Mt Grant General Hospital Laboratory

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification and change of director survey conducted at your facility on January 21- 22, 2025. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of the Blood Bank Quality Control logs and an interview with the laboratory manager, the laboratory failed to ensure that laboratory reagents were not used after the expiration date. Findings include: 1. A review of the 2023 and 2024 Blood Bank Quality Control logs found that Ortho Confidence Antibody (lot CNF363) expired on 11/12/2024 and was used on 11/30/2024. 2. A review of the 2023 and 2024 Blood Bank Quality Control logs found that 0.8% Selectogen I (lot VS631) expired on 11/26/2024 and was used on 11/30/2024. 3. A review of the 2023 and 2024 Blood Bank Quality Control logs found that 0.8% Selectogen II (lot VS631) expired on 11/26/2024 and was used on 11/30/2024. 4. A review of the 2023 and 2024 Blood Bank Quality Control logs found that MTS Diluent 2 (lot MD181) expired on 11/26/2024 and was used on 12/14/2024, 12/16/2024, 12/18/2024 and 12/23/2024. 5. An interview with the laboratory manager on 1/21/2024 at approximately 3:00 PM confirmed these findings. This is a repeat deficiency that was cited at the CLIA recertification survey on 11/17/2022. The laboratory performs approximately 289 immunohematology tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on 11/17/2022. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of calibration verification records for the Siemens EPOC blood gas analyzer and interview with the interim laboratory manager, the laboratory failed to ensure that analytic systems records including calibration verification records were retained for at least two years. Findings include: 1. Calibration records reviewed for the Siemens EPOC blood gas analyzer for 2021 and 2022 revealed there were no records of calibration verifications for 2021. 2. The interim laboratory manager interviewed on 11/17/2022 at approximately 3:00 PM indicated that the 2021 records may be stored in a storage area and not easily retrieved. The laboratory performs approximately 83,007 chemistry tests annually. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have 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 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of the Blood Bank Quality Control (QC) forms for 9/12/2022 and 9 /15/2022 and interview with the interim laboratory manager, the laboratory failed to ensure that laboratory reagents were not used after their expiration date. Findings include: 1. Review of the Blood Bank Quality Control forms for 9/12/2022 and 9/15 /2022 revealed that expired reagents were used to perform QC. Anti-A expired on 9/03 /2022, Anti-B expired on 8/25/2022, A1 and B1 cells expired on 9/02/2022, Screen cells I and II expired on 9/02/2022, AHG expired on 8/31/2022, check cells expired on 9/02/2022, and corQC reagent cells expired on 9/02/2022. The laboratory performed ABO/Rh, antibody screens, and compatibility testing on 9/12/2022 and 9/15 /2022. 2. The interim laboratory manager confirmed the findings during the interview on 11/17/2022 at approximately 2:00 PM. The laboratory performs approximately 289 immunohematology tests annually. 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 calibration verification records for the Siemens EPOC blood gas analyzer and interview with the interim laboratory manager, the laboratory failed to perform calibration verification at least once every 6 months. Findings include: 1. Calibration records reviewed for the Siemens EPOC blood gas analyzer for 2021 and 2022 revealed there were no calibration verifications records for 2021. Calibration verifications were performed on 4/07/2022 and 11/11/2022. 2. The interim laboratory manager interviewed on 11/17/2022 at approximately 3:00 PM was unable to locate the 2021 calibration verification records and indicated that the records may be stored in a storage area and not easily retrieved. The laboratory performs approximately 83,007 chemistry tests annually. -- 2 of 4 -- D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Triage D-Dimer test procedure, review of the quality control records, review of the laboratory's Individualized Quality Control Plans (IQCP), and interview with the interim laboratory manager, the laboratory failed to perform two levels of external controls each day of testing patient samples. Findings include: 1. The Triage D-Dimer test procedure stated, ". . .external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by your laboratory's standard quality control procedures." 2. Review of the QC log for the Triage D-Dimer test from January to October 2022 revealed that two levels of external QC were performed every 30 days or with each new lot number or shipment of test cassettes. 3. The laboratory's IQCP procedures did not list the D-Dimer test. 4. The interim laboratory manager interviewed on 11/17/2022 at approximately 2:30 PM confirmed the findings. The laboratory performs approximately 23,961 hematology tests annually. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records, review of quality control (QC) records, review of calibration verification records, and interview with the interim laboratory manager, the laboratory director failed to ensure that the quality assessment (QA) programs are maintained to assure the quality of laboratory services provided. Findings include: The QA program failed to identify and take

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on 4/08/2021. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on a sample survey of the laboratory test worksheet for manual tests, review of the copy machine's number of fax transmission confirmations from 2/01/2021 through 2/08/2021, and interview with the technical supervisor, the Condition: Facility Administration was not met. The laboratory failed to report SARS-CoV-2 (COVID- 19) test results as required for tests performed from 2/01/2021 through 2/08/2021. Findings include: 1. The laboratory began SARS-CoV-2 testing using the BinaxNow Rapid COVID-19 Antigen Card Test in 9/2020 and began reporting the test results to the authority by fax transmission. 2. A sample survey of the laboratory test worksheets for SARS-CoV-2 (COVID-19) reviewed from 2/01/2021 through 2/08 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 -- /2021 revealed that the laboratory performed 107 SARS-CoV-2 tests during the time period. 3. Review of the copy machine's log of the number of fax transmission confirmations for 2/01/2021 through 2/08/2021 to the authority's fax number revealed that the number of tests performed and the number of results reported to the authority did not match for the time period. DATE TESTED FAXED 2/1/2021 24 0 2/2/2021 23 25 2/3/2021 26 25 2/4/2021 5 12 2/5/2021 1 0 2/6/2021 2 0 2/7/2021 1 0 2/8/2021 25 35 total 107 97 4. The technical supervisor interviewed during the on-site inspection on 4/08/2021 at approximately 4:00 PM indicated that the laboratory did not confirm that all the tests performed were reported to the reporting authority. The technical supervisor stated that the laboratory performs approximately 100 SARS- CoV-2 tests monthly. 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 laboratory procedures for the serum pregnancy and infectious mononucleosis, review of the quality control logs for the two tests, review of the Daily Order Log, and interview with the technical supervisor, the laboratory failed to test a negative and positive control at least once a day patient specimens were tested. Findings include: 1. Laboratory procedure, HCG by SUREVUE, stated, "Known positive and Negative controls are run each day of shipment, new Lot and/or at least once a month." 2. Laboratory procedure, Infectious Mononucleosis by Acceava Mono II stated, "External Positive and Negative controls are run each new lot, new shipment and/or at least once a month." 3. Review of the quality control logs for the SURE- VUE Serum/Urine hCG-STAT and the Infectious Mononucleosis by Acceava Mono II for January to April 2021 revealed that quality control testing with negative and positive control materials was performed once a month. 4. Review of the Daily Order Log revealed a qualitative serum pregnancy (HCG) test performed on 3/11/2021. The quality control was performed on 3/01/2021 for the current lot number of tests in use. 5. The technical supervisor interviewed during the on-site survey on 4/08/2021 at approximately 3:00 PM indicated that the negative and positive controls were not tested each day of patient testing. The laboratory performs approximately 365,00 chemistry and 200 general immunlogy tests annually. D5537 ROUTINE CHEMISTRY CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the epoc System Manual for blood gas analysis and interview with -- 2 of 3 -- the technical supervisor, the laboratory failed to perform a low and high control testing each day of patient testing. Findings include: 1. The epoc System Manual for blood gas analysis in section 9.2 Recommended Quality Control for epoc System stated, "Follow federal, state, and local requirements for quality control testing." 2. The technical supervisor interviewed during the on-site survey on 4/08/2021 at approximately 11:00 AM indicated that external quality controls were tested with each new lot number of test cartridges and once per month. The laboratory did not test two levels of quality control each day of patient testing. The laboratory performs approximately 365,000 chemistry tests annually. D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on review of the epoc Correlation Studies with the Istat instrument and interview with the technical consultant and the technical supervisor, the technical consultant failed to follow the laboratory procedure for the verification of the epoc System for blood gas analysis. Findings include: 1. During an interview with the technical consultant during the on-site survey on 4/08/2021 at approximately 11:00 AM, the technical consultant indicated that the number of samples to be evaluated for the correlation studies to verify the performance specifications for new instruments was 20 and indicated procedure, Laboratory Quality Management, Inter-Instrument Correlation as the source of the number of samples. 2. Laboratory procedure, Laboratory Quality Management, Section Inter-Instrument Correlation, stated, "A random sampling of at least 20 patient samples for all routine analytes and tests are tested on both instruments and the results recorded on the appropriate worksheets." 3. Review of the epoc Correlation Studies for the new blood gas analysis instrument showed 18 samples for carbon dioxide and 19 samples for pH and oxygen were evaluated for the studies. 4.. The technical supervisor interviewed during the on-site survey on 4/08/2021 at approximately 11:00 AM indicated that there were other patient samples tested in parallel on the epoc System and the Istat instrument but did not document the findings. The laboratory performs approximately 365,000 chemistry tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on 4/08/2021. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on a sample survey of the laboratory test worksheet for manual tests, review of the copy machine's number of fax transmission confirmations from 2/01/2021 through 2/08/2021, and interview with the technical supervisor, the Condition: Facility Administration was not met. The laboratory failed to report SARS-CoV-2 (COVID- 19) test results as required for tests performed from 2/01/2021 through 2/08/2021. Findings include: 1. The laboratory began SARS-CoV-2 testing using the BinaxNow Rapid COVID-19 Antigen Card Test in 9/2020 and began reporting the test results to the authority by fax transmission. 2. A sample survey of the laboratory test worksheets for SARS-CoV-2 (COVID-19) reviewed from 2/01/2021 through 2/08 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 -- /2021 revealed that the laboratory performed 107 SARS-CoV-2 tests during the time period. 3. Review of the copy machine's log of the number of fax transmission confirmations for 2/01/2021 through 2/08/2021 to the authority's fax number revealed that the number of tests performed and the number of results reported to the authority did not match for the time period. DATE TESTED FAXED 2/1/2021 24 0 2/2/2021 23 25 2/3/2021 26 25 2/4/2021 5 12 2/5/2021 1 0 2/6/2021 2 0 2/7/2021 1 0 2/8/2021 25 35 total 107 97 4. The technical supervisor interviewed during the on-site inspection on 4/08/2021 at approximately 4:00 PM indicated that the laboratory did not confirm that all the tests performed were reported to the reporting authority. The technical supervisor stated that the laboratory performs approximately 100 SARS- CoV-2 tests monthly. 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 laboratory procedures for the serum pregnancy and infectious mononucleosis, review of the quality control logs for the two tests, review of the Daily Order Log, and interview with the technical supervisor, the laboratory failed to test a negative and positive control at least once a day patient specimens were tested. Findings include: 1. Laboratory procedure, HCG by SUREVUE, stated, "Known positive and Negative controls are run each day of shipment, new Lot and/or at least once a month." 2. Laboratory procedure, Infectious Mononucleosis by Acceava Mono II stated, "External Positive and Negative controls are run each new lot, new shipment and/or at least once a month." 3. Review of the quality control logs for the SURE- VUE Serum/Urine hCG-STAT and the Infectious Mononucleosis by Acceava Mono II for January to April 2021 revealed that quality control testing with negative and positive control materials was performed once a month. 4. Review of the Daily Order Log revealed a qualitative serum pregnancy (HCG) test performed on 3/11/2021. The quality control was performed on 3/01/2021 for the current lot number of tests in use. 5. The technical supervisor interviewed during the on-site survey on 4/08/2021 at approximately 3:00 PM indicated that the negative and positive controls were not tested each day of patient testing. The laboratory performs approximately 365,00 chemistry and 200 general immunlogy tests annually. D5537 ROUTINE CHEMISTRY CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the epoc System Manual for blood gas analysis and interview with -- 2 of 3 -- the technical supervisor, the laboratory failed to perform a low and high control testing each day of patient testing. Findings include: 1. The epoc System Manual for blood gas analysis in section 9.2 Recommended Quality Control for epoc System stated, "Follow federal, state, and local requirements for quality control testing." 2. The technical supervisor interviewed during the on-site survey on 4/08/2021 at approximately 11:00 AM indicated that external quality controls were tested with each new lot number of test cartridges and once per month. The laboratory did not test two levels of quality control each day of patient testing. The laboratory performs approximately 365,000 chemistry tests annually. D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on review of the epoc Correlation Studies with the Istat instrument and interview with the technical consultant and the technical supervisor, the technical consultant failed to follow the laboratory procedure for the verification of the epoc System for blood gas analysis. Findings include: 1. During an interview with the technical consultant during the on-site survey on 4/08/2021 at approximately 11:00 AM, the technical consultant indicated that the number of samples to be evaluated for the correlation studies to verify the performance specifications for new instruments was 20 and indicated procedure, Laboratory Quality Management, Inter-Instrument Correlation as the source of the number of samples. 2. Laboratory procedure, Laboratory Quality Management, Section Inter-Instrument Correlation, stated, "A random sampling of at least 20 patient samples for all routine analytes and tests are tested on both instruments and the results recorded on the appropriate worksheets." 3. Review of the epoc Correlation Studies for the new blood gas analysis instrument showed 18 samples for carbon dioxide and 19 samples for pH and oxygen were evaluated for the studies. 4.. The technical supervisor interviewed during the on-site survey on 4/08/2021 at approximately 11:00 AM indicated that there were other patient samples tested in parallel on the epoc System and the Istat instrument but did not document the findings. The laboratory performs approximately 365,000 chemistry tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on September 5, 2018. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) evaluations, review of CASPER Report 155, and interview with the laboratory manager, the laboratory failed to initiate and document remedial action for an unacceptable analyte result. Findings include: 1. Review of the API PT evaluation showed an unacceptable result for creatine kinase for one out of five PT samples tested from the second testing event of 2017. 2. Review of the CASPER Report 155 showed a score of 80% for creatine kinase from the second testing event of 2017. 3. The laboratory manager stated during the on-site survey on 9/05/18 at approximately 1:30 PM that the unacceptable result was not noticed and there was no remedial action taken and documented. 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 -- 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 patient test reports, laboratory incident reports, quality control results,

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was generated as a result of the CLIA proficiency testing desk review, conducted off-site for your laboratory on 6/06/18. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 desk review of federal database CASPER Report 155D, American Proficiency Institute (API) Proficiency Performance Summary, and the laboratory's 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 -- Checklist for