Oklahoma On Demand Urgent Care

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/22/2025. The laboratory was found in compliance with standard-level deficiencies cited. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) (b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to test proficiency testing samples the same number of times that patient samples were tested for one of five Hematology/Coagulation proficiency testing events reviewed. Findings include: (1) On 10/22/2025 at 10:30 am the laboratory supervisor stated CBC (Complete Blood Count) testing was performed using the Sysmex XP-300 analyzer; (2) A review of Hematology/Coagulation proficiency testing records for five events (First 2024, Second 2025, Third 2024, First 2025, Second 2025) identified specimens had been tested in duplicate as follows: (a) First 2024 Event - Five of five samples were tested in duplicate for CBC testing (i) Sample HSY-01 was tested on 03/19/2024 at 08:13 am and 03/20/2025 at 07:04 pm; (ii) Sample HSY-02 was tested on 03/19/2024 at 08:16 am and 03/20/2024 at 07:05 pm; (iii) Sample HSY-03 was tested on 03/19/2024 at 08:18 am and 03/20/2024 at 07: 07 pm; (iv) Sample HSY-04 was tested on 03/19/2024 at 08:19 am and 03/20/2024 at 07:08 pm; (v) Sample HSY-05 was tested on 03/219/2024 at 08:21 am and 03/20 /2024 at 07:12 pm. (3) The records were reviewed with the laboratory supervisor who stated on 10/22/2025 at 10:30 am, the samples had been tested in duplicate as stated above and patient samples were not routinely tested in this manner. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 -- 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 policy, and interview with the laboratory supervisor, the written competency assessment policy for assessing the technical consultant based on the position responsibilities did not define the frequency of the assessment to be performed, and the laboratory failed to document the competency assessment for the technical consultant, based on the position responsibilities as listed in Subpart M, for one of one technical consultant during the review period of 12/06 /2023 through the current date. Findings include: (1) A review of written policies and interview with the laboratory supervisor on 10/22/2025 at 11:30 am identified the written competency assessment policy for assessing the technical consultant based on the position responsibilities did not define the frequency of the assessment; (2) Further review of personnel records and Form CMS 209, identified no evidence competency assessments had been performed for one of one person listed as the technical consultant during the review period of 12/06/2023 through the current date; (3) The findings were reviewed with the laboratory supervisor who stated on 10/22/2025 at 11: 58 am, competency assessment had not been performed for the role of technical consultant, and the competency assessment policy for assessing the technical consultant based on the position responsibilities did not define the frequency of the assessment as stated above. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 supervisor, the laboratory failed to ensure the laboratory temperature was maintained as required by the manufacturer for Becton Dickson (BD) Vacutainer tubes for 19 of 241 days of patient testing from January 2025 to August 2025. Findings include: (1) On 10/22/2025 at 11:30 am, observation of the laboratory identified that BD Vacutainer tubes were routinely stored in the laboratory; (2) A review of the package insert for the Vacutainer tubes identified the manufacturer required the tubes to be stored at 4-25 degrees Celsius; (3) A review of temperature records identified the temperature readings were greater than 25 degrees Celsius for 19 of 241 days of patient testing; (4) The records were reviewed with the laboratory supervisor who stated on 10/22/2025 at 11:30 am, the laboratory temperature had not been maintained as required by the manufacturer. -- 2 of 3 -- 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, manufacturer's instructions, and interview with the laboratory supervisor, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures for one of one analyzer reviewed from January 2025 through the current date. Findings include: (1) On 10/22 /2025 at 11:28 am, the laboratory supervisor stated the laboratory performed CBC (WBC (White Blood Cell), RBC (Red Blood Cell), Hgb (Hemoglobin), Hct (Hematocrit), Plt (Platelet)) testing using the Sysmex XP-300 analyzer; (2) A review of the manufacturer's maintenance log showed the following required daily and weekly maintenance procedures: (a) Daily: (i) Perform Shutdown (ii) Verify Backgroud (iii) Verify Vacuum Pressure (iv) Check Trap Chamber (v) Perform Quality Control (b) Weekly: (i) Clean SRV Tray (3) A review of maintenance logs from January 2025 through the current date identified daily and weekly maintenance procedures had not been documented as performed as follows: (a) Daily: (i) July 12,13,14,15,23,26,27 (ii) August 29 (iii) September 6,7,14,20,21,28 (b) Weekly: (i) Between 03/12/2025 and 03/24/2025 (ii) Between 09/15/2025 and 10/08/2025 (4) The records were reviewed with the laboratory supervisor who stated on 10/22/2025 at 12: 33 pm, the daily and weekly maintenance procedures had not been documented as performed as stated above. D5807 TEST REPORT CFR(s): 493.1291(d) (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 records and interview with the laboratory supervisor, the laboratory failed to ensure reference intervals were determined as appropriate for the laboratory's patient population for two of two patient reports reviewed. Findings include: (1) On 10/22/2025 at 1:00 pm, the laboratory supervisor stated the laboratory performed CBC (Complete Blood Count) testing using the Sysmex XP-300 hematology analyzer; (2) Review of two patient CBC reports (the first report was for an adult female patient with the testing performed on 09/26/2025 at 06:06 pm and the second report was for an adult male patient with the testing performed on 04/18/2025 at 04:50 pm) identified both reports included the same reference intervals for the following CBC parameters: (a) WBC (White Blood Cell) count - 3.1-10.3 (10^3/mL); (b) RBC (Red Blood Cell) count - 4.20-5.40 (10^6/mL); (c) Hemoglobin - 12.0-15.1 g /dL; (d) Hematocrit - 36.0-44.0 %; (e) Platelets - 150-400 (10^3/mL). (3) The reports were reviewed with the laboratory supervisor who stated on 10/22/2025 at 01:00 pm, the patient reports did not include gender specific reference ranges for WBC, RBC, Hemoglobin, Hematocrit, and Platelets. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 12/06/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant and the laboratory supervisor 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 technical consultant, the laboratory failed to have a written policy to assess the competency of the technical consultant, based on the position responsibilities as listed in Subpart M, for one of one person. Findings include: (1) A review of the laboratory policy and procedure manual identified no evidence of a policy for assessing the competency of the technical consultant, 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 January 2022 through the current date identified competencies, based on job responsibilities, had not been performed for one of one person listed as the technical consultant; (3) The findings were reviewed with the technical consultant who stated on 12/06/2023 at 03:05 pm a policy had not been written and competencies had not been performed. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the 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 -- 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: Based on a review of records, policies and procedures, and interview with the technical consultant and laboratory supervisor, the laboratory failed to follow their written policy for verifying the stated values of control materials prior to implementation for six of 12 lot numbers used during the review period of 01/04/2023 through the current date. Findings include: (1) On 12/06/2023 at 11:18 am, the laboratory supervisor stated the following: (a) The laboratory performed CBC (Complete Blood Count) testing using the Sysmex XP-300 hematology analyzer; (b) Three levels of EIGHTCHECK-3WP X-TRA QC (Quality Control) materials were tested each day of patient testing; (c) The manufacturer's provided ranges were used to determine acceptability of quality control results. (2) A review of the policy titled, "XP-300 Procedure" under section E. "Starting a New Lot of Controls" stated the following: (a) "Parallel test new controls by analyzing the three levels of control a minimum of twice a day for 5 days prior to expiration of the previous lot. After a minimum of 10 data points are accumulated and values are running within assay ranges, the lot may be placed into production. The new lot will be validated prior to the current lot expiration." (3) A review of records for 12 control lot numbers used from 01/04/2023 through the current date identified the laboratory did not follow their policy for verifying new QC lot numbers as follows: (a) Lot #30810710, 30810711, and 30810712 used from 04/02/2023 through 06/27/2023 - Tested two days prior to expiration date of the previous lot number; (b) Lot #32490710, 32490711, and 32490712 put into use on 09/27/2023 through the current date - Tested three days prior to expiration date of the previous lot. (4) The findings were reviewed with the technical consultant and laboratory supervisor. Both stated on 12/06/2023 at 12:38 pm, the laboratory did not follow their written policy. 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 observation, a review of records, and interview with the technical consultant and the laboratory supervisor, the laboratory failed to ensure laboratory supplies were stored as required by the manufacturer for five of five months reviewed in 2023. Findings include: (1) On 12/06/2023 at 11:15 am, observation of the laboratory identified the following materials: (a) One package of BD Vacutainer PST Gel and Lithium Heparin blood collection tubes, lot #3194811 - the storage requirement as stated on the package was 4 to 25 degrees C (Centigrade); (2) A review of temperature records between January 2023 through May 2023 identified documented temperatures warmer than 25 degrees C for five of five months as follows: (a) January -- 2 of 4 -- 2023, five of 31 temperatures were documented as warmer than 25 degrees C (b) February 2023, three of 28 temperatures were documented as warmer than 25 degrees C (c) March 2023, ten of 31 temperatures were documented as warmer than 25 degrees C (d) April 2023, five of 30 temperatures were documented as warmer than 25 degrees C (e) May 2023, four of 31 temperatures were documented as warmer than 25 degrees C (3) The records were reviewed with the technical consultant and the laboratory supervisor on 12/06/2023 at 4:01 pm, who stated that the blood collection tubes had not been stored 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 laboratory supervisor, the laboratory failed to ensure expired material was not available for use. Findings include: (1) On 12 /06/2023 at 11:15 am, the laboratory supervisor stated CBC (Complete Blood Count) testing was performed using the Sysmex XP 300 hematology analyzer; (2) Observation of the laboratory on 12/06/2023 at 11:18 am identified the following supplies that appeared to be available for use: (a) Six tubes of BD Vacutainer PST Gel and Lithium Heparin 83 Units, lot #2259105 with an expiration date of 09/30/2023 (3) Interview with the laboratory supervisor on 12/06/2023 at 1:22 pm confirmed the expired materials were available for use. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document 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, manufacturer's instruction manual, and interview with the technical consultant and laboratory supervisor, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures on the Sysmex XP-300 hematology analyzer during the review period of January 2023 through November 2023. Findings include: (1) On 12/06/2023 at 11:15 am, the laboratory supervisor stated CBC (Complete Blood Count) testing was performed using the Sysmex XP-300 hematology analyzer; (2) A review of the "Sysmex XP-300 Maintenance Checklist" on section 14.8 Appendix of the manufacturer's instructions manual required the following maintenance procedures: (a) Weekly "Clean SRV tray" (b) Every 3 months "Clean SRV" (3) A review of maintenance logs from January 2023 through November 2023 identified maintenance had not been documented as performed for the following: (a) Weekly: i. Between 03/23/2023 and 04/03/2023 ii. Between 04/17/2023 and 05/04/2023 iii. Between 07/21/2023 and 08/01/2023 iv. Between 09/22/2023 and 10/02/2023 v. Between 10/23/2023 and 11/06/2023 (c) -- 3 of 4 -- Every 3 months: i. After 04/14/2023 (4) The records were reviewed with the technical consultant and laboratory supervisor who stated on 12/06/2023 at 3:45 pm, maintenance procedures had not been documented as performed as stated above. 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 technical consultant and laboratory supervisor, the laboratory failed to ensure patient test reports included the name of the laboratory location for one of one patient CBC (Complete Blood Count) report reviewed. Findings Include: (1) On 12/06/2023 at 01:30 pm, the technical consultant and laboratory supervisor stated CBC testing was performed using the Sysmex XP-300 analyzer; (2) A review of one patient report with testing performed on 09/18/2023 identified the report did not include the name of the laboratory. The name on the report stated "Main Office" and the name of the laboratory (as stated on the Clia certificate was "Oklahoma On Demand Urgent Care"); (3) The report was reviewed with the technical consultant and laboratory supervisor. Both stated on 12/06 /2023 at 04:00 pm, the laboratory name was not included on the patient report. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The initial survey was performed on 12/29/2021. The findings were reviewed with the laboratory supervisor and technical consultant at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulation: 493.1409; D6033: Technical Consultant D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to ensure the proficiency testing program released proficiency testing results to HHS and the State Agency. Findings include: (1) Prior to the onsite survey (08/30/2021), the surveyor printed the laboratory's proficiency testing scores for review from the CMS Casper database. The scores included on the Casper Report 0096D, did not report for the 2020 and 2021 proficiency testing events. It appeared the laboratory did not participate in proficiency testing; (2) On 12/29/2021 at 10:25 am, the technical consultant stated to the surveyor: (a) The laboratory performed CBC (Complete Blood Count) testing using the Sysmex XP-300 Analyzer beginning 02/14 /2020. (3) The surveyor asked the technical consultant if the laboratory participated in proficiency testing during 2020 and 2021. On 12/29/2021 at 10:55 am, the technical consultant stated that all available proficiency testing events had been performed in 2020 and 2021; (4) The surveyor then reviewed the proficiency 2020 Hematology Comparative Evaluation First, Second, and Third events and the 2021 Hematology Comparative Evaluation First and Second events. On all five events the providers CLIA No stated, "Not on file"; (5) The technical consultant stated on 12/29/2021 at 03: 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 -- 06 pm, the laboratory had not authorized release of proficiency testing scores for the 2020 and 2021. 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 policy, and interview with the technical consultant, the laboratory failed to have a written technical consultant competency policy based on the position responsibilities as listed in Subpart M for one of one technical consultant. Findings include: (1) On 12/29/2021, the surveyor reviewed the competency assessment policy. It did not include guidance for assessing the competency of the technical consultant; (2) The surveyor then reviewed personnel records for competency assessments performed during 2020, and 2021. There was no evidence of competencies performed for the technical consultant based on their job responsibilities; (3) The surveyor asked the technical consultant if a written policy to evaluate the technical consultant based on job responsibilities was available. The technical consultant stated on 12/29/2021 at 03:26 pm a policy had not been written and the above competencies had not been performed. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document 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, manufacturer's instructions, and interview with the laboratory supervisor and technical consultant, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures for nine of nine months. Findings include: (1) On 12/29/2021 at 10:20 am, the technical consultant stated to the surveyor that CBC (Complete Blood Count) testing was performed on the Sysmex XP-300 analyzer; (2) The surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. The requirements for weekly maintenance were as follows: (a) Clean SRV Tray (3) The surveyor then reviewed maintenance records for nine months (January 2021 through September 2021). There was no evidence the weekly maintenance had been performed: (a) Between 01/31/2021 through 09/01/2021. (4) The surveyor reviewed the records with the technical consultant and laboratory supervisor. Both stated on 12/29/2021 at 02:07 pm, the weekly maintenance had been performed but had not documented as required. 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 -- 2 of 4 -- and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of records and interview with laboratory supervisor and technical consultant, the laboratory failed to make appropriate reference ranges available for two of two patient reports. Findings include: (1) On 12/29/2021 at 10:25 am, the technical consultant stated the laboratory performed CBC (Complete Blood Count) testing using the Sysmex XP-300 analyzer; (2) The surveyor reviewed two patient CBC reports - the first report was for an adult female patient with the testing performed on 12/28/2021 at 08:06 pm; the second report was for an adult male patient with the testing performed on 11/23/2021 at 02:51 pm. Both reports included the same reference intervals for the CBC parameters of RBC (Red Blood Cell), Hemoglobin, and Hematocrit which were: (a) RBC - 4.2 - 5.40 10^6/l (b) Hemoglobin - 12.0 - 15.1 g/dL (c) Hematocrit - 36.0 - 44.0 % (3) The surveyor reviewed the findings with laboratory supervisor and the technical consultant. Both stated on 12/29/2021 at 11:05 am the patient reports did not include gender specific reference ranges. NOTE: Routinely, female reference intervals for the analytes RBC, Hemoglobin, and Hematocrit are lower than male reference intervals. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor and technical consultant, the technical consultant failed to provide technical oversight in accordance with 493.1413 of this subpart. Findings include: (1) The technical consultant failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant 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)(i) 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; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's -- 3 of 4 -- degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor and technical consultant, the laboratory failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications for one of five competency evaluations performed. Findings include: (1) On 12/29/2021, the surveyor reviewed records for five persons performing moderate complexity testing in 2020 and 2021. The records showed the evaluation for one of five persons had been performed by an individual who did not meet the regulatory qualification requirements of the technical consultant: (a) Testing Person #1 - The 08/12/2020 evaluation had been performed by the laboratory supervisor (this person had earned a master's degree in clinical laboratory science but did not have at least 1 year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible). (2) The surveyor explained to the laboratory supervisor and technical consultant that all components of the competency evaluations must be performed by a person who qualifies as a technical consultant (an individual with a minimum of a masters degree in a chemical, physical or biological science or medical technology from an accredited institution, and at least 1 year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service). The laboratory supervisor and technical stated to the surveyor on 12/29/2021 at 11:39 am, the evaluation had been performed by an individual who did not meet the years of experience of a technical consultant. -- 4 of 4 --