Muscogee (Creek) Nation Medical Center

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/01,02,03,04/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with lead technologist #1, lead technologist #2, laboratory manager #1, laboratory manager #2, director of laboratory services, acting secretary of health, assistant director of laboratory services, and the laboratory director during an exit conference performed at the conclusion of the survey. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/01,02,03,04/2022. The laboratory was found out of compliance with the following CLIA Condition of Participation: 493.1409; D6033: Technical Consultant The findings were reviewed with the chief operating officer, administrator, quality improvement, laboratory director, director of laboratory services, and assistant director of laboratory services 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 director of laboratory services, the laboratory failed to ensure an adequate alarm system was in place for the blood bank refrigerator. Findings include: (1) On 11/01/2022 at 10:50 am, the director of laboratory services 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) The surveyor reviewed the laboratory's written policy for performing alarm checks on the refrigerator. The policy titled, "Blood Bank Refrigerator and Freezer Alarm Check" stated "Periodic alarm checks shall be performed at 3-month intervals to ensure proper functioning of temperature gauges"; (3) On 11/03/2022, a review of alarm check records during 2021 and to date in 2022 identified alarm checks had not been performed between 09/07/21 and 02/17/22; (4) The records were reviewed with the director of laboratory services who stated on 11/03/2022 at 11:42 am, the alarm checks had not been performed as required by policy. 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 -- 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 director of laboratory services, the laboratory failed to have a written policy to assess the competency of the technical consultant, general supervisor, and technical supervisor, based on the position responsibilities as listed in Subpart M. Findings include: (1) On 11/02/2022, a review of the competency assessment policy revealed there was no guidance, including the frequency, for assessing the competency of the technical consultant, general supervisor, and technical supervisor; (2) A review of personnel records for competency assessments performed during the review period of 2021 through the current date in 2022 revealed competencies, based on job responsibilities had not been performed as follows: (a) Technical Consultant - Not performed since 03/19/2021; (b) General Supervisor - Not performed during the review period; (c) Technical Supervisor - Not performed during the review period. (3) The findings were reviewed with the director of laboratory services who stated on 11 /03/2022 at 01:10 pm, a policy had not been written and competencies had not been performed for the positions as shown above. 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. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures and interview with the director of laboratory services, the laboratory failed to have written procedure for coagulation lot rollover studies. Findings include: (1) On 11/02/2022 at 11:00 am, the director of laboratory services stated the laboratory began using the ACL TOP 300 analyzer on 9 /19/21 to perform PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing; (2) A review of manufacturer's instructions for reagent lot rollover studies identified the manufacturer stated to perform the normal patient mean studies following laboratory policy; (3) A review of laboratory policies and procedures identified no evidence of a coagulation reagent lot rollover procedure, including guidance for screening normal donors; (4) The findings were reviewed with the director of laboratory services who stated on 11/03/2022 at 03: 57 pm, the laboratory did not have a written procedure for performing coagulation lot rollover studies. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system -- 2 of 7 -- 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 director of laboratory services, the laboratory failed to ensure the demonstrated reportable ranges were utilized for one of two new test systems introduced into the laboratory. Findings include: (1) On 11/01/2022 at 10:40 am, the director of laboratory services stated the laboratory began performing Troponin I testing using the Biosite Triage Meter Pro analyzer as a backup method to the Abbott Architect Plus ci4100 analyzer on 10/05/2022; (2) On 11/02 /2022 a review of the performance specification records for the new test system identified the laboratory had demonstrated a reportable range of 0.06-26.7 ng/ml; (3) The manual titled, "Laboratory Testing Procedures" which contained the reportable ranges being used by the laboratory, was reviewed with the director of laboratory services. On 11/03/2022 at 11:04 am, the director of laboratory services stated the laboratory was using the reportable range of 0.05-30 ng/ml instead of the reportable range that had been demonstrated by the laboratory. 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 director of laboratory services, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures on one of four analyzers reviewed. Findings include: (1) On 11/01/2022 at 10:45 am, the director of laboratory services stated CBC (Complete Blood Count) testing was performed using the Cell- Dyn Ruby analyzer; (2) On 11/03/2022, a review of the "Cell-Dyn Operator's Manual" in Section 9 titled "Scheduled Maintenance Procedures" required the following maintenance procedures: (a) Weekly - "Clean Loader Compartments" (b) Monthly - "Extended Auto-Clean" (3) A review of maintenance records from January 2022 through September 2022 identified the following: (a) The weekly Clean Loader Compartments procedure had not been documented as performed between 02/26/2022 and 03/08/2022; (b) The monthly Extended Auto-Clean procedure had not been documented as performed during January 2022. (4) The records were reviewed with the director of laboratory services who stated on 11/03/2022 at 11:30 am, the maintenance had not been documented as performed. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification -- 3 of 7 -- procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of records and interview with the director of laboratory services, the laboratory failed to perform calibration verification procedures at least once every 6 months for 14 of 25 analyte reviewed on the Abbott Architect Plus ci4100 analyzer. Findings include: (1) On 11/01/2022 at 11:00 am, the director of laboratory services stated ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), Alkaline Phosphatase, Total Bilirubin, Direct Bilirubin, Amylase CK (Creatine Kinase), Uric Acid, Hemoglobin A1c, Acetaminophen, Salicylate, TSH (Thyroid Simulating Hormone), LDL (Low Density Lipoprotein), and HDL (High Density Lipoprotein) testing were performed on the Abbott Architect Plus ci4100 analyzer; (2) A review of 2022 calibration records revealed the calibration procedures for the above analytes were performed with less than three levels of calibrators therefore, calibration verification procedures, using three or more levels of calibration materials that included a low, mid, and high value, were required every six months; (3) A review of records for 2021 and to date in 2022 identified calibration verification had not been performed at least once every six months as follows: (a) ALT not performed prior to 01/26/2022 (b) AST not performed prior to 01/26/2022 (c) Alkaline Phosphatase not performed prior to 01/26/2022 (d) Total Bilirubin not performed between 03/29/2021 and 04/06/2022 (e) Direct Bilirubin not performed between 03/29/2021 and 04/06 /2022 (f) Amylase not performed prior to 01/26/2022 (g) CK not performed prior to 01 /26/2022 (h) Uric Acid not performed prior to 04/06/2022 (i) Hemoglobin A1c not performed during the review period (j) Acetaminophen not performed between 01/25 /2022 and 10/16/2022 (k) Salicylate not performed between 01/26/2022 and 10/16 /2022 (l) TSH not performed between 06/13/2021 and 10/24/2022 (m) LDL not performed between 03/31/2021 and 04/06/2022 (n) HDL not performed between 03/31 /2021 and 04/06/2022 (4) The records were reviewed with the director of laboratory services who stated on 11/04/2022 at 10:25 am, calibration verification procedures had not been performed every six months. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must -- 4 of 7 -- have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on a review of records and interview with the director of laboratory services, the laboratory failed to have a system that twice a year evaluated and defined the relationship between test results using different methods for one of two analytes. Findings include: (1) On 11/01/2022 at 10:45 am, the director of laboratory services stated the laboratory performed Lactate testing as follows: (a) Using the Abbott Architect Plus ci4100 analyzer as the primary method; (b) Using the IL GEM 4000 analyzer as the backup method. (2) On 11/03/2022, records were requested to prove the relationship between the testing performed using the different test methods had been evaluated twice annually during the review period of January 2021 through the current date; (3) The director of laboratory services stated on 11/03/2022 at 11:42 am, there was no documentation to show the relationship between the testing using the two methods had been evaluated twice annually during the review period. 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, Bio-Rad TOX/See Drug Screen test package insert, and interview with the director of laboratory services, 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 11/01/2022 at 10:42 am, the director of laboratory services stated Urine Drug Screen testing was performed using the Bio-Rad TOX/See Drug Screen test; (2) On 11/03/2022, a review of the Bio-Rad TOX/See Drug Screen test package insert stated, "This test provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used"; (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 director of laboratory services who stated on 11/03/2022 at 03: 51 pm the patient report did not include the disclaimer. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 -- 5 of 7 -- The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records and interview with the director of laboratory services, the technical consultant failed to provide technical supervision in accordance with 493.1413 of this subpart. Findings include: (1) The technical consultant failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on a review of records and interview with the director of laboratory services, the laboratory failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications for one of 22 -- 6 of 7 -- competency evaluations. Findings include: (1) On 11/01/2022, a review of records for seven persons performing moderate complexity testing in 2021 and to date in 20221 revealed the following for one of 13 testing persons: (a) Directory of Laboratory Services/Testing Person #14 - The 05/31/2022 evaluation had been performed by an individual who did not meet the regulatory requirements of a technical consultant. (2) The records were reviewed with the director of laboratory services who stated on 11 /01/2022 at 03:00 pm, the evaluation had been performed by an individual who did not meet the qualifications of a technical consultant. -- 7 of 7 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 12/08,09,10,11/2020. The findings were reviewed with laboratory director, laboratory manager, laboratory support specialists, quality manager, and chief operating officer administration during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulation: 493.1409; D6033: Technical Consultant 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 failed to ensure attestation statements were signed by the laboratory director or designee for one of 28 events; and failed to ensure proficiency testing records were maintained for a minimum of two years for four of 28 events. Findings include: ATTESTATION (1) On 12/08/2020, the surveyor reviewed 2019 and 2020 proficiency testing records, with the following identified: (a) Second 2020 Microbiology Event - The attestation statement had not been signed by the laboratory director or designee. (2) The surveyor reviewed the records with the laboratory 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 -- manager. The laboratory manager stated on 12/08/2020 at 04:05 pm the attestation statement had not been signed by the laboratory director as indicated above. GRADED EVALUATIONS (1) On 12/08/2020, the surveyor reviewed 2019 and 2020 proficiency testing records, with the following identified: (a) Graded evaluations could not be located for four of the events (i) First 2019 Hematology/Coagulation Event (ii) First 2019 Microbiology Event (iii) Second 2019 Microbiology Event (iv) First 2020 Hematology/Coagulation Event (2) The surveyor asked the laboratory manager if the graded evaluations from the proficiency testing provider were available. The laboratory manager stated on 12/08/2020 at 04:10 pm, performance evaluations were not available during the survey. 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 review and evaluate proficiency testing results for three of 28 events. Findings include: FAILURE (1) On 12/08/2020, the surveyor reviewed 2019 and 2020 proficiency testing records and identified the following failure: (a) Third 2019 Chemistry Core Event (i) BUN (Blood Urea Nitrogen) - The laboratory failed the result for 1 of 5 samples (CH-14); (2) The surveyor could not locate evidence in the records proving the failure had been addressed; (3) The surveyor reviewed the records with the laboratory manager and asked if

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 subspecialties of General Immunology, ABO Group and D (Rho) Typing, Unexpected Antibody Detection, and Compatibility Testing. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for HIV testing. Refer to D2082 and D2084; (2) The laboratory failed to achieve satisfactory 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 -- performance for two consecutive testing event for ABO Group and D (Rho) Typing. Refer to D2160 and D2162; (3) The laboratory failed to achieve satisfactory performance for two consecutive testing events for Unexpected Antibody Detection. Refer to D2170 and D2172; (4) The laboratory failed to achieve satisfactory performance for two consecutive testing events for Compatibility Testing. Refer to D2179 and D2181. D2082 GENERAL IMMUNOLOGY CFR(s): 493.837(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 successful performance for HIV testing. Findings include: (1) The laboratory failed to achieve satisfactory performance on the first event in 2018 and the second event in 2018. Refer to D2084. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The recertification survey was performed on 08/27/18 through 08/31/18. The findings were reviewed with the laboratory manager and Regional Medical Laboratory support staff during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1213; D5022: Toxicology 493.1271; D5026: Immunohematology 493.1250; D5400: Analytic Systems 493.1403; D6000: Laboratory Director, Moderate Complexity 493.1409 D6033: Technical Consultant 493.1441; D6076: Laboratory Director, High Complexity D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to enroll in a proficiency testing program for Chemistry testing. Findings include: (1) On the first day of survey, the surveyor reviewed proficiency testing records for 2017 and to date in 2018. There was no evidence the laboratory was enrolled in a proficiency program for the first 2018 Chemistry Core event (the analytes in the event include: Serum Acetone, Alcohol, CKTotal (Creatine Kinase), D- Dimer, Pro-BNP (B-Type Natriuretic Peptide), Troponin I, Albumin, Alkaline Phosphatase, ALT (Alanine Aminotransferase), Amylase, AST (Aspartate Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- Aminotransferase), Direct Bilirubin, Total Bilirubin, Total Calcium, Chloride, Cholesterol HDL, Total Cholesterol, CO2, Creatinine, Glucose, Lactic Acid, LDL Cholesterol, Lipase, Magnesium, Phosphorus, Potassium, Sodium, Total Protein, Triglycerides, Urea Nitrogen, Uric Acid, HCG (Human Chorionic Gonadotropin), Acetaminophen, Carbamazepine, Digoxin, Gentamicin, Lithium, Phenytoin, Salicylates, Valproic Acid, Vancomycin, Glycated Hemoglobin, pCO2, pH, PO2, Free Thyroxine and TSH (Thyroid Stimulating Hormone); (2) Following the survey on 10 /04/18, the surveyor called the laboratory manager to clarify the laboratory Proficiency Testing enrollment. The laboratory manager stated that the laboratory had submitted the invoice for payment. The hospital did not pay the bill until after the first event deadline. 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 and technical consultant, the laboratory failed to ensure proficiency testing attestation statements had been signed by the laboratory director or designee. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017 and 2018 proficiency testing records. The following was identified for 3 of 21 testing events: (a) First 2017 Immunohematology Event (i) The attestation was not signed by the laboratory director or designee (b) Second 2017 Immunohematology Event (i) The attestation was not signed by the laboratory director or designee (c) Third 2017 Immunohematology Event (i) The attestation was not signed by the laboratory director or designee (2) The findings were reviewed with the laboratory manager and technical consultant who stated the attestation had not been signed as indicated above. D3035 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(ii) In addition, the laboratory must retain immunohematology records, blood and blood product records, and transfusion records as specified in 21 CFR 606.160(b)(3)(ii), (b) (3)(iv), (b)(3)(v), and (d). This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to maintain Blood Bank thermograph charts for at least 2 years. Findings include: (1) Later on the fourth day of the survey, the surveyor observed the thermograph temperature recorder for the blood bank refrigerator. The refrigerator -- 2 of 15 -- had a recorder connected to it for continuously recording the temperature on thermograph charts (Note: units of packed cells must be stored at 1-6 degrees Centigrade). Each chart monitored the temperature for a 7 day period; (2) The surveyor reviewed 52 refrigerator charts dated from 01/03/17 through 02/28/18. The review indicated that charts were not available for review between 10/25/17 through 12/18/17: (3) The surveyor asked the laboratory manager if the Blood Bank charts between 10/25/17 through 12/18/17 were available for review. The laboratory manager stated the thermograph charts could not be located for the above dates. D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 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 manager and technical consultant, the laboratory failed to ensure the requirements were met for the subspecialty of Toxicology. Findings include: (1) The laboratory failed to perform a negative and positive control each day of patient testing. Refer to D5449; (2) The laboratory failed to to have an ongoing mechanism for performing effective analytic quality assessment. Refer to D5791. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records, policies and procedures, and interview with the laboratory manager and technical consultant, the laboratory failed to ensure the requirements were met for the specialty of Immunohematology. Findings include: (1) The laboratory failed to ensure reagents had not exceeded their expiration date. Refer to D5417; (2) The laboratory failed to ensure blood products were stored appropriately that included an adequate temperature alarm system that is regularly inspected. Refer to D5555; (3) The laboratory failed to have an ongoing mechanism for performing analytic quality assessment. Refer to D5791. 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 review and evaluate proficiency testing results. Findings include: -- 3 of 15 -- (1) On the first day of the survey, the surveyor reviewed 2017 and 2018 proficiency testing records. The following biases were identified (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program: (a) Second 2017 Chemistry Core Event (i) Chloride - 5 of 5 results exhibited a negative bias (aa) Sample CH-06 - SDI of -3.1 (bb) Sample CH-07 - SDI of -2.0 (cc) Sample CH-08 - SDI of -2.4 (dd) Sample CH-09 - SDI of -2.5 (ee) Sample CH-10 - SDI of -2.6 (ii) Cholesterol, Total - 4 of 5 results exhibited a positive bias (aa) Sample CH-06 - SDI of 2.4 (bb) Sample CH-07 - SDI of 2.1 (cc) Sample CH-08 - SDI of 2.5 (dd) Sample CH-09 - SDI of 2.3 (iii) Triglycerides - 5 of 5 results exhibited a positive bias (aa) Sample CH-06 - SDI of 2.6 (bb) Sample CH-07 - SDI of 2.5 (cc) Sample CH-08 - SDI of 2.1 (dd) Sample CH-09 - SDI of 2.1 (ee) Sample CH-10 - SDI of 2.6 (b) Third 2017 Chemistry Core Event (ii) Cholesterol, Total - 3 of 5 results exhibited a positive bias (aa) Sample CH-13 - SDI of 2.6 (bb) Sample CH-14 - SDI of 2.6 (cc) Sample CH- 15 - SDI of 2.7 (2) The surveyor could not locate evidence in the records proving the biases had been identified and addressed; (3) The records were reviewed with the laboratory manager who stated the biases had not been addressed. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on a review of records and an interview with the laboratory manager, the laboratory failed to provide written instructions to clients collecting and referring hematology and chemistry specimens. Findings include: (1) On the first day of the survey, the laboratory manager stated the following to the surveyor: (a) The laboratory performed CBC (Complete Blood Count) testing using the Cell-Dyn Ruby analyzer; (i) Hematology specimens were transported to the laboratory from outside home health agencies. (b) The laboratory performed routine chemistry testing using the Abbott Architect analyzer; (i) Routine chemistry specimens were transported to the laboratory from outside home health agencies. (2) The surveyor asked the laboratory manager if instructions (e.g., client service manual) had been written and provided to the home health agencies which would explain the laboratory's specimen handling policies (e.g., collection, preservation, storage, transport, testing schedule times, and how to obtain additional assistance for unusual circumstances). The laboratory manager stated specimen handling instructions had not been written and provided to the clients. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. -- 4 of 15 -- This CONDITION 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, testing person #1/hematology supervisor and technical consultant, the laboratory failed to monitor and evaluate the overall quality of analytic systems for each specialty and subspecialty of testing performed. Findings include: (1) The laboratory failed to follow written policies. Refer to D5401; (2) The laboratory failed to follow the manufacturer's instructions for verifying flagged results. Refer to D5411; (3) The laboratory failed to perform a negative and positive control each day of patient testing. Refer to D5449; (4) The laboratory failed to use control materials of a similar matrix to that of patient specimens. Refer to D5465; (5) The laboratory failed to have an ongoing mechanism for performing analytic quality assessment. Refer to D5791. 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. This STANDARD is not met as evidenced by: Based on a review of written policies and procedures, and interview with the laboratory manager and testing person #1/hematology supervisor, the laboratory failed to follow written policies. Findings include: HEMATOLOGY - CELL-DYN RUBY (1) On the first day of the survey, the laboratory manager stated the following to the surveyor: (a) CBC (Complete Blood Count) was performed using the Abbott Cell- Dyn Ruby analyzer; (b) The laboratory had a policy to ensure the verification of new hematology quality control material. (2) On the third day of the survey, the surveyor reviewed the policy titled, "Complete Blood Count Abbott Cell-dyn Ruby" which stated, "Each lab will establish a mean and an acceptable range for each new lot of control material that is used. The mean however, should fall within the manufacturer's listed mean range. Verify the new control lot by running each level of control 3 times in its respective file to ensure that the mean of all 3 runs is within the range shown on the assay sheet. Run the new control twice a day for 5 days. Use the mean of 10 runs to verify that the new lot yields expected results."; (3) The surveyor then reviewed records for 3 QC (Quality Control) lot numbers and identified the following: (a) For 1 (Lot# 8057 - low, normal and high) of 3 QC lot numbers (i) The QC material was ran one time before put into use on 03/16/18. (4) The surveyor reviewed the records and policy with the laboratory manager and testing person #1/hematology supervisor who stated the laboratory had not followed their written policy for ensuring the verification of new hematology QC materials. CHEMISTRY - ABBOTT ARCHITECT (1) On the first day of the survey, the laboratory manager stated the following to the surveyor: (a) Routine Chemistry testing was performed using the Abbott Architect analyzer; (b) The laboratory had a quality control (QC) policy to ensure acceptable control results. (2) On the third day of the survey, the surveyor reviewed the policy titled, "Chemistry Policy" which stated, "C. Modified Westgard Rules will be used where applicable to interpret Quality Control (QC) results and determine when a method is considered acceptable control for each run and whether or not patient results can be released for reporting. 1. For each level of control a QC value may exceed the mean by +/- 2 Standard Deviation (SD) but be within +/- 3 SD range. If the QC Value exceeds the 2SD for a second consecutive day,