Hermann Area District Hospital

Summary Statement of Deficiencies D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of proficiency testing (PT), immunohematology quality control (QC), initial training, quality control and quality assessment program, and interviews, the laboratory director (LD) failed to provide overall management and direction of the laboratory. The LD failed to ensure PT testing reports received were reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of patient blood bank worksheet, blood bank policies, laboratory procedures, 2023/2024 Vitros 5600 calibration records, Sysmex CA-660 coagulation quality control (QC) records, coagulation patient reports, blood bank QC log, observation, blood bank patient crossmatch tags, nursing progress notes, physician progress notes, hospital policy and procedure manual, lack of documentation of communication with laboratory,

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of immunohematology compatibility testing proficiency testing (PT) results for 2022/2023 reported to the CLIA database by the PT provider and phone interview with the laboratory manager, the laboratory failed to successfully participate in PT. See tag D2173; failure to attain an overall event score of 100 percent for compatibility testing. See tag D2181; unsatisfactory performance in two out of three consecutive testing events for the analyte; compatibility testing. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of immunohematology compatibility testing proficiency testing (PT) results and phone interview with the laboratory manager, the laboratory failed to attain an overall testing performance score of 100 percent for the third PT event in 2022 and the first PT event in 2023. Findings: 1. Review of compatibility testing PT results for 2022/2023 showed the laboratory obtained a score of 80 percent in the third testing event in 2022 and 80 percent in the first testing event in 2023. 2. Phone interview with the laboratory manager on May 25, 2023 at 08:30 AM confirmed the laboratory failed to attain a testing performance score of 100 percent for compatibility testing for the third PT event in 2022 and the first PT event in 2023. 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 review of immunohematology proficiency testing (PT) results and phone interview with the laboratory manager, the laboratory failed to achieve satisfactory performance for compatibility testing in two out of three testing events for 2022/2023. Findings: 1. Review of the immunohematology PT results for the third testing event of 2022 revealed the laboratory obtained an unsatisfactory score of 80 percent for compatibility testing. 2. Review of the immunohematology PT results for the first testing event of 2023 revealed the laboratory obtained an unsatisfactory score of 80 percent for compatibility testing. 3. Phone interview with the laboratory manager on May 25, 2023 at 08:30 AM confirmed the laboratory failed to achieve satisfactory performance for compatibility testing in two out of three consecutive events in 2022 /2023. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel policy, personnel records, and interview with the technical supervisor (TS) #1, the laboratory failed to establish and follow written policies to assess competency for five of five testing personnel during 2019, 2020 and to date May 12,2021. Findings: 1. The "Orientation, Teaching and Competency" policy states, "Competency is verified by the laboratory director or supervisor. Routine competency is verified on an annual basis, usually in conjunction with performance appraisal. The form must be signed by the employee and laboratory director." The policy failed to address semiannual competency evaluations during the first year individuals test patient specimens. (493.1451) 2. The laboratory director or supervisor failed to evaluate and document annual competency evaluations for testing personnel during 2019, 2020, and to date May 12, 2021. (Refer to D6128) 3. Interview with TS #1 on May 12, 2021 at 3:15 PM confirmed the laboratory failed to follow the written policy for conducting annual competency and failed to establish a policy for conducting semiannual competency during the first year individuals test patient specimens. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on lack of blood bank testing procedures, lack of chemistry test procedures, observation of the urinalysis centrifuge, review of function check records, review of Ortho Diagnostics Vitros 5600 quality control (QC) records, review of Sysmex CA- 600 Prothrombin Time (PT) QC records, review of the laboratory's "Quality Control Monitoring" procedure, review of hematology records, review of the "Prothrombin Time" procedure, review of Siemens Dade Innovin package insert, review of Sysmex CA-600 analyzer, review of manufacturer's instructions, review immunohematology records, and interviews, the laboratory failed to meet the condition of analytic systems. The laboratory failed to provide a written procedure manual for all tests, assays, and examinations performed by the laboratory (Refer to D5401); the laboratory failed to define a protocol to verify the urine centrifuge was operating at the appropriate speed for obtaining urine sediment for microscopic examination (Refer to D5435); the laboratory failed to establish criteria for acceptability of control materials providing quantitative results (Refer to D5469); the laboratory failed to document the quality of staining materials each day of use for manual differentials (Refer to D5473); the laboratory failed to ensure alkaline phosphatase (ALP) and troponin-I QC met criteria for acceptability before reporting patient results (Refer to D5481); the laboratory failed to include two levels of control material each 8 hours of operation for PT, the laboratory failed to verify the correct International Sensitivity Index (ISI) value was being used for calculating the INR value (Refer to D5545); and the laboratory failed to follow manufacturer's instructions for incubator temperature verification (Refer to D5551). 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 lack of blood bank testing procedures, lack of chemistry test procedures, and interview with the technical supervisor (TS) #1, the laboratory failed to provide a written procedure manual for all tests, assays, and examinations performed by the laboratory. Findings: 1. Review of procedures showed no procedures for blood bank or chemistry testing. 2. Interview with the TS #1 on May 12, 2021 at 1:30 PM confirmed the laboratory could not provide a written procedure manual for all tests, assays, and examinations performed by the laboratory. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a -- 2 of 10 -- function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation of the urinalysis centrifuge, review of function check records, and interview with the technical supervisor (TS) #1, the laboratory failed to define a protocol to verify the urine centrifuge was operating at the appropriate speed for obtaining urine sediment for microscopic examination. Findings: 1. Observation of the urinalysis centrifuge revealed the centrifuge was operating at a speed of 1500 RPMs. 2. Review of function check records revealed no documentation to show the laboratory verified the urine centrifuge speed of 1500 RPMs. 3 Interview with TS #1 on May 12, 2021 at 3:15 PM confirmed the laboratory failed to define a protocol to verify the RPMs required for obtaining urine sediment. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Ortho Diagnostics Vitros 5600 quality control (QC) records, Sysmex CA-600 Prothrombin Time (PT) QC records, the laboratory's "Quality Control Monitoring" procedure, and interview with the technical supervisor (TS) #1, the laboratory failed to establish criteria for acceptability of control materials providing quantitative results. Findings: 1. Review of the Ortho Diagnostics Vitros 5600 QC records, Sysmex CA-600 PT QC records and the laboratory's "Quality Control Monitoring" procedure showed the laboratory did not establish and define statistical parameter criteria (mean and standard deviations) for acceptability of quantitative QC results reported on the chemistry and coagulation analyzers. 2. Interview with the TS #1 on May 12, 2021 at 3:00 PM confirmed the laboratory failed to establish criteria for acceptability of control materials providing quantitative results. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) -- 3 of 10 -- (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of hematology records and interview with the technical supervisor (TS) #1, the laboratory failed to document the quality of staining materials each day of use for manual differentials for 2019, 2020 and to date May 12, 2021. Findings: 1. Review of hematology records revealed the laboratory failed to document the quality of staining materials each day of use for manual differentials. 2. Interview with TS #1 on May 12, 2021 at 3:15 PM confirmed the laboratory failed to document the quality of the manual differential stain each day of use. 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: Based on review of the Ortho Diagnostics Vitros 5600 quality control (QC), and interview with the technical supervisor (TS) #1, the laboratory failed to ensure alkaline phosphatase (ALP) and troponin-I QC met criteria for acceptability before reporting patient results for 33 of 73 testing days in March, April, and to date May 12, 2021. Findings: 1. Review of QC showed the laboratory's acceptable established ranges as: ALP Level 1 Lot # P7690 as 103 - 116 ALP Level 2 Lot # T7911 as 439 - 478 Troponin-I Level 3 Lot # CXL21123 as 30.537 - 34.463 2. Review of ALP Level 1 QC showed: March 13, 2021 Level 1 QC result of 102 March 26, 2021 Level 1 QC result of 101 March 27, 2021 Level 1 QC result of 100 April 15, 2021 Level 1 QC result of 102 April 28, 2021 Level 1 QC result of 102 April 29, 2021 Level 1 QC result of 102 May 3, 2021 Level 1 QC result of 102 May 6, 2021 Level 1 QC result of 102 May 7, 2021 Level 1 QC result of 100 May 9, 2021 Level 1 QC result of 102 3. Review of ALP Level 2 QC showed: March 3, 2021 Level 2 QC result of 438 March 4, 2021 Level 2 QC result of 436 March 8, 2021 Level 2 QC result of 437 March 15, 2021 Level 2 QC result of 438 March 18, 2021 Level 2 QC result of 429 March 20, 2021 Level 2 QC result of 437 March 21, 2021 Level 2 QC result of 433 March 23, 2021 Level 2 QC result of 435 March 28, 2021 Level 2 QC result of 431 April 10, 2021 Level 2 QC result of 436 April 11, 2021 Level 2 QC result of 436 April 12, 2021 Level 2 QC result of 426 April 13, 2021 Level 2 QC result of 430 April 14, 2021 Level 2 QC result of 436 April 21, 2021 Level 2 QC result of 436 April 30, 2021 Level 2 QC result of 432 May 1, 2021 Level 2 QC result of 433 May 2, 2021 Level 2 QC result of 438 May 3, 2021 Level 2 QC result of 431 May 4, 2021 Level 2 QC result of 429 May 9, 2021 Level 2 QC result of 437 4. Review of Level 3 troponin-I QC showed: April 15, 2021 Level 3 troponin-I QC result of 34.600 April 21, 2021 Level 3 troponin-I QC result of 30.300 April 29, 2021 Level 3 troponin-I QC result of 29.600 April 30, 2021 Level 3 troponin-I QC result of 30.300 May 1, 2021 Level 3 troponin-I QC result of 30.500 May 3, 2021 Level 3 troponin-I QC result of 30.400 May 5, 2021 Level 3 troponin-I QC result of 29.900 May 6, 2021 Level 3 troponin-I QC result of 30.100 May 7, 2021 Level 3 troponin-I QC result of 30.300 May 8, 2021 -- 4 of 10 -- Level 3 troponin-I QC result of 29.600 May 9, 2021 Level 3 troponin-I QC result of 30.200 May 10, 2021 Level 3 troponin-I QC result of 30.100 May 11, 2021 Level 3 troponin-I QC result of 30.500 4. Interview with TS #1 on May 12, 2021 at 12:00 PM confirmed the laboratory failed to ensure alkaline phosphatase (ALP) and troponin-I QC met criteria for acceptability before reporting patient results. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the "Prothrombin Time (PT)" procedure, Sysmex CA-600 PT quality control (QC) records, Siemens Dade Innovin package insert, Sysmex CA-600 analyzer, and interview with the technical supervisor (TS) #1, the laboratory failed to include two levels of control material each 8 hours of operation for PT for 3 of 73 patient testing days in March, April and to date May 12, 2021 and failed to verify the correct International Sensitivity Index (ISI) value was being used for calculating the INR value. Findings: 1. Review of the PT procedure states that "controls should be tested at the initiation of testing, upon reagent changes and at least once each 8 hour shift". 2. Review of Sysmex CA-600 PT QC showed QC was not performed every 8 hours on April 16, 2021. Acceptable PT QC was performed on April 15, 2021 at 9:18 PM and not again until April 16, 2021 at 9:06 PM. 3. Review of Sysmex CA-600 PT QC showed QC was not performed every 8 hours on April 28, 2021. Acceptable PT QC was performed on April 28, 2021 at 5:16 AM and not again until April 29, 2021 at 5:32 AM. 4. Review of Sysmex CA-600 PT QC showed QC was not performed every 8 hours on May 4, 2021. Acceptable PT QC was performed on May 4, 2021 at 4:27 AM and not again until May 5, 2021 at 2:03 PM. 5. Review of the Siemens Dade Innovin package insert lot #549762 expiration 10-31-2022 showed the ISI value as 1.02 for Sysmex CA-600 analyzer. 6. Review of the Sysmex CA-600 analyzer showed Siemens Dade Innovin lot# 549762 currently in use onboard the analyzer with an ISI value as 1.04. The laboratory was unable to provide documentation of when Siemens Dade Innovin lot# 549762 was put into use. 7. Interview with the TS #1 on May 12, 2021 at 10:00 AM confirmed the laboratory failed to include two levels of control material each 8 hours of operation for PT and failed to verify the correct ISI value was being used for calculating the INR value. 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, -- 5 of 10 -- as specified in this section. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, immunohematology records, and interview with the technical supervisor (TS) #1, the laboratory failed to follow manufacturer's instructions for incubator temperature verification during 2019, 2020 and to date May 12, 2021. Findings: 1. The manufacturer's instructions for incubator temperature verification states,"Fluid temperature measurements should be made with an unused card and a calibrated thin wire digital meter. Temperature must read 37 degrees C. +/- 2 degrees C." 2. Review of immunohematology records showed the laboratory failed to verify the temperature of the incubator used for antibody detection and extended crossmatch procedures. 3. Interview with TS #1 on May 12, 2021 at 3: 15 PM confirmed the laboratory failed to verify the temperature of the incubator as stated in the manufacturer's instructions. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the "Quality Control Monitoring" procedure, Ortho Diagnostics Vitros 5600 quality control (QC), Sysmex CA-600 Prothrombin Time (PT) quality control QC records, and interview with the technical supervisor #1 (TS), the laboratory failed to establish written procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems. Findings: 1. Review of the "Quality Control Monitoring" procedure states "It is the policy of this laboratory that no tests will be released unless proper QC has been performed and verified to be within established ranges." The procedure did not define what established ranges meant and did not include an ongoing mechanism to monitor and assess QC that did not fall within established ranges. 2. Review of Ortho Diagnostics Vitros 5600 QC showed the laboratory failed to ensure alkaline phosphatase (ALP) and troponin-I QC were within established ranges before reporting patient results for 33 of 73 testing days in March, April and to date May 12, 2021. 3. Review of Sysmex CA-600 PT QC showed QC was not performed every 8 hours for 3 of 73 testing days in March, April and to date May 12, 2021. 4. Interview with the TS #1 on May 12, 2021 at 12:30 PM, the TS stated "they follow Westgard rules for quality control." The laboratory was unable to provide documentation of an established policy stating that Westgard rules should be followed for QC. 5. Interview with the TS #1 on May 12, 2021 at 12:30 PM confirmed the laboratory failed to establish written procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests -- 6 of 10 -- and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of Complete Blood Count (CBC) procedure, CBC patient report, and interview with the technical supervisor #1 (TS), the laboratory failed to ensure the CBC procedure reference ranges matched the reference ranges on the CBC patient report. Findings: 1. Review of the CBC procedure showed the reference ranges as: White blood cell count (WBC): Male 4.0 - 11.0 Female 4.0 - 11.0 Red blood cell count (RBC): Male 4.40 - 6.30 Female 4.20 - 5.50 Hemoglobin (Hgb): Male 14.0 - 18.0 Female 12.0 - 16.0 Hematocrit (Hct): Male 41 - 51% Female 37 - 47% Mean corpuscular volume (MCV): Male 80.0 - 97.0 Female 80.0 - 97.0 Red cell distribution width (RDW): Male 11.6 - 16.5 Female 11.6 - 16.5 2. Review of the CBC patient report showed the reference ranges as: WBC: Male 3.5 - 10.5 Female 3.5 - 10.5 RBC: Male 4.32 - 5.72 Female 3.90 - 5.03 Hgb: Male 13.5 - 17.5 Female 12.0 - 15.5 Hct: Male 38.8 - 50.0% Female 34.9 - 44.5% MCV: Male 81.2 - 95.1 Female 81.6 - 98.3 RDW: Male 11.8 - 15.6 Female 11.9 - 15.5 3. Interview with the TS #1 on May 12, 2021 at 1:30 PM confirmed that the CBC procedure reference ranges did not match the CBC patient report reference ranges. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of verification procedures, proficiency testing records for 2019 and 2020, quality control (QC) program, procedure manuals, and interviews, the laboratory director (LD) failed to provide overall management and direction of the laboratory. The LD failed to ensure verification procedures used for the Vitros 5600 chemistry analyzer and the Rapid Point blood gas analyzer were adequate (Refer to D6086); failed to ensure all proficiency testing reports received were reviewed by appropriate staff and evaluated (Refer to D6091); failed to ensure an approved

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of immunohematology compatibility testing proficiency testing (PT) results for 2020 reported to the CLIA database by the PT provider and phone interview with the laboratory manager, the laboratory failed to successfully participate in PT. See tag D2173; failure to attain an overall event score of 100 percent for compatibility testing. See tag D2181; unsatisfactory performance in two out of three consecutive testing events for the analyte; compatibility testing. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of immunohematology compatibility testing proficiency testing (PT) results and phone interview with the laboratory manager, the laboratory failed to attain an overall testing performance score of 100 percent for the first and third testing events for 2020. Findings: 1. Review of compatibility PT results for 2020 showed the laboratory obtained a score of 80 percent in the first testing event and 0 percent in the third testing event. 2. Phone interview with the laboratory manager on February 8, 2021 at 08:30 AM confirmed the laboratory failed to attain a testing performance score of 100 percent for compatibility testing in the first and third testing events of 2020. 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 review of immunohematology proficiency testing (PT) results and phone interview with the laboratory manager, the laboratory failed to achieve satisfactory performance for compatibility testing in two out of three testing events for 2020. Findings: 1. Review of the immunohematology PT results for the first testing event of 2020 revealed the laboratory obtained an unsatisfactory score of 80 percent for compatibility testing. 2. Review of the immunohematology PT results for the third testing event of 2020 revealed the laboratory obtained an unsatisfactory score of 0 percent for compatibility testing. 3. Phone interview with the laboratory manager on February 8, 2021 at 08:30 AM confirmed the laboratory failed to achieve satisfactory performance for compatibility testing in two out of three consecutive events in 2020. -- 2 of 2 --