Teton Valley Hospital

Summary Statement of Deficiencies 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 American Proficiency Institute (API) and an interview with the laboratory manager on 5/16 /2023, the laboratory failed to have the laboratory director attest to the integration of PT samples with routine testing of patient samples in 2022. The findings include: 1. A review of PT results from API for microbiology 2021 event three (3), chemistry core and hematology 2022 event one (1) and chemistry core, chemistry miscellaneous and hematology 2022 event two (2) identified that the laboratory failed to have the laboratory director attest that the PT samples were testing with patient samples. 2. An interview with the laboratory manager on 5/16/2023 at 10:06 am confirmed that the laboratory director failed to sign attestations for above specialties. 3. The laboratory reports performing 140,144 tests annually. 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 the Centers for Medicare and Medicaid Services (CMS) 209 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 -- personnel form, competency assessment records and an interview with the laboratory manager on 5/16/2023, the laboratory failed to follow written policies and procedures to assess testing personnel competency in 2022. The findings include: 1. The CMS 209 identified eight (8) testing personnel performing moderate and high complexity testing. 2. A review of competency assessment records identified four (4) of eight (8) testing personnel failed to have an annual competency assessment for 2022. 3. An interview with the laboratory manager on 5/16/2023 at 9:10 am confirmed the above finding. 4. The laboratory reports performing 140,144 moderate and high complexity tests annually. 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 review of proficiency testing (PT) documentation from the American Proficiency Institute (API) and an interview with the laboratory manager on 5/16 /2023, the laboratory failed to document the review of PT results for the specialty of hematology. The findings include: 1. A review of PT documents for the specialty of hematology from API identified that the laboratory failed to document the review and evaluation of PT results by the laboratory director for event two (2) in 2022. 2. An interview with the laboratory manager on 5/16/2023 at 10:00 am confirmed that the laboratory director failed to document the review of PT results for hematology event two (2) in 2022. 3. The laboratory reports performing 42,480 hematology tests annually. -- 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 a review of training documentation, competency assessments, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview with the laboratory manager on 8/10/2021, the laboratory failed to establish and follow written policies and procedures to assess testing personnel in accordance with 42 C.F. R. 493.1451(b)(7)(8). The findings include: 1. A review of training and competency records identified that five (5) of eight (8) testing personnel listed on the CMS 209 failed to have documentation of six (6) month competency which included the six parameters as listed in 493.1451(b)(7)(8). 2. A review of training and competency records identified eight (8) of eight (8) testing personnel listed on the CMS 209 failed to have documentation of annual competency which included the six parameters as listed in 493.1451(b)(7)(8) for 2020. 3. An interview with the laboratory manager on 8 /10/2021 at 8:25 am confirmed the above findings. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). 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 -- This STANDARD is not met as evidenced by: Based on review proficiency testing (PT) records and an interview with the laboratory manager on 8/10/2021, the laboratory failed to evaluate the accuracy of any analyte, specialty or subspecialty that was assigned an artificial score of 100% because it was ungraded by the PT provider. The findings include: 1. A review of Immunology /Immunohematology 2020 event 1 records from American Proficiency Institute (API) identified a C-Reactive Protein sample (CRP-01) that was given an artificial score of 100% that the laboratory failed to evaluate for accuracy. 2. A review of Immunology /Immunohematology 2020 event 2 records from API identified a C-Reactive Protein sample (CRP-03) that was given an artificial score of 100% that the laboratory failed to evaluate for accuracy. 3. A review of Hematology/Coagulation 2020 event 3 records from API identified one urine sediment sample (US-06) was ungraded due to lack of consensus resulting in an artificial score of 100% that the laboratory failed to evaluate for accuracy. 4. A review of Chemistry 2020 event 1 records from API identified a Vitamin B-12 sample (IA-02) that was given an artificial score of 100% that the laboratory failed to evaluate for accuracy. 5. A review of Chemistry 2020 event 2 records from API identified a Vitamin B-12 sample (IA-06) and a 25-OH Vitamin D sample (IAS-06) that were given an artificial score of 100% that the laboratory failed to evaluate for accuracy. 6. A review of Routine Microbiology Combination 2020 event 1 records from College of American Pathologists (CAP) identified that one urine culture bacterial identification sample (UC-03) was ungraded due to lack of consensus resulting in an artificial score of 100% that the laboratory failed to evaluate for accuracy. 7. An interview with the laboratory manager on 8/10 /2021 at 9:30 am confirmed that the laboratory did not evaluate the accuracy of ungraded PT results that were given an artificial score of 100%. 8. The laboratory reports performing 123,320 moderate and high complexity tests annually. 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 a random record review of Quality Control (QC) documentation and an interview with the laboratory manager on 8/10/2021, the laboratory failed to successfully perform two levels of QC daily for each quantitative procedure. The findings include: 1. A random record review of QC from the Ortho Vitros 5600 identified that the laboratory did not have a result on 4/9/2021 for level 3 Biorad QC lot number 45793 for the following analytes: glucose, total protein, uric acid, albumin, triglyceride,cholesterol, amylase, chloride, potassium, sodium, carbon dioxide, phosphorus, creatinine, urea, calcium, magnesium, alkaline phosphatase, alanine aminotransferease, aspartate aminotransferase, creatine kinase. 2. An interview with the laboratory manager on 8/10/2021 at 10:48 am confirmed that there were not two levels of QC on 4/9/2021 for the above analytes. 3. The laboratory performed chemistry testing for nine (9) patients on 4/9/2021. D5451 CONTROL PROCEDURES -- 2 of 3 -- CFR(s): 493.1256(d)(3)(iii)(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-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a random review of immunohematology quality control (QC) records, patient records and an interview with the laboratory manager on 8/10/2021, the laboratory failed to document control material results with graded or titered reactivity and include negative control material. The findings include: 1. A random record review of immunohematology QC and immunohematology patient logs for 2019, 2020 and 2021 identified that the laboratory failed to document QC with a graded or titered reactivity and a negative control on 11/9/2019, 4/27/2020, 4/28/2020, 2/16 /2021, 3/16/2021, 5/14/2021 and 5/18/2021 as required by regulation for all immunohematology testing. 2. One (1) patient blood and Rh type was performed on 11 /9/2019 and the laboratory failed to document positive QC (1-4+) and negative QC. 3. One (1) patient blood, Rh type and antibody screen was performed on 4/27/2020 and the laboratory failed to document positive QC (1-4+) and negative QC. A Crossmatch of two (2) units was performed for this patient on 4/28/2020 and the laboratory failed to document positive QC (1-4+) and negative QC. 4. One (1) patient blood and Rh type, antibody screen and a crossmatch of two (2) units was performed on 2/16/2021 and the laboratory failed to document positive QC (1-4+) and negative QC. 5. One (1) patient blood and Rh type, antibody screen and a crossmatch of two (2) units was performed on 3/16/2021 and the laboratory failed to document positive QC (1-4+) and negative QC. 6. One (1) patient antibody screen was performed on 5/14/2021 and the laboratory failed to document positive QC (1-4+) and negative QC. 7. Four (4) units had blood and Rh type performed as unit checks on 5/18/2021 and the laboratory failed to document positive QC (1-4+) and negative QC. 8. An interview with the laboratory manager on 8/10/2021 at 4:10 pm confirmed the above findings. 9. The laboratory reports performing 430 immunohematology tests annually. D5503 BACTERIOLOGY CFR(s): 493.1261(a)(2) (a) The laboratory must check the following for positive and negative reactivity using control organisms: (a)(2) Each week of use for gram stains. This STANDARD is not met as evidenced by: Based on a review of the "Gram Stain Control Result Log" and an interview with the laboratory manager on 8/11/2021, the laboratory failed to check the reactivity of the gram stain reagents using control organisms weekly. The findings include: 1. A review of the "Gram Stain Control Result Log" identified that the laboratory failed to perform gram stain controls weekly for the month of April 2021 using a gram positive and gram negative organism. 2. An interview with the laboratory manager on 8/11 /2021 at 8:20 am confirmed that the laboratory failed to QC the gram stain reagents weekly. 3. The laboratory reports performing 150 gram stains annually. -- 3 of 3 --

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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and graded results from the American Proficiency Institute (API), the laboratory failed to successfully participate in PT for the specialty of Parasitology for two (2) of three (3) consecutive testing events. The findings include: 1. A PT desk review revealed the laboratory had unsatisfactory scores for the 3rd event of 2020 and the 1st event of 2021 for the specialty of parisitology. See D2055 D2055 PARASITOLOGY 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 -- CFR(s): 493.829(e) 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. This STANDARD is not met as evidenced by: Based on a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and graded results from the American Proficiency Institute (API), the laboratory failed to achieve an overall testing event score of satisfactory performance for two (2) consecutive testing events for the specialty of parasitology for the analyte Giardia Antigen. The findings include: 1. A PT desk review of report 155D and graded results from API revealed the laboratory failed to achieve satisfactory results for the specialty of parasitology from API for the analyte Giardia Antigen. Analyte Year Event Score Giardia Antigen 2020 3 0 Giardia Antigen 2021 1 40 -- 2 of 2 --

Summary Statement of Deficiencies 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 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 proficiency testing (PT) reviews, laboratory documents, and an interview with the laboratory manager, the laboratory failed to document and maintain records of proficiency testing to include each step in processing, testing, reporting, and signatures for the Attestation Statements for the specialties of hematology, chemistry, microbiology, immunohematology, and immunology. Findings: 1. A review of PT records from CAP revealed the laboratory failed to retain all instrument result data, intermediate worksheets, reporting worksheets for the Vitros 5600 chemistry /immunoassay analyzer, Sysmex XS-1000i hematology analyzer, Sysmex CA-620 coagulation analyzer, and microbiology worksheets for CAP 2019 event 1. 2. A review of PT records from CAP revealed the laboratory testing personnel and the laboratory director failed to sign the Attestation Statements for chemistry, hematology, microbiology, immunology, and immunohematology specialties for 2019 event 1. 3. A review of PT records from CAP and American Proficiency Institute (API) revealed the laboratory director failed to sign the Attestation Statements for chemistry, hematology, microbiology, immunology, and immunohematology Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 17 -- specialties for 2018 event 1, 2, and 3. 4. An interview with the laboratory manager on June 5, 2019 at 10:50 AM, confirmed the laboratory director failed to sign the Attestation Statements from CAP and API. 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: A. Based on laboratory records review and an interview with the laboratory manager, the laboratory failed to retain the Sysmex CA-620 coagulation, Sysmex XS-1000i hematology, and the Vitros 5600 immunoassay manufacturer's quality control assay reference sheets since the last survey on July 24, 2017. Findings: 1. A review of the quality control documents for both hematology, hemostasis, and immunoassay quality controls revealed the laboratory failed to retain the manufacturer's quality control assay reference sheets. 2. An interview with the laboratory manager on June 5, 2019 at 1:10 PM, confirmed the laboratory failed to retain the quality control reference assay sheets for the analyzers. B. Based on instrument quality control records review and an interview with the laboratory manager, the laboratory failed to retain the Sysmex CA-620 coagulation instrument data for quality control test results since the last survey on July 24, 2017. Findings: 1. A review of quality control and patient data print-outs from the Sysmex CA-620 coagulation analyzer for Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) revealed the laboratory failed to retain the instrument print-outs prior to June 1, 2019. 2. An interview with the laboratory manager on June 5, 2019 at 1:10 PM, confirmed the laboratory failed to retain the quality control and patient data from the instrument. C. Based on a record review and an interview with the laboratory manager, the laboratory failed to include the lot numbers, date of receipt and/or opened, and expiration dates for gram stain and catalase reagents since the last survey on July 24, 2017. Findings: 1. A review of the quality control worksheets for catalase and gram stain reagent revealed the laboratory failed to include the lot numbers, received dates, and expiration dates. 2. The laboratory documented 27 gram stain control reactions and 36 catalase reactions since the last survey. 3. An interview with the laboratory manager on June 6, 2019 at 11:05 AM, confirmed the laboratory failed to record all quality control documentation on the worksheets. 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 observations, record reviews, and interviews with the laboratory manager, -- 2 of 17 -- the laboratory failed to monitor and evaluate the overall quality of the laboratory, as well as correct problems identified for the test systems for chemistry (D5411, D5439, and D5469), hematology, coagulation (D5403, D5411, D5469, and D5783), microbiology (D5415, D5445, 5471, D5477, D5507, and D5787) since the last survey on July 24, 2017. 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 a proficiency testing desk review and the laboratory's PT results from the College of American Pathologists, the laboratory repeatedly failed to successfully participate in proficiency testing for the analyte Ethanol. Refer to D2118. D2118 TOXICOLOGY CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review and the laboratory's graded PT results from the College of American Pathologists, the laboratory repeatedly failed to achieve successful performance for the analyte Ethanol in three (3) out of 3 testing events. Findings: Analyte Year Event Score Ethanol 2018 1 0% Ethanol 2018 3 0% Ethanol 2019 1 60% 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 the deficiencies cited under the Laboratory Director's responsibilities and subsequent unsuccessful performance in proficiency testing, the Laboratory Director failed to provide overall management and direction for the laboratory. See 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 a proficiency testing (PT) desk review and the laboratory's PT results from the College of American Pathologists, the Laboratory Director failed to ensure that the laboratory maintained successful participation in proficiency testing for the analyte Ethanol. Findings: Analyte Year Event Score Ethanol 2018 1 0% Ethanol 2018 3 0% Ethanol 2019 1 60% -- 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 a proficiency testing desk review, the laboratory failed to successfully participate in proficiency testing for the analyte alcohol (blood). Refer to D2118. D2118 TOXICOLOGY CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. 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 a proficiency testing desk review and the laboratory's graded results from the College of American Pathologists, the laboratory failed to achieve satisfactory performance in two out of three testing events for blood alcohol. Findings: Analyte Year Event Score Alcohol 2018 1 0% Alcohol 2018 3 0% -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review, the laboratory failed to successfully participate in proficiency testing for the subspecialty Parasitology. Refer to D2055. D2055 PARASITOLOGY CFR(s): 493.829(e) 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. 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 a proficiency testing desk review and the laboratory's graded results from the American Proficiency Institute, the laboratory failed to achieve satisfactory performance in two consecutive testing events for Parasitology. Findings: Analyte Year Event Score Parasitology 2018 1 0% Parasitology 2018 2 0% -- 2 of 2 --