Labcorp Oklahoma, Inc Royal Ave

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/15/20222. The findings were reviewed with the director of out-patient operations and regional manager at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (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 regional manager, the laboratory failed to have control procedures that monitored the accuracy and precision of the complete analytic process for ESR testing for three of four lot numbers. Findings include: (1) On 03/15/2022 at 09:45 am, the regional manager stated the following to surveyor #1: (a) Automated ESR (Erythrocyte Sedimentation Rate) testing was performed using the Polymedco Sedimat analyzer; (b) Two levels (Normal and Abnormal) of Polymedco Sed-Chek 2 controls materials were performed each day of patient testing. (2) Surveyor #1 reviewed the package insert for the control materials which stated, "Results depend on differences in equipment, reagents, supplies, and techniques. Therefore, a lab should establish its own acceptable ranges"; (3) Surveyor 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 -- #1 reviewed QC records for four lot numbers of control materials used from 03/01 /2021 through the current date and identified that, although the laboratory had established their own acceptable ranges, they were utilizing the package insert guideline ranges to determine patient acceptability for three of four lot numbers as follows: (a) Normal control lot #11003201N and Abnormal control lot #11003201A - In use from 03/01/2021 through 02/28/2022 (i) Abnormal control - The laboratory had established a range of 44.27-57.59 but was using the package insert range of 35-65. (b) Normal control lot #11002211N and Abnormal control lot #11001211A - Put into use on 03/01/2022 and was currently in use (i) Normal control - The laboratory had established a range of 3.1-4.7 but was using the package insert range of 1-11; (ii) Abnormal control - The laboratory had established a range of 43.6-48 but was using the package insert range of 39-67. (4) Surveyor #1 reviewed the records with the regional manager who stated on 03/15/2022 at 12:00 pm, the laboratory had used the manufacturer's ranges to determine patient acceptability instead of using their established ranges as shown above. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a review of records and interview with the regional manager, the technical consultant failed to ensure an initial training included complete documentation of all moderate complexity testing performed for one of one person. Findings include: (1) On 03/15/2022 at 09:45 am, the regional manager stated to surveyor #1 the following testing were performed in the laboratory: (a) CBC (Complete Blood Count) testing using the Sysmex XS-1000i analyzer; (b) Microscopic Urine Sediment analysis; (c) ESR (Erythrocyte Sedimentation Rate) testing using the Polymedco Sedimat analyzer; (d) Specific Gravity testing using a refractometer. (2) Surveyor #2 then reviewed 2020 and 2021 personnel records for one person requiring initial training for the above testing, with the following identified: (a) Testing Person #2 - Although the initial training was completed by 03/30/2020, the initial training was not documented as performed until 03/03/2021. (3) Surveyor #2 reviewed the findings with the regional manager who stated on 03/15/2022 at 10:05 am that, the initial training had been performed but not signed until 03/03/2021 as indicated above. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the regional manager, the technical consultant failed to ensure a semiannual evaluation included complete documentation of all moderate complexity testing performed for one of one person. Findings include: (1) On 03/15/2022 at 09:45 am, the regional manager stated to surveyor #1 the following testing were performed in the laboratory: (a) CBC (Complete Blood Count) testing using the Sysmex XS-1000i analyzer; (b) Microscopic Urine Sediment analysis; (c) ESR (Erythrocyte Sedimentation Rate) testing using the Polymedco Sedimat analyzer; (d) Specific Gravity testing using a refractometer. (2) Surveyor #2 then reviewed 2020 and 2021 personnel records for one person requiring a semiannual competency for the above testing, with the following identified: (a) Testing Person #2 - The semiannual competency had been documented (03/20 - 08/20) as performed on 03/03/2021. (3) Surveyor #2 reviewed the findings with the regional manager who stated on 03/15/2022 at 10:05 am that, the semiannual competency had been performed but not signed until 03/03/2021 as indicated above. D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of records and interview with the regional manager, the technical consultant failed to ensure an annual evaluation included complete documentation of all moderate complexity testing performed for one of two persons. Findings include: (1) On 03/15/2022 at 09:45 am, the regional manager stated to surveyor #1 the following testing were performed in the laboratory: (a) CBC (Complete Blood Count) testing using the Sysmex XS-1000i analyzer; (b) Microscopic Urine Sediment analysis; (c) ESR (Erythrocyte Sedimentation Rate) testing using the Polymedco Sedimat analyzer; (d) Specific Gravity testing using a refractometer. (2) Surveyor #2 then reviewed 2020 and 2021 personnel records for two persons requiring annual competencies for the above testing, with the following identified for one of two persons: (a) Testing Person #2 - 2020 annual competency had been dated as 03/03 /2021; (b) Testing Person #2 - 2021 annual competency had been dated as 01/14/2022. (3) Surveyor #2 reviewed the findings with the regional manager who stated on 03/15 /2022 at 10:05 am that, the 2020 annual competency had been performed but not signed until 03/03/2021 and the 2021 annual competency had been performed but not signed until 01/14/2022 as indicated above. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/29/2020. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with technical consultant #3 and the outreach operations director 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 policy, and interview with technical consultant #3, the laboratory failed to have a written technical supervisor, technical consultant, and general supervisor competency policy based on the position responsibilities as listed in Subpart M. Findings include: (1) During the survey, the surveyor reviewed the competency assessment policy. It did not include guidance for assessing the competency of the technical supervisor, technical consultant, and general supervisor; (2) The surveyor then reviewed personnel records for competency assessments performed during 2018 and 2019. There was no evidence of competencies performed for the technical supervisor, technical consultant #3, and general supervisor, based on their job responsibilities; (3) The surveyor asked technical consultant #3 if a written policy to evaluate the technical supervisor, technical consultant, and general supervisor based on job responsibilities was available. Technical consultant #3 stated a policy had not been written and the above competencies had not been performed. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) 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 -- 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 technical consultant #3, the laboratory failed to review and evaluate proficiency testing results for 1 of 6 events. Findings include: (1) During the survey, the surveyor reviewed 2018 and 2019 proficiency testing records. The following failure was identified, in which there was no evidence of

Summary Statement of Deficiencies D0000 The findings were reviewed with the Oklahoma City Regional Manager for Regional Medical Laboratory, and the Oklahoma Regional Medical Laboratory director at the conclusion of the survey. D6068 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425 The testing personnel are responsible for specimen processing, test performance, and for reporting test results. This STANDARD is not met as evidenced by: Based on a review of records, written procedure, and interview with the Oklahoma City Regional Manager for Regional Medical Laboratory, and the Oklahoma Regional Medical Laboratory director, the laboratory failed to ensure an individual who performed testing followed the laboratory's procedure for test analyses. Findings include: (1) At the beginning of the survey, the Oklahoma City Regional Manager for Regional Medical Laboratory, stated manual WBC (White Blood Cell) differential testing was performed in the laboratory according to the laboratory's criteria (i.e. WBC suspect flag, etc.); (2) During the survey, the surveyor reviewed 4 patient records from 2017 and 2018 chosen at random. Of the 4 reports reviewed, 2 reported WBC counts from the manual differential testing did not equal 100 cells: (a) Patient #1: Testing was performed on 08/03/17 and a manual WBC differential of 98 cells was reported; (b) Patient #3: Testing was performed on 10/05/17 and a manual WBC differential of 90 cells was reported. (3) The surveyor reviewed the manual differential procedure included in the "Hematology Policies for Reporting CBC, DF, Criticals, Interferences, Action limit Deltas and Suspect Messages (Hem-07 OKC)." The procedure stated that "Differentials are routinely 100 cell counts."; (4) The surveyor reviewed the findings with the Oklahoma City Regional Manager for 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 -- Regional Medical Laboratory and the Oklahoma Regional Medical Laboratory director, who agreed a WBC count of 100 cells had not been performed for the 2 patients listed above. -- 2 of 2 --