Mercyone New Hampton Medical Center

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on 10/2/2024, the laboratory was found to be out of compliance with the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R 493.803 Condition: Successful Participation D6076 - 42 C.F.R 493.1441 Condition: Laboratory Director, high complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute 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 -- (API), the laboratory failed to successfully participate in two consecutive testing events in the subspecialty of compatibility testing. The laboratory had unsatisfactory scores for 2024 event 1 and 2024 event 2. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance (100% or greater) for two consecutive testing events in the subspecialty, compatibility testing. The findings include: 1. For 2024 event 1, the laboratory received an unsatisfactory performance score of 60% for the subspecialty, compatibility testing. 3. For 2024 event 2, the laboratory received an unsatisfactory performance score of 80% for the subspecialty, compatibility testing. 3. The CASPER 155 report and graded results from API confirm the findings listed above. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from American Proficiency Institute (2024 event 1 and 2024 event 2), the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2181. -- 2 of 2 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of patient test records, the laboratory's Individualized Quality Control Plan (IQCP), quality control (QC) records, and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at 1:30 pm on 07/25 /2024, the laboratory failed to perform a positive and negative control with each new lot of Giardia/Cryptosporidium Quik Chek test kits for one out of one lot number (lot 062325, expiration 07/01/2024) used in February 2024. The findings include: 1. Patient A had Giardia/Cryptosporidium testing performed on 02/17/2024. 2. Review of the laboratory's IQCP indicated that the laboratory intended to perform QC with each new lot and shipment of Giardia/Cryptosporidium Quik Chek test kits. 3. The laboratory's records indicated that the laboratory began using lot 062325 (expiration 07 /01/2024) on 12/04/2023 but did not perform or document QC. 4. At the time of the survey, personnel identifier #2 confirmed that the laboratory did not have additional QC records for lot 062325 (expiration 07/01/2024) of the Giardia/Cryptosporidium Quik Chek test kit. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- 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: Based on review of patient testing records, quality control (QC) records, and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at 11:31 am on 07/25/2024, the laboratory failed to perform negative QC each day of patient testing for one out of five days of unexpected antibody detection testing in February 2024. The findings include: 1. Patient B had unexpected antibody detection testing performed on 02/14/2024. 2. QC records indicated the laboratory performed a positive control on reagent Search-Cyte Plus I (lot 001, expiration 02/17 /2024) and reagent Search-Cyte Plus II (lot 001, expiration 02/17/2024) on 02/14 /2024. 3. At the time of the survey, the laboratory did not have records of a negative control being performed on reagent Search-Cyte Plus I (lot 001, expiration 02/17 /2024) and reagent Search-Cyte Plus II (lot 001, expiration 02/17/2024) on 02/14 /2024. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Biomeriuex Vitek 2 quality control (QC) records, the laboratory's microbiology QC policy, and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at 1:48 pm on 07/25/2024, the laboratory failed to use two or more substrates or reagents to check each lot number of identification (ID) cards for two out of two lots of ID cards. The findings include: 1. The day of the survey, the laboratory had in use lot 2422850403 (expiration 09/15/2025) of GP ID cards. The laboratory began using it on 05/24/2024. 2. The laboratory's microbiology QC policy stated, "Using streamline QC testing, the following organisms should be tested for Gram Positive Identification cards (GP): Enterococcus casseliflavus ATCC 700327 and Staphylococcus saprophyticus ATCC BAA-750. 3. On 05/24/2024, the laboratory performed QC on lot 2422850403 (expiration 09/15/2025) of GP ID cards with Staphylococcus saprophyticus ATCC BAA-750 only. 4. The day of the survey, the laboratory had in use lot 2412619503 (expiration 01/17/2025) of GN ID cards. The laboratory began using it on 05/24/2024. 5. The laboratory's microbiology QC policy stated, "Using streamline QC testing, the following organisms should be tested for Gram Negative Identification cards (GP): Enterobacter hormaechei ATCC 700323 and Stenotrophomonas maltophilia ATCC 17666. 6. On 05/24/2024, the laboratory performed QC on lot 2412619503 (expiration 01/17/2025) of GN ID cards with -- 2 of 4 -- Stenotrophomonas maltophilia ATCC 17666 only. 7. At the time of the survey, personnel identifier #2 confirmed that the laboratory did not have additional QC records for the GP and GN ID cards listed above. 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 the laboratory's blood bank alarm check policy, blood bank alarm check records, and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at 11:31 am on 07/25/2024, the laboratory failed to document the high and low activation temperatures and nurse response notes as part of the alarm system inspection for six out of six time periods from 01/01/2023- 06/30 /2024. The findings include: 1. The laboratory's policy stated that the blood bank alarm system would be checked on a quarterly basis by an outside company. It also stated, "Record both the low and high activation temperatures, the date, and the name or initials of the person performing the test. Document nursing personnel verified that the remote alarm rang at the nurse's station." 2. Review of the blood bank refrigerator alarm check documentation from the outside company indicated the checks were performed on 02/07/2023, 05/23/2023, 07/19/2023, 11/13/2023, 03/13/2024, and 05/22 /2024. 3. The records did not indicate at what temperature the high and low alarm activation occurred nor at what time the nursing station responded to the alarm. 4. At the time of the survey, the laboratory did not have additional blood bank alarm check records. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of the New Hampton 2024 CLIA Volumes form, lack of comparison activity records, and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at 12:53 pm on 07/25/2024, the laboratory failed to perform and document comparison activities twice annually for the analytes, sodium, potassium, chloride, glucose, lactate, and creatinine, for three out of three time periods from 01/01/2023 - 07/25/2024. The findings include: 1. The laboratory performed the following analytes on the Beckman Coulter DxC600i test system: sodium, potassium, chloride, glucose, lactate, and creatinine. 2. As a backup method, the laboratory performed the analytes listed above on the Siemens EPOC test system. 3. At the time -- 3 of 4 -- of the survey, personnel identifier #2 confirmed that comparison testing had not been performed between the Beckman Coulter DxC600i and Siemens EPOC test systems for the analytes, sodium, potassium, chloride, glucose, lactate, and creatinine, from 01 /01/2023 - 07/25/2024. 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 personnel records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at 8:20 am on 07/25/2024, the technical supervisor failed to assess and document the competency of individuals performing high complexity testing at least annually for five out of eight testing personnel (laboratory personnel identifiers #2, #3, #5, #6, and #9) in 2023. -- 4 of 4 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of proficiency testing records and reports, the laboratory failed to successfully participate in a proficiency testing program for the analytes, prothrombin time (PT) and partial thromboplastin time (PTT), for two out of three consecutive testing events: 2022 event 2 and 2023 event 1 (refer to D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) reports and records, the laboratory failed to achieve satisfactory performance for the analytes, prothrombin time (PT) and partial thromboplastin time (PTT), for two out of three consecutive PT events for unsuccessful participation. The findings include: 1. The laboratory received unsatisfactory performance scores of 20% for 2022 testing event 2 and 60% for 2023 testing event 1 for the analyte, prothrombin time (PT). 2. The laboratory received unsatisfactory performance scores of 20% for 2022 testing event 2 and 60% for 2023 testing event 1 for the analyte, partial thromboplastin time (PTT). -- 2 of 2 --

Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of coagulation reagent studies, observations of the coagulation analyzer and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 10:00 am on 06/22/2022, the laboratory fails to meet the hematology (coagulation) requirements for test system/equipment/reagent verification as specified in the standard D5411. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observations made during the survey, review of coagulation reagent studies, and confirmed by laboratory personnel identifier #2 (refer to Laboratory Personnel Report) at approximately 10:00 am on 06/22/2022, the laboratory failed to enter the correct normal patient mean into the coagulation analyzer; perform patient poor plasma studies; and verify the manual calculation of the international normalized ratio (INR) for lot number N0320573, expiration date 2024-03 of prothrombin time 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 -- reagent. The findings include: 1. The laboratory started using lot number N0320573, expiration date 2024-03 of prothrombin time reagent on 6/1/2022. 2. The laboratory established a normal patient mean of 10.7 seconds for lot number N0320573, expiration date 2024-03 of prothrombin time reagent. 3. Observations made the day of the survey, indicated the laboratory programmed the normal patient mean of 11.8 seconds into the coagulations analyzer. 4. At the time of the survey, the laboratory did not have documentation of platelet poor plasma studies or a manual check of the INR. 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: A. Based on review of the Sysmex hematology procedure and calibration records and interview with laboratory personnel identifier #2 (refer to Laboratory Personnel Report) at approximately 9:45 am on 06/22/2022, the laboratory failed to calibrate the hematology analyzer according to the manufacturer's instructions for three out of four time periods from 1/1/2021 - 6/22/2022. The findings include: 1. The Sysmex hematology procedure states that the hematology analyzer will be calibrated every six months according to manufacturer's instructions. 2. The laboratory calibrated the Sysmex hematology analyzer on 5/12/2021. 3. At the time of the survey, the laboratory did not have records indicating that calibrations had been performed any other time between 1/1/2021 - 6/22/2022. B. Based on review of the Cepheid bacteriology analyzer operator's manual, lack of calibration records and interview with laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 1:00 pm on 6/22/2022, the laboratory failed to calibrate the Cepheid bacteriology analyzer annually in 2021. The findings include: 1. The Cepheid operator's manual stated the analyzer must be calibration annually. 2. At the time of the survey, the laboratory did not have calibration records from 2021. 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: Based on review of individualized quality control plans (IQCP), quality control (QC) -- 2 of 3 -- records and confirmed by laboratory personnel identifier #2 (refer to Laboratory Personnel Report) at approximately 2:30 pm on 06/22/2022, the laboratory failed to perform a negative and positive control for one out of one lot number of Cryptosporidium and Giardia test kits in March 2022. The findings include: 1. On 3/9 /2022 the laboratory performed cryptosporidium and giardia testing using lot number 0921033, expiration date 2/1/2023 of test kit. 2. The IQCP for the Cryptosporidium and Giardia test kit stated QC would be performed with each lot and or shipment of test kits. 3. At the time of the survey, the laboratory did not have QC records for lot number 0921033, expiration date 2/1/2023 of Cryptosporidium and Giardia test kit. 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 personnel records and confirmed by laboratory personnel identifiers #1 and #2 (refer to the Laboratory Personnel Report) at approximately 8:30 am on 06/22/2022, the technical supervisor failed to assess and document the complete competency of individuals performing high complexity testing at least annually for four out of eight testing personnel in 2021. The 2021 annual competencies for testing personnel #2 - #5 did include each test system. -- 3 of 3 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of proficiency records and reports, the laboratory fails to successfully participate in a proficiency testing program for the analyte, compatibility testing, for three consecutive testing events: 2019 event 2, 2019 event 3, and 2020 event 1 (refer to D2181). D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing reports and records, the laboratory fails to achieve satisfactory performance for the analyte, compatibility testing, for three consecutive proficiency testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 60% for 2019 testing event 2, 80% for 2019 testing event 3 and zero for 2020 testing event 1. -- 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 review of proficiency records and reports, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty, compatibility testing, for two out of two consecutive proficiency testing events: 2019 events 2 and 3 (refer to D2181). D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing reports and records, the laboratory failed to achieve satisfactory performance for the analyte, compatibility testing, for two out of two consecutive testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 60% for 2019 testing event 2 and 80% for 2019 testing event 3. -- 2 of 2 --