Pmo Medical, Pllc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 08/13/2025. 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. 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. In addition, retain the following: This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory director, QA (quality assurance) manager, and technical manager, the laboratory failed to retain temperature and humidity records, and maintenance logs for at least two years during the review period of January 2024 through the day of the survey. Findings include: (1) On 08/13/2025 at 09:30 am, the laboratory director stated 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; (2) Observation of the laboratory refrigerator identified patient urine specimens were stored in the refrigerator with a manufacturer's storage requirement of 2-8 degrees Centigrade (C); (3) A review of the operator's manual titled "Viva-ProE System Operator's Guide" under section A-7 "Technical Specifications" identified the manufacturer required the analyzer be operated at an ambient temperature of 15 to 32 degrees C (Centigrade), and a relative humidity of 15 to 85 % (non-condensing); (4) 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) 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 -- Empty waste containers (ii) Fill treated water container (iii) Prime the system and check syringes (iv) Check cuvette blank (v) Check/replace 10% cleaning solution in the W position of sample rotor (vi) Check daily report (vii) Check reagent rotor compartment (viii) Check acid solution on reagent rotor (ix) Check reagent inventory (b) Weekly (i) Rinse probes (c) Monthly: (i) Clean treated water and waste containers (ii) Check/fill cooling fluid (iii) Clean instrument exterior (iv) Clean reagent rotor compartment (d) Quarterly: (i) Replace drying block (e) Semi-annual: (i) Replace stirrer belts (ii) Replace water filter (iii) Run the clean system procedure (f) Yearly: (i) Replace syringes (ii) Replace photometer lamp (g) Every 10,000 tests (i) Replace cuvette rotor (5) A review of temperature and humidity records and maintenance logs from January 2024 through the day of the survey identified temperature and humidity records, and maintenance logs could not be located for April 2024, and for the period between July 2024 to May 2025; (6) Therefore, since the temperature and humidity records and maintenance logs had not been maintained for at least 2 years, it could not be determined if the temperature and humidity had been monitored and were acceptable, and if the required maintenance had been performed for the periods stated above. 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 August 2023 through the current date. Findings include: (1) On 08/13/2025 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 annually accuracy verification requirement. (2) A review of records from August 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 8/13/2025 at 10:58 am confirmed Urine Drug Screen had not been verified for accuracy at least twice annually in 2023 and 2024 as indicated above. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) 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 QA (quality assurance) manager -- 2 of 3 -- and technical manager, and a phone call with the laboratory director, the laboratory 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. Findings include: (1) On 08/13/2025, a review of personnel records for one person performing moderate complexity testing identified the following: (a) Testing Person - The initial training was completed on 10/11/2024. There was no evidence a semiannual evaluation had been performed to date. (2) Interview with the QA (quality assurance) manager and technical manager on 08/13/2025 at 09:15 am, and a phone call communication with the laboratory director following the survey on 08/19/2025 at 04:00 pm confirmed a semiannual competency evaluation had not been performed as stated above. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 08/01/2023. The laboratory was found out of compliance with the following CLIA Conditions: 493.1441; D6076: Laboratory Director, High Complexity Testing 493.1487; D6168: Testing Personnel, High Complexity Testing The findings were reviewed with the laboratory director and Trinity consultant 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 08/01/2023 at 11:37 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 6 -- 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 and interview with the laboratory director, the laboratory failed to ensure three of three reagents were stored as required by the manufacturer, in a room denoted as the office. Findings include: (1) Observation of the office and interview with laboratory director on 08/01/2024 at 09:40 am, identified the following: (a) One Liter of Elitech System Solution, lot #22-0745, storage temperature of 15-25 degrees C (Centigrade). The solution was used for the Siemens Viva Pro-E analyzer; (b) One liter of Avantor Sodium Hypochlorite, batch #2312509832, storage temperature of 18-25 degrees C. The solution was used for the Siemens Viva Pro-E analyzer; (c) One liter of Avantor Sodium Hydroxide, batch #22L2061006, storage temperature of 18-25 degrees C. The solution was used for the Siemens Viva Pro-E analyzer. (2) Interview with the laboratory director on 08/01 /2024 at 09:42 am confirmed the laboratory was not monitoring the temperature of the office. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, 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 and interview with the laboratory director, laboratory failed to ensure patient test reports included included the name of the laboratory location and a unique identifier for three of three patient Urine Drug Screen testing reports reviewed. Findings Include: (1) On 08/01/2023 at 09:40 am, the laboratory director stated Urine Drug Screen (Amphetamine, Benzodiazepines, Buprenorphine, Cocaine, Methadone, Opiate, and Oxycodone) pH, Specific Gravity, and Oxidant testing were performed using the Siemens Viva Pro-E analyzer; (2) A review of three patient reports (testing performed on 03/01/2023, 07/31/2023, 08/01/2023) identified the following for three of three patient reports: (a) The name of the laboratory on the reports did not match the name on the Clia certificate. The name on the patient reports was "PMO Sallisaw" and the name on the Clia certificate was "PMO Medical, PLLC"; (b) Although the reports included the patient name and date of birth, they did not include a unique identifier. (3) The findings were reviewed with the laboratory director who stated on 08/01/2023 at 01:05 pm, the laboratory name on the patient -- 2 of 6 -- report did not match the name on the Clia certificate and the reports did not include a unique identifier. 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 two testing persons performing testing from October 2021 through the current date. Findings include: (1) A review of personnel records for two persons performing moderate complexity testing identified the following for one of two persons: (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 12/28/2022. (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. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records, manufacturer's instructions, FDA database, and interview with the laboratory director, the laboratory director failed to meet the qualification requirements for high complexity testing. Findings include: (1) The laboratory performed high complexity pH, Specific Gravity, and Oxidant testing using the Siemens Viva Pro-E analyzer and the laboratory director did not meet the regulatory qualifications for high complexity testing. Refer to D6078. D6078 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1443 The laboratory director must be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b) (1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2) Be a doctor of medicine, a doctor of osteopathy or doctor of podiatric medicine licensed to -- 3 of 6 -- practice medicine, osteopathy or podiatry in the State in which the laboratory is located; and (b)(2)(i) Have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(2)(ii) Have at least 2 years of experience directing or supervising high complexity testing; or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and-- (b)(3)(i) Be certified and continue to be certified by a board approved by HHS; or (b)(3)(ii) Before February 24, 2003, must have served or be serving as director of a laboratory performing high complexity testing and must have at least-- (b)(3)(ii)(A) Two years of laboratory training or experience, or both; and (b)(3)(ii)(B) Two years of laboratory experience directing or supervising high complexity testing. (b)(4) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; or (b)(5) On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located; or (b)(6) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, the American Osteopathic Board of Pathology, or possess qualifications that are equivalent to those required for certification. This STANDARD is not met as evidenced by: Based on a review of records, FDA database, patient and interview with the laboratory director, the laboratory director failed to ensure the laboratory director met the regulatory qualifications for pH, Specific Gravity, and Oxidant testing using the Siemens Viva Pro-E which was not cleared or approved by the FDA. Findings include: (1) On 08/01/2023 at 09:40 am, the laboratory director stated the following: (a) Urine Drug Screen (Amphetamine, Benzodiazepines, Buprenorphine, Cocaine, Methadone, Opiate, and Oxycodone) pH, Specific Gravity, and Oxidant testing were performed using the Siemens Viva Pro-E analyzer; (b) pH, Specific Gravity, and Oxidant testing were used to determined the acceptability of the sample for Urine Drug testing. (2) A review of three patient reports (testing performed on 03/01/2023, 07/31/2023, 08/01/2023) identified the laboratory reported the results for the pH, Specific Gravity, and Oxidant testing; (3) A review of the manufacturer's package insert for the above testing, under "Intended Use" stated, "This test is for forensic /toxicology use only"; (4) A review of the FDA (Food and Drug Administration) test classification database did not include a classification for the tests (if a test is not included on the FDA site, then it did not go through the FDA approval process, which defaults the classification of the test as high complexity); (5) A review of the laboratory director credentials identified the laboratory director did not meet the regulatory qualifications for a high complexity laboratory director; (6) The findings were reviewed with the laboratory director who stated on 08/01/2023 at 12:45 pm, the pH, Specific Gravity, and Oxidant testing were included on the patient report and they were not aware the tests had not been FDA approved. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. -- 4 of 6 -- This CONDITION is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to ensure two of three testing persons met the qualification requirements to perform high complexity testing. Findings include: (1) The laboratory failed to ensure that each person performing high complexity pH, Specific Gravity, and Oxidant testing met the qualification requirements. Refer to D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control -- 5 of 6 -- values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on a review of records, FDA database, and interview with the laboratory director, the laboratory failed to ensure that each person performing high complexity testing met the qualification requirements for two of three persons listed on the CMS- 209. Findings include: (1) On 08/01/2023 at 09:40 am, the laboratory director stated the following: (a) Urine Drug Screen (Amphetamine, Benzodiazepines, Buprenorphine, Cocaine, Methadone, Opiate, and Oxycodone), pH, Specific Gravity, and Oxidant testing were performed using the Siemens Viva Pro-E analyzer; (b) pH, Specific Gravity, and Oxidant testing were used to determined the acceptability of the sample for Urine Drug testing. (2) A review of three patient reports (testing performed on 03/01/2023, 07/31/2023, 08/01/2023) identified the laboratory reported the results for the pH, Specific Gravity, and Oxidant testing; (3) A review of the manufacturer's package insert for the above testing, under "Intended Use" stated, "This test is for forensic/toxicology use only"; (4) A review of the FDA (Food and Drug Administration) test classification database did not include a classification for the tests (if a test is not included on the FDA site, then it did not go through the FDA approval process, which defaults the classification of the test as high complexity); (5) A review of the Laboratory Personnel Report (Form CMS-209) and education records for three testing persons identified two of three testing persons did not meet the qualification requirements to perform high complexity testing; (6) The findings were reviewed with the laboratory director who stated on 08/01/2023 at 12:45 pm, the pH, Specific Gravity, and Oxidant testing were included on the patient report and they were not aware the tests had not been FDA approved. -- 6 of 6 --

Summary Statement of Deficiencies D0000 The initial survey was performed on 04/21/2021. The findings were reviewed with the laboratory director 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 director, the laboratory failed to ensure an attestation statement was signed by the analyst for 1 of 2 events. Findings include: (1) On 04/21/2021, the surveyor reviewed 2020 proficiency testing records, with the following identified: (a) Second 2020 Chemistry Event - The attestation statement had not been signed by the analyst. (2) The surveyor reviewed the records with the laboratory director. The laboratory director stated on 04/21/2021 at 10:50 am the attestation statement had not been signed by the analyst as indicated above. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 -- 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 a review of records and interview with the laboratory director, the laboratory failed to ensure control materials were not used beyond the manufacturer's expiration date for 1 of 1 bottle of control material; and failed to ensure calibration materials were not used beyond the manufacturer's expiration date for 2 of 2 bottles. Findings include: (1) On 04/21/2021 at 09:35 am, the laboratory director 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) Three levels (level 3, 4, and 5) of UTAK quality control materials were performed each day of patient testing; (c) Two levels of Syva Specific Gravity calibrators were performed weekly. (2) On 04/21/2021 at 09:50 am, the surveyor observed the following: (a) One bottle of UTAK Validity Control Level 4 (Lot# C2685) with an expiration date of 03/31/2021; (b) One bottle of Syva Specific Gravity Validity Calibrator (Lot# 3T618UL-N1) with an expiration date of 03/26/2021; (c) One bottle of Syva Specific Gravity Validity Calibrator (Lot# 3T628UL-N1) with an expiration date of 03/26/2021. (3) The surveyor showed the expired material to the laboratory director. The laboratory director stated on 04/21/2021 at 10:00 am, the expired materials were available for use 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: Based on a review of records and interview with the laboratory director, the laboratory failed to perform calibration verification procedures at least once every 6 months for -- 2 of 3 -- the analytes performed on the Viva Pro E analyzer for 2 of 12 months. Findings include: (1) On 04/21/2021 at 09:35 am, the laboratory director stated to the surveyor an 11-panel urine drug screen (Amphetamine, Barbiturate, Benzodiazepine, Buprenorphine, Cocaine, Methadone, Opiates, Oxycodone) testing was performed using Viva Pro E analyzer; (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 director, who stated on 04/21/2021 at 11:30 am, calibration verification procedures had not been performed in 2020 as indicated above. D5807 TEST REPORT CFR(s): 493.1291(d) 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 director, the laboratory failed to provide normal reference intervals for 1 of 1 Urine Drug Screen test report. Findings include: (1) On 04/21/2021 at 09:35 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. (2) The surveyor reviewed 1 test report for a patient tested on 04/23/2020 at 11:33 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 director, who stated on 04/21/2021 at 11:55 am the patient report did not include a normal reference range as indicated above. -- 3 of 3 --