Pmo Medical, Pllc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/02/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director and technical manager 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 a review of records, written policies and procedures, and interview with the laboratory director, the laboratory failed to establish a written policy to assess the competency of the clinical consultant, based on the position responsibilities listed in Subpart M, for one of one person. Findings include: (1) On 07/02/2025, a review of the laboratory policy and procedure manual identified no evidence of a policy for assessing the competency of the clinical consultant based on the position responsibilities, including the frequency of the assessments; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of September 2023 through the current date identified, although competencies, based on position responsibilities, had been performed for one of one person listed as the clinical consultant on 08/17/2023 and 08/22/2024, the assessment policy was not available for review; (3) The findings were reviewed with the laboratory director who stated on 07/02/2025 at 09:35 am, a written policy was not available, although competencies had been performed for the position as stated above. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) 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 -- 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 and QA (quality assurance) manager, the laboratory failed to verify the accuracy of Urine Drug Screen testing at least twice annually during the review period of September 2023 through the current date. Findings include: (1) On 07/02/2025 at 09:20 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 annually accuracy verification requirement. (2) A review of records from September 2023 through the current date identified the following: (a) No evidence the laboratory had participated in proficiency testing during the second 2024 event for all analytes; (b) No evidence the laboratory had participated in proficiency testing during the second 2023 event for the analyte Methadone. (3) Interview with the laboratory director on 07/02/2025 at 09:50 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 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 and QA (quality assurance) 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 January 2025 through June 2025. Findings include: (1) On 07/02/2025 at 09:00 am, the laboratory director stated the laboratory performed urine drug testing (Amphetamines, Benzodiazepine, Buprenorphine, Cocaine, Methadone, and 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 (3) A review of maintenance records from January 2025 through June 2025 identified daily and monthly maintenance had not been documented as performed as follows: (a) Daily: (i) Between 01/01/2025 and 06/30/2025 (b) Monthly: (i) Between 01/01/2025 and 03/30 /2025 (ii) Between 04/30/2025 and 06/02/2025 (4) Interview with the laboratory director and QA manager on 07/02/2025 at 10:30 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 08/24/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director and the Trinity consultant during an exit conference performed 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 a review of records, written policies and procedures, and interview with the laboratory director, the laboratory failed to follow their written policy to assess the competency of the clinical consultants, based on the position responsibilities as listed in Subpart M, for two of two persons. Findings include: (1) A review of the laboratory policy and procedure manual identified a policy titled, "Competency Check" which required the competency of the clinical consultant be assessed annually; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of December 2020 through the current date identified competencies, based on job responsibilities, had not been performed for two of two persons listed as clinical consultant on Form CMS- 209 since 12/10/2020; (3) The findings were reviewed with the laboratory director who stated on 08/24/2023 at 11:00 am the policy had not been followed and competencies had not been performed for the clinical consultants since 12/10/2020. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) 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 -- 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, observation, and interview with the laboratory director, the laboratory failed to maintain lab temperatures were within the laboratory's acceptable range for three of three months reviewed. Findings include: (1) A review of temperature records identified the laboratory defined an acceptable laboratory temperature range of 20-30 degrees Celsius; (2) A review of the temperature records from July 2022, Jan 2023, and July 2023 identified: (a) July 2022 - two of 19 temperature readings were documented as less than 20 degrees Celsius; (b) January 2023 - One of 16 temperature readings were documented as less than 20 degrees Celsius; (c) July 2023 - One of 19 temperature readings were documented as less than 20 degrees Celsius; (3) The records were reviewed with the laboratory director who stated on 08/24/2023 at 11:00 am, the laboratory temperature had not been maintained as defined by the laboratory. 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 laboratory director, 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 between 10/20/2021 to 11/21/2022. Findings include: (1) A review of personnel records for one person performing moderate complexity testing since October 2021 identified the following for one of one person: (a) Testing Person #3 - The initial training was complete on 10/20/2021. There was no evidence an evaluation had been performed between 10/20/2021 and 11/21/2022. (2) The records were reviewed with the laboratory director who stated on 08/24/2023 at 11:00 am, a semiannual competency evaluation had not been performed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The initial survey was performed on 08/11/2021. The findings were reviewed with the laboratory supervisor at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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 supervisor, the laboratory failed to ensure the accuracy of testing was verified at least twice annually. Findings include: (1) On 08/11/2021 at 11:00 am, the laboratory supervisor stated to the surveyor the laboratory began performing urine drug testing (Amphetamines, Barbiturates, Benzodiazepine, Buprenorphine, Cocaine, Methadone, Opiates, Oxycodone, Oxidant, pH, Specific Gravity) using the Viva Pro E analyzer on 01/23 /2020; (2) The surveyor reviewed records for testing performed in 2020 and identified the accuracy of the specific gravity and oxidant testing had not been verified twice annually during the review period; (3) The surveyor reviewed the records with the laboratory supervisor, who stated on 08/11/2021 at 11:15 am, the accuracy of urine drug testing had not been verified twice in 2020 as indicated above. 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. 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 -- 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 control materials were not used beyond the manufacturer's open vial stability for 3 of 3 months. Findings include: (1) On 08/11/2021 at 11:00 am, the laboratory supervisor stated the following to the surveyor: (a) The laboratory performed qualitative urine drug testing on the Vivo Pro E analyzer for the analytes Amphetamine, Barbiturate, Benzodiazepine, Buprenorphine, Cocaine, Methadone, Opiate, and Oxycodone; (b) The laboratory performed quantitative Oxidant, Specific Gravity, and pH testing for urine specimens on the Viva Pro E analyzer; (c) Two levels of Siemens Emit quality control materials were performed each day of patient testing. (2) The surveyor reviewed the manufacturer's information sheet for the control materials. Under the section, "Stability" the manufacturer stated, " Once opened, the Emit calibrators/Controls are stable for 5 weeks when recapped and stored at 2-8C when not in use."; (3) The surveyor reviewed quality control records for 2 lot numbers of quality control materials used from 05/20/2021 through the day of the survey (08/11/2021). It was identified controls had been used beyond the manufacturer's open vial stability date for 2 of 2 lot numbers reviewed as follows: (a) Level 0 (negative control) - Lot# 9A508UL-N4 had an open date of 06/22/2021 (written on the bottle and observed by the surveyor at 01:30 pm); (1) The quality control material was available for use beyond the manufacturer's open vial stability of 07/27/2021; (b) Level 5 (positive control) - Lot# 9A608LU-N5 had an open date 05/20 /2021 (written on the bottle and observed by the surveyor at 01:30 pm); (1) The quality control material was available for use beyond the manufacturer's open vial stability of 06/24/2021. (4) The surveyor reviewed the records with the laboratory supervisor, who stated on 08/11/2021 at 01:41 pm the controls had been used beyond the manufacturer's stability date as indicated above; (5) The surveyor reviewed patient testing records and identified that urine drug testing had been performed when the laboratory used quality control materials beyond the manufacturer's stability to assess the acceptable performance of the analyzer on 06/29/2021 at 10:58 am, 06/30/2021 at 03:15 pm, 07/01/2021 at 11:05 am, 07/28/2021 at 10:31 am, 07/27/2021 at 01:45 pm, 07/29/2021 at 1045 am, 08/10/2021 at 12:46 pm, and 08/11/2021 at 10:11 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) -- (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 -- 2 of 4 -- 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 laboratory supervisor, the laboratory failed to perform calibration verification procedures at least once every 6 months for the analytes performed on the Viva Pro E analyzer for 2 of 12 months. Findings include: (1) On 08/11/2021 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 Viva Pro E analyzer; (2) The surveyor reviewed 2020 and 2021 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 and 2021 for the analyzer and identified calibration verification had not been performed until 08/03 /2021 (due 07/2020 and 01/2021); (4) The surveyor then reviewed the records with the laboratory supervisor, who stated on 08/11/2021 at 11:25 am, calibration verification procedures had not been performed in 2020 as indicated above. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory supervisor, the laboratory failed to follow the manufacturer's quality control specifications for 2 of 2 lot numbers. Findings include: (1) On 08/11/2021 at 11:00 am, the laboratory supervisor stated the following to the surveyor: (a) The laboratory performed urine drug testing on the Vivo Pro E analyzer,which included the following quantitative adulterant testing: (i) Oxidant (ii) Specific Gravity (iii) pH (b) Five levels of UTAK Adulterant Toxicology control materials were performed each day of patient testing; (2) The surveyor reviewed the manufacturer's instructions for the control materials which stated "Laboratories should establish their own statistical values for precision and expected ranges."; (3) The surveyor then reviewed QC (Quality Control) records for 2 lot number of control materials used from 10/12 /2020 through 08/11/2021 as follows: (a) Level 2 lot #C4786 - The laboratory had used the following ranges: (1) Oxidant range of 0.0 - 25.0 (2) pH range of 3.0 - 4.5 (b) Level 3 lot #C4565 - The laboratory had used the following range: (1) pH range of 8.0 - 10.5 (4) The surveyor asked the laboratory supervisor for the documentation to prove the laboratory had established their own mean and expected ranges. The laboratory supervisor stated on 08/11/2021 at 01:43 pm, the records could not be located. D5807 TEST REPORT CFR(s): 493.1291(d) -- 3 of 4 -- Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of a patient report and interview with the laboratory supervisor, the laboratory failed to provide normal reference intervals for 1 of 1 Urine Drug Screen test report. Findings include: (1) On 08/11/2021 at 11:00 am, the laboratory supervisor stated the following to the surveyor: (a) The laboratory performed qualitative Amphetamine, Barbiturate, Benzodiazepine, Buprenorphine, Cocaine, Methadone, Opiate, and Oxycodone testing for urine specimens on the Viva Pro E analyzer; (b) The laboratory performed quantitative Oxidant, Specific Gravity, and pH testing for urine specimens on the Viva Pro E analyzer. (2) The surveyor reviewed 1 test report for a patient tested on 08/11/2021 at 10:11 am. The report did not include a normal reference range for all of the analytes listed above; (3) The report was reviewed with the laboratory supervisor, who stated on 08/11/2021 at 11:28 am the patient report did not include a normal reference range as indicated above. -- 4 of 4 --