DMPM-A 2023 a. Method: Norfentanyl Specimen: DMPM-01 Your Grade: See Note 28 b. Method: Methadone Metabolite Specimen: DMPM-02 Your Grade: See Note 28 c. Method: Hydrocodone Specimen: DMPM-03 Your Grade: See Note 28 d. Method: Norhydrocodone Specimen: DMPM-03 Your Grade: See Note 28 II. DMPM-A 2024 a. Method: Oxycodone Specimen: DMPM-01 Your Grade: See Note 28 b. Method: Noroxycodone Specimen: DMPM-01 Your Grade: See Note 28 c. Method: Methamphetamine Specimen: DMPM-01 Your Grade: See Note 28 d. Method: Gabapentin Specimen: DMPM-02 Your Grade: See Note 28 e. Method: Norfentanyl Specimen: DMPM-02 Your Grade: See Note 28 f. Method: Morphine Specimen: DMPM-02 Your Grade: See Note 28 g. Method: Methadone Metabolite Specimen: DMPM-03 Your Grade: See Note 28 h. Method: Naloxone Specimen: DMPM-03 Your Grade: See Note 28 Review of CAP PT Results Booklet revealed the following: "Actions Laboratories Should Take when PT Result is Not Graded ...Code 28 Action Required: ...Document that the laboratory performed a self-evaluation and compared its results to the proper statistics supplied in the participant summary." The surveyor requested documentation of the above for all analytes not scored by the proficiency testing program in 2023 and 2024 on 06/04/2024 at 11:45 AM. No documentation was provided. 3. In an interview on 06/04/2024 at 11:45 AM, the laboratory director confirmed the laboratory failed to document review of analytes not scored by the proficiency program for one of two in 2023 and one of one performed in 2024. Word Key LCMS- Liquid Chromatography Mass Spectrometry 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: I. Based on surveyor observation, review of laboratory policy, American Association -- 2 of 4 -- of Bioanalysts (AAB) proficiency testing (PT) results, and confirmed in interview, the laboratory failed to follow their own policy for analytes not scored by the proficiency program for three of three in 2023 and two of two performed in 2024. Findings included: 1. During a tour of the laboratory on 06/04/2024 at 10:00 AM, the surveyor observed one LCMS analyzer (Serial Number: ARZ1610804) and one IR 500 chemistry analyzer (Serial Number: 140302) performing urine drug testing on patient samples. 2. Review of laboratory policy, "Proficiency Testing" (Reviewed by the laboratory director on 06/03/2024) revealed the following: " ...Procedure: ...All attestation forms must be signed and dated by the testing personnel and medical director/designated individual." 3. Review of AAB PT results in 2023 and 2024 revealed no attestation signature pages included in the laboratory PT documentation. Further review of PT documentation revealed the following: "Reporting Results ...2. Be sure to keep attestation statements printed from your online reporting form ...The attestation statements must be signed for each analyte by the analyst performing the procedure and kept in your files for inspection purposes. In addition to analysts signatures, the director or director's designee must sign only once for each reporting form." The surveyor requested the above attestation documentation, and none was provided. 4. In an interview on 06/04/2024 at 11:45 AM, testing person 1 (TP-1) stated they did not keep the PT attestation pages in 2023 and 2024. This confirmed the laboratory failed to follow their own policy for analytes not scored by the proficiency program for three of three in 2023 and two of two performed in 2024. II. Based on surveyor observation, review of laboratory policy, College of American Pathologists (CAP) proficiency testing (PT) results, and confirmed in interview, the laboratory failed to follow their own policy for analytes not scored by the proficiency program for one of two in 2023 and one of one performed in 2024. Findings included: 1. During a tour of the laboratory on 06/04/2024 at 10:00 AM, the surveyor observed one LCMS analyzer (Serial Number: ARZ1610804) and one IR 500 chemistry analyzer (Serial Number: 140302) performing urine drug testing on patient samples. 2. Review of laboratory policy, "Proficiency Testing" (Reviewed by the laboratory director on 06/03/2024) revealed the following: " ...Assessing Ungraded Proficiency Performance To ensure accuracy with all proficiency testing, un-graded proficiency testing result will be reviewed and self-graded." 3. Review of CAP PT records in 2023 and 2024 revealed the following: 2. Review of CAP PT records in 2023 and 2024 revealed the following: Drug Monitoring for Pain Management PT (DMPM) I. DMPM-A 2023 a. Method: Norfentanyl Specimen: DMPM-01 Your Grade: See Note 28 b. Method: Methadone Metabolite Specimen: DMPM-02 Your Grade: See Note 28 c. Method: Hydrocodone Specimen: DMPM-03 Your Grade: See Note 28 d. Method: Norhydrocodone Specimen: DMPM-03 Your Grade: See Note 28 II. DMPM-A 2024 a. Method: Oxycodone Specimen: DMPM-01 Your Grade: See Note 28 b. Method: Noroxycodone Specimen: DMPM-01 Your Grade: See Note 28 c. Method: Methamphetamine Specimen: DMPM-01 Your Grade: See Note 28 d. Method: Gabapentin Specimen: DMPM-02 Your Grade: See Note 28 e. Method: Norfentanyl Specimen: DMPM-02 Your Grade: See Note 28 f. Method: Morphine Specimen: DMPM-02 Your Grade: See Note 28 g. Method: Methadone Metabolite Specimen: DMPM-03 Your Grade: See Note 28 h. Method: Naloxone Specimen: DMPM-03 Your Grade: See Note 28 Review of CAP PT Results Booklet revealed the following: "Actions Laboratories Should Take when PT Result is Not Graded ...Code 28 Action Required: ...Document that the laboratory performed a self-evaluation and compared its results to the proper statistics supplied in the participant summary." The surveyor requested documentation of the above for all analytes not scored by the proficiency testing program in 2023 and 2024 on 06/04/2024 at 11:45 AM. No documentation was provided. 4. In an interview on 06/04/2024 at 11:45 AM, the laboratory director confirmed the laboratory failed to follow their own policy for analytes not scored by -- 3 of 4 -- the proficiency program for one of two in 2023 and one of one performed in 2024. Word Key LCMS- Liquid Chromatography Mass Spectrometry D6126 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(vi) The procedures for evaluation of the competency of the staff must include, but are not limted to assessment of problem solving skills. This STANDARD is not met as evidenced by: Based on Centers for Medicare and Medicaid Services (CMS) 209 personnel form, personnel competencies from 2022-2024, and confirmed in interview, revealed the technical supervisor failed to evaluate problem solving skills for one of one testing personnel from 2022-2024. Findings Included: 1. Review of CMS-209 form submitted at time of survey, revealed one testing person (TP-1) performing moderate and high complexity testing. 2. Review of TP-1 competencies in 2022, 2023 and 2024, revealed the following section titled: "Assessment of Problem Solving Skills" All questions listed under this section were left blank on each of the competencies, and the competencies were signed by the technical supervisor (TS-1). The surveyor requested documentation on 06/04/2024 at 11:50 AM of the assessment of problem solving skills for TP-1 in 2022, 2023 and 2024. No documentation was provided. 3. In an interview on 06/04/2024 at 11:45 AM, the laboratory director confirmed the technical supervisor failed to evaluate problem solving skills for one of one testing personnel from 2022-2024. -- 4 of 4 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. 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: I. Based on a review of the laboratory's submitted Centers for Medicare and Medicaid Services (CMS)-116 form, the laboratory's policies, the laboratory's proficiency testing records from 2021, and staff interview, it was revealed that the laboratory failed to have documentation of verifying the accuracy of the non-regulated urine toxicology analyte, Norhydromorphone, at least twice annually in 2021. Findings include: 1. A review of the laboratory's CMS-116 form submitted at survey revealed the following non-regulated urine toxicology analyte was tested by the laboratory: Norhydromorphone 2. A review of the laboratory policy titled, "Proficiency Testing" revealed the following: "Drugs of abuse are not analytes within the specialties /subspecialties that are regulated by CLIA. For analytes that do not require proficiency testing or analytes that are not regulated, the laboratory will verify the accuracy of the test procedure twice annually through external assessment programs or split sample comparisons with another laboratory's instrument/method." 3. A review of the laboratory's proficiency testing records revealed the laboratory failed to have documentation of performing twice annual accuracy assessments for the non- regulated urine toxicology analyte Norhydromorphone in 2021. 4. An interview with the laboratory director on 8/31/22 at 10:00 a.m. in the hallway outside of the laboratory, after review of the records, confirmed the above findings. II. Based on a 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 -- review of the laboratory's policies, a review of the laboratory's proficiency testing records from 2021, and staff interview, it was revealed that the laboratory failed to define the acceptability criteria for the twice annual accuracy assessments of non- regulated toxicology analytes. Findings include: 1. A review of the laboratory's policy titled "Proficiency Testing" revealed the following: "Assessment for Non-Regulated Analytes- Alternate Proficiency When testing is performed on analytes that are not regulated, an alternate proficiency may be performed twice a year to validate the accuracy of the testing procedure. - The comparison of the results must be within the acceptable limits for reporting, i.e., A positive result would be positive, negative result neg, or the same bacteria. If the result is numerical, both results should compare according to the CMS guidelines or as Approved by the Laboratory Director." 2. A review of the laboratory's proficiency testing records from 2021 revealed the laboratory sent samples to a reference laboratory for comparison of results. A CV% (coefficient of variation) was calculated for each analyte. 3. Further review of the laboratory's policies and the proficiency testing records revealed the laboratory failed to define the acceptable CV% value for the toxicology analytes. 4. An interview with the laboratory director on 8/31/22 at 9:30 a.m. in the hallway outside of the laboratory, after review of the records, confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory representatives. The survey process was discussed and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in COMPLIANCE with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

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 record review and interview with the Testing Person the laboratory failed to maintain maintenance records and temperature logs for 4 months (March 18- June 18) out of 2 years reviewed (October 16-October 18). Findings Included: Review of maintenance records on the toxicology screening analyzer revealed no documentation of daily maintenance on April 2, 5, 16, 18, 19 and May 3, 15 in 2018. No pH's documentation was provided for May 18. Documentation of refrigerator temperatures were missing from March 18- June 18. Freezer temperatures were missing in April and May 18. Room temperature, humidity, and incubator temperatures were missing for April and May 18. During an interview on 11/02/18 at 5:00 PM the Testing Person revealed that she started working in June 18 and could not locate the missing records. 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 AAB (American Association of Bioanalysts) proficiency testing and interview with the Laboratory Director the laboratory failed to verify the accuracy of the toxicology screening for 2 out of 2 years (2016-2018) reviewed. Findings 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 -- Included: Review of AAB proficiency testing revealed that the laboratory was using the quantitative proficiency testing. Review of patient test reports revealed that the laboratory was reporting semi qualitative values. During an interview on 11/02/18 at 12:35 PM the Laboratory Director confirmed that the proficiency testing performed did not cover the testing performed to determine accuracy. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observations, record review and interview with the Testing Person the laboratory failed to label the mobile phase A and B bottles with the lot numbers used to make the solutions since starting Toxicology confirmation testing 02/18. Findings Included: During a tour of the laboratory on 11/02/18 at 9:30 AM it was observed 2 glass bottles labeled "A" and "B". Review of policy and procedures (last reviewed by the Laboratory Director on 11/01/18) revealed that "Reagents, solutions, standards, and controls will be labeled as to content, date of preparation and expiration date." During an interview on 11/02/18 at 9:40 AM the Testing Person confirmed that it was Mobile Phase A and Mobile Phase B in the bottles and showed a log sheet of the date made and put in use. This deficiency was corrected on-site. -- 2 of 2 --