Battle Mountain General Hospital Lab

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on January 13-14, 2025. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the laboratory 2023 and 2024 American Proficiency Institute (API) Proficiency Testing (PT) records, and an interview with the laboratory manager, the laboratory director failed to attest to the routine integration of the PT samples and to ensure the analysts performing the testing signed the attestations. Findings include: 1. A review of the 2023 and 2024 API PT records found that the second testing event for Chemistry Miscellaneous in 2023 was missing the attestation. 2. A review of the 2023 and 2024 API PT records found that the first event of Microbiology in 2024 did not have the laboratory director's signature. 3. An interview with the laboratory manager on January 13, 2025, at approximately 3:00 PM confirmed these findings. The laboratory performs approximately 50,355 chemistry and 1350 Microbiology tests annually. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) 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 -- (d) 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, blood banking control logs, a review of the transfusion logs, and an interview with the laboratory manager, the laboratory failed to perform and document blood banking quality controls (QC). Findings include: 1. The laboratory director approved policy titled "Quality Assurance For Blood Bank" stated that quality controls must be performed "Daily whenever patient testing takes place". 2. A review of the 2023 and 2024 transfusion records found that patients were tested on the following dates: 6/11/2023, 8/25/2023, 1/10 /2024, 3/11/2024, 6/28/2024, and 6/30/2024. 3. A review of the 2023 and 2024 blood banking QCs revealed that the laboratory failed to document the daily QC required when patient testing is performed according to the patient testing dates listed in finding number 2 above. 4. An interview with the laboratory manager on January 13, 2025, at approximately 3:00 PM confirmed these findings. The laboratory performs approximately 120 immunohematology tests annually. D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, blood banking controls logs and an interview with the laboratory manager, the laboratory failed to establish written policies and procedures for the temporary use of expired reagents when non- expired reagents are not available. Findings include: 1. The laboratory director approved policy titled "Quality Assurance For Blood Bank" states "Do not use the reagents after the expiration date shown on the vials, when circumstance prevents the shipment of new reagents in a timely manner refer to the "Delay in Shipment" bulletin". The delay in shipment bulletin was not available for review. 2. The screen cell reagent (lot 3SS554) expired 11/26/2024 and was used on 11/27/2024, 12/3/2024, 12/12/2024 and 12/13/2024. 3. The A1/B cells (lot A860) expired 12/10/2024 and was used on 12/12/2024 and 12/13/2024. 4. The Coombs cells (lot K989) expired 12/3 /2024 and was used on 12/12/2024 and 12/13/2024. 5. A comment on the blood bank control logs indicated that each expired reagents were tested twice on the days of use -- 2 of 3 -- after the expiration date. 6. There was no laboratory director policy available to indicate that this is the correct process for using expired blood bank control reagents. 7. An interview with the laboratory manager on January 13, 2025, at approximately 3: 00 PM confirmed these findings. The laboratory performs approximately 120 immunohematology tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on 11/08-09/2022. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) records for blood gases and interview with the respiratory care supervisor and the laboratory manager, the laboratory failed to test blood gas PT samples by personnel who routinely perform the testing in the laboratory. Findings include: 1. PT records reviewed for blood gases for American Proficiency Institute (API) PT program for 2021 and 2022, revealed that the PT testing was performed by the respiratory care supervisor for the testing events. 2. Interview with the respiratory care supervisor on 11/09/2022 at approximately 11:30 AM revealed that venous blood gas testing on the Opti CCA T52 was performed by the three clinical laboratory testing personnel when the respiratory care supervisor was not on duty. 3. The laboratory manager indicated on 11/09/2022 at approximately 11:45 AM, that the three clinical laboratory testing personnel did not participate with the blood gas PT testing events. The laboratory performs approximately 41,183 chemistry tests annually. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 observation and interview with the laboratory manager, the laboratory failed to ensure that laboratory reagents were not used after their expiration date. Findings include: 1. A tour of the microbiology section revealed a bottle of Gram's iodine which expired on 9/22/2022 available for use. The bottle was opened on 9/26/2022 and used for quality control testing. A new shipment of unexpired Gram's iodine was received by the laboratory on 10/24/2022. 2. The media refrigerator contained an open box of thioglycollate tubes which expired on 10/17/2022 available for use. A box of unexpired thioglycollate tubes was found in the refrigerator. 3. The laboratory manager confirmed the findings during the survey on 11/08/2022 at approximately 1: 00 PM. The laboratory performs approximately 799 microbiology tests annually. 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 review of the Triage D-Dimer test procedure, review of the quality control records for the Triage D-Dimer and interview with the laboratory manager, the laboratory failed to perform two levels of external controls each day of testing patient samples. Findings include: 1. The laboratory failed to perform two levels of external controls each day of patient testing. The quality control records reviewed for January to October 2022 revealed that two levels of controls were performed every 30 days and with each new shipment of of the test cassettes. 2. The laboratory's procedure, "Triage D-Dimer" test procedure states, "The use of positive and/or negative controls is recommended to assess each shipment of product, and at least every 30 days, or whenever the laboratorian wishes to verify the performance of the controls or the test." 3. The laboratory manager confirmed the findings during the survey on 11/08 /2022 at approximately 3:00 PM and indicated that the Individualized Quality Control Plan was not developed for the Triage D-Dimer test. The laboratory performs approximately 27,543 hematology tests annually. D5813 TEST REPORT CFR(s): 493.1291(g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure, "Critical Laboratory Values," review of laboratory reports, and interview with the laboratory manager, the laboratory failed to follow the director approved procedure and document that critical values were called to the responsible party in the computer system. Findings include: 1. A review of two patient reports with critical values, on the laboratory computer system, patient with initials, JO from 5/09/2022 with a glucose value of 535 and patient with initials, JR from 6/29/2022 with a positive blood culture, revealed that the laboratory staff did not document the name of the person notified in the laboratory information system as required by the laboratory procedure, "Critical Laboratory Values." 2. "Critical Laboratory Values," states, "8. Document the receiver's name in the computer system. 9. If delivered face-to-face document the receiver's name in the computer system." 3. The laboratory manager confirmed the findings during the survey on 11/09/2022 at approximately 10:45 AM. The laboratory performs approximately 41,183 chemistry and 799 microbiology tests annually. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on review of patient reports for November 2022, review of the laboratory procedure, "Corrected Reports," and interview with the laboratory manager, the laboratory failed to follow the director approved laboratory procedure and add required documentation to the corrected reports. Findings include: 1. Patient report reviewed for patient with initials, RL from 11/06/2022, revealed corrected results for calcium. On 11/06/2022 at 9:59 PM, the result was amended from 9.0 to 0.0. On 11/07 /202 at 8:55 AM, the calcium result was amended from 0.0 to 8.9. There was no documentation of who was notified, time of notification, and the date of notification in the LIS as required by the laboratory procedure. 2. Laboratory procedure,, "Corrected Reports," states, "4.a. Healthcare providers or healthcare personnel must be notified when changes in reported results may affect patient treatment. Any results that is corrected and has gone from normal value to an abnormal value or from an abnormal value to a normal value must be called to the caregiver or RN immediately. Documentation of notification must be put into the LIS. This documentation must include: who was notified, time of notification, and the date of notification." 3. The laboratory manager confirmed the findings during the survey on 11/09/2022 at approximately 10:45 AM. The laboratory performs approximately 41,183 chemistry tests annually. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on review of laboratory records, review of laboratory procedures and interview with the laboratory manger, the laboratory director failed to ensure that quality assessment (QA) programs were maintained to assure the quality of laboratory services provided. Findings include: 1. The QA program failed to identify and take

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was generated as a result of the CLIA proficiency testing desk review conducted off-site for your laboratory on 8/07/2022. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 desk review of federal database CASPER Report 155D and American Proficiency Institute (API) proficiency testing (PT) evaluation forms on 8/07/2022, 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 -- the laboratory did not successfully participate in a proficiency testing program. The laboratory's failure to achieve an overall satisfactory proficiency testing event performance for two consecutive testing events for the first and second testing events of 2022 with a score of 60% in each event resulted in unsuccessful proficiency testing performance for the analyte, sodium. Findings include: The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for sodium in the first and second testing events of 2022. 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 desk review of federal database CASPER Report 155D and API PT evaluation forms on 8/07/2022, the laboratory did not successfully participate in a proficiency testing program. Findings include: 1. The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for sodium in the first and second testing events of 2022. 2. CASPER Report 155D and the API PT evaluation both reported scores of 60% for the first and second testing events of 2022. 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 desk review of federal database CASPER Report 155D and API PT evaluation forms on 8/07/2022, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory Director was not met. The laboratory director failed to provide overall management and direction in accordance with CFR 493.1407. Findings include: The laboratory director failed to ensure that the laboratory successfully participated in a PT program approved by CMS; as described in subpart 1 of this part for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA. 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on desk review of federal database CASPER Report 155D and API PT evaluation forms on 8/07/2022, the laboratory director failed to ensure that proficiency testing samples were tested as required. Findings include: 1. The laboratory failed to achieve satisfactory performance for sodium in the first and second testing events of 2022 resulting in unsuccessful PT performance. 2. CASPER Report 155D and API PT evaluation forms reviewed reported 60% scores for sodium for the first and second testing events of 2022. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on 3/31/2021. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 review of the laboratory's patient reports and interview with the laboratory supervisor, the laboratory failed to verify the blood gas reference intervals (normal values) for venous blood are appropriate for the laboratory's patient population. Findings include: 1. An interview with the respiratory services supervisor on 3/31 /2021 at approximately 1:45 PM revealed that the laboratory added testing for blood gases using venous blood in November 2020. The supervisor confirmed that the laboratory did not verify the reference intervals for venous blood gases were appropriate for the laboratory's patient population and used the same reference intervals used for arterial blood gases. 2. Review of patient blood gas reports, Patient #56639 from 1/04/2021 reported at 8:48 PM from a venous sample, and Patient #50810 from 1/27/2021 reported at 5:35 PM from an arterial sample, used the same 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 -- reference intervals for the different specimen types. 3. The laboratory performs approximately 30 blood gas analyses annually. 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 review of the blood bank's worksheets, the blood bank quality control records, and the laboratory's policy, and interview with the laboratory manager, the laboratory failed to follow their policy and perform tests using a negative and positive control material at least once a day patient specimens are examined. Findings include: 1. A review of the blood bank's worksheets and quality control records from 8/07 /2020 through 3/30/2021 revealed quality control testing was not performed and documented on 11/13/2020 and 2/18/2021. 2. ABO and Rh typing was performed on 11/13/2020 and ABO and Rh typing, antibody screen, and compatibility testing were performed on 2/18/2021. 3. Laboratory procedure, "Quality Assurance for Blood Bank," effective 10/18/2018, section VIII. When to Run the Quality Control states, "Quality control must be run at least to include: 2. Daily whenever patient testing takes place." 4. The laboratory manager confirmed the findings during the on-site survey on 3/31/2021 at approximately 3:00 PM. 5. The laboratory performs approximately 116 immunohematology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was generated as a result of the CLIA proficiency testing desk review, conducted off-site for your laboratory on 4/27/2020. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 self-reporting by the laboratory director and laboratory manager on 4/22 /2020 and desk review of the American Proficiency Institute (API) proficiency testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- (PT) evaluation forms, the laboratory did not successfully participate in a proficiency testing program. The laboratory's failure to achieve an overall satisfactory proficiency testing event performance for two out of three testing events for basophils, red cell count, hematocrit, hemoglobin, white cell count, and platelet count, with a score of 0% for each listed analyte for the second testing event of 2019 and with a score of 60% for each listed analyte for the first testing event of 2020, resulted in unsuccessful proficiency testing performance. Findings include: The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for basophils, red cell count, hematocrit, hemoglobin, white cell count, and platelet count in the second testing event of 2019 and the first testing event of 2020 with scores of 0% and 60%, respectively. The laboratory director and laboratory manager contacted the CLIA surveyor on 4/22/2020 at approximately 9:30 AM to report the PT failure. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on self-reporting by the laboratory director and laboratory manager on 4/22 /2020 and desk review of the American Proficiency Institute (API) proficiency testing (PT) evaluation forms, the laboratory did not successfully participate in a proficiency testing program. The laboratory's failure to achieve an overall satisfactory proficiency testing event performance for two out of three testing events for basophils, red cell count, hematocrit, hemoglobin, white cell count, and platelet count, with a score of 0% for each listed analyte for the second testing events of 2019 and with a score of 60% for each listed analyte for the first testing event of 2020, resulted in unsuccessful proficiency testing performance. Findings include: The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for basophils, red cell count, hematocrit, hemoglobin, white cell count, and platelet count with a score of 0% for each listed analyte for the second testing event of 2019 and a score of 60% for each listed analyte for the first testing event of 2020. The laboratory director and laboratory manager contacted the CLIA surveyor on 4/22/2020 at approximately 9:30 AM to report the PT failure. 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 self-reporting by the laboratory director and laboratory manager on 4/22 /2020 and desk review of the API PT evaluation report, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory Director was not met. The laboratory director failed to provide overall management and direction in accordance with CFR 493.1407. Findings include: The laboratory director failed to ensure that the laboratory successfully participated in a PT program approved by CMS; as described -- 2 of 3 -- in subpart 1 of this part of each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA. 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 self-reporting by the laboratory director and laboratory manager on 4/22 /2020 and desk review of the API PT evaluations, the laboratory director failed to ensure that PT samples were tested as required under Subpart H of this part. Findings include: The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for basophils, red cell count, hematocrit, hemoglobin, white cell count, and platelet count with a score of 0% for each listed analyte for the second testing event of 2019 and a score of 60% for each listed analyte for the first testing event of 2020. The laboratory director and laboratory manager contacted the CLIA surveyor on 4/22/2020 at approximately 9:30 AM to report the PT failure. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on August 29-30, 2018. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) evaluations, review of the laboratory's performance review and