Jefferson County Hospital

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/8,9,10,11/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the administrative laboratory director, technical consultant and chief executive officer at the conclusion of the survey. D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on a review of policies and procedures, records, and interview with the technical consultant, the laboratory failed to follow written policy for alarm system checks for the blood bank refrigerator during the review period of June 2023 through the current date. Findings include: (1) On 04/10/2025 at 10:45 am, the technical consultant stated units of packed red blood cells were routinely maintained in the blood bank refrigerator for patient transfusions; (2) Policy review revealed a policy for performing alarm checks quarterly for the blood bank refrigerator; (3) A review of records revealed there were no blood bank alarm checks documented from 06/01/2023 through 03/14/2024. (3) Interview with the technical consultant on 04/10/2025 at 10: 45 am confirmed the laboratory failed to follow the policy for performing alarm checks for blood product storage. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policies and procedures, and interview with the administrative laboratory director, the laboratory failed to follow their written policy to assess the competency of the technical consultant and general supervisor based on the position responsibilities as listed in Subpart M, for one of one person during the review period of May 2023 through the current date. Findings include: (1) On 04/08 /2025, a review of the laboratory policy titled "JCH Laboratory Competency Assessment Procedure" required competencies for the technical consultant and general supervisor based on job responsibilities be performed annually; (2) A review of the Form CMS-209 and personnel records for competency assessments performed during the review period of May 2023 through the current date identified competencies, based on job responsibilities, had not been performed as follows: (a) Technical consultant - not documented as performed prior to 03/27/2025 (b) General supervisor - not documented as performed prior to 03/27/2025 (3) The findings were reviewed with the administrative laboratory director who stated on 04/08/2025 at 03: 09 pm, the competencies had not been performed for the positions as shown above. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation and interview with the administrative laboratory director, the laboratory failed to ensure five of five types of blood collection tubes were stored as required by the manufacturer in the central supply room. Findings include: (1) Observation of the central supply room and interview with the administrative laboratory director on 04/08/2025 at 2:00 pm, identified the following: (a) Four packages of BD Vacutainer PST Gel and Lithium Heparin tubes, lot # 4318900, storage temperature of 4-25 degrees (C) centigrade; (b) Four packages of BD Vacutainer K2 EDTA 7.2 mg tubes, lot # 4318853, storage temperature of 4-25 degrees C; (c) Four packages of BD Vacutainer Serum Collection tubes, lot # 4198181, storage temperature of 4-25 degrees C; (d) Nine bottles of BD BACTEC aerobic/F culture vials, lot # 4358877, storage temperature of 2-25 degrees C; (e) Nine bottles of BD BACTEC anaerobic/F culture vials, lot # 4241909, storage temperature of 2-25 degrees C. (2) Interview with the administrative laboratory director on 04/08 /2025 at 02:00 pm confirmed the laboratory was not monitoring the temperature of the Central Supply Room. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) -- 2 of 6 -- (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview with the technical consultant, the laboratory failed to label one of two containers with the identity, expiration date, and lot number of the contents. Findings include: (1) On 04/08/2025 at 11:35 am, the technical consultant stated the laboratory stained peripheral blood smears to perform manual differential testing; (2) Observation on 04/08/2025 at 11:37 am identified one unlabeled Coplin jar, appearing to contain material used to stain peripheral blood smears; (3) The findings were reviewed with the technical consultant who on 04/08/2025 at 11:38 am stated the Coplin jar contained staining material had not been labeled with the identity, expiration date, and lot numbers. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with the technical consultant, the laboratory failed to ensure expired supplies were not available for use. Findings include: (1) Observation of the laboratory on 04/08/2025 at 10:10 am, identified the following expired supplies were available for use: (a) One hundred BD Vacutainer Citrate Tubes with 3.2% buffered sodium citrate, lot #4102214, expired 01/31/2025 (2) Interview with the technical consultant on 04/08/2025 at 11:13 am confirmed the expired supplies were available for use. 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 instructions, and interview with the technical consultant, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures for two of two analyzers. Findings include: ACL ELITE (1) On 04/08/2025 at 11:35 am, the technical consultant stated the laboratory performed PT/INR, PTT, and D-Dimer testing using the ACL Elite coagulation analyzer; (2) A review of the "ACL Elite/Elite Pro System Maintenance Log" from the manufacturer showed the following required maintenances: (a) Weekly: (i) Clean instrument surface (ii) Clean rinse/waste reservoir (w/Clean A) (iii) Verify needles alignment (b) Biweekly: (i) Clean rotor -- 3 of 6 -- holder and optic path (ii) Reboot analyzer, (b) Monthly: (i) Clean air filter (3) A review of maintenance logs from August 2024 through March 2025 identified maintenance had not been documented as performed as follows: (a) Weekly: (i) Between 08/03/2024 and 08/17/2024 - Clean rinse/waste reservoir (w/CleanA) and verify needle alignment procedures were not performed (ii) Between 09/28/2024 and 10/13/2024 (iii) Between 01/25/2025and 02/08/2025 - Clean rinse/waste reservoir (w /CleanA) and verify needle alignment procedures were not performed (b) Biweekly: (i) Between 08/17/2024 and 09/07/2024 (ii) Between 09/21/2024 and 10/13/2024 (iii) Between 11/16/2024 and 12/15/2024 (iv) Between 12/15/2024 and 01/05/2025 (vi) Between 01/18/2025 and 02/15/2025 (vii) Between 02/15/2025 and 03/08/2025 (c) Monthly: (i) Between 08/16/2024 and 10/13/2024 (ii) Between 11/03/2024 and 01/05 /2025 (4) The records were reviewed with the technical consultant who stated on 04/11 /2025 at 09:15 am maintenance procedures had not been documented as performed as stated above. SYSMEX XN 550 (1) On 04/08/2025 at 11:30 am, the technical consultant stated the laboratory performed CBC (Complete Blood Count) testing using the Sysmex XN-550 analyzer; (2) A review of the manufacturer's instruction manual titled, "XN-L Series XN-550/XN-450/XN-350 - Troubleshooting", section 2.17 "Maintenance and Inspection Checklist" showed the following required maintenance procedure: (a) "Weekly - Routine Cleaning" (3) A review of maintenance logs from August 2024 through March 2025 identified maintenance had not been documented as performed as follows: (a) Weekly: (i) between 09/07/204 and 09/15/2024 (ii) between 10/19/2024 and 11/02/2024 (iii) between 11/23/2024 and 12 /01/2024 (iv) between 12/28/2024 and 01/06/2025 (4) The records were reviewed with the technical consultant who stated on 04/09/2025 at 04:52 pm, the weekly maintenance procedures had not been documented as performed as stated above. 48517 Based on a review of records, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures for the Ortho Vitros XT 7600 analyzer between June 2023 and December 2024. Findings include: (1) On 04/10 /2025 at 10:00 am, the technical consultant stated that chemistry and immunoassay testing was performed using the Ortho Vitros XT 7600 analyzer; (2) A review of the manufacturer's maintenance log showed the following required maintenance procedures: (a) Monthly; (i) Clean Cuvette Arm, Cuvette incubator, PM discard chute, Clean/Replace evaporation caps, PM incubator slot and insert blade channels, microsensor cover and ring areas, uIA reagent supply top cover, supply 3 pack opener, versa tip supply, reagent cooler filter; (ii) Perform system backup; (b) Bimonthly; (i) Change vapor adsorption cartridge; (ii) Clean master computer filter; (d) Six month; (i) Perform correction factors; (ii) Replace VITROS VersaTip Loader Compressor Filter; (iii) Replace system filter; (iv) Perform pad reflectance test. (3) A review of maintenance logs from June 2023 through December 2024 identified no documentation maintenance had been performed as follows: (a) Monthly - There was no documentation that monthly maintenance was performed for eight of 19 months; (b) Bimonthly - There was no documentation that bimonthly maintenance was performed for 14 of 19 months; (d) Six month - There was no documentation that six month maintenance was performed between 06/01/2023 and 11/01/2024. (4) The records were reviewed with the technical consultant who stated on 04/10/2025 at 10: 00 am, the analyzer maintenance had not been documented as performed as stated above. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using -- 4 of 6 -- the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of records and interview with the administrative laboratory director, the laboratory failed to perform calibration verification procedures at least once every six months for the Ortho Vitros 7600 test system during the review period of 06/01/2023 through the current date. Findings include: (1) On 04/09/2025 at 10:45 am, the administrative laboratory director stated the laboratory performed direct low density lipoprotein (DLDL) testing using the Ortho Vitros 7600 chemistry and immunoassay analyzer; (2) A review of records from 06/01/2023 through the current date identified no evidence the calibration verification procedures had been performed for DLDL between 06/01//2023 and 10/24/2024. (3) The findings were reviewed with the administrative laboratory director, who stated on 04/09/2025 at 10:45 am, the calibration verification procedures had not been performed every six months as stated 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. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to follow their policy for monitoring the effectiveness of their QCP (Quality Control Plan) for five of five test systems. Findings include: (1) On 04/08 /2025 at 11:21 am, the technical consultant stated the laboratory performed the following testing and IQCP's (Individualized Quality Control Plans) had been developed for the test systems: (a) Blood Gas (pH, pCO2, pO2) testing using the iSTAT 1 analyzer and the EG6+ cartridge; (b) BNP testing using the iSTAT1 analyzer; (c) CK-MB testing using the iSTAT1 analyzer; (d) Troponin I testing using the iSTAT1 analyzer; (e) Sodium, Potassium, Chloride, CO2, Ionized Calcium, Glucose, BUN, and Creatinine testing using the iSTAT 1 analyzer and the Chem 8+ cartridge. (2) On 04/10/2025 a review of the IQCP's for the above test systems identified that QA (Quality Assessment) reviews of the QCP's were to be performed on an annual basis for each test system; (3) A review of records for the test systems -- 5 of 6 -- from April 2023 through the current date identified no documentation that annual QA reviews had been performed prior to 03/10/2025; (4) The records were reviewed with the technical consultant who stated on 04/10/2025 at 09:15 am, annual QA reviews had not been documented as performed for the above test systems. -- 6 of 6 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/17,18,19/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant at the conclusion of the survey. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policies and procedures, and interview with the technical consultant, the laboratory failed to have a written policy to assess the competency of the general supervisor, based on the position responsibilities as listed in Subpart M, for one of one person serving as general supervisor. Findings include: (1) On 05/18/2023 a review of the laboratory policy and procedure manual identified no evidence of a policy for assessing the competency of the general supervisor, including the frequency of the assessments; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of June 2021 through the current date identified competencies, based on job responsibilities, had not been performed for one of one person listed as general supervisor until 05/18/2023; (3) The findings were reviewed with the technical consultant who stated on 05/19/2023 at 09:00 am a policy had not been written and competencies had not been performed for the general supervisor until 05/18/2023. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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 technical consultant, the laboratory failed to follow their written policy for reporting a patient PT (Prothrombin Time) result beyond the reportable range for one of one report reviewed. Findings include: (1) On 05/17/2023 at at 10:55 am, the technical consultant stated the laboratory performed PT/INR (Prothrombin Time/International Normalized Ratio) testing using the ACL Elite analyzer; (2) On 05/18/2023 a review of a patient PT report performed on 09/14/2021, identified the PT result was reported as 178.0 seconds; (3) A review of the policy titled, "JCH PT Elite Policy" under "Reporting Results" stated "Report results that are above linearity as >115 sec"; (4) The findings were reviewed with the technical consultant who stated on 05/18/2023 at 01:45 pm, the policy had not been followed for reporting the result beyond the reportable range. 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 the technical consultant, the laboratory failed to follow the manufacturer's instructions for implementing two of two coagulation reagents. Findings include: (1) On 05/17/2023 at 11:43 am, the laboratory manager stated the laboratory performed PTT (Partial Thromboplastin Time) testing using the ACL Elite analyzer; (2) On 01/26/2023 at 09: 15 am, the laboratory manager stated the current PTT reagent, SynthaSIL lot #N1117768, was put into use on 01/28/2022; (3) A review of the manufacturer's instructions contained in the "Hemostasis Performance Manual" under "Establishing A Normal Reference Interval" under the heading "Specimen Collection and Preparation" stated the following for a 20 donor study: (a) "Donors should be healthy and have no known pathological conditions. Don't use samples from inpatients (due to medical conditions and treatment regiments). Donors should not be on medication affecting coagulation, including (but not limited to) oral contraceptives, estrogen therapy (HRT), anticoagulants, high-dose aspirin, etc"; (b) "Donors should span the adult age range"; (c) Donors should be equally divided between male/female". (4) A review of the implementation records for the PTT reagent identified that, although the laboratory had used 20 donors (identified as ten males and ten females), there was no documentation to show the health status and medication history of the donors to ensure they met the requirements for a normal donor; (5) The records were reviewed with the laboratory manager and testing person #2. Both stated on 01/27/2023 at 10:15 am, there was no documentation to prove the the health status and medication history of the donors. -- 2 of 7 -- D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to utilize the demonstrated reportable ranges for five of five analytes reviewed on the Ortho Vitros XT 7600 analyzer. Findings include: (1) On 05/17/2023 at 11:30 am, the technical consultant stated the laboratory began using the Ortho Vitros 7600 analyzer to perform routine chemistry testing, which included the analytes Alkaline Phosphatase, ALT (Alanine Aminotransferase), Amylase, Lipase, and Glucose using the Ortho Vitros XT 7600 analyzer in June 2022; (2) On 05/18 /2023 a review of the performance specification records identified the laboratory had demonstrated the following reportable ranges: (a) Alkaline Phosphatase - 14.9-1164.8 U/L (b) ALT - 7.9-717 U/L (c) Amylase - 43.7-892 U/L (d) Glucose - 33.6-600.8 mg /dl (e) Lipase - 21.6-1964 U/L (3) Interview with the laboratory manager on 05/18 /2023 at 03:40 pm, confirmed the laboratory was using the following manufacturer's reportable ranges instead of the reportable ranges that had been demonstrated by the laboratory: (a) Alkaline Phosphatase - 20-1500 U/L (b) ALT - 4-750 U/L (c) Amylase - 30-1200 U/L (d) Glucose - 20-625 mg/dl (e) Lipase - 10-2000 U/L 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. -- 3 of 7 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to perform calibration verification procedures at least once every 6 months for two of two analyte requiring calibration verification using the Ortho XT Vitros 7600 analyzer. Findings include: (1) On 05/17/2023 at 11:30 am, the technical consultant stated the laboratory began using the Ortho Vitros 7600 analyzer to perform routine Procalcitonin and DLDL (Direct Low Density Lipoprotein) testing using the Ortho Vitros XT 7600 analyzer in June 2022; (2) A review of calibration records for 2023 identified the calibration procedures for the above analytes were performed with less than three levels of calibrators therefore, calibration verification procedures, using three or more levels of calibration materials that included a low, mid, and high value, were required every six months; (3) A review of records from 04 /05/2022 through the current date identified calibration verification had not been performed at least once every six months as follows: (a) Procalcitonin - Not performed since 04/05/2022 (performed during the implementation of the analyzer); (b) DLDL - Not performed since 04/05/2022 (performed during the implementation of the analyzer). (4) The records were reviewed with the technical consultant who stated on 05/18/2023 at 10:20 am, calibration verification procedures had not been performed every six months. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant and testing person #3, the laboratory failed to have control procedures that monitored the accuracy and precision of the complete analytic process for three of three months reviewed for testing performed using the the Ortho Vitros XT 7600 analyzer. Findings include: (1) On 05/17/2023 at 11:30 am, the technical consultant stated the following: (a) The laboratory began using the OrthoVitros XT 7600 analyzer to perform Albumin, Alkaline Phosphatase, ALT (Alanine Aminotransferase, AST (Aspartate Aminotransferase), BUN, Calcium, Chloride, CO2, Creatinine, Glucose, Potassium, Sodium, Total Bilirubin, Total Protein, Total Cholesterol, HDL (High Density Lipoprotein), Triglyceride, Troponin I, CKMB (Creatine Kinase Isoenzyme), Vancomycin, Alcohol, Ammonia, Lactic Acid, Procalcitonin, Lipase, and Amylase testing in June 2022; (b) Two levels of QC (quality control) materials were tested each day of patient testing. (2) On 05/19/2023 a review of records from February 2023 through April 2023 identified no evidence, such as Levey-Jennings graphs and cumulative statistical data, to prove that QC results had been monitored for variances (i.e.,biases, shifts, trends); (3) Interview with the technical consultant on 05/19/2023 at 10:15 am confirmed that QC data to include -- 4 of 7 -- Levey-Jennings graphs and cumulative statistical data were reviewed each month on the analyzer (viewed on the analyzer's computer screen), however, there was no record of the reviews since the data had not been printed and maintained. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (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 technical consultant, the laboratory failed to perform QC (quality control) as stated in the IQCP's (Individualized Quality Control Plans) for two of six test systems. Findings include: (1) On 05/17/2023 at 11:15 am, the technical consultant stated the laboratory performed the following testing and IQCP's had been developed for the test systems: (a) Urine Drug Screen testing using the Jant Accutest test kit; (b) Troponin I testing using the cTnI cartridge and the iSTAT 1 analyzer. (2) On 05/18/2023 a review of the QCP's (Quality Control Plans) for the above IQCP's identified the following: (a) Urine Drug Screen - Two levels of QC materials were to be tested on a weekly basis and with new lot numbers of test kits; (b) Troponin I - Two levels of QC materials were to be tested on a monthly basis and with new lot numbers of cartridges. (3) A review of QC records for the test systems from June 2022 through April 2023 identified that QC testing had not been performed as stated in the QCP's as follows: (a) Urine Drug Screen - There was no documentation to prove QC had been performed between: (i) 12 /24/2022 and 01/01/2023 (ii) 02/11/2023 and 02/19/2023 (iii) 03/29/2023 and 04/16 /2023 (b) Troponin I - There was no documentation to prove QC had been performed between: (i) 01/05/2023 and 03/30/2023 (ii) 03/30/2023 and 05/04/2023 (c) Blood Gas - There was no documentation to prove QC had been performed between: (i) 02 /25/2022 and 04/05/2022. (4) The records were reviewed with the technical consultant who stated on 05/18/2023 at 03:05 pm, QC had not been performed as stated above. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant and testing person #3, the laboratory failed to follow the manufacturer's specifications for the Vitros Performance Verifier Controls for two of two lot numbers used from 02/19/2023 through the current date. Findings include: (1) -- 5 of 7 -- On 05/17/2023 at 11:30 am, the technical consultant stated the following: (a) The laboratory began using the OrthoVitros XT 7600 analyzer to perform Amylase, Glucose, Chloride, and Lipase testing in June 2022; (b) Two levels of Vitros Performance Verifier QC (quality control) materials were tested each day of patient testing (level one lot #D8955 and level two lot #G9072 were in use during the review period). (2) On 05/19/2023 a review of the manufacturer's instructions (package insert) for the control materials identified the manufacturer provided a range of means for the laboratory to use when establishing their mean with new lot numbers of QC materials and provided a fixed SD (standard deviation) for the laboratory to utilize for each analyte; (3) Interview with testing person #3 on 05/19/2023 at 09:30 am and a review of records for the analytes Amylase, Glucose, Chloride, and Lipase confirmed the following: (a) Although the laboratory utilized the manufacturer's SD for each analyte, they did not establish their own means when new lot numbers of QC materials were put into use; (b) The laboratory calculated the means from the range of means instead of establishing laboratory specific means. (4) The records were reviewed with the technical consultant and testing person #3. Both stated on 05/19 /2023 at 09:40 am, the laboratory did not follow the manufacturer's instructions for the control materials. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of records, written policy, and interview with the technical consultant, the laboratory failed to comply with 21 CFR 606.160(b)(3)(v). The laboratory failed to ensure that emergency release of blood forms had been signed by the physician for one of one emergency release reviewed. Findings include: (1) On 05 /17/2023 at 11:05 am, the technical consultant stated the laboratory maintained units of (PRBC's) packed red blood cells. The units were to be used for patient transfusions; (2) On 05/18/2023 a review of the manual titled, "Laboratory Blood Bank Policy and Procedure" contained the policy titled, "Emergency Issue of Blood Products" and stated, "When the lab receives the call for the uncrossmatched blood, the patient information is entered on the BBK Emergency issue Forms (both copies). The O Negative units are delivered to the emergency department along with one copy of the BK Emergency Issue Form for the physician to sign..."; (3) Review of documentation for emergency issue of one unit of O Negative PRBC's to a patient on 09/14/2021 at 02:03 pm, identified the "BBK Emergency Issue Form" appeared to be signed by a nurse practitioner and not a physician. (4) The documentation was reviewed with the technical consultant who stated on 05/19/2023 at 01:05 pm, the ER release had not been signed by a physician. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and -- 6 of 7 -- identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to ensure patient test reports included the name and address of the laboratory location where the testing was performed for five of nine reports reviewed. Findings include: (1) On 05/18/2023, a review of patient reports identified the reports did not include the name and address of the laboratory location where testing was performed for the following: (a) Patient BNP testing performed on 11/20/2022 at 07: 23 am; (b) Patient Qualitative Serum HCG testing performed on 01/01/2023 at 10:55 pm; (c) Patient Troponin I testing performed on 02/19/2023 at 03:04 pm; (d) Patient Lactic Acid testing performed on 05/15/2023 at 07:31 pm; (e) Patient CMP (Comprehensive Metabolic Panel) and Lipid Panel testing performed on 05/17/2023 at 04:41 am. (2) The reports were reviewed with the technical consultant who stated on 05/18/2023 03:45 pm, the reports included the name and address of the main hospital location and not the name and address of the laboratory location where the testing was performed. -- 7 of 7 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/19,20,2021. The findings were reviewed with technical consultant #1 and technical consultant #2 at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the laboratory failed to have a written technical consultant and general supervisor competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) On 05/19/2021, the surveyor reviewed personnel records for competency assessments performed during 2019, 2020, and to date in 2021. There was no evidence competencies had been performed for the technical consultant and general supervisor based on job responsibilities; (2) The surveyor asked technical consultant #1 if a written policy to evaluate the technical consultant and general supervisor, based on job responsibilities, was available and if competencies had been performed during the review period. Technical consultant #1 stated to the surveyor on 05/19 /2021 at 02:47 pm, a policy to evaluate the technical consultant and general supervisor based on job responsibilities had not been written; and competencies had not been performed. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the laboratory failed to ensure the demonstrated reportable range was utilized for a new analyzer for 2 of 2 test methods. Findings include: (1) On 05/19/2021 at 10:40 am, technical consultant #1 stated to the surveyor: (a) The laboratory performed Sodium, Potassium, Chloride, Blood Urea Nitrogen (BUN), Ionized Calcium, TCO2, Glucose, Creatinine and Hematocrit testing using two iSTAT analyzers (serial numbers: 393493 and 389725) and Chem 8+ cartridge beginning 07/14/2020; (b) The laboratory performed pH, TCO2, and Po testing using two iSTAT analyzers (serial numbers: 393493 and 389725) and the EEG+ cartridge beginning 02/10/2020. (2) On 05/20 /2021, the surveyor requested the performance verification records to verify how the laboratory demonstrated performance verification on the Chem 8+ cartridge and EEG+ cartridge prior to reporting patient results on two iSTAT analyzers. The surveyor reviewed the records and identified the following: (a) Chem 8+ cartridge (i) TCO2 - The laboratory's reportable range was verified to report out patient values between 12 - 43 mmol/L. The manufacturer's reportable range was 5 - 50 mmol/L; (ii) Glucose - The laboratory's reportable range was verified to report out patient values between 25 - 583 mg/dL. The manufacturer's reportable range was 20 - 700 mg/dL. (b) EG6+ cartridge; (i) PCO2 - The laboratory's reportable range was verified to report out patient values between 18.7 - 91.9 mmHg. (3) The surveyor reviewed patient records between 12/05/2020 and 04/04/2021, and obtained the following examples of CO2, Glucose, and PCO2 patient testing that were reported outside the laboratory's verified reportable range as follows: (a) TCO2 patient testing (i) Patient resulted on 01/04/2021 at 03:21 am a value of >50 mmol/L; (ii) Patient resulted on 02 /08/2021 at 06:42 pm a value of >50 mmol/L; (iii) Patient resulted on 04/04/2021 at 06:47 pm a value of >50 mmol/L. (b) Glucose patient testing (i) Patient resulted on 12 /05/2020 at 06:09 pm a value of >700 mg/dL. (c) PCO2 patient testing (i) Patient resulted on 1/04/2021 at 03:48 pm a value of 126 mmHg; (ii) Patient resulted on 04/04 /2021 at 06:46 pm a value of >130.0 mmHg; (iii) Patient resulted on 04/04/2021 at 07: 30 pm a value of 115.5 mmHg. (4) The surveyor reviewed the findings with the technical consultant #1 who stated on 05/20/2021 at 02:05 pm, the laboratory was not using the reportable ranges that had been demonstrated by the laboratory. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the laboratory failed to ensure data supported the QC frequency as defined in the QCP portion of the IQCP. Findings include: (1) On 05/19/2021 at 10:40 am, technical consultant #1 stated the following to the surveyor: (a) The laboratory performed Blood Gas (pH, pCO2, pO2) testing using two iSTAT analyzers (serial numbers: 393493 and 389725) and the EG6+ cartridge beginning 02/10/2020; (b) The laboratory performed Sodium, Potassium, Chloride, Blood Urea Nitrogen (BUN), Ionized Calcium, TCO2, Glucose, Creatinine, Hemoglobin and Hematocrit testing using two iSTAT analyzers (serial numbers: 393493 and 389725) and the Chem 8+ cartridge beginning 07/14/2020; (b) An IQCP had been developed for the test systems above. (2) The surveyor reviewed the IQCP (dated as effective on 01/15/2020 for the EG6+ cartridge; and 07/13/2020 for the Chem 8+ cartridge) and identified the QCP required two levels of external QC materials be performed once each month (i.e., approximately each 30 days); (3) The surveyor then reviewed the supporting documentation for the QCP and identified the following: (a) The laboratory had not tested external QC materials to support the QC frequency of monthly, as defined in the QCP; (b) Two levels of QC had been tested for 2 days (not at least 30 days). (4) The surveyor reviewed the records with technical consultant #1 and asked if additional documentation was available to support the reduced external QC frequency of monthly. Technical consultant #1 stated QC had not been tested for at least 30 days. 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 2 of 12 units of packed red blood cells. Findings include: (1) On 05/19 /2021 at 10:55 am, technical consultant #1 stated to the surveyor the laboratory stored units of packed red blood cells in the blood bank refrigerator. The units were to be used for patient transfusions; (2) The surveyor reviewed the hospital policy regarding transfusion reactions. The policy titled, "Blood Product Transfusion Policy and Procedure" under the section titled, "DOCUMENTATION", stated: (a) "Vital Signs" (i) "Pre-transfusion vital signs should be taken within the 30 minutes preceding the transfusion." (ii) "Next set of vitals signs should be taken 15 minutes (+/- 5 minutes) after the beginning of the transfusion." (iii) "Subsequent vital signs should then be taken every 30 minutes (+/- 5 minutes) thereafter until the unit of blood product is -- 3 of 4 -- completely infused." (iv) "All vital signs should be documented in the TAR system when possible. When TAR documentation is not able to be used, the paper Blood Transfusion Records should be used." (v) "If the patient is not in crisis, it is preferable to do the 30-minute post-transfusion vital signs prior to spiking the second unit of blood." (vi) "In emergencies only, vital signs may be recorded separately on anesthesia /surgery/emergency department records." (3) The surveyor then reviewed records for 12 units of PRBCs (Packed Red Blood Cells) that had been transfused between 01/14 /2019 through 07/28/2019 for 6 patients, and identified the following: (a) Vitals signs the first 15 minutes after the transfusion started (i) Patient # J00000618553 - Transfused with 1 unit PRBCs (unit # W091020455662) on 12/22/2020. The transfusion started at 09:05 pm and the first vital was documented at 10:50 pm (1 hour 45 minutes later). (b) Vitals signs every 30 minutes after the first 15 minutes of the transfusion (i) Patient #J00000623009 - Transfused with 1 unit PRBCs (unit #W09102114255) on 01/17/2021. The transfusion started at 07:04 pm and ended at 08: 17 pm. Vitals were document at 07:19 pm, 07:34 pm and 08:17 pm (43 minutes later). (4) The surveyor reviewed the findings with the director of nursing. The director of nursing stated on 05/19/2021 at 01:45 pm the written policy and procedure for blood administration had not been followed as indicated above. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the laboratory failed to make appropriate reference ranges available. Findings include: (1) On 05/19/2020 at 10:05 am, technical consultant #1 stated to the surveyor the ACL Elite analyzer was used to perform PT (ProthrombinTime) testing; (2) On 05/19/2020, the surveyor reviewed the implementation records for the current lot number of reagent and identified the following: (a) PT reagent - RecombiPlasTin 2G lot # N0100845 had been put into use on 05/04/2021; (b) The laboratory had established a PT normal reference interval of 10.3 - 12.6 seconds. (3) The surveyor then reviewed a patient PT report dated 05/08/2021 with a normal reference range of 9.9 -12.9 seconds; (4) The surveyor reviewed the findings with technical consultant #1. On 05 /19/2021 at 04:45 pm technical consultant #1 stated that although the laboratory had established a PT normal reference interval with a PT reagent lot change, the laboratory had not implemented the change into the laboratory's computer information system as indicated above. -- 4 of 4 --

Summary Statement of Deficiencies D0000 Recertification survey was performed on 02/04/19 through 02/06/19. The findings were reviewed with the technical consultant, testing person #1, testing person #2 and the chief executive officer during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1210; D5016: Routine Chemistry 493.1403; D6000: Laboratory Director, Moderate Complexity D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to ensure proficiency testing attestation statements had been signed by the laboratory director or designee. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017, 2018, and 2019 proficiency testing records. The following was identified for 5 of 61 testing events: (a) J-A 2017 Transfusion Medicine Event (i) The attestation was not signed by the laboratory director or designee. (b) J-B 2017 Transfusion Medicine Event (i) The attestation was not signed by the laboratory director or designee. (c) J-A 2018 Transfusion Medicine Event (i) The attestation was 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 -- not signed by the laboratory director or designee. (d) J-B 2018 Transfusion Medicine Event (i) The attestation was not signed by the laboratory director or designee. (e) J-C 2018 Transfusion Medicine Event (i) The attestation was not signed by the laboratory director or designee. (2) The findings were reviewed with the technical consultant who stated the attestations had not been signed as indicated above. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to ensure the requirements were met for the subspecialty of Routine Chemistry for Troponin I, CKMB, BNP (Brain Natriuretic Peptide), and ABG (G3+ cartridge: pH, pCO2, pO2) testing. Findings include: (1) The laboratory failed to perform two levels of quality control materials each day of patient Troponin I, CKMB (Creatine Kinase, Isoenzyme), BNP (Brain Natriuretic Peptide), and ABG (Arterial Blood Gas G3+ cartridge: pH, pCO2, pO2) testing. Refer to D5447; (2) The laboratory failed to have an ongoing mechanism for performing analytic quality assessment. Refer to D5791. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to review and evaluate proficiency testing results. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017, 2018 and 2019 proficiency testing records. The following biases were identified (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) Hematology Auto Differentials - FH9-C 2017 Event (i) Eosinophils Absolute- 4 of 5 results exhibited a negative bias (aa) FH9 - 12 SDI of -10.6 (bb) FH9 - 13 SDI of -11.3 (cc) FH9 - 14 SDI of -11.5 (dd) FH9 - 15 SDI of -11.2 (ii) Basophils Absolute - 4 of 5 results exhibited a negative bias (aa) FH9 - 12 SDI of -10.0 (bb) FH9 - 13 SDI of -6.5 (cc) FH9 - 14 SDI of -11.1 (dd) FH9 - 15 SDI of -10.8 (b) Hematology Auto Differentials - FH9-B 2018 Event (i) Lymphocytes % - 3 of 5 results exhibited a negative bias (aa) FH9 - 07 SDI of -2.1 (bb) FH9 - 08 SDI of -2.1 (cc) FH9 - 10 SDI of -2.2 (c) Critical Care Aqueous Blood Gas - AQI-A 2018 Event (i) pH - 3 of 5 results exhibited a negative bias (aa) AQI - 02 SDI of -2.0 (bb) AQI- 04 SDI of -2.0 (cc) AQI - 05 SDI of -2.1 (2) The surveyor further reviewed the records and could not locate documentation verifying the biases had been identified and addressed; (3) The surveyor then reviewed the records with the technical consultant, and asked if the biases had been addressed. The technical consultant stated the biases had not been addressed. -- 2 of 9 -- D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to verify the accuracy of testing when the proficiency testing program did not evaluate submitted results. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017, 2018 and 2019 proficiency testing records and identified the following had not been evaluated by the proficiency testing program: (a) Hematology Auto Differentials (i) FH9-C 2017 Event (aa) 5 of 5 Blood Cell Identification, BCP-26, BCP-27, BCP-27, BCP-29, BCP-30 (b) Urine Drug Screening (i) UDS-C 2017 Event (aa) 1 of 1 Opiate Group, UDS-14 (c) Hematology Auto Differentials (i) FH9-B 2018 Event (aa) 5 of 5 Blood Cell Identification, BCP- 16, BCP-17, BCP-18, BCP-19, BCP-20. (d) Plasma Cardiac Markers (i) PCARM-C 2018 Event (aa) 1 of 1 B-Type Natriuretic Pep PCAR-12 (2) The surveyor further reviewed the records and could not locate documentation verifying the laboratory had performed a self-evaluation of the non-graded results; (3) The surveyor asked the technical consultant if the results had been documented as evaluated. The technical consultant reviewed the records and stated the non-graded results had not been documented as reviewed. 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 the technical consultant, the laboratory failed to follow the manufacturer's instructions for verifying morphology flags, precision determination of a new analzyer and changing lot numbers of quality control materials. Findings include: HEMATOLOGY (1) On the first day of the survey, the technical consultant stated that CBC (Complete Blood Count) testing was performed on the Sysmex XS-1000i analyzer; (2) On third day of the survey, the surveyor reviewed the manufacturer's instructions for verifying morphology flags obtained on the analyzer. The following were examples of flags, with the corresponding instructions: (a) Immature Grans? - "Perform manual differential" (b) Left Shift? - "Perform manual differential" (c) Neutrophilia - "Review manual smear" (d) PLT Clumps? - "Verify on slide. Recollect sample if present." (3) The surveyor randomly reviewed 9 patient records which contained morphology flags from CBC testing performed between 07/07/18 throught 02/06/19. For 3 of the records, there was no evidence the laboratory followed the manufacturer's instructions for verifying the flags. The findings for the 3 records were: (a) Patient testing was -- 3 of 9 -- performed on 04/07/18, with Left Shift? flags obtained; (b) Patient testing was performed on 07/07/18, with Immature Gran? flag obtained; (c) Patient testing was performed on 12/04/18, with Neutrophilia and PLT Clumps? flag obtained. (4) The surveyor reviewed the records with the technical consultant, who stated the flags obtained for the above 3 patients had not been verified. PRECISION DETERMINATION INSTALLATION OF A NEW ANALYZER (1) On the fourth day of the survey, the technical consultant stated to the surveyor the IL ACL Elite analyzer was put into use to perform PT/INR (Prothrombin Time/International Normalized Ratio), PTT (Partial Thromblplastin Time) and D-Dimer testing on 06/09 /17; (2) The surveyor reviewed the manufacturer's Hemostasis Performance Verification Manual instructions for the Precision Determination of the IL ACL Elite, which were as follows: (a) Section 5-1 titled "PRECISION DETERMINATION," required 20 replicates using the following screening guidelines: (i) "TOTAL RUN PRECISION: Analyze the chosen materials over a number of runs and days so that there is a minimum total number of 20 replicates at each concentration (more days will give a better estimate of the day-to-day variability). Try to evenly balance the numbers of replicates per day in order to not bias the data to one or another." (3) The implementation records were reviewed by the surveyor with the following identified: (a) The minimum number of 20 replicates had not been documented as performed (i) 18 replicates had been documented as performed (4) The surveyor review the manufacturer's instructions with the technical consultant who stated the Total Run Precision had not been performed according to manufacturer instructions. CHANGING LOT NUMBER CONTROL (1) On the fourth day of the survey, the technical consultant stated to the surveyor the IL ACL Elite analyzer was put into use to perform PT/INR (Prothrombin Time/International Normalized Ratio) testing on 06 /09/17; (2) The surveyor reviewed the manufacturer's Hemostasis Performance Verification Manual instructions for the Changing Lot Number of Control of the IL ACL Elite, which were as follows: (a) Section 10-9 titled "CHANGING LOT NUMBER OF CONTROL," required 20 replicates using the following screening guidelines: (i) "2. Perform at least 20 runs (once per day for 20 days) of each test for each level of control. A greater number of runs may improve the statistics of the assay range." (3) The surveyor reviewed PT records and identifed the quality control lot numbers changed in June 2018.The laboratory failed to follow manufacturer instruction for changing the lot numbers as follows: (a) The minimum number of 20 replicates had not been documented as performed (i) 15 replicates had been documented as performed for PT normal lot# N0771137 quality control and PT abnormal lot# N0871604 quality control (4) The surveyor review the manufacturer's instructions with the technical consultant who stated the change in control lot numbers had not been performed according to manufacturer instructions. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: -- 4 of 9 -- Based on a review of records, observation, and interview with the technical consultant, the laboratory failed to ensure materials were being stored as required. Findings include: (1) On the first day of the survey, the surveyor observed the outpatient draw station. The following were examples of materials being stored in the area, along with the manufacturer's storage requirements: (a) Blood Collection tubes used for CBC (Complete Blood Count) testing performed on the Sysmex XS-1000i analyzer and collecting reference (send out) specimens: (i) BD Vacutainer PST Gel and Lithium Heparin tubes (8 tubes of lot# 8187744 with a storage requirement of 4- 25 degrees Celsius) (ii) BD Vacutainer K2 EDTA tubes (25 tubes of lot#8249525 with a storage requirement of 4-25 degrees Celsius) (b) Blood Collection tubes used for Coagulation testing performed on the IL ACL Elite analyzer: (i) BD Vacutainer Buffer Sodium Citrate 3.2% tubes (9 tubes of lot#81565595 with a storage requirement of 4-25 degrees Celsius) (2) The surveyor reviewed temperature records for January 2018 through June 2018 and could not locate documented temperature records for the outpatient draw station; (3) The surveyor asked the technical consultant if the temperature of the draw station was being monitored. The technical consultant stated the laboratory was not monitoring the temperature of the outpatient draw station. 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 technical consultant, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Findings include: (1) On the first day of the survey, the technical consultant stated the following to the surveyor: (a) CBC (Complete Blood Count) testing was performed on the Sysmex XS-1000i analyzer; (b) Coagulation testing PT/INR (Prothrombin Time/International Normalized Ratio, PTT (Partial Thromboplastin Time) and D-Dimer was performed on the IL ACL Elite analyzer. (2) On the second day of the survey, the surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs: (a) Sysmex 1000i Weekly Maintenance (i) Power Down IPU (b) IL ACL Elite Weekly Maintenance (i) Clean Instrument Surfaces (ii) Clean Rinse/Waste Reservoir (iii) Verify Needles alignment (3) The surveyor then reviewed maintenance records for 19 months (June 2017 through December 2018). There was no evidence the following maintenance had been performed: (a) Sysmex 1000i Weekly Maintenance (i) Between 10/22/18 and 11/05/18 (b) IL ACL Elite Weekly Maintenance (i) Between 07/10/17 and 07/21/17 (ii) Between 07/28/17 and 08/07/17 (iii) Between 04 /09/18 and 04/22/18 (4) The surveyor reviewed the records with the technical consultant, who stated the maintenance had not been documented as performed as required. 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-- -- 5 of 9 -- 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 technical consultant, the laboratory failed to perform two levels of control materials each day of patient Troponin I, CKMB (Creatine Kinase, Isoenzyme), BNP (Brain Natriuretic Peptide), and ABG (Arterial Blood Gas G3+ cartridge: pH, pCO2, pO2) testing Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor the laboratory performed Troponin I, CKMB, BNP and ABG (G3+ cartridge: pH, pCO2, pO2) testing using the Abbott iSTAT analyzer; (2) On the third day of the survey, the surveyor asked the technical consultant if an IQCP (Individualized Quality Control Plan) had been developed for the test system. The technical consultant stated an IQCP had been approved by the laboratory director on 01/16/19. Therefore, the surveyor determined two levels of QC (quality control) materials must be performed each day of patient testing before the IQCP was approved by the laboratory director on 01/16/19; (3) The surveyor reviewed QC and patient testing records for July 2017 through December 2018. The review indicated negative and positive QC materials had not been performed 47 of 47 days of patient testing reviewed; (4) The surveyor reviewed the records with the technical consultant who stated two levels of QC materials had not been performed each day of patient testing; (5) The following patient Troponin I, CKMB, BNP, and ABG testing had been performed when two levels of QC materials had not been tested: (a) Troponin I (i) Patient #2 - testing performed on 07/02/17 (ii) Patient #5 - testing performed on 08 /01/17 (iii) Patient #9 - testing performed on 09/05/17 (iv) Patient #12 - testing performed on 10/13/17 (v) Patient #16 - testing performed on 11/12/17 (vi) Patient #18 - testing performed on 12/09/17 (vii) Patient #22 - testing performed on 01/04/18 (viii) Patient #25 - testing performed on 01/17/18 (ix) Patient #26 - testing performed on 02/05/18 (x) Patient #29 - testing performed on 03/04/18 (xi) Patient #33 - testing performed on 05/10/19 (xii) Patient #35 - testing performed on 06/04/18 (xiii) Patient #43 - testing performed on 10/01/18 (xiv) Patient #44 - testing performed on 11/03/18 (xv) Patient #46 - testing performed on 12/13/18 (b) CKMB (i) Patient #3 - testing performed on 07/02/17 (ii) Patient #7 - testing performed on 08/06/17 (iii) Patient #13 - testing performed on 10/13/17 (iv) Patient #20 - testing performed on 12/19/17 (v) Patient #24 - testing performed on 01/17/18 (vi) Patient #28 - testing performed on 02 /19/18 (vii) Patient #30 - testing performed on 03/04/18 (viii) Patient #32 - testing performed on 04/10/18 (ix) Patient #34 - testing performed on 05/28/18 (x) Patient #36 - testing performed on 06/14/18 (xi) Patient #38 - testing performed on 07/10/18 (xii) Patient #47 - testing performed on 12/22/18 (c) BNP (i) Patient #4 - testing performed on 07/20/17 (ii) Patient #8 - testing performed on 08/20/17 (iii) Patient #11 - testing performed on 09/22/17 (iv) Patient #15 - testing performed on 10/23/17 (v) Patient #19 - testing performed on 12/12/17 (vi) Patient #27 - testing performed on 02 /13/18 (d) ABG (i) Patient #1 - testing performed on 07/02/17 (ii) Patient #6 - testing performed on 08/06/17 (iii) Patient #10 - testing performed on 09/12/17 (iv) Patient #14 - testing performed on 10/23/17 (v) Patient #17 - testing performed on 11/26/17 (vi) Patient #21 - testing performed on 12/24/17 (vii) Patient #23 - testing performed on 01/09/18 (viii) Patient #31 - testing performed on 04/10/18 (ix) Patient #37 - testing performed on 06/22/18 (x) Patient #39 - testing performed on 07/15/18 (xi) Patient #40 - testing performed on 08/13/18 (xii) Patient #41 - testing performed on 09 /02/18 (xiii) Patient #42 - testing performed on 10/01/18 (xiv) Patient #45 - testing performed on 11/07/18 -- 6 of 9 -- D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to ensure units of blood were stored under appropriate conditions. Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor that units of packed red blood cells were stored in the blood bank refrigerator. The units were to be used for patient transfusions; (2) On the third day of the survey, the technical consultant stated to the surveyor Blood Bank alarms were checked quarterly for high/low activation; (3) The surveyor reviewed the refrigerator alarm check records from 06/01/17 through the 3rd day of the survey (02/05/19). The records indicated the alarm checks had not been performed quarterly. They had not been performed between 08/21/17 and 02/02/19; (4) The surveyor reviewed the records with the technical consultant who stated the alarm checks had not been performed quarterly as required. 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, manufacturer's instructions, observation, and interview with the technical consultant, 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 follow the manufacturer's instructions for verifying morphology flags, precision determination of a new coagulation analyzer and changing lot number of quality control materials. Refer to D5411; (b) The laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Refer to D5429; (c) The laboratory failed to ensure materials were being stored as required. Refer to D5413; (d) The laboratory failed to perform two levels of control materials each day of patient Troponin I, CKMB, BNP (Brain Natriuretic Peptide), and ABG (G3+ cartridge: pH, pCO2, pO2, HCO3) testing. Refer to D5447. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory -- 7 of 9 -- 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 technical consultant, the laboratory failed to ensure reference intervals were determined as appropriate for the laboratory's patient population. Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor CBC (Complete Blood Count) testing was performed using the Sysmex XS-1000i analyzer; (2) On the second day of the survey, the surveyor reviewed two patient CBC reports - the first report was for an adult male patient with the testing performed on 04/07/18 at 09:47 am; the second report was for an adult female patient with the testing performed on 12/07/18 at 11:35 am. Both reports included the same reference intervals for the CBC parameters of RBC (Red Blood Cell), Hemoglobin, and Hematocrit which were: (a) RBC - 4.2 - 6.1 10x6/L (b) Hemoglobin - 12.0 - 16.0 g/dL (c) Hematocrit - 37.0 - 47.0 % (3) The surveyor reviewed the findings with the technical consultant, who stated the patient reports did not include gender specific reference ranges. NOTE: Routinely, female reference intervals for the analytes RBC, Hemoglobin, and Hematocrit are lower than male reference intervals. 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 and interview with the technical consultant, the laboratory director failed to provide overall management and direction. Findings include: (1) The laboratory director failed to ensure a quality control program was maintained to ensure the quality of laboratory services. Refer to D6020; (2) The laboratory director failed to ensure a quality assessment program had been established and maintained. Refer to D6021. 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 the technical consultant, the laboratory director failed to ensure a quality control program was maintained to ensure the quality of laboratory services for Troponin I, CKMB, BNP (Brain Natriuretic Peptide), and ABG (G3+ cartridge: pH, pCO2, pO2) testing Findings -- 8 of 9 -- include: (1) The laboratory director failed to ensure two levels of quality control materials were performed each day of patient testing. Refer to D5447; 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. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory director failed to ensure a quality assessment program had been established and maintained. Findings include: (1) The laboratory director failed to ensure an ongoing mechanism for performing effective analytic quality assessment. Refer to D5791. -- 9 of 9 --