Pmo Medical, Pllc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/23/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, quality assurance manager, and technical manager at the conclusion of the survey. 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 a review of records and interview with the laboratory director, QA (quality assurance) manager, and technical manager, the laboratory failed to verify the accuracy of Urine Drug Screen testing at least twice annually during the review period of June 2023 through the current date. Findings include: (1) On 07/23/2025 at 09:30 am, the laboratory director stated the following: (a) The laboratory performed Urine Drug Screen testing for the detection of Amphetamine, Benzodiazepine, Buprenorphine, Cocaine, Methadone, Opiate, Oxycodone using the Siemens Healthineers Viva-ProE analyzer; (b) The laboratory enrolled and participated in a proficiency testing program to meet the twice annual accuracy verification requirement. (2) A review of records from June 2023 through the current date identified the following: (a) No evidence the laboratory had participated in proficiency testing during the second 2023 event for the analyte Methadone; (b) No evidence the laboratory had participated in proficiency testing during the second 2024 event for all analytes. (3) Interview with the laboratory director on 07/23/2025 at 10: 18 am confirmed Urine Drug Screen had not been verified for accuracy at least twice annually in 2023 and 2024 as indicated above. D5429 MAINTENANCE AND FUNCTION CHECKS 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 -- CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, QA (quality assurance) manager and technical manager, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures on the Siemens Healthineers Viva-ProE analyzer during the review period of October 2024 through June 2025. Findings include: (1) On 07/23/2025 at 09:30 am, the laboratory director stated the laboratory performed urine drug testing (Amphetamine, Benzodiazepine, Buprenorphine, Cocaine, Methadone, Opiate, Oxycodone) using the Siemens Healthineers Viva-ProE analyzer; (2) A review of the operator's manual titled "Viva-ProE System Operator's Guide" under section 7.1.3 "Maintenance Checklist" showed the following required maintenance procedures: (a) Daily: (i) Check reagent rotor compartment (b) Monthly: (i) Clean treated water and waste containers (ii) Clean instrument exterior (iii) Clean reagent rotor compartment (iv) Check/fill cooling fluid (c) Quarterly: (i) Replace drying block (3) A review of maintenance records from October 2024 through June 2025 identified daily, monthly, and quarterly maintenance had not been documented as performed as follows: (a) Daily: (i) Between 10/01/2024 and 06/30/2025 (b) Monthly: (i) Between 10/07/2024 and 12/17/2024 (clean treated water and waste containers not performed) (ii) Between 10/07/2024 and 03/17/2025, 04/04/2025 and 06/30/2025 (Clean instrument exterior not performed) (iii) Between 11/24/2024 and 04/4/2025 (Clean reagent rotor compartment not performed) (iv) Between 01/17/2025 and 03/14/2025, 04/29/2025 and 06/09/2025 (Check/fill cooling fluid not performed) (c) Quarterly: (i) Prior to 01 /20/2025 (4) Interview with the laboratory director, QA manager, and technical manager on 07/23/2025 at 10:50 am confirmed the maintenance procedures had not been documented as performed as stated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/07/2023. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the laboratory representative at the conclusion of the survey. 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 a review of records, manufacturer's instructions, observation, and interview with the laboratory representative and testing person, the laboratory failed to ensure materials were stored as required by the manufacturer for one of four months reviewed; and failed to ensure the laboratory humidity was maintained as defined by the laboratory for four of four months reviewed. Findings include: REFRIGERATOR TEMPERATURES (1) On 06/07/2023 at 10:20 am, the laboratory representative stated Urine Drug Screen testing, which included the analytes Amphetamine, Benzodiazepine, Buprenorphine, Cocaine, Methadone, Opiates, and Oxycodone using the Siemens Viva Jr analyzer; (2) On 06/07/2023 at 09:30 am, observation of the contents of the white Frigidaire refrigerator (a label on the refrigerator denoted it as "Refrigerator #1") identified the following: (a) One box of Siemens Syva Emit II Plus Oxycodone Assay, Lot #R4, manufacturer's storage requirement as stated on the box was 2-8 degrees C (Centigrade); (b) One box of Siemens Syva Emit II Plus Opiate Assay, Lot #R5, manufacturer's storage requirement as stated on the box was 2-8 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 -- degrees C (Centigrade); (c) One box of Siemens Syva Emit II Plus Methadone Assay, lot #R5, manufacturer's storage requirement as stated on the box was 2-8 degrees C (Centigrade); (d) One box of Siemens Syva Emit II Plus Cocaine Metabolite Assay, Lot #S3, manufacturer's storage requirement as stated on the box was 2-8 degrees C (Centigrade). (3) A review of temperature records identified documented temperature records for refrigerator #1 and refrigerator #2, however it could not be determined if the records documented for refrigerator #1 were correct. Interview with the testing person on 06/07/2023 at 10:00 am confirmed Refrigerator #1 was denoted as Refrigerator #2 in the temperature records; (4) Review of the temperature records for Refrigerator #2 (these temperatures correlated to the refrigerator with the label that stated "Refrigerator #1") identified temperatures warmer than 8 degrees C for one of four months reviewed as follows: (a) January 2023 - Two of 15 temperature readings were documented as warmer than 8 degrees C. (5) The records were reviewed with the laboratory representative and testing person. Both stated on 06/07/2023 at 11:00 am, the materials had not been stored stored as required by the manufacturer. HUMIDITY (1) A review of the operator's manual for the Siemens Viva Jr analyzer on page A-7 under "Environment Specifications" identified the manufacturer required the analyzer be operated at a humidity of 15-85%; (2) A review of humidity records identified the laboratory defined an acceptable laboratory humidity range of 20-70%; (3) A review of the humidity records from January through April 2023 identified the humidity readings were less than 20% (the lowest limit as defined by the laboratory) for four of four months as follows: (a) January 2023 - Ten of 14 humidity readings were documented as less than 20%; (b) February 2023 - Six of 16 humidity readings were documented as less than 20%; (c) March 2023 - Seven of 18 humidity readings were documented as less than 20%; (d) April 2023 - One of 14 humidity readings were documented as less than 20%. (4) The records were reviewed with the laboratory representative who stated on 06/07/2023 at 11:00 am, the laboratory humidity had not been maintained as defined by the laboratory. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The initial survey was performed on 07/07/2021. The findings were reviewed with the laboratory director and laboratory supervisor during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with standard- level deficiencies cited. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to ensure an attestation statement was signed by the analyst for 1 of 3 events. Findings include: (1) On 07/07/2021, the surveyor reviewed 2020 and 2021 proficiency testing records, with the following identified: (a) First 2020 Chemistry Event - The attestation statement had not been signed by the analyst. (2) The surveyor reviewed the records with the laboratory supervisor. The laboratory supervisor stated on 07/07/2021 at 03:21 pm the attestation statement had not been signed by the analyst as indicated above. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 -- 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 a review of records and interview with the laboratory supervisor, the laboratory failed to ensure materials had been stored as required for 3 of 3 months. Findings include: (1) On 07/07/2021 at 10:45 am, the laboratory supervisor stated to the surveyor the laboratory performed urine drug testing (Amphetamine, Barbiturate, Benzodiazepine, Buprenorphine, Cocaine, Creatinine, Methadone, Opiate, Oxycodone, pH, and Specific Gravity) on the Siemens Viva-Jr analyzer; (2) The surveyor reviewed temperature records from February 2020 through April 2020. The documented refrigerator temperatures were colder than 2 C (the coldest temperature allowed for the materials) during 3 of 3 months as follows: (a) February - 12 of 19 days temperatures had been documented (days 3,4,6,10,19,20,21,24,25,26,27,28); (b) March - 13 of 22 days temperatures had been documented (days 2,3,4,6,9,10,11,12,13,20,23,25,31); (c) April - 8 of 14 days temperatures had been documented (days 1,2,15,16,22,27,28,29). (3) The surveyor reviewed the records with the laboratory supervisor, who stated on 07/07/2021 at 3:40 pm, the refrigerator temperatures were unacceptable for the materials as indicated above. 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: -- 2 of 3 -- Based on a review of records and interview with the laboratory supervisor, the laboratory failed to perform calibration verification procedures at least once every 6 months for the analytes performed on the Siemens Viva-Jr analyzer for 2 of 12 months. Findings include: (1) On 07/07/2021 at 11:00 am, the laboratory supervisor stated to the surveyor an 11-panel urine drug screen (Amphetamine, Barbiturate, Benzodiazepine, Buprenorphine, Cocaine, Methadone, Opiates, Oxycodone, Oxidant, pH, and Specific Gravity) testing was performed using Siemens Viva-Jr analyzer beginning 12/26/2019; (2) The surveyor reviewed 2020 calibration records with the laboratory supervisor, and identified calibration procedures had not been performed with calibration materials that included a low, mid, and high value as required every six months; (3) The surveyor reviewed calibration verification records for 2020 for the analyzer and identified calibration verification had not been performed during the review period; (4) The surveyor then reviewed the records with the laboratory supervisor, who stated on 07/07/2021 at 03:24 pm, calibration verification procedures had not been performed in 2020 as indicated above. -- 3 of 3 --