Community Hospital

Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/05/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, quality assurance specialist, director of hospital laboratory operations, laboratory supervisor, hospital transfusion services manager, and chief operating officer during an exit conference performed 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 a review of records, manufacturer's instructions, observation, and interview with the laboratory supervisor and technical consultant, the laboratory failed to follow the manufacturer's instructions for i-Stat creatinine testing. Findings include: (1) On 09 /05/2023 at 0930 am, the technical consultant stated Creatinine testing was performed using the Abbott i-Stat analyzer; (2) Observation of the emergency room refrigerator on 09/05/2023 at 09:30 am identified one i-Stat Creatinine cartridge, lot #A220678, expired 09/04/2022; (3) The findings were discussed with the technical consultant who stated on 09/05/2023 at 09:30 am, the cartridge was being stored beyond the expiration date, and was available for use. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as 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 -- appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on a review of records, nursing policy, and interview with the hospital transfusion services manager and laboratory director the facility failed to ensure written policies were followed for preventing transfusion reactions for four of five units transfused. Findings include: (1) On 9./5/2023 at 2:00 pm, the laboratory director stated that the laboratory performed Crossmatch Testing, which consisted of ABO/Rh, Antibody Screen, and Compatibility testing (performed between the patient and red blood cell donor unit(s)); (2) The policy "Blood and Blood Products Administration" defined the parameters of issuing blood products from the blood bank; (3) The surveyor reviewed the policy which stated: (a) "Blood/blood components must be infused over a time period not to exceed four (4) hours." (b) "PACKED RED BLOOD CELLS (PRBC)": (i) 5. "Document the date and time of initiation of administration of blood products and signature of RN who started the product on the Transfusion Record where indicated." (ii) 7. "Document completion date and time of blood product." (4) A review of transfusion records for five units of blood transfused with the hospital transfusion services director. For four or five units transfused, the policy was not followed by nursing personnel: (a) Unit #W091023198292 - The unit was checked out from the blood bank on 05/26/2023 at 02:38 pm and there was no documentation of when the transfusion was completed; (b) Unit #W091023202093 - The unit was checked out from the blood bank on 05/05 /2023 at 07:16 pm and there was no documentation of when the transfusion was completed; (c) Unit #W091023195646 - The unit was checked out from the blood bank on 05/08/2023 at 01:46 pm and there was no documentation of when the transfusion was completed; (d) Unit #W091023195163 - The unit was checked out from the blood bank on 05/08/2023 at 02:52 pm and there was no documentation of when the transfusion was completed; (5) Interview with the laboratory director 09/05 /2023 at 02:00 pm confirmed that the transfusion stop times had not been documented. 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 technical consultant, the laboratory failed to ensure expired supplies were not available for use. Findings include: (1) Observation of the emergency room on 09/05/2023 at 09:30 am, identified the following expired collection tubes that appeared to be available for use: (a) Six Bactec Lytic/10 Anaerobic /F blood culture bottles, lot #2290037, expiration date of 07/31 /2023 (b) Six Bactec Plus Aerobic F blood culture bottles, lot#2277247, expiration date of 07/31/2023 (c) Four Bactec Peds Plus /F blood culture bottles, lot#2277311, expiration date of 7/31/2023 (2) Interview with the technical consultant on 09/05/2023 at 09:30 am confirmed the Bactec bottles were available for use. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/02/2021. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, technical consultant #1 and technical consultant #2 at the conclusion of the survey. 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 technical consultant #1, the laboratory failed to ensure the reportable ranges were utilized for new test methods. Findings include: (1) On 09/02/2021 at 11:00 am, technical consultant #1 stated the following to the surveyor: (a) The laboratory began performing Glucose, Hematocrit, Hemoglobin, Ionized Calcium, CO2, Potassium, Sodium, pH, pCO2, and pO2 testing using the iSTAT 1 analyzer (Serial Number 331789) and the CG8+ cartridge on 02/02 /2020; (b) The laboratory began performing Glucose, Hematocrit, Hemoglobin, Potassium, Sodium, BUN (Blood Urea Nitrogen), pH, pCO2, and pO2 using the iSTAT 1 analyzer (Serial Number 342535) and the EC8+ cartridge on 07/13/2021. (2) The surveyor reviewed the performance specification records for the new test systems and identified the laboratory had demonstrated the following reportable ranges: (a) CG8+ Cartridge (i) Glucose - 31-578 mg/dl (ii) Hematocrit - 11.0-66.0% (iii) Ionized Calcium - 0.35-2.23 mmol/L (iv) pH - 6.5-7.9 (v) pCO2 - 19.0-91.1 mm/Hg (vi) pO2 - 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 -- 56-427 mm/Hg (vii) Potassium - 2.3-7.9 mmol/L (viii) Sodium - 102-178 mmol/L (b) EC8+ Cartridge (i) Glucose - 31-568 mg/dl (ii) Hematocrit - 12-67% (iii) pH - 6.521- 7.875 (iv) pCO2 - 22.5-101.5 mmHg (v) Potassium 2.3-7.8 mmol/L (vi) Sodium - 101- 178 mmol/L (vii) Chloride - 60-126 mmol/L (3) The surveyor then requested documentation to show the reportable ranges that were being utilized by the laboratory. The laboratory was using the following manufacturer's reportable ranges: (a) CG8+ Cartridge (i) Glucose - 20-700 mg/dl (ii) Hematocrit - 15-75 % (iii) Ionized Calcium - .25-2.5 mmol/L (iv) pH - 6.5-8.2 (v) pCO2 - 5.0-130.0 mm/Hg (vi) pO2 - 5.0-800.0 mm/Hg (vii) Potassium - 2.0-9.0 mmol/L (viii) Sodium - 100-180 mmol/L (b) EC8+ Cartridge (i) Glucose - 20-700 mg/dl (ii) Hematocrit - 15-75 % (iii) pH - 6.5- 8.2 (iv) pCO2 - 5.0-130.0 mmHg (v) Potassium 2.0-9.0 mmol/L (vi) Sodium - 100- 180 mmol/L (vii) Chloride - 65-140 mmol/L (4) The surveyor reviewed the findings with technical consultant #1 and technical consultant #2. Both stated on 09/02/2021 12:45 pm, the laboratory was not using the reportable ranges that had been demonstrated by the laboratory as shown 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 technical consultant #1 and technical consultant #2 the laboratory failed to ensure patient test reports included the address of the laboratory location where the testing was performed. Findings include: (1) On 09/02/2021 at 09:40 am, technical consultant stated to the surveyor ABO/Rh and Antibody Screen testing were performed in the laboratory; (2) The surveyor reviewed a patient report with ABO/Rh and Antibody Screen testing performed on 05/03/2021 at 05:42 pm. The report did not include the address of the laboratory location; (3) The surveyor reviewed the reports with technical consultant #1 and technical consultant #2. Both stated on 09/02/2021 at 04:00 pm, the report included the address of the sister laboratory and not the address of the laboratory location where the testing was performed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/04/19. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, vice president of clinical services/system CNO, quality assurance manager, laboratory manager, and laboratory supervisor during an exit conference performed at the conclusion of the survey. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, laboratory supervisor, and quality assurance manager, the laboratory failed to ensure proficiency testing samples were tested by personnel who routinely performed patient testing. Findings include: (1) At the beginning of the survey, the laboratory supervisor stated to the surveyor, the following testing was performed at the point of care in the hospital: (a) Blood Gas (pH, pCO2, pO2) and Lactate testing were performed by the nursing and respiratory therapy staff using the iSTAT 1 analyzer and the CG4+ cartridge; (b) Troponin I testing was performed by the nursing staff using the iSTAT 1 analyzer and the cTnI cartridge. (2) The surveyor asked the laboratory manager for clarification of who performed the above testing. The laboratory manager stated the following to the surveyor: (a) There were eleven nursing and respiratory therapy staff members who routinely performed Blood Gas and Lactate testing at the point of care; (b) There were six nursing staff members who routinely performed Troponin I testing at the point of care. (2) The surveyor reviewed proficiency testing records and identified that 9 of 10 events performed in 2018 and 2019 had been tested by the same person (respiratory therapist) or laboratory personnel as follows: (a) Blood Gas and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Lactate testing (i) AQI-A 2018 Event - 5 of 5 samples (AQ-01, AQ-02, AQ-03, AQ- 04, AQ-05) had been tested by respiratory therapist #1; (ii) AQI-B 2018 Event - 5 of 5 samples (AQ-06, AQ-07, AQ-08, AQ-09, AQ-10) had been tested by respiratory therapist #1; (iii) AQI-C 2018 Event - 5 of 5 samples (AQ-11, AQ-12, AQ-13, AQ-14, AQ-15) had been tested by respiratory therapist #1; (iv) AQI-A 2019 Event - (AQ-01, AQ-02, AQ-03, AQ-04, AQ-05) had been tested by respiratory therapist #1; (v) AQI- B 2019 Event - (AQ-06, AQ-07, AQ-08, AQ-09, AQ-10) had been tested by respiratory therapist #1. (b) Troponin I testing (i) PCARM-A 2018 Event - 5 of 5 samples (PCAR-01, PCAR-02, PCAR-03, PCAR-04, PCAR-05) had been tested by laboratory testing person #7; (ii)PCARM-C 2018 Event - 5 of 5 samples (PCAR-11, PCAR-12, PCAR-13, PCAR-14, PCAR-15) had been tested by a previous laboratory testing person; (iii) PCARM-A 2019 Event - 5 of 5 samples (PCAR-01, PCAR-02, PCAR-03, PCAR-04, PCAR-05) had been tested by laboratory testing person #7; (iv) PCARM-B 2019 Event - 5 of 5 samples (PCAR-06, PCAR-07, PCAR-08, PCAR-09, PCAR-10) had been tested by laboratory testing person #4. (3) The surveyor reviewed the findings with the the laboratory manager, laboratory supervisor, and quality assurance manager, who stated the following: (a) Blood Gas and Lactacte proficiency testing had not been rotated among the operators who routinely perform the testing; (b) Tropoinin I proficiency testing had been performed by laboratory staff instead of persons who routinely perform the patient testing at the point of care. 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 laboratory manager, laboratory supervisor, and quality assurance manager, the laboratory failed to review and evaluate verification data prior to implementing a new iSTAT analyzer. Findings include: (1) At the beginning of the survey, the laboratory supervisor stated to the surveyor one iSTAT 1 analyzer was used to perform point of care Blood Gas (pH, pCO2, pO2) and Lactate testing using the CG4+ cartridge and Troponin I testing using the cTnI cartridge; (2) The quality assurance manager stated to the surveyor a new iSTAT 1 analyzer was put into use to perform Blood Gas, Lactate, and Tropoinin I testing at the point of care on 03/13/19; (3) The surveyor reviewed the performance specification records for the analyzer. The documentation showed the performance specifications had been demonstrated on 03/06/19, but the data had not been reviewed and signed off as approved by the laboratory until 09/03/19; (4) The records were reviewed with the laboratory supervisor, laboratory manager, and quality assurance manager. All stated the performance specifications had not been signed and dated as approved prior to putting the analyzer into use for patient testing. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) -- 2 of 5 -- (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 laboratory supervisor and laboratory manager, the laboratory failed to define the number and type of quality control testing when implementing an IQCP. Findings include: (1) At the beginning of the survey, the laboratory supervisor stated to the surveyor the following was performed at the point of care by respiratory therapy and nursing staff using the iSTAT 1 analyzer: (a) Troponin I testing using the cTnI test cartridge; (b) pH, pCO2, pO2, and Lactate testing using the CG4+ cartridge. (2) Later during the survey, the laboratory supervisor stated to the surveyor IQCP's (Individualized Quality Control Plan) had been developed for the test systems; (3) The surveyor reviewed the IQCP's. The QCP (Quality Control Plan) portions of the IQCP's did not include the number and type of QC (Quality Control) materials; (4) The surveyor reviewed the QCP with the laboratory supervisor and laboratory manager. Both stated the QCP did not include the number and type of QC testing for the test systems. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of records and interview with the quality assurance manager and laboratory manager, the laboratory failed to ensure that blood products were stored under appropriate conditions in the Satellite Refrigerator. Findings include: (1) During the survey, the quality assurance manager and laboratory manager stated the following to the surveyor: (a) The blood bank department in the laboratory opened 05/17/19; (b) Units of packed red blood cells, used for patient transfusions, were routinely stored in the laboratory blood bank refrigerator. It was the policy of the laboratory to perform alarm checks on the refrigerator on a monthly basis; (c) The laboratory was staffed Monday through Friday, 6:00 am - 6:30 pm; (d) The hospital acquired an additional blood bank refrigerator on 05/16/19 (small Helmer refrigerator), located in the Med Surg area of the hospital (the laboratory denoted the refrigerator as the Satellite Refrigerator); (e) At 6:00 pm each evening, units of packed red blood cells, crossmatched for specific patients, were transferred to the satellite refrigerator and stored in the event a patient required a transfusion when the laboratory was not -- 3 of 5 -- staffed. (2) The surveyor reviewed alarm check records for 2019. There were no records to substantiate the alarm checks for the Satellite Refrigerator had been performed prior to putting into use and monthly since the refrigerator had been put into use on 05/16/19; (3) The surveyor reviewed the records with the quality assurance manager and laboratory manager and asked if alarm checks had been performed on the Satellite Refrigerator prior to putting into use and monthly since. Both stated alarm checks had not been performed prior to putting into use and had not been performed monthly. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor and laboratory manager, the laboratory failed to have a policy for monitoring the effectiveness of their IQCP. Findings include: (1) At the beginning of the survey, the laboratory supervisor stated to the surveyor the following was performed at the point of care by respiratory therapy and nursing staff using the iSTAT 1 analyzer: (a) Troponin I testing using the cTnI test cartridge; (b) pH, pCO2, pO2, and Lactate testing using the CG4+ cartridge. (2) Later during the survey, the laboratory supervisor stated to the surveyor IQCP's (Individualized Quality Control Plan) had been developed for the test systems; (2) The surveyor reviewed the IQCP's (dated as approved 08/2019). The QA (Quality Assessment) portion of the IQCP's did not include a schedule for evaluating the QCP's (Quality Control Plan) to ensure they continued to provide accurate and reliable results; (3) The surveyor reviewed the records with laboratory supervisor and laboratory manager and asked if there was a policy to address how the laboratory will monitor the IQCP's, including the frequency of the reviews. The laboratory supervisor and laboratory manager stated to the surveyor a policy had not been written. D6005 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(c) 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. (c) The laboratory director must be accessible to the laboratory to provide onsite, telephone or electronic consultation as needed. This STANDARD is not met as evidenced by: Based on a review of records, written policy, and interview with the quality assurance manager, the laboratory director failed to delegate responsibilities, in writing, to the technical consultant. Findings include: (1) At the beginning of the survey, the laboratory supervisor stated to the surveyor the following was performed at the point of care by respiratory therapy and nursing staff using the iSTAT 1 analyzer: (a) -- 4 of 5 -- Troponin I testing using the cTnI test cartridge; (b) pH, pCO2, pO2, and Lactate testing using the CG4+ cartridge. (2) Later during the survey, the surveyor reviewed proficiency testing records for 2018 and 2019 and identified the attestation statements had been signed as follows: (a) First Event AQI-A 2018 (for Blood Gas (pH, pCO2, pO2) and Lactate testing) had been signed by previous technical consultant #1; (b) First Event PCARM-A 2018 (for Troponin I testing) had been signed by previous technical consultant #1; (c) Second Event AQI-B 2018 had been signed by previous technical consultant #2; (d) Second Event PCARM-B 2018 had been signed by previous technical consultant #2; (e) Third Event AQI-C 2018 had been signed by the laboratory manager (listed as technical consultant #3 on the Laboratory Personnel Report form CMS-209); (f) Third Event PCARM-C 2018 had been signed by the laboratory manager; (g) First Event AQI-A 2019 had been signed by the quality assurance manager (listed as technical consultant #2 on the form CMS-209); (h) First Event PCARM-A 2019 had been signed by the laboratory supervisor (listed as technical consultant #1 on the form CMS-209); (i) Second Event AQI-B 2019 had been signed by the laboratory supervisor; (j) Second Event PCARM-B 2019 had been signed by the laboratory supervisor. (3) The surveyor asked the quality assurance manager if the laboratory director had delegated the technical consultants the above responsibility. The quality assurance manager provided the surveyor with a policy titled, "Technical Consultant Delegation". The surveyor reviewed the delegation form, which provided the laboratory name and location as the sister location located on Southwest 89th Street in Oklahoma City and was not for this laboratory location; (4) The surveyor reviewed the documentation with the quality assurance manager who stated the delegation was not for this laboratory and was specific for the sister laboratory located on Southwest 89th Street. NOTE: The Interpretive Guidelines state "The laboratory director may delegate to a technical consultant, in writing, the responsibilities in: 493.1407(e)(3), (4), (5), (6), (7), (11), (12), and (13)." -- 5 of 5 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for the analyte CKMB. Refer to D2094 and D2096; 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 -- D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to achieve a successful performance for the analyte CKMB. Findings include: (1) The laboratory failed to achieve satisfactory performance on the First 2018 and Second 2018 events. NOTE: The only acceptable