Elite Pain & Health Pc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/04/2025 through 06/05/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the clinical consultant, technical supervisor, and general supervisor at the conclusion of the survey. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of written policies and procedures and interview with the technical supervisor, the written policy did not define the frequency of the assessments for the clinical consultant, technical consultant, technical supervisor, and general supervisor based on the position responsibilities for one of one clinical consultant, one of one technical consultant, one of one technical supervisor, and one of one general supervisor. Findings include: (1) A review of the competency assessment policy titled, "Job Descriptions" identified it did not define the frequency of the assessments; (2) Interview with the technical supervisor on 06/04/2025 at 11:23 am confirmed that although the competencies based on the position responsibilities of the clinical consultant, technical consultant, technical supervisor, and general supervisor had been performed annually, the policy did not define the frequency of assessments. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. 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 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical supervisor, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures on the AB Sciex 3200 analyzer during the review period of July 2024 and May 2025. Findings include: (1) On 06/04/2025 at 09:52 am, the general supervisor stated the laboratory performed urine drug testing (6- Acetylmorphine, Alprazolam, Amphetamine, Buprenorphine, Carisoprodol, Benzoylecgonine, Codeine, Diazepam, EDDP, Fentanyl, Hydrocodone, Hydromorphone, MDA, MDMA, Meperidine, Meprobamate, Methadone, Methamphetamine, Morphine, Norbuprenorphine, Nordiazepam, Norfentanyl, O- Desmethyl-cis-Tramadol, Oxycodone, Oxymorphone, Tapentadol, TCH-COOH, Tramadol) using the AB Sciex 3200 analyzer; (2) A review of the operator's manual titled "Sciex 3200 Systems - System User Guide" under section 7 "Service and Maintenance Information - Mass Spectrometer" showed the following required maintenance procedures: (a) Daily: (i) Clean curtain plate (b) Weekly: (i) Inspect the level of roughing pump oil (c) Every 6 months: (i) Replace card cage air filter (3) A review of maintenance records from July 2024 through May 2025 identified daily, weekly, and 6-month maintenance had not been documented as performed as follows: (a) Daily: (i) Between 07/01/2024 and 05/31/2025 (b) Weekly: (i) Between 7/01/2024 and 05/31/2025 (c) Every 6 Months: (i) Between 7/01/2024 and 05/31/2025 (4) Interview with the technical supervisor on 06/04/2025 at 03:20 pm confirmed the maintenance procedures had not been documented as performed as stated above. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H for one of three proficiency testing events reviewed in 2024 and 2025. Findings include: (1) On 06/04/2025, a review of 2024 and 2025 proficiency testing events identified an attestation statement had not been signed before the graded evaluation was completed by the proficiency testing program for one of three events reviewed: (a) First Chemistry Miscellaneous Event 2025 - The graded evaluation was completed on 05/27/2025 and the attestation statement had not been signed by the laboratory director. (2) The records were reviewed with the technical consultant who stated on 06/04/2025 at 01:10 pm the attestation statement had not been signed as stated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/29/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant, general supervisor, and testing person #2 during an exit conference performed at the conclusion of the survey. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on interview with the technical consultant/technical supervisor, the laboratory failed to provide written instructions to clients collecting and referring specimens for Urine Drug Screen testing on the Thermo Fisher MGC 240 analyzer and Urine Drug Confirmatory testing on the ABSciex LCMS 3200 analyzer. Findings include: (1) On 06/29/2023 at 10:50 am, the technical consultant/technical supervisor stated the following was performed: (a) Urine Drug Screen testing using the Thermo Fisher MCG 240 test system; (b) Urine Drug Confirmatory testing using the ABSciex LCMS 3200 analyzer; (c) Specimens were transported to the laboratory from two sister clinics. (2) Interview with the technical consultant/technical supervisor on 06/29/2023 at 11:05 am confirmed the laboratory did not provide written instructions (i.e.,client service manual) to the clients to explain the laboratory's specimen handling policies. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 a review of records, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to ensure the laboratory humidity was maintained as required by the manufacturer of the Thermo Fisher MGC 240 analyzer for seven of 11 months reviewed. Findings include: (1) On 06/29/2023 at 10:50 am, the technical consultant stated Urine Drug Screen testing was performed using the Thermo Fisher MCG 240 test system; (2) A review of the operator's manual for the test system identified the manufacturer required the analyzer be operated at a humidity of 40-80% with no condensation; (3) A review of humidity records from July 2022 through May 2023 identified the humidity readings were less than 40% for seven of 11 months as follows: (a) October 2022 - Four of eight humidity readings were documented as less than 40%; (b) November 2022 - Four of seven humidity readings were documented as less than 40%; (c) December 2022 - Seven of nine humidity readings were documented as less than 40%; (d) January 2023 - Seven of eight humidity readings were documented as less than 40%; (e) February 2023 - Five of six humidity readings were documented as less than 40%; (f) March 2023 - Four of eight humidity readings were documented as less than 40%; (g) April 2023 - Two of four humidity readings were documented as less than 40%. (4) The records were reviewed with the technical consultant who stated on 06/29/2023 at 02:25 pm, the laboratory humidity had not been maintained as required by the manufacturer. 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 the general supervisor the laboratory failed to ensure three of three expired supplies were not available for use. Findings include: (1) Observation of the laboratory on 06/29/2023 at 11:20 am, identified the following expired reagents, used for Urine Drug Screen testing on the Thermo Fisher MGC 240 analyzer, that appeared to be available for use: (a) Two bottles of Thermo Fisher Acid Wash Solution - lot #74240348 with an expiration date of 03/2023; (b) One bottle of Cedia DAU Negative Calibrator - lot #74497741 with an open bottle stability of 60 days; was opened and in-use on 03/15/2023, and was beyond the open bottle stability date. (2) Interview with the general supervisor on 06/29/2023 at 11:20 a.m. confirmed the Thermo Fisher Acid Wash Solution and Cedia DAU Negative Calibrator were available for use. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, -- 2 of 3 -- either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of records, Thermo Fisher Assay data sheet, and interview with the technical consultant, the laboratory failed to ensure test reports for Urine Drug Screen testing included information required for interpretation for one of one patient report. Findings include: (1) On 06/29/2023 at 10:50 am, the technical consultant stated Urine Drug Screen testing was performed using the Thermo Fisher MCG 240 test system; (2) A review of the Thermo Fisher test assay data sheet stated, "The assay provides only a preliminary atypical test result. A more specific alternative chemical method must be used in order to obtain confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used." (3) A review of one patient report with Urine Drug Screen test results reported on 05/19 /2023 identified the report did not include a disclaimer with the manufacturer's statement that the results were preliminary and guidance on obtaining a confirmed analytical result; (4) The findings were discussed with the technical consultant who stated on 06/19/2023 at 1:15 pm, the patient report did not include the disclaimer. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the technical consultant failed to ensure competency evaluations for moderate complexity testing had been performed semiannually during the first year of testing for one of one testing person performing testing from February 2022 through the current date. Findings include: (1) On 06/29/2023 a review of personnel records for one person performing moderate complexity testing identified the following for one of one person: (a) Testing Person #1 - The initial training was complete on 02/17/2022. There was no evidence a semiannual competency evaluation had been performed between 02/17/22 through 02/17/23. (2) The records were reviewed with the technical consultant who stated on 06/29/2023 at 11:20 am, a semiannual competency evaluation had not been performed. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/28/2021. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant and testing person at the conclusion of the survey. 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 a review of records, manufacturer's instructions, and interview with the technical consultant and testing person, the laboratory failed to retain temperature and humidity logs for at least 2 years. Findings include: (1) On 06/28/2021 at 10:00 am, the testing person stated to the surveyor urine drug screen testing for Amphetamine, Barbiturates, Buprenorphine, Cocaine Metabolite, Ethanol, Methadone, PCP (Phencyclidine), Opiates, Oxycodone, and THC (Tetrahydrocannabinol) was performed using the Medica EasyRA analyzer; (2) The surveyor reviewed the manufacturer's requirements in the operator's manual. The manufacturer required the analyzer be operated at a temperature of 15-30 degrees C (Centigrade) and less than 85% humidity. In addition, the laboratory stored urine samples in the refrigerator at 2- 8 degrees C up to 3 days prior to testing; (3) The surveyor requested room temperature, humidity, and refrigerator records from 06/01/2020 through the day of the survey. The technical consultant provided the surveyor with logs beginning 08/25 /2020 and stated on 06/28/2021 at 11:30 am, temperature and humidity records prior to 08/25/2020 could not be located; (4) Therefore, since the temperature records had not been maintained for at least 2 years, the surveyor could not determine if the refrigerator, room temperature, and humidity had been monitored and were acceptable from 06/01/2020 through 08/24/2020. 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 -- 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) -- (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 a review of records and interview with the technical consultant and testing person, the laboratory failed to perform calibration verification procedures at least once every 6 months for urine drug screen testing for 2 of 12 months. Findings include: (1) On 06/28/2021 at 10:00 am, the testing person stated to the surveyor urine drug screen testing for Amphetamine, Barbiturates, Buprenorphine, Cocaine Metabolite, Ethanol, Methadone, PCP (Phencyclidine), Opiates, Oxycodone, and THC (Tetrahydrocannabinol) was performed using the Medica EasyRA analyzer; (2) The surveyor reviewed 2021 calibration records and identified calibration procedures had been performed with one level of calibrator. Since the calibration procedures included only one level, calibration verification procedures, using three or more levels of calibration materials that included a low, mid, and high value, were required every six months; (3) The surveyor reviewed calibration verification records from January 2020 through the day of the survey and identified calibration verification had not been performed between 04/10/2020 and 02/12/2021; (4) The surveyor then reviewed the records with the technical consultant, who stated calibration verification procedures had not been performed as shown above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The initial survey was performed on 06/28/19. The findings were reviewed with the technical consultant and laboratory director during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with a standard- level deficiencies cited. D5779