Memorial Hospital

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions: 493.803; D2016: Successful Participation 493.1403; D6000: Laboratory Director, Moderate Complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to successfully participate in a 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 -- testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to achieve satisfactory performance in three consecutive proficiency testing events for the analyte Blood Gas pO2. (Refer to D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte Blood Gas pO2 in three consecutive testing events. Findings include: (1) The laboratory received the following scores: (a) 40% on the third 2022 event (b) 60% on the first 2023 event (c) 60% on the second 2023 event D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the American Proficiency Institute, the laboratory demonstrated non-initial unsuccessful participation for the analyte Blood Gas pO2 in three consecutive testing events. The laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the American Proficiency Institute, the laboratory demonstrated non-initial unsuccessful participation for the analyte Blood Gas pO2 in three consecutive testing -- 2 of 3 -- events. The laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions 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 Casper 0155D report and proficiency testing Comparative Evaluation obtained from American Proficiency Institute for the third 2022 and first 2023 events, the laboratory failed to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- successfully participate in a proficiency testing program for the subspecialty of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for the analyte Blood Gas pO2. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the the laboratory failed to achieve satisfactory performance for the analyte pO2 in two consecutive testing events. Findings include: (1) The laboratory received a score of 40% on the third 2022 event and a score of 60% on the first 2023 event. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte pO2 in two consecutive events. The laboratory failed to achieve a passing score of 80% for the third 2022 event and first 2023 event. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte pO2 in two consecutive events. The laboratory failed to achieve a passing score of 80% for the third 2022 event and first 2023 event. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions 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 Casper 0155D report and proficiency testing Comparative Evaluation obtained from American Proficiency Institute for the second and third 2022 events, the laboratory failed to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- successfully participate in a proficiency testing program for the subspecialty of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for the analyte Glucose. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluation obtained from American Proficiency Institute, the the laboratory failed to achieve satisfactory performance for the analyte Glucose in two consecutive testing events. Findings include: (1) The laboratory received a score of 0% on the second 2022 event and a score of 40% on the third 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 Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte Glucose in two consecutive events. The laboratory failed to achieve a passing score of 80% for the second 2022 event and third 2022 event. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte Glucose in two consecutive events. The laboratory failed to achieve a passing score of 80% for the second 2022 event and third 2022 event. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/19,20,21/2022. The laboratory was found out of compliance with the following CLIA Conditions of Participation: 493.801; D2000: Enrollment and Testing of Samples 493.1421; D6063: Laboratories Performing Moderate Complexity Testing; Testing Personnel The findings were reviewed with technical consultant #1 and the laboratory manager 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 technical consultant #1, the laboratory failed to enroll in a proficiency testing program for Free Thyroxine testing for five of five events reviewed. Findings include: (1) On 10/19/2021, a review proficiency testing records for 2021 (first, second and third events) and to date in 2022 (first and second events) identified no evidence the laboratory was enrolled in proficiency testing for Free Thyroxine testing for 5 of 5 events; (2) The records were reviewed with technical consultant #1 who stated on 10/19/2022 at 04:30 pm, the laboratory had not enrolled in proficiency testing for Free Thyroxine testing. 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 7 -- 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 technical consultant #1, the laboratory failed to evaluate the accuracy for six of six analytes at least twice annually. Findings include: (1) On 10/19/2021 at 01:30 pm, technical consultant #1 stated the following: (a) Procalcitonin testing was performed on the Roche Cobas e411 analyzer in the laboratory; (b) Salicylate testing was performed on the Roche Cobas Integra 400 analyzer in the laboratory; (c) Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, and Methemoglobin were performed on the Gem Premier 5000 analyzer in the respiratory therapy department. (2) A review of 2021 and 2022 proficiency testing records identified the laboratory had not enrolled and participated in proficiency testing for the six analytes, therefore, it was determined the laboratory must verify the accuracy of the testing at least twice annually; (3) Interview with technical consultant #1 on 10/19/2021 at 04:30 pm confirmed the laboratory did not have a method in place to verify the accuracy of Procalcitonin, Salicylate, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, and Methemoglobin testing twice annually and the accuracy of the testing had not been verified for accuracy during 2021 and to date in 2022. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of written policies and procedures and interview with technical consultant #1, the laboratory failed to have a written procedure for Manual Differential testing using the Cellavision. Findings include: (1) On 10/21/2022 at 10: 00 am, technical consultant #1 stated the laboratory began performing Manual Differential testing using the Cellavision on 08/01/2022; (2) A review of the Hematology procedure manual identified no evidence of a written procedure for Manual Differential testing using the Cellavision; (3) The findings were reviewed with technical consultant #1 who stated on 10/21/2022 at 10:55 am, the laboratory did not have a written procedure for performing manual differentials using the Cellavision. 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. -- 2 of 7 -- This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with technical consultant #1, the laboratory failed to follow the manufacturer's implementation instructions for verifying the normal reference range for two of two new analytes. Findings include: (1) On 10/19/2022 at 01:35 pm, technical consultant #1 stated the laboratory began using the ACL Elite analyzer to perform PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing in January 2022; (2) On 10/20/2022, a review of the manufacturer's implementation instructions under "Normal Reference Interval" stated to use a "minimum of 40 normal donors screened per lab policy". A review of the laboratory policy required using equal numbers of males and females and stated, "All samples should have patient age, sex, and medication history documented. Normal Samples are defined as patients with no major disease state who are not currently taking any anticoagulants (including HIGH dose aspirin low dose is acceptable), or hormone replacement (including birth control)"; (3) A review of the records for the normal reference range study for PT and PTT identified the laboratory had not followed the manufacturer's instructions as follows: (a) Although 40 donors had been used, there was no documentation of the donors age,gender, medication and health history. (4) The records were reviewed with technical consultant #1 who stated on 10/20/22 at 04: 30 pm, the laboratory had not followed the manufacturer's instructions for verifying the normal reference range. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the laboratory failed to ensure the demonstrated reportable ranges were utilized for one of one new test system introduced into the laboratory. Findings include: (1) On 10/19 /2022 at 01:35 pm, technical consultant #1 stated the laboratory began using the ACL Elite analyzer to perform PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing in January 2022; (2) On 10/20/2022, a review of the performance specification records for the new test system identified the following: (a) PT - The laboratory had demonstrated a reportable range of 10.9-42.0; (b) PTT - The laboratory had demonstrated a reportable range of 25.6-50.6. (3) Interview with technical consultant #1 on 10/21/2022 at 01:05 pm confirmed the laboratory was not using the reportable ranges that had been demonstrated as follows: (a) PT - The laboratory was using the manufacturer's reportable range of 8.0-115; (a) PTT - The laboratory was using the manufacturer's reportable range of 5.5-113. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) -- 3 of 7 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with technical consultant #1, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures on one of four analyzers. Findings include: (1) On 10/19/2022 at 01:30 pm, technical consultant #1 stated CBC (Complete Blood Count) testing was performed using the Sysmex XS 1000i analyzer; (2) On 10/20 /2022, a review of the manufacturer's maintenance log showed the following manufacturer required weekly maintenance procedure: (a) "Power Down IPU" (3) A review of maintenance logs from January 2022 through August 2022 revealed the weekly maintenance had not been documented as performed between: (a) 03/23/2022 and 04/06/2022 (b) 08/10/2022 and 08/24/2022 (4) The records were reviewed with technical consultant #1 who stated on 10/20/2022 at 03:24 pm, the weekly 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 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 #1, the laboratory failed to perform calibration verification procedures at least once every 6 months for two of two chemistry analyzers. Findings include: ROCHE COBAS INTEGRA 400 (1) On 10/19/2021 at 01:30 pm, technical consultant #1 stated the laboratory performed Albumin, Alkaline Phosphatase, ALT (Alanine Aminotransferase), Ammonia, Amylase, AST (Aspartate Aminotransferase), Total Bilirubin, Direct Bilirubin, BUN (Blood, Urea, Nitrogen), Calcium, Chloride, Cholesterol, CO2, CK (Creatine Kinase), Creatinine, Direct LDL (Low Density Lipoprotein), Glucose, HDL (High Density Lipoprotein), Lactic Acid, Lipase, -- 4 of 7 -- Magnesium, Phosphorus, Potassium, Total Protein, Sodium, and Triglycerides using the Roche Cobas Integra 400 analyzer; (2) On 10/21/2022 a review of 2022 calibration records identified the calibration procedures for the above analytes had been performed with less than three levels of calibrators therefore, calibration verification procedures, using three or more levels of calibration materials that included a low, mid, and high value, were required every six months; (3) A review of analyzer records from January 2021 through the current date in 2022 identified no evidence calibration verification procedures had been performed; (4) Interview with technical consultant #1 on 10/21/2022 at 11:57 am confirmed calibration verification had not been performed at least once every six months for the above analytes during 2021 and to date in 2022. ROCHE COBAS E411 (1) On 10/19/2021 at 01:30 pm, technical consultant #1 stated the laboratory performed CKMB (Creatine Kinase Isoenzyme), Troponin I, Troponin T, Vitamin B12, Vitamin D, Procalcitonin, TSH (Thyroid Stimulating Hormone), Free T4 (Thyroxine), and HCG (Human Chorionic Gonadotropin) testing using the Roche Cobas e411 analyzer; (2) On 10/21/2022 a review of 2022 calibration records identified the calibration procedures for the above analytes had been performed with less than three levels of calibrators therefore, calibration verification procedures, using three or more levels of calibration materials that included a low, mid, and high value, were required every six months; (3) A review of analyzer records from January 2021 through the current date in 2022 identified calibration verification had not been performed as follows during the review period: (a) Prior to or after 10/18/2021 for CKMB, HCG, TSH, Troponin I, and Troponin T; (b) Not performed during the review period for Vitamin B12, Vitamin D, Procalcitonin, and Free T4. (4) Interview with technical consultant #1 on 10/21/2022 at 11:57 am confirmed calibration verification had not been performed at least once every six months for the above analytes during 2021 and to date in 2022 as shown above. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of written policies and interview with technical consultant #1, the laboratory failed to ensure that written policies provided safety for individuals being transfused for one of three patients reviewed. Findings include: (1) On 10/19/2022 at 01:40 pm technical consultant #1 stated the laboratory stored units of PRBC's (packed red blood cells) in the blood bank refrigerator. The units were to be used for patient transfusions; (2) On 10/21/2022, a review of the hospital policy titled, "Blood and Blood Product Administration" stated "Vital signs should be monitored throughout the transfusion: every 15 minutes for 30 minutes than every 30 minutes thereafter until completion of the transfusion"; (3) A review of records for three patients receiving -- 5 of 7 -- transfusions in October 2021, February 2022, and August 2022 identified no evidence the policy had been followed for one patient for two of three units transfused as follows: (a) Patient #105927 (i) Unit #W091021331075 - The transfusion began on 10 /01/2021 at 10:30 pm and ended on 10/02/2021 at 12:40 am. Vital signs had been documented in a space designated for 15 minutes after the beginning of the transfusion, but the time had not been documented, and there was no documentation of additional vitals as required by policy; (ii) Unit #W091021315658 - The transfusion began on 10/02/2021 at 12:50 am and ended on 10/02/2021 at 03:15 am. Vital signs had been documented in a space designated for 15 minutes after the beginning of the transfusion, but the time had not been documented and there was no documentation of additional vitals as required by policy. (4) The records were reviewed with technical consultant #1 who stated on 10/21/2022 at 11:55 am, the documentation of the vitals for the above units were not available because they had not been scanned into the computer system. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the technical consultant failed to evaluate personnel performing moderate complexity testing in the respiratory therapy department at least annually for one of one person. Findings include: (1) On 10/20/2022, a review of personnel records for persons performing moderate complexity testing in the respiratory therapy department during 2020, 2021, and to date in 2022 identified no evidence of an annual evaluation during 2021 for one of one person (testing person #14): (a) The semi-annual competency had been performed on 07/22/2020 and an annual competency had been performed on 08/17 /2022. (2) The findings were reviewed with technical consultant #1 who stated on 10 /20/2022 at 10:10 am, an annual competency evaluation had not been performed during 2021. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the laboratory failed to ensure an individual who performed moderate complexity testing met the educational qualifications for one of eight persons peforming testing in the respiratory therapy department. Findings include: (1) The laboratory failed to a ensure testing person met the educational qualifications. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) -- 6 of 7 -- (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the laboratory failed to ensure a testing person met the educational qualifications to perform moderate complexity testing for one of eight testing persons performing testing in the respiratory therapy department. Findings include: (1) On 10/20/2022 at 09:30 am, technical consultant #1 stated Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, and Methemoglobin testing were performed on the Gem Premier 5000 analyzer in the respiratory therapy department by eight testing persons as listed on the CMS-209, Laboratory Personnel Report: (2) A review of personnel records for testing person #14 revealed no evidence of an education document to ensure the individual met the moderate complexity personnel requirements; (3) The findings were reviewed with technical consultant #1, who stated on 10/20/2022 at 10:10 am, the education document was not available. -- 7 of 7 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 12/14,15,16/2020 The findings were reviewed with the technical consultant #1, technical consultant #2, and chief operating officer during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulation: 493.1447; D6108: Technical Supervisor D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the laboratory failed to following the manufacturer's instructions for specimen transport and storage for one of 10 patient specimens. Findings include: (1) On 12/14/2020 at 11:30 am, technical consultant #1 stated the following to the surveyor: (a) The laboratory performed COVID-19 testing using the following instrument (i) Abbott ID Now - qualitative detection of nucleic acid from the SARS-CoV-2 viral RNA in direct nasal swabs. (2) On 12/15/2020, the surveyor reviewed the manufacturer's product insert titled, "ID NOW COVID-19" which stated, "Direct nasal, throat or nasopharyngeal swabs should be tested as soon as possible after collection. If immediate testing is not possible, the nasal, throat or nasopharyngeal swab can be held in its original package (or placed in a conical tube and capped tightly) at room temperature (15-30C) for up to one (2) hours prior to testing. If a direct nasal, throat or nasopharyngeal swab specimen will be held longer than two (2) hours, it must be refrigerated at 2-8C and tested within 24 hours from the time of sample collection."; (3) On 12/15/2020, the surveyor reviewed 10 test reports for patients tested from 11/05 /2020 through 12/14/2020 and identified the following: (a) Patient Report #5 - Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- Specimen collection date and time (12/12/2020 at 06:05 am) and the result date and time (12/13/2020 at 07:26 pm), 37 hours and 21 minutes later. (4) The surveyor reviewed the records with technical consultant #1. Technical consultant #1 stated on 12/15/2020 at 03:30 pm the laboratory could not prove the results had been interpreted within one (2) hours after collection as indicated above or refrigerated and tested within 24 hours according to the manufacturer's instructions. 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 technical consultant #1, the laboratory failed to ensure attestation statements were signed by the laboratory director for one of 18 events. Findings include: (1) On 12/14/2020, the surveyor reviewed 2019 and 2020 proficiency testing records, with the following identified: (a) Second Immunohematology 2019 - The attestation statement had not been signed by the laboratory director. (2) The surveyor reviewed the records with technical consultant #1 who stated on 12/14/2020 at 04:35 pm, the attestation statement had not been signed by the laboratory director as indicated above. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with technical consultant #1, the laboratory failed to follow the manufacturer's instructions for test timing for Ammonia testing and Vitamin B12 testing for three of five test reports. Findings include: (1) On 12/14/2021 at 12:45 pm, technical consultant #1 state to the surveyor: (a) The laboratory performed Ammonia testing using the Integra 400; (b) The laboratory performed Vitamin B12 testing using the Cobas e411. (2) On 12/15/2020, the surveyor reviewed the manufacturer's instructions under the section titled, "Specimen collection and preparation" the following was identified: (a) Ammonia - "Place immediately on ice and centrifuge, preferably at 4C. Perform -- 2 of 13 -- analysis within 20-30 minutes of venipuncture or freeze separated plasma immediately." (b) Vitamin B12 - "Due to possible evaporation effects, samples, calibrators and controls on the analyzers should be analyzed/measured within 2 hours.". (3) On 12/15/2021, the surveyor then reviewed patient testing records from 10 /06/2020 through 12/12/2020 and identified the following for three of five patient test reports: (a) Ammonia (i) Patient #109970 - The collection date and time was on 10/06 /2020 at 12:30 pm and the result date and time was on 10/06/2020 at 01:48 pm (one hour and 18 minutes later). (ii) Patient #21760 - The collection date and time was on 12/01/2020 at 01:50 pm and the result date and time was on 12/01/2020 at 04:06 pm (two hours and 16 minutes later). (b) Vitamin B12 (i) Patient #109419 -The collection date and time was on 12/08/2020 at 12:11 pm and the result date and time was on 12 /08/2020 at 02:54 pm (2 hours and 43 minutes later). (4) The surveyor reviewed the findings with technical consultant #1. Technical consultant #1 stated on 12/15/2021 at 04:15 pm, the laboratory could not prove the specimen was collected, tested, and resulted as required by the manufacturer. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with technical consultant #1, the laboratory failed to follow the manufacturer's instructions for implementing one of one coagulation reagent. Findings include: (1) On 12/14 /2020 at 12:40 pm, technical consultant #1 stated to the surveyor the ACL Elite analyzer was used to perform PT/INR (Prothrombin Time/International Normalized Ratio). The INR was calculated using the PT reference interval mean; (2) On 12/16 /2020 the surveyor reviewed the manufacturer's instructions contained in the "Hemostasis Performance Verification Manual" for implementing new reagents, which stated, "When changing to a new lot number of reagent or a new reagent, it is important to establish a new normal reference interval, establish new assay control ranges, and perform a comparison study for all tests". In addition, the manufacturer required the following: (a) Section titled "Establishing a Normal Reference Interval" (i) "Donors should be healthy and have no known pathological conditions. Don't use samples from in-patients (due to medical conditions and treatment regiments). Donors should not be on medication affecting coagulation, including (but not limited to) oral contraceptives, estrogen therapy (HRT), anticoagulants, high-does aspirin, etc."; (3) The surveyor reviewed the implementation records for Recombiplastin PT reagent lot #N0696619, with the following identified: (a) There was no evidence of the age and health status of the donors. (4) The surveyor reviewed the findings with technical consultant #1 who stated on 12/16/2020 at 02:55 pm, the manufacturer's instructions had not been followed for the reagent lot change as specified above. 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 -- 3 of 13 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the laboratory failed to ensure reagents had not exceeded their expiration date for one of nine days. Findings include: (1) On 12/14/2020 at 01:10 pm, technical consultant #1 stated to the surveyor Crossmatch testing was performed in the laboratory which included ABO Typing using Ortho MTS Gel system; (2) On 12/15/2020, the surveyor reviewed quality control and patient testing records for testing performed from 12/16 /2019 through 12/29/2019 and identified expired Ortho Confidence system (Ortho Confidence Cell 1, Ortho Confidence Cell 2, and Ortho Confidence Antibody) used to validate blood bank procedures had been used one of nine days of testing reviewed. The quality control and patient testing had been performed on 12/20/2019 using the following expired reagents: (a) Ortho Confidence System lot #CNF171, expiration date 12/19/2019. (3) The surveyor reviewed the records with technical consultant #1 who stated on 12/15/2020 at 04:10 pm new reagents were used but not documented on the Daily Blood Bank Quality Control log. 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, manufacturer's reportable ranges, and interview with technical consultant #1, the laboratory failed to ensure the reportable ranges were utilized for two of two new test methods. Findings include: COBAS e411 (1) On 12/14 /2020 at 01:15 pm, technical consultant #1 stated to the surveyor, TSH (Thyroid Stimulating Hormone), Vitamin B12, and Vitamin D testing were performed using the Cobas e411 (Serial number 18R5-05) and available for patient use on 07/01/2020; (2) On 12/15/2020, the surveyor reviewed the performance specification records and identified the laboratory had demonstrated the following reportable ranges: (a) TSH - 0.09 - 92.91L (b) Vitamin B12 - 241.1 - 2000 pg/mL (c) Vitamin D - 5 - 96.9 g/mL (3) The surveyor then requested documentation to show the reportable ranges that were being utilized by the laboratory. The laboratory was using the following manufacturer's reportable ranges: (a) TSH - 0.005 - 100.0 L (b) Vitamin B12 - 50.0 - 2000 pg/mL (c) Vitamin D - 5 - 100.0 g/mL (4) The surveyor reviewed the findings with technical consultant #1, who stated on 12/15/2020 at 03:30 pm, the laboratory was not using the reportable ranges that had been demonstrated by the laboratory as shown above. GEM PREMIER 5000 (1) On 12/14/2020 at 01:25 pm, technical consultant #1 stated to the surveyor, Arterial Blood Gas testing was performed using the Gem Premier 5000 and available for patient use on 03/12/2020; (2) On 12/15 /2020, the surveyor reviewed the performance specification records identified the laboratory had demonstrated the following reportable ranges: (a) pH - 7.0 - 7.72 (b) pO2 - 32.0 - 551.0 mmHg (c) pCO2 - 19.0 - 124.0 mmHg (3) The surveyor then -- 4 of 13 -- requested documentation to show the reportable ranges that were being utilized by the laboratory. The laboratory was using the following manufacturer's reportable ranges: (a) pH - 7.0 - 7.92 (b) pO2 - 6.0 - 690.0 mmHg (c) pCO2 -6.0 - 125.0 mmHg (4) The surveyor reviewed the findings with technical consultant #1, who stated on 12/15 /2020 at 04:30 pm, the laboratory was not using the reportable ranges that had been demonstrated by the laboratory as shown 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 and interview with technical consultant #1, the laboratory failed to ensure units of blood were stored under appropriate conditions for one of nine refrigerator temperature charts. Findings include: (1) On 12/14/2020 at 01: 00 pm, technical consultant #1 stated the following to the surveyor: (a) The laboratory stored units of packed red blood cells in the blood bank refrigerator; (b) The units were to be used for patient transfusions. (2) On 12/14/2020 at 01:10 pm, the surveyor observed the thermograph temperature recorder for the blood bank refrigerator. It had a recorder connected to it for continuously recording the temperature on thermograph charts (Note: units of packed cells must be stored at 1-6 degrees (C) Centigrade). Each chart monitored the temperature for a seven day period; (3) On 12/16/2020, the surveyor reviewed nine refrigerator charts dated from 05/04/2020 through 07/07/2020. The review showed that one of nine charts had not been changed by the 7th day of usage as follows: (a) Chart #1 - The chart was put into use on 05/04/2020 and removed on 05/12/2020 (8 days). (4) The surveyor reviewed the findings with technical consultant #1 who stated on 12/16/2020 at 11:15 am, the chart had not been changed by the 7th day as stated above. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of a patient reports and interview with technical consultant #1, the laboratory failed to provide appropriate normal reference intervals for one of one test report for Beta HCG testing; one of one test report for ProBNP testing; one of one test report for Arterial Blood Gas testing; one of one test report for Ammonia testing; and one of one test report for Prothrombin Time testing. Findings include: BETA HCG, PROBNP, ARTERIAL BLOOD GAS, AMMONIA NORMAL REFERENCE RANGES (1) On 12/14/2020 at 11:25 am, technical consultant #1 stated the following to the surveyor: (a) Quantitative Beta HCG (Human Chorionic Gonadotropin) and -- 5 of 13 -- ProBNP testing were performed on the Cobas e411analyzer; (b) Arterial Blood Gas (pH, pCO2, pO2) testing was performed on the GEM Premier 5000 analyzer; (c) Ammonia testing was performed on the Cobas 400 Plus analyzer. (2) The surveyor reviewed the following reports and identified the following: (a) Patient report on 12/14 /2020 at 02:33 pm did not include a normal reference range for Beta HCG testing; (b) Patient report on 11/30/2020 at 08:22 pm did not include a normal reference range for ProBNP testing; (c) Patient report on 11/21/2020 at 06:05 pm did not include normal reference rangeS for Arterial Blood Gas testing; (d) Patient report on 11/30/2020 at 03: 14 pm did not include a normal reference range for Ammonia testing. (3) The surveyor reviewed the reports with technical consultant #1, who stated on 12/15/2020 at 04:20 pm the above patient reports did not include normal reference ranges as indicated above. PROTHROMBIN TIME NORMAL REFERENCE RANGE (1) On 12/14/2020 at 11:35 am, technical consultant #1 stated the following to the surveyor (a) Technical consultant #1 stated to the surveyor the laboratory performed PT (Prothrombin Time) testing on the ACL Elite analyzer. In addition the following reagent was put into use on 03/04/2020: (a) Recombinplastin PT reagent lot #N0696619 (2) On 12/16/2020, the surveyor reviewed the PT reagent implementation records and identified the laboratory had verified a PT normal reference interval of 10.6 - 12.9 seconds; (3) On 12/16/2020, the surveyor then reviewed a patient PT report dated 11/24/2020 at 06:16 am with a normal reference range of 9.3 - 13.5 seconds; (4) The surveyor reviewed the findings with technical consultant #1. On 12 /16/2020 at 02:45 pm, technical consultant #1 stated that although the laboratory had established a PT normal reference interval with the PT reagent lot change, the laboratory had not implemented the change into the laboratory's computer information system. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the technical supervisor failed to provide technical supervision in accordance with 493.1447 of this subpart. Findings include: (1) The technical supervisor failed to ensure the individual who performed the duties and responsibilities of the technical supervisor met the educational qualifications. Refer to D6111. D6111 TECHNICAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1449 (a) The technical supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory may perform anatomic and clinical laboratory procedures and tests in all specialties and subspecialties of services except histocompatibility and clinical cytogenetics services provided the individual functioning as the technical supervisor-- (b)(1) Is 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)(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or Possesses qualifications that are equivalent to -- 6 of 13 -- those required for such certification. (c) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, the individual functioning as the technical supervisor must-- (c)(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 (c)(1)(ii) Be certified in clinical pathology 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 (c)(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 (c)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (c)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (c)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; and (c)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology. (d) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycobacteriology, the individual functioning as the technical supervisor must-- (d)(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 (d)(1)(ii) Be certified in clinical pathology 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 (d) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (d)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (d)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (d)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (d)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 -- 7 of 13 -- months experience in high complexity testing within the subspecialty of mycobacteriology. (e) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycology, the individual functioning as the technical supervisor must-- (e)(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 (e)(1)(ii) Be certified in clinical pathology 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 (e) (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 (e)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (e)(3)(ii) Have at least 1 year of laboratory training or experience, or both in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(4) (i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (e)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (e)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology. (f) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of parasitology, the individual functioning as the technical supervisor must-- (f)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (f)(1)(ii) Be certified in clinical pathology 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 (f)(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 (f)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; (f)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (f)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (f)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (f)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum -- 8 of 13 -- of 6 months experience in high complexity testing within the subspecialty of parasitology. (g) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of virology, the individual functioning as the technical supervisor must-- (g)(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 (g)(1)(ii) Be certified in clinical pathology 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 (g) (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 (g)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (g)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (g)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (g)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology. (h) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of diagnostic immunology, the individual functioning as the technical supervisor must- (h)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (h)(1)(ii) Be certified in clinical pathology 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 (h)(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 (h)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (h)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of diagnostic immunology; or (h)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (h)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (h)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology. (i) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of chemistry, the individual functioning as the technical supervisor must-- (i)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the -- 9 of 13 -- laboratory is located; and (i)(1)(ii) Be certified in clinical pathology 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 (i)(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 (i)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (i)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of chemistry; or (i) (4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (i)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (i)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry. (j) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of hematology, the individual functioning as the technical supervisor must-- (j)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (j)(1)(ii) Be certified in clinical pathology 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 (j)(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 (j)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of hematology (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (j) (3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (j)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of hematology; or (j)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (j)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology; or (j) (5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (j)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology. (k)(1) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of cytology, the individual functioning as the technical supervisor must-- (k)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (k)(1)(ii) Meet one of the following requirements-- (k)(1)(ii)(A) Be certified in anatomic pathology 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 (k)(1)(ii) (B) Be certified by the American Society of Cytology to practice cytopathology or possess qualifications that are equivalent to those required for such certification; (l) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of histopathology, the individual functioning as the technical supervisor must-- (l)(1) Meet one of the following requirements: (l)(1)(i)(A) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or -- 10 of 13 -- osteopathy in the State in which the laboratory is located; and (l)(1)(i)(B) Be certified in anatomic pathology 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; (l)(1)(ii) An individual qualified under 493.1449(b) or paragraph (l)(1) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (l)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens. (l)(2) For tests in dermatopathology, meet one of the following requirements: (l)(2)(i)(A) 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-- (l) (2)(i)(B) Meet one of the following requirements: (l)(2)(i)(B)(1) Be certified in anatomic pathology 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 (l)(2)(i)(B)(2) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B) (3) Be certified in dermatology by the American Board of Dermatology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(ii) An individual qualified under 493.1449(b) or paragraph (l)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens. (l) (3) For tests in ophthalmic pathology, meet one of the following requirements: (l)(3)(i) (A) 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-- (l)(3)(i)(B) Must meet one of the following requirements: (l)(3)(i)(B)(1) Be certified in anatomic pathology 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 (l)(3)(i)(B)(2) Be certified by the American Board of Ophthalmology or possess qualifications that are equivalent to those required for such certification and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or (l)(3)(ii) An individual qualified under 493.1449(b) or paragraph (1)(3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (1)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or (m) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of oral pathology, the individual functioning as the technical supervisor must meet one of the following requirements: (m)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (m)(1)(ii) Be certified in anatomic pathology 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 (m)(2) Be certified in oral pathology by the American Board of Oral Pathology or possess qualifications for such certification; or (m)(3) An individual qualified under 493.1449(b) or paragraph (m)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (m)(1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens. (n) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of radiobioassay, the individual functioning as the technical supervisor must-- (n)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (n)(1)(ii) Be certified in clinical pathology by the American -- 11 of 13 -- Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (n)(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 (n)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (n)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of radiobioassay; or (n)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (n)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (n)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay. (o) If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either-- (o)(1)(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 (o)(1)(ii) Have training or experience that meets one of the following requirements: (o)(1)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(1)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or (o)(2)(i) Have an earned doctoral degree in a biological or clinical laboratory science from an accredited institution; and (o)(2)(ii) Have training or experience that meets one of the following requirements: (o) (2)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(2)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(2)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility. (p) If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning as the technical supervisor must-- (p)(1)(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 (p)(1)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics; or (p)(2)(i) Hold an earned doctoral degree in a biological science, including biochemistry, or clinical laboratory science from an accredited institution; and (p)(2)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics. (q) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of immunohematology, the individual functioning as the technical supervisor must-- (q)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (q)(1)(ii) Be certified in clinical pathology 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 (q)(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 (q)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology. Note: The technical supervisor requirements for "laboratory training or experience, or both'' in each -- 12 of 13 -- specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service. For example, an individual, who has a doctoral degree in chemistry and additionally has documentation of 1 year of laboratory experience working concurrently in high complexity testing in the specialties of microbiology and chemistry and 6 months of that work experience included high complexity testing in bacteriology, mycology, and mycobacteriology, would qualify as the technical supervisor for the specialty of chemistry and the subspecialties of bacteriology, mycology, and mycobacteriology. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the technical supervisor failed to ensure that individuals who performed the duties and responsibilities of the technical supervisor, met the qualifications for two of six proficiency testing attestation forms. Findings include: (1) On 12/14/2020, the surveyor reviewed the Laboratory Personnel Report (Form CMS-209), that had been completed by the laboratory. The form listed the same individual as the laboratory director and the technical supervisor; (2) The surveyor then reviewed proficiency testing records for the following events: (a) Immunohematology - First 2019, second 2019, third 2019, first 2020, second 2020, and third 2020. (3) The documentation showed that the attestation statements for two of six events (first and third 2019) had been signed by technical consultant #1 instead of the laboratory director/technical supervisor (technical consultant #1 had a bachelor degree in science); (4) The findings were reviewed with technical consultant #1 who stated to the surveyor on 12/14/2020 at 04:30 pm, the attestation statements for the above events had been signed by a person who did not qualify as a technical supervisor. -- 13 of 13 --

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 ABO Group and D (Rho) Typing. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for ABO Group Typing. Refer to D2160 and D2162. 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 -- D2160 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(e) (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) For any unacceptable analyte or unsatisfactory 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 ABO Group Typing. Findings include: (1) The laboratory failed to achieve satisfactory performance on the First 2020 Event and the Second 2020 Event. Refer to D2162. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The recertification survey was performed 09/17,18,19/18. The laboratory was found out of compliance with the following CLIA regulation: 493.1409; D6033: Technical Consultant The findings were reviewed with chief operating officer, technical consultant, laboratory manager, and respiratory therapy department supervisor during an exit conference performed 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, observation, and interview with the laboratory manager, technical consultant, and testing person #3 the laboratory failed to maintain quality control records for at least 2 years. Findings include: (1) On the first day of the survey, the laboratory manager stated to the surveyors Ammonia testing was performed using the Siemens Dimension EXL 200 analyzer; (2) On the second day of the survey, the laboratory manager stated to surveyor #1 three levels of Bio-Rad Liquichek Ammonia quality control (QC) materials were tested on the analyzer each day of patient testing: (3) Surveyor #1 then observed the following lot numbers of QC materials in the refrigerator, that were currently in use for Ammonia testing: (a) Bio- Rad Liquichek Ammonia controls level 1 lot #54191, level 2 lot #54192, and level 3 lot #54193. (4) Surveyor #1 asked the technical consultant and testing person # 3 for documentation verifying how the laboratory established their means and limits of acceptability for the QC materials, and the dates the materials were put into use for patient testing. Testing person #3 stated the materials were put into use on 04/01/17, however, there was no documentation verifying the establishment of the means and limits; (5) Surveyor #1 reviewed QC records from 04/01/17 through 08/31/17; 12/01 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- /17 through 12/31/17; and 06/01/18 through 08/31/18. There was no evidence in the records to substantiate how the means and limits had been derived; (6) Surveyor #1 reviewed the findings with the technical consultant who stated documentation to substantiate how the means and limits had been established could not be located. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to thoroughly review and evaluate proficiency testing results. Findings include: (1) On the first day of the survey, surveyor #2 reviewed 2017 and 2018 proficiency testing records and identified the following failures, in which