Americahealth Inc Idaho Falls

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid (CMS) Proficiency Testing (PT) data report (Report 155D), PT reports from the College of American Pathologists (CAP) and an interview with the operations manager on 10/19/2022, the laboratory failed to enroll in PT for the specialty of chemistry for 2022. The findings include: 1. Review of Report 155D and PT reports from CAP identified that the laboratory failed to enroll in PT for the sub-specialty of routine chemistry for the following analytes: albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, urea, calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin and total protein for 2022. 2. Review of Report 155D and PT reports from CAP identified that the laboratory failed to enroll in PT for the sub-specialty of endocrinology for the following analytes: thyroid-stimulating hormone, thyroxine, triiodothyronine, free thyroxine for 2022. 3. An interview with the operations manager on 10/19/2022 at 12:48 pm confirmed the above findings. 4. The laboratory reports performing 39,025 chemistry tests annually. D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 18 -- For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid (CMS) Proficiency Testing (PT) data report (Report 155D), PT reports from the College of American Pathologists (CAP) and an interview with the operations manager on 10/19/2022, the laboratory failed to verify the accuracy at least twice annually of tests not included in subpart I for the specialty of chemistry for 2022. The findings include: 1. A review of Report 155D and PT reports from CAP identified that the laboratory failed to verify the accuracy at least twice annually for the sub-specialty of routine chemistry for the analyte carbon dioxide in 2022. 2. A review of Report 155D and PT reports from CAP identified that the laboratory failed to verify the accuracy at least twice annually the sub-specialty of endocrinology for the following analytes: thyroglobulin antibody and thyroid peroxidase antibodies in 2022. 3. An interview with the operations manager on 10/19/2022 at 12:48 pm confirmed the above findings. 4. The laboratory reports performing 39,025 chemistry tests annually. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documentation from the College of American Pathologists (CAP) and an interview with the operations manager on 10/19 /2022, the laboratory failed to have testing personnel and the laboratory director attest to the integration of PT samples with routine testing of patient samples in 2021 and 2022. The findings include: 1. A review of PT results from CAP for urine toxicology, qualitative, ethanol biomarkers and drugs of abuse identified that the laboratory failed to have the testing personnel and the laboratory director attest that the PT samples were tested with patient samples for all testing events in 2021 and 2022. 2. An interview with the operations manager on 10/19/2022 at 12:48 pm confirmed that the laboratory failed to have documentation of signed attestations available at the time of survey. 3. The laboratory reports performing 30,025 urine toxicology tests annually. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test -- 2 of 18 -- system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documentation from the College of American Pathologists (CAP) and an interview with the operations manager on 10/19 /2022, the laboratory failed to retain PT documents in 2021 and 2022. The findings include: 1. A review of PT results from CAP for urine toxicology, qualitative, ethanol biomarkers and drugs of abuse identified that the laboratory failed retain documentation of raw testing data for all events in 2021 and 2022. 2. A review of PT results from CAP for urine toxicology, qualitative, ethanol biomarkers and drugs of abuse identified that the laboratory failed retain documentation of graded results for events one and two in 2022. 3. An interview with the operations manager on 10/19 /2022 at 12:48 pm confirmed that the laboratory failed to have documentation of raw data and graded results available at the time of survey. 4. The laboratory reports performing 30,025 urine toxicology tests annually. 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 a review of the Centers for Medicare and Medicaid (CMS) proficiency testing (PT) data report (Report 155D), graded results from the College of American Pathologists (CAP) and an interview with the operations manager on 10/19/2022, the laboratory failed to successfully participate and achieve an overall satisfactory score for two consecutive testing events in 2022 for the specialty of hematology. See D2131 D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. -- 3 of 18 -- This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid (CMS) Proficiency Testing (PT) data report (Report 155D), graded PT results from the College of American Pathologists (CAP) and an interview with the operations manager on 10/19 /2022, the laboratory failed to achieve satisfactory performance for two (2) consecutive PT events for the specialty of hematology. The findings include: 1. A review of Report 155D and graded PT results from CAP identified that the laboratory failed to achieve satisfactory performance for events one (1) in 2022 and two (2) in 2022 for the specialty of hematology for the analytes: Analyte Year Event Score WBC 2022 1 0% WBC 2022 2 0% RBC 2022 1 0% RBC 2022 2 0% Hematocrit 2022 1 0% Hematocrit 2022 2 0% Hemoglobin 2022 1 0% Hemoglobin 2022 2 0% Platelet 2022 1 0% Platelet 2022 2 0% WBC differential 2022 1 0% WBC differential 2022 2 0% 2. An interview with the operations manager on 10/19/2022 at 12:48 pm confirmed that there was no additional PT documents. 3. The laboratory reports performing 5,000 CBC tests annually. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on direct observations, lack of documentation and interviews with the operations manager and technical supervisor on 10/19/2022, the laboratory failed to provide evidence of initial training, competency assessments, quality control performance, calibration performance, instrument maintenance performance, proficiency testing performance, sample testing policies, policies for sample collection, processing and transport, proper reagent storage, discontinuing reagent use after expiration for comprehensive metabolic panels. See D5209, D5311, D5403, D5413, D5417, D5429, D5437 and D5447 D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on direct observations, lack of documentation and interviews with the operations manager and technical supervisor on 10/19/2022, the laboratory failed to provide evidence of initial training, competency assessments, quality control performance, calibration performance, instrument maintenance performance, proficiency testing performance, sample testing policies, policies for sample collection, processing and transport, proper reagent storage, discontinuing reagent use after expiration for thyroxine, triiodothyronine, free thyroxine, thyroid stimulating hormone, Thyroglobulin Antibody and Thyroid peroxidase antibody testing . See D5209, D5311, D5403, D5413, D5417, D5429, D5437 and D5447 -- 4 of 18 -- D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on direct observations, lack of documentation and interviews with the operations manager and technical supervisor on 10/19/2022, the laboratory failed to provide evidence of initial training, quality control performance, calibration performance, instrument maintenance performance, policies for sample collection, processing and transport, storage of reagents at proper temperature, discontinuing reagent use after expiration for urine toxicology testing. See D5209, D5311, D5403, D5413, D5417, D5429, D5437 and D5447 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 direct observations, lack of documentation and interviews with the operations manager and technical supervisor on 10/19/2022, the laboratory failed to provide evidence of initial training, competency assessments, quality control performance, calibration performance, instrument maintenance performance, instrument verification, proficiency testing performance, sample testing policies, policies for sample collection, processing and transport, proper reagent storage, discontinuing reagent use after expiration for complete blood counts. See D5209, D5311, D5403, D5413, D5417, D5421, D5429, D5437 and D5447 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 a review of competency assessments and an interview with the technical supervisor (TS) on 10/19/2022, the laboratory failed to have documentation of six month competency for one of three testing personnel. The findings include: 1. A review of competency assessments identified that the laboratory failed to have six month competency assessment for one testing personnel (TP1) testing on the Abbott Architect ci4100 and the CELL-DYN Ruby. 2. An interview with the TS on 10/19 /2022 at 3:06 confirmed that there was no six month competency assessment for TP1 for the Abbott Architect ci4100 and the CELL-DYN Ruby. 3. The laboratory reports performing 44,025 moderate and high complexity testing annually. -- 5 of 18 -- D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a record review of proficiency testing (PT) from College of American Pathologists (CAP) and an interview with the operations manager on 10/19/2022, the laboratory failed to review PT and evaluate results that were less than 100% for 2021 and 2022. The findings include: 1. A review of PT records from CAP for Ethanol biomarkers in 2021 identified that the laboratory failed to evaluate the results for the following; Ethyl glucuronide 67% and Ethyl sulfate 67% for event one, Ethyl glucuronide 0% and Ethyl sulfate 3% for event two. 2. A review of PT records from CAP for Ethanol biomarkers in 2022 identified that the laboratory failed to evaluate the results for the following; Ethyl glucuronide 67% and Ethyl sulfate 33% for event one. 3. A review of PT records from CAP for urine toxicology, qualitative in 2021 identified that the laboratory failed to evaluate the results for the following; UT-03 0%, UT-04 0% for event one, UT-07 0% for event two and UT-11 0%, UT-13 0% and UT-15 0% for event three. 4. A review of PT records from CAP for urine toxicology, qualitative in 2022 identified that the laboratory failed to evaluate the results for the following; UT-05 0% for event one, UT-10 0% for event two. 5. An interview with the operations manager on 10/19/2022 at 12:48 pm confirmed that there was no documentation of PT review. 6. The laboratory reports performing 30,025 urine toxicology tests annually. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on a lack of documentation and an interview with the operations manager on 10 /19/2022, the laboratory failed to provide written procedures for the company's other urgent care and behavior health locations for specimen collection, specimen labeling, specimen storage and transport. The findings include: 1. A lack of documents available at the time of inspection identified that the laboratory failed to provide a written procedure to their locations that included sample collection, sample labeling, sample storage and transportation conditions for chemistry, hematology, virology and toxicology testing. 2. An interview with the operations manager on 10/19/2022 at 12: 58 confirmed that this facility was testing samples for the company's other urgent care and behavior health locations. 3. An interview with the operations manager on 10/19 /2022 at 12:48 pm confirmed that there were no written policies for their other facilities. 4. The laboratory reports performing 44,025 moderate and high complexity tests annually. -- 6 of 18 -- 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 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 record review and interview with the laboratory manager on 01/29/21, the laboratory failed to report SARS-Co-V-2 test results as required for 42 of 42 days reviewed from October 02, 2020 through January 28, 2021. Findings include: 1. The laboratory performs SARS-CoV-2 serology testing on the Premier Biotech SARS CoV-2 rapid antibody as of October 02, 2020 and SARS-CoV-2 antigen testing on the Abbott ID Now platform since 01/22/2021. 2. Review of laboratory's patient test logs from 10/01/2020 to 01/29/2021 and interview with the laboratory manager on 01/29 /21 revealed that laboratory does not have a process for reporting SARS-CoV-2 testing results to the state of Idaho public health or the Secretary of HHS. 3. Patient testing records revealed that SARS-CoV-2 test results were not reported as required for 21 days in October 2020, 3 days in November 2020, 7 days in December 2020, and 11 days in January 2021. 4. The laboratory patient testing records revealed that the laboratory performed (64) SARS-CoV-2 rapid antibody patient tests from 10/02 /20 through 01/28/21 and (18) SARS-CoV-2 rapid antigen tests from 01/22/21 to 01 /28/21 . 5. 82 SARS-CoV-2 test results were not reported as required during the period of review. 6. The laboratory manager confirmed by interview on 01/29/2021 at 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 -- 09:00 a.m., that the laboratory does not have a policy or procedure for reporting SARS-CoV-2 test results and had not reported SARS-CoV-2 test results since initiating SARS-CoV-2 patient testing on 10/02/2020. 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 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 record review and interview with the laboratory manager on 01/29/21, the laboratory failed to report SARS-Co-V-2 test results as required for 42 of 42 days reviewed from October 02, 2020 through January 28, 2021. Findings include: 1. The laboratory performs SARS-CoV-2 serology testing on the Premier Biotech SARS CoV-2 rapid antibody as of October 02, 2020 and SARS-CoV-2 antigen testing on the Abbott ID Now platform since 01/22/2021. 2. Review of laboratory's patient test logs from 10/01/2020 to 01/29/2021 and interview with the laboratory manager on 01/29 /21 revealed that laboratory does not have a process for reporting SARS-CoV-2 testing results to the state of Idaho public health or the Secretary of HHS. 3. Patient testing records revealed that SARS-CoV-2 test results were not reported as required for 21 days in October 2020, 3 days in November 2020, 7 days in December 2020, and 11 days in January 2021. 4. The laboratory patient testing records revealed that the laboratory performed (64) SARS-CoV-2 rapid antibody patient tests from 10/02 /20 through 01/28/21 and (18) SARS-CoV-2 rapid antigen tests from 01/22/21 to 01 /28/21 . 5. 82 SARS-CoV-2 test results were not reported as required during the period of review. 6. The laboratory manager confirmed by interview on 01/29/2021 at 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 -- 09:00 a.m., that the laboratory does not have a policy or procedure for reporting SARS-CoV-2 test results and had not reported SARS-CoV-2 test results since initiating SARS-CoV-2 patient testing on 10/02/2020. 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 D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on testing record review and interview with the testing personnel (L) on 11/5 /2020, the laboratory failed to at least twice annually, verify the accuracy of any test or procedure it performs that is not included in subpart I for unregulated analytes and tests in accordance with of 42 C.F.R. 493.1236(c)(1). The findings include: 1. The laboratory initiated Liquid Chromatography Mass Spec (LC/MS) for Urine Toxicology testing June 1, 2020. The laboratory did not have policies or procedures established to perform verification of accuracy for its urine toxicology testing methods. 2. The laboratory initiated Primier BioTech SARS CoV-2 rapid IgM/IgG antibody testing, a moderate complexity platform as determined by the FDA emergency use authorization (EUA) for the manufacturer Hangzhou Biotest Biotech Co. Ltd and distributed by Primier BioTech. a. The laboratory did not have policies or procedures to establish verification of accuracy for the SARS CoV-2 antibody testing. The laboratory had no documentation of verification of accuracy being performed for the SARS CoV-2 antibody testing prior to testing and reporting patient specimens. 3. The laboratory testing personnel (L) confirmed by interview on 11/05/2020 that the laboratory had not established policies and procedures for performing twice annual verification of accuracy for the testing methods listed above. 5. The laboratory reports performing 1,115 Urine Toxicology patient specimens annually, and 1000 SARS CoV- 2 antibody patient specimens. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 8 -- 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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control (QC) records, their policies and procedures and interview with the testing personnel (L) on 11/05/2020, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. The findings include: 1. The laboratory records indicated gaps of documented QC being performed for the dates June 1, 2020 and June 3, 2020 for the LC/MS urine toxicology testing. The laboratory did not have documentation of

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 proficiency testing (PT) desk review, the laboratory failed to successfully participate in proficiency testing for the analyte Cell Identification or White Blood Cell Identification. 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. 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 -- This STANDARD is not met as evidenced by: Based on proficiency testing (PT) desk review and the laboratory's graded PT results from the Medical Laboratory Evaluation (MLE), the laboratory failed to achieve satisfactory performance for Cell Identification (I.D.) or White Blood Cell I.D. on two out of three consecutive testing events. Findings: Analyte Year Event Score Cell I.D. 2017 #2 60% Cell I.D. 2018 #1 53% -- 2 of 2 --