Purcell Municipal Hospital

Summary Statement of Deficiencies D0000 The recertification survey was performed on 08/20,21,22/2024. The laboratory was found out of compliance with the following CLIA Conditions: 493.801; D2000: Enrollment and Testing of Samples 493.1250; D5400: Analytic Systems 493.1403; D6000: Laboratory Director The findings were reviewed with the laboratory director, chief executive officer, Operation/Finance Manager, lead technologist, and testing person #8 during an exit conference performed at the conclusion of the survey. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of records and interview with the laboratory director and lead technologist, the laboratory failed to enroll in a proficiency testing program for Mononucleosis, Qualitative Serum Pregnancy, and Rheumatoid Factor testing for five of five events reviewed. Findings include: (1) On 08/20/2024, a review of proficiency testing records for 2023 (first, second, and third events), and 2024 (first and second events) identified no evidence the laboratory was enrolled in proficiency testing for Mononucleosis, Qualitative Serum Pregnancy, and Rheumatoid Factor testing for five of five events; (2) The records were reviewed with the laboratory director and lead technologist who stated on 08/20/2024 at 12:40 pm, the laboratory had not enrolled in the proficiency testing as stated above; (3) A review of the test volume list completed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 18 -- for the survey identified the laboratory performed approximately 35 Mononucleosis, 204 Qualitative Serum Pregnancy, and 173 Rheumatoid Factor tests annually. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on a review of records, hospital policy, and interview with the laboratory director, lead technologist, and nursing director, the facility failed to ensure written policies were followed for preventing transfusion reactions for three of three units of packed red-blood cells transfused. Findings include: (1) On 08/20/2024 at 1:30 pm, the laboratory director stated that blood transfusions were performed by nursing staff; (2) On 08/21/2024, a review of the hospital policy titled, "Blood Products Administration" stated: (a) "Baseline vital signs should be recorded immediately prior to infusion, and every five (5) minutes for the first fifteen minutes, then every fifteen (15) minutes for the remainder of the hour, then every hour and again at the end of the transfusion." (3) A review of transfusion records for three units identified the vitals had not been documented as performed for the five and 15 minute increments as required by policy: (a) Unit #W091024200689 - The unit was started 05/07/2024 at 12: 07 pm and vital signs had not been documented as performed as follows: (i) The five minute vitals had not been documented between 12:07 pm and 12:25 pm; (ii) The 15 minute vitals had not been documented between 12:25 pm and 01:25 pm. (b) Unit #W091024187172 - The unit was started 05/07/2024 at 02:45 pm and vital signs had not been documented as performed as follows: (i) The five minute vitals had not been documented between 02:45 pm and 03:00 pm; (ii) The 15 minute vitals had not been documented between 03:00 pm and 04:15 pm. (c) Unit #W091024267423 - The unit was started on 07/03/2024 at 09:55 am and vital signs had not been documented as performed as follows: (i) The five minute vitals had not been documented between 09: 55 am and 10:10 am; (ii) One 15 minute vital had not been documented between 10: 40 am and 11:40 am. (4) The records were reviewed with the nursing director who stated on 08/22/2024 at 01:30 pm, the vital signs had not been documented according to policy. 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 interview with the laboratory director, the laboratory failed to establish a written clinical consultant competency assessment policy, based on the position responsibilities as listed in the Subpart M. Findings include: (1) A review of written policies and interview with the laboratory director on 08/20/2024 at 04:15 pm identified no evidence of a policy for assessing -- 2 of 18 -- the competency of the clinical consultant; (2) A review of Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of January 2023 through the current date identified no documentation competency assessments had been performed based on position responsibilities for one of one clinical consultant; (3) The findings were reviewed with the laboratory director on 08/20/2024 at 04:15 pm, who confirmed the laboratory failed to define and perform assessments based on the specific position responsibilities. 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 director, the laboratory failed to review and evaluate proficiency testing results for one of four Hematology Proficiency testing events reviewed from January 2023 through the current date. Findings include: (1) A review of Hematology Proficiency testing records for four events (first, second, and third 2023 and first 2024) identified the following failure with no evidence that

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing providers. The laboratory was found out of compliance with the following CLIA Conditions of Participation: 493.803; D2016: Successful Participation 493.1407; D6000: Laboratory Director, Moderate Complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the American Association of Bioanalysts and the laboratory for the third 2021 event; and the proficiency testing Comparative Evaluation obtained from American Proficiency 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 -- Institute for the first 2022 event; the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Routine Chemistry for the analyte CK (Creatine Kinase). Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for the analyte CK. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the American Association of Bioanalysts and the laboratory for the third 2021 event; and the proficiency testing Comparative Evaluation obtained from American Proficiency Institute for the first 2022 event; the laboratory failed to achieve satisfactory performance for the analyte CK (Creatine Kinase) in two consecutive events. Findings include: (1) The laboratory received a score of 0% on the third 2021 event and a score of 0% on the first 2022 event. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the American Association of Bioanalysts and the laboratory for the third 2021 event; and the proficiency testing Comparative Evaluation obtained from American Proficiency Institute for the first 2022 event; the laboratory failed to achieve satisfactory performance for the analyte CK (Creatine Kinase) in two consecutive events. The laboratory failed to achieve a passing score of 80% for the third 2021 event and first 2022. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the American -- 2 of 3 -- Association of Bioanalysts and the laboratory for the third 2021 event; and the proficiency testing Comparative Evaluation obtained from American Proficiency Institute for the first 2022 event; the laboratory failed to achieve satisfactory performance for the analyte CK (Creatine Kinase) in two consecutive events. The laboratory failed to achieve a passing score of 80% for the third 2021 event and first 2022. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 08/09,10,11,12/2022. The laboratory was found out of compliance with the following CLIA Conditions of Participation: 493.1250; D5400: Analytic Systems 493.1403; D6000: Laboratory Director 493.1409; D6033: Technical Consultant The findings were reviewed with the laboratory manager and technical consultant 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, manufacturer's instructions, quality control package inserts, and interview with the laboratory manager and technical consultant, the laboratory failed to monitor and evaluate the overall quality of analytic systems and correct identified problems for each specialty and subspecialty of testing performed. Findings include: (1) The laboratory failed to follow the manufacturer's instructions for implementing two of four coagulation reagents. Refer to D5411; (2) The laboratory failed to demonstrate the performance specifications for one of two new test methods. Refer to D5421; (3) The laboratory failed to follow the manufacturer's instructions for performing maintenance procedures on the Beckman Coulter Access 2 analyzer for five of 12 months. Refer to D5429; (4) The laboratory failed to perform calibration verification every six months for Hemoglobin A1c testing performed on the Bio-Rad DC-10 analyzer. Refer to D5439; (5) The laboratory failed to have control procedures that monitored the accuracy and precision of the testing process; Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 19 -- and that would detect immediate errors that would occur due to test system failure, adverse environmental conditions, and operator performance for CKMB, Troponin I, PSA, and TSH testing seven of seven months. Refer to D5441; (6) The laboratory failed to perform two levels of quality control materials four of five days of patient Troponin I and CKMB testing reviewed and two of 21 days of patient Hemoglobin A1c testing reviewed. Refer to D5447; (7) The laboratory failed to perform a negative and positive control material 32 of 34 days of patient urine drug screen testing and 34 of 35 days of qualitative serum pregnancy testing. Refer to D5449; (8) The laboratory failed to follow the manufacturer's specifications for Bio-Rad Liquichek Diabetes control materials for two of two lot numbers. Refer to D5479; (9) The laboratory failed to perform one sample of control material each 8 hours of patient blood gas testing using a combination of control materials that include both low and high values on each day of testing for 13 of 18 patients reviewed. Refer to D5537; (10) The laboratory failed to have a system that twice a year evaluated and defined the relationship between test results using different methodologies for two of two test methods. Refer to D5775; (11) The laboratory failed to have an ongoing mechanism for performing quality assessment. Refer to D5791. 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 laboratory manager and technical consultant, the laboratory failed to follow the manufacturer's instructions for implementing two of four coagulation reagents. Findings include: (1) On 08/09/2022 at 10:00 am, the laboratory manager stated the ACL TOP analyzer was used to perform patient PT/INR (Prothrombin Time /International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing (the INR was calculated using the PT reference interval mean); (2) On 08/11/2022 at 10:40 am, the laboratory manager stated the reagents were put into use as follows: (a) PT Reagent - HemosIL RecombiPlastIN 2G, lot #N1117938 was put into use on 03/22 /2022; (b) PTT Reagent - HemosIL SynthasIL, lot #N0129380 was put into use on 06 /22/2022. (3) A review of the manufacturer's instructions contained in the "Hemostasis Performance Verification Manual" for implementing new reagents, revealed the following: (a) Under the section titled, "Establishing a Normal Reference Interval" stated for a 20- donor study: (i) "Donors should be equally divided between male/female"; (ii) "Determine the mean, standard deviation (SD) and range once the data has been collected.....For non-Gaussian distributions, such as PT, a geometric mean is recommended". (b) Under the section titled, "Comparison Study" stated: (i) "Normal and Abnormal samples are tested. The new methodology or reagents is assessed against the comparative (usually the current) methodology or reagents"; (ii) "At least 50% of the samples should be outside of the laboratory normal reference interval, if possible"; (iii) "At least 40 specimens should be analyzed" (4) A review of the implementation records for the reagent lot changes revealed the following: (a) HemoSIL RecombiPlastIN 2G (i) Normal Reference Interval (aa) The laboratory had used 18 donors instead of 20, which included eight males and ten females; (bb) The normal patient mean that had been calculated was not the geometric mean. (ii) -- 2 of 19 -- Comparison Study (aa) The laboratory had used 18 normal and two abnormal samples, instead of 20 normal and 20 abnormal specimens. (b) HemoSIL SynthasIL (i) Comparison Study (aa) The laboratory had used 20 normal samples and did not include 20 abnormal samples. (5) The records were reviewed with the laboratory manager and technical consultant. Both stated on 08/11/2022 at 11:15 am, the manufacturer's instructions had not been followed for the reagent lot changes; (6) The following were examples of patient testing: (a) PT/INR Testing (i) Patient #656697875 - Testing performed on 04/25/2022 (ii) Patient #657640693 - Testing performed on 05/17/2022 (iv) Patient #657777513 - Testing performed on 05/20/2022 (v) Patient #658798409 - Testing performed on 06/14/2022 (vi) Patient #659073939 - Testing performed on 06/23/2022 (vii) Patient #659427482 - Testing performed on 06 /29/2022 (viii) Patient #660529846 - Testing performed on 07/26/2022 (ix) Patient #660830447 - Testing performed on 08/02/2022 (b) PTT Testing (i) Patient #659256087 - Testing performed on 06/25/2022 (ii) Patient #659439841 - Testing performed on 06/29/2022 (iii) Patient #660852439 - Testing performed on 08/02/2022 D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager and technical consultant, the laboratory failed to demonstrate the performance specifications for one of two new test methods. Findings include: (1) On 08/09/2022 at 03:26 pm, the technical consultant stated the test stated the Fisher Health SureVue Serum hCG STAT test kit was put into use to perform patient serum qualitative pregnancy testing on 07/21/2021; (2) A review of records for the test kit revealed no evidence the performance specifications (accuracy, precision, reportable range, and verification of reference range, as applicable for the test system) had been demonstrated; (3) Interview with the technical consultant on 04/09/2022 at 03:26 pm confirmed the performance specifications, as applicable had not been demonstrated prior to putting the test kit into use for patient testing; (4) Refer to D5449 for examples of patient testing performed. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager and technical consultant, the laboratory failed to follow the -- 3 of 19 -- manufacturer's instructions for performing maintenance procedures on the Beckman Coulter Access 2 analyzer for five of 12 months. Findings include: (1) On 08/09/2022 at 10:00 am, the laboratory manager stated CKMB, Troponin I, HCG (Human Chorionic Gonadotropin), TSH (Thyroid Stimulating Hormone), Free T4 (Thyroxine), LH (Luteinizing Hormone), Testosterone, Transferrin, Vitamin B12, and Vitamin D testing were performed on the Beckman Coulter Access 2 analyzer; (2) On 08/12 /2022, a review of the manufacturer's maintenance requirements, as stated on the manufacturer's maintenance log required the following: (a) Daily (i) Check Zone Temperature (ii) Check System Supplies (iii) Check Liquid Waste Container (iv) System Backup Successful? (v) Inspect Fluidic Module (vi) Clean Probe Exteriors (vii) Prime Substrate (iii) Run Daily Clean System (b) Weekly (i) Clean Instrument Exterior (ii) Check Waste Filter Bottle (iii) Inspect/Clean Primary Probe (iv) Replace /Clean Aspirate Probes (v) Run System Check (3) A review of maintenance records from August 2021 through July 2022 revealed maintenance had not been documented as performed as follows: (a) Daily (i) Check Zone Temperature, Check System Supplies, Check Liquid Waste Container, System Backup Successful?, Inspect Fluidic Module, Clean Probe Exteriors, Prime Substrate, and Run Daily Clean System had not been documented as performed between 09/19/21 and 09/21/2021; and between 09/23 /2021 and 09/26/2021; (ii) Inspect Fluidic Module, Clean Probe Exteriors, Prime Substrate, and Run Daily Clean System had not been documented as performed between 05/04/2022 and 05/07/2022; and between 05/11/2022 and 05/14/2022; (iii) Clean Probe Exteriors and Prime Substrate had not been documented as performed between 05/22/2022 and 05/24/2022; (iv) Inspect Fluidic Module, Clean Probe Exteriors, Prime Substrate, and Run Daily Clean System had not been documented as performed between 07/24/2022 and 07/30/2022. (b) Weekly (i) Replace/Clean Aspirate Probes had not been documented as performed between 08/06/2021 and 08 /27/2021; (ii) Clean Instrument Exterior, Check Waste Filter Bottle, Inspect/Clean Primary Probe, Replace/Clean Aspirate Probes, and Run System Check had not been documented as performed between 08/27/2021 and 09/22/2021. (4) The records were reviewed with the laboratory manager and technical consultant. Both stated on 08/12 /2022 at 10:10 am, the maintenance had not been documented as performed as shown above. 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 -- 4 of 19 -- 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 laboratory manager and technical consultant, the laboratory failed to perform calibration verification every six months for Hemoglobin A1c testing performed on the Bio-Rad DC-10 analyzer. Findings include: (1) On 08/09/2022 at 09:50 am, the laboratory manager stated Hemoglobin A1c testing was performed on the Bio-Rad DC-10 analyzer; (2) On 08/10/2022, a review of calibration records revealed the routine calibrations were performed using two calibrators, therefore calibration verification procedures, using at least three levels of calibration materials were required; (3) A review of records from January 2021 through the current date revealed calibration verification had not been performed prior to 08/07/2022; (4) The records were reviewed with the laboratory manager and technical consultant. Both stated on 08/10/2022 at 03:40 pm, calibration verification had not been performed every six months; (5) The following were examples of patient testing performed (patient number represents sample number): (a) Patient #639285136 - Testing performed on 03/05/2021 (b) Patient #639460455 - Testing performed on 03 /10/2021 (c) Patient #64096405 - Testing performed on 04/05/2021 (d) Patient #646560174 - Testing performed on 08/30/2021 (e) Patient #647864207 - Testing performed on 09/29/2021 (f) Patient #648925169 - Testing performed on 10/23/2021 (g) Patient #650002987 - Testing performed on 11/17/2021 (h) Patient #650760075 - Testing performed on 12/06/2021 (i) Patient #653863211 - Testing performed on 02 /16/2022 (k) Patient #654313355 - Testing performed on 02/28/2022 (l) Patient #654544753 - Testing performed on 03/04/2022 (m) Patient #655258373 - Testing performed on 03/22/2022 (n) Patient #655700995 - Testing performed on 04/01/2022 (o) Patient #656703054 - Testing performed on 04/25/2022 (p) Patient #657041608 - Testing performed on 05/03/2022 (q) Patient #657671762 - Testing performed on 05 /18/2022 (r) Patient #658848615 - Testing performed on 06/15/2022 (s) Patient #659215788 - Testing performed on 06/24/2022 (t) Patient #659650595 - Testing performed on 07/05/2022 (u) Patient #660241951 - Testing performed on 07/19/2022 (v) Patient #660273537 - Testing performed on 07/20/2022 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, quality control package inserts, and interview with the laboratory manager and technical consultant, the laboratory failed to have control procedures that monitored the accuracy and precision of the testing process; and that -- 5 of 19 -- would detect immediate errors that would occur due to test system failure, adverse environmental conditions, and operator performance for PTT testing for one of one month; and CKMB, Troponin I, PSA, and TSH testing for seven of seven months. Findings include: ACL TOP ANALYZER (1) On 08/09/2022 at 10:00 am, the laboratory manager stated the ACL TOP analyzer was used to perform patient PTT (Partial Thromboplastin Time) testing; (2) On 08/11/2022 at 10:40 am, the laboratory manager stated the following two levels of control materials were performed each eight hours of patient testing and were put into use on 06/22/2022: (a) HemosIL Normal Control 1, lot #N0129618 and HemosIL Abnormal Control 3, lot #N0129621. (3) A review of QC (Quality Control) records for patient testing performed from 07/01 /2022 through 07/31/2022 revealed the following for one of two levels of QC (HemosIL Abnormal Control 3): (a) A two SD (Standard Deviation) range of 53.89- 56.98 had been established by the laboratory when the lot number had been put into use. A range of 50.2-67.8 had been used to evaluate QC results, which was beyond the established range. (4) The records were reviewed with the technical consultant, who stated on 08/11/2022 at 01:54 pm, the laboratory had used a range wider than the established range to evaluate QC results as shown above; (5) Refer to D5411 for examples of patient testing performed. BECKMAN COULTER ACCESS 2 ANALYZER (1) On 08/09/2022 at 10:05 am, the laboratory manager stated the Beckman Coulter Access 2 analyzer was used to perform CKMB (Creatine Kinase Isoenzyme), Troponin I, PSA (Prostate Specific Antigen), and TSH (Thyroid Stimulating Hormone) testing; (2) On 08/12/2022 at 10:30 am, the laboratory manager stated two levels of QC materials were performed each day of CKMB and Troponin I patient testing and three levels of QC materials were performed each day of PSA and TSH patient testing. The laboratory established means and two SD ranges were established for each analyte prior to putting new lot numbers of QC materials into use. The following control materials were currently in use: (a) CKMB and Troponin I testing - Bio-Rad Liquichek Cardiac Markers Plus controls; Level one lot #87831 and Level three lot #87833; (b) PSA and TSH - Bio-Rad Liquichek Immunoassays controls; Level one lot #85271, Level two lot #85272, and Level three lot #85273. (3) A review of QC records (Levey-Jennings graphs and cumulative calculated data; and QC package inserts) from January through July 2022 revealed the following: (a) CKMB and Troponin I (i) The Levey-Jennings graphs reflected the lot numbers in use during the review period as level one lot #29891 and level three lot #29893 (which were not the correct lot numbers); (ii) There was no documentation to show the establishment of the QC ranges, therefore the package insert ranges were used as a guide for the review (note: the package insert ranges were to be used by the laboratory as a guide while establishing QC ranges). The following were identified for two of two QC materials for CKMB and two of two QC materials for Troponin I: (aa) CKMB level one - The laboratory was using a range of 0.60-5.20 which was wider than the package insert guideline range of 1.81-3.16; (bb) CKMB level two - The laboratory was using a range of 3.0-20.20 which was wider than the package insert guideline range of 11.2-15.7; (cc) Troponin I level one - The laboratory was using a range of 0.014-0.394 which was wider than the package insert guideline range of 0.113-0.312; (dd) Troponin I level two - The laboratory was using a range of 0.410- 1.73 which was wider than the package insert guideline range of 0.798-1.53. (b) PSA and TSH (i) The Levey-Jennings graphs reflected the lot numbers in use during the review period as level one lot #85261, level two lot #85262, and level three lot #29893 (which were not the correct lot numbers); (ii) There was no documentation to show the establishment of the QC ranges, therefore the package insert ranges were used as a guide for the review. The following were identified for three of three QC materials for PSA and two of three QC materials for TSH: (aa) PSA level one - Beginning 07/01/2022, the laboratory was using a range of -15.8-16.4 which was -- 6 of 19 -- wider than the package insert guideline range of 0.325-.502; (bb) PSA level two - Beginning 07/01/2022, the laboratory was using a range of 2.77-5.33 which was wider than the package insert guideline range of 3.17-4.60; (cc) PSA level three - The laboratory was using a range of 14-31.3 which was wider than the package insert guideline range of 22-31.6; (dd) TSH level one - Beginning 07/01/2022, the laboratory was using a range of -0.12-1.474 which was wider than the package insert guideline range of 0.535-0.762; (ee) TSH level two - Beginning 07/01/2022, the laboratory was using a range of 3.58-7.26 which was wider than the package insert guideline range of 4.17-6.07. (4) The records were reviewed with the laboratory manager and technical consultant. Both stated the following on 08/12/2022 at 12:25 pm: (a) CKMB and Troponin I (i) The laboratory had not updated the computer with the new QC lot numbers when the Bio-Rad Liquichek Cardiac Markers Plus level one lot #87831 and level three lot #87833 had been put into use. The exact date the new lot numbers were put into use could not be determined, but they were in use during the review period; (ii) It could not be determined how ranges had been derived that were wider than the package insert guideline ranges for each level of control material. (b) PSA and TSH (i) The laboratory had not updated the computer with the new QC lot numbers when the Bio-Rad Liquichek Immunoassay level one lot #85261, level two lot #85262, and level three lot #29893 had been put into use. The exact date the new lot numbers were put into use could not be determined, but they were in use during the review period; (ii) It could not be determined how ranges had been derived that were wider than the package insert guideline ranges for each level of control material. (5) Examples of patient testing performed during this timeframe (patient number represents hospital account number): (a) CKMB and Troponin I (i) Patient #90722005026 - Testing performed on 01/05/2022 (ii) Patient #907220160117 - Testing performed on 01/16/2022 (iii) Patient #907220200153 - Testing performed on 01/20/2022 (iv) Patient #907220390149 - Testing performed on 02/08/2022 (v) Patient #907220520158 - Testing performed on 02/21/2022 (vi) Patient #907220820112 - Testing performed on 03/23/2022 (vii) Patient #907220980079 - Testing performed on 04/08/2022 (viii) Patient #907221240099 - Testing performed on 05/04/2022 (ix) Patient #907221360064 - Testing performed on 05/16/2022 (x) Patient #907221540046 - Testing performed on 06/03/2022 (xi) Patient #90722167005 - Testing performed on 06/16/2022 (xii) Patient #907221710098 - Testing performed on 06/20/2022 (xiii) Patient #907221830002 - Testing performed on 07/02/2022 (xiv) Patient #907222020023 - Testing performed on 07/21/2022 (b) PSA (i) Patient #907220100165 - Testing performed on 01/10/2022 (ii) Patient #907220590169 - Testing performed on 02/28/2022 (iii) Patient #907220680096 - Testing performed on 03/09/2022 (iv) Patient #907220770093 - Testing performed on 03/18/2022 (v) Patient #907221010112 - Testing performed on 04/11/2022 (vi) Patient #90722110104 - Testing performed on 04/21/2022 (vii) Patient #907221450072 - Testing performed on 05/25/2022 (viii) Patient #907221730010 - Testing performed on 06/22/2022 (ix) Patient #907221870048 - Testing performed on 07/07/2022 (x) Patient #9072221920104 - Testing performed on 07/13/2022 (xi) Patient #907222060075 - Testing performed on 07/25/2022 (c) TSH (i) Patient #907220120003 - Testing performed on 01/12/2022 (ii) Patient #907220470135 - Testing performed on 02/16/2022 (iii) Patient #907220610139 - Testing performed on 03/02/2022 (iv) Patient #907220890155 - Testing performed on 03/30/2022 (v) Patient #907221040122 - Testing performed on 04/14/2022 (vi) Patient #907221110099 - Testing performed on 04/21/2022 (vii) Patient #907221220132 - Testing performed on 05/02/2022 (viii) Patient #907221220164 - Testing performed on 05/03/2022 (ix) Patient #907221500008 - Testing performed on 05/30/2022 (x) Patient #907221570049 - Testing performed on 05/06/2022 (xi) Patient #907221680088 - Testing performed on 06/17/2022 (xii) Patient #907221870069 - -- 7 of 19 -- Testing performed on 07/06/2022 (xiii) Patient #907221970001 - Testing performed on 07/16/2022 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 and technical consultant, the laboratory failed to perform two levels of quality control materials four of five days of patient Troponin I and CKMB testing reviewed and two of 21 days of patient Hemoglobin A1c testing reviewed. Findings include: TROPONIN I AND CKMB (1) On 08/09/2022 at 09:45 am, the laboratory manager stated patient Troponin I and CKMB testing were performed using the BioSite Triage Meter Pro as the back-up method to the Beckman Coulter Access 2 analyzer; (2) On 08/09/2022 at 03:00 pm, the technical consultant stated an IQCP (Individualized Quality Control Program) had not been developed for the test system; (3) A review of QC (Quality Control) and patient testing records for testing performed from January 2022 through April 2022 revealed two levels of QC materials had not been performed each day of patient testing for four of five days reviewed; (4) The records were reviewed with the laboratory manager and technical consultant. Both stated on 08/09/2022 at 03:23 pm, two levels of QC materials had not been performed each day of patient testing; (5) The following were the days of patient testing reviewed when two levels of QC materials had not been tested (patient number represents sample number): (a) Patient #653104722 - Testing performed on 01/28/2022 (b) Patient #653122536 - Testing performed on 01/29/2022 (c) Patient #653133043 - Testing performed on 01/30/2022 (d) Patient #653168609 - Testing performed on 01/31/2022 (e) Patient #656862809 - Testing performed on 04/28/2022 HEMOGLOBIN A1C (1) On 08/09/2022 at 09:47 am, the laboratory manager stated patient Hemoglobin A1c testing was performed using the Bio-Rad D 10 analyzer; (2) A review of QC and patient testing records for testing performed in July 2022 revealed that two levels of QC materials had not been performed each day of patient testing for two of 21 days reviewed; (3) The records were reviewed with the laboratory manager and technical consultant. Both stated on 08 /09/2022 at 03:20 pm, two levels of QC materials had not been performed each day of patient testing; (4) The following were the days of patient testing reviewed when two levels of QC materials had not been tested (patient number represents sample number): (a) Patient #660241951 - Testing performed on 07/19/2022 (b) Patient #660273537 - Testing performed on 07/20/2022 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. -- 8 of 19 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager and technical consultant, the laboratory failed to perform a negative and positive control material 32 of 34 days of patient urine drug screen testing and 34 of 35 days of qualitative serum pregnancy testing. Findings include: URINE DRUG SCREEN (1) On 08/09/2022 at 09:40 am, the laboratory manager stated patient urine drug screen testing was performed using the Bio-Rad TOX/See urine drug screen test kit; (2) On 08/09/2022 at 02:45, the technical consultant stated the test kit was put into use for patient testing on 08/02/2021 and an IQCP (Individualized Quality Control Program) had not been developed for the test system; (3) A review of QC (Quality Control) and patient testing records for testing performed in August 2021, March 2022, and July 2022 revealed negative and positive QC materials had not been performed each day of patient testing for 32 of 34 days; (4) The records were reviewed with the laboratory manager and technical consultant. Both stated on 08/09/2022 at 03:05 pm, negative and positive QC materials had not been performed each day of patient testing; (5) The following were the days of patient testing reviewed when negative and positive QC materials had not been performed (patient number represents sample number or medical record number): (a) Patient #645321489 - Testing performed on 08/02/2021 (b) Patient #645481117 - Testing performed on 08/05/2021 (c) Patient #645529669 - Testing performed on 08/06/2021 (d) Patient #645943298 - Testing performed on 08 /11/2021 (e) Patient #645808996- Testing performed on 08/12/2021 (f) Patient #6458466112 - Testing performed on 08/13/2021 (g) Patient #645876929 - Testing performed on 08/14/2021 (h) Patient #645958037 - Testing performed on 08/16/2021 (i) Patient #646028620 - Testing performed on 08/18/2021 (j) Patient #646110675 - Testing performed on 08/19/2021 (k) Patient #646149920 - Testing performed on 08 /20/2021 (l) Patient #646270257 - Testing performed on 08/24/2021 (m) Patient #646318808 - Testing performed on 08/25/2021 (n) Patient #655261322 - Testing performed on 03/01/2022 (o) Patient #231564 - Testing performed on 03/02/2022 (p) Patient #8188 - Testing performed on 03/07/2022 (q) Patient #236043 - Testing performed on 03/10/2022 (r) Patient #227030 - Testing performed on 03/15/2022 (s) Patient #233377 - Testing performed on 03/21/2022 (t) Patient #218465- Testing performed on 03/22/2022 (u) Patient #5517 - Testing performed on 03/25/2022 (v) Patient #52675 - Testing performed on 03/26/2022 (w) Patient #234056 - Testing performed on 03/30/2022 (x) Patient #90548 - Testing performed on 07/01/2022 (y) Patient #237102 - Testing performed on 07/05/2022 (z) Patient #29257 - Testing performed on 07/08/2022 (aa) Patient #59181 - Testing performed on 07/10/2022 (bb) Patient #237168 - Testing performed on 07/14/2022 (cc) Patient #49978 - Testing performed on 07/18/2022 (dd) Patient #2588 - Testing performed on 07/22/2022 (ee) Patient #237269 - Testing performed on 07/23/2022 (ff) Patient #42447 - Testing performed on 07/30/2022 QUALITATIVE SERUM PREGNANCY (1) On 08/09 /2022 at 09:45 am, the laboratory manager stated Fisher Health SureVue Serum hCG STAT test kit to perform patient qualitative pregnancy testing; (2) On 08/09/2022 at 03:26 pm, the technical consultant stated the test kit was put into use for patient testing on 07/21/2021 and an IQCP (Individualized Quality Control Program) had not been developed for the test system; (3) A review of QC (Quality Control) and patient testing records for testing performed from 01/21/2022 through 08/03/2022 revealed negative and positive QC materials had not been performed each day of patient testing for 34 of 35 days of testing; (4) The records were reviewed with the laboratory manager and technical consultant. Both stated on 08/09/2022 at 03:43 pm, negative and positive QC materials had not been performed each day of patient testing; (5) The following were the days of patient testing reviewed when negative and positive QC -- 9 of 19 -- materials had not been performed (numbers represent specimen number or medical record number): (a) Patient #652772580 - Testing performed on 01/21/2022 (b) Patient #652819965 - Testing performed on 01/22/2022 (c) Patient #652483242 - Testing performed on 01/23/2022 (d) Patient #653083290 - Testing performed on 01 /28/2022 (e) Patient #654041853 - Testing performed on 02/21/2022 (f) Patient #654412230 - Testing performed on 03/02/2022 (g) Patient #32484 - Testing performed on 03/07/2022 (h) Patient #228276 - Testing performed on 03/08/2022 (i) Patient #24991 - Testing performed on 03/10/2022 (j) Patient #211075 - Testing performed on 03/11/2022 (k) Patient #47713 - Testing performed on 03/15/2022 (l) Patient #29035 - Testing performed on 03/18/2022 (m) Patient #43941 - Testing performed on 03/25/2022 (n) Patient #236290 - Testing performed on 04/04/2022 (o) Patient #229722 - Testing performed on 04/07/2022 (p) Patient #236192 - Testing performed on 04/14/2022 (q) Patient #66330 - Testing performed on 04/20/2022 (r) Patient #203359 - Testing performed on 04/21/2022 (s) Patient #236465 - Testing performed on 04/22/2022 (t) Patient #326529 - Testing performed on 04/25/2022 (u) Patient #58823 - Testing performed on 04/27/2022 (v) Patient #73483 - Testing performed on 04/28/2022 (w) Patient #215914 - Testing performed on 05/03/2022 (x) Patient #221128 - Testing performed on 05/08/2022 (y) Patient #220575 - Testing performed on 05/17/2022 (z) Patient #29426 - Testing performed on 06/03/2022 (aa) Patient #168152 - Testing performed on 06/06/2022 (bb) Patient #35529 - Testing performed on 06/09/2022 (cc) Patient #237145- Testing performed on 07/11/2022 (dd) Patient #237194 - Testing performed on 07/18/2022 (ee) Patient #50759 - Testing performed on 07/21/2022 (ff) Patient #15911 - Testing performed on 07/26/2022 (gg) Patient #203555 - Testing performed on 07/28/2022 (hh) Patient # 214353 - Testing performed on 08/03/2022 D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager and technical consultant, the laboratory failed to follow the manufacturer's specifications for Bio-Rad Liquichek Diabetes control materials for two of two lot numbers. Findings include: (1) On 08/09/2022 at 09:50 am, the laboratory manager stated: (a) Hemoglobin A1c testing was performed on the Bio- Rad DC-10 analyzer; (b) Two levels of Bio-Rad Liquichek Diabetes control materials were performed each day of patient testing. (2) On 08/10/2022, a review of the manufacturer's instructions (package insert) for the control materials stated, "The mean values and the corresponding +/-3SD ranges in the Assignment of Values Data Charts were derived from replicate analyses and are specific for this lot of product. Data from Unity Interlaboratory Program are included in the determination of some ranges. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides"; (3) A review of QC (Quality Control) records for two lot numbers of control materials revealed the following: (a) Level one lot #55781 and level three lot #55783 were put into use on 02/16/2022 and were -- 10 of 19 -- currently in use; (b) The laboratory had not established their own acceptable ranges and were using the manufacturer's guideline ranges as follows: (i) Level One - 4.15- 6.35 (ii) Level Three - 11.8-16.1 (4) The records were reviewed with the laboratory manager and technical consultant. Both stated on 08/10/2022 at 03:34 pm, the laboratory had not followed the manufacturer's instructions for the control materials; (5) The following were examples of patient Hemoglobin A1c testing performed (number represents specimen number): (a) Patient #653863211 - Testing performed on 02/16/2022 (b) Patient #654313355 - Testing performed on 02/28/2022 (c) Patient #654544753 - Testing performed on 03/04/2022 (d) Patient #655258373 - Testing performed on 03/22/2022 (e) Patient #655700995 - Testing performed on 04/01/2022 (f) Patient #656703054 - Testing performed on 04/25/2022 (g) Patient #657041608 - Testing performed on 05/03/2022 (h) Patient #657671762 - Testing performed on 05 /18/2022 (i) Patient #658848615 - Testing performed on 06/15/2022 (j) Patient #659215788 - Testing performed on 06/24/2022 (k) Patient #659650595 - Testing performed on 07/05/2022 (l) Patient #660241951 - Testing performed on 07/19/2022 (m) Patient #660273537 - Testing performed on 07/20/2022 D5537 ROUTINE CHEMISTRY CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) 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 laboratory manager and technical consultant, the laboratory failed to perform one sample of control material each 8 hours of patient blood gas testing using a combination of control materials that include both low and high values on each day of testing for 13 of 18 patients reviewed. Findings include: (1) On 08/10/2022 at 10:30 am, the laboratory manager stated the following: (a) Blood gas testing (pH, pCO2, pO2) was performed on the EPOC analyzer; (b) One level of quality control (QC) material was tested each eight hours of patient testing. (2) A review of QC and patient records for testing performed in January 2022, March 2022, and July 2022 revealed that the performance of QC materials did not include both low and high values on each day of testing for 13 of 18 patients reviewed (patient number represents sample number): (a) Patient #652317944 had been tested on 01/11/2022 at 03:09 pm. Level one QC had not been performed and level three QC had been performed at 01:48 pm; (b) Patient #652488927 had been tested on 01/15/2022 at 07:54 pm. Level one QC had been performed at 02:14 am and level three QC had not been performed; (c) Patient #652693798 had been tested on 01 /19/2022 at 08:02 pm. Level one QC had not been performed and level three QC had been performed at 07:44 pm; (d) Patient #652953001 had been tested on 01/25 2022 09:54 pm. Level one QC had been performed at 09:45 pm and level three QC had not been performed; (e) Patient #654412231 had been tested on 03/02/2022 at 06:58 am. Level one QC had not been performed and level three QC had been performed at 06: 53 am; (f) Patient #654735911 had been tested on 03/09/2022 at 01:19 pm. Level one QC had not been performed and level three QC had been performed at 12:58 pm; (g) Patient #654893830 had been tested on 03/13/2022 at 07:56 pm. Level one QC had not been performed and level three QC had been performed at 07:50 pm (h) Patient #655269942 had been tested on 03/22/2022 at 11:45 am. Level one QC had been performed at 11:31 am and level three QC had not been performed; (i) Patient -- 11 of 19 -- #659542985 had been tested on 07/01/2022 at 06:58 pm. Level one and level three QC had not been performed; (j) Patient #659614653 had been tested on 07/04/2022 at 10:54 pm. Level one QC had not been performed and level three QC had been performed at 10:00 pm; (k) Patient #659744291 had been tested on 07/07/2022 at 12: 48 pm. Level one QC had not been performed and level three QC had been performed at 12:43 pm; (l) Patient #660307649 had been tested on 07/20/2022 at 06:01 pm. Level one QC had not been performed and level three QC had been performed at 05: 56 pm; (m) Patient #660652749 had been tested on 07/28/2022 at 06:15 pm. Level one QC had not been performed and level three QC had been performed at 06:09 pm. (3) The records were reviewed with the technical consultant who stated on 08/10/2022 at 12:23 pm, QC testing had not been performed each eight hours to include both low and high values on each day of patient testing. 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 and technical consultant, the laboratory failed to have a system that twice a year evaluated and defined the relationship between test results using different methodologies for two of two test methods. Findings include: (1) On 08/09/2022 at 09:40 am, the laboratory manager stated the Beckman Coulter Access 2 analyzer was used as the primary method of performing CKMB and Troponin I testing and the Alere Triage Meter Pro was used as the back-up method; (2) A review of records for testing performed on both test systems from 07/2021 through 07/2022 revealed no evidence the relationship between testing performed on the two test methods had been evaluated at least twice annually; (3) The findings were reviewed with the laboratory manager and technical consultant. Both stated on 08/09/2022 at 03:00 pm, the relationship between the testing performed on the two test methods had not been evaluated twice annually. 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, quality control package inserts, and interview with the laboratory manager and 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 -- 12 of 19 -- the manufacturer's instructions for implementing two of four coagulation reagents. Refer to D5411; (b) The laboratory failed to demonstrate the performance specifications for one of two new test methods. Refer to D5421; (c) The laboratory failed to follow the manufacturer's instructions for performing maintenance procedures on the Beckman Coulter Access 2 analyzer for five of 12 months. Refer to D5429; (d) The laboratory failed to perform calibration verification every six months for Hemoglobin A1c testing performed on the Bio-Rad DC-10 analyzer. Refer to D5439; (e) The laboratory failed to have control procedures that monitored the accuracy and precision of the testing process; and that would detect immediate errors that would occur due to test system failure, adverse environmental conditions, and operator performance for CKMB, Troponin I, PSA, and TSH testing seven of seven months. Refer to D5441; (f) The laboratory failed to perform two levels of quality control materials four of five days of patient Troponin I and CKMB testing reviewed and two of 21 days of patient Hemoglobin A1c testing reviewed. Refer to D5447; (g) The laboratory failed to perform a negative and positive control material 38 of 40 days of patient urine drug screen testing and 36 of 37 days of qualitative serum pregnancy testing. Refer to D5449; (h) The laboratory failed to follow the manufacturer's specifications for Bio-Rad Liquichek Diabetes control materials for two of two lot numbers. Refer to D5479; (i) The laboratory failed to perform one sample of control material each 8 hours of patient blood gas testing using a combination of control materials that include both low and high values on each day of testing for 13 of 18 patients reviewed. Refer to D5537; (j) The laboratory failed to have a system that twice a year evaluated and defined the relationship between test results using different methodologies for two of two test methods. Refer to D5775. 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, manufacturer's instructions, quality control package inserts, and interview with the laboratory manager and technical consultant, the laboratory director failed to provide overall management and direction for moderate complexity testing. Findings include: (1) The laboratory director failed to ensure the individual who performed the duties and responsibilities of the laboratory director, met the qualifications. Refer to D6003; (2) The laboratory director failed to ensure verification procedures for new test systems were adequate to determine the performance characteristics. Refer to D6013; (3) The laboratory director failed to ensure test methods were performed as required for accurate and reliable results. Refer to D6014; (4) The laboratory director failed to ensure proficiency testing attestations, stating samples were tested as required under Subpart H, were signed by an individual meeting the regulatory qualifications for three of six attestation statements. Refer to D6016; (5) The laboratory director failed to ensure a quality control program was maintained to ensure the quality of laboratory services. Refer to D6020; (6) The laboratory director failed to ensure a quality assessment program had been established and maintained. Refer to D6021. D6003 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1405 AND 493.1406 -- 13 of 19 -- The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of moderate complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R of this part. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the Laboratory is located; and (b)(2)(ii) Have had laboratory training or experience consisting of: (b)(2)(ii)(A) At least one year directing or supervising non- waived laboratory testing; or (b)(2)(ii)(B) Beginning September 1, 1993, have at least 20 continuing medical education credit hours in laboratory practice commensurate with the director responsibilities defined in 493.1407; or (b)(2)(ii)(C) Laboratory training equivalent to paragraph (b)(2)(ii)(B) of this section obtained during medical residency. (For example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution; and (b)(3)(i) Be certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or the American Board of Medical Laboratory Immunology; or (b)(3)(ii) Have had at least one year experience directing or supervising non-waived laboratory testing; (b)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; (b)(4)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing; and (b)(4)(iii) In addition

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report, proficiency testing Comparative Evaluation obtained from American Proficiency Institute for the third 2021 event; and proficiency testing documentation from American Association of Bioanalysts and the laboratory for the first 2022 event; the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Bacteriology. Findings include: (1) The laboratory failed to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- achieve satisfactory performance for two consecutive testing events for Strep A Culture. Refer to D2026 and D2028. D2026 BACTERIOLOGY CFR(s): 493.823(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) Remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report, proficiency testing Comparative Evaluation obtained from American Proficiency Institute for the third 2021 event; and proficiency testing documentation from American Association of Bioanalysts and the laboratory for the first 2022 event; the laboratory failed to achieve successful performance for Strep A Culture testing. Findings include: (1) The laboratory failed to achieve satisfactory performance on the third event in 2021 with the American Association of Bioanalysts and the first event in 2022 with the American Proficiency Institute. Refer to D2028. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the laboratory. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from laboratory, the laboratory failed to successfully participate in a proficiency testing program for the specialty of Hematology and the subspecialty of General Immunology. Findings include: (1) The laboratory failed to achieve satisfactory performance for two of three testing events for Prothrombin Time. Refer to D2128 and D2130; (2) 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 3 -- failed to achieve satisfactory performance for two of three events for Rheumatoid Factor. Refer to D2082 and D2084. D2082 GENERAL IMMUNOLOGY CFR(s): 493.837(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluation obtained from the laboratory, the laboratory failed to achieve successful performance for Rheumatoid Factor testing. Findings include: (1) The laboratory failed to achieve satisfactory performance on the first event in 2021 and the third event in 2021. Refer to D2084. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Endocrinology. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for the analyte Cortisol. Refer to D2105 and D2107; Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D2105 ENDOCRINOLOGY CFR(s): 493.843(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to achieve successful performance for the analyte Cortisol. Findings include: (1) The laboratory failed to achieve satisfactory performance on the Second 2020 Event and the Third 2020 Event. Refer to D2107. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/21,22,23,24,25/2020. Immediate Jeopardy was determined during the survey due to issues identified with Blood Bank testing. The laboratory voluntarily ceased patient testing, which abated the Immediate Jeopardy. The laboratory was found out of compliance with the following CLIA regulations: 493.1217; D5026: Immunohematology 493.1250; D5400: Analytic Systems 493.1443; D6000: Moderate Complexity Laboratory Director 493.1409; D6033: Technical Consultant 493.1441; D6076: High Complexity Laboratory Director 493.1447; D6108: Technical Supervisor The findings were reviewed with general supervisor/technical consultant #1 at the conclusion of the survey. 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 general supervisor/technical consultant #1 and technical consultant #2, the laboratory director or designee failed to sign proficiency testing attestation statements for 2 of 32 events. Findings include: (1) On 09/21/20201, surveyor #2 reviewed 2019 and 2020 proficiency testing records and identified the following for 2 of 32 events: (a) Q1 Chemistry 2019 Event - The Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 23 -- attestation statement had not been signed by the laboratory director or designee; (a) Q3 Nonchemistry 2019 Event - The attestation statement had not been signed by the laboratory director or designee. (2) Surveyor #2 reviewed the findings with the general supervisor/technical consultant #1 and technical consultant #2. The technical consultant #2 stated on 09/21/2021 at 03:00 pm, the attestation statements had not been signed by the laboratory director or designee. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records, manufacturer's instructions, observation, and interview with the general supervisor/technical consultant #1 and technical consultant #2, the laboratory failed to ensure the requirements were met for the specialty of Immunohematology. Findings include: (1) The laboratory failed to have written procedures for Blood Bank testing. Refer to D5401; (2) The laboratory failed to perform function checks on the blood bank centrifuge as required by the manufacturer. Refer to D5431; (3) The laboratory failed to provide evidence a negative and positive control material had been performed each day of patient Immunohematology testing. Refer to D5449; (4) The laboratory failed to ensure units of blood were stored under appropriate conditions. Refer to D5555; (5) The laboratory failed to have an ongoing mechanism for performing quality assessment. Refer to D5791. 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 the general supervisor/technical consultant #1, the laboratory failed to have a written competency policy for the general supervisor and technical consultant based on the job responsibilities as listed in Subpart M. Findings include: (1) On 09/21/2020, surveyor #2 reviewed personnel records for competency assessments performed during 2019 through 09/21/2020. There was no evidence competencies had been performed for the general supervisor, technical consultant #1, and technical consultant #2 based on their job responsibilities; (2) Surveyor #2 asked the general supervisor/technical consultant #1 if a written policy to evaluate the positions based on job responsibilities was available and if competencies had been performed during the review period. The general supervisor /technical consultant #1 stated on 09/21/2020 at 1:30 pm a policy to evaluate the general supervisor and technical consultant based on job responsibilities had not been written; and competencies had not been performed. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE -- 2 of 23 -- CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the general supervisor/technical consultant #1 and technical consultant #2, the laboratory failed to verify the accuracy of Cerebral Spinal Fluid manual cell counts at least twice annually. Findings include: (1) On 09/21/2021 at 01:15 pm, the general supervisor/technical consultant #1 and technical consultant #2 stated manual Cerebral Spinal Fluid cell counts for WBC (White Blood Cells) and RBC (Red Blood Cells) were performed using a hemacytometer; (2) Surveyor #2 reviewed 2019 and 2020 records. There was no documentation which would confirm that the accuracy of the interpretations had been verified in 2019 and to date (09/21/2020) in 2020; (3) Surveyor #2 asked the general supervisor/technical consultant #1 and technical consultant #2, if manual Cerebral Spinal Fluid cell counts had been verified for accuracy in 2019 and to date in 2020. Technical consultant #2 stated on 09/21/2020 at 03:35 pm the accuracy of the testing had not been been verified. 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 written policies and procedures, manufacturer's instructions, observation, and interview with general supervisor/technical consultant #1 and technical consultant #2, the laboratory failed to monitor and evaluate the overall quality of analytic systems. Findings include: (1) The laboratory failed to have written procedures for Blood Gas testing. Refer to D5401; (2) The laboratory failed to ensure policies had been approved, signed, and dated by the laboratory director before use. Refer to D5407; (3) The laboratory failed to ensure control materials were not used beyond the expiration date. Refer to D5417; (4) The laboratory failed to verify the reportable range for a new test method; and failed to ensure the the performance specifications of a new test system were approved by the laboratory. Refer to D5421; (5) The laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Refer to D5429; (6) The laboratory failed to perform calibration verification procedures at least once every 6 months. Refer to D5439; (7) The laboratory failed to have control procedures that monitored the accuracy and precision of the testing process for Hematology, Coagulation, and Chemistry testing. Refer to D5441; (8) The laboratory failed to perform quality control as stated in the IQCP for Clostridium difficile testing. Refer to D5445; (9) The laboratory failed to have an ongoing mechanism for performing effective analytic quality assessment. Refer to D5791. -- 3 of 23 -- 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 general supervisor/technical consultant #1 and technical consultant #2, the laboratory failed to have written procedures for Blood Bank and Blood Gas testing. Findings include: BLOOD BANK (1) On 09/21/2021 at 11:45, technical consultant #2 stated to surveyor #2 the laboratory performed ABO/Rh Type, Antibody Screen, and Compatiblity testing using the Ortho ID MTS Gel system; (2) Surveyor #2 requested the procedure manual for the testing. Technical consultant #2 stated on 09/21/2021 at 02:28 pm, a procedure manual was not available for the above testing. BLOOD GAS (1) On 09/21/2021 at 11:10 am, technical consultant #2 stated to surveyor #2 that Arterial Blood Gas Testing was performed using the EPOC analyzer beginning 08/31 /2020; (2) Surveyor #2 asked the general supervisor/technical consultant #1 and technical consultant #2 for the EPOC procedure manual; (3) Technical consultant #2 stated on 09/23/2021 at 01:17 pm a procedure manual was not available for the above testing. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of policies and interview with the general supervisor/technical consultant #1 and technical consultant #2, the laboratory failed to ensure policies had been approved, signed, and dated by the laboratory director before use. Findings include: (1) On 09/21/2021 at 11:10 am, technical consultant #2 stated the following to the surveyor: (a) The laboratory performed the following tests on the Alere Triage Analyzer: (i) D-Dimer (ii) CKMB (iii) Urine Drug Screen (b) IQCP's (Individualized Quality Control Plan) had been developed for the test systems. (2) Survyor #2 reviewed the IQCP's (dated as effective on 01/07/2016) and identified the QCP's (Quality Control Plans) had not been approved, signed, and dated by the laboratory director; (3) Surveyor #2 reviewed the records with the general supervisor/technical consultant #1 and technical consultant #2 who both stated on 09/23/2020 at 02:30 pm the QCP's had not been approved, signed, and dated by the laboratory director. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. -- 4 of 23 -- This STANDARD is not met as evidenced by: Based on observation and interview with the general supervisor/technical consultant #1 and technical consultant #2, the laboratory failed to ensure control materials were not used beyond the expiration date. Findings include: (1) On 09/21/2020 at 11:30 am, surveyor #2 observed the contents of the laboratory refrigerator and identified the following expired material: (a) BioRad Liquichek Specialty Immunoassay Control Level 1 (lot #60241) - Printed on the bottle was the manufacturer's expiration date of 08/31/2020; (b) BioRad Liquichek Specialty Immunoassay Control Level 1 (lot #60242) - Printed on the bottle was the manufacturer's expiration date of 08/31/2020. (2) The technical consultant #2 stated the QC (Quality Control) materials were used to perform Vitamin D testing on the Beckman Coulter DxC 6000i; (3) The QC material was shown to the general supervisor/technical consultant #1 and technical consultant #2. The general supervisor/technical consultant #1 and technical consultant #2 both stated on 09/21/2020 at 11:40 am were not aware the material had expired. 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 general supervisor/technical consultant #1 and technical consultant #2, the laboratory failed to verify the reportable range for a new test method; and failed to ensure the the performance specifications of a new test system were approved by the laboratory. Findings include: (1) On 09/21 /2020 at 11:10 am, technical consultant #2 stated to surveyor #2 that Arterial Blood Gas Testing was performed using the EPOC analyzer beginning 08/31/2020; (2) Surveyor #2 reviewed performance specification records for the analyzer and identified the following: (a) No evidence the reportable range had been verified; (b) No evidence the performance specifications of the new test system were approved by the laboratory. (3) Surveyor #2 reviewed the validation records with the general supervisor/technical consultant #1 and technical consultant #2. Technical consultant #2 stated on 09/23/2020 at 02:37 pm the laboratory had not verified the reportable range and approved the performance specifications as indicated above. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the -- 5 of 23 -- general supervisor/technical consultant #1 and technical consultant #2, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Findings include: DC-10 GLYCOHEMOGLOBIN TESTING (1) On 09 /21/2020 at 11:47 am, the general supervisor/technical consultant #1 and technical consultant #2 stated to surveyor #2 that Glycohemoglobin testing was performed on the D-10 analyzer; (2) Surveyor #2 reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. The requirements for daily maintenance were as follows: (a) Check Method Settings (b) Check Reagent Levels (c) Check Reagent Onboard Expiration Date(s) (d) Cartridge Injection Count (e) Check Waste Level (f) Pressure Reading (g) Check for Leaks (h) Check Paper Supply (i) Remove Samples (j) Wipe Spills (3) Surveyor #2 then reviewed maintenance records for 4 months (February 2020 through May 2020). There was no evidence the daily maintenance had been performed: (a) Between 04/20/2020 and 04 /24/2020 (b) Between 04/27/2020 and 05/04/2020 (c) Between 05/15/2020 and 05/19 /2020 (4) Surveyor #2 reviewed the records with the general supervisor/technical consultant #1 and technical consultant #2, who stated on 09/22/2021 at 02:47 pm the maintenance had not been performed as required as indicated above. IRIS URINALYSIS TESTING (1) On 09/21/2020 at 11:40 am, the general supervisor /technical consultant #1 and technical consultant #2 stated to surveyor #2 that urinalysis testing was performed on the Iris analyzer; (2) Surveyor #2 reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. The requirements for monthly maintenance were as follows: (a) Perform Instrument Calibration (b) Perform Backup (3) Surveyor #2 then reviewed maintenance records for 6 months (April 2019 through October 2019). There was no evidence the monthly maintenance had been performed: (a) Between 05/06/2019 and 07/01/2019 (4) Surveyor #2 reviewed the records with the general supervisor /technical consultant #1 and technical consultant #2, who stated on 09/23/2021 at 04: 27 pm the maintenance had not been performed as required as indicated above. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. 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 general supervisor/technical consultant #1, the laboratory failed to perform function checks on the blood bank centrifuge as required by the manufacturer. Findings include: (1) On 09/21/2020 at 11:45, technical consultant #2 stated to surveyor #2 the laboratory performed ABO/Rh Type, Antibody Screen, and Compatiblity testing using the Ortho ID MTS Gel system; (2) On 09/23 /2020, surveyor #2 reviewed the manufacturer's instructions for the MTS centrifuge used to process the specimens. The instructions stated the following for confirming daily checks: (a) "Check that the tachometer RPM display reads 895 +/- 25"; (b) "Check that the timer display begins at 10:00 minutes and counts down (9:59, 9:58, etc.). When the timer reaches zero, the display becomes blank". (3) Surveyor #2 reviewed records for patient testing performed in May and August 2019; and January through July 2020. There was no documentation to prove the tachometer RPM and timer displays had been checked for 2 of 5 days in 2019 and 51 of 51 days in 2020 -- 6 of 23 -- when patient Type and Screen Testing (consisted of ABO/Rh and Antibody Screen) and Crossmatch Testing (consisted of ABO/Rh, Antibody Screen, and Compatibility testing) had been performed; (4) On 09/24/2020, surveyor #2 reviewed the records with the general supervisor/technical consultant #1 who stated there was no documentation to prove the tachometer and timer displays had not been checked; (5) The following patient testing had been performed when the tachometer display and timer display had not been documented as observed (number represents medical record number): (a) Patient #32183 - Type and Screen performed on 05/03/2020 (b) Patient #1817 - ABO/Rh Type performed on 08/21/2020 (c) Patient #228712- ABO /Rh type performed on 01/09/2021 (d) Patient #224992- Crossmatch performed on 01 /10/2021 (e) Patient #1817 - Type and Screen performed on 01/13/2020 (f) Patient #1773 - Crossmatch performed on 01/15/2020 (g) Patient #3442 - Crossmatch performed on 01/18/2020 (h) Patient #1817 - Crossmatch performed on 01/24/2020 (i) Patient #80027 - Crossmatch performed on 01/26/2020 (j) Patient #228906 - Type and Screen performed on 01/27/2020 (k) Patient #210543 - Crossmatch performed on 01 /27/2020 (l) Patient #228968 - Crossmatch performed on 02/01/2020 (m) Patient #226671 - Crossmatch performed on 02/02/2020 (n) Patient #228967 - Crossmatch performed on 02/03/2020 (o) Patient #228207 - Type and Screen performed on 02/06 /2020 (p) Patient #228967 - Crossmatch performed on 02/20/2020 (q) Patient #205928 - Crossmatch performed on 02/20/2020 (r) Patient #229211 - ABO/Rh type performed on 02/22/2020 (s) Patient #2912 - Type and Screen performed on 02/24 /2020 (t) Patient #8636 - Crossmatch performed on 02/28/2020 (u) Patient #1046082 - Crossmatch performed on 02/29/2020 (v) Patient #211513 - Crossmatch performed on 03/02/2020 (w) Patient #215103 - Crossmatch performed on 03/06/2020 (x) Patient #17743 - Crossmatch performed on 03/11/2020 (y) Patient #25006 - Crossmatch performed on 03/16/2020 (z) Patient #229544 - Crossmatch performed on 03/27/2020 (aa) Patient #26735 - Crossmatch performed on 04/03/2020 (bb) Patient #19753 - ABO/Rh type performed on 04/04/2020 (cc) Patient #17743 - Crossmatch performed on 04/06/2020 (dd) Patient #217147 - ABO/Rh type performed on 04/08/2020 (ee) Patient #16063 - Crossmatch performed on 04/14/2020 (ff) Patient #25103 - Crossmatch performed on 04/18/2020 (gg) Patient #80027 - Crossmatch performed on 04/21/2020 (hh) Patient #35248 - Antibody screen performed on 04/27/2020 (ii) Patient #229709 - Crossmatch performed on 04/28/2020 (jj) Patient #43938 - Crossmatch performed on 05/02/2020 (kk) Patient #47231 -Type and Screen performed on 05/05/2020 (ll) Patient #41626 - Type and Screen performed on 05/07 /2020; (mm) Patient #21059 - Crossmatch performed on 05/28/2020 (nn) Patient #22059 - Crossmatch performed on 06/03/2020 (oo) Patient #17743 - Crossmatch performed on 06/17/2020 (pp) Patient #28112 - Type and Screen performe on 06/18 /2020 (qq) Patient #7967 - Crossmatch performed on 06/18/2020 (rr) Patient #74333 - Crossmatch performed on 06/22/2020 (ss) Patient #91692 - Crossmatch performed on 06/24/2020 (tt) Patient #227906 - ABO/Rh performed on 06/27/2020 (uu) Patient #29464 - Crossmatch performed on 07/01/2020 (vv) Patient #66571 - Crossmatch performed on 07/09/2020 (ww) Patient #25103 - Crossmatch performed on 07/10 /2020 (xx) Patient #34880 - Crossmatch performed on 07/14/2020 (yy) Patient #17743 - Crossmatch performed on 07/15/2020 (zz) Patient #45029 - Crossmatch performed on 07/16/2020 (aaa) Patient #227379 - Crossmatch performed on 07/19 /2020 (bbb) Patient #21059 - Type and Screen performed on 07/24/2020 (ccc) Patient #25103 - Crossmatch performed on 07/29/2020 (ddd) Patient #17921 - Crossmatch performed on 07/29/2020 D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) -- 7 of 23 -- 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. 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 calibration verification procedures at least once every 6 months. Findings include: (1) On 09/24/2020 at 1:00 pm, technical consultant #2 stated to surveyor #1 Albumin, Alkaline Phosphatase, ALT (Alanine Aminotransferase), Amylase AST (Aspartate Aminotransferase), BUN (Blood, Urea, Nitrogen), CO2, Direct Bilirubin, Total Bilirubin, Calcium, Potassium, CK (Creatine Kinase), Chloride, Sodium, Creatinine, Glucose, Lipase, Magnesium, Phosphorus, Total Protein, HDL (High Density Lipoprotein), Total Cholesterol, Triglyceride, Lactate, GGT (Gamma-Glutamyl Tranferase), LD (Lactate Dehydrogenase), CRP (C- Reactive Protein), Alcohol, Transferrin, Uric Acid, Iron, Ammonia, and Salicylate testing were performed using the Beckman Coulter Unicel SXC 600i analyzer; (2) Surveyor #1 reviewed 2020 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 level, 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) Surveyor #1 reviewed calibration verification records performed from November 2018 through the current date and identified that calibration verification had not been performed as follows: (a) Alcohol - During the review period of 11/05/2018 to date (b) Ammonia - During the review period of 11/05/2018 to date (c) Iron - After - During the review period of 11/05/2018 to date (d) Magnesium - Between 11/05/2018 and 12/30/2019, and after 12/30/2019 (e) Uric Acid - After 11/05/2018 (f) Albumin, Alkaline Phosphatase, ALT, Amylase AST, BUN, CO2, Direct Bilirubin, Total Bilirubin, Calcium, Potassium, CK, Chloride, Sodium, Creatinine, Glucose, Lipase, Phosphorus, Total Protein, HDL, Total Cholesterol, Triglyceride, Lactate, GGT, LD, CRP, Transferrin, and Salicylate - After 12/30/2019 (4) Surveyor #1 reviewed the records with technical consultant #2 and asked if there were additional records to prove calibration verification had been performed every 6 months. Technical consultant #2 stated to surveyor #1 on 09/24/2020 pm at 3:20 pm calibration verification procedures had not been performed as required; (5) The following are examples of patient CMP* testing performed when calibration verification had not been performed: (a) Patient -- 8 of 23 -- #52335 - Testing performed on 06/30/2020 (b) Patient #225964 - Testing performed on 07/01/2020 *Comprehensive Metabolic Panel (CMP) - Albumin, Alkaline Phosphatase, ALT, AST, BUN, Calcium, Chloride, CO2, Creatinine, Glucose, Potassium, Sodium, Total Bilirubin and Total Protein 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 and interview with the general supervisor/technical consultant #1 and technical consultant #2, the laboratory failed to have control procedures that monitored the accuracy and precision of the testing process for Hematology, Coagulation, and Chemistry testing for 8 of 8 months. Findings include: HEMATOLOGY (1) On 09/21/2020 at 11:50 am, technical consultant #2 stated the following to surveyor #2: (a) CBC (Complete Blood Count) testing was performed using the Beckman Coulter DXH 800 analyzer: (b) Three levels of QC (quality control) materials were performed each day of patient testing. (2) On 09/23/2020 surveyor #2 requested QC records (i.e., Levey-Jennings data) for the above testing performed from January 2020 through August 2020 to ensure QC had been monitored for variances. Technical consultant #2 stated on 09/23/2020 at 02:10 pm there were no records (i.e., Levey-Jennings data) proving the control results had been monitored for variances during the review period; (3) The following are examples of patient CBC testing performed when control results had not been monitored for shifts and trends: (a) Patient #23356 - Testing performed on 01/22/2020 (b) Patient #33816 - Testing performed on 01/29/2020 (c) Patient #210355 - Testing performed on 01/30/2020 (d) Patient #27125 - Testing performed on 02/26/2020 (e) Patient #14491 - Testing performed on 02/27/2020 (f) Patient #32114 - Testing performed on 03/30/2020 (g) Patient #212181 - Testing performed on 03/31/2020 (h) Patient #34606 - Testing performed on 04/30/2020 (i) Patient #68564 - Testing performed on 05/29/2020 (j) Patient #20060 - Testing performed on 05/29/2020 (k) Patient #52335 - Testing performed on 06/30/2020 (l) Patient #225964 - Testing performed on 07/01/2020 COAGULATION (1) On 09/21/2020 at 11:57 am, technical consultant #2 stated the following to surveyor #2: (a) PT/INR (Prothrombin Time/International Normalized Ratio), PTT (Partial Thromboplastin Time), and D-dimer testing were performed using the IL ACL TOP analyzer: (b) Two levels of QC materials were performed each eight hours of patient testing. (2) On 09/23/2020 surveyor #2 requested QC records (i. e., Levey-Jennings data) for the above testing performed from January 2020 through August 2020 to ensure QC had been monitored for variances. Technical consultant #2 stated on 09/23/2020 at 02:30 pm there were no records (i.e., Levey-Jennings data) proving the control results had been monitored for variances during the review period; (3) The following are examples of patient PT/INR testing performed when control -- 9 of 23 -- results had not been monitored for shifts and trends: (a) Patient #13734 - Testing performed on 01/30/2020 (b) Patient #34863 - Testing performed on 02/21/2020 (c) Patient #4184 - Testing performed on 02/25/2020 (d) Patient #57067 - Testing performed on 02/27/2020 (e) Patient #60971 - Testing performed on 03/26/2020 (f) Patient #4184 - Testing performed on 03/31/2020 (g) Patient #1492 - Testing performed on 04/29/2020 (h) Patient #57625 - Testing performed on 04/30/2020 (i) Patient #23122 - Testing performed on 05/22/2020 (j) Patient #20841 - Testing performed on 05/26/2020 (k) Patient #60971 - Testing performed on 05/28/2020 (l) Patient #13734 - Testing performed on 06/25/2020 (m) Patient #22209 - Testing performed on 06/30/2020 (n) Patient #4184 - Testing performed on 07/07/2020 CHEMISTRY (1) On 09/24/2020 at 1:00 pm, general supervisor/technical consultant #1 stated the following to surveyor #1: (a) Albumin, Alkaline Phosphatase, ALT (Alanine Aminotransferase), Amylase AST (Aspartate Aminotransferase), BUN (Blood, Urea, Nitrogen), CO2, Direct Bilirubin, Total Bilirubin, Calcium, Potassium, CK (Creatine Kinase), Chloride, Sodium, Creatinine, Glucose, Lipase, Magnesium, Phosphorus, Total Protein, HDL (High Density Lipoprotein), Total Cholesterol, Triglyceride, Lactate, GGT (Gamma-Glutamyl Tranferase), LD (Lactate Dehydrogenase), CRP (C-Reactive Protein), Alcohol, Transferrin, Uric Acid, Iron, Ammonia, and Salicylate testing were performed using the Beckman Coulter Unicel SXC 600i analyzer; (b) Two levels of QC materials were performed each day of patient testing. (2) Surveyor #1 requested QC records (i.e., Levey-Jennings data) for the above testing performed from January 2020 through August 2020 to ensure QC had been monitored for variances. The general supervisor/technical consultant #1 stated on 09/24/2020 at 3:40 pm there were no records (i.e., Levey-Jennings data) proving the control results had been monitored for variances during the review period; (3) The following are examples of patient CMP* testing performed when control results had not been monitored for shifts and trends: (a) Patient #23356 - Testing performed on 01/22/2020 (b) Patient #33816 - Testing performed on 01/29/2020 (c) Patient #210355 - Testing performed on 01/30/2020 (d) Patient #27125 - Testing performed on 02/26/2020 (e) Patient #14491 - Testing performed on 02/27/2020 (f) Patient #32114 - Testing performed on 03/30/2020 (g) Patient #212181 - Testing performed on 03/31/2020 (h) Patient #34606 - Testing performed on 04/30/2020 (i) Patient #68564 - Testing performed on 05/29/2020 (j) Patient #20060 - Testing performed on 05/29/2020 (k) Patient #52335 - Testing performed on 06/30/2020 (l) Patient #225964 - Testing performed on 07/01/2020 *Comprehensive Metabolic Panel (CMP) - Albumin, Alkaline Phosphatase, ALT, AST, BUN, Calcium, Chloride, CO2, Creatinine, Glucose, Potassium, Sodium, Total Bilirubin and Total Protein 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 general supervisor/technical -- 10 of 23 -- consultant #1 and technical consultant #2, the laboratory failed to perform quality control as stated in the IQCP for Clostridium difficile testing. Findings include: (1) On 09/21/2021 at 11:25 am, the general supervisor/technical consultant #1 and technical consultant #2 stated the following to the surveyor: (a) The laboratory performed Clostridium difficile testing using the Quidel Solona kit; (i) Two levels of quality control materials were tested monthly, according to the laboratory IQCP (Individualized Quality Control Plan); (ii) The results for two levels of control materials must be acceptable in order to report patient results. (2) Surveyor #2 reviewed Clostridium difficile quality control records for testing performed from January 2019 through August 2020. For the review period, the following was identified for 2 of 20 months: (a) Monthly quality control results could not be located for the following: (i) Between 01/07/2019 and 04/17/2019 (3) Surveyor #2 reviewed the records with the general supervisor/technical consultant #1 and technical consultant #2, the technical consultant #2 stated on 09/23/2021 at 03:17 pm quality control had not been performed as stated in the IQCP. 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 general supervisor/technical consultant #1 and technical consultant #2, the laboratory failed to provide evidence a negative and positive control material had been performed each day of patient Immunohematology testing. Findings include: (1) On 09/21/2021 at 11:45, technical consultant #2 stated to surveyor #2 the laboratory performed ABO/Rh Type, Antibody Screen, and Compatibility testing using the Ortho ID MTS Gel system; (2) On 09/24 /2021, surveyor #2 reviewed Immunohematology records for testing performed during 01/09/2020 through 07/29/2020. There was no evidence quality control testing had been performed for 51 of 51 days when patient Type and Screen Testing (consisted of ABO/Rh and Antibody Screen) and Crossmatch Testing (consisted of ABO/Rh, Antibody Screen, and Compatibility testing) as follows: (a) Patient #228712- ABO/Rh type performed on 01/09/2020 ; (b) Patient #224992- Crossmatch performed on 01/10 /2021; (c) Patient #1817 - Type and Screen performed on 01/13/2020; (d) Patient #1773 - Crossmatch performed on 01/15/2020; (e) Patient #3442 - Crossmatch performed on 01/18/2020; (f) Patient #1817 - Crossmatch performed on 01/24/2020; (g) Patient #80027 - Crossmatch performed on 01/26/2020; (h) Patient #228906 - Type and Screen performed on 01/27/2020; (i) Patient #210543 - Crossmatch performed on 01/27/2020; (j) Patient #228968 - Crossmatch performed on 02/01 /2020; (k) Patient #226671 - Crossmatch performed on 02/02/2020; (l) Patient #228967 - Crossmatch performed on 02/03/2020; (m) Patient #228207 - Type and Screen performed on 02/06/2020; (n) Patient #228967 - Crossmatch performed on 02 /20/2020; (o) Patient #205928 - Crossmatch performed on 02/20/2020; (p) Patient #229211 - ABO/Rh type performed on 02/22/2020; (q) Patient #2912 - Type and Screen performed on 02/24/2020; (r) Patient #8636 - Crossmatch performed on 02/28 /2020; (s) Patient #1046082 - Crossmatch performed on 02/29/2020; (t) Patient #211513 - Crossmatch performed on 03/02/2020; (u) Patient #215103 - Crossmatch -- 11 of 23 -- performed on 03/06/2020; (v) Patient #17743 - Crossmatch performed on 03/11/2020; (w) Patient #25006 - Crossmatch performed on 03/16/2020; (x) Patient #229544 - Crossmatch performed on 03/27/2020; (y) Patient #26735 - Crossmatch performed on 04/03/2020; (z) Patient #19753 - ABO/Rh type performed on 04/04/2020; (aa) Patient #17743 - Crossmatch performed on 04/06/2020; (bb) Patient #217147 - ABO/Rh type performed on 04/08/2020; (cc) Patient #16063 - Crossmatch performed on 04/14 /2020; (dd) Patient #25103 - Crossmatch performed on 04/18/2020; (ee) Patient #80027 - Crossmatch performed on 04/21/2020; (ff) Patient #35248 - Antibody screen performed on 04/27/2020; (gg) Patient #229709 - Crossmatch performed on 04/28 /2020; (hh) Patient #43938 - Crossmatch performed on 05/02/2020; (ii) Patient #47231 -Type and Screen performed on 05/05/2020; (jj) Patient #41626 - Type and Screen performed on 05/07/2020; (kk) Patient #21059 - Crossmatch performed on 05 /28/2020; (ll) Patient #22059 - Crossmatch performed on 06/03/2020; (mm) Patient #17743 - Crossmatch performed on 06/17/2020; (nn) Patient #28112 - Type and Screen performe on 06/18/2020; (oo) Patient #7967 - Crossmatch performed on 06/18 /2020; (pp) Patient #74333 - Crossmatch performed on 06/22/2020; (qq) Patient #91692 - Crossmatch performed on 06/24/2020; (rr) Patient #227906 - ABO/Rh performed on 06/27/2020; (ss) Patient #29464 - Crossmatch performed on 07/01 /2020; (tt) Patient #66571 - Crossmatch performed on 07/09/2020; (uu) Patient #25103 - Crossmatch performed on 07/10/2020; (vv) Patient #34880 - Crossmatch performed on 07/14/2020; (ww) Patient #17743 - Crossmatch performed on 07/15 /2020; (xx) Patient #45029 - Crossmatch performed on 07/16/2020; (yy) Patient #227379 - Crossmatch performed on 07/19/2020; (zz) Patient #21059 - Type and Screen performed on 07/24/2020; (aaa) Patient #25103 - Crossmatch performed on 07 /29/2020; (bbb) Patient #17921 - Crossmatch performed on 07/29/2020. (3) The surveyor reviewed the records with the general supervisor/technical consultant #1 and technical consultant #2, the general supervisor/technical consultant #1 and technical consultant stated on 09/24/2021 at 03:35 pm there was no evidence quality control testing had been performed as indicated above. 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, observation, and interview with technical consultant #2, the laboratory failed to ensure units of blood were stored under appropriate conditions. Findings include: ALARM CHECKS (1) On 09/21/2020 at 11:45, technical consultant #2 stated to surveyor #2 units of packed red blood cells were stored in the blood bank refrigerator. The units were to be used for patient transfusions; (2) On 09/23/2020, a procedure for performing alarm checks on the blood bank refrigerator could not be located (refer to D5401). Technical consultant #2 stated to surveyor #2 on 09/23/2020 at 2:30 pm, the low and high refrigerator alarm checks were to be performed quarterly (Note: units of packed cells must be stored at 1- 6 degrees Centigrade). (3) Surveyor #2 reviewed records for 2019 and 2020. There was no evidence alarm checks had been performed after 12/31/2019; (4) Surveyor #2 -- 12 of 23 -- reviewed the findings with technical consultant #2 who stated on 09/23/2020 at 3:00 pm, there was no documentation to prove alarm checks had been performed in 2020. THERMOGRAPH CHARTS (1) On 09/21/2020 at 12:00 pm, surveyor #1 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. Each chart monitored the temperature for a 7 day period; (2) On 09/23/2020 surveyor #2 requested refrigerator charts from 12/30/2019 through the current date. Technical consultant #2 stated to surveyor #2 on 09/23/2020 at 10:30 am that refrigerator charts were not available from 12/30/2019 through 08/12/2020; (3) Since the refrigerator charts were not available for review, surveyor #2 could not substantiate that units of packed red blood cells had been stored under appropriate conditions and continuously monitored over a 24-hour period. 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 written policies and procedures, manufacturer's instructions, observation, and interview with the general supervisor/technical consultant #1 and technical consultant #2, the 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 Blood Bank testing and Blood Gas Testing. Refer to D5401; (b) The laboratory failed to ensure policies had been approved, signed, and dated by the laboratory director before use. Refer to D5407; (c) The laboratory failed to ensure control materials were not used beyond the expiration date. Refer to D5417; (d) The laboratory failed to ensure the the performance specifications of a new test system were approved by the laboratory. Refer to D5421; (e) The laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Refer to D5429; (f) The laboratory failed to perform function checks on the blood bank centrifuge as required by the manufacturer. Refer to D5431; (g) The laboratory failed to perform calibration verification procedures at least once every 6 months. Refer to D5439; (h) The laboratory failed to have control procedures that monitored the accuracy and precision of the testing process for Hematology, Coagulation, and Chemistry testing. Refer to D5441; (i) The laboratory failed to perform quality control as stated in the IQCP for Clostridium difficile testing. Refer to D5445; (j) The laboratory failed provide evidence a negative and positive control material had been performed each day of patient Immunohematology testing. Refer to D5449; (k) The laboratory failed to ensure units of blood were stored under appropriate conditions. Refer to D5555. 39088 Based on a review of records and interview with the general supervisor /technical consultant #1 and technical consultant #2, the laboratory failed to have a policy for monitoring the effectiveness of their IQCP. Findings include: (1) On 09/21 /2020 at 11:010 am, technical consultant stated the following to the surveyor: (a) The laboratory performed the following tests on the Alere Triage Analyzer: (i) D-Dimer; (ii) CKMB (iii) Urine Drug Screen (b) An IQCP (Individualized Quality Control Plan) -- 13 of 23 -- had been developed for each test system. (2) Surveyor #2 reviewed the IQCP (dated as approved on 01/07/2016). The QA (Quality Assessment) portion of the IQCP did not include a schedule for evaluating the QCP (Quality Control Plan) to ensure it continued to provide accurate and reliable results; (3) Surveyor #2 reviewed the records with the general supervisor/technical consultant #1 and technical consultant #2, and asked if, in addition to the ongoing monitoring, the QA plan addressed how the laboratory will evaluate the QCP, including the frequency of the reviews. The technical consultant #2 stated on 09/23/2020 at 10:02:45 pm, the QA plan did not include an evaluation of the QCP, and the frequency of the reviews. 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, manufacturer's instructions, written policies and procedures, observation, and interview with the general supervisor/technical consultant #1 and technical consultant #2, the laboratory director failed to provide overall management and direction for moderate complexity testing. 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 proficiency testing samples were tested as required under Subpart H. Refer to D6016; (4) The laboratory director failed to ensure a quality control program was maintained to ensure the quality of laboratory services. Refer to D6020; (5) The laboratory director failed to ensure a quality assessment program had been established and maintained. Refer to D6021; (6) The laboratory director failed to ensure that an approved procedure manual was available to all personnel responsible for the testing process. Refer to D6031. 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 and interview with the general supervisor/technical consultant #1 and technical consultant #2, 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 the reportable ranges had been verified for a new test method; and failed to -- 14 of 23 -- ensure the the performance specifications of a new test system were approved by the laboratory. Refer to D5421. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, observation, and interview with the general supervisor/technical consultant #1 and technical consultant #2, 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 cont

Summary Statement of Deficiencies D0000 The survey was performed 06/18/18 - 06/20/18. The laboratory was found to be in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory manager, technical consultant, and CEO at the conclusion of the survey. 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 the technical consultant and the laboratory manager, the laboratory failed to maintain documentation of quality control testing for at least 2 years. Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor the laboratory used the Ortho ID-MTS Gel System for patient ABO/Rh Type, Antibody Screen, and Compatibility testing; (2) On the second day of the survey, the surveyor reviewed records for the testing from 02/01 /17 through the first day of the survey and identified during 7 of the 16 months reviewed, the lot numbers of gel cards used for QC (Quality Control) testing had not been documented: (a) April 2017 (b) August 2017 (c) December 2017 (d) January 2018 (e) February 2018 (f) March 2018 (g) April 2018 (3) The surveyor reviewed the records with the technical consultant and the laboratory manager who stated to the survey the laboratory failed to include lot numbers of the gel cards used in blood bank testing as listed above: (4) The surveyor explained to the technical consultant and to the laboratory manager, the laboratory must document complete QC records, which would include lot numbers of testing materials. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 -- CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant and the laboratory manager, the laboratory failed to evaluate the accuracy of bleeding time testing at least twice annually. Findings include: (1) On the second day of the survey, the technical consultant stated to the surveyor the laboratory performed patient bleeding time testing; (2) The surveyor asked the technical consultant and the laboratory manager if the laboratory had verified the accuracy of the bleeding time testing procedure at least twice annually in 2017 and to date in 2018. The technical consultant and the laboratory manager stated to the surveyor, the laboratory had not verified bleeding time accuracy in 2017 and to date in 2018. 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 technical consultant and the laboratory manager, the laboratory failed to follow its written policy and procedure for the testing performed. Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor the laboratory performed qualitative serum HCG (Human Chorionic Gonadatropin) testing using the Quidel QuickVue+ One Step test kit. In addition, the technical consultant stated to the surveyor the laboratory had established and implemented an IQCP (Individualized Quality Control Plan) to reduce the performance of external QC (Quality Control) materials from 2 levels each day of patient testing to each 30 days, and/or with a new lot number, or if a review of patient results indicates a potential problem; (2) The surveyor reviewed QC and patient records for the testing from 02/01/17 through the first day of the survey and identified the laboratory failed to follow the IQCP for the testing: (a) Test kit, Lot #703424: QC testing had not performed from 11/01/17 through 12/29/17 (b) Test kit, Lot #703628: QC testing had not been performed from 12/29/17 through 03/05/18 (c) Test kit, Lot #703751: QC testing had not been performed from 03/05/18 through 05/14/18 (3) The surveyor reviewed the findings with the technical consultant and the laboratory manager, who stated to the surveyor the laboratory failed to follow its IQCP for the performance of external QC. 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 -- 2 of 3 -- 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: Based on a review of records, manufacturer's instructions, observation of the freezer, and interview with the technical consultant and the laboratory manager, the laboratory failed to ensure materials were stored as required. Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor the laboratory performed Troponin I and CKMB testing using the Alere Triage Meter Pro analyzer and testing cuvettes and used the Alere Total 5 Control materials to ensure acceptability of the test method; (2) On the third day of the survey, the surveyor observed the contents of the GE Deep Freeze in the laboratory. The surveyor identified 2 boxes of Alere Total 5 Control materials stored inside and the manufacturer's storage requirements: (a) 1 box, Level 1, Lot C3400A. The manufacturer required a storage temperature colder than or equal to -20 degrees C (Centigrade) (b) 1 box, Level 2, Lot C3403A. The manufacturer required a storage temperature colder than or equal to -20 degrees C (3) The surveyor reviewed temperature records from 12/01/17 through 05/31/18 for the GE Deep Freeze and identified the laboratory's acceptable temperature range of -15 to -20 degrees C, would allow the Alere Total 5 Control materials to be stored at temperatures warmer than the required temperature range; (4) The surveyor reviewed the findings with the technical consultant and the laboratory manager, who stated to the surveyor the laboratory's acceptable temperature limits for the GE Deep Freeze would allow storage of the Alere Total 5 Control materials warmer than the manufacturer's storage requirements. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of records, observation, and interview with the technical consultant and the laboratory manager, the laboratory failed to ensure testing materials had not exceeded their expiration date. Findings include: (1) On the third day of the survey, the surveyor observed the contents of the True laboratory refrigerator. The surveyor identified a box of Synchron HDL Calibrators, Lot #M610131, expiration date 05/31 /18 stored inside; (2) The surveyor showed the expired materials to the technical consultant and the laboratory manager who stated to the surveyor the expired materials were available for use and should have been discarded once they expired. -- 3 of 3 --