Burgess Health Center

Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of blood bank procedures, blood bank records, chemistry quality control (QC) records, laboratory policies and patient test reports and confirmed by interview with the General Supervisor, the laboratory failed to ensure they had written procedures for retyping blood donor units transfused to patients as specified in D5401, ensure the laboratory performed two levels of QC each day of patient testing as specified in D5447, and ensure the laboratory retyped donor units transfused to patients as specified in D5553. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of blood bank procedures and confirmed by general supervisor #1 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 -- (GS #1) at 10:06 am on 12/9/2025, the laboratory failed to have a procedure for retyping blood donor units that are received in the laboratory and transfused to patients. The findings include: 1. The laboratory did not retype two donor units transfused to Patient A on 10/15/2025. Refer to D5553. 2. At the time of the survey, GS #1 confirmed the laboratory did not have a procedure for retyping blood donor units transfused to patients. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on review of chemistry quality control (QC) records and confirmed by general supervisor #1 (GS #1) at 2:06 pm on 12/9/2025, the laboratory failed to perform two levels of chemistry controls on five out of 31 days of patient testing from 7/1/2025 - 7 /31/2025. The findings include: 1. On 7/2/2025, the laboratory only performed diabetes control 2 for the analyte, glycated hemoglobin. 2. On 7/6/2025, the laboratory only performed immunology control 3 for the analyte, c-reactive protein. 3. On 7/14 /2025, the laboratory only performed multiqual control 1 for the analyte, phosphorus. 4. On 7/18/2025, the laboratory only performed IP control 3 for the analyte, thyroid stimulating hormone. 5. On 7/26/2025, the laboratory only performed IP control 3 for the analyte, salicylate. 6. At the time of the survey, GS #1 confirmed the laboratory did not perform two levels of QC on the above dates. GS #1 also confirmed the laboratory reported out patient test results on the above dates for the analytes listed. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). This STANDARD is not met as evidenced by: Based on review of blood bank records and confirmed by general supervisor #1 (GS #1) at 10:06 am on 12/9/2025 the laboratory failed to document the donor unit retype for two out of two units of blood transfused on 10/15/2025. The findings include: 1. On 10/15/2025 the laboratory crossmatched and distributed two units of blood (W037925203244 and W037925181039) to Patient A. 2. The laboratory failed to document the retype of donor unit numbers W037925203244 and W037925181039. 3. At the time of the survey, GS #1 confirmed the laboratory did not have documentation of the retype for donor unit numbers W037925203244 and W037925181039. This is a repeat deficiency, previously cited on 10/26/2023. D5783

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on June 3, 2025. The laboratory was found to be out of compliance with the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R 493.803 Condition: Successful Participation D6076 - 42 C.F.R 493.1441 Condition: Laboratory Director, high complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the Wisconsin State Laboratory of Hygiene and American Proficiency Institute, the laboratory failed to successfully 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 -- participate in two out of three consecutive testing events for the analyte, compatibility testing. The laboratory had unsatisfactory scores for 2022 event 3, 2023 event 2, 2024 event 2 and 2025 event 1. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) (e) 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the Wisconsin State Laboratory of Hygiene (WSLH) and American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for two out of three consecutive testing events in the subspecialty, compatibility testing. The findings include: 1. For 2022 event 3, the laboratory received an unsatisfactory performance score of 80% for the subspecialty, compatibility testing. 2. For 2023 event 2, the laboratory received an unsatisfactory performance score of 60% for the subspecialty, compatibility testing. 3. For 2024 event 2, the laboratory received an unsatisfactory performance score of 80% for the subspecialty, compatibility testing. 4. For 2025 event 1, the laboratory received an unsatisfactory performance score of 80% for the subspecialty, compatibility testing. 5. The CASPER 155 report and graded results from WSLH and API confirm the findings listed above. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the Wisconsin State Laboratory of Hygiene and American Proficiency Institute (2022 event 3, 2023 event 2, 2024 event 2, and 2025 event 1), the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the Wisconsin State Laboratory of Hygiene and American Proficiency Institute (API), the laboratory director failed to -- 2 of 3 -- ensure successful participation in an HHS approved proficiency testing program. Refer to D2181. -- 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory failed to successfully participate in two consecutive testing events in the subspecialty of ABO group and D (Rho) typing. The laboratory had unsatisfactory scores for 2023 events 3 and 2024 event 1. Refer to D2163. D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance (100% or greater) for two consecutive testing events in the subspecialty, ABO group and D (Rho) typing. The findings include: 1. For 2023 event 3, the laboratory received an unsatisfactory performance score of 90% for the subspecialty, ABO group and D (Rho) typing. 2. For 2024 event 1, the laboratory received an unsatisfactory performance score of 90% for the subspecialty, ABO group and D (Rho) typing 3. The CASPER 155 report and graded results from API confirm the findings listed above. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from API (2023 event 3 and 2024 event 1), the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2163. -- 2 of 2 --

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 review of proficiency testing (PT) records and the laboratory test list and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at 8:40 am on 10/26/2023, the laboratory failed to enroll in an approved proficiency testing program for the analytes: alkaline phophatase, albumin, total protein, amylase, iron, magnesium, thiiodothyronine (free T3), thyroxine (free T4), and thyroid-stimulating hormone (TSH). The laboratory switched proficiency testing programs in 2023, and failed to enroll in PT for the listed analytes. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: 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 -- Based on review of coagulation reagent lot studies and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 11:41 am on 10 /26/23, the laboratory failed to retain the specific data used to calculate the normal patient mean for lot number 564602, expiration date 7/9/2024 of Innovin (prothromin time reagent). The findings include: 1. The laboratory establishes a new normal patient mean for each specific lot number of Innovin. 2. The coagulation reagent lot studies for lot number 564602, expiration date 7/9/2024 of Innovin revealed a normal patient mean of 10.7 seconds. 3. At the time of the survey, the laboratory did not have the specific data including the number of patients or the individual patient results that the laboratory used to calculate the normal patient mean. 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 review of proficiency testing records and the laboratory test list and confirmed by laboratory personnel #1 (refer to the Laboratory Personnel Report) at 8: 40 am on 10/26/2023, the laboratory failed to verify the accuracy twice annually for two out of two time periods for the following analytes: total iron binding capacity, lactic acid, lipase, phosphorus, and beta hydroxybutyrate from 1/1/2023 - 10/26/2023. The findings include: 1. The laboratory switched proficiency testing companies in 2023. 2. At the time of the survey, the laboratory did not enroll in PT for the above analytes. Additionally, the laboratory had not verified the accuracy of the analytes by a different method. 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 blood bank maintenance logs and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 9:36 am on 10/26 /2023, the laboratory failed to perform and document the blood bank dispenser maintenance and volume checks for four out of four weeks in June 2023. The findings include: 1. The blood bank maintenance log states that the laboratory would clean and perform volume checks of the blood bank dispenser weekly. 2. At the time of the survey, the laboratory did not perform and document the weekly maintenance in June 2023. 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; -- 2 of 4 -- (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 review of calibration and calibration verification records and the Dimension Hemoglobin A1C assay instructions for use, and confirmed by laboratory personnel identifiers #1 (refer to the Laboratory Personnel Report) at 10:57 am on 10/26/2023, the laboratory failed to perform calibration verification procedures every six months for three out of three time periods for the analyte, hemoglobin A1C from 1/1/2022 - 10 /26/2023. The findings include: 1. The laboratory performed calibrations on the hemoglobin A1C reagent every 30 days as per the Dimension Hemoglobin A1C assay instructions for use. 2. The hemoglobin portion of the calibration used 2 calibrators and the hemoglobin A1C portion of the calibration used 5 calibrators. 3. At the time of the survey, the laboratory did not perform calibration verification procedures which included a minimal (zero) value, a mid-point value and maximum value for the analyte, hemoglobin A1C. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (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 review of the Unit Type and Crossmatch Procedure, blood bank records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 9:36 am on 10/26/2023 the laboratory failed to document the donor unit retype for two out of two units of blood transfused on 6/20/2023. The findings include: 1. On 6/20/2023 the laboratory crossmatched and distributed two units of blood (W037923140577 and W037923143740) to patient A. 2. The Unit Type and Crossmatch Procedure states that each unit of blood will be retyped prior to distribution. 3. Laboratory procedure included documenting the retype of the donor units, including the forward type reactions, on the blood unit inventory log. 4. Laboratory procedure also included documenting the donor unit type on the -- 3 of 4 -- crossmatch worksheet. However, the crossmatch worksheet did not include the donor unit forward type reactions. 5. The laboratory failed to document the retype of donor unit numbers W037923140577 and W037923143740 on the blood unit inventory log. 6. The laboratory did document the donor unit type on the crossmatch worksheet for both units. However, since the donor unit retype reactions are not documented on the crossmatch worksheet, it could not be verified that the laboratory had actually performed the unit retype. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of the laboratory test list, lack of comparison records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 10: 34 am on 10/26/2023, the laboratory failed to perform twice annual comparison studies for three out of three time periods for the analytes: influenza A, influenza B, respiratory syncytial virus (RSV), SARS-CoV-2, and Clostridioides difficile (C. diff) toxin from 1/1/2022 - 10/23/2023. The findings include: 1. The laboratory performs influenza A, influenza B, RSV and SARS-CoV-2 testing on both the Biofire and Cepheid test systems. 2. The laboratory performs C. diff toxin testing using both the Biofire and TechLab C. Diff Complete test kit. 3. At the time of the survey, the laboratory did not perform comparison testing for the above analytes. -- 4 of 4 --

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 review of proficiency records and reports, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty, compatibility testing, for two out of three consecutive proficiency testing events: 2022 event 3 and 2023 event 2 (refer to D2181). D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive 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 -- testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing reports and records, the laboratory failed to achieve satisfactory performance for the subspecialty, compatibility testing, for two out of three consecutive testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 80% for 2022 testing event 3 and 60% for 2023 testing event 2. -- 2 of 2 --

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 review of proficiency testing records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11:00 am on 11/13/2019, the laboratory failed to enroll in an approved proficiency testing program for the subspecialty, bacteriology (Clostridium difficile) in 2019. The findings include: 1. The laboratory began performing Clostridium difficile testing with the Alere C Diff Quik Chek Complete test system in November 2018. 2. At the time of the survey, the laboratory failed to enroll in an approved proficiency testing program for the subspecialty, bacteriology (Clostridium difficile) in 2019. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of Sysmex CA-600 coagulation test system records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 3:45 pm on 11/13/2019, the laboratory failed to verify the manual calculation of the international normalized ratio (INR) for one out of one lot number of thromboplastin (549729, expiration 02/01/2021). The findings include: 1. At the time of the survey, the laboratory had in use thromboplastin lot number 549729 (expiration 02/01/2021). 2. The coagulation reagent verification records for thromboplastin lot number 549729 did not include verification of the accuracy of the INR calculation from the instrument. 3. Personnel identifier #1 confirmed that the laboratory did not verify the accuracy of the INR calculation from the instrument. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of Siemens Dimension calibration verification records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 3:00 pm on 11/13/2019, the laboratory failed to perform and document calibration verification procedures every six months on the Siemens Dimension EXL 200 for one out of two time periods from January 2019- November 2019 for the following analytes: sodium, potassium, and chloride. The findings include: 1. The laboratory performed calibration verification on the analytes, sodium, potassium, and chloride in January 2019. 2. At the time of the survey, personnel identifier #1 confirmed that the laboratory did not have calibration verification records for the analytes, sodium, potassium, and chloride for the time period between July 2019 and November 2019. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) -- 2 of 4 -- 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 lack of Individualized Quality Control Plan (IQCP) records, review of quality control (QC) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 1:00 pm on 11/13/2019, the laboratory failed to perform a positive and negative control each day of patient testing for the Legionella Binax NOW Urinary Antigen Card test system. The findings include: 1. The laboratory performed controls with each new lot number and shipment of kits and monthly. 2. Laboratory personnel identifier #1 indicated that the laboratory intended to follow manufacturer's instructions for performing QC. 5. At the time of the survey, the laboratory did not have an IQCP for the Legionella Binax NOW Urinary Antigen Card test system. D5783

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 review of proficiency records and reports, the laboratory failed to successfully participate in a proficiency testing program for the analyte, partial thromboplastin time, for two consecutive testing events: 2019 events 1 and 2 (refer to D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) reports and records, the laboratory failed to achieve satisfactory performance for the analyte, partial thromboplastin time, for two consecutive PT events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 40% for 2019 testing event 1 and 20% for 2019 testing event 2. -- 2 of 2 --