Madison Memorial Hospital Lab

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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded results from the College of American Pathologists (CAP) and a phone interview with the laboratory manager the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) proficiency testing events in 2024 and 2025 for the specialty of routine chemistry. 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 -- (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 Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded results from the College of American Pathologists (CAP), and a phone interview with the laboratory manager on 10/28/2025, the laboratory failed to achieve satisfactory performance for the same analyte in two (2) of three (3) testing events for the analyte: P02 blood gas. The findings include: 1. A PT desk review of report 155D and graded results from CAP revealed the laboratory failed to achieve satisfactory results for the specialty of routine chemistry for the analyte: P02 blood gas. Analyte Event Score PO2 Blood Gas 2024 - 3 40 PO2 Blood Gas 2025 - 2 60 2. A phone interview with the laboratory manager on 10/28/2025 at 3:53 PM confirmed these findings. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, laboratory procedures, training and competency assessment records and an interview with the technical supervisor (TS) on 11/5/2024, the laboratory failed to follow written procedures to assess testing personnel competency and to establish a procedure for competency asessments for the TS and general supervisor (GS) in 2023 and 2024. The findings include: 1. The CMS 209 identified 34 testing personnel (TP) performing moderate and high complexity testing of which 12 were new since the last inspection on 10/21/2022. 2. A review of laboratory procedures identified that the laboratory established a procedure to assess TP initial training, semiannual and annual competency but failed to establish a procdure for competency assessment performance for the TS and GS. 3. A review of training and competency assessment records identified that the laboratory failed to have six month competency assessments for six (6) TP. 4. A review of training and competency assessment records identified that the laboratory failed to have annual competency assessments for 16 TP performing EPOC testing in 2023 and one (1) in 2024. 5. A review of training and competency assessment records identified that the laboratory failed to have annual competency assessments for three (3) TP performing testing in the main laboratory in 2024. 6. A review of training and competency assessment records identified that the laboratory failed to have competency assessments for the TS and GS. 7. An interview with the TS on 11/5/2024 at 8:57 am confirmed the above findings. 8. The laboratory reports performing 564,424 tests annually. 9. This is a repeat deficiency from the previous inspections on 1/28/2021 and 10/21/2022. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's patient test records, laboratory's policy, manufacturer's instructions, and interview, the laboratory failed to meet the requirements of for the preanalytic system for seven of twenty lactic acid specimens and six of twenty ammonia specimens reviewed as evidenced by: 1. The laboratory failed to follow laboratory policy and manufacturer's instructions for specimen collection and handling with the 15 minute centrifugation time frame prior to analysis for seven of twenty lactic acids and six of twenty ammonia specimens. (See D5311) 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 review of the laboratory's patient test records, laboratory's policy, manufacturer's instructions, and interview with technical consultant of chemistry, the laboratory failed to follow laboratory policy and manufacturer's instructions for specimen collection and handling with the 15 minute centrifugation time frame prior to analysis for seven of twenty lactic acid and six of twenty ammonia specimens reviewed as evidenced by: Ammonia: 1. In review of the manufacturer instructions for use (the Vitros chemistry system 7200) for ammonias states under special precautions, "Centrifuge specimens and remove plasma from the cellular material within 15 minutes of collection." 2. In review of the laboratory's policy and confirmed with testing person #1 at 1022 on Nov. 5, 2024, he stated that the lab uses the manufacturer's instructions as part of their policy. 3. The following patients, six of twenty reviewed were outside the 15 minute time frame: a. patient #8325490 collected 11/2/2024 at 0448 received into the laboratory at 0516, 28 minutes. b. patient #8325462 collected 10/29/2024 at 2146 received into the laboratory at 2211, 25 minutes. c. patient #8323838 collected 10/29/2024 at 1144 received into the laboratory at 1204, 20 minutes. d. patient #8323501 collected 10/13/2024 at 2047 received into the laboratory at 2132, 45 minutes. e. patient #8323390 collected 10/14 /2024 at 1515 received into the laboratory at 1541, 26 minutes. f. patient #8323178 collected 10/15/2024 at 1749 received into the laboratory at 1904, 75 minutes. 4. The laboratory performs 198 ammonias per year according to their test volume report. 5. In interview with testing person #1 at 1022 on Nov. 5, 2024 stated that they follow -- 2 of 6 -- manufacturer's instructions for ammonias testing and confirmed they may not be following their procedure and manufacturer's instructions. Lactic Acid: 1. In review of the manufacturer's instructions for use (the Vitros chemistry system 7200) for lactic acid states under special precautions, "Centrifuge specimens and remove plasma from the cellular material within 15 minutes of collection." 2. The following patients seven of twenty reviewed were outside of the 15 minute time frame: a. patient # 8325878 collected on 11/1/2024 at 1724 received in the laboratory at 1819, 55 minutes. b. patient # 8325415 collected on 10/29/2024 at 1542 received in the laboratory at 1607, 25 minutes. c. patient # 8325201 collected on 10/29/2024 at 0440 received in the laboratory at 0459, 19 minutes. d. patient # 8323957 collected on 10/17/2024 at 0739 received in the laboratory at 0828, 49 minutes. e. patient # 8323782 collected on 10/15 /2024 at 1748 received in the laboratory at 1816, 28 minutes. f. patient #8323772 collected on 10/15/2024 at 1510 received in the laboratory at 1533, 23 minutes. g. patient #8323512 collected on 10/13/2024 at 2119 received in the laboratory at 2135, 16 minutes. 3. The laboratory performs 1068 lactic acid test per year according the their test volume report. 4. In interview with testing person #1 0945 on Nov. 5, 2024, stated that they follow manufacturer's instructions and that lactic acids tests had to be separated cells from the plasma within 15 minutes. He confirmed that they were not following the procedure or instructions. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 a review of the Centers for Medicare and Medicaid (CMS) proficiency testing (PT) data report (Report 155D), graded results from the College of American Pathologists (CAP) and an interview with the laboratory manager on 10/08/24, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2024 for the specialty of toxicology. See D2111, and D2118 D2111 TOXICOLOGY CFR(s): 493.845(c) 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 participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid (CMS) Proficiency Testing (PT) data report (Report 155D), graded PT results from the College of American Pathologists (CAP) and an interview with the laboratory manager on 10/08 /24, the laboratory failed to participate in two (2) consecutive PT events for the analytes phenobarbitol and phenytoin for the year 2024. The findings include: 1. A review of Report 155D and graded PT results from API identified that the laboratory failed to participate and hence failed to achieve satisfactory performance for events one (1) and two (2) in 2024 for the specialty of toxicology for the analytes phenobarbitol and phenytoin. Analyte Year Event Score Phenobarbitol 2024 1 0% Phenobarbitol 2024 2 0% Phenytoin 2024 1 0% Phenytoin 2024 2 0% 2. An interview with the laboratory manager on 10/08/2024 at 10:47 AM confirmed the above findings. D2118 TOXICOLOGY CFR(s): 493.845(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 review of the Centers for Medicare and Medicaid (CMS) Proficiency Testing (PT) data report (Report 155D), graded PT results from the College of American Pathologists (CAP) and an interview with the laboratory manager on 10/08 /24, the laboratory failed to achieve satisfactory performance for two (2) consecutive PT events for the analytes phenobarbitol and phenytoin. The findings include: 1. A review of Report 155D and graded PT results from API identified that the laboratory failed to achieve satisfactory performance for events one (1) in 2024 and two (2) in 2024 for the specialty of toxicology for the analyte phenytoin. Analyte Year Event Score Phenobarbitol 2024 1 0% Phenobarbitol 2024 2 0% Phenytoin 2024 1 0% Phenytoin 2024 2 0% 2. An interview with the laboratory manager on 10/08/2024 at 10:47 AM confirmed the above findings. -- 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 an off-site Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded results from the College of American Pathologists (CAP), and a phone interview with the technical supervisor on 03/26/2024 the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events for the subspecialty routine chemistry. Refer to D2089 and D2097. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) 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 participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data reprot (Report155D), graded results from the College of American Pathologists (CAP), and a telephone interview with the technical supervisor on 03/26/2024, the laboratory failed to participate in two (2) of three (3) testing events in 2023 for the specialty routine chemistry for the analyte Creatine Kinase Isoenzymes (CK-Iso) The Findings Include: 1. A PT desk review of the laboratory's graded 2023 results from CAP revealed that the laboratory failed to participate in testing for events two (2) and three (3) in 2023 for the specialty of routine chemistry for the analyte: Creatine Kinase Isoenzymes (CK-Iso) Analyte Year Event Score CK- Iso 2023 2 0 CK- Iso 2023 3 0 2. A review of the CAP PT results from 2023 events two (2) and three (3) revealed the laboratory received scores of zero (0) for each event, respectively, due to non-participation for the analyte Creatine Kinase Isoenzymes (CK- Iso). 3. A telephone interview with the technical supervisor at 1:08 PM on 03/26/2024 confirmed the results. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the College of American Pathologists (CAP), and a telephone interview with the technical supervisor on 03/26/2024, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) consecutive testing events in 2023 for the subspecialty of routine chemistry for the analyte Creatine Kinase Isoenzymes (CK- Iso) The Findings Include: 1. A PT desk review of the laboratory's graded 2023 and 2024 results from CAP revealed that the laboratory failed to achieve satisfactory scores for two consecutive testing events in the subspecialty of Routine Chemistry for the analyte Creatine Kinase Isoenzymes (CK-Iso) Analyte Year Event Score CK-Iso 2023 2 0 CK-Iso 2023 3 0 2. A review of the CAP PT results from 2023 events two (2) and three (3) revealed the laboratory received scores of (0) for each event, respectively, for the analyte:Creatine Kinase Isoenzymes (CK-Iso). 3. A telephone interview with the technical supervisor at 1:08 PM on 03/26/2024 confirmed the results. -- 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 a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded results from the College of American Pathologists (CAP) and a telephone interview with the Laboratory Manager on 08/03/2023 at 04:15 PM, the laboratory failed to successfully participate in proficiency testing for Immunohematology Compatibility Testing 2 (two) out of 3 (three) events for 2023. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) 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 an overall testing event score of satisfactory 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 a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), the laboratory's graded results from the College of American Pathologists (CAP) and a phone interview with the laboratory manager on August 03, 2023 at 4:15 PM the laboratory failed to achieve an overall testing event score of satisfactory performance for (2) two out of (3) three testing events for Immunohematology Compatibility testing for 2023. The findings include: 1. A PT desk review of Report 155D and graded PT results from CAP identified that the laboratory failed to achieve satisfactory scores for immunohematology compatibility testing. Analyte Year Event Score Compatibility Testing 2023 1 80% Compatibility Testing 2023 2 80% 2. A telephone interview with the laboratory manager on .August 8, 2023 at 4:15 PM confirmed the above findings. 3. The laboratory performs 300 Immunohematology Compatability tests per year -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of competency assessments, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview with the laboratory manager on 10/20/2022, the laboratory failed to follow written policies and procedures to assess testing personnel competency in 2021. The findings include: 1. A review of competency assessment records identified seven (7) of fifteen (15) testing personnel listed on the CMS 209 failed to have documentation of annual competency for 2021. 2. An interview with the laboratory manager on 10/20/2022 at 8:26 am confirmed that competency assessments were not performed in 2021. 3. The laboratory reports performing 577,980 moderate and high complexity tests annually. 4. This is a repeat deficiency from the previous inspection on 1/28/2021. 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 record review of Sysmex CA 620 coagulation documentation and an 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 -- interview with testing personnel 2 (TP2) on 10/21/2022, the laboratory failed to perform a normal patient Prothrombin (PT) mean study for the current lot of Dade Innovin. The findings include: 1. A record review of coagulation documentation identified that the laboratory failed to perform a PT normal patient study to determine the correct mean to be used in the calculation of patient International Normalized Ratio (INR) for the current lot of Dade Innovin, 56417. 2. An interview with TP2 on 10/21/2022 at 8:31 am confirmed that the laboratory failed to perform a normal patient PT mean study for the current lot of Innovin. 3. The laboratory reports performing 200 PT/INR tests annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the Biomerieux Vidas 3 maintenance logs and an interview with testing personnel 1 (TP1) on 10/20/2022, the laboratory failed to perform maintenance as required by the manufacturer. The findings include: 1. A review of the Biomerieux Vidas 3 maintenance logs identified that the laboratory failed to perform monthly maintenance, cleaning the SPR block, as required by the manufacturer in February, March, April, May, June and July of 2022. 2. An interview with TP1 on 10/20/2022 at 4:26 pm confirmed that the laboratory failed to document monthly maintenance on the Vidas 3 for six months in 2022. 3. The laboratory reports performing 689 tests annually on the Vidas 3. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of calibration records, instrument documents for the Biomerieux Vidas 3 and an interview with testing personnel 1 (TP1), the laboratory failed to verify the reportable range at least once every six months for procalcitonin in 2021 and 2022. The findings include: 1. A review of calibration records and documents for the Biomerieux Vidas 3 identified that the laboratory failed to perform verifications of the reportable range for the analyte procalcitonin at least every six months in 2021 and 2022. 2. An interview with TP1 on 10/20/2021 at 5:08 pm confirmed that the laboratory had not verified the reportable range of procalcitonin at least once every six months in 2021 and 2022. 3. The laboratory reports performing 689 procalcitonin tests annually. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a record review of Sysmex CA 620 coagulation quality control (QC) documentation, patient results, and an interview with testing personnel 1 (TP1) on 10 /20/2022, the laboratory failed to perform two levels of QC every eight hours of patient testing. The findings include: 1. A random record review of prothrombin time (PT) and partial thromboplastin time (PTT) QC identified that the laboratory failed to document two levels of QC every 8 hours when patient testing occurred for four days in March 2021 and three days in May 2022. 2. A review of the laboratory's patient results identified three patient PT/INRs reported on 3/27/2021, five patient PT/INRs and three PTTs reported on 3/26/2021, two patient PT/INRs and one PTT reported on 3/25/2021, one patient PT/INR reported on 3/23/2021, three patient PT/INRs and one PTT reported on 5/19/2022, two patient PT/INRs reported on 5/10/2022, and one patient PT/INR and two PTTs reported on 5/3/2022 without two levels of QC within eight hours. 3. An interview with TP1 on 10/20/2022 at 3:03 confirmed that the above patient results were reported without two levels of QC. 4. The laboratory reports performing 200 PT/INRs and 400 PTTs annually. -- 3 of 3 --

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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and graded results from the American Proficiency Institute (API), the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2021 for the specialty of hematology. See D2123, D2131 D2123 HEMATOLOGY CFR(s): 493.851(c) 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 participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the American Proficiency Institute (API) and a telephone interview with the laboratory manager on 3 /11/2022, the laboratory failed to participate in one (1) of three (3) testing events in 2021 for the specialty of hematology. The findings include: 1. A PT desk review of Report 155D and graded PT results from API identified that the laboratory failed to participate in testing for event one (1) in 2021 for the specialty of hematology for the analytes: white blood cell (WBC) differential, erythrocyte (RBC) count, hematocrit, hemoglobin, leukocyte count, mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), mean corpuscular volume (MCV), platelet count, red cell distribution width (RDW), nucleated RBC, partial thromboplastin time, prothrombin time, fibrinogen, international normalized ratio, reticulocyte count, reticulocyte count manual, WBC count body fluid/CSF (manual), RBC count body fluid/CSF (manual), sedimentation rate, body fluid crystals, sperm count, and sperm morphology resulting in scores of zero (0). 2. A telephone interview with the laboratory manager on 3/11/2022 at 12:57 pm confirmed the above findings. D2131 HEMATOLOGY CFR(s): 493.851(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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the American Proficiency Institute (API) and telephone interview with the laboratory manager on 3 /11/2022, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2021 for the specialty of hematology. The findings include: 1. A PT desk review of Report 155D and graded PT results from API identified that the laboratory failed to successfully participate in testing for events one (1) and three (3) in 2021 for the specialty of hematology for the analytes white blood cell (WBC) differential, red cell distribution width (RDW), nucleated RBC, reticulocyte count, reticulocyte count manual, WBC count body fluid /CSF (manual), body fluid crystals, sperm count, sperm morphology and sperm morphology Specialty Year Event Score hematology 2021 1 0% hematology 2021 3 12% 2. A telephone interview with the laboratory manager on 3/11/2022 at 12:57 pm confirmed the above findings. -- 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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and graded results from the American Proficiency Institute (API), the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) consecutive testing events in 2021 for the specialty of microbiology. See D2028, D2046, D2055 D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 -- 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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) , graded PT results from the American Proficiency Institute (API) and email correspondence with the technical supervisor, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) consecutive testing events in 2021 for the subspecialty of bacteriology. The findings include: 1. A PT desk review of Report 155 and graded PT results from API identified that the laboratory failed to achieve satisfactory scores for the subspecialty of bacteriology for the analytes: Campylobacter culture, sputum culture and Vancomycin-Resistance Enterococci (VRE) culture. Analyte Year Event Score Campylobacter 2021 2 50% Campylobacter 2021 3 0% Sputum Culture 2021 2 0% Sputum Culture 2021 3 0% VRE culture 2021 2 50% VRE culture 2021 2 0% 2. Email correspondence with the technical supervisor on 11/3/2021 confirmed the above failures. D2046 MYCOLOGY CFR(s): 493.827(e) 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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the American Proficiency Institute (API) and email correspondence with the technical supervisor, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) consecutive testing events in 2021 for the subspecialty of mycology. The findings include: 1. A PT desk review of Report 155 and graded PT results from API identified that the laboratory failed to achieve satisfactory scores for the subspecialty of mycology for the test potassium hydroxide (KOH). Analyte Year Event Score KOH 2021 2 0% KOH 2021 3 0% 2. Email correspondence with the technical supervisor on 11/3/2021 confirmed the above failures. D2055 PARASITOLOGY CFR(s): 493.829(e) 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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the American Proficiency Institute (API) and email correspondence with the technical supervisor, the laboratory failed to successfully participate and achieve an overall satisfactory -- 2 of 3 -- score for two (2) of three (3) consecutive testing events in 2021 for the subspecialty of parasitology. The findings include: 1. A PT desk review of Report 155 and graded PT results from API identified that the laboratory failed to achieve satisfactory scores for the subspecialty of parasitology. Analyte Year Event Score Parasitology 2021 2 60% Parasitology 2021 3 0% 2. Email correspondence with the technical supervisor on 11/3 /2021 confirmed the above failures. -- 3 of 3 --

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from American Proficiency Institute (API), College of American Pathologists (CAP) and an interview with the Technical Supervisor (TS) on 1/27/2021, the laboratory failed to enroll in proficiency testing to verify the accuracy of testing of the platelet function assay in accordance with 493.1236(c)(1). The findings include: 1. A review of proficiency testing records from API and CAP identified that the laboratory failed to verify the accuracy of testing for the platelet function assay biannually for 2020. 2. An interview with the TS on 1/27/2021 at 10:20 am confirmed that the laboratory failed to verify the accuracy of testing for the platelet function assay biannually for 2020. 3. The laboratory reports performing two platelet function tests annually. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of immunohematology quality control (QC) records, training and competency records, laboratory policies and procedures and an interviews with the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- Technical Supervisor (TS) on 1/27/2021 and 1/28/2021, the laboratory failed to meet the the requirements specified in 493.1230 through 493.1256, 493.1271, and 493.1281 through 493.1299. The findings include: 1. The laboratory failed to have training and competency assessments documented for the testing personnel listed on the CMS 209 that were performing immunohematology testing. See D5209 2. The laboratory failed to establish a procedure for all immunohematology QC testing. See D5403 3. The laboratory failed to perform and document acceptable QC daily for immunohematology before reporting patient results. See D5401, D5447 [Repeat Deficiency], D5451 and D5481. 4. Interviews with the TS on 1/27/2021 and 1/28 /2021 confirmed the above findings. 5. The laboratory reports performing 9,489 immunohematology tests annually. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of training documentation and competency assessments, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview on 1/27/2021 with the Technical Supervisor (TS), the laboratory failed to establish and follow written policies and procedures to assess testing personnel in accordance with 42 C.F.R. 493.1451(b)(7)(8). The findings include: 1. A review of training and competency records identified that three (3) of ten (10) testing personnel listed on the CMS 209 had start days after the previous survey (9/18/2018) and the laboratory failed to have documentation of initial training. 2. A review of training and competency records identified that two(2) of ten (10) testing personnel listed on the CMS 209 failed to have documentation of six (6) month competency which included the six parameters as listed in 493.1451(b)(7)(8). 3. A review of training and competency records identified seven (7) of ten (10) testing personnel listed on the CMS 209 failed to have documentation of annual competency which included the six parameters as listed in 493.1451(b)(7)(8) for 2019 and eight (8) of ten (10) testing personnel listed on the CMS 209 failed to have documentation of annual competency which included the six parameters as listed in 493.1451(b)(7)(8) for 2020. 4. An interview with the TS on 1/27/2021 at 9:10 am confirmed the above findings. 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 record review of proficiency testing (PT) from American Proficiency Institute (API) and an interview with the Technical Supervisor (TS) on 1/27/2021, the laboratory failed to review PT and evaluate results that were less than 100% but greater than or equal to 80% for 2020. The findings include: 1. A review of PT records from API for event one of 2020 identified that the laboratory failed to evaluate the results for the following analytes; Lactate (blood gas) 80%, Lipase 80%, NT pro- -- 2 of 12 -- BNP 80%, Carbamazepine 80%, Gentamicin 80%, Salicylates 80% Carboxyhemoglobin 80%, and Molecular Virology Meningitis 97%. 2. A review of PT records from API for event two of 2020 identified that the laboratory failed to evaluate the results for the following analytes; Creatinine Kinase, Isoenzyme 80%, NT pro-BNP 80%, Molecular Virology Respiratory 99% and Compatibility Antigen Identification 80%. 3. A review of PT records from API for event three of 2020 identified that the laboratory failed to evaluate the results for the following analytes; Creatinine (blood gas) 80%, TIBC 80%, Hemoglobin (blood oximetry) 80%, Methemoglobin 80%, and Mycology Identification 80%. 4. An interview with the TS on 1/27/2021 at 8:30 am, confirmed that the laboratory failed to review and evaluate PT results from API that were less than 100% but greater than or equal to 80% for 2020. 5. The laboratory reports performing 519,353 moderate and high complexity tests annually. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review proficiency testing (PT) records and an interview with the Technical Supervisor (TS) on 1/27/2021 the laboratory failed to evaluate the accuracy of any analyte, specialty or subspecialty that was assigned an artificial score of 100% because it was ungraded by the PT provider. The findings include: 1. A review of Immunology/Immunohematology 2020 event 3 records from American Proficiency Institute (API) identified three ungraded samples, Antibody Identification, Antibody Screen and Direct Antiglobin, due to lack of consensus, that were given an artificial score of 100% that the laboratory failed to evaluate for accuracy. 2. A review of Microbiology 2020 event 3 records from API identified the laboratory failed to evaluate for accuracy two (2) Shiga toxin molecular samples that were ungraded due to no appropriate peer group resulting in an artificial score of 100%, one ungraded parasitology and one ungraded anaerobic wound culture sample due lack of consensus, resulting in an artificial score of 100%. 3. A review of Microbiology 2020 event 1 records from API identified 24 samples for Pneumonia resistance genes that were ungraded due to no appropriate peer group resulting in an artificial score of 100% that the laboratory failed to evaluate for accuracy. 4. A review of Hematology /Coagulation 2020 event 1 records from API identified one body fluid crystal samples, 6 sperm classification samples and two sperm morphology samples that were ungraded due to lack of consensus resulting in an artificial score of 100% that the laboratory failed to evaluate for accuracy. 5. An interview with the TS on 1/27/2021 at 8:30 am confirmed that the laboratory did not evaluate the accuracy of ungraded PT results that were given an artificial score of 100%. 6. The laboratory reports performing 519,353 moderate and high complexity tests annually. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic -- 3 of 12 -- systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of quality control (QC) records, laboratory policies and procedures,

Summary Statement of Deficiencies 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 proficiency testing (PT) record review and an interview with the laboratory manager, the laboratory failed to enroll in PT for Syphilis, Rubella, Hepatitis B surface antigen (HbsAg), and Anti-human immunodeficiency virus (HIV) analytes since the last survey on July 21, 2017. Findings: 1. A review of PT records from the American Proficiency Institute (API) revealed the laboratory failed to enroll in PT for the analytes Syphilis, Rubella, HbsAg, and HIV since the last survey. 2. An interview on September 18, 2018 at 8:30 AM, with the laboratory manager, confirmed the laboratory was not enrolled in a CMS-approved PT program for the listed analytes since the last survey. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and an interview with the laboratory manager, the laboratory director and/or designee failed to sign the attestation statements from the American Proficiency Institute (API) for the specialty of hematology, immunohematology, microbiology, and chemistry from since last survey on July 21, 2017. This is a repeat deficiency. Findings: 1. A review of API PT records from 2017 and 2018, revealed the laboratory director and/or designee failed to sign the attestation statements for the specialty of hematology, immunohematology, microbiology, and chemistry for the 2017 and 2018 events. 2. An interview on September 18, 2018 at 8:30 AM, with the laboratory manager, confirmed the laboratory director or designee failed to sign the attestation statements. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 record review and an interview with the laboratory manager, the laboratory failed to verify the accuracy of fetal screen, semen count, Hepatitis C (HepC), and vitamin D at least twice a year since the last survey on July 21, 2017. Findings: 1. A record review of proficiency testing revealed the laboratory failed to document the accuracy of fetal screen, semen count, HepC, and vitamin D at least twice a year since the last survey. 2. An interview on September 18, 2018 at 8:30 AM, with the laboratory manager, confirmed the laboratory failed to document the accuracy of fetal screen, semen count, HepC, and vitamin D at least twice a year. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a record review and an interview with the microbiology lead, the laboratory director failed to approve, sign, and date the MicroScan Walkaway bacteria identification system and the 6 analytes tested on the Cepheid Gene Xpert Individualized Quality Control Plan (IQCP) since the last survey on July 21, 2017. This is a repeat deficiency. Findings: 1. A review of the IQCPs for the Walkaway and tests performed on the Cepheid Gene Xpert, revealed the laboratory director failed to approve, sign, and date the IQCPs. 2. An interview on September 18, 2018 at 4:00 PM, with the microbiology lead, confirmed the laboratory director failed to sign and date the IQCPs. 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 -- 2 of 6 -- 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 record review and an interview with the laboratory manager, the laboratory failed to perform and document calibration verification activities at least once every 6 months, after major maintenance or parts replacement, issues with quality control, or verification of reportable range on the Siemens Centaur XP Immunoassay analyzer since the last survey on July 21, 2017. Findings: 1. A review of calibration records revealed the laboratory failed to perform calibration verification activities on vitamin D, vitamin B-12, testosterone, parathyroid hormone, insulin, folate, cortisol, follicular stimulating hormone, progesterone, prolactin, phenytoin, valproic acid, total triiodothyronine, Luteinizing hormone, and carbamazepine on the Siemens Centaur immunoassay analyzer since the last survey. 2. An interview on September 18, 2018 at 9:50 AM, with the laboratory manager, confirmed the laboratory failed to perform calibration verifications activities for the listed analytes. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory manager, the laboratory failed to meet the manufacturer's requirements for performing the mean closure time since the last survey on July 17, 2017. Findings: 1. A review of the Siemens PFA-100 instruction manual revealed the laboratory failed to meet the -- 3 of 6 -- quality control testing requirement that the control group values should be between 110-160 seconds. 2. An interview on September 18, 2018 at 9:50 AM, with the laboratory manager, confirmed the laboratory failed to follow the manufacturer's instructions for donor control testing. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory manager, the laboratory failed to perform control procedures at least once each day of patient testing on the Siemens PFA-100 instrument used for the detection of platelet dysfunction since the last survey on July 17, 2017. Findings: 1. A review of the quality control records for the PFA-100 instrument revealed the laboratory failed to perform quality control at least once each day of patient testing since the last survey. 2. An interview on September 18, 2018 at 9:50 AM with the laboratory manager, confirmed the laboratory failed to perform quality control each day of patient testing and did not write an Individualized Quality Control Plan for the test system. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of quality control records and an interview with the laboratory manager, the laboratory failed to test two levels of quality control material for both Hepatitis B surface antigen (HbsAg) and D-dimer prior to reporting patient results between February 26, 2018 through May 16, 2018. Findings: 1. A review of the HbsAg quality control records performed on the Siemens Centaur immunoassay between February 26, 2018 through March 6, 2018 revealed the laboratory failed to test two levels of quality control materials prior to 8 patients HbsAg results reported. 2. A review of the D-dimer quality control records performed on the Sysmex CA-500 coagulation between May 14 through May 16, 2018, revealed the laboratory failed to test two levels of quality control materials prior to 6 patients D-dimer results being reported during that time. 3. An interview on September 18, 2018, at 2:30 PM, with the laboratory manager, confirmed 8 HbsAg and 6 D-dimer tests were reported without two levels of quality control performed. -- 4 of 6 -- D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory manager, the laboratory failed to establish or verify the criteria for acceptability of control materials for Hepatitis B surface antigen (HbsAg) performed on the Centaur immunoassay analyzer during the dates reviewed from February 26 through March 6, 2018. Findings: 1. A review of quality control records for HbsAg revealed the laboratory failed to establish and verify the acceptability of unassayed quality control material. 2. An interview on September 18, 2018, at 10:30 AM, with the laboratory manager, confirmed the laboratory failed to verify a patient sample used as quality control material. 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. (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 record review and an interview with the bloodbank lead, the laboratory failed to perform compatibility testing to detect IgM antibodies using the Ortho Workstation since the last survey on July 17, 2017. Findings: 1. A review of quality control records revealed the laboratory failed to perform an immediate spin crossmatch for the detection of IgM antibodies for ABO incompatibilities. 2. An interview on September 18, 2018, at 5:05 PM, with the bloodbank lead, confirmed the laboratory failed to perform an immediate spin to demonstrate ABO incompatibilities. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT -- 5 of 6 -- CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a record review and an interview with the microbiology lead, the laboratory failed to establish and follow a written policy or procedure to monitor, assess, and correct problems in the MicroScan Walkaway system for bacteria identification and antimicrobial susceptibility testing since the last survey on July 17, 2017. Findings: 1. A review of the Individualized Quality Control Plan (IQCP) for the Walkaway microbiology system revealed the laboratory failed to write a Quality Assessment Plan (QAP) for the test system. 2. An interview on September 18, 2018, at 4:00 PM, with the microbiology lead, confirmed the laboratory failed to write a QAP to provide a system that reviews the functions of the Walkaway system. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

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 proficiency testing (PT) desk review, the laboratory failed to successfully participate in proficiency testing for the analyte Thyroid stimulating hormone. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) desk review and the laboratory ' s graded PT results from the American Proficiency Institute (API), the laboratory failed to achieve successful performance for the analyte Thyroid stimulating hormone (TSH) in two out of three testing events. Findings: Analyte Year Event Score TSH 2018 1 0% TSH 2018 2 40% -- 2 of 2 --