Cimarron Memorial Hospital

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/10,11,12,13/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the chief executive officer and technical consultant #2 during an exit conference performed at the conclusion of the survey. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions: 493.803; D2016: Successful Participation 493.1403; D6000: Laboratory Director, Moderate Complexity 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 obtained from the Casper 0155D report and proficiency testing Comparative Evaluation obtained from American Proficiency Institute for the second and third 2023 events, the laboratory failed to 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 -- 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 Chloride. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the the laboratory failed to achieve satisfactory performance for the analyte Chloride in two consecutive testing events. Findings include: (1) The laboratory received a score of 60% on the second 2023 event and a score of 0% on the third 2023 event. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte Chloride in two consecutive events. The laboratory failed to achieve a passing score of 80% for the second 2023 event and third 2023 event. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte Chloride in two consecutive events. The laboratory failed to achieve a passing score of 80% for the second 2023 event and third 2023 event. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/03,04,05/2021. The findings were reviewed with the laboratory director and technical consultant #2 at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulation: 493.1409; D6033: Technical Consultant 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 #2, the laboratory failed to have a written technical consultant competency policy based on the position responsibilities as listed in Subpart M for one of one technical consultant. Findings include: (1) On 05/04/2021, the surveyor reviewed the competency assessment policy. It did not include guidance for assessing the competency of the technical consultant; (2) The surveyor then reviewed personnel records for competency assessments performed during 2019 and 2020. There was no evidence of competencies performed for the technical consultant based on their job responsibilities; (3) The surveyor asked technical consultant #2 if a written policy to evaluate the technical consultant based on job responsibilities was available. Technical consultant #2 stated on 05/04/2021 at 03:10 pm a policy had not been written and the above competencies had not been performed. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with technical consultant #2, the laboratory failed to follow the manufacturer's instructions for test timing for a qualitative anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG test for two of three test reports; and failed to follow the manufacturer's instructions for test timing for a blood gas cartridge for one of one test reports. Findings include: HEALGEN COVID-19 IgG/IgM TEST KIT (1) On 05/03/2021 at 10:45 am, technical consultant #2 stated to the surveyor: (a) The laboratory performed anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG testing using the Healgen COVID-19 IgG/IgM test kit. (2) On 05/04/2021, the surveyor reviewed the manufacturer's instructions under the section titled, "Positive Control Testing" which stated: (a) "5. The result should be read in 10 minutes. Do not interpret the result after 15 minutes.". (3) On 05/04/2021, the surveyor reviewed patient testing records from 02/16/2021, 03/04/2021, and 04/20 /2021 and identified the following for two of three patient test reports: (a) Patient #041457 - The collection date and time were 02/16/2021 at 11:45 am and approval date and time were 02/16/2021 at 11:45 am; (i) Since the collection date and time were the same as the approval date and time, the surveyor was not able to determine the sample was read within 10 minutes. (b) Patient #042986- The collection date and time were 04/20/2021 at 01:25 pm and approval date and time were 04/20/2021 at 02: 21 pm (56 minutes later). (4) The surveyor reviewed the findings with technical consultant #2. Technical consultant #2 stated on 05/04/2021 at 03:13 pm, the laboratory could not prove the specimen was collected, tested, and read within 10 minutes as required by the manufacturer. ARTERIAL BLOOD GAS TESTING (1) On 05/03/2021 at 10:20 am, technical consultant #2 stated the following to the surveyor: (a) The laboratory began performing pH, pCO2, and pO2, testing using the iSTAT1 analyzer (serial number 324888) and CG4+ cartridge on 02/23/2021; (2) On 05/04/2021, the surveyor reviewed the manufacturer's instructions under the section titled, "Mixing and Test Timing (time from collection to cartridge fill) for Chemistry and Blood Gas Cartridge". For test timing, the instructions stated, "Samples for pH, PCO2, PO2, TCO3 and ionized calcium should be tested within 10 minutes."; (3) On 05/04/2021, the surveyor then reviewed a patient testing record on 03/06/2021 and identified the following for one of one patient test report: (a) Patient #043916 - The collection date and time were 03/06/2021 at 07:50 am and the result date and time were 03/09/2021 at 04:51 pm (three days, nine hours and one minute later). (4) The surveyor reviewed the findings with technical consultant #2. Technical consultant #2 stated on 05/04/2021 at 04:26 pm, the laboratory could not prove the specimen was collected and tested within 10 minutes as required by the manufacturer. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. -- 2 of 7 -- This STANDARD is not met as evidenced by: Based on a review of written policies and procedures, and interview with technical consultant #2, the laboratory failed to have a written procedure for Urine Microscopic testing. Findings include: (1) On 05/03/2021 at 10:35 am, technical consultant #2 stated to the surveyor Urine Microscopic testing was performed in the laboratory; (2) On 05/03/2021, the surveyor reviewed the laboratory policy and procedure manual, and was unable to locate a written procedure for Urine Microscopic testing; (3) The surveyor reviewed the procedure manual with technical consultant #2, who stated on 05/03/2021 at 04:10 pm, the procedure had been written but could not be located. 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 #2, the laboratory failed to demonstrate the reportable ranges for two of two new test methods. Findings include: iSTAT 1 ANALYZER AND CG4+ CARTRIDGE (1) On 05/03/2021 at 10:20 am, technical consultant #2 stated the following to the surveyor: (a) The laboratory began performing pCO2, pO2, and Lactate testing using the iSTAT1 analyzer (serial number 324888) and CG4+ cartridge on 02/23/2021; (2) On 05/04/2021, the surveyor reviewed the performance specification records for the new test systems and could not locate documentation to prove the laboratory had demonstrated the reportable ranges; (3) On 05/04/2021, surveyor #2 reviewed the findings with the laboratory manager and the technical consultant. The laboratory manager stated on 10/21/2021 at 02:35 pm, the laboratory did not demonstrate the reportable ranges as indicated above. iSTAT 1 ANALYZER AND CHEM 8+ CARTRIDGE (1) On 05/03/2021 at 10:20 am, technical consultant #2 stated the following to the surveyor: (a) The laboratory began performing Sodium, Potassium, Chloride, Ionized Calcium, Total CO2, Glucose, BUN, Creatinine testing using the iSTAT1 analyzer (serial number 324888) and Chem 8+ cartridge on 06/05/2020; (2) On 05/04/2021, the surveyor reviewed the performance specification records for the new test system and could not locate documentation to prove the laboratory had demonstrated the reportable ranges; (3) On 05/04/2021, surveyor #2 reviewed the findings with the laboratory manager and the technical consultant. The laboratory manager stated on 10/21/2021 at 02:40 pm, the laboratory did not demonstrate the reportable ranges as indicated above. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. -- 3 of 7 -- This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with technical consultant #2, the laboratory failed to follow the manufacturer's instructions for performing monthly maintenance procedures for one of three months; and failed to follow the manufacturer's instructions for performing quarterly maintenance for one of one quarter. Findings include: (1) On 05/03/2021 at 10:25 am, technical consultant #2 stated the laboratory performed CBC (Complete Blood Count) testing using the Sysmex KX-21N analyzer; (2) On 05/04/20201, the surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. (a) The requirements for monthly maintenance were as follows: (i) Clean Transducer (ii) Clean Waste Chamber (b) The requirement for quarterly maintenance was as follows: (i) Clean SRV (3) The surveyor then reviewed maintenance records for three months (January 2021 through March 2021) with the following identified: (a) There was no evidence the monthly maintenance had been performed between 02 /12/2021 through 04/04/2021; (b) There was no evidence the first 2021 quarterly maintenance had been performed during the review period. (4) The surveyor reviewed the records with technical consultant #2. Technical consultant #2 stated on 05/04/2021 at 10:15 am, the monthly maintenance and quarterly maintenance had been performed but had not documented as required. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (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 technical consultant #2, the laboratory failed to perform a negative and positive control material each day of patient testing for one of three days of patient reports. Findings include: (1) On 05/03 /2021 at 10:30 am, technical consultant #2 stated the following to the surveyor: (a) Clostridium difficile testing was performed using the Quik Chek Complete test kit; (b) The laboratory performed negative and positive QC materials each day of patient testing. (2) On 05/04/20201, the surveyor reviewed QC and patient testing records from 02/11/2020 through 09/25/2020. The review showed that negative and positive QC materials had not been performed one of three days of patient testing reviewed. The specific day was on 03/15/2020; (3) The surveyor reviewed the records with technical consultant #2, who stated on 05/04/2021 at 04:10 pm, negative and positive QC materials had not been performed each day of patient testing as indicated above. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to -- 4 of 7 -- the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (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 written policies and interview with technical consultant #2, the laboratory failed to ensure that written policies provided safety for individuals being transfused for two of six units of packed red blood cells. Findings include: (1) On 05 /03/2021 at 10:55 am, technical consultant #2 stated to the surveyor the laboratory stored units of packed red blood cells in the blood bank refrigerator. The units were to be used for patient transfusions; (2) On 05/04/2021, the surveyor reviewed the hospital policy regarding transfusion reactions. The policy titled, "BLOOD TRANSFUSION" under the section titled, "PROCEDURE", stated: (a) "8. Obtain from laboratory. Sign out blood on "Blood Bank Issue Log." Hang the blood within 30 minutes of removing from Blood Bank refrigerator.". (b) "Adult: Give 1 unit PRBC over 2-3 hours (DO NOT exceed 4 hours).". (3) The surveyor then reviewed records for two units of PRBCs (Packed Red Blood Cells) that had been transfused between 04/13/2020 through 08/15/2020 for four patients, and identified the following: (a) Hang the blood within 30 minutes (i) Patient #1 - Transfused with one unit of PRBC (unit #W200225128919) on 04/13/2020. The unit was obtained from the laboratory at 06:10 pm and documented the hang time as 07:30 pm (one hour twenty minutes later). (b) Transfusion exceeds four hours (i) Patient #2 - Transfused with one unit of PRBC (unit #W204920465686) on 08/15/2020. The transfusion start time was documented at 01:40 pm and the transfusion end time was documented at 06: 40 (five hours later). (4) On 05/04/2021, the surveyor reviewed the findings with technical consultant #2. Technical consultant #2 stated on 05/04/2021 at 03:45 pm the written policy and procedure for blood administration had not been followed as indicated above. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2, the laboratory failed to make appropriate reference ranges available for two of two patient reports. Findings include: (1) On 05/03/2021 at 10:25 am, technical consultant #2 stated the laboratory performed CBC (Complete Blood Count) testing using the Sysmex KX-21N analyzer; (2) On 05/03/2021, the surveyor reviewed the written laboratory procedure titled, "Laboratory Assigned Reference Values" which stated (a) 18 years to 999 Female RBC (Red Blood Cells) - 4.20 - 5.40 X 10^6/L (b) 18 years to 999 Males RBC - 4.70 - 6.0 X 10^6/L (2) On 05/03/2021, the surveyor reviewed two patient CBC reports - the first report was for an adult female patient with the testing performed on 04/30/2021 at 07:32 am; the second report was for an adult male patient with the testing performed on 05/03/2021 at 04:55 pm. Both reports included the same -- 5 of 7 -- reference intervals for the CBC parameter of RBC (Red Blood Cell) which were: (a) RBC - 3.5- 6.0 X 10^6/L (3) The surveyor reviewed the findings with technical consultant #2. The technical consultant #2 stated on 05/03/2021 at 05:00 pm the patient reports did not include gender specific reference ranges. NOTE: Routinely, female reference intervals for the analytes RBC are lower than male reference intervals. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records and interview with technical consultant #2, 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 -- 6 of 7 -- 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 technical consultant #2, the laboratory failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications for two of four competency evaluations performed. Findings include: (1) On 05/03/2021, the surveyor reviewed records for four persons performing moderate complexity testing in 2019 and 2020. The records showed the evaluation for one of four persons had been performed by an individual who did not meet the regulatory qualification requirements of the technical consultant: (a) Testing Person #1 - The 06/23/2020 evaluation had been performed by testing person #3(this person had earned an associates degree in an applied science). (b) Testing Person #2 - The 06/23/2020 evaluation had been performed by testing person #3. (2) The surveyor explained to technical consultant #2 that all components of the competency evaluations must be performed by a person who qualifies as a technical consultant (an individual with a minimum of a masters degree in a chemical, physical or biological science or medical technology from an accredited institution, and at least 1 year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service). Technical consultant #2 stated to the surveyor on 05/03/2021 at 02: 55 pm, the evaluation had been performed by an individual who did not meet the educational requirements of a technical consultant. -- 7 of 7 --

Summary Statement of Deficiencies D0000 The recertification survey was performed 03/27/19 - 03/29/19. The laboratory was found out of compliance with the following CLIA regulations: 1. D5024: 493.1215: Condition: Hematology 2. D6000: 493.1403: Condition: Laboratory Director, Moderate Complexity 3. D6033: 493.1409: Condition: Technical Consultant, Moderate Complexity The findings were reviewed with the laboratory manager at the conclusion of the survey. D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to retain records of the demonstration of performance specifications for new test sytems. Findings include: DIAGNOSTICA STAGO START 4 (1) On the first day of the survey, the laboratory manager stated to the surveyor the laboratory began using the Dianostica Stago STart 4 coagulation analyzer on 06/01/18 to perform patient PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing; (2) On the second day of the survey, the surveyor reviewed the laboratory's demonstration of performance specifications (i.e., accuracy and precision) and establishment, or verification of reference intervals for the new test system. The surveyor could not locate the raw data (i.e. analyzer printouts) from the accuracy and precision studies; (3) The surveyor asked the laboratory manager for the raw data obtained during the implementation studies. The laboratory manager stated to the surveyor, the raw data had not been retained but the results were reviewed and summaries of the testing were available that verified the results were acceptable; (4) The surveyor explained to the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- laboratory manager, all documentation from the demonstration of performance specifications for a new test system was to be retained for at least 2 years after the laboratory no longer used the analyzer. SIEMENS VIVA E (1) The laboratory manager stated to the surveyor the laboratory performed patient urine drug screen testing from 06/16/17 through 06/08/18 using the Siemens Viva E analyzer. The testing screened for the following: (a) 6-Acetylmorphine (b) Amphetamine (c) Benzodiazepine (d) Cocaine Metabolites (e) Opiates (f) THC (Cannabinoid) (g) Buprenorphine (h) Oxycodone (i) Ecstasy (j) Ethyl Alcohol (2) The surveyor reviewed the manufacturer's "Validation Binder," which included instructions for the demonstration of the performance specifications of accuracy. The instructions stated, "Run 10 specimens on your analyzer for all tests. Name patients One through Ten. Send same to reference laboratory for comparison. Run qualitative testing (positive and negative) on the patients. Compare results to make sure they match. Place in Section 2 of the Validation Binder"; (3) The surveyor then reviewed the laboratory's implementation records dated 05/31/17. The surveyor could not locate the raw data (i. e., analyzer printouts) from the accuracy studies. The surveyor asked the laboratory manager for the raw data obtained in the accuracy studies. The laboratory manager stated to the surveyor, the analyzer printouts had not been retained from the accuracy study, but the results had been reviewed and a summary was available that verified the accuracy was acceptable; (4) The surveyor explained to the laboratory manager, all documentation from the demonstration of performance specifications for a new test system was to be retained for at least 2 years after the laboratory no longer used the analyzer. 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, written policies and procedures, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to ensure the requirements were met for the specialty of Hematology. Findings include: (1) The laboratory failed to ensure a written procedure no longer in use had been discontinued. Refer to D5409; (2) The laboratory failed to follow the manufacturer's instructions for the testing performed in the laboratory. Refer to D5411; (3) The laboratory failed to follow the manufacturer's specifications for quality control materials. Refer to D5479; (4) The laboratory failed to have an ongoing mechanism for performing effective analytic quality assessment. Refer to D5791. 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 review of written policies and procedures, and interview with the laboratory manager, the laboratory failed to indicate procedures no longer in use as discontinued, -- 2 of 10 -- with the date of discontinuance. Findings include: (1) On the first day of the survey, the laboratory manager stated the following to the surveyor: (a) The laboratory began urine drug screen testing on 06/16/17 using the Siemens Viva E analyzer. The testing was discontinued on 06/08/18; (b) The laboratory performed coagulation testing (i.e. PT/INR-Prothrombin Time/International Normalized Ratio and PTT-Partial Thromboplastin Time) using the Hemochron Jr. Signature + test system until 05/31/18 when it was replaced with the Diagnostica Stago STart 4 on 06/01/18; (c) The laboratory began using the GenMark ePlex test system for the detection of bacterial and viral stool and respiratory pathogens on 10/24/17. The testing was discontinued on 07/30/18; (d) The laboratory performed chemistry testing (i.e. Albumin, Glucose, Potassium, etc.) using the Dimension Xpand Plus analyzer. The testing was discontinued on 10/20/18. (2) The surveyor reviewed the laboratory policy and procedure manual, which included detailed procedures for testing performed on the Siemens Viva E, Hemochron Jr. Signature +, GenMark ePlex, and the Dimension Xpand Plus analyzers. There was no evidence the procedures had been discontinued; (3) The surveyor reviewed the procedures with the laboratory manager. The laboratory manager stated to the surveyor the test procedures listed above, should have been indicated as discontinued, with the dates of discontinuance. NOTE: Discontinued procedures must be maintained for two years as required at 493.1105(a) (2). D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of records, manufacturers' instructions, and interview with the laboratory manager, the laboratory failed to follow the manufacturers' instructions for the testing performed in the laboratory. Findings include: ACCURACY (1) On the first day of the survey, the laboratory manager stated to the surveyor the laboratory began using the Diagnostica Stago STart 4 coagulation analyzer on 06/01/18 to perform patient PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing; (2) On the second day of the survey, the surveyor asked the laboratory manager for the manufacturer's implementation instructions. The laboratory manager stated to the surveyor there were no instructions included with the analyzer when it was purchased. The surveyor then reviewed the surveyor's copy of the manufacturer's "Method Validation Procedure, Acceptance Criteria, and Implementation" guidelines. The manufacturer required the following for the demonstration of the performance specification of accuracy: (a) "Collect 40 specimens in the anticoagulant currently in use."; (b) "The number of samples utilized follows the minimum numbers recommended by CLSI. Any deviation from these numbers will be the responsibility of the customer."; (c) "Using the existing system (old instrument, old anticoagulant and old reagents) Perform testing on 40 samples for the routine tests." (3) The surveyor then reviewed the laboratory's implementation records and identified the laboratory failed to use the manufacturer's minimum number of 40 samples: (a) PT: 17 samples were used (b) PTT: 19 samples were used (4) The surveyor reviewed the findings with the laboratory manager and explained when a new test system is implemented, the laboratory must follow the manufacturer's -- 3 of 10 -- instructions to demonstrate the laboratory can obtain performance specifications comparable to the manufacturer's, prior to using the test system for patient testing; (5) The laboratory manager stated to the surveyor, the laboratory did not follow the manufacturer's instructions as listed above; (6) Examples of patients tested when the laboratory failed to follow the manufacturer's instructions for the implementation of the coagulation analyzer, included the following: (a) PT/INR: (i) Patient #5: Testing performed 06/02/18 (ii) Patient #6: Testing performed 06/15/18 (iii) Patient #7: Testing performed 06/17/18 (iv) Patient #8: Testing performed 06/27/18 (v) Patient #9: Testing performed 06/30/18 (vi) Patient #10: Testing performed 07/02/18 (vii) Patient #11: Testing performed 07/10/18 (viii) Patient #12: Testing performed 07/24 /18 (ix) Patient #13: Testing performed 08/08/18 (x) Patient #14: Testing performed 08 /17/18 (xi) Patient #15: Testing performed 08/23/18 (xii) Patient #16: Testing performed 09/18/18 (xiii) Patient #17: Testing performed 09/11/18 (xiv) Patient #18: Testing performed 09/17/18 (xv) Patient #19: Testing performed 10/10/18 (xvi) Patient #20: Testing performed 10/22/18 (xvii) Patient #21: Testing performed 10/25 /18 (xviii) Patient #22: Testing performed 10/20/18 (xix) Patient #23: Testing performed 11/05/18 (xx) Patient #24: Testing performed 11/19/18 (xxi) Patient #25: Testing performed 11/21/18 (xxii) Patient #26: Testing performed 12/10/18 (xxiii) Patient #27: Testing performed 12/15/18 (xxiv) Patient #28: Testing performed 12/18 /18 (xxv) Patient #29: Testing performed 01/09/19 (xxvi) Patient #30: Testing performed 01/11/19 (xxvii) Patient #31: Testing performed 01/31/19 (xxviii) Patient #32: Testing performed 02/13/19 (xxix) Patient #33: Testing performed 02/22/19 (xxx) Patient #34: Testing performed 02/28/19 (b) PTT: (i) Patient #35: Testing performed 10/20/18 (ii) Patient #36: Testing performed 10/23/18 (iii) Patient #37: Testing performed 11/21/18 REFERENCE INTERVAL (1) On the second day of the survey, the surveyor asked the laboratory manager for the manufacturer's implementation instructions. The laboratory manager stated to the surveyor there were no instructions included with the analyzer when it was purchased. The surveyor then reviewed the surveyor's copy of the manufacturer's "Method Validation Procedure, Acceptance Criteria, and Implementation" guidelines. The manufacturer required the following for the establishment of the reference intervals (i.e. normal ranges) when a new test system is implemented: (a) "Reference range data will be collected during method validations." (b) "For routine tests (PT, PTT), the number of reference samples as suggested by CLSI is 120 donors for non-parametric analysis": (i) "50% of the routine reference samples should be processed and assayed "fresh"; (ii) "Any deviation from this minimum 120 sample requirement will be noted on the final signoff sheet"; (iii) "Collect 'normal donors' in 3.2% sodium citrate according to CLSI guidelines (H21-A5)"; (iv) "Criteria for reference range 'normal' donors:" (aa) "Age": (i) "Include ages that span the population, reflecting your patient diversity. (Be careful not to use all young lab employees.)" (bb) "Sex": (i) "Equal numbers of males and females" (cc) "Drug History": (i) "Patients excluded if taking the following drugs: (aaa) "Birth control or estrogen containing products" (bbb) "Coumadin" (ccc) "Heparin (UFH, LMWH or heparinoid)" (ddd) "Direct Thrombin Inhibitors" (eee) "Antibiotics" (dd) "Conditions": (i) "Patients excluded if they are pregnant or have any known immunologic diseases" (ii) "Note: Possible source for normal samples is ambulatory out-patient surgery, i.e. eye surgery." (2) The surveyor reviewed the laboratory's implementation records and identified the laboratory failed to follow the manufacturer's instructions for establishing the reference intervals, as follows: (a) PT: (i) 17 samples were utilized instead of 120 normal patient samples; (ii) There was no documentation of the donor: (aa) Age (bb) Sex (cc) Medication history (dd) Health conditions (b) PTT: (i) 19 samples were utilized instead of 120 normal patient samples; (ii) There was no documentation of the donor: (aa) Age (bb) Sex (cc) Medication history (dd) Patient health conditions (3) The surveyor reviewed the -- 4 of 10 -- findings with the laboratory manager and explained the manufacturer required that a full reference interval study (i.e. 120 screened normal patient samples) be performed if one had not been performed for the new test system, prior to use; (4) The laboratory manager stated to the surveyor, the laboratory did not follow the manufacturer's instructions as indicated above; (5) For examples of patients tested when the laboratory failed to follow the manufacturer's instructions, see above. TRANSIT TEMPERATURE (1) On the first day of the survey, the laboratory manager stated to the surveyor the laboratory used the i-STAT 1 analyzer and performed ABG's (Arterial Blood Gases-pH, pO2, pCO2) testing. In addition, the laboratory manager stated the laboratory used the G3+ cartridge to perform ABG testing until 03/07/18, when it was replaced with the CG4+ test cartridge (pH, pO2, pCO2, and Lactic Acid); (2) The surveyor reviewed the manufacturer's instructions (operator's manual) for the test system. The instructions stated, "Read and Record Temperature Strip with Each New Shipment of Cartridges. Record the information on the temperature strip card on the 'Receipt of New Cartridges' log. Retain logs for two years in a file for quality control"; (3) The surveyor reviewed the findings with the laboratory manager and asked if the information from the temperature strip included in new shipments of test cartridges was documented and maintained. The laboratory manager stated to the surveyor the condition of the temperature strip was noticed but was not documented and maintained; (4) Therefore, the surveyor could not determine that the temperature of each shipment of test cartridges received between 01/01/18 and 03/27/19 had been acceptable upon receipt. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Findings include: (1) On the first day of the survey, the laboratory manager stated to the surveyor the laboratory performed patient urine drug screen testing from 06/16/17 through 06/08/18 using the Siemens Viva E analyzer. The testing screened for the following: (a) 6-Acetylmorphine (b) Amphetamine (c) Benzodiazepine (d) Cocaine Metabolites (e) Opiates (f) THC (Cannabinoid) (g) Buprenorphine (h) Oxycodone (i) Ecstasy (j) Ethyl Alcohol (2) On the second day of the survey, the surveyor reviewed the manufacturer's daily maintenance procedures for the analyzer, which included the following: (a) Fill water container with 10 liters of DI water and 25mL of System Solution; (b) Empty waste containers (follow safety instructions for working with potentially infectious material); (c) Check rotor blank results for SD errors. Change cuvette rotor if necessary; (d) Set onboard reagent expiration dates to four weeks. Discard reagent bottles and their contents at the expiration date or when a new lot of reagent will be used; (e) Fill HCl bottle on the reagent rotor with 0.1 N HCl; (f) Fill tube in W position on sample rotor with Needle rinse; (g) Remove measurement disk cover and inspect wash arm, mixer belt and measurement rotor; (h) Check that the reagent rotor compartment is being cooled; (i) Perform an instrument Fill System. (3) The surveyor then reviewed the laboratory's maintenance records and identified the daily maintenance procedures had not been performed as required on the following days of -- 5 of 10 -- patient testing: (a) 11/17/17: Patient #3 (b) 03/30/18: Patient #4 (4) The surveyor reviewed the records with the laboratory manager. The laboratory manager stated to the surveyor, the maintenance had not been performed as indicated above. 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, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to have control procedures that would detect immediate errors that would occur due to test system failure, adverse environmental conditions, and operator performance for a chemistry analyte. Findings include: (1) On the first day of the survey, the laboratory manager stated to the surveyor: (a) The laboratory performed chemistry testing (i.e., AST (Aspartate Aminotransferase), etc.) using the Dimension Xpand Plus analyzer until 10/20/18 when the testing was discontinued; (b) Two levels (Level I and Level II) of BioRad Lyphochek Assayed Chemistry QC (Quality Control) materials were tested each day of patient testing; (c) The laboratory established its own means and SD (Standard Deviation) for the limits of acceptability. (2) On the third day of the survey, the surveyor reviewed QC records (i.e. Levey Jennings (LJ) graphs) from 6 months (November 2017; January, March, July, and September 2018; and February 2019) for 6 analytes (Albumin, AST, CK (Creatinine Kinase), Potassium, TSH (Thyroid Stimulating Hormone), and Total Protein). The laboratory utilized 2 QC lot numbers during the review period-Level 1, Lot #26431 and Level 2, Lot #26432; (3) The surveyor identified from the review of the LJ graphs, that Level 1, Lot #26431, had no control outliers during 5 of the 6 months reviewed for the analyte AST.(Approximately 1 out of every 20 control results should be defined as unacceptable and there were no results that were beyond the laboratory's established range). In addition, the following was identified for the review period: (a) The laboratory established: (i) A mean of 43.0 with an SD +/- 2.0 (ii) The 2SD acceptable range was 41.0 - 46.0 (b) The LJ graphs included the following: (i) The mean of 43.0 with an SD +/- 10.7 was used (ii) The 2SD acceptable range in use was 21.6 - 64.4 (4) The surveyor then reviewed the manufacturer's assay value sheets, specific for the lot number of the Level 1 QC material. It stated, "The mean values and corresponding +/- 3SD ranges in the Assignment of Values Data Charts were derived from replicate analyses and are specific for this lot of product." The assay value sheet included the following information for AST and QC Level 1: (i) The mean was 40.9 with an SD +/- 3.78 (ii) The 3SD acceptable range was 33.3 - 48.4 (iii) The laboratory used an SD of +/- 10.7, which was wider than the manufacturer's SD of 3.78. (5) The surveyor reviewed the findings with the laboratory manager, who stated to the surveyor the laboratory thought the absence of outliers indicated QC was acceptable; (6) Patients with testing performed during the period the laboratory failed -- 6 of 10 -- to monitor AST testing for immediate errors, included the following: (a) Patient #1: Testing performed 06/19/18 (b) Patient #2: Testing performed 08/31/18 NOTE: D5441 was cited at the previous recertification survey performed 05/15/2017 to 05/17 /17. 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 records, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to follow the manufacturer's specifications for quality control materials. Findings include: (1) On the first day of the survey, the laboratory manager stated to the surveyor the laboratory began using the Diagnostica Stago STart 4 coagulation analyzer on 06/01/18 to perform patient PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing; (2) The laboratory manager also verified with the surveyor, two levels of QC (Quality Control) materials were performed each 8 hours of patient testing: (a) Pacific Hemostasis Level I (Normal) (b) Pacific Hemostasis Level II (Abnormal) (3) The surveyor reviewed the manufacturer's instructions for the QC materials, which stated, "Ranges must be determined in each laboratory with each change of lot number, reagent, or instrument." In addition, the "Certificate of Analysis" specific for each level and lot number stated, "Actual values recovered in the user laboratory will depend on reagent lot number, instrument and technique in use. Each laboratory should establish ranges using instrument, reagent and technique in place;" (4) The surveyor then reviewed the QC records from 05/14/18 (implementation of the analyzer) to 03/27/19. From the records of the establishment of the QC ranges, the surveyor identified 4 lot numbers had been utilized during the review period: (a) Level I, Lot #246830 - Used from 05/14/18 to 03/27/19 (b) Level II: (i) Lot #912298 - Used from 05/14/18 to 06/1/18 (ii) Lot #301824 - Used from 06/01/18 to 02/08/19 and from 02/20/19 to 03/27/19 (iii) Lot #290517 - Used from 02/10/19 to 02/19/19 (5) From the review, the surveyor determined for 1 of the 4 lot numbers utilized (Level II, Lot #301824), the laboratory failed to establish QC ranges (i.e. mean and 2SD (Standard Deviation) from at least 30 replicates) before it was returned to use on 02/20 /19. In addition, the laboratory continued to use the QC ranges established for Lot #290517 after Lot #301824 was returned to use; (6) The surveyor reviewed the findings with the laboratory manager and asked if additional documentation was available to show the ranges had been established for Level II, Lot #301824 before it was put into use on 02/20/19. The laboratory manager stated to the surveyor there was no documentation located which showed the laboratory established the QC ranges before the lot number was returned to use on 02/20/19; (7) Patients tested when the laboratory failed to follow the manufacturer's instructions to establish ranges for QC materials, included the following: (a) Patient #32: PT Testing performed 02/13/19 (b) Patient #33: PT Testing performed 02/22/19 D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) -- 7 of 10 -- (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, manufacturers' instructions, written policies and procedures, and interview with the laboratory manager, the laboratory failed to monitor and evaluate the overall quality of analytic systems. Findings include: (1) The laboratory failed to ensure written procedures no longer in use had been discontinued. Refer to D5409; (2) The laboratory failed to follow the manufacturers' instructions for the testing performed in the laboratory. Refer to D5411; (3) The laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Refer to D5429; (4) The laboratory failed to have control procedures that would detect immediate errors that would occur due to test system failure, adverse environmental conditions, and operator performance for a chemistry analyte. Refer to D5441; (5) The laboratory failed to follow the manufacturer's specifications for quality control materials. Refer to D5479. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to follow the manufacturer's instructions for urine drug screen testing. Findings include: (1) On the first day of the survey, the laboratory manager stated to the surveyor the laboratory performed patient urine drug screen testing from 06/16/17 through 06/08/18 using the Siemens Viva E analyzer. The testing screened for the following: (a) 6-Acetylmorphine (b) Amphetamine (c) Benzodiazepine (d) Cocaine Metabolites (e) Opiates (f) THC (Cannabinoid) (g) Buprenorphine (h) Oxycodone (i) Ecstasy (2) On the second day of the survey, the surveyor reviewed the manufacturer's instructions (package insert) for the testing performed, which stated, "The Emitt II Plus Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC /MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used."; (3) The surveyor reviewed 2 patient urine drug screening test reports. For 2 of the 2 test reports, the laboratory failed to follow the manufacturer's requirement that urine drug screen results are preliminary and must be confirmed with another method (i.e., GC /MS); (4) The surveyor reviewed the findings with the laboratory manager who stated -- 8 of 10 -- to the surveyor the laboratory failed to follow the manufacturer's requirement that screening results must be confirmed by another method for final results; (5) Examples of testing performed when the laboratory failed to follow the manufacturer's requirement for urine drug screen testing included the following: (a) Patient #3: Testing performed 11/17/17 (b) Patient #4: Testing performed 03/30/18 D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records, manufacturers' instructions, written policies and procedures, and interview with the laboratory manager, the laboratory director failed to provide overall management and direction in accordance with 493.1407 of this subpart. Findings include: (1) The laboratory director failed to ensure test methods were performed as required by the manufacturer to ensure accurate and reliable results were reported. Refer to D6014; (2) The laboratory director failed to ensure a quality assessment program had been established and maintained. Refer to D6021. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager, the laboratory director failed to ensure test methods were performed as required by the manufacturer to ensure accurate and reliable results were reported. Findings include: (1) The laboratory director failed to ensure the laboratory followed the manufacturer's instructions. Refer to D5411; (2) The laboratory director failed to ensure the laboratory followed the manufacturer's specifications for quality control materials. Refer to D5479. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. -- 9 of 10 -- This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, written policies and procedures, and interview with the laboratory manager, the laboratory director failed to ensure a quality assessment program had been established and maintained. Findings include: (1) The laboratory director failed to ensure an ongoing mechanism for performing effective analytic quality assessment. Refer to D5791. 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, manufacturer's instructions, and interview with the laboratory manager, 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 establishment and maintenance of acceptable levels of analytic performance. Refer to D6042. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, policies and procedures, and interview with the laboratory manager, the technical consultant failed to ensure the establishment and maintenance of acceptable levels of analytic performance. Findings include: (1) The technical consultant failed to ensure policies and procedures were current. Refer to D5409; (2) The technical consultant failed to ensure the manufacturer's instructions were followed. Refer to D5411; (3) The technical consultant failed to ensure the manufacturer's instructions for quality control materials were followed. Refer to D5479. -- 10 of 10 --