Progressive Medical Mgmt Dba Panola Medical Center

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (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 review of manufacturer's instructions for the Stago STA Satellite coagulation system, the manufacturer's package insert for STA-Neoplastine C1 Plus prothrombin time (PT) reagent Lot #267015, patient test count from 12/1/2024 through 4/23/2025, and observation of the ISI (International Sensitivity Index) value in the STA Satellite coagulation system on 4-23-2025 at 3:00 p.m., the laboratory failed to follow manufacturer's instructions for setting up the STA Satellite coagulation system to calculate the INR (International Normalized Ratio) for patient PT testing when PT reagent Lot #267015 was put in use for patient testing on 12/1 /2024. Findings include: 1. Manufacturer's instructions for the Stago STA Satellite coagulation system state to enter the ISI value from the package insert with each new lot of PT reagent for correct calculation of the INR. 2. Review of the package insert for the current STA-Neoplastine C1 Plus PT reagent, Lot #267015, put in use on 12/1 /2024, revealed the ISI value for this lot of PT reagent was 1.32. 3. The ISI value observed in the STA Satellite coagulation system on 4/23/2025 at 3:00 p.m. was 1.30. 4. Review of patient PT test counts from 12/1/2024 through 4/23/2025 revealed 136 patient PT tests were performed and results were reported during this time frame, when the incorrect ISI value was used to calculate patient INR results. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 -- (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of patient test logs, quality control (QC) records for the Siemens Dimension EXL with LM chemistry analyzer from 5/23/2023 through 4/23/2025, manufacturer's package inserts for Bio-Rad Liquichek Immunoassay Plus controls, Bio-Rad Liquichek Cardiac controls, Bio-Rad Liquichek Plus LT and Bio-Rad Liquichek Qualitative Urine Toxicology controls and interviews with the General Supervisor (GS) and Testing Personnel (TP) #2 listed on the CMS 209 personnel form, it was determined the laboratory used those Bio-Rad quality control material for quality control testing after they had exceeded their expiration dates. Findings include: 1. Review of the manufacturer's package inserts for Bio-Rad Liquichek Immunoassay Plus Controls Level 1 (Lot #85351) and Level 3 (Lot #85353) revealed these two levels of controls had an expiration date of 2/28/2025. These controls were used as quality control testing for Vancomycin and Quantitative Beta HCG patient testing from 3/5/2025 through 4/21/2025. A total of eleven Beta HCG and five Vancomycin patients' results were reported during this time frame. 2. Review of the manufacturer's package inserts for Bio-Rad Liquicheck Cardiac Level 1B (Lot# 67685) and Level 3 (Lot# 67683) revealed these two levels of controls had an expiration date of 2/28 /2025. These controls were used as quality control testing for Troponin and BNP (LNTP) testing from 3/6/2025 through 4/23/2025. A total of thirty-one BNP (LNTP) and two Troponin patients' results were reported during this time frame. 3. Review of the manufacturer's package inserts for Bio-Rad Liquicheck Qualitative Urine Positive Control (Lot # 74712) revealed an expiration date of 1/31/2025 and Negative Control (Lot# 68150) revealed an expiration date of 2/28/2025. These controls were used as quality control testing for Amphetamines, Barbiturates, Benzodiazapine, Cocaine, Ecstasy, Methamphetamine, Opiates, PCP (Phencyclidine) and THC (Tetrahydrocannabinol) testing from 2/28/2025 through 4/23/2025. A total of twenty- two urine drug screens were performed and reported during this time frame. 4. An interview with the GS and TP #2 on 4/23/2025 at 10:00 a.m., confirmed the laboratory used Bio Rad controls that had exceeded their expiration dates for Troponin, BNP (LNTP), Vancomycin, Quantitative Beta HCG and urine drug screen testing and a total of seventy-one patient tests were reported. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) Equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer. The laboratory must do the following: This STANDARD is not met as evidenced by: Based on review of Ortho Clinical Diagnostics MicroTyping System (MTS) Dispenser Operating Instructions, Transfusion Service Testing Record and Blood Bank Daily/Weekly maintenance records from 3/10/2023 through 3/28/2025, and lack -- 2 of 4 -- of calibration checks for the two MTS dispensers, in use for ABO/Rh and compatibility testing, the laboratory failed to follow manufacturer's instructions for performing calibration checks for the MTS 2 diluent dispenser and MTS 2 Plus diluent dispenser for 18 of 24 months reviewed. Findings include: 1. The Ortho Clinical Diagnostics MTS Dispenser Operating Instructions state, "A calibration check should be done as part of a routine laboratory quality control schedule and after each repair." 2. Review of Blood Bank Daily/Weekly maintenance records from 3/10 /2023 through 3/28/2025 revealed the laboratory's maintenance policy included monthly calibration checks for the MTS 2 diluent dispenser and MTS 2 Plus diluent dispenser, but there was no documentation of calibration checks for the two MTS dispensers from 9/4/2023 through 3/28/2025 (18 of 24 months reviewed). 3. Review of the Transfusion Service Testing Record from 3/10/2023 through 3/28/2025 revealed ABO/Rh and compatibility testing were performed each month during this time frame. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the Transfusion Service Testing Record and blood bank reagent quality control (QC) records from 3/10/2023 through 3/28/2025, the laboratory failed to document performance of quality control for the reagent gel cards used for ABO grouping, Rh typing, antibody detection, and compatibility testing for three, of eighteen, days in April 2023 and three, of eighteen, days in May 2023 when testing was performed on ten patients, with eight units of packed red blood cells (PRBC) issued for transfusion to five of these patients. Findings include: Review of the Transfusion Service Testing Record and blood bank reagent QC records from 3/10 /2023 through 3/28/2025 revealed that quality control for the blood bank reagent gel cards was not documented, as performed, on the following days when ABO grouping, Rh typing, antibody detection (Ab screen), and compatibility testing were performed on ten patients: 4/24/2023--ABO/Rh and Ab screen performed on Patient #3161119 and #3161233. 4/26/2023--ABO/Rh, Ab screen, and compatibility testing performed on Patient #3161296 for one unit of PRBC transfused on 4/26/2023. ABO/Rh and Ab screen performed on Patient #3160886. 4/27/2023--ABO/Rh, Ab screen, and compatibility testing performed on Patient #3161616 for two units of PRBC transfused on 4/27/2023. ABO/Rh and Ab screen performed on Patient #3160159. 5/2 /2023--ABO/Rh, Ab screen, and compatibility testing performed on Patient #3162041 for two units of PRBC transfused on 5/3/2023. ABO/Rh and Ab screen performed on Patient #3162189. 5/20/2023--ABO/Rh, Ab screen, and compatibility testing -- 3 of 4 -- performed on Patient #3163938 for one unit of PRBC transfused on 5/20/2023. 5/23 /2023--ABO/Rh, Ab screen, and compatibility testing performed on Patient #3164207 for two units of PRBC transfused on 5/23/2023. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records including competencies, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interview with the General Supervisor (GS), the Technical Supervisor (TS) failed to evaluate and document the performance of four of five new testing personnel (TP) responsible for performing moderate and high complexity laboratory testing at least semiannually during the first year of employment. Findings Include: 1. Review of the laboratory personnel records since the last survey on 3/8/2023, revealed the semiannual competency evaluations available the day of survey were performed by the GS for the performance of four of five new laboratory testing personnel (TP #5, TP #6, TP #7 and TP #8). 2. The General Supervisor confirmed in an interview on 4/23/2025 at 2:30 p.m., the six-month competencies available the day of survey were performed by her and not the TS listed on the CMS 209 form. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of laboratory testing personnel competency records for testing personnel (TP) as listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interview with the General Supervisor (GS), the annual evaluations for moderate and high complexity testing personnel (TP) were performed by staff other than the Technical Supervisor (TS) for six of nine testing personnel. Findings include: 1. Review of the laboratory personnel records available on 4/23 /2025 revealed annual evaluations/competencies for moderate and high complexity testing personnel were performed by the GS. TP #3- for the years 2023 and 2024 TP #4- for the year 2024 TP #5- for the years 2023 and 2024 TP #6- for the years 2023 and 2024 TP #7- for the years 2023 and 2024 TP #8- for the years 2023 and 2024 2. Interview with the General Supervisor/TP #1 on 4/23/2025 at 2:30 p.m., confirmed the annual evaluation/competencies for moderate and high complexity testing had not been documented as performed by the Technical Supervisor listed on the CMS 209 form. Six of nine laboratory testing personnel did not have annual evaluations /competencies performed by the TS. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The following condition level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Condition: Successful participation, proficiency testing 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 6 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 -- /26/2023, the laboratory failed to maintain satisfactory performance in two of three testing events (2022 - Event 2 and 2023 - Event 1) resulting in unsuccessful performance in Immunohematology for Compatibility Testing. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute and CASPER reports 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 6/26 /2023, the laboratory has not successfully performed proficiency testing for Compatibility Testing in two of three testing events. Findings include: A review of the laboratory records from the American Proficiency Institute and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for Compatibility Testing: Year 2022 - 2nd Event: 60% Year 2023 - 1st Event: 80% -- 2 of 2 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory proficiency testing (PT) records from 8/12 /2021 through 3/8/2023 and confirmation by testing personnel (TP) # 1 and # 8 listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form at 11: 30 a.m. on 3/8/2023, the laboratory failed to retain 7 of 24 PT attestation statements and 2 of 24 PT evaluations for at least 2 years. Findings include: 1. Review of PT records for 2021-3rd event and 2022-1st, 2nd, and 3rd events revealed the laboratory did not retain the following records: a. Signed attestation statements were not kept for 7 of 24 events. This included Microbiology 2021-3rd event, Miscellaneous Chemistry 2022-1st event, Core Chemistry 2022-1st event and Blood Gas 2021-3rd event, 2022- 1st, 2nd, and 3rd events. b. Graded PT evaluation reports were not kept for 2 of 24 events. This included Miscellaneous Chemistry 2022-2nd event and Immunohematology/Immunology 2021-3rd event. 2. TP # 1 and # 8 confirmed in an interview at 11:30 a.m. on 3/8/2023 that the proficiency testing records listed above were not retained. 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 5 -- This STANDARD is not met as evidenced by: Based on review of the Stago STA-Satellite Procedures and Reference Manual, the manufacturer's package insert for Stago activated partial thromboplastin time (APTT) Reagent Lot #260971, coagulation testing quality control (QC) logs from 9/1/2021 through 3/8/2023, and interview with General Supervisor #2, listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, on 3/8/2023 at 11:45 a. m., the laboratory failed to follow the manufacturer's Lot Conversion Protocol with 1 of 1 lot conversions for APTT Reagent Lot #260971, put in use in August 2022 for patient APTT testing on the Stago STA-Satellite coagulation system. Findings include: 1. Review of the manufacturer's package insert for Stago APTT Reagent Lot #260971 and coagulation testing QC logs from 9/1/2021 through 3/8/2023 revealed Stago APTT Reagent Lot #260971 was put in use for patient testing in August 2022. 2. Review of the Stago STA-Satellite Procedures and Reference Manual revealed the Lot Conversion Protocol states, "Lot conversion studies should be performed prior to starting a new lot number of protime or APTT reagent." 3. On 3/8/2023 there was no documentation available of lot conversion studies performed on 1 of 1 lot conversions (APTT Reagent Lot #260971). 4. In an interview on 3/8/2023 at 11:45 a.m., General Supervisor #2, listed on the CMS 209 personnel form, confirmed the Lot Conversion Protocol was not performed for Stago APTT Reagent Lot #260971 before it was put in use for patient testing in August 2022. 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 the Siemens Rapid Point 500e blood gas analyzer records including quality control, maintenance, operating manual, and a lack of calibration records from 08/10/2021 through 3/7/2023 and confirmation with testing personnel #7 (as listed on the Centers for Medicare and Medicaid Services 209 Personnel form) at 12:00 p.m. on 3/8/2023, the laboratory failed to document as performed calibration verification (CVM) on the Siemens Rapid Point 500e blood gas analyzer every 6 -- 2 of 5 -- months for pCO2, pH, pO2. Three of three verifications were missed during the timeframe reviewed. Findings include: 1. Calibration verification is required every 6 months on any assay which is calibrated with less than 3 levels of calibration material. 2. Review of the calibration procedure for the Siemens Rapid Point 500e Blood Gas Analyzer revealed that less than 3 levels of calibration material are used during routine calibration. 3. There were no records to indicate that calibration verification /linearity had been performed on the Siemens Rapid Point 500e for pH, pCO2 and pO2 since installation on 6/30/2021. 4. Testing personnel #7 confirmed in an interview at 12:00 p.m. on 3/8/2023 that the CVM (calibration verification) on pH, pCO2 and pO2 was not performed every 6 months for a total of 3 of 3 six-month periods. 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 review of the manufacturer's package inserts for Stago STA-COAG controls and Stago STA-LIATEST controls, coagulation testing quality control (QC) logs from 9/1/2021 through 3/8/2023, and interview with General Supervisor #2, listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, on 3/8/2023 at 11:45 a.m., the laboratory failed to verify the manufacturer's stated values of Stago quality control for 4 of 4 levels put into use during the review period. This included the STA-COAG normal and abnormal controls, Lot #260839, for prothrombin (PT) and activated partial thromboplastin time (APTT) testing in use on 10/20/2022 and Stago STA-LIATEST normal and abnormal controls, Lot #260548, for D-Dimer testing in use in August 2022. Findings include: 1. Review of the manufacturer's package inserts for Stago STA-COAG controls and coagulation testing QC logs from 9 /1/2021 through 3/8/2023 revealed the Stago STA-COAG normal and abnormal controls, Lot #260839, currently in use, were put in use for PT and APTT testing on 10 /20/2022. 2. Review of the manufacturer's package inserts for Stago STA-LIATEST controls and coagulation testing QC logs from 9/1/2021 through 3/8/2023 revealed Stago STA-LIATEST normal and abnormal controls, Lot #260548, currently in use, were put in use for D-Dimer testing in August 2022. 3. On 3/8/2023 there was no documentation available for review of verification of the manufacturer's stated ranges for 4 of 4 levels of Stago quality control before they were put in use for patient testing. This included 2 levels of STA-COAG controls (Lot #260839) and 2 levels of STA-LIATEST controls (Lot #260548). 4. In an interview on 3/8/2023 at 11:45 a.m., -- 3 of 5 -- General Supervisor #2, listed on the CMS 209 personnel form, confirmed that the manufacturer's ranges were not verified for these lots of controls before they were put in use. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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 review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, personnel records since the last survey on 7/11/19, and confirmation by the general supervisor, the laboratory failed to establish and follow written policies and procedures to assess general supervisor competency. Findings include: Review of the CMS 209 personnel form and personnel records revealed no documentation of assessment of the general supervisor's competency since the last survey on 7/11/19. The general supervisor confirmed the laboratory failed to establish written policies and procedures to assess general supervisor competency. 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 the Sysmex XT-4000i hematology analyzer maintenance logs since the last survey on 7/11/19 and confirmation by the general supervisor, the laboratory failed to perform and document monthly maintenance for the Sysmex XT- 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 -- 4000i hematology analyzer, as defined by the manufacturer, for eleven months during this time frame. Findings include: Review of the Sysmex XT-4000i hematology analyzer maintenance logs since the last survey on 7/11/19 revealed the monthly maintenance as defined by the manufacturer - Cleaning the sampler right rack pool, left rack pool, analysis line, and sample rack - was not documented as performed for the months of February, May, June, July, August, October, November, and December of 2020 and the months of February, May, and June of 2021. The general supervisor confirmed the monthly maintenance was not performed for these months. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of respiratory personnel records from 7/11/19 through 8/12/21, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interview with testing personnel (TP) #7 (respiratory supervisor), and the laboratory general supervisor, the technical consultant (TC) failed to evaluate and document the performance of TP #1, responsible for performing blood gas testing, at least semiannually during the first year of employment. Findings include: 1. Review of the personnel records for TP #1 revealed there was no semiannual evaluation/competency documented as performed by the technical consultant during the first year of testing patients using a moderate complexity blood gas testing procedure. TP #1 began employment on 1/13/20 as blood gas testing personnel and had no 6 month evaluation performed by the TC. 2. Interview with the TP #7 (respiratory supervisor) and general supervisor at 2:00 p.m. on 8/12/21 confirmed the 6 month evaluation/competency was not performed on TP #1 during the first year of testing patient samples. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of respiratory testing personnel (TP) records including the Centers of Medicare and Medicaid Services (CMS) 209 personnel form and interview with the respiratory supervisor (TP #7) and laboratory general supervisor listed on the CMS 209 form, the technical consultant failed to evaluate annually and document the performance of respiratory testing personnel #3 through #8 who are responsible for performing moderate blood gas testing. Findings include: 1. Based on respiratory personnel records available for review on the day of survey, there were no annual evaluations/competencies performed by the technical consultant on the following TP since the last survey on 7/11/19: TP # 7 - No annual evaluations for 2020 or 2021 TP # 3, #4, #5, #6, #8 - No annual evaluation for 2020 2. Interview with the respiratory -- 2 of 3 -- supervisor (TP#7) confirmed the annual evaluation/competencies for TP #3 through #8 available the day of survey had not been documented as performed by the technical consultant. -- 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 6/10/20, the laboratory has not successfully participated in proficiency testing for ABO/RHO. Findings include: Our records indicate the following proficiency testing scores for your laboratory for ABO/RHO: PROFICIENCY TESTING PROVIDER: American Proficiency Institute ABO/RHO: Year 2019 3rd Event 80% Year 2020 1st Event 0% Scores less than 100% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of 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 2 -- analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 6/10/20, the laboratory has not successfully participated in proficiency testing for ABO/RHO. Findings include: Our records indicate the following proficiency testing scores for your laboratory for ABO/RHO: PROFICIENCY TESTING PROVIDER: American Proficiency Institute ABO/RHO: Year 2019 3rd Event 80% Year 2020 1st Event 0% Scores less than 100% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --

Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the CytoTherm-4S Plasma Thawing Water Bath Owner's Manual and interview on 7-10-19 at 10:00 a.m. with Laboratory Testing Personnel #19, listed on the Center for Medicare and Medicaid Services (CMS) 209 Laboratory personnel form, the laboratory failed to perform and document the Overtemperature Alarm Test every three months, as specified by the manufacturer, since 9-2-18. Findings include: The CytoTherm-4S Plasma Thawing Water Bath Owner's Manual states that the Overtemperature Alarm Test should be performed every three months. There was no documentation available on the day of the survey of the performance of the Overtemperature Alarm Test since 9-2-18. Laboratory Testing Personnel #19 confirmed in an interview on 7-10-19 at 10:00 a.m. there was no documentation of the performance of the Overtemperature Alarm Test since 9-2-18. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on review of Pro-Lab Amnio Test Nitrazine/phenaphthazin quality control (QC) records from 9/18 and interview with testing personal on 7/11/19 at 9:00 am, the OB/GYN nursing services failed to perform two levels of QC each day of patient testing when using the Pro-Lab Amnio Nitrazine/phenaphthazin swab test. Findings include: 1. Two levels of external control material must be tested and documented each day of patient testing unless the laboratory chooses to establish an Individualized Quality Control Plan (IQCP). 2. The 2 levels of QC required by the manufacturer for the Amnio Nitrazine/phenaphthazin swab test are Pro Lab Buffer Solutions: QC 1 acid (5.0) and QC 2 base (pH 7.5). 3. Based on interview with the OB/GYN nursing supervisor and review of the hospital LIS, 83 Pro-Lab Amnio Nitrazine /Phenaphthazin swab tests were performed and reported on OB/GYN patients without 2 levels of QC performed on the day of testing. 4. There was no documentation of an IQCP. On the bottom of the QC/patient Amnio Nitrazine/phenaphthazin test log was a statement: "Perform QC with each lot/shipment and each day of patient testing." D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the bioMerieux BacT ALERT 3D Microbial Detection System procedure, lack of documentation of microbiological culture media quality control (QC) records, lack of an Individualized Quality Control Plan (IQCP), and confirmation with testing personnel #16 on 7/10/19 at 10:00 am, the laboratory failed to check each new lot number or shipment of blood culture media for sterility, ability to support growth, and to document physical characteristics of the media. Findings include: According to blood culture QC records from 9/2/18 through the day of survey, 7/10/19, and interview with testing personnel #16, the laboratory was retaining the manufacturer's Certificate of Conformance which states that each lot number of bioMerieux BacT ALERT 3D blood culture bottles exhibited the established requirements for pH, sterility and growth performance. The laboratory did not check each new lot number or shipment of media for sterility, ability to support growth and document physical characteristics of the media or develop an IQCP. The laboratory performed 1,161 blood cultures from 9/2/18 through 7/10/19. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the -- 2 of 5 -- alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the blood bank procedure manual, documentation of blood bank alarm checks since 9-2-18, and interview with Laboratory Testing Personnel #19, listed on the CMS 209 Laboratory personnel form, the laboratory failed to document, as performed, quarterly plasma freezer temperature alarm checks, according to the laboratory's written policy. Findings include: Review of the blood bank procedure manual revealed the laboratory's written Blood Bank Refrigerator/Freezer Alarm Check policy states, "These alarms must be checked quarterly for proper functioning." Documentation of blood bank alarm checks since 9-2-18 and interview with Laboratory Testing Personnel #19 on 7-10-19 at 10:00 a.m. revealed the laboratory failed to document, as performed, plasma freezer temperature alarm checks since 9-2- 18. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: 1. Based on review of the CMS 209 Personnel form and Respiratory personnel records since 9/2/18, the technical consultant failed to evaluate and document the performance of Respiratory Testing Personnel #3 and #6 semiannually during the first year they performed moderate complexity testing. Findings Include: Review of the CMS 209 Personnel form and Respiratory personnel records since 9/2/18 revealed no semiannual evaluations were performed by the technical consultant documenting the performance of Respiratory Personnel #3 (date of hire 7/20/17) and Respiratory Personnel #6 (date of hire 2/17/18). 22079 2. Based on review of the CMS 209 Laboratory personnel form and personnel records since 9-2-18, the technical consultant failed to evaluate and document the performance of Laboratory Testing Personnel #12 and #19 semiannually during the first year these individuals performed moderate complexity testing. Findings include: Review of the CMS 209 Laboratory personnel form and personnel records since 9-2-18 revealed no semiannual evaluations by the technical consultant documenting the performance of Laboratory Testing Personnel #12, date of hire 8-15-18, and Laboratory Testing Personnel #19, date of hire 8-24-18. The only evaluations by the technical consultant documenting the performance of these two individuals for moderate complexity testing were dated 7-8-19. 3. Based on review of the CMS 209 OB Department personnel form and personnel records since 9-2-18, the technical consultant failed to evaluate and document the performance of OB Department Testing Personnel #1, #4, #6, and #12 semiannually during the first year these individuals performed moderate complexity testing. Findings include: Review of the CMS 209 OB Department personnel form and personnel records since 9-2-18 revealed no semiannual evaluations by the technical consultant documenting the performance of OB Department Testing Personnel #1, date of hire 6-28-18, Testing Personnel #4, date of hire 5-22-18, Testing Personnel #6, date of hire 2-28-18, and Testing Personnel #12, date of hire 5-6-18, for performing Pro-Lab Diagnostics Amniotest Nitrazine testing. -- 3 of 5 -- D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: 1) Based on review of the CMS 209 Respiratory personnel form and personnel records since 9/2/18, the technical consultant failed to evaluate and document the performance of the Respiratory Department Testing Personnel #1, #2, #7, #8, and #9, responsible for moderate complexity testing at least annually for 2018. Findings include: Review of the CMS 209 Respiratory personnel form and personnel records since 9/2/18 revealed no annual evaluations were performed and documented by the technical consultant of Respiratory Testing Personnel #1, #2, #7 #8 and #9 performing blood gas testing. 22079 2) Based on review of the CMS 209 OB Department personnel form and personnel records since 9-2-18, the technical consultant failed to evaluate and document the performance of OB Department Testing Personnel #1 through #7 and #10 through #17, responsible for moderate complexity testing, at least annually. Findings include: Review of the CMS 209 OB Department personnel form and personnel records since 9-2-18 revealed no annual evaluations by the technical consultant documenting the performance of OB Department Testing Personnel #1 through #7 and #10 through #17 for performing Pro-Lab Diagnostics AmnioTest Nitrazine testing. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of the CMS 209 OB Department personnel form and personnel records since 9-2-18, the laboratory director failed to ensure that OB Department Testing Personnel #8 and #9, responsible for moderate complexity testing, had the appropriate training prior to performing patient testing. Findings include: Review of the CMS 209 OB Department personnel form and personnel records since 9-2-18 revealed no documentation of training for OB Department Testing Personnel #8, date of hire 4-1-19, and OB Department Testing Personnel #9, date of hire 2-21-19, for performing Pro-Lab Diagnostics AmnioTest Nitrazine testing prior to performing patient testing. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on review of the CMS 209 Laboratory personnel form and personnel records since 9-2-18, the technical supervisor failed to evaluate and document the performance of Laboratory Testing Personnel #12 and #19 semiannually during the first year these individuals performed high complexity testing. Findings include: Review of the CMS 209 Laboratory personnel form and personnel records since 9-2- 18 revealed no semiannual evaluations by the technical supervisor documenting the performance of Laboratory Testing Personnel #12, date of hire 8-15-18, and Laboratory Testing Personnel #19, date of hire 8-24-18, for high complexity testing. -- 5 of 5 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider) on 1/23/2018, the laboratory had not successfully participated in proficiency testing for ABO/RHO. Findings include: Our records indicate the following proficiency testing scores for your laboratory for ABO/RHO. PROFICIENCY TESTING PROVIDER: American Proficiency Institute ABO/RHO: Year 2017 1st Event 90% Year 2017 3rd Event 90% Scores less than 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 -- 100% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) 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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider) on 1/23/2018, the laboratory had not successfully participated in proficiency testing for ABO/RHO. Findings include: Our records indicate the following proficiency testing scores for your laboratory for ABO/RHO. PROFICIENCY TESTING PROVIDER: American Proficiency Institute ABO/RHO: Year 2017 1st Event 90% Year 2017 3rd Event 90% Scores less than 100% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --