Okmulgee Pediatrics & Family Care

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/18/2025. The laboratory was found in compliance with standard-level deficiencies cited. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (b)(7) 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 testing person #1, the laboratory failed to ensure a proficiency testing attestation statement had been signed and dated by the laboratory director or designee for one of five Hematology events reviewed from 2024 through 2025. Findings include: (1) A review of the first, second, and third 2024; and first and second 2025 Hematology proficiency testing records identified the following for one of five events: (a) Second 2025 Event - The attestation statement had not been signed and dated by the laboratory director or designee. (2) The findings were reviewed with testing person #1 who stated on 11/18/2025 at 12:20 pm, the attestation statement had not been signed and dated by the laboratory director or designee. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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: 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 -- Based on a review of manufacturer's instructions, assay sheet, and interview with testing person #1, the laboratory failed to ensure materials were not used beyond the open vial stability. Findings include: (1) On 11/18/2025 at 10:30 am, testing person #1 stated the following: (a) The laboratory performed Hemogram testing using the ABX Horiba Micros 60 analyzer; (b) Three levels of ABX Minotrol 16 QC (Quality Control) materials were tested each day of patient testing. (2) A review of the manufacturer's storage and stability instructions and assay sheet for the control materials contained in Minotrol 16 package insert required once the controls are opened, the controls are stable for 30 days when stored at 2 - 8 degrees C (Centigrade); (3) On 11/18/2025 at 10:40 am, observation of the refrigerator contents identified the following: (a) ABX Minotrol 16 QC material level 1, lot #52651601 - open date was not posted on the bottle, and modified expiration date could not be determined; (b) ABX Minotrol 16 QC material level 2, lot #52651602 - open date was not posted on the bottle, and modified expiration date could not be determined; (c) ABX Minotrol 16 QC material level 3, lot #52651603 - open date was not posted on the bottle, and modified expiration date could not be determined. (4) The findings were reviewed with testing person #1, who stated on 11/18/2025 at 01:00 pm, the controls had not been dated with the appropriate modified expiration date. 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 testing person #1, 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 11/18/2025 at 10:40 am, testing person #1 stated the laboratory performed hemogram (WBC (White Blood Cell), RBC (Red Blood Cell), Hgb (Hemoglobin), Hct (Hematocrit), MCV (Mean Corpuscular Volume), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), and PLT (Platelet Count) testing using the ABX Horiba Micro 60 analyzer; (2) On 11/18/2025, a review of the manufacturer's maintenance log showed the following required daily maintenance procedures: (a) Daily Cleaning (b) Check Reagents (c) Check Waste Level (d) Check Printer Paper (e) Run Start Up (3) A review of maintenance logs from January 2025 through the current date identified daily maintenance had not been documented as performed as follows: (a) January 21, 22, 23 (b) February 18, 19, 20 (c) March 28, 31 (d) April 01, 02, 03, 04, 07 (e) May 22, 23, 26, 27, 28, 29, 30 (f) June 02, 03, 04, 05, 06, 09, 10, 11, 12, 13 (g) July 24, 25, 28, 29, 30, 31 (h) September 30 (i) October 30,31 (4) The records were reviewed with testing person #1 who stated on 11/18/2025 at 01:20 pm, the daily maintenance procedures had not been documented as performed as stated above. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number -- 2 of 4 -- of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on a review of records and interview with the testing person, the laboratory failed to verify the stated value of control materials before they were put into use for nine of 12 lot numbers. Findings include: (1) On 11/18/2025 at 10:30 am, testing person #1 stated the following: (a) The laboratory performed Hemogram testing using the ABX Horiba Micros 60 analyzer; (b) Three levels of ABX Minotrol 16 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; (d) Laboratory ran the new lot of QC materials in parallel with the old lots for 10 to 20 times before putting it into use. (2) A review of records for 12 control lot numbers identified no evidence the provided ranges were verified before the lot numbers were put into use for nine of 12 lot numbers as follows: (a) Low-level lot #51531601, normal-level lot #51531602, and high-level lot #51531603 - No evidence the QC materials had been parallel tested prior to implementation on 06/17/2025; (b) Low-level lot #52091601, normal-level lot #52091602, and high-level lot #52091603 - No evidence the QC materials had been parallel tested prior to implementation on 09 /02/2025; (c) Low-level lot #52651601, normal-level lot #52651602, and high-level lot #52651603 - No evidence the QC materials had been parallel tested prior to implementation on 10/27/2025; (3) The findings were reviewed with the testing person who stated on 05/15/2025 at 12:15 pm the manufacturer's ranges had not been verified before the above lot numbers had been put into use. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/17/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director and testing person #1 at the conclusion of the survey. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on observation and interview with testing person #1, the laboratory failed to ensure waived test kits were stored as required by the manufacturer, in a room denoted as the store room. Findings include: (1) Observation of the store room and interview with testing person #1 on 10/17/2023 at 09:30 am, identified the following: (a) Six boxes of Quidel QuikVue Strep A, lot # 708663, storage temperature of 15-30 degrees Celsius; (b) Two boxes of BD Veritor Sars-Co-V-2 , lot # 3251389, storage temperature of 2-30 degrees Celsius; (c) Seven boxes of BD Veritor Sars-CoV-2 & Flu A+B lot # 3185306, storage temperature of 2-30 degrees Celsius. (2) Interview with testing person # 1 on 10/17/2023 at 09:30 am confirmed the laboratory was not monitoring the temperature of the store room. 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 2 -- This STANDARD is not met as evidenced by: Based on observation and interview with testing person #1, the laboratory failed to ensure expired supplies were not available for use. Findings include: (1) Observation of the laboratory on 10/17/2023 at 09:00 am, identified the following expired collection swabs that appeared to be available for use: (a) Diagnostic Hybrids 3ml UTM Swabs - lot # 212015 with an expiration date of 07/31/2023. (b) Diagnostic Hybrids 3ml VCM Swabs - lot # 214375 with an expiration date of 07/31/2023. (2) Interview with testing person #1 10/17/2023 at 09:00 am confirmed the Diagnostic Hybrid swabs were available for use. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/13/2021. The findings were reviewed with testing person #1 at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulation: 493.1409; D6033: Technical Consultant D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1, the laboratory failed to following the manufacturer's instructions for specimen transport and storage for 5 of 5 patient specimens. Findings include: (1) On 10/13/2021 at 10:30 am, testing person #1 stated the following to the surveyor: (a) The laboratory performed COVID- 19 testing using the following instrument: (i) BD Veritor System - qualitative detection of SARS-CoV-2 nucleocapsid antigens from direct nasal swabs. (2) The surveyor reviewed the manufacturer's product insert titled, "BD Veritor System". Under the section titled, "Specimen Transport and Storage" which stated, "Freshly collected specimens should be processed as soon as possible, but no later than one hour after specimen collection. It is essential that correct specimen collection and preparation methods be followed."; (3) The surveyor reviewed 5 test reports for patients tested on 04/07/2021 and 10/12/2021 and identified the following: (a) Patient Report #1 - Although the specimen collection date and time (04/07/2021 at 09:42 am) was documented, the result date and time was not on the patient report; (b) Patient Report #2 - Although the specimen collection date and time (04/07/2021 at 11:50 am) was documented, the result date and time was not on the patient report; (c) Patient Report #3 - Although the specimen collection date and time (10/12/2021 at 10:41 am) 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 -- was documented, the result date and time was not on the patient report; (d) Patient Report #4 - Although the specimen collection date and time (10/12/2020 at 11:04 am) was documented, the result date and time was not on the patient report; (e) Patient Report #5 - Although the specimen collection date and time (10/12/2021 at 03:19 pm) was documented, the result date and time was not on the patient report. (4) The surveyor was not able to determine if the results had been interpreted within 1 hour after inoculation since the specimen collection date and time was not on the patient report; (5) The surveyor reviewed the records with testing person #1. Testing person #1 stated on 10/13/2021 at 02:00 pm the laboratory could not prove the results had been interpreted within 1 hour after inoculation as indicated above. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1, the laboratory failed to review and evaluate proficiency testing results for 1 of 5 events. Findings include: (1) On 10/13/2021, the surveyor reviewed 2020 and 2021 proficiency testing records. The following biases were identified (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) First 2020 Hematology Event (i) MCH (Mean Corpuscular Hemoglobin) - 3 of 5 results exhibited a positive bias (aa) Sample HEM-01 - SDI of 2.0 (bb) Sample HEM-03 - SDI of 2.3 (cc) Sample HEM-05 - SDI of 3.2 (2) The surveyor could not locate evidence in the records proving the biases had been identified and addressed; (3) The records were reviewed with testing person #1. Testing person #1 stated on 10/13/2021 at 01:10 pm the biases had not been addressed. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records, and interview with testing person #1, the laboratory failed to demonstrate the reportable ranges for a relocated analyzer. Findings include: (1) On 10/13/2021 at 10:30 am, testing person #1 stated to the surveyor the laboratory relocated the Horiba ABX Micros 60 analyzer to a new location on 08/25/2020 to perform CBC (Complete Blood Count) testing; (2) The surveyor reviewed the performance specification records for the analyzer and identified the laboratory had not demonstrated the reportable ranges for each analyte: (3) The surveyor reviewed the findings with testing person #1 who stated on 10/13/2021 at 02:35 pm the reportable ranges had not been verified. -- 2 of 4 -- 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 testing person #1, 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 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 testing person #1, the laboratory -- 3 of 4 -- failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications for 3 of 4 competency evaluations performed. Findings include: (1) On 10/13/21, the surveyor reviewed records for 4 persons performing moderate complexity testing in 2020 and to date in 2021 (10/13 /2021). The records showed the evaluations for 3 of 4 persons had been performed by an individual who did not meet the regulatory qualification requirements of the technical consultant: (a) Testing Person #2 - The 02/24/2020 and 02/25/2021 evaluations had been performed by testing person #1 (this person had earned a high school diploma); (b) Testing Person #3 - The 08/27/2020 ad 08/20/2021 evaluations had been performed by testing person #1; (c) Testing Person #4 - The 08/31/2021 evaluation had been performed by testing person #1. (2) The surveyor reviewed the records with testing person #1 and explained 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 bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution, and at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service). Testing person #1 stated to the surveyor on 10/13/2021 at 10:50 am, the above evaluations had been performed by an individual who did not meet the educational qualifications of a technical consultant. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on 09/16/19. The findings were reviewed with the laboratory director, technical consultant, and testing person #1 during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulation: 493.1409; D6033: Technical Consultant D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 technical consultant, the laboratory failed to test proficiency testing samples the same number of times that patient samples were tested. Findings include: (1) At the beginning of the survey, the technical consultant stated to the surveyor the laboratory performed Hemogram testing using the Horiba Micros 60 analyzer; (2) Later during the survey, the surveyor reviewed Hematology proficiency testing records for 5 events (First 2018, Second 2018, Third 2018, First 2019, and Second 2019 Events) and identified the specimens had been tested multiple times for 4 of 5 events as follows: (a) First 2018 Event (i) Sample HEM-03 was tested two times (03/20/18 at 10:02 a.m. and 03/20/18 at 10:08 a. m.) with the results obtained from the first run reported to the proficiency testing program. (b) Third 2018 Event (i) Sample HEM-11 was tested two times (11/26/18 at 01:31 p.m. and 11/26/18 at 01:50 p.m.) with the results obtained from the first run reported to the proficiency testing program; (ii) Sample HEM-13 was tested two times (11/26/18 at 01:41 p.m. and 11/26/18 at 01:56 p.m.) with the results obtained from the first run reported to the proficiency testing program. (c) First 2019 Event (i) Sample HEM-02 was tested two times (03/15/19 at 08:44 a.m. and 03/15/19 at 09:00 a.m.) with the results obtained from the first run reported to the proficiency testing program. 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 -- (d) Second 2019 Event (i) Sample HEM-08 was tested two times (07/11/19 at 11:39 a. m. and 07/11/19 at 11:55 a.m.) with the results obtained from the first run reported to the proficiency testing program. (3) The surveyor reviewed the records with the technical consultant and asked if patient samples were tested in the same manner. The technical consultant stated patient specimens were routinely tested one time and not in duplicate as the proficiency testing specimens had been tested. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to perform at least two levels of control testing at least once a day patient specimens were tested. Findings include: (1) At the beginning of the survey, the technical consultant stated to the surveyor: (a) The laboratory performed Hemogram testing using the Horiba ABX Micros 60 hematology analyzer; (b) Three levels (low, normal and high) of Horiba quality control (QC) materials were to be tested each day of patient testing. (2) Later during the survey, the surveyor reviewed QC and patient records for testing performed between January 2019 through March 2019. It was identified QC testing had not been performed each day of patient testing for 1 of 63 days: (a) Patient Testing performed on 02/26/19. (3) The surveyor reviewed the records with the technical consultant. The technical consultant stated QC testing had not been performed each day of patient testing. 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 the manufacture's instructions and interview with the technical consultant, the laboratory failed to follow the manufacturer's specifications for quality control materials. Findings include: (1) At the beginning of the survey, the technical consultant stated to the surveyor: (a) Hemogram testing was performed on the Horiba ABX Mircros 60 hematology analyzer; (b) The laboratory tested 3 levels (Low, Normal, High) of Horiba Minotrol Quality Control (QC) materials each day of patient testing. (2) Later during the survey, the surveyor reviewed the manufacturer's instructions titled, "Quality Control Guidelines" which stated, (a) "The published assay means and ranges of a commerical hematology control (Diffitrol, Minotrol 18 or others) are considered a ranges of means." (3) The surveyor then reviewed QC records for testing performed from May 2019 through the day of the survey (09/16/19). It was identified the laboratory had used the package insert ranges, instead of laboratory -- 2 of 4 -- established ranges, to determine acceptability of QC results for 3 of 12 lot numbers: (a) Low, Normal, and High control lot MX419 used from 09/04/19 through 09/16/19. (4) The surveyor reviewed the findings with the technical consultant who stated the laboratory had used the package insert ranges instead of laboratory established ranges for determining acceptability of QC results. 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 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 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 -- 3 of 4 -- 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 technical consultant, the laboratory failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications. Findings include: (1) At the beginning of the survey, the surveyor reviewed records for 6 persons performing moderate complexity testing in 2018 and 2019. The records indicated the evaluations for 3 of 6 persons had been performed by an individual who did not meet the regulatory qualification requirements of the technical consultant: (a) Testing Person #3 (i) The 2018 evaluation had been performed by the testing person #2 on 02 /20/18 (this person had earned a high school diploma); (ii) The 2019 evaluation had been performed by the testing person #2 on 02/20/19. (b) Testing Person #4 (i) The 2018 evaluation had been performed by the testing person #2 on 01/08/18; (ii) The 2019 evaluation had been performed by the testing person #2 on 01/09/19. (c) Testing Person #5 (i) The 2018 evaluation had been performed by the testing person #2 on 09 /19/18; (ii) The 2019 evaluation had been performed by the testing person #2 on 09/05 /19. (2) The surveyor explained to the 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 bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution, and at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service). -- 4 of 4 --