Monroe Regional Hospital

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing program. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation (proficiency testing) D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 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 -- (graded copies from the American Proficiency Institute (API) and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 9/30/2024, the laboratory failed to achieve satisfactory performance in two of three testing events (2023-Event 3, and 2024-Event 2) resulting in unsuccessful participation in Hematology for WBC DIFFERENTIAL. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute (API) and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 9 /30/2024, the laboratory has not successfully performed proficiency testing for WBC DIFFERENTIAL in two of three testing events. Findings include: A review of the laboratory records from the American Proficiency Institute (API) and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for WBC DIFFERENTIAL: WBC DIFFERENTIAL: Year 2023- 3rd Event 73% Year 2024- 2nd Event: 47% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing records (graded copies from the American Proficiency Institute (API) and CASPER reports 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 9/30 /2024, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing records (graded copies from the American Proficiency Institute (API) and CASPER report 0153D -- 2 of 3 -- /0155D from the Centers for Medicare and Medicaid Services data system) on 9/30 /2024, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of the Medonic M Series hematology analyzer records including quality control, maintenance, and calibration records and confirmation with testing personnel (TP) #2 as listed on the Centers for Medicare and Medicaid Services 209 Personnel form, the laboratory failed to perform calibration on CBC (complete blood count) performed on the Medonic M Series every 6 months as required by the written laboratory procedure manual and instrument manufacturer for 1 of 4 calibrations due since the last survey.. Findings include: 1. Review of the Medonic M Series calibration records revealed calibration was performed on 1/6/2023, 7/11/2023 and 7 /10/2024. 2. Review of the Medonic M Series calibration records revealed 1 of 4 calibrations from 12/6/2022 to 7/11/2023 was not performed every 6 months as required by the manufacturer. 3. Interview with the TP #2 on 7/11/2024 at 12:00 p.m confirmed CBC calibrations were not performed every 6 months for 1 of 4 calibrations required.. D5439 CALIBRATION AND CALIBRATION VERIFICATION 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 -- 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 Stratus CS STAT analyzer records, to include calibration and QC (quality controls), lack of documentation and interview with testing personnel (TP) #2, the laboratory failed to perform calibration verification on the Stratus CS analyzer every 6 months for ProBNP, D-dimer and Troponin for three of three six- month calibration verifications. Findings include: 1. Review of the Stratus CS records from 12/7/2022 through 7/11/2024, revealed calibration verification had not been performed every 6 months according to manufacturer's instructions. The last documentation of calibration verification/linearity performed on the Stratus CS was on 1/27/2023. 2. Calibration verification is required every 6 months on any assay which is calibrated with less than 3 levels of calibration material. These 3 tests mentioned only have 1 or 2 calibrators provided by the manufacturer to use during calibration for ProBNP, D-dimer and Troponin. 3. The TP #2 confirmed in an interview on 7/11/2024 at 1:00 p.m. that calibration verification was not performed at the appropriate time frame or frequency during the period of 12/7/2022 through 7/11 /2024. Three of three six-month calibration verifications required were not performed and exceeded the 6-month time frame required by the manufacturer. THIS IS A REPEAT DIFFICIENCY D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: A. Based on review of quality control (QC) records for the Sysmex CA 600 Coagulation analyzer and patient test logs, the laboratory failed to ensure at least 2 -- 2 of 6 -- levels of QC (quality control) material met the laboratory and manufacturer's criteria for acceptability before reporting patient test results. Findings Include: 1. Review of the Sysmex CA 600 records (including QC patient logs and QC/patient analyzer printouts) from 1/1/2023 through 6/27/2024 revealed on the following days one or both levels (Level 1 and Level 3) of PT(prothrombin time) and PTT (partial prothrombin time) QC was outside of acceptable range: 3/17/2023, 3/20/2023, 3/21 /2023, 3/22/2023, 5/4/2023, 5/6/2023, 5/7/2023, 6/8/2023, 6/27/2023, 6/29/2023, 7/25 /2023, 7/27/2023, 10/5/2023, 10/13/2023, 10/21/2023, 10/23/2023, 11/9/2023, 12/12 /2023, 1/14/1024, 1/18/2024, 3/26/2024 2. Review of the retained patient PT/ PTT and QC logs along with the analyzer patient results and QC printouts revealed approximately 25 patient PT and PTT tests reported on the days listed and QC was not in manufacturers and laboratory range. B. Based on review of QC records for the Stratus CS STAT fluorometric analyzer, QC assay sheets, patient test logs and analyzer printouts, the laboratory failed to ensure at least 2 levels of QC material met the laboratory and manufacturer's criteria for acceptability before reporting patient test results. Findings Include: 1. Review of the Stratus CS analyzer records (including QC and patient test logs, analyzer printouts, QC assay sheets) from 1/1/2023 through 6/30 /2024, revealed one or both levels (Level 1 and Level 2) of D dimer, ProBNP, and Troponin were out of acceptable range on thr following days: Troponin I------------------ 04/04/2024 - 1 patient tested 04/06/2024 - 1 patient tested 04/08/2024 - 1 patient tested 04/11/2024 - 2 patients tested 04/12/2024 - 2 patients tested 04/25 /2024 - 2 patients tested 04/26/2024 - 3 patients tested 04/28/2024 - 3 patients tested 04/29/2024 - 3 patients tested 05/06/2024 - 4 patients tested 05/09/2024 - 5 patients tested 05/10/2024 - 4 patients tested 05/11/2024 - 4 patients tested 05/20/2024 - 5 patients tested 05/23/2024 - 1 patient tested 05/24/2024 - 2 patients tested 05/25/2024 - 2 patients tested 05/26/2024 - 4 patients tested 05/27/2024 - 2 patients tested 05/28 /2024 - 2 patients tested 05/29/2024 - 4 patients tested 05/31/2024 - 2 patients tested 06/01/2024 - 1 patient tested D dimer---------------------- 04/26/2024 - 1 patient tested 05/11/2024 - 1 patient tested 05/20/2024 - 2 patients tested 05/26/2024 - 2 patients tested 05/27/2024 - 2 patients tested 05/28/2024 - 1 patient tested 05/29/2024 - 1 patient tested 06/01/2024 - 1 patient tested ProBNP--------------------- 04/04/2024 - 3 patients tested 04/12/2024 - 2 patients tested 05/06/2024 - 1 patient tested 05/10/2024 - 5 patients tested 05/11/2024 - 2 patients tested 05/20/2024 - 1 patient tested 05/22 /2024 - 1 patient tested 05/23/2024 - 4 patients tested 05/28/2024 - 5 patients tested 05 /29/2024 - 3 patients tested 05/31/2024 - 3 patients tested 06/01/2024 - 2 patients tested 2. Review Stratus CS patient and QC logs along with the analyzer patient result and QC printouts revealed approximately 103 patient Troponin I, ProBNP and D dimer tests reported on the days listed and QC was not in manufacturer's and laboratory range. 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 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 Immunohematology (blood bank) records and Jewett temperature -- 3 of 6 -- graphs from 12/7/2022 through 7/11/2024, the laboratory failed to follow the manufacturer's instructions for equipment operation. Findings Include: 1. Review of the Immunohematology records and Jewett recorder graphs revealed the laboratory failed to change the temperature recorder graphs every seven days (according to manufacturer's instructions) as follows: 03/07/2023 through 03/20/2023 03/20/2023 through 03/30/2023 04/06/2023 through 04/14/2023 04/21/2023 through 05/01/2023 05/01/2023 through 05/10/2023 05/10/2023 through 05/18/2023 05/18/2023 through 05/30/2023 06/06/2023 through 06/14/2023 06/14/2023 through 06/22/2023 07/04 /2023 through 07/21/2023 07/12/2023 through 07/26/2023 07/26/2023 through 08/03 /2023 08/31/2023 through 09/09/2023 09/08/2023 through 09/19/2023 10/29/2023 through 10/27/2023 12/11/2023 through 12/20/2023 01/02/2024 through 01/10/2024 06/12/2024 through 06/20/2024 06/20/2024 through 06/28/2024 2. Review of blood bank Jewett refrigerator graphs revealed 19 of 80 weeks the refrigerator graphs were not removed at seven days required by the manufacturer's instructions. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of Respiratory department testing records, policy and procedure manual and interview with the blood gas testing personnel (TP) #8/Respiratory Supervisor, the Technical Consultant (TC) failed to document review of the Radiometer ABL 80 Co-Ox Flex Quality Controls(QC), calibration verification records and room temperature logs for 13 of 13 months. Findings Include: 1. Review of respiratory department records from 6/2/2023 through 7/8/2024 revealed no documentation of review by the TC for the following records: a. Respiratory department temperature logs (room) since 6/2/2023 (13 of 13 months) b. Radiometer ABL 80 Co-Ox Flex calibration verification (linearity) since the last survey. 4 of 4 not reviewed. c. Radiometer ABL 80 Co-Ox Flex QC from 6/2/2023 through 7/8/2024 (13 of 13 months) 2. Interview with TP #8/Respiratory Supervisor on 7/11/2024 at 3:00 p. m. confirmed there was no available documentation of review of these records by the Technical Consultant. 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 testing personnel (TP) as listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interview with the Laboratory Manager and Respiratory Supervisor, the Technical Consultant (TC) failed to evaluate and document the performance of three of eleven blood gas testing personnel at least semiannually during the first year of moderate complexity testing. Findings include: 1. Review of the respiratory (blood gas) personnel records since the -- 4 of 6 -- last survey on 12/7/2022 revealed no semiannual evaluation available for the performance of three of eleven testing personnel. a. TP #15 initial training-09/29 /2022, semiannual evaluation due-03/2023 b. TP #16 initial training-05/08/2023, semiannual evaluation due-11/2023 c. TP #17 initial training-07/16/2023, semiannual evaluation due-01/2024 2. The Laboratory Manager and Respiratory Supervisor confirmed in an interview on 7/11/2024 at 3:00 p.m., there was no 6-month evaluation /competency performed on TP #15, TP#16 and TP#17. 3. The TC failed to document 6-month competency evaluations on three of eleven blood gas testing personnel since the last survey. 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 testing personnel (TP) as lsited on the Centers of Medicare and Medicaid Services (CMS) 209 personnel form, and interview with the Laboratory Manager and Respiratory Supervisor, the Technical Consultant failed to evaluate the performance for ten of eleven blood gas testing personnel, at least annually. Findings include: 1. Review of the Respiratory (blood gas) personnel records since the last survey on 12/7/2022 revealed no annual competency/evaluations of performance for ten of eleven blood gas testing personnel listed. a. TP #8 - competency /evaluation for 2023 and 2024 b. TP #9 - competency /evaluation for 2023 and 2024 c. TP #10 - competency /evaluation for 2023 and 2024 d. TP #11 - competency /evaluation for 2023 and 2024 e. TP #12 - competency /evaluation for 2023 f. TP #13 - competency /evaluation for 2023 and 2024 g. TP #14 - competency /evaluation for 2023 and 2024 h. TP #15 - competency /evaluation for 2023 i. TP #16 - competency /evaluation for 2024 j. TP #18 - competency /evaluation for 2023 and 2024 2. The Laboratory Manager and Respiratory Supervisor confirmed in an interview on 7/11/2024 at 3:00 p. m. that no annual competency evaluation had been documented as performed by the Technical Consultant. 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. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records including the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interviews with the General Supervisor (GS) and testing personnel (TP#2), the Technical Supervisor (TS) failed to evaluate and document the performance of testing personnel # 4 responsible for performing high complexity (blood bank) testing at least semiannually during the first year of employment. Findings Include: 1. Based on the laboratory personnel records available for review on 7/11/2024, there was no semiannual competency on high complexity testing performed by the Technical Supervisor for TP #4 since the last -- 5 of 6 -- survey. One of one new laboratory testing personnel had not had a semiannual evaluation/competency. 2. Interview with the GS and TP#2 confirmed the semiannual competency/evaluation for moderate and high complexity had not been documented as perfomed by the TS. 3. According to the personnel records for TP #4 the initial laboratory training was 6/20/2022. The semiannual competency should have been performed on 12/2022. D6128 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 annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's 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 (TP) as listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interviews with the General Supervisor/TP#1 and TP#2, the evaluations for high complexity were either not signed by the Technical Supervisor(TS) or not performed for seven of seven testing personnel. Findings include: 1. Review of the laboratory personnel records available on 7/11/2024 revealed no annual evaluations/competencies for Immunohematology were performed by the TS for the following individuals listed on the CMS 209 form: TP #1- for the years 2023 and 2024 TP #2- for the year 2024 TP #3- for the year 2024 TP #4- for the year 2023 TP #5- for the year 2023 TP #6- for the years 2023 and 2024 TP #7- for the years 2023 and 2024 2. Interview with both General Supervisor/TP#1 and TP#2 on 7/11/2024 at 3:00 p.m. confirmed the annual evaluation/competencies for moderate/high complexity testing (one form) had not been documented as performed by the Technical Supervisor listed on the CMS 209 form. Seven of seven laboratory testing personnel did not have annual evaluations /competencies. THIS IS A REPEAT DEFICIENCY -- 6 of 6 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of the Medonic M Series hematology analyzer records including quality control, maintenance, and calibration records and confirmation with testing personnel (TP) #2 as listed on the Centers for Medicare and Medicaid Services 209 Personnel form, the laboratory failed to perform calibration on CBC (complete blood count) performed on the Medonic M Series every 6 months as required by the written laboratory procedure manual and instrument manufacturer for 1 of 4 calibrations due since the last survey.. Findings include: 1. Review of the Medonic M Series calibration records revealed calibration was performed on 1/6/2023, 7/11/2023 and 7 /10/2024. 2. Review of the Medonic M Series calibration records revealed 1 of 4 calibrations from 12/6/2022 to 7/11/2023 was not performed every 6 months as required by the manufacturer. 3. Interview with the TP #2 on 7/11/2024 at 12:00 p.m confirmed CBC calibrations were not performed every 6 months for 1 of 4 calibrations required.. D5439 CALIBRATION AND CALIBRATION VERIFICATION 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 -- 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 Stratus CS STAT analyzer records, to include calibration and QC (quality controls), lack of documentation and interview with testing personnel (TP) #2, the laboratory failed to perform calibration verification on the Stratus CS analyzer every 6 months for ProBNP, D-dimer and Troponin for three of three six- month calibration verifications. Findings include: 1. Review of the Stratus CS records from 12/7/2022 through 7/11/2024, revealed calibration verification had not been performed every 6 months according to manufacturer's instructions. The last documentation of calibration verification/linearity performed on the Stratus CS was on 1/27/2023. 2. Calibration verification is required every 6 months on any assay which is calibrated with less than 3 levels of calibration material. These 3 tests mentioned only have 1 or 2 calibrators provided by the manufacturer to use during calibration for ProBNP, D-dimer and Troponin. 3. The TP #2 confirmed in an interview on 7/11/2024 at 1:00 p.m. that calibration verification was not performed at the appropriate time frame or frequency during the period of 12/7/2022 through 7/11 /2024. Three of three six-month calibration verifications required were not performed and exceeded the 6-month time frame required by the manufacturer. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: A. Based on review of quality control (QC) records for the Sysmex CA 600 Coagulation analyzer and patient test logs, the laboratory failed to ensure at least 2 levels of QC (quality control) material met the laboratory and manufacturer's criteria -- 2 of 6 -- for acceptability before reporting patient test results. Findings Include: 1. Review of the Sysmex CA 600 records (including QC patient logs and QC/patient analyzer printouts) from 1/1/2023 through 6/27/2024 revealed on the following days one or both levels (Level 1 and Level 3) of PT(prothrombin time) and PTT (partial prothrombin time) QC was outside of acceptable range: 3/17/2023, 3/20/2023, 3/21 /2023, 3/22/2023, 5/4/2023, 5/6/2023, 5/7/2023, 6/8/2023, 6/27/2023, 6/29/2023, 7/25 /2023, 7/27/2023, 10/5/2023, 10/13/2023, 10/21/2023, 10/23/2023, 11/9/2023, 12/12 /2023, 1/14/1024, 1/18/2024, 3/26/2024 2. Review of the retained patient PT/ PTT and QC logs along with the analyzer patient results and QC printouts revealed approximately 25 patient PT and PTT tests reported on the days listed and QC was not in manufacturers and laboratory range. B. Based on review of QC records for the Stratus CS STAT fluorometric analyzer, QC assay sheets, patient test logs and analyzer printouts, the laboratory failed to ensure at least 2 levels of QC material met the laboratory and manufacturer's criteria for acceptability before reporting patient test results. Findings Include: 1. Review of the Stratus CS analyzer records (including QC and patient test logs, analyzer printouts, QC assay sheets) from 1/1/2023 through 6/30 /2024, revealed one or both levels (Level 1 and Level 2) of D dimer, ProBNP, and Troponin were out of acceptable range on thr following days: Troponin I------------------ 04/04/2024 - 1 patient tested 04/06/2024 - 1 patient tested 04/08/2024 - 1 patient tested 04/11/2024 - 2 patients tested 04/12/2024 - 2 patients tested 04/25 /2024 - 2 patients tested 04/26/2024 - 3 patients tested 04/28/2024 - 3 patients tested 04/29/2024 - 3 patients tested 05/06/2024 - 4 patients tested 05/09/2024 - 5 patients tested 05/10/2024 - 4 patients tested 05/11/2024 - 4 patients tested 05/20/2024 - 5 patients tested 05/23/2024 - 1 patient tested 05/24/2024 - 2 patients tested 05/25/2024 - 2 patients tested 05/26/2024 - 4 patients tested 05/27/2024 - 2 patients tested 05/28 /2024 - 2 patients tested 05/29/2024 - 4 patients tested 05/31/2024 - 2 patients tested 06/01/2024 - 1 patient tested D dimer---------------------- 04/26/2024 - 1 patient tested 05/11/2024 - 1 patient tested 05/20/2024 - 2 patients tested 05/26/2024 - 2 patients tested 05/27/2024 - 2 patients tested 05/28/2024 - 1 patient tested 05/29/2024 - 1 patient tested 06/01/2024 - 1 patient tested ProBNP--------------------- 04/04/2024 - 3 patients tested 04/12/2024 - 2 patients tested 05/06/2024 - 1 patient tested 05/10/2024 - 5 patients tested 05/11/2024 - 2 patients tested 05/20/2024 - 1 patient tested 05/22 /2024 - 1 patient tested 05/23/2024 - 4 patients tested 05/28/2024 - 5 patients tested 05 /29/2024 - 3 patients tested 05/31/2024 - 3 patients tested 06/01/2024 - 2 patients tested 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 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 Immunohematology (blood bank) records and Jewett temperature graphs from 12/7/2022 through 7/11/2024, the laboratory failed to follow the manufacturer's instructions for equipment operation. Findings Include: 1. Review of the Immunohematology records and Jewett recorder graphs revealed the laboratory failed to change the temperature recorder graphs every seven days (according to -- 3 of 6 -- manufacturer's instructions) as follows: 03/07/2023 through 03/20/2023 03/20/2023 through 03/30/2023 04/06/2023 through 04/14/2023 04/21/2023 through 05/01/2023 05/01/2023 through 05/10/2023 05/10/2023 through 05/18/2023 05/18/2023 through 05/30/2023 06/06/2023 through 06/14/2023 06/14/2023 through 06/22/2023 07/04 /2023 through 07/21/2023 07/12/2023 through 07/26/2023 07/26/2023 through 08/03 /2023 08/31/2023 through 09/09/2023 09/08/2023 through 09/19/2023 10/29/2023 through 10/27/2023 12/11/2023 through 12/20/2023 01/02/2024 through 01/10/2024 06/12/2024 through 06/20/2024 06/20/2024 through 06/28/2024 2. Review of blood bank Jewett refrigerator graphs revealed 19 of 80 weeks the refrigerator graphs were not removed at seven days required by the manufacturer's instructions. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of Respiratory department testing records, policy and procedure manual and interview with the blood gas testing personnel (TP) #8/Respiratory Supervisor, the Technical Consultant (TC) failed to document review of the Radiometer ABL 80 Co-Ox Flex Quality Controls(QC), calibration verification records and room temperature logs for 13 of 13 months. Findings Include: 1. Review of respiratory department records from 6/2/2023 through 7/8/2024 revealed no documentation of review by the TC for the following records: a. Respiratory department temperature logs (room) since 6/2/2023 (13 of 13 months) b. Radiometer ABL 80 Co-Ox Flex calibration verification (linearity) since the last survey. 4 of 4 not reviewed. c. Radiometer ABL 80 Co-Ox Flex QC from 6/2/2023 through 7/8/2024 (13 of 13 months) 2. Interview with TP #8/Respiratory Supervisor on 7/11/2024 at 3:00 p. m. confirmed there was no available documentation of review of these records by the Technical Consultant. 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 testing personnel (TP) as listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interview with the Laboratory Manager and Respiratory Supervisor, the Technical Consultant (TC) failed to evaluate and document the performance of three of eleven blood gas testing personnel at least semiannually during the first year of moderate complexity testing. Findings include: 1. Review of the respiratory (blood gas) personnel records since the last survey on 12/7/2022 revealed no semiannual evaluation available for the performance of three of eleven testing personnel. a. TP #15 initial training-09/29 /2022, semiannual evaluation due-03/2023 b. TP #16 initial training-05/08/2023, semiannual evaluation due-11/2023 c. TP #17 initial training-07/16/2023, semiannual -- 4 of 6 -- evaluation due-01/2024 2. The Laboratory Manager and Respiratory Supervisor confirmed in an interview on 7/11/2024 at 3:00 p.m., there was no 6-month evaluation /competency performed on TP #15, TP#16 and TP#17. 3. The TC failed to document 6-month competency evaluations on three of eleven blood gas testing personnel since the last survey. 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 testing personnel (TP) as lsited on the Centers of Medicare and Medicaid Services (CMS) 209 personnel form, and interview with the Laboratory Manager and Respiratory Supervisor, the Technical Consultant failed to evaluate the performance for ten of eleven blood gas testing personnel, at least annually. Findings include: 1. Review of the Respiratory (blood gas) personnel records since the last survey on 12/7/2022 revealed no annual competency/evaluations of performance for ten of eleven blood gas testing personnel listed. a. TP #8 - competency /evaluation for 2023 and 2024 b. TP #9 - competency /evaluation for 2023 and 2024 c. TP #10 - competency /evaluation for 2023 and 2024 d. TP #11 - competency /evaluation for 2023 and 2024 e. TP #12 - competency /evaluation for 2023 f. TP #13 - competency /evaluation for 2023 and 2024 g. TP #14 - competency /evaluation for 2023 and 2024 h. TP #15 - competency /evaluation for 2023 i. TP #16 - competency /evaluation for 2024 j. TP #18 - competency /evaluation for 2023 and 2024 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. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records including the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interviews with the General Supervisor (GS) and testing personnel (TP#2), the Technical Supervisor (TS) failed to evaluate and document the performance of testing personnel # 4 responsible for performing high complexity (blood bank) testing at least semiannually during the first year of employment. Findings Include: 1. Based on the laboratory personnel records available for review on 7/11/2024, there was no semiannual competency on high complexity testing performed by the Technical Supervisor for TP #4 since the last survey. One of one new laboratory testing personnel had not had a semiannual evaluation/competency. 2. Interview with the GS and TP#2 confirmed the semiannual competency/evaluation for moderate and high complexity had not been documented as perfomed by the TS. 3. According to the personnel records for TP #4 the initial laboratory training was 6/20/2022. The semiannual competency should have been performed on 12/2022. -- 5 of 6 -- D6128 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 annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's 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 (TP) as listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interviews with the General Supervisor/TP#1 and TP#2, the evaluations for high complexity were either not signed by the Technical Supervisor(TS) or not performed for seven of seven testing personnel. Findings include: 1. Review of the laboratory personnel records available on 7/11/2024 revealed no annual evaluations/competencies for Immunohematology were performed by the TS for the following individuals listed on the CMS 209 form: TP #1- for the years 2023 and 2024 TP #2- for the year 2024 TP #3- for the year 2024 TP #4- for the year 2023 TP #5- for the year 2023 TP #6- for the years 2023 and 2024 TP #7- for the years 2023 and 2024 2. Interview with both General Supervisor/TP#1 and TP#2 on 7/11/2024 at 3:00 p.m. confirmed the annual evaluation/competencies for moderate/high complexity testing (one form) had not been documented as performed by the Technical Supervisor listed on the CMS 209 form. Seven of seven laboratory testing personnel did not have annual evaluations /competencies. THIS IS A REPEAT DEFICIENCY -- 6 of 6 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation (proficiency testing) D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 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 -- (graded copies from the American Proficiency Institute (API) and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 3/15/2024, the laboratory failed to maintain satisfactory performance in two of two testing events (2023-Event 3 and 2024-Event 1) resulting in unsuccessful participation for CHOLESTEROL (TOTAL) and ALCOHOL (BLOOD). Refer to D2096 and 2118. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute (API) and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 3 /15/2024, the laboratory has not successfully performed proficiency testing for CHOLESTEROL (TOTAL) in two of two testing events. Findings include: A review of the laboratory records from the American Proficiency Institute (API) and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for CHOLESTEROL (TOTAL): CHOLESTEROL (TOTAL): Year 2023-3rd Event 0% Year 2024-1st Event 20% 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute (API) and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 3 /15/2024, the laboratory has not successfully performed proficiency testing for ALCOHOL (BLOOD) in two of two testing events. Findings include: A review of the laboratory records from the American Proficiency Institute (API) and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for ALCOHOL (BLOOD): ALCOHOL (BLOOD): Year 2023-3rd Event 0% Year 2024- 1st Event 40% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing records (graded copies from the American Proficiency Institute and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 3/15/2024, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing records (graded copies from the American Proficiency Institute and CASPER report 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 3/15/2024, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096 and D2118. -- 3 of 3 --

Summary Statement of Deficiencies 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: A. Based on review of the Siemens Stratus CS analyzer maintenance records from 1 /21/2021 through 12/7/2022 and interview with the laboratory manager/TP (testing personnel) #1 as listed on the CMS (Centers for Medicare & Medicaid Services) 209 form at 2:00 p.m. on 12/7/2022, the laboratory failed to document as performed the monthly maintenance on the Stratus CS analyzer as required by the manufacturer. Findings include: 1. Review of the Siemens Stratus CS records from 2/1/2021 through 12/6/2022 revealed the following monthly maintenance had not been documented as performed since 2/1/2021. Monthly: a. Clean the air filter b. Clean instrument surfaces- Sample door area, lower cannula chamber seal, waste container area, tip chute, pak shield 2. TP#1 at 1:30 p.m. on 12/7/2022 confirmed in an interview that monthly maintenance was not documented as performed for the Siemens Stratus CS analyzer. B. Based on review of the Sysmex CA 600 Coagulation analyzer maintenance records from 2/1/2022 through 12/7/2022 and interview with the laboratory manager/TP #1 at 2:30 p.m. on 12/7/2022, the laboratory failed to document as performed the weekly and quarterly maintenance on the Sysmex CA 600 analyzer as required by the manufacturer. Findings include: 1. Review of the Sysmex CS records form 2/1/22 through 12/7/2022 revealed the following weekly and quarterly maintenance had not been documented as performed since 2/1/2022. Weekly: Clean instrument interior / exterior Quarterly: a. Perform LED calibration b. Clean DI water rinse bottle with alcohol 2. TP #1 at 2:30 p.m. on 12/7/2022 confirmed weekly and quarterly maintenance was not documented as performed for the Sysmex CA -600. 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 -- 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 chemistry laboratory records from 1/21/2021 through 12/6/2022 and confirmation by the laboratory manager/testing personnel (TP) #1 at 3:00 p.m. on 12/6/2022, the laboratory failed to retain and document as performed calibration verification on the Siemens Dimension EXL chemistry analyzer every 6 months for sodium, potassium and chloride. Findings include: 1. Review of Siemens Dimension EXL calibration records revealed that Sodium (NA), Potassium (K), and Chloride (CL) are each calibrated with a 2 point calibrator 2. Calibration verification is required every 6 months on any assay which is calibrated with less than 3 calibration materials. 3. Calibration verification was only documented as performed on NA, K, and CL on 3 /26/2021 and on 2/8/2022 since 1/21/2021. 4. The Lab manager/TP #1 confirmed in an interview at 3:00 p.m. on 12/6/2022 that Na, K and Cl calibration verifications were performed every 6 months in 2021 and 2022 but there was no documentation available for review on the day of survey. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: A. Based on a lack of quality control (QC) records for C difficile Complete Toxin A&B test kit and interview with the lab manager/testing personnel (TP) #1 as listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form on 12/7 -- 2 of 12 -- /2022 at 3:00 p.m., the laboratory failed to document a positive and negative control on each day of patient testing for C difficile toxin since 1/21/2021. Findings Include: 1. Interview with the Lab manager/TP #1 at 3:00 p.m. on 12/7/2022 confirmed that TP were performing two levels of QC (positive and negative) each day of patient testing with the C difficile Complete Toxin A & B test kit but did not document the QC as performed. Patient results were manually entered into the LIS (laboratory information system), but QC was not. 2. There was no IQCP (Individualized Quality Control Plan) available for review on the day of survey. An IQCP is required after 1/1/2016 if two levels of quality control (QC) are not performed each day of use for moderate/high complexity testing. 3. Based on data from the laboratory information system, approximately 12 patient specimens were tested during the past fiscal year. B. Based on review of QC and patient testing logs from 5/11/2022 until 12/7/2022 and interview with the Laboratory manager/TP #1 and TP #3 on 12/7/2022 at 3:00 p.m., the laboratory failed to include a positive and negative control on each day of patient testing for the Alere serum/urine pregnancy test kit when testing serum pregnancy tests which are moderate complexity. Findings Include: 1. Interview with the Lab manager/TP #1 and TP #3 at 3:00 p.m. on 12/7/2022 confirmed that testing personnel were not performing two levels of QC (positive and negative) each day of patient testing when testing serum samples with the Alere serum/urine pregnancy test kit. Serum samples are moderate complexity and require QC on each day of use. 2. According to the QC logs, the serum QC positive and negative material was performed once a month or with each new lot number of test kit. 3. There was no IQCP (Individualized Quality Control Plan) available for review on the day of survey. An IQCP is required after 1/1/2016 if two levels of quality control (QC) are not performed each day of use for moderate/high complexity testing. 4. Review of the Alere serum/urine pregnancy QC and patient result logs from 1/11/2022 through 12/7 /2022 revealed no QC was performed on the days patient serum pregnancy tests were tested and reported. a. For the period between 5/9/2022 and 12/4/2022, serum samples were tested with no QC on 13 days: 5/9/2022, 5/12/2022, 5/16/2022, 5/17/2022, 5/19 /2022, 6/23/2022, 7/2/2022, 7/21/2022, 7/26/2022, 9/4/2022, 10/22/2022, 10/25/2022, 12/4/2022. b. Approximately 140 patients were tested and reported during that time period according to the laboratory information system. 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 review of immunohematology quality control (QC) records and the blood bank patient workbook from 2/18/2021 through 12/7/2022, the laboratory failed to document the performance of quality control on each day of patient blood bank testing. Findings include: Review of immunohematology QC records from 2/18/21 -- 3 of 12 -- through 12/7/2022 revealed the laboratory failed to document the performance of quality control, to include the following, to indicate the immunohematology reagents were functioning properly before patient specimens were analyzed and reported. 1. Positive control for ABO Antisera (ABO grouping) 2. Positive and negative control for Rh Antisera (Rh typing) 3. Positive and negative control for Anti-human globulin sera (Coombs sera) 4. Positive control for antibody screening cells Quality control was not performed on the following days when patients and donors were tested: 4/22 /2021 - Patient # 1046556 - Type, Rh, Crossmatch - 2 units (W041021050760, W041021043321) 5/3/2021 - Patient # 1047297- Type, Rh, Crossmatch - 2 units (W22721001377, W041621009789) 5/10/2021 -Patient # 1047297- Type, Rh, Crossmatch - 2 units (W041621002981, W036221454389) 6/11/2021- Patient #1048616- Type, Rh, Crossmatch - 1 unit (W036221484917) 8/13/2021 - Patient #1050465 -Type, Rh, Crossmatch - 2 units (W041221035056), W041121029350) 8/22 /2021 - Patient # 1050527- Type, Rh, Crossmatch - 2 units (W036221505244), W036221511288) 9/22/2021 - Patient MR#4011022- Type, Rh 9/26/2021 - Patient # 1052218 - Type, Rh Antibody Screen 1/20/2022 - No Patient # recorded - Type, Rh, Crossmatch -3 units(W042521092820, W042521092821, W042522004788) 1/25 /2022 - Patient #1056753 -Type, Rh, Crossmatch -2 units (W036221563489, W036221564300) 10/27/2022 - Patient #1066892 - Type, Rh, Antibody Screen D6099 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(9) The laboratory director must ensure that consultation is available to the laboratory's clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records including the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interviews with the lab manager/testing personnel (TP) #1 and TP #17 on 12/7/2022, the laboratory director failed to ensure that a qualified technical supervisor was available to oversee high complexity toxicology testing. Findings include: 1. Based on the laboratory personnel records available for review on 12/7/22, there was no documentation of annual evaluations/competencies performed by the laboratory director for the technical supervisor #2 listed on the CMS 209 form since the last survey. 2. Interview with both lab manager/TP#1 and TP#17 on 11/7/22 at 3:00 p.m. confirmed an annual evaluation /competency for technical supervisor #2 in toxicology not been documented as performed by the laboratory director for 2021 and 2022. D6101 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(11) The laboratory director must employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records including the Centers of Medicare and Medicaid Services (CMS) 209 personnel form and interviews with the lab -- 4 of 12 -- manager/TP #1 and TP #17 on 12/7/2022, the laboratory director failed to ensure that a qualified Technical Supervisor (TS) was overseeing high complexity LC/MS testing. Findings include: 1. Based on the laboratory personnel records available for review on 12/7/22, there was no documentation of annual evaluations/competencies performed by the laboratory director for the TS #2 listed on the CMS 209 form since the last survey. There was no evidence the laboratory director had employed a qualified TS to provide appropriate consultation for toxicology confirmation testing. 2. Interview with both lab manager/TP#1 and TP#17 on 11/7/22 at 3:00 p.m. confirmed no annual evaluations/competencies for TS #2 in toxicology had been documented as performed by the laboratory director for 2021 and 2022. D6111 TECHNICAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1449 (a) The technical supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory may perform anatomic and clinical laboratory procedures and tests in all specialties and subspecialties of services except histocompatibility and clinical cytogenetics services provided the individual functioning as the technical supervisor-- (b)(1) Is a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or Possesses qualifications that are equivalent to those required for such certification. (c) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, the individual functioning as the technical supervisor must-- (c)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (c)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (c)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (c)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (c)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (c)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; and (c)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology. (d) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycobacteriology, the individual functioning as the technical supervisor must-- (d)(1)(i) Be a doctor of medicine or -- 5 of 12 -- doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (d)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (d) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (d)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (d)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (d)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (d)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology. (e) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycology, the individual functioning as the technical supervisor must-- (e)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (e)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (e) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (e)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (e)(3)(ii) Have at least 1 year of laboratory training or experience, or both in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(4) (i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (e)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (e)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology. (f) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of parasitology, the individual functioning as the technical supervisor must-- (f)(1)(i) Be -- 6 of 12 -- a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (f)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (f)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (f)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; (f)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (f)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (f)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (f)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology. (g) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of virology, the individual functioning as the technical supervisor must-- (g)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (g)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (g) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (g)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (g)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (g)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (g)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology. (h) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of diagnostic immunology, the individual functioning as the technical supervisor must- (h)(1)(i) Be -- 7 of 12 -- a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (h)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (h)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (h)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (h)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of diagnostic immunology; or (h)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (h)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (h)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology. (i) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of chemistry, the individual functioning as the technical supervisor must-- (i)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (i)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (i)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (i)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (i)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of chemistry; or (i) (4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (i)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (i)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry. (j) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of hematology, the individual functioning as the technical supervisor must-- (j)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (j)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (j)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (j)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of hematology (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (j) (3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical -- 8 of 12 -- laboratory science from an accredited institution; and (j)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of hematology; or (j)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (j)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology; or (j) (5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (j)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology. (k)(1) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of cytology, the individual functioning as the technical supervisor must-- (k)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (k)(1)(ii) Meet one of the following requirements-- (k)(1)(ii)(A) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (k)(1)(ii) (B) Be certified by the American Society of Cytology to practice cytopathology or possess qualifications that are equivalent to those required for such certification; (l) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of histopathology, the individual functioning as the technical supervisor must-- (l)(1) Meet one of the following requirements: (l)(1)(i)(A) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (l)(1)(i)(B) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (l)(1)(ii) An individual qualified under 493.1449(b) or paragraph (l)(1) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (l)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens. (l)(2) For tests in dermatopathology, meet one of the following requirements: (l)(2)(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (l) (2)(i)(B) Meet one of the following requirements: (l)(2)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B)(2) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B) (3) Be certified in dermatology by the American Board of Dermatology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(ii) An individual qualified under 493.1449(b) or paragraph (l)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens. (l) (3) For tests in ophthalmic pathology, meet one of the following requirements: (l)(3)(i) (A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (l)(3)(i)(B) Must meet one of the following requirements: (l)(3)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(3)(i)(B)(2) Be certified by the American Board of Ophthalmology or possess qualifications that are equivalent to those required for such certification and have -- 9 of 12 -- successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or (l)(3)(ii) An individual qualified under 493.1449(b) or paragraph (1)(3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (1)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or (m) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of oral pathology, the individual functioning as the technical supervisor must meet one of the following requirements: (m)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (m)(1)(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (m)(2) Be certified in oral pathology by the American Board of Oral Pathology or possess qualifications for such certification; or (m)(3) An individual qualified under 493.1449(b) or paragraph (m)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (m)(1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens. (n) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of radiobioassay, the individual functioning as the technical supervisor must-- (n)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (n)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (n)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (n)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (n)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of radiobioassay; or (n)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (n)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (n)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay. (o) If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either-- (o)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (o)(1)(ii) Have training or experience that meets one of the following requirements: (o)(1)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(1)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or (o)(2)(i) Have an earned doctoral degree in a biological or clinical laboratory science from an accredited institution; and (o)(2)(ii) Have training or experience that meets one of the following requirements: (o) (2)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(2)(ii)(B)(1) Have 2 years of laboratory training -- 10 of 12 -- or experience, or both, in the specialty of general immunology; and (o)(2)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility. (p) If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning as the technical supervisor must-- (p)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (p)(1)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics; or (p)(2)(i) Hold an earned doctoral degree in a biological science, including biochemistry, or clinical laboratory science from an accredited institution; and (p)(2)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics. (q) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of immunohematology, the individual functioning as the technical supervisor must-- (q)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (q)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (q)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (q)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology. Note: The technical supervisor requirements for "laboratory training or experience, or both'' in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service. For example, an individual, who has a doctoral degree in chemistry and additionally has documentation of 1 year of laboratory experience working concurrently in high complexity testing in the specialties of microbiology and chemistry and 6 months of that work experience included high complexity testing in bacteriology, mycology, and mycobacteriology, would qualify as the technical supervisor for the specialty of chemistry and the subspecialties of bacteriology, mycology, and mycobacteriology. This STANDARD is not met as evidenced by: Based on review of the CMS 209 personnel form and review of personnel records and education documents on 12/7/2022 at 1:00 p.m., the laboratory has an individual designated as technical supervisor (TS #2) for high complexity LC/MS testing who does not meet the qualification requirements of 493.1449 of this subpart. D6121 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on interviews with the laboratory manager/TP (testing personnel) #1 and TP#17 on 12/7/22 at 3:00 p.m., the individual listed as technical supervisor (TS) #2 has not made on-site visits to supervise the toxicology laboratory or to observe the performance of testing personnel performing high complexity testing. There was no documentation on 12/7/22 that the individual listed as TS #2 had visited the -- 11 of 12 -- toxicology laboratory to observe patient preparation and testing, instrument maintenance and function checks since the last survey. The technical supervisor has only been available by phone and email to provide consultation during the testing of toxicology confirmation drug testing. D6123 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of the Acquity Waters TQS 1311 LC/MS toxicology analyzer records from 9/1/2021 through 12/7/2022, and interview with TP# 17 as listed on the CMS 209 Personnel Report at 1:00 pm on 12/7/2022, the TS (technical supervisor) failed to document review of the records listed below. Findings include: 1. Review of the Acquity Waters TQS 1311 LC/MS records from 9/1/2021 through 12/7/2022 revealed the following records were not documented as reviewed by the TS. a. Acquity Waters TQS 1311 monthly review summary form to include: *Environment charts *Maintenance documents *Levy Jennings graphs * Instrument problem log * Additional tests * Periodic reviews b. Daily/Weekly maintenance c. Monthly/Quarterly /Semi-Annual/As needed maintenance checklist d. Quality Controls (QC) summary reports. e. Proficiency testing results 2. Interview with TP #17 and lab manager/TP #1 at 1:00 p.m. on 12/7/2022 confirmed there was no documented review of the above mentioned maintenance and QC records. D6128 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 annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's 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 (TP) records including the Centers of Medicare and Medicaid Services (CMS) 209 personnel form and interviews with the laboratory manager/TP#1 and TP#17 on 12/7/22, the evaluations completed on the toxicology TP#17 were performed by an individual not qualified as a technical supervisor (TS #2). Findings include: 1. Based on the laboratory personnel records available for review on 12/7/22, the evaluations available were performed by an individual listed on the CMS 209 form as TS #2 who does not quality as TS according to the qualification requirements in 493.1449. 2. Interview with both laboratory manager/TP#1 and TP#17 on 12/7/22 at 3:00 p.m. confirmed the annual evaluation /competencies for toxicology had been documented as performed by the technical supervisor listed on the CMS 209 form for 2021 and 2022. -- 12 of 12 --

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 report 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 10/10 /2022, the laboratory failed to maintain satisfactory performance in two of two testing events (1st event of 2022 and 2nd event of 2022) resulting in unsuccessful performance for Blood Cell Identification. Refer to D2130. 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on 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 10/10 /2022, the laboratory has not successfully performed proficiency testing for Blood Cell Identification in two of two testing events. Findings include: A review of the laboratory records from the American Proficiency Institute (API) and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for Blood Cell Identification: Year 2022 - 1st Event: 60% Year 2022 - 2nd Event: 0% -- 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 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 1/28/2022, the laboratory has not successfully participated in proficiency testing for COMPATIBILITY TESTING. Findings include: Our records indicate the following proficiency testing scores for your laboratory for COMPATIBILITY TESTING: PROFICIENCY TESTING PROVIDER: American Proficiency Institute COMPATIBILITY TESTING: Year 2021 1st Event 0% Year 2021 3rd Event 80% Scores less than 100% for these analytes or parameters 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. 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 proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 1/28/2022, the laboratory has not successfully participated in proficiency testing for COMPATIBILITY TESTING. Findings include: Our records indicate the following proficiency testing scores for your laboratory for COMPATIBILITY TESTING: PROFICIENCY TESTING PROVIDER: American Proficiency Institute COMPATIBILITY TESTING: Year 2021 1st Event 0% Year 2021 3rd Event 80% Scores less than 100% for these analytes or parameters 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 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 6/10/2021, 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 2020 3rd Event 80% Year 2021 1st Event 0% Scores less than 100% for this 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 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. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte 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 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 6/10/2021, 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 2020 3rd Event 80% Year 2021 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 D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 the laboratory blood bank procedure manual, Emergency Transfusion Request form, and confirmation with staff at 10:30 a.m. on the day of survey, 10/11/18, the laboratory did not follow their blood bank procedure during two emergency release situations. Findings include: Review of the Blood Bank records revealed that testing personnel failed to follow the laboratory policy on emergency release of uncrossmatched blood on 2/28/17 and 6/16/17 when 3 units of uncrossmatched packed cells were given to two patients. There was no documentation on the Blood Bank workbook that crossmatches were completed on these units after they were released for transfusion. The Emergency Transfusion Request form states "...routine compatibility testing should be carried out as soon as possible, and the laboratory should report immediately any incompatibility of unit(s) transfused." The procedure in the Blood Bank manual for "Emergency Release of Blood in Urgent Situations" states, When urgent release is requested: 1. Issue uncrossmatched blood, if necessary, and immediately begin crossmatching procedures. 2. Indicate in a conspicuous fashion on the attached tag or label that compatibility testing has not been completed at the time of issue. 3. Complete compatibility testing promptly. If incompatibility is detected at any stage of testing, immediately notify the patient's physician and the Blood Bank Medical Director or Chief Technologist. On 2/18/17 Patient 02000117640 was given 1 unit of Uncrossmatched packed cells (W041617003923)--there was no crossmatch for this unit with this patient documented on the Blood Bank workbook. On 6/16/17 Patient 02000122013 was 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 -- given 2 units of Uncrossmatched packed cells (W068517022314, W068517014390)-- there were no crossmatches for these units with this patient documented on the Blood Bank workbook. -- 2 of 2 --