Creek Nation Community Hospital

Summary Statement of Deficiencies D0000 The recertification survey was performed on 02/03,04,05/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory quality assurance specialist, quality improvement specialist, laboratory supervisor, hospital administrator, director of laboratory services, assistant director of laboratory services, and laboratory director during an exit conference performed at the conclusion of the survey. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 operator manual, and interview with the laboratory supervisor, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures on the Abbott Cell-Dyn Emerald 22 analyzer during the review period of January 2024 through January 2025. Findings include: (1) On 02/03/2025 at 10:00 am, the laboratory supervisor stated the laboratory began using the Abbott Cell Dyn Emerald 22 as a backup method for performing CBC (Complete Blood Count) testing on 04/21/2023; (2) A review of the Abbott Cell-Dyn Emerald 22 Operator's Manual, section 9-12 titled "Preventive Maintenance Schedule" stated the syringe piston should be lubricated quarterly; (3) A review of maintenance logs from January 2024 through January 2025 identified required quarterly maintenance had not been documented as performed for the following periods: (a) Between 01/01/2024 and 06/21/2024 (b) Between 06/21/2024 and 12/25/2024 (4) The records were reviewed with laboratory supervisor who stated on 02/05/2025 at 03:15 pm, maintenance procedures had not been documented as performed as stated above. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory supervisor, the laboratory failed to follow the manufacturer's instructions for performing calibrations for one of two analyzers. Findings include: (1) On 02/03 /2025 at 10:00 am, the laboratory supervisor stated the laboratory began using the Abbott Cell Dyn Emerald 22 as a backup method for performing CBC (Complete Blood Count) testing on 04/21/2023; (2) A review of the Cell Dyn Emerald 22 operator's manual, section 6-3 titled, "When to Calibrate" stated calibration should occur at least once every six months; (3) A review of records from November 2022 through July 2023 identified no documentation to prove the analyzer had been calibrated between installation on 11/02/2022 and 07/06/2023 (due May 2023); (4) Interview with the technical consultant on 02/05/2025 at 12:00 pm confirmed there were no records to prove the analyzer had been calibrated as required by the manufacturer. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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: -- 2 of 3 -- Based on a review of records and interview with the laboratory quality assurance specialist, the laboratory failed to perform calibration verification procedures at least once every six months for the Abbott Architect test system during the review period of 02/01/2023 through the current date. Findings include: (1) On 02/04/2025 at 10:45 am, the laboratory quality assurance specialist stated the laboratory performed Acetaminophen, Albumin, Alkaline Phosphatase, Ammonia, Amylase, Aspartate Transferase, Direct Bilirubin, Total Bilirubin, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Creatinine Kinase, Carbon Dioxide, Creatinine, Ethanol, Glucose, High-Density Lipoprotein, Hemoglobin A1C, Lactate, Lipase, Magnesium, Phosphorus, Potassium, Salicylate, Sodium, Total Protein, Triglyceride, and Thyroid Stimulating Hormone testing using the Abbott Architect ci4100 chemistry and immunoassay analyzer; (2) A review of records from 02/01/2023 through the current date identified no evidence the calibration verification procedures had been performed for each analyte listed above between 12/28/2023 and 11/25/2024. (3) The findings were reviewed with the laboratory quality assurance specialist, who stated on 02/04 /2025 at 10:45 am, the calibration verification procedures had not been performed every six months as stated above. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/10,11,12/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the administrative director of hospital services, director of quality, quality specialist #1, quality specialist #2, laboratory director, director of laboratory services, assistant director of laboratory services, laboratory supervisor, and testing person #5 during an exit conference performed at the conclusion of the survey. 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, assistant director of laboratory services, and the laboratory supervisor, the laboratory failed to follow their written procedure for coagulation lot rollover studies for two of four reagent lot numbers. Findings include: (1) On 01/10 /2023 at 10:30 am, the assistant director of laboratory services stated the laboratory performed PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing using the ACL TOP 300 analyzer; (2) On 01/11 /2023 at 02:45 pm, the assistant director of laboratory services stated the following reagents were put into use on 08/31/2022: (a) PT Reagent - HemosIL RecombiPlasTin, lot #N0129629 (b) PTT Reagent - HemosIL APTT-SP, lot #N0129380 (3) A review of the procedure titled, "ACL TOP New Reagent Lot Studies Work Instructions" identified the following: (a) The section titled, "Verification of Reference Interval" stated "Minimum of 20 screened normal samples (10 male and 10 female)"; (b) The section titled, "Comparison Study" stated Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- "Minimum of 20 normal samples (can be the same used in VRI study); Minimum of 20 abnormal samples that span the AMR, Run all samples concurrently with the old and new lots of reagents". (4) A review of the implementation records for the new reagent lot numbers identified the written procedure had not been followed: (a) For the verification of reference interval, eight male and 13 female donor samples had been used; (b) For the comparison study, the 20 abnormal samples did not span the AMR (Analytical Measurement Range) of the analyzer: (i) PT - The AMR was 8.0- 320.0 and the samples that had been used spanned a range of 17.3-34.7; (ii) PTT - The AMR was 16.0-400.0 and the samples that had been used spanned a range of 33.2- 47.1. (5) The records were reviewed with the director of laboratory services, assistant director of laboratory services, and the laboratory supervisor. All stated on 01/12/2023 at 12:04 pm, the laboratory had not followed their procedure for the coagulation lot rollover studies. 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 assistant director of laboratory services, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures for one of five analyzers reviewed from 08/01/2021 through 12/31/2022. Findings include: (1) On 01/10/2023 at 10:45 am, the assistant director of laboratory services stated the following: (a) The Abbott Architect ci4100 analyzer consisted of the c4000 and i1000SR modules; (b) HCG (human Chorionic Gonadotropin), TSH (thyroid stimulating hormone), Free T4 (Thyroxine), Folate, Vitamin D, Vitamin B12, Acetaminophen, Digoxin, Dilantin, Valproic Acid, and Vancomycin testing were performed on the i1000SR module. (2) On 01/12/2023, a review of the "Architect Systems Operations Manual" identified the following maintenance requirements for the i1000SR module: (a) Section 6440 "Daily Maintenance" required the following: (i) Clean the outside of the probes in the wash zone (ii) Mix the microparticle bottles on the reagent carousel (iii) Dry the vacuum pump filter (iv) Flush and prime the wash zone, pre-trigger, and trigger manifolds (v) Verify that a backup has been peformed in the last thirty (30) days. If it has not the operator is instructed to perform one (vi) Check the database integrity (b) Sections 6407, 6445, and 6450 "Weekly" required the following: (i) Probe Cleaning - Manual (ii) Pipettor/WZ Probe Cleaning (iii) Wash Cup Cleaning (c) Section 6405 "Monthly" required the following: (i) Air Filter Cleaning (3) A review of maintenance records from 08/01/2021 through 12/31/2022 identified no documentation to prove the maintenance procedures had been performed as follows: (a) Daily - Between 12/31/2021 and 02/01/2022 (b) Weekly - Between 12 /31/21 and 02/04/2022 (c) Monthly - Between 12/10/2021 and 02/11/2022 (4) The records were reviewed with the assistant director of laboratory services who stated on 01/12/2023 at 02:30 pm, there were no records to prove the above maintenance procedures had been performed. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) -- 2 of 5 -- (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records and interview with the director of laboratory services, assistant director of laboratory services, and laboratory supervisor, the laboratory failed to follow their policy for monitoring the effectiveness of their QCP (Quality Control Plan) for one of one test system. Findings include: (1) On 01/10/2023 at 10:15 am, the assistant director of laboratory services stated the following: (a) Urine Drug Screen testing was performed using the Bio-Rad TOX/SEE test kit; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) On 01/11/2023, a review of the IQCP identified that QA (Quality Assessment) reviews of the QCP (Quality Control Plans) were to be performed on an annual basis; (3) A review of records for the test systems during 2021 and 2022 identified no documentation an annual QA review had been performed during 2022; (4) The records were reviewed with the director of laboratory services, assistant director of laboratory services, and laboratory supervisor. All stated on 01/11/2023 at 12:55 pm, an annual QA review had not been documented as performed in 2022. 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 patient reports and interview with the director laboratory services and assistant director of laboratory services, the laboratory failed to make appropriate reference ranges available for two of two coagulation reagent lot number changes. Findings include: (1) On 01/10/2023 at 10:30 am, the assistant director of laboratory services stated the laboratory performed PT/INR (Prothrombin Time /International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing using the ACL TOP 300 analyzer; (2) On 01/11/2023 at 02:45 pm, the assistant director of laboratory services stated the following reagents were put into use on 08/31 /2022: (a) PT Reagent - HemosIL RecombiPlasTin, lot #N0129629 (b) PTT Reagent - HemosIL APTT-SP, lot #N0129380 (3) A review of PT and PTT reagent implementation records identified the following normal reference intervals had been verified: (a) PT - 9.5-11.9 (b) PTT - 27.0-37.9 (4) A review of two random patient reports identified the following: (a) PT Patient Report - Testing performed on 01/04 /2023 at 11:06 am had a normal reference range of 9.4-12.6; (b) PTT Patient Report - Testing performed on 10/23/2022 at 01:09 pm had a normal reference range of 25.1- 36.5. (5) The reports and implementation records were reviewed with the director of laboratory services who stated on 01/12/2022 at 01:42 pm, the laboratory had not updated the normal reference ranges into the laboratory's computer information system. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 3 of 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)(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 review of records and interview with the director of laboratory services, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H for four of eight events reviewed in 2022. Findings include: (1) On 01/10 /2023, a review of 2022 proficiency testing events identified the attestation statements had been signed approximately two to four months after the samples had been tested for four of eight events reviewed: (a) First 2022 Hematology/Coagulation Event - The sample testing had been completed on 03/23/2022 and the attestation statement had not been signed by the laboratory director until 06/03/2022; (b) Second 2022 Hematology/Coagulation Event - The sample testing had been completed on 07/29 /2022 and the attestation statement had not been signed by the laboratory director until 09/30/2022; (c) Third 2022 Hematology/Coagulation Event - The sample testing had been completed on 11/30/2022 and the attestation statement had not been signed by the laboratory director until 01/06/2023; (d) First 2022 Chemistry Core Event - The sample testing had been completed on 02/01/2022 and the attestation statement had not been signed by the laboratory director until 06/03/2022. (2) The records were reviewed with the director of laboratory services who stated on 01/10/2022 at 03:40 pm, the attestation had not been signed until approximately two to four months after the proficiency samples had been tested. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a review of records and interview with the assistant director of laboratory services, the laboratory director failed to ensure that personnel performing moderate complexity testing had the appropriate training for one of two persons. Findings include: (1) On 01/10/2023, a review of personnel records identified the following for one of two testing persons hired after the previous recertification: (a) Testing Person #8 - This person was hired to perform patient testing on 12/06/2021. There was no documentation this person had been initially trained. A competency evaluation had not been documented as performed until 12/14/2022. (2) The records were reviewed with the assistant director of laboratory services who stated on 01/10/2023 at 01:40 -- 4 of 5 -- pm, there was no documentation to prove the testing person had been initially trained to perform moderate complexity testing. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of records and interview with the assistant director of laboratory services, the technical consultant failed to evaluate personnel performing moderate complexity testing at least annually for two of six persons. Findings include: (1) On 01 /10/2023, a review of personnel records for six persons who performed moderate complexity testing during 2021, 2022, and to date in 2023 identified no evidence of annual evaluations as follows: (a) Testing Person #2 - Annual competencies had not been documented as performed between 06/08/2020 and 12/14/2022; (b) Testing Person #4 - Annual competencies had not been documented as performed between 09 /17/2020 and 12/15/2022. (2) The records were reviewed with the assistant director of laboratory services who stated on 01/10/2023 at 01:30 pm, the annual competency evaluations had not been performed as shown above. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/26,27,28,29/2021. The findings were reviewed with the laboratory director, director of laboratory services, laboratory manager, technical consultant #2, testing person #1, testing person #2, testing person #8, laboratory phlebotomist, four laboratory consultants, administrative director, chief operating officer, and director of quality during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2, the laboratory failed to maintain quality control records for at least 2 years for four of four control lot numbers. Findings include: MULTI-CHEM QUALITY CONTROL MATERIAL (1) On 04/29/2021 at 01:00 pm, technical consultant #2 stated to surveyor #2: (a) The laboratory performed routine chemistry testing using the Abbott Architect 4100 (some examples of the analytes tested: Albumin, Alkaline Phosphatase, ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), Amylase, Calcium, Chloride, Cholesterol, CO2, Creatinine, Direct Bilirubin, Glucose, Sodium, Magnesium, Potassium); (b) Two levels of QC (Quality Control) materials were performed each day of patient testing for routine chemistry testing. (2) Surveyor #2 reviewed two Multi-Chem QC lot numbers, Lot# 16701171 - Level one and Lot# 16701173 - Level three. On 04/29/2022 at 01:10 pm, surveyor #2 asked technical consultant #2 for the laboratory's documentation of how their means and limits of acceptability, and the dates the materials were put into use for patient testing. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- Technical consultant #2 stated on 04/29/2021 at 01:30 pm, the QC materials were put into use in January 2019, however there was no documentation to prove how the means and acceptable limits were established; (3) Surveyor #2 then requested QC printouts from the analyzer, with the means and limits the laboratory was currently using to determine acceptability of QC results. Although it appeared to surveyor #2 (by reviewing the laboratory's control ranges, printed from the analyzer) that the laboratory had established the means and limits of acceptability, there was no documentation to substantiate how the means and limits had been derived; (4) Surveyor #2 reviewed the findings with technical consultant #2. Technical consultant #2, stated on 04/29/2021 at 02:10 pm, although the laboratory had established their means and limits when the new lot numbers were put into use, the records had not been maintained for at least 2 years. HEMOGLOBIN A1C AND BNP QUALITY CONTROL RECORDS (1) On 04/29/2021 at 01:00 pm, technical consultant #2 stated to surveyor #2: (a) The laboratory performed Hemoglobin A1c and BNP (Brain Natriuretic Peptide) testing using the Abbott Architect 4100 analyzer; (b) Two levels of quality control materials were performed each day of patient testing. (2) On 04/29 /2021, surveyor #2 reviewed BNP quality control records between July 2019 through March 2020 but could not located quality control records for the following: (a) July 2019 - A1c quality control lot# 9042 level two; (b) November 2019 - BNP quality control lot# 23696 level two. (3) Surveyor #2 reviewed the records with technical consultant #2. Technical consultant #2 stated on 04/29/2021 at 01:45 pm the laboratory did not maintain quality control records for two years. 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 consultant and laboratory manager, the laboratory failed to review and evaluate proficiency testing results for three of 28 events. Findings include: (1) On 04/26/2021, the surveyor reviewed 2019, 2020, and 2021 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 2019 Chemistry Core Event (i) Glucose - five of five results exhibited a negative bias (aa) Sample CH-11 - SDI of -5.5 (bb) Sample CH-12 - SDI of -6.2 (cc) Sample CH-13 - SDI of -4.6 (dd) Sample CH-14 - SDI of -4.9 (ee) Sample CH-15 0 SDI of -4.3 (b) First 2020 Chemistry Core Event (i) Glucose - three of five results exhibited a negative bias (aa) Sample CH-02 - SDI of -4.3 (bb) Sample CH-04 - SDI of -2.1 (cc) Sample CH-05 - SDI of -2.9 (c) Second 2020 Chemistry Core Event (i) AST (Aspartate Aminotransferase) - three of five results exhibited a negative bias (aa) Sample CH-07 - SDI of -2.0 (bb) Sample CH-09 - SDI of -2.1 (cc) Sample CH-10 - SDI of -2.3 (ii) Direct Bilirubin - three of five results exhibited a negative bias (aa) Sample CH-08 - SDI of -2.7 (bb) Sample CH-09 - SDI of -2.4 (cc) Sample CH-10 - SDI of -2.7 (iii) Glucose - four of five results exhibited a negative bias (aa) Sample CH-07 - SDI of -4.1 (bb) Sample CH-08 - SDI of -2.5 (cc) Sample CH-09 - SDI of -4.9 (dd) Sample CH-10 - SDI of -2.9 (iv) Lipase - five of five exhibited a positive bias (aa) Sample CH-06 - SDI of 7.4 (bb) Sample CH-07 - SDI of 9.1 (cc) Sample CH-08 - SDI of 7.6 (dd) Sample CH-09 - SDI of 9.4 (ee) Sample CH-10 - SDI of 7.4 (2) The surveyor could not locate evidence in the records proving the biases had been identified and addressed; (3) The records were -- 2 of 9 -- reviewed with the laboratory consultant and the laboratory manager. The laboratory manager stated on 04/26/2021 at 02:40 pm the biases had not been addressed as indicated 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 the policy and procedure manual and interview with the laboratory manager, the laboratory failed to follow written procedures for the Helmer Platelet Agitator for four of four quarterly clean and maintenance; and failed to follow written procedures for establishing initial QC ranges for two of two lot numbers. Findings include: HELMER PLATELET AGITATOR PF96i QUARTERLY CLEAN AND MAINTENANCE (1) On 04/26/2021 at 10:55 am, the laboratory manager stated to surveyor #2: (a) The laboratory used the Helmer Platelet Agitator PF96i to store platelets ordered for patient transfusion. (2) On 04/28/2021, surveyor #2 reviewed the policy for the Helmer Platelet Agitator PF96i quarterly clean and maintenance which stated: (a) "Test the Motion Alarm" (b) "Clean the fan located on the underside of base" (c) "Clean the shelves of Platelet Agitator with Caviwipe" (2) On 04/28/2021, surveyor #2 reviewed the 2019, 2020, and 2021 Helmer Platelet Agitator PF96i quarterly clean and maintenance records and identified the following: (a) 2019 quarterly clean and maintenance records had not been documented as performed. (3) Surveyor #2 review the records with the laboratory manager. The laboratory manager stated on 04/28/2021 at 02:47 pm, the laboratory did not follow the laboratory's quarterly clean and maintenance written procedure in 2019 as indicated above. ESTABLISH QUALITY CONTROL RANGES (1) On 04/29/2021 at 01:00 pm, technical consultant #2 stated to surveyor #2: (a) The laboratory performed TSH (Thyroid Stimulating Hormone) testing using the Abbott Architect 4100 analyzer ; (2) Surveyor #2 reviewed the laboratory's written policy and procedure titled, "Chemistry Policy", which stated under the section, "D. For Abbott Architect Ci4100": (a) "1. To establish initial QC (Quality Control) ranges for each new lot number of control, analyze a minimum of 20 samples, preferably over several days. Establish the mean and SD for each analyte for each level.". (3) Surveyor #2, reviewed QC records for two lot numbers and identified the following: (a) Bio-Rad Liquichek Immunoassay lot# 85231 (level one) mean and SD was established using 15 analyzed samples and put into use on 01/01/2021; (b) Bio-Rad Liquichek Immunoassay lot# 85233 (level two) mean and SD was established using 15 analyzed samples and put into use on 01/01/2021. (3) Surveyor #2 reviewed the records with technical consultant #2. Technical consultant #2 stated on 04/29/21 at 01:55 pm, the laboratory had not followed the laboratory's written procedure for establishing initial QC ranges 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 -- 3 of 9 -- can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory consultant, the laboratory failed to ensure the validation had been reviewed and evaluated by the laboratory for one of one new test kit. Findings include: (1) On 04/26/2021 at 01:55 pm, the laboratory consultant stated to surveyor #1 the laboratory began performing Qualitative Serum Pregnancy testing using the OSOM hCG Combo test on 03/08 /2021; (2) Surveyor #1 reviewed the validation data for test system. There was no documentation the laboratory had reviewed and evaluated the validation data to approve the new test method; (3) Surveyor #1 reviewed the records with the laboratory consultant who stated on 04/26/2021 at 02:42 pm, there was no documentation to prove that the validation data had been reviewed and evaluated by the laboratory. (NOTE: The interpretive guidelines at 493.1253(b)(1) state, "The laboratory is responsible for verifying the performance specifications of each nonwaived unmodified FDA-cleared or approved test system that it introduces, prior to reporting patient test results." In addition, the interpretive guidelines state, "Prior to introducing a test for routine patient testing, the laboratory must review and evaluate the verification data.") 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 consultant and laboratory manager, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures for one of four months. Findings include: (1) On 04/26/2021 at 10:00 am, the laboratory consultant and laboratory manager stated to surveyor #2: (a) The laboratory performed urinalysis testing using the Clinitek Advantus. (2) On 04/27/2021, surveyor #2 reviewed the manufacturer's maintenance requirements as stated on the maintenance logs. The daily maintenance requirements were as follows: (a) Daily (i) Clean Push Bar (ii) Discard used reagent strips (iii) Clean fixed platform (iv) Clean moving table (v) Clean hold down plate from fixed platform (vi) Inspect the calibration bar for scratches, or marks (3) Surveyor #2 then reviewed maintenance records for four months (January 2021 through April 2021). The following was identified: (a) There was no evidence the daily maintenance had been performed as follows: (i) Between 03/25/2021 and 03/27 /2021 (ii) Between 03/27/2021 and 04/01/2021 (4) Surveyor #2 reviewed the records with the laboratory consultant and the laboratory manager. The laboratory manager stated on 04/27/2021 at 01:45 pm, the daily maintenance had not been documented as performed as indicated above. D5435 MAINTENANCE AND FUNCTION CHECKS -- 4 of 9 -- CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, written policy, and interview with the laboratory manager, the laboratory failed to follow their written protocol for ensuring the centrifuge was functioning properly for two of five function checks. Findings include: (1) On 04/26/2021 at 10:00 am, the laboratory manager stated the following to surveyor #1: (a) Urine sediment examinations were performed in the laboratory; (b) Patient specimens had been processed in the Horizon 614V Drucker centrifuge at a speed of 1500-2000 rpm (revolutions per minute) for 5 minutes until 03/31/2021, when the laboratory obtained a new centrifuge. (2) Surveyor #1 reviewed the policy titled, "Maintenance and Function Checks" which stated, "Function checks for RPM and timer accuracy are performed by the MCNDH Net Facilities Department twice a year or as specified by the equipment manufacturer"; (3) Surveyor #1 reviewed the centrifuge records from May 2019 through March 2021. The records showed that, although the centrifuge speed and timer checks had been performed twice annually, the results for the speed and timer checks performed on 11/13/2020 and 03/23/2021 had not been documented to ensure the centrifuge was processing specimens at the appropriate speed and time; (4) Surveyor #1 reviewed the findings with the laboratory manager who stated on 04/26/2021 at 11:30 am, the results for two of the centrifuge speed and timer checks had not been documented as stated above. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to perform at least two levels of control testing each day patient specimens were tested for two of 20 patients. Findings include: (1) On 04/26/2021 at 11:40 am, the laboratory manager stated to surveyor #2: (a) The laboratory performed D-Dimer testing and CKMB testing using the Alere Triage Meter analyzer ; (b) Two levels (low and high) of quality control (QC) materials were to be tested each day of patient testing. (2) On 04/29/2021, surveyor #2 reviewed QC and patient records for testing performed between January 2020 through February 2021. It was identified QC testing had not been performed each day of patient testing for two of 20 days of patient testing: (a) D-Dimer testing (i) Patient (37200500155) teasing performed on 02 -- 5 of 9 -- /15/2020 at 02:24 pm. (b) CKMB (i) Patient (37210060071) testing performed on 01 /30/2021 at 09:12 pm (3) Surveyor #2 reviewed the records with the laboratory manager. The laboratory manager stated on 04/29/2021 at 11:50 am QC testing had not been documented as performed each day of patient testing as indicated above. 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 the laboratory consultant, the laboratory failed to perform a negative and positive control material each day of Qualitative Serum Pregnancy testing for one of four days. Findings include:, (1) On 04 /26/2021 at 01:55 pm, the laboratory consultant stated to surveyor #1 the laboratory began performing Qualitative Serum Pregnancy testing using the OSOM hCG Combo test on 03/08/2021; (2) Surveyor #1 reviewed quality control (QC) and patient records from 03/08/2021 through 04/08/2021, which showed that QC had not been performed on one of four days. The specific day was 03/28/2021; (3) Surveyor #1 reviewed the findings with the laboratory consultant who stated on 04/26/2021 at 02:40 pm, QC testing had not been performed each day of patient testing. 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 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 the director of nursing, the laboratory failed to ensure that written policies provided safety for individuals being transfused for five of 15 units of packed red blood cells. Findings include: (1) On 04 /26/2021 at 10:55 am, the laboratory manager stated to surveyor #2 the laboratory stored units of PRBC (packed red blood cells) in the blood bank refrigerator. The units were to be used for patient transfusions; (2) On 04/28/2021, surveyor #2 reviewed the hospital policy regarding transfusion reactions. The policy titled, "Administration of Blood & Blood Products" under the section titled, "N. Document vital signs as follows:", stated: (a) "1. Pre-transfusion" (b) "2. 5 minutes after start time" (c) "3. 15 minutes after start time" (d) "4. 60 minutes after start time" (e) "5. -- 6 of 9 -- And every 60 minutes thereafter until transfusion is complete." (f) "6. Post transfusion" (3) Surveyor #2 reviewed records for 15 units of PRBCs (Packed Red Blood Cells) that had been transfused between 02/24/2019 through 04/25/2021 for six patients, and identified the following: (a) 5 minutes after start time (i) Patient# 80097053 - Transfused with one unit PRBC (unit# W091020372543) on 10/12/2020. The transfusion started at 02:04 pm and the first vital was documented at 04:45 pm (two hours 45 minutes later); (ii) Patient# 80097053 - Transfused with one unit PRBC (unit# W091020361350) on 10/12/2020. The transfusion started at 04:58 pm and the first vital was documented at 06:28 pm (one hour 30 minutes later). (b) 15 minutes after start time (i) Patient# 80090076 - Transfused with one unit PRBC (unit# W091020226609) on 06/03/2020. The transfusion started at 12:45 am, vitals were taken at 12:50 am and 01:20 am (30 minutes later); (ii) Patient# 80042825 - Transfused with one unit PRBC (unit# W091020298771) on 08/13/2020. The transfusion started at 08:37 pm, vitals were taken at 08:43 pm, 08:50 pm, and 10:15 pm (one hour 38 minutes later); (iii) Patient# 80042825 - Transfused with one unit PRBC (unit# W09102089668) on 09/17/2020. The transfusion started at 03:02 pm, vitals were taken at 03:07 pm and 04:32 pm (one hour 25 minutes later). (4) Surveyor #2 reviewed the findings with the director of nursing. The director of nursing stated on 04/28/2021 at 03:05 pm the written policy and procedure for blood administration had not been followed as indicated above. 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 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 laboratory manager, the laboratory failed to have a system that twice a year evaluated and defined the relationship between test results using different analyzers. Findings include: (1) On 04 /26/2021 at 10:30 am, the laboratory manager stated to surveyor #2 (a) BUN (Blood Urea Nitrogen), Calcium, Chloride, Creatinine, Glucose, Potassium, and Sodium testing were performed on two analyzers as follows: (i) The Abbott Architect 4100 analyzer as the primary analyzer; (ii) The Abbott iSTAT analyzer (serial number #343109) using the Chem 8+ cartridge as the back-up analyzer. (b) Troponin I and CKMB testing were performed on two analyzers as follows: (i) The Abbott Architect 4100 analyzer as the primary analyzer; (ii) Alere Triage Meter as the back-up analyzer. (c) D-Dimer testing was performed on two analyzers as follows: (i) The ACL TOP as the primary analyzer; (ii) Alere Triage Meter as the back-up analyzer. (2) On 04/27/2021, surveyor #2 reviewed the comparison data for the analyzers and identified the following: (a) BUN (Blood Urea Nitrogen), Calcium, Chloride, Creatinine, Glucose, Potassium, and Sodium testing (i) For testing performed from January 2020 through the second day of the survey (04/27/2021), there was no evidence the relationship between the analyzers had been evaluated twice in 2020 and to date in 2021. The relationship between the analyzers had been evaluated on 11/20 /2020 (not prior to that date and after that date). (b) Troponin I and CKMB testing (i) For testing performed from November 2018 through the second day of the survey (04 /27/2021), there was no evidence the relationship between the analyzers had been -- 7 of 9 -- evaluated twice in 2019 and twice in 2020. The comparison had not been evaluated between 11/16/2018 and 12/29/2020. (c) D-Dimer testing (i) For testing performed from November 2018 through the second day of the survey (04/27/2021), there was no evidence the relationship between the analyzers had been evaluated twice in 2019 and twice in 2020. The comparison had not been evaluated between 11/20/2018 and 03 /29/2021. (3) Surveyor #2 reviewed the records with the laboratory manager who stated on 04/27/2021 at 01:35 pm, the relationship between the analyzers had not been evaluated twice annually 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 the laboratory consultant and laboratory manager, the laboratory failed to make appropriate reference ranges available for two of two reagent lot number changes; the laboratory failed to make appropriate reference ranges available for two of two patient SARS-CoV-2 antibody patient reports. Findings include: REAGENT LOT NUMBER CHANGES - NORMAL REFERENCE RANGE (1) On 04/26/2021 at 10:00 am, the laboratory manager stated surveyor #2 the laboratory performed PT/INR (Prothrombin Time /International Normalized Ratio) PTT (Partial Thromboplastin Time) testing on the ACL Top analyzer. In addition the following reagents were put into use on 03/01 /2021: (a) Recombinplastin PT reagent lot# N1099299 (b) SynthASil PTT Reagent lot# N1199759 (2) Surveyor #2 reviewed the PT and PTT reagent implementation records and identified the laboratory had verified the following: (a) PT normal reference interval of 9.9 - 12.7 seconds; (b) PTT normal reference interval of 28.4 - 40.62 seconds. (3) Surveyor #2 then reviewed a patient PT and PTT report dated 04/24 /2021 at 08:29 pm with the following: (a) PT normal reference range of 9.7-12.5 seconds; (b) PTT normal reference range of 26.9 - 37.7 seconds. (4) Surveyor #2 surveyor reviewed the findings with the laboratory consultant and laboratory manager. On 04/26/2021 at 02:55 pm, the laboratory manager stated that although the laboratory had established a PT and PTT normal reference interval with the PT and PTT reagent lot change, the laboratory had not implemented the change into the laboratory's computer information system. SARS-CoV-2 ANTIBODY PATIENT REPORT (1) On 04/26/2021 at 10:10 am, the laboratory manager stated surveyor #2 the laboratory performed SARS-CoV-2 antibody (IgG) testing on the Abbott Architect 4100 analyzer; (2) On 04/29/2021, surveyor #2 reviewed two patient SARS-CoV-2 antibody reports dated 02/25/2021 at at 03:28 pm and 04/08/2021 at 04:17 pm. The patient reports did not include a normal reference range for IgG antibody; (3) The report was reviewed with the laboratory manager, who stated on 04/29/2021 at 02:40 pm, the two patient reports did not include a normal reference range as indicated above. 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 -- 8 of 9 -- 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 review of records and interview with the laboratory consultant and laboratory manager, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H for one of 28 events. Findings include: (1) On 04/26/2021, surveyor #2 reviewed 2019, 2020, and 2021 proficiency testing events. For one of 28 events, the attestation statements had been signed approximately two months after the samples had been tested (not within a timeframe for the director to attest that, at the time of testing, the proficiency samples had been tested as required) as follows: (a) Third 2020 Hematology/Coagulation Event - The sample testing had been completed on 11/20/2020, and the attestation statement had not been signed by the laboratory director/designee until 01/31/2021. (2) Surveyor #2 reviewed the findings with the laboratory consultant and laboratory manager. The laboratory manager stated on 04/26 /2021 at 02:35 pm the attestations had been signed approximately two months after the proficiency samples had been tested. Surveyor #2 explained that attestation statements must be signed within a timeframe to definitively attest to the fact that proficiency samples were tested in the same manner as patient specimens. -- 9 of 9 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/15,16,17/2018. The laboratory was found out of compliance with the following CLIA regulations: 493.1250; D5400: Analytic Systems 493.1403; D6000: Laboratory Director 493.1409; D6033: Technical Consultant 493.1447; D6108: Technical Supervisor The findings were reviewed with the administrator, director of quality, quality improvement specialist, blood bank /coagulation department supervisor, hematology department supervisor, and urinalysis department supervisor during an exit conference performed at the conclusion of the survey. 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. This CONDITION is not met as evidenced by: Based on a review of records, written policies and procedures, manufacturer's instructions, and interview with technical consultant #2, the hematology department supervisor, blood bank/coagulation department supervisor, urinalysis department supervisor, and the chemistry department supervisor, the laboratory failed to monitor and evaluate the overall quality of analytic systems. Findings include: (1) The laboratory failed to have written procedures for manual differential and urine microscopic testing. Refer to D5401; (2) The laboratory failed to follow the manufacturer's instructions for establishing normal reference intervals for a new coagulation analyzer; and failed to follow the manufacturer's instructions to ensure flagged results were addressed for hematology. Refer to D5411; (3) 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 22 -- failed to demonstrate the performance specifications for new test methods; and failed to ensure the verified reportable ranges were used by the laboratory. Refer to D5421; (4) The laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Refer to D5429; (5) The laboratory failed to perform calibration verification procedures at least once every 6 months. Refer to D5439; (6) The laboratory failed to perform a negative and positive control material each day of patient Urine Drug Screen testing. Refer to D5449; (7) The laboratory failed to ensure units of blood were stored under appropriate conditions. Refer to D5555; (8) The laboratory failed to have an ongoing mechanism for performing effective 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 technical consultant #2, the hematology department supervisor and the urinalysis department supervisor, the laboratory failed to have written procedures for manual differential and urine microscopic testing. Findings include: MANUAL DIFFERENTIAL (1) On the first day of the survey, technical consultant #2 stated to the surveyor manual differential testing was performed in the laboratory; (2) On the third day of the survey, the surveyor requested the manual differential procedure from the hematology department supervisor; (3) The hematology department supervisor was unable to locate a written procedure for performing manual differential testing and stated to the surveyor a procedure had not been written. URINE MICROSCOPIC (1) On the first day of the survey, technical consultant #2 stated to the surveyor urine microscopic testing was performed in the laboratory; (2) On the third day of the survey, the surveyor requested the urine microscopic procedure from the urinalysis department supervisor; (3) The urinalysis department supervisor was unable to locate a written procedure for performing urine microscopic testing and stated to the surveyor a procedure had not been written. 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, manufacturer's instructions, and interview with technical consultant #2, the blood bank/coagulation department supervisor, and the hematology department supervisor, the laboratory failed to follow the manufacturer's instructions for establishing normal reference intervals for a new coagulation analyzer; and failed to follow the manufacturer's instructions to ensure flagged results -- 2 of 22 -- were addressed for hematology. Findings include: COAGULATION (1) On the first day of the survey, technical consultant #2 stated the following to the surveyor: (a) The hospital moved to a new location and the laboratory began patient testing in the new location on 05/10/18; (b) A new ACL TOP analyzer was put into use to perform PT /INR (Protime/International Normalized Ratio), PTT (Partial Thromboplastin Time) and D-dimer testing at the new location on 05/10/18. The laboratory had used the ACL Elite analyzer to perform PT/INR and PTT testing at the previous hospital location. (2) On the second day of the survey, the surveyor reviewed the manufacturer's instructions for establishing a normal reference interval which stated (the laboratory did not have the instructions, however, the surveyor had a copy of the instructions obtained from other laboratories using the same test system): (a) "You must decide before starting which type of study to perform. Will you perform a full reference interval study or will you be verifying a previous reference interval? Either 120 or 20 normal donors following these screening guidelines": (i) "Donors should be healthy and have no known pathological conditions. Don't use patients (they are at the hospital for a medical reason). Donors should not be on medication affecting coagulation, including (but not limited to) oral contraceptives, estrogen therapy (HRT), anticoagulants, high dose aspirin, etc. Donors should span the adult age range. Pediatric ranges should be established separately. Donors should be equally divided between male/female". (b) In addition, the instructions stated, "If you choose to do a full reference interval study, test 120 donors. Ideally specimens will be analyzed over a number of days, resulting in values that represent average run-to-run variation. If you choose to verify a range, you may use a 20-donor study under specific conditions. The main conditions are as follows: The original site must have done a full reference range study The original site must have used the identical type of analytical system (method, instrument and reagents)". (3) To determine if the laboratory should perform a 20 or 120 sample study, the surveyor asked technical consultant #2 if the laboratory had ever performed a full reference interval study (120 sample study) on the ACL Elite analyzer. Technical consultant #2 verified there was no evidence to prove a 120 sample study had ever been performed. Based on the manufacturer's guidelines, the surveyor determined an initial 120 sample study was required, then subsequent studies may be performed using 20 samples due to the following: (a) There was no evidence a 120 sample study had been performed on the previous analyzer (ACL Elite). (4) The surveyor reviewed the implementation records for the analyzer. The following was identified for PT, PTT, and D-dimer: (a) The lot numbers that were in use when the analyzer was implemented were: (i) PT Reagent - RecombiPlasTin 2G lot #N1173928 (ii) PTT Reagent - SynthASil Lot #N1274655 (iii) D-dimer Reagent - lot #B30326 (b) The normal reference intervals had been established for each test performed on the analyzer as follows: (i) PT and PTT (aa) 21 donors had been utilized; (bb) There was no evidence of the health status (healthy with no pathological conditions) for the 21 donors; (cc) There was no evidence of the medication history for 6 of the donors; (dd) There was no evidence of the age and gender for 6 of the donors. (ii) D-dimer (aa) 23 donors had been utilized; (bb) There was no evidence the donors were healthy, with no pathological conditions; (cc) There was no evidence of the donors medication history; (dd) There was no evidence of the age and gender of the donors. (5) The surveyor reviewed the records with technical consultant #2 and the blood bank /coagulation department supervisor. Both stated the following: (a) The laboratory did not perform the 120 sample study; (b) The laboratory had not documented the health status and medication history for the donors as indicated above; (c) The laboratory had not documented the age and gender for the donors as indicated above. (6) The following were examples of patient testing performed when the normal reference intervals had not been established for the new analyzer as required: (a) Patient #19 - PT/INR testing performed on 05/10/18 (b) Patient #20 - D-dimer testing performed on -- 3 of 22 -- 05/11/18 (c) Patient #21 - PT/INR, PTT, and D-dimer testing performed on 05/14/18 (d) Patient #22 - PT/INR testing performed on 05/16/18 (e) Patient #23 - PT/INR and PTT testing performed on 05/18/18 (f) Patient #24 - D-dimer testing performed on 05 /21/18 (g) Patient #25 - PT/INR testing performed on 05/24/18 (h) Patient #26 - PT /INR, PTT, and D-dimer testing performed on 05/26/18 (i) Patient #27 - PT/INR and PTT testing performed on 05/29/18 (j) Patient #28 - D-dimer testing performed on 0/7 /02/18 (k) Patient #29 - PT/INR and PTT testing performed on 07/05/18 (l) Patient #30 - PT/INR and PTT testing performed on 07/10/18 (m) Patient #31 - D-dimer testing performed on 07/10/18 (n) Patient #32 - PT/INR and PTT testing performed on 07/16/18 (o) Patient #33 - PT/INR testing performed on 07/17/18 (p) Patient #34 - PT /INR, PTT, and D-dimer testing performed on 07/20/18 (q) Patient #35 - PT/INR and PTT testing performed on 07/26/18 (r) Patient #36 - PT/INR and PTT testing performed on 07/27/18 (s) Patient #37 - PT/INR and PTT testing performed on 07/30 /18 (t) Patient #38 - PT/INR and PTT testing performed on 09/02/18 (u) Patient #39 - PT/INR testing performed on 09/04/18 (v) Patient #40 - PT/INR testing performed on 09/14/18 (w) Patient #41 - PT/INR testing performed on 09/19/18 (x) Patient #42 - PT /INR and PTT testing performed on 09/21/18 (y) Patient #43 - PT/INR and PTT testing performed on 09/22/18 (z) Patient #44 - PT/INR, PTT, and D-dimer testing performed on 09/24/18 (aa) Patient #45 - D-dimer testing performed on 09/26/18 HEMATOLOGY (1) On the first day of the survey, technical consultant #2 stated to the surveyor CBC (Complete Blood Count) testing, which included a 5 part automated differential, was performed on the Cell Dyn Ruby analyzer; (2) On the third day of the survey, the surveyor reviewed the manufacturer's instructions for verifying flags, and randomly reviewed CBC instrument printouts for testing performed in May 2018 and August 2018. With the assistance of the hematology department supervisor, the surveyor identified 11 patient records which contained flags. For 3 of the 11 patient records, the following was identified: (a) Patient #16 - RBC (Red Blood Cell) Morph flag obtained on 05/11/18 at 08:11 am (i) The manufacturer's instructions stated, "Review a stained smear for abnormal RBC or PLT morphology and follow your laboratory's review criteria"; (ii) There was no evidence in the records the laboratory reviewed a stained smear as required. (b) Patient #17 - The RBC result exceeded the linearity of the analyzer and displayed as ">>>>" on 05/11/18 at 01:53 pm (i) The manufacturer's instructions stated, "Specimens with results that exceed the linearity should be diluted with Diluent/Sheath according to the laboratory's procedure and repeated. (Be sure to correct the results for the dilution factor used.)"; (ii) Although the laboratory performed a dilution on the sample to obtain a result for RBC, there was no indication in the records that the result had been obtained by dilution, and there was no procedure available for the surveyor's review to determine if the appropriate diluent was used and the dilution factor that was used. (c) Patient #18 - A "Sampling Error" flag was obtained on 08/03/18 at 05:07 pm, indicated by an asterisk (*) for each analyte (WBC (White Blood Cell), RBC, Hemoglobin, Hematocrit, MCV (Mean Corpuscular Volume), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), Platelet, Neutrophil-% and absolute, Lymphocyte-% and absolute, Monocyte-% and absolute, Eosinophil-% and absolute, and Basophil-% and absolute) (i) The manufacturer's instructions stated, "The following summarizes all of the parameters marked with an asterisk (*) requiring further result validation". Listed in the table under the heading, "Instrument and Data Invalidating Alerts" was "Sampling Error"; (ii) There was no evidence in the records the laboratory had identified the Sampling Error message and attempted to further validate each analyte marked with an asterisk. (3) The surveyor reviewed the records with the hematology department supervisor who printed the final CBC reports for each patient above for further review. The hematology department supervisor stated the laboratory did not follow the manufacturer's instructions as indicated above, and -- 4 of 22 -- stated the following to the surveyor: (a) For patient #16, the results were reported without a slide review to verify the RBC Morph flag; (b) For patient #17, the laboratory had performed a dilution to obtain a result for the analyte RBC. The laboratory did not have a written procedure for performing dilutions for results that exceed the linearity of the analyzer; (c) For patient #18, the results were reported with the sampling error and with each parameter marked with an asterisk, and no further action was taken. 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, written procedure, and interview with technical consultant #2, the urinalysis department supervisor, and the hematology department supervisor, the laboratory failed to demonstrate the performance specifications for new test methods; and failed to ensure the verified reportable ranges were used by the laboratory. Findings include: URINE DRUG TEST KIT (1) On the second day of the survey, technical consultant #2 stated to the surveyor the laboratory began using the Bio-Rad TOX/See Drug Screen Test kit to perform patient Urine Drug Screen testing on 10/05/17; (2) The surveyor requested documentation from technical consultant #2 to substantiate the performance specifications (i.e., accuracy, precision) had been demonstrated for the test kit before it had been put into use; (3) Technical consultant #2 stated to the surveyor, the performance specifications had not been demonstrated for the test kit; (4) The following were examples of patient Urine Drug Screen testing performed when the performance specifications had not been demonstrated prior to beginning patient testing: (a) Patient #1 - testing performed on 10/05/17 (b) Patient #2 - testing performed on 10/13/17 (c) Patient #3 - testing performed on 10/25/17 (d) Patient #4 - testing performed on 11/07/17 (e) Patient #5 - testing performed on 11/18 /17 (f) Patient #6 - testing performed on 11/28/17 (g) Patient #7 - testing performed on 11/30/17 (h) Patient #8 - testing performed on 05/16/18 (i) Patient #9 - testing performed on 05/21/18 (j) Patient #10 - testing performed on 05/25/18 (k) Patient #11 - testing performed on 05/28/18 (l) Patient #12 - testing performed on 07/02/18 (m) Patient #13 - testing performed on 07/17/18 (n) Patient #14 - testing performed on 09 /06/18 (o) Patient #15 - testing performed on 09/18/18 CLINITEK ADVANTUS (1) On the first day of the survey, technical consultant #2 stated the following to the surveyor: (a) The hospital moved to a new location and the laboratory began patient testing in the new location on 05/10/18; (b) A new Clinitek Advantus analyzer was put into use to perform Urinalysis testing (for the analysis of Leukocytes, Nitrites, Protein, Blood, Glucose, Ketones, Bilirubin, Urobilinogen, pH, Specific Gravity, and Creatinine in patient urine specimens) on 05/10/18. (2) On the second day of the survey, the surveyor requested records from the urinalysis department supervisor to substantiate the performance specifications (i.e., accuracy, precision, reportable range, and reference range) had been demonstrated for the new test system before it had been put into use; (3) The urinalysis department supervisor stated to the surveyor the -- 5 of 22 -- performance specifications had not been demonstrated for the test system; (4) The following were examples of patient Urinalysis testing performed when the performance specifications had not been demonstrated prior to beginning patient testing: (a) Patient #46 - testing performed on 05/10/18 (b) Patient #47 - testing performed on 05/14/18 (c) Patient #48 - testing performed on 05/18/18 (d) Patient #49 - testing performed on 05/28/18 (e) Patient #50 - testing performed on 07/05/18 (f) Patient #51 - testing performed on 07/11/18 (g) Patient #52 - testing performed on 07 /19/18 (h) Patient #53 - testing performed on 07/25/18 (i) Patient #54 - testing performed on 07/30/18 (j) Patient #55 - testing performed on 09/10/18 (k) Patient #56 - testing performed on 09/16/18 (l) Patient #57 - testing performed on 09/23/18 (m) Patient #58 - testing performed on 09/26/18 (n) Patient #59 - testing performed on 09 /30/18 CELL DYN RUBY (1) On the first day of the survey, technical consultant #2 stated to the surveyor, a new Cell Dyn Ruby analyzer was put into use to perform patient *CBC (Complete Blood Count) testing on 05/10/18 when the laboratory moved to their new location; (2) On the second day of the survey, the surveyor reviewed validation records for the analyzer and identified the reportable ranges had been verified for WBC (White Blood Cell) and Platelet as follows: (a) WBC - 0.76- 90.28 (b) Platelet - 8.0-2041.25 (3) On the third day of the survey, the surveyor reviewed the procedure titled, "Complete Blood Count Abbott Cell-Dyn Ruby". Under the heading "XVI. Limitation", the procedure defined the reportable ranges as follows: (a) WBC - 0.68-230.0 (b) Platelet - 0.90-2175 (4) The surveyor reviewed the findings with the hematology department supervisor who stated the laboratory was not using the reportable ranges that had been verified by the laboratory for WBC and Platelet; (5) The following were examples of patient CBC testing performed when the laboratory was not using the verified reportable ranges for the analytes WBC and Platelet: (a) Patient #46 - testing performed on 05/10/18 (b) Patient #47 - testing performed on 05/14/18 (c) Patient #48 - testing performed on 05/18/18 (d) Patient #49 - testing performed on 05/28/18 (e) Patient #50 - testing performed on 07/05/18 (f) Patient #51 - testing performed on 07/11/18 (g) Patient #53 - testing performed on 07 /25/18 (h) Patient #54 - testing performed on 07/30/18 (i) Patient #55 - testing performed on 09/10/18 (m) Patient #56 - testing performed on 09/16/18 (n) Patient #57 - testing performed on 09/23/18 (o) Patient #58 - testing performed on 09/26/18 (p) Patient #59 - testing performed on 09/30/18 *CBC consists of the analytes WBC, RBC (Red Blood Cell), Hemoglobin, Hematocrit, Platelet, MCV (Mean Corpuscular Volume), MCH (Mean Corpuscular Hemoglobin), and MCHC (Mean Corpuscular Hemoglobin Concentration) 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 technical consultant #2 and the chemistry department supervisor, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Findings include: (1) On the first day of the survey, technical consultant #2 stated the following to the surveyor: (a) *CMP, Amylase, Ammonia, Direct Bilirubin, BNP (B- Type Natriuretic Peptide), CK (Creatine Kinase), CKMB (Creatine Kinase Iso- enzyme), CRP (C-Reative Protein), Hemoglobin A1C, HDL (High Density -- 6 of 22 -- Lipoprotein), Lactic Acid, Lipase, Magnesium, Phosphorus, PSA (Prostate Specific Antigen), Triglycerides, Troponin I, Uric Acid, Ferritin, Folate, Vitamin B12, TSH (Thyroid Stimulating Hormone), Free T4, HCG (Human Chorionic Gonadotropin), Acetaminophen, Carbamazepine, Ethanol, Lithium, Dilantin, Salicylate, Theophylline, Urine Drug Screen, Valproic Acid, and Vancomycin testing were performed on the Abbott Architect Plus Ci4100 analyzer; (b) The analyzer was installed in the new hospital location in November 2017, however, patient testing did not begin at the new location until 05/10/18. (2) On the third day of the survey, the surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. The requirements were as follows: (a) Weekly (i) Check ICT Components (ii) Clean Mixers (iii) Clean Sample/Reagent Probes (iv) Clean Cuvettes with Detergent (v) Check HC Waste Pump Tubing (3) The surveyor then reviewed maintenance records for the analyzer from May 2018 through the third day of the survey. The following was identified: (a) Check ICT Components not documented as performed between: (i) 06/22/18 and 07/02/18 (ii) 09/28/18 and 10/10 /18 (b) Clean Mixers not documented as performed between: (i) 06/22/18 and 07/02 /18 (ii) 09/28/18 and 10/10/18 (c) Clean Sample/Reagent Probes not documented as performed between: (i) 06/22/18 and 07/02/18 (ii) 05/28/18 and 06/08/18 (iii) 09/28 /18 and 10/10/18 (d) Clean Cuvettes with Detergent not documented as performed between: (i) 06/22/18 and 07/02/18 (ii) 09/28/18 and 10/10/18 (e) Check HC Waste Pump Tubing not documented as performed between: (i) 06/22/18 and 07/02/18 (ii) 09 /28/18 and 10/10/18 (3) The surveyor reviewed the records with the chemistry department supervisor who stated the above maintenance procedures had not been documented as being performed as required. *Comprehensive Metabolic Panel (CMP) - Albumin, Alkaline Phosphatase, ALT (Alanine Amino Transferase), AST (Aspartate Amino Transferase), BUN (Blood Urea Nitrogen), Calcium, Chloride, CO2, Creatinine, Glucose, Potassium, Sodium, Total Bilirubin and Total Protein NOTE: D5429 was cited on the previous recertification survey performed 04/03/17-04/05/17. 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 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. -- 7 of 22 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2 and the chemistry department supervisor, the laboratory failed to perform calibration verification procedures at least once every 6 months. Findings include: ABBOTT ARCHITECT (1) On the first day of the survey, technical consultant #2 stated the following to the surveyor: (a) The laboratory performed Acetaminophen, Alkaline Phosphatase, ALT (Alanine Aminotransferase), Ammonia, Amylase, AST (Aspartate Aminotransferase), Chloride, CK (Creatine Kinase), Hemoglobin A1c, HDL (High Density Lipoprotein), Lipase, Lithium, LDH (Lactate Dehydrogenase), LDL (Low Density Lipoprotein), Potassium, Salicylate, and Sodium testing using the Abbott Architect Plus ci4100 analyzer; (b) The analyzer was installed in the new hospital location in November 2017, however, patient testing did not begin at the new location until 05/10/18. (2) On the third day of the survey, the chemistry department supervisor stated to the surveyor (and provided records to substantiate) quality control materials were tested each day and maintenance procedures were performed until the laboratory began patient testing on 05/10/18; (3) The surveyor reviewed 2018 calibration records and identified that calibration procedures for the above analytes had been performed with one or two levels of calibrators. Since the calibration procedures included only one or two levels, calibration verification procedures, using three or more levels of calibration materials that included a low, mid, and high value, were required every six months; (4) The surveyor could not locate records to verify calibration verification procedures had been performed for the above analytes since the analyzer was installed in 11/2017 (due 5/2018); (5) The surveyor asked the chemistry department supervisor if calibration verification procedures had been performed since 11/2017. The chemistry department supervisor stated calibration verification procedures had not been performed since the analyzer was installed in 11/2017; (6) The following were examples of patient testing performed when calibration verification procedures had not been performed (NOTE: CMP testing includes the analytes Alkaline Phosphatase, ALT, AST, Chloride, Potassium, and Sodium): (a) Patient #20 - CMP and CK testing performed on 05/11/18 (b) Patient #10 - CMP, CK, and Hemoglobin A1c testing performed on 05/25/18 (c) Patient #11 - CMP and CK testing performed on 05/28/18 (d) Patient #60 - CMP, HDL, and LDL testing performed on 07/02/18 (e) Patient #29 - CMP and CK testing performed on 07/05/18 (f) Patient #30 - CMP and Hemoglobin A1c testing performed on 07/10/18 (g) Patient #33 - CMP testing performed on 07/17 /18 (h) Patient #35 - CMP and CK testing performed on 07/26/18 (i) Patient #14 - Amylase and CMP testing performed on 09/06/18 (j) Patient #15 - Ammonia and CMP testing performed on 09/18/18 (k) Patient #61 - CMP, Hemoglobin A1c, HDL, and LDL testing performed on 09/21/18 (l) Patient #45 - CMP testing performed on 09 /26/18 (m) Patient #59 - CMP and Amylase testing performed on 09/30/18 BIOSITE TRIAGE (1) On the first day of the survey technical consultant #2 stated to the surveyor the laboratory performed CKMB and Troponin I testing using the Biosite Triage Meter Plus analyzer as the back-up method (the primary method was the Abbott Architect); (2) On the second day of the survey, technical consultant #2 stated to the surveyor, the laboratory moved the analyzer from the previous location to the new location, therefore, the analyzer had been in use since the previous recertification survey; (3) The surveyor reviewed calibration verification records for 2017 and to date in 2018 (since calibration procedures were not routinely performed, calibration verification procedures, using three or more levels of calibration materials, were required every 6 months). There was no evidence calibration verification procedures had been performed after 02/07/18 (due in August 2018); (3) The surveyor reviewed the records with technical consultant #2 who stated calibration verification procedures had not been performed every six months for CKMB and Troponin I since 02/07/18; (4) The following were examples of patient CKMB and Troponin I testing performed -- 8 of 22 -- when calibration verification had not been performed every six months: (a) Patient #62 - testing performed on 03/16/18 (b) Patient #63 - testing performed on 03/17/18 (c) Patient #64 - testing performed on 04/27/18 (d) Patient #26 - testing performed on 05/26/18 (e) Patient #32 - testing performed on 07/16/18 (f) Patient #35 - testing performed on 07/26/18 (g) Patient #36 - testing performed on 07/27/18 (h) Patient #38 - testing performed on 09/02/18 (i) Patient #41 - testing performed on 09/19/18 (j) Patient #43 - testing performed on 09/22/18 (k) Patient #44 - testing performed on 09 /24/18 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 Urine Drug Screen testing. Findings include: (1) On the second day of the survey, technical consultant #2 stated to the surveyor the laboratory began using the Bio-Rad TOX/See Drug Screen Test kit to perform patient Urine Drug Screen testing on 10/05/17; (2) The surveyor asked technical consultant #2 if an IQCP (Individualized Quality Control Plan) had been developed for the test system. Technical consultant #2 stated an IQCP had not been developed. Therefore, the surveyor determined negative and positive QC (quality control) materials must be performed each day of patient testing; (3) The surveyor reviewed QC and patient testing records for October 2017, May 2018, July 2018, and September 2018. The review indicated negative and positive QC materials had not been performed 14 of 15 days of patient testing reviewed; (4) The surveyor reviewed the records with technical consultant #2, who stated negative and positive QC materials had not been performed each day of patient testing; (5) The following patient Urine Drug Screen testing had been performed when negative and positive QC materials had not been tested: (a) Patient #1 - testing performed on 10/05/17 (b) Patient #2 - testing performed on 10/13 /17 (c) Patient #3 - testing performed on 10/25/17 (d) Patient #4 - testing performed on 11/07/17 (e) Patient #5 - testing performed on 11/18/17 (f) Patient #6 - testing performed on 11/28/17 (g) Patient #7 - testing performed on 11/30/17 (h) Patient #8 - testing performed on 05/16/18 (i) Patient #10 - testing performed on 05/25/18 (j) Patient #11 - testing performed on 05/28/18 (k) Patient #12 - testing performed on 07 /02/18 (l) Patient #13 - testing performed on 07/17/18 (m) Patient #14 - testing performed on 09/06/18 (n) Patient #15 - testing performed on 09/18/18 D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document -- 9 of 22 -- all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of records and interview with the blood bank/coagulation department supervisor, the laboratory failed to ensure units of blood were stored under appropriate conditions. Findings include: (1) On the first day of the survey, the blood bank/coagulation department supervisor stated to the surveyor units of packed red blood cells were stored in the Helmer blood bank refrigerator. The units were to be used for patient transfusions; (2) The surveyor observed the thermograph temperature recorder for the blood bank refrigerator. The refrigerator 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; (3) The surveyor reviewed 19 refrigerator charts dated from 05/07/18 through 05/14/18. The review indicated that 6 of 19 charts had not been changed by the 7th day of as follows: (a) Chart #1 - The chart was put into use on 05/14/18 and removed on 05/23/18 (9 days); (b) Chart #2 - The chart was put into use on 05/30/18 and removed on 06/07/18 (8 days); (c) Chart #3 - The chart was put into use on 07/12/18 and removed on 07/20/18 (8 days); (d) Chart #4 - The chart was put into use on 07/28/18 and removed on 08/06/18 (9 days); (e) Chart #5 - The chart was put into use on 08/20/18 and removed on 08/28/18 (8 days); (f) Chart #6 - The chart was put into use on 09/18/18 and removed on 09/26/18 (8 days). (4) The surveyor reviewed the charts with the blood bank/coagulation department supervisor who stated the 6 charts had not been changed by the 7th day, as indicated above. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records, written policies and procedures, manufacturer's instructions, and interview with technical consultant #2, the hematology department supervisor, blood bank/coagulation department supervisor, urinalysis department supervisor, and the chemistry department supervisor, the laboratory failed to have an ongoing mechanism for performing effective analytic quality assessment. Findings include: (1) It was determined the laboratory did not have an effective mechanism for performing analytic quality assessment because of the following issues identified during the survey: (a) The laboratory failed to have written procedures for manual differential and urine microscopic testing. Refer to D5401; (b) The laboratory failed to follow the manufacturer's instructions for establishing normal reference intervals for a new coagulation analyzer; and failed to follow the manufacturer's instructions to ensure flagged results were addressed for hematology. Refer to D5411; (c) The laboratory failed to demonstrate the performance specifications for new test methods; and failed to ensure the verified reportable ranges were used by the laboratory. Refer to D5421; (d) The laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Refer to D5429; (e) The laboratory failed to perform calibration verification procedures at least once every 6 months. Refer to D5439; (f) The laboratory failed to perform a negative and positive control material -- 10 of 22 -- each day of patient Urine Drug Screen testing. Refer to D5449; (g) The laboratory failed to ensure units of blood were stored under appropriate conditions. Refer to D5555. NOTE: D5791 was cited on the previous recertification survey performed 04 /03/17-04/05/17. 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, written policies and procedures, manufacturer's instructions, and interview with technical consultant #2, the blood bank/coagulation department supervisor, hematology department supervisor, urinalysis department supervisor, and the chemistry department supervisor, the laboratory director failed to provide overall management and direction. Findings include: (1) The laboratory director failed to ensure verification procedures for new test systems were adequate to determine the performance characteristics. Refer to D6013; (2) 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; (3) The laboratory director failed to ensure a quality control program was maintained to ensure the quality of laboratory services. Refer to D6020; (4) The laboratory director failed to ensure a quality assessment program had been established and maintained. Refer to D6021; (5) The laboratory director failed to ensure policies and procedures were available. Refer to D6031. NOTE: D6000 was cited on the previous recertification survey performed 04/03/17-04/05/17. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a review of records, written procedure, and interview with technical consultant #2, the urinalysis department supervisor, and the hematology department supervisor, the laboratory director failed to ensure verification procedures for new test systems were adequate to determine the performance characteristics. Findings include: (1) The laboratory director failed to ensure performance specifications were demonstrated for new test methods; and failed to ensure the verified reportable ranges were used by the laboratory. Refer to D5421. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) -- 11 of 22 -- 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 technical consultant #2, the blood bank/coagulation department supervisor, and the hematology department supervisor, 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 manufacturer's instructions were followed for establishing normal reference intervals for a new coagulation analyzer, and addressing flags for hematology. Refer to D5411; (2) The laboratory director failed to ensure the manufacturer's instructions were followed for performing maintenance procedures. Refer to D5429. NOTE: D6014 was cited on the previous recertification survey performed 04/03/17-04/05/17. D6020 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 the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2 and the chemistry department supervisor, the laboratory director failed to ensure a quality control program was maintained to ensure the quality of laboratory services. Findings include: (1) The laboratory director failed to ensure calibration verification procedures were performed at least once every 6 months. Refer to D5439; (2) The laboratory director failed to ensure negative and positive control materials were performed each day of patient Urine Drug Screen testing. Refer to D5449. NOTE: D6020 was cited on the previous recertification survey performed 04/03/17-04/05/17. 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. -- 12 of 22 -- This STANDARD is not met as evidenced by: Based on a review of records, written policies and procedures, manufacturer's instructions, and interview with technical consultant #2, the hematology department supervisor, blood bank/coagulation department supervisor, urinalysis department supervisor, and the chemistry department supervisor, the laboratory director failed to ensure a quality assessment program had been established and maintained. Findings include: (1) The laboratory director failed to ensure the laboratory had an ongoing mechanism for performing effective analytic quality assessment. Refer to D5791. NOTE: D6021 was cited on the previous recertification survey performed 04/03/17-04 /05/17. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on a review of written policies and procedures, and interview with technical consultant #2, the hematology department supervisor and the urinalysis department supervisor, the laboratory director failed to ensure policies and procedures were available. Findings include: (1) The laboratory director failed to ensure written procedures were available for manual differential and urine microscopic testing. Refer to D5401. 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, written procedure, manufacturer's instructions, and interview with technical consultant #2, the blood bank/coagulation department supervisor, hematology department supervisor, chemistry department supervisor, and the urinalysis department supervisor, 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 that verification procedures were adequate to determine the performance characteristics. Refer to D6040; (2) The technical consultant failed to ensure the establishment and maintenance of acceptable levels of analytic performance. Refer to D6042; (3) The technical consultant failed to ensure evaluations included all moderate complexity testing performed. Refer to D6054. D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) -- 13 of 22 -- The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on a review of records, written procedure, and interview with technical consultant #2, the urinalysis department supervisor, and the hematology department supervisor, the technical consultant failed to ensure that verification procedures were adequate to determine the performance characteristics. Findings include: (1) The technical consultant failed to ensure the performance specifications were demonstrated for new test methods; and failed to ensure the verified reportable ranges were used by the laboratory. Refer to D5421. 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, and interview with technical consultant #2, the blood bank/coagulation department supervisor, hematology department supervisor, and the chemistry department supervisor, the technical consultant failed to ensure the establishment and maintenance of acceptable levels of analytic performance. Findings include: (1) The laboratory director failed to ensure the manufacturer's instructions were followed for establishing normal reference intervals for a new coagulation analyzer, and addressing flags for hematology. Refer to D5411; (2) The technical consultant failed to ensure the manufacturer's instructions were followed for performing maintenance procedures. Refer to D5429; (3) The technical consultant failed to ensure calibration verification procedures were performed at least once every 6 months. Refer to D5439; (4) The technical consultant failed to ensure negative and positive control materials were tested each day of patient Urine Drug Screen testing. Refer to D5449. NOTE: D6042 was cited on the previous recertification survey performed 04/03/17-04/05/17. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2, the technical consultant failed to ensure evaluations included all moderate complexity testing performed. Findings include: (1) On the first day of the survey, technical consultant #2 stated to the surveyor the following testing was performed in the laboratory: (a) -- 14 of 22 -- Manual Differential testing (b) Blood Gas (pH, pCO2, pO2) and Lactate testing using the Gem Premier 3500 analyzer (2) The surveyor then reviewed personnel records for 8 persons performing Manual Differential and Blood Gas/Lactate testing in the laboratory (hematology department supervisor/testing person #1, urinalysis department supervisor/testing person #2, chemistry department supervisor/testing person #3, te