Burke Primary Care

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 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 surveyor observation, review of package inserts and testing personal (TP) #1 interview, 10/09/25, the laboratory failed to monitor the temperature in the downstairs storage room in which laboratory test kits were stored. Findings: At approximately 2: 30 p.m. surveyor observed the following boxes of test kits on shelves in the downstairs storage room: 1. 1 box of "Consult Strep A Tests Dipstick". 2. 1 box of "Consult Hcg Urine Tests Dipstick". 3. 1 box of "Quick Vue RSV Test". 4. 2 boxes of "Consult Influenza A & B Tests Cassette". 5. 1 box of "Hemosure iFOB test". 6. 2 boxes of "One Step + ER fecal occult blood". 7. 1 box of "Globe Scientific Sedi- Rate". 8. 8 boxes of "Cepheid Xpert Xpress CoV-2/Flu/RSV plus". Review of package inserts for the above listed test kits revealed the following: 1. Test kits #1 through # 6 listed above require a storage and stability temperature of 36 - 86 degrees Fahrenheit (F). 2. Test kit # 7 listed above requires a storage and stability temperature of 59 - 86 degrees F. 3. Test kit # 8 listed above requires a storage and stability temperature of 2 - 8 degrees Celsius (C). Interview with TP #1 at time of observation confirmed the laboratory failed to monitor the temperature of the downstairs storage room. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on review of laboratory procedure, surveyor observation and interview with TP #1 11/28/23, the laboratory failed to label quality control (QC) reagent for glycosylated hemoglobin (HgA1c) testing performed on the TOSOH G8 analyzer with an expiration date after opening. Findings: Review of laboratory procedure "TOSOH G8 Procedure Manual" revealed "TOSOH Controls...After opening, sets are stable for one week when stored at 2-8 degrees Celsius (C).". During laboratory tour at approximately 3:30 p.m., surveyor observed 2 bottles of QC reagent, TOSOH Bioscience Inc Hemoglobin A1c Control, Level 1 and 2, Lot #7134, on a shelf in the door of a small white refrigerator with an open date of 10/3/23. The 2 bottles of QC reagent were not labeled with an expiration date. The QC reagents expired on 10/17 /23 and were available for use until date of survey. Interview with TP #1 during time of laboratory tour confirmed the 2 bottles of QC reagent were not labeled with an expiration date. He also confirmed the QC reagents were stable for one week after opening and had expired 10/17/23. The QC reagents were disposed of immediately. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 surveyor observation and interview with TP #1 11/28/23, the laboratory failed to discard 5 blood collection tubes that had exceeded their expiration date. Findings: During laboratory tour at approximately 3:30 p.m., surveyor observed 5 dark blue top BD Vacutainer trace element tubes with an expiration date of 10/31/23 available for use in the phlebotomy station. Interview with phlebotomist at time of laboratory tour confirmed the 5 blood collection tubes had expired. The phlebotomist disposed of them immediately. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of operators manual and review of maintenance logs 11/28/23, the laboratory failed to change the filter as required on the TOSOH G8 analyzer from 7/24 /23 until 8/21/23, a period of approximately 27 days. Findings: Review of operators manual for the TOSOH G8 analyzer revealed "SECTION 1...Daily Maintenance Procedure...5. Record filter count. Change filter after 400 injections." Review of maintenance logs for the TOSOH G8 analyzer revealed a filter count of 412 on 7/24 /23 and a filter count of 1588 on 8/18/23. The filter was changed on 8/21/23. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of laboratory procedure, review of 2023 TOSOH G8 analyzer calibration records and interview with testing personnel (TP #1) 11/28/23, the laboratory failed to perform monthly calibration of the glycosylated hemoglobin (HbA1c) for 3 of 6 months reviewed. Findings: The laboratory began testing HbA1c on the TOSOH G8 analyzer in June of 2023. Review of laboratory procedure "Tosoh G8 Calibration adjustments:" revealed "...if qc is acceptable with not shifts or trends, -- 2 of 5 -- calibration can be ran monthly or bi-monthly. BPC will be running a monthly calibration unless there are issues with QC." Review of 2023 calibration records for HbA1c revealed no documentation of monthly calibrations in August, September and October of 2023. Interview with TP #1 at approximately 12:00 p.m. confirmed there was no documentation of monthly calibrations in August, September and October of 2023. He stated he thought they were performed but could not locate any documentation of the calibrations. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory records, review of laboratory procedures and review of 2022 and 2023 quality control (QC) records for the Alere Triage meter 11/28/23, the laboratory failed to perform D-dimer external QC every 30 days as established by the laboratory's individual quality control program (IQCP) for 1 of 23 months reviewed. Findings: Review of laboratory records revealed the laboratory had established an IQCP for the performance of D-dimer testing on the Alere Triage meter in 2016. Review of laboratory procedure "Alere Triage D-Dimer" revealed "External controls are run in accordance with the manufacturer's instructions, with each lot or shipment and at least every 30 days." Review of 2022 and 2023 D-dimer QC records revealed external QC was performed 11/9/22. The next performance of external QC was documented on 1/23/23, a period of approximately 74 days in which external QC was not performed. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of 2021, 2022 and 2023 laboratory quality assessment (QA) records, review of the laboratory's policies and procedures, and interview with TP #1 11/28/23, the laboratory failed to establish a QA policy for review of calculated chemistry results and failed to perform reviews to verify the accuracy of the calculated results for approximately three years during 2021, 2022, and 2023. Findings: Review of 2021, 2022 and 2023 laboratory QA records revealed no documentation of a periodic review of the following calculated chemistry results: 1. Albumin/Globulin ratio 2. Low-density lipoprotein (LDL) calculation 3. Bun/Creatinine ratio 4. Estimated glomerular filtration rate (eGFR) Review of the laboratory's policies and procedures -- 3 of 5 -- revealed the laboratory did not have a policy for review of calculated chemistry results to ensure the accuracy of results reported. Interview with TP #1 at approximately 4:00 p.m. confirmed the laboratory had not established a QA policy that included a periodic review of calculated chemistry results. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of laboratory records, review of laboratory procedure and review of 2021, 2022 and 2023 laboratory quality assessment (QA) records 11/28/23, the laboratory director failed to ensure the individual quality control plan (IQCP) established for D-dimer testing on the Alere Triage Meter was reviewed annually to assure the accuracy of D-dimer testing, a period of approximately 3 years in which an annual review was not performed. Findings: Review of laboratory records revealed the laboratory had established an IQCP for the performance of D-dimer testing on the Alere Triage meter in 2016. Review of laboratory procedure "Alere Triage D-Dimer" revealed "External controls are run in accordance with the manufacturer's instructions, with each lot or shipment and at least every 30 days. ...This plan will be reviewed annually and following any QC failure and will be revised if needed.". Review of 2021, 2022 and 2023 laboratory QA records revealed no documentation of an annual review of the IQCP established for the D-dimer testing. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and review of 2021, 2022, and 2023 hematology quality control records 11/28/23, testing personnel failed to follow the laboratory's procedure for verification of each new lot of hematology quality control material. Review of the laboratory's "QUALITY CONTROL" policy revealed "... New Quality Control Lot Verification For each new lot of controls, we will run each level at least five times on different days, at different times of the day, and by different operators, while the old lot is still in use as daily QC. We will then compare our results with those of the manufacturer to ensure that the integrity of the materials has been maintained and that we can achieve the manufacturer's specifications. ... QUALITY CONTROL PROCEDURES ... 1. Verification We will not implement a new lot of control material until it has been verified as described above. ..." Review of 2021, 2022, and 2023 hematology records revealed the laboratory failed to follow their policy for verifying each new lot of Boule Con-Diff -- 4 of 5 -- hematology quality control material. Examples: 1. For lot #22106-31, 32, 33, all verification testing was performed the same day (10/12/21) by the same person. 2. For lot #22201-31, 32, 33, all verification testing was performed the same day (5/13/22). 3. For lot #22307-31, 32, 33, all verification testing was performed the same day (9/19 /23). -- 5 of 5 --

Summary Statement of Deficiencies 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 CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2023 API (American Proficiency Institute) proficiency testing results 11/20/23, the laboratory failed to successfully participate in proficiency testing for Total Cholesterol on two of three consecutive testing events. See the deficiency cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 CMS Casper reports 153D and 155D and desk review of 2023 API proficiency testing results 11/20/23, the laboratory failed to successfully participate in proficiency testing for Total Cholesterol on two of three consecutive testing events, resulting in unsuccessful performance. Findings: Desk review of CMS Casper reports 153D and 155D and desk review of 2023 API proficiency testing results revealed: 1. The laboratory received a score of 40% for Total Cholesterol on the 2023 API Chemistry Core 1st event. 2. The laboratory failed to participate and received a score of 0% for Total Cholesterol on the 2023 API Chemistry Core 3rd 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 desk review of CMS Casper reports 153D and 155D and desk review of 2023 API proficiency testing results 11/20/23, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. See the deficiency cited at 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 desk review of CMS Casper reports 153D and 155D and desk review of 2023 API proficiency testing results 11/20/23, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: Desk review of CMS Casper reports 153D and 155D and desk review of 2023 API proficiency testing results revealed: 1. The laboratory received a score of 40% for Total Cholesterol on the 2023 API Chemistry Core 1st event. 2. The laboratory failed to participate and received a score of 0% for Total Cholesterol on the 2023 API Chemistry Core 3rd event. -- 2 of 2 --

Summary Statement of Deficiencies 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 CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 API(American Proficiency Institute) proficiency testing results 10/19/20, the laboratory failed to successfully participate for HDL(high-density lipoprotein) Cholesterol, Magnesium, and Uric Acid in two consecutive testing events and failed to successfully participate for Endocrinology in two out of three consecutive testing events. See the deficiency cited at D2096 and D2108. 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 -- 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 CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 API(American Proficiency Institute) proficiency testing results 10/19/20, the laboratory failed to achieve satisfactory performance for HDL(high-density lipoprotein) Cholesterol, Magnesium, and Uric Acid in two consecutive testing events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for HDL Cholesterol, Magnesium, and Uric Acid on the 2020 Chemistry Core 2nd event. 2. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory provided unacceptable responses for 4 of 5 samples, resulting in a score of 20% for HDL Cholesterol, Magnesium, and Uric Acid on the 2020 Chemistry Core 3rd event. D2108 ENDOCRINOLOGY CFR(s): 493.843(g) Failure to achieve an overall testing event score of satisfactory performance for 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 CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 API(American Proficiency Institute) proficiency testing results 10/19/20, the laboratory failed to achieve satisfactory performance for the subspecialty of Endocrinology on two out of three consecutive testing events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper report 155D and 2020 API Proficiency testing results revealed the laboratory provided unacceptable responses for 4 of 5 samples for TSH(thyroid stimulating hormone), resulting in an overall score of 60% for the subspecialty of Endocrinology on the 2020 Chemistry Core 1st event. 2. Desk review of CMS Casper report 155D and 2020 API Proficiency testing results revealed the laboratory provided unacceptable responses for 4 of 5 samples for TSH and Free Thyroxine, resulting in an overall score of 20% for the subspecialty of Endocrinology on the 2020 Chemistry Core 3rd 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. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 API(American Proficiency Institute) proficiency testing results 10/19/20, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. See the deficiency cited at 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 desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 API(American Proficiency Institute) proficiency testing results 10/19/20, the laboratory director failed to ensure successful participation as required in Subpart H. Findings: 1. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for HDL Cholesterol, Magnesium, and Uric Acid on the 2020 Chemistry Core 2nd event. 2. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory provided unacceptable responses for 4 of 5 samples, resulting in a score of 20% for HDL Cholesterol, Magnesium, and Uric Acid on the 2020 Chemistry Core 3rd event. 3. Desk review of CMS Casper report 155D and 2020 API Proficiency testing results revealed the laboratory provided unacceptable responses for 4 of 5 samples for TSH(thyroid stimulating hormone), resulting in an overall score of 60% for the subspecialty of Endocrinology on the 2020 Chemistry Core 1st event. 4. Desk review of CMS Casper report 155D and 2020 API Proficiency testing results revealed the laboratory provided unacceptable responses for 4 of 5 samples for TSH and Free Thyroxine, resulting in an overall score of 20% for the subspecialty of Endocrinology on the 2020 Chemistry Core 3rd event. -- 3 of 3 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of 2018 and 2019 API (American Proficiency Institute) proficiency testing records, and interview with TP (testing personnel) 2/6/20, the laboratory failed to test proficiency samples in the same manner as patient specimens are routinely tested. The laboratory's "QUALITY ASSESSMENT PLAN" states "... 6. Proficiency Testing This laboratory will enroll in formal proficiency testing appropriate to the test menu and treats all proficiency test challenge specimens the same as patient specimens. ... " The "GENERAL LABORATORY QUALITY SYSTEMS" policy states "... We will treat the proficiency testing specimens exactly as we treat patient samples, from accessioning through reporting. We will repeat the tests only if we would repeat patient samples under the same conditions (for example, if the result is a critical value). ..." The laboratory's "Critical Lab Values Policies and Procedure" states "... Procedure: In- house Critical Lab Values: All critical value laboratory results requires specimen to be re-run to verify accuracy of results. ... Laboratory staff will document all critical communication in LabDaq LIS system..." Review of 2018 and 2019 API proficiency testing records revealed the laboratory failed to test proficiency samples in 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 4 -- manner as patient specimens are routinely tested. Examples: 1. 2018 3rd event hematology - sample HSY-14 had a critical value for hemoglobin. There was no documentation that the sample was retested to confirm the critical value. 2. 2019 3rd event hematology - sample HSY-12 had a critical value for hemoglobin. There was no documentation that the sample was retested to confirm the critical value. 3. There was no documentation available at the time of the survey to show that hematology proficiency samples for the 2018 3rd event and the 2019 3rd event were accessioned and reported in the LIS (laboratory information system). During interview at approximately 11:30 a.m., TP #1 stated that patient specimens with panic values are retested to confirm and the repeat testing is documented in the LIS. He stated proficiency samples should be treated the same way. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, review of 2018 and 2019 calibration records, interview with TP (testing personnel) 2/6/20, and review of 2/7/20 email, the laboratory failed to discard calibration material that exceeded its expiration date. The Boule Cal calibrator assay sheet states "Open vial stability 5 days". The Medonic M- series User's Manual states "Section 7: Calibration ... 7.1 Preparations before calibration ... Never use an open vial longer than recommended by the manufacturer ...". Review of 2018 and 2019 calibration records for the Medonic M-series hematology analyzer revealed the analyzer was calibrated on the following dates: 3/22 /18, 6/5/18, 9/10/18, 10/2/18, 11/7/18, 3/7/19, 4/3019, and 9/18/19. Review revealed the calibration performed 10/2/18 included an assay sheet for Boule Cal lot #21803-24 with an expiration date of 6/7/18. During interview 2/6/19 at approximately 1:40 p.m., TP #1 stated that the Medonic won't let you use an expired calibrator, so they must have put the wrong package insert with the 10/2/18 calibration. In an email to the surveyor 2/7/20, TP #1 stated that the laboratory used the calibrator from the calibration performed 9/18/18 (lot #21807-44, expiration 10/12/18) to calibrate the analyzer on 10/2/18. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, review of the laboratory's policies and procedures, review of 2018, 2019, and 2020 hematology records, and interview with TP (testing personnel) 2/6/20, the laboratory failed to perform and document all maintenance as specified by the manufacturer for the Medonic M-series hematology analyzer. The Medonic M-series User's Manual states "Section 8: Cleaning, Maintenance & Transport ... 8.1 Daily Cleaning ... Clean the aspiration and pre-dilute -- 2 of 4 -- probes using an alcohol wipe. Remove possible traces of salt crystals or blood at the top of the aspiration and pre-dilute probes, probe rinse cup, and around top of sampling device probe inlet (if applicable) using a paper tissue with a disinfecting solution. ..." The laboratory's "ANALYTIC SYSTEMS" policy states "... 5. Maintenance and Function Checks ... Procedure We follow the manufacturer's recommended schedule for routine preventive maintenance and for professional service. We document all activities on our Preventive Maintenance forms ...". Review of 2018, 2019, and 2020 hematology records revealed the laboratory had not documented daily cleaning of the Medonic M-series hematology analyzer. During interview at approximately 3:05 p.m., TP #1 confirmed that they had not documented daily cleaning. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of personnel records, review of 2018 and 2019 PT (proficiency testing) records, and interview with TP(testing personnel #1) 2/6/20, the LD(laboratory director) failed to ensure TC (technical consultant) duties were performed by personnel meeting the qualification requirements for a TC and failed to ensure that all duties were properly performed. Findings: The laboratory's "GENERAL LABORATORY QUALITY SYSTEMS" policy states for PERSONNEL COMPETENCY, " The laboratory director is responsible for competency assessments or has reassigned responsibility of testing personnel competency assessments to the technical consultant...." Under PROFICIENCY TESTING POLICY, the policy states, "The director will carefully evaluate any unacceptable, unsatisfactory, or unsuccessful proficiency testing result in an effort to identify the cause of failure....." Review of the laboratory's policies and procedures revealed a letter of delegation from the LD dated 1/2/19. The LD delegated the following responsibilities to TP#1: "Signing the Proficiency Testing Attestation Forms" and "Review, initiating