Mangum Regional Medical Center

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/12,13,14/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory manager, technical consultant, and hospital administrator at the conclusion of the survey. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, policy and procedure, and interview with the technical consultant and laboratory manager, the laboratory failed to follow their written protocol for ensuring the urine centrifuge was functioning properly during the review period of April 2023 through the current date. Finding include: (1) On 11/12/2024 at 11:00 am, the technical consultant and laboratory manager stated the laboratory performed microscopic urine sediment examination and the specimens were processed using the Unico PowerSpin LX centrifuge at a speed of 2000-25000 rpm (revolutions per minute) for 5 minutes; (2) A review of the centrifuge function check policy titled, "Blood and Urine Centrifuges" stated "It is recommended that the centrifuge's RPM and timer be checked and calibrated at least every 6 months. The variable speed centrifuge will be set at 2,000-2500 RPM for 5 minutes which is for the urine specimens." (3) On 01/18/2024 a review of the centrifuge records from April 2023 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 -- through the current date identified the following: (a) Function check performed on 10 /23/2023 - The centrifuge speed had been checked at 2015 rpm and the timer had been checked at 10 minutes instead of five minutes; (b) Function check performed on 04/29 /2024 - The centrifuge record identified speed and timer check had been reported as "Pass - Max rpm accuracy" and "Pass Timer accuracy" - The actual speed and time that had been obtained had not been recorded. (4) The records were reviewed with the technical consultant and laboratory manager who stated on 11/13/2024 at 01:00 pm, the laboratory had not followed their policy for ensuring the centrifuge was functioning properly as stated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/14,15,16/2022. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the administrator, chief clinical officer, technical consultant, and laboratory manager during an exit conference performed at the conclusion of the survey. D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. 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 manager, the laboratory failed to ensure an adequate alarm system was in place for the blood bank refrigerator for three of eight alarm checks. Findings include: (1) On 11/16/2022 at 09:20 am, the laboratory manager stated the laboratory routinely maintained 2 units of O negative and 2 units of O positive packed red blood cells in the blood bank refrigerator. The units were available for emergency patient transfusions; (2) A review of the policy titled "Blood Bank Alarm System" required the alarm checks be performed on a quarterly basis and stated the following: (a) "Blood units will be maintained between 2-6 Degrees C in a continuously monitored refrigerator (allowable storage is 1-6 degrees C.)"; (b) "The alarm points are set at 1.5 degrees C and 5.5 degrees C. This maintains the units between 1-6 degrees C". (3) A review of alarm check records from January 2021 through the current date in 2022 identified the high alarm checks sounded at temperatures beyond the acceptable range for storing blood products for three of eight alarm checks performed as follows: (a) 04/20/2021 - The documented high alarm 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 -- temperature was 6.2 (b) 10/25/2021 - The documented high alarm temperature was 6.1 (c) 04/19/2022 - The documented high alarm temperature was 6.6 (4) The findings were revived the the technical consultant and laboratory manager. Both stated on 11/16 /22 at 09:45 am the documented temperatures for the high alarm checks above were not acceptable. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of policies and interview with the technical consultant and laboratory manager, the laboratory failed to ensure one of three policies had been approved, signed, and dated by the laboratory director. Findings include: (1) On 11/15 /2022 at 11;20 am, the laboratory manager stated the following: (a) The laboratory began performing pH, pCO2, pO2, and Lactate testing using the CG4+ cartridge and the iSTAT 1 analyzer on 10/25/2021; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) A review of the IQCP identified the QCP (Quality Control Plan) for the test system had not been approved, signed, and dated by the laboratory director; (3) The records were reviewed with the technical consultant and laboratory manager. Both stated on 11/15/22 at 11:25 am, the QCP for the above test system had not been approved, signed, and dated by the current laboratory director. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on a review of the procedure manual and interview with the technical consultant and laboratory manager, the laboratory failed to ensure that written procedures no longer in use had been discontinued for two of two procedures reviewed. Findings include: (1) On 11/14/2022 at 03:00 pm, the laboratory manager stated the laboratory discontinued ABO/Rh typing, Antibody Screen, and Compatibility testing on 08/18/2022; (2) A review of the manual titled, "Laboratory Policies and Procedures" identified the following procedures: (a) "Quality Control for the MTS Gel Test System" (b) "Immediate Spin Crossmatch Using MTS Buffered Gel Card" (3) The procedures were reviewed with the technical consultant and laboratory manager. Both stated on 11/14/2022 at 03:44 pm, the procedures should have been indicated as discontinued. 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 -- 2 of 4 -- instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, observation, and interview with the technical consultant and laboratory manager, the laboratory failed to ensure materials were stored as required for ten of ten months. Findings include: (1) On 11/16/2022 at 09:54 am, observation of the contents of the Kenmore chest freezer identified the following materials with a manufacturer's storage requirement of -20 to -70 degrees C (Centigrade): (a) Bio-Rad Liquid Assayed Multiqual level 3 controls, lot #45893 - five boxes containing 12 bottles each and one box containing 7 bottles; (b) Bio-Rad Liquid Assayed Multiqual level 1 controls, lot #45891 - five boxes containing 12 bottles each and one box containing five bottles; (c) Bio-Rad Liquichek Immunoassay plus level 3 controls, lot #85283 - five boxes containing 12 bottles each and one box containing five bottles; (d) Bio-Rad Liquichek Immunoassay plus level 1 controls, lot# 85281 - five boxes containing 12 bottles each and one box containing six bottles. (2) A review of temperature records for ten months (January 2022 through October 2022) identified the documented temperatures were warmer than -20 degrees C (the warmest temperature allowed for the materials) during ten of ten months as follows: (a) January 2022 - 12 of 31 temperatures were documented as warmer than -20 degrees C (b) February 2022 - 19 of 28 temperatures were documented as warmer than -20 degrees C (c) March 2022 - 23 of 31 temperatures were documented as warmer than -20 degrees C (d) April 2022 - 18 of 30 temperatures were documented as warmer than -20 degrees C (e) May 2022 - 22 of 31 temperatures were documented as warmer than -20 degrees C (f) June 2022 - 16 of 30 temperatures were documented as warmer than -20 degrees C (g) July 2022 - 11 of 31 temperatures were documented as warmer than -20 degrees C (h) August 202 - 7 of 31 temperatures were documented as warmer than -20 degrees C (i) September 2022 - 14 of 30 temperatures were documented as warmer than -20 degrees C (j) October 2022 - 5 of 31 temperatures were documented as warmer than -20 degrees C (3) The records were reviewed with the technical consultant and laboratory manager. Both stated on 11/16/22 at 10:07 am, the materials were not being stored as required by the manufacturer. 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 the technical consultant and laboratory manager, the laboratory failed to utilize the demonstrated reportable ranges for one of one new test method. Findings include: (1) On 11/15/2022 at 11;20 am, the laboratory manager stated the laboratory began performing pH, pCO2, pO2, and -- 3 of 4 -- Lactate testing using the CG4+ cartridge and the iSTAT 1 analyzer on 10/25/2021; (2) A review of the performance specification records identified the laboratory had demonstrated the following reportable ranges: (a) pCO2 - 18.3-88 mm/Hg (b) pO2 - 62-427 mm/Hg (c) Lactate - 0.72-16.92 mmol/L (3) Interview with the technical consultant and laboratory manager on 11/15/2022 at 12:25 pm confirmed the laboratory was using the following manufacturer's reportable ranges instead of the reportable ranges that had been demonstrated by the laboratory: (a) pCO2 - 15-130 mm/Hg (b) pO2 - 15-530 mm/Hg (c) Lactate - 0.30-20.0 mmol/L 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, MedTox Scan Drugs of Abuse test system package insert, and interview with the technical consultant and laboratory manager, the laboratory failed to ensure test reports for Urine Drug Screen testing included information required for interpretation for one of one patient report. Findings include: (1) On 11/15/2022 at 10:35 am, the laboratory manager stated Urine Drug Screen testing was performed using the Profile V Medtox Scan Drugs of Abuse test system; (2) On 11/16/2022, a review of the Profile V Medtox Scan Drugs of Abuse test package insert stated, "The Profile-V MedTox Scan Drugs of Abuse test system provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS), high performance liquid chromatography (HPLC) or liquid chromatography/tandem mass spectrometry (LC /MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained." (3) A review of one patient report with Urine Drug Screen test results reported on 11/02/2022 identified the report did not include a disclaimer with the manufacturer's statement that the results were preliminary and guidance on obtaining a confirmed analytical result; (4) The findings were discussed with the technical consultant and laboratory manager. Both stated on 11/16/2022 at 10:45 am the patient report did not include the disclaimer. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/19,20/2020. The laboratory was found out of compliance with the following CLIA regulations: 493.1215; D5024: Hematology 493.1403; D6000: Laboratory Director 493.1409; D6033: Technical Consultant The findings were reviewed with the laboratory supervisor and technical consultant at the conclusion of the survey. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records, and interview with the laboratory supervisor, the laboratory failed to ensure the requirements were met for the specialty of Hematology for D-dimer testing. Findings include: (1) The laboratory failed to perform two levels of quality control testing each eight hours of D-dimer testing. Refer to D5545; (2) The laboratory failed to demonstrate precision and verify the reference range; and failed to ensure the demonstrated reportable range was utilized for D-dimer testing. Refer to D5421. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- 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 have a written general supervisor competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) On 11/19/2020, surveyor #2 reviewed personnel records for competency assessments performed during 2019 and 2020. There was no evidence competencies had been performed for the general supervisor based on job responsibilities; (2) Surveyor #2 asked the laboratory supervisor and technical consultant if a written policy to evaluate the general supervisor, based on job responsibilities, was available and if competencies had been performed during the review period. Both stated to surveyor #2 on 11/19/2020 at 01:00 pm, a policy to evaluate the general supervisor based on job responsibilities had not been written; and competencies had not been performed. 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 the laboratory supervisor and technical consultant, the laboratory failed to review and evaluate proficiency testing results for 2 of 21 events. Findings include: (1) On 11/19/2020, surveyor #2 reviewed 2019 and 2020 proficiency testing records and identified the following failures: (a) Third 2019 Hematology Event (i) Neutrophil, seg, or band - The laboratory failed the results for 1 of 5 samples (DIF-03); (b) First 2020 Hematology Event (i) Monocytes - The laboratory failed the results for 1 of 5 samples (DIF-01). (2) Surveyor #2 could not locate evidence in the records proving the failures had been addressed; (3) Surveyor #2 reviewed the records with the laboratory supervisor and technical consultant, and asked if

Summary Statement of Deficiencies D0000 The recertification survey was performed 10/08/18 to 10/12/18. The laboratory was found out of compliance with the following CLIA regulations: 493.1213: D5024: Condition: Hematology 493.1230: D5200: Condition: General Laboratory Systems 493.1250: D5400: Condition: Analytic Systems 493.1403: D6000: Condition: Laboratory Director Moderate Complexity 493.1409: D6033: Condition: Technical Consultant 493.1441: D6076: Condition: Laboratory Director High Complexity The findings were reviewed with the corporate officers and the laboratory manager at the conclusion of the survey. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to examine blood cell identification proficiency testing in the same manner as patient specimens. Findings include: (1) On the first day of the survey, the laboratory manager verified the laboratory routinely performed manual WBC (White Blood Cell) differential testing; (2) The surveyor reviewed proficiency testing records for 5 hematology testing events performed in 2017 and 2018. The records indicated the following for Blood Cell Identification (i.e. WBC differential): (a) Second 2017 Event: (i) Documentation found in the records indicated the 5 blood cell identification Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 30 -- challenge pictures had been viewed by 4 testing persons (testing persons #1 and #3, and previous testing persons #9 and #11) before the results were submitted to the proficiency testing program. (b) First 2018 Event: (i) Documentation found in the records indicated the 5 blood cell identification challenge pictures had been viewed by 5 testing persons (testing persons #1, #2, #3, and #4 and previous testing person #10) before the results were submitted to the proficiency testing program. (c) Second 2018 Event: (i) Documentation indicated the 5 blood cell identification challenge pictures had been viewed by 5 testing persons (testing persons #1, #2, #3, #5 and #8, and by previous testing person #10) before the results were submitted to the proficiency testing program. (3) On the third day of the survey, the surveyor reviewed the findings with the laboratory manager, who confirmed blood cell identification challenge proficiency testing pictures were routinely reviewed by all available testing persons. The final result was selected from the majority of answers given by the testing persons. In addition, the laboratory manager confirmed it was the laboratory's practice for one testing person to perform patient manual differentials. 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 manager, the laboratory director failed to sign proficiency testing attestation statements to attest the proficiency testing samples were analyzed in the same manner as patient specimens. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017 and 2018 proficiency testing records and identified attestation statements had been signed by a person who did not qualify as a technical consultant (if delegated in writing for moderate complexity testing); (2) The following was identified for 8 of the 8 events reviewed from 2018: (a) Second 2018 Core Chemistry Event: (i) The attestation form was signed by the laboratory manager who earned an Associate of Applied Science degree in medical laboratory science, which did not meet the educational requirements of a Technical Consultant or a Laboratory Director for moderate complexity testing. (b) Third 2018 Microbiology Event: (i) The attestation form was signed by the laboratory manager who did not qualify as a Technical Consultant or a Laboratory Director for moderate complexity testing. (3) The surveyor explained to the laboratory manager, proficiency testing attestation statements for moderate complexity testing must be signed by the laboratory director or a technical consultant (if delegated) to attest the proficiency testing samples were tested in the same manner as patient specimens. NOTE: The Interpretive Guidelines under D2015, stated, "For moderate complexity testing, in accordance with 493.1407(e)(4)(i), the director may delegate the responsibility for signing the attestation statement to a technical consultant meeting the qualifications of 493.1409. For high complexity testing, in accordance -- 2 of 30 -- with 493.1445(e)(4)(i), the director may delegate the responsibility for signing the attestation statement to a technical supervisor meeting the qualifications of 493.1447." D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records, manufacturer's instructions, written policies and procedures, FDA database, information provided by the manufacturer's distributor, correspondence with the CMS Central Office FDA liaison, observation, and interview with the laboratory manager and testing person #3, the laboratory failed to ensure the requirements were met for the specialty of Hematology. Findings include: (1) The laboratory failed to ensure a written policy included the correct normal patient reference range established by the laboratory for the CA-660 and failed to include a written procedure for twice per year accuracy verification of Bleeding Time testing. Refer to D5403; (2) The laboratory failed to follow the manufacturer's instructions for implementing the Sysmex CA-660 analyzer. Refer to D5411; (3) The laboratory failed to label and store testing materials appropriately. Refer to D5415; (4) The laboratory failed to establish the performance specifications of precision, reportable range, analytical sensitivity, and analytical specificity, and establish the reference interval for an Erythrocyte Sedimentation Rate test system, not cleared or approved by the FDA. Refer to D5423; (5) The laboratory failed to ensure the manufacturer's required maintenance procedures had been performed for the Sysmex XN-550 and the CA-660 analyzers. Refer to D5429; (6) The laboratory failed to have control procedures that detected immediate errors and monitored the accuracy and precision of the analytic process of CBC testing. D5441; (7) The laboratory failed to follow the manufacturer's quality control specifications for ESR testing. Refer to D5479; (8) The laboratory failed to have an ongoing mechanism for performing effective analytic quality assessment. Refer to D5791; (9) The laboratory failed to make appropriate reference ranges available for coagulation testing. Refer to D5807. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of records, written policies and procedures, and interview with the laboratory manager, the laboratory failed to monitor and evaluate the overall quality of general laboratory systems. Findings include: (1) The laboratory failed to have a written competency policy that explained each component required for assessment of the competency of testing persons. Refer to D5209; (2) The laboratory failed to -- 3 of 30 -- review and evaluate proficiency testing results. Refer to D5211; (3) The laboratory failed to have an ongoing mechanism for performing general laboratory systems quality assessment. Refer to D5291. 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 manager, the written policy and procedure for assessing employee competency failed to include the six required procedures. Findings include: (1) On the first day of the survey, the surveyor reviewed the laboratory's "Competency and Orientation Plan." The policy did not include the six required procedures to assess testing person competency; (2) The surveyor asked the laboratory manager if the laboratory had a policy in place which explained how the laboratory assessed the competency of testing personnel and included the following components as part of a competency evaluation: (a) Direct observations of routine patient test performance, including patient preparation, specimen handling, processing and testing, required at 493.1413(b)(8)(i). Refer to D6047; (b) Monitoring the recording and reporting of test results, required at 493.1413(b)(8)(ii). Refer to D6048; (c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records, required at 493.1413(b)(8)(iii). Refer to D6049; (d) Direct observation of performance of instrument maintenance and function checks, required at 493.1413(b)(8)(iv). Refer to D6050; (e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples, required at 493.1413(b)(8)(v). Refer to D6051; (f) Assessment of problem solving skills, required at 493.1413(b)(8)(vi). Refer to D6052. (3) The laboratory manager stated to the surveyor the laboratory's written policy did not include the six required components listed above to assess testing person competency. NOTE: For non-waived testing, the regulations require initial training, a semiannual evaluation during the first year, and an annual evaluation thereafter for each testing person for ensuring competency. 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 the laboratory manager, the laboratory failed to thoroughly review and evaluate proficiency testing results. Findings include: (1) On the first day of the survey, the surveyor reviewed the 2017 and 2018 proficiency testing records. The following biases (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency testing program) were identified: (a) First 2018 Chemistry Core Event (i) Amylase: 3 of 5 results exhibited a Negative bias (aa) CH-01: SDI -2.5 (bb) CH-02: SDI -2.0 (cc) CH- -- 4 of 30 -- 05: SDI -2.4 (ii) Myoglobin: 4 of 5 results exhibited a Negative bias (aa) CM-01: SDI -2.4 (bb) CM-02: SDI -1.9 (cc) CM-03: SDI -2.0 (dd) CM-04: SDI -1.9 (iii) Troponin T: 3 of 5 results exhibited a Negative bias (aa) CM-02: SDI -2.0 (bb) CM-04: SDI -2.5 (cc) CM-05: SDI -2.4 (In addition, the result was unacceptable) (iv) Total Cholesterol: 3 of 5 results exhibited a Negative bias (aa) CH-01: SDI -1.9 (bb) CH-02: SDI -2.1 (cc) CH-05: SDI -2.4 (b) First 2018 Miscellaneous Chemistry Event (i) ALT (Alanine Aminotransferase): 3 of 5 results exhibited a Negative bias (aa) CH-11: SDI -3.1 (bb) CH-12: SDI -2.3 (cc) CH-14: SDI -2.4 (c) Second 2017 Chemistry Core Event (i) Amylase: 5 of 5 results exhibited a Negative bias (aa) CH-06: SDI -2.2 (bb) CH-07: SDI -2.0 (cc) CH-08: SDI -2.0 (dd) CH-09: SDI -2.8 (ee) CH-10: SDI -2.3 (2) There was no documentation found in the records the laboratory identified the biases and took