Essentia Health Sandstone

Summary Statement of Deficiencies D0000 The Essentia Health Sandstone laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the Proficiency Testing desk review performed on October 17, 2023. The following condition-level deficiency was cited: 493.803 Successful participation in proficiency testing The following standard-level deficiency was cited: 493.863 Compatibility testing . 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 (PT) scores from the American Proficiency Institute (API), the laboratory failed to successfully participate in Compatibility 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 PT under the specialty of Immunohematology in 2023. Findings are as follows: 1. The laboratory failed to participate in the 1st Immunohematology testing event in 2023 which resulted in a score of 0% for all analytes. See D2178 2. The laboratory failed to achieve satisfactory performance for Compatibility Testing in two out of three consecutive testing events in 2023, constituting unsuccessful participation for the analyte. D2181 . D2178 COMPATIBILITY TESTING CFR(s): 493.863(c) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: . Based on a review of proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to participate in the 1st Immunohematology testing event in 2023 which resulted in a score of 0% for all analytes. Findings are as follows: 1. The API Performance Summary and Comparative Evaluation PT report from the 2023 1st Immunohematology testing event was reviewed on October 17, 2023. 2. The report indicated the laboratory received a 0% score for failure to participate in PT for all Immunohematology analytes, including Compatibility Testing. . 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 proficiency testing (PT) scores from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for Compatibility Testing in two out of three consecutive testing events in 2023, constituting unsuccessful participation for the analyte. Findings are as follows: 1. API Performance Summary and Comparative Evaluation PT reports from the 2023 Immunohematology 1st Event and the 2023 Immunohematology 2nd Event were reviewed on October 17, 2023. 2. The reports indicated the laboratory had unsatisfactory performance for Compatibility Testing in two out of three consecutive events, leading to unsuccessful participation. Unsatisfactory PT performance for Compatibility Testing was obtained in the following events: Event Score -2023 1st event 0% -2023 2nd event 80% . -- 2 of 2 --

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 document review and interview with laboratory personnel, the Laboratory Director or designee and Testing Personnel failed to attest to the integration of proficiency testing samples into the routine patient workload on 1 of 16 occasions in 2021, and 4 of 9 occasions in 2022 . Findings are as follows: 1. The laboratory performed Hematology / Coagulation and Chemistry testing as confirmed by the Technical Supervisor (TS) during a tour of the laboratory on 09/29/22 at 9:10 a.m. 2. The laboratory performed proficiency testing (PT) using the American Proficiency Institute (API) and College of American Pathologists (CAP) as PT providers. 3. The Laboratory Director and Testing Personnel were required to sign the attestation statements as established in the Proficiency Testing Policy located in the on-line (MediaLab) manual. 4. The Laboratory Director or designee and Testing Personnel failed to attest to the integration of PT samples into the routine patient workload for a total of 5 of 31 API & CAP PT events reviewed in the November 2020 through September 2022 timeframe. See below. Event Specialty missing attestation 2021-3 API - Hematology / Coagulation (document not signed) 2022-A CAP - CGSA4 (document not signed) 2022-1 API - Chemistry Core (document not signed) 2022-2 API - Chemistry Core (document not signed) 2022-1 API - Chemistry Miscellaneous (document not signed) 5. In an interview on 09/29/22 at 1:05 p.m., the TS confirmed the above findings. . D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(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 4 -- 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 document review and interview with laboratory personnel, the laboratory failed to investigate two unacceptable proficiency testing (PT) results in 2021 and one unacceptable proficiency testing (PT) result in 2022. Findings are as follows: 1. The laboratory performed Microbiology and Chemistry testing as confirmed by the Technical Supervisor (TS) during a tour of the laboratory on 09/29/22 at 9:10 a.m. 2. The laboratory performed proficiency testing (PT) using the American Proficiency Institute (API) as PT provider. 3. The laboratory received the following unacceptable PT results in 2021 and 2022. See below. 2021 Microbiology - 2nd event Sample: GS- 06 Test: Gram Stain 2021 Hematology / Coagulation - 3rd event Sample: BFL-04 Test: RBC (Manual - CSF/BF) 2022 Chemistry Core - 2nd event Sample: CH-07 Test: Total Protein 4. Investigation of unacceptable PT results was required as established in the Proficiency Testing Policy located in the on-line (MediaLab) manual. 5. Investigation of the unacceptable PT results were not found during review of laboratory records. The laboratory was unable to provide investigation documentation upon request. 6. In an interview on 09/29/22 at 1:05 p.m., the TS 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). This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of one non-graded non-regulated proficiency testing (PT) result in 2021 when the PT program did not obtain the agreement required for scoring, and failed to verify the accuracy of two non-regulated, and five regulated proficiency testing (PT) results when the laboratory received a zero score for non-participation in 2022 . Findings are as follows: 1. The laboratory performed Microbiology testing as confirmed by the Technical Supervisor (TS) during a tour of the laboratory on 09/29 /22 at 9:10 a.m. 2. The laboratory performed proficiency testing (PT) using the American Proficiency Institute (API) as PT provider. 3. The laboratory failed to verify the accuracy of one non-graded non-regulated proficiency testing (PT) result in 2021 when the PT program did not obtain the agreement required for scoring. See below: 2021 Hematology / Coagulation - 3rd event Sample: YKP-03 Test: Vaginal Wet Prep (KOH) 4. The API report referred the laboratory to the expected result data summary for evaluation of the non-graded test result. The data summary for the above sample was not present in laboratory records. An evaluation of the non-graded result was not found in laboratory records. The laboratory was unable to provide an evaluation of the non-graded result upon request. 5. The laboratory failed to verify the accuracy of two non-graded non-regulated, and five non-graded regulated proficiency testing (PT) results when the laboratory received a zero score for non-participation. See below: -- 2 of 4 -- 2022 Microbiology - 2nd event Samples: GS-06 thru GS-10 Test: Gram Stain & Morphology 2022 Microbiology - 2nd event Samples: KOH-03 thru KOH-04 Test: KOH (Glass Slide) 6. The laboratory failed to submit results to API for seven PT samples prior to the submission deadline for the 2022 Microbiology second testing event. API assigned a zero score for failure to participate. 7. A self-evaluation of the seven results was not found during review. The laboratory was unable to provide a self-evaluation of the results upon request. 8. Evaluation of non-graded PT results was required as established in the Proficiency Testing Policy located in the on-line (MediaLab) manual. 9. In an interview on 09/29/22 at 1:05 p.m., the TS confirmed the above findings. . D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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 document review and interview with laboratory personnel, the Laboratory Director or designee, and/or Testing Personnel, failed to attest to the integration of proficiency testing samples into the routine patient workload on one occasion in 2018, three occasions in 2019, and one occasion in 2020. Findings are as follows: 1. The laboratory performed Chemistry, Microbiology, Immunohematology, and Hematology testing as confirmed by the Technical Supervisor 3 (TS3) during a tour of the laboratory on 10/29/20 at 8:10 a.m. 2. The laboratory performed proficiency testing (PT) using the American Proficiency Institute (API) and College of American Pathologists (CAP) PT providers. 3. The Laboratory Director and Testing Personnel were required to sign the attestation statements as established in the Proficiency Testing policy located in the Laboratory Policies & Procedures manual. 4. The Laboratory Director (LD) or designee, or Testing Personnel (TP), failed to attest to the integration of PT samples into the routine patient workload for 5 of 33 API PT events reviewed in the August 2018 through October 2020 timeframe. See below. Event / Missing attestation documentation 2018-3 Chemistry Core No TP signature 2019-2 Microbiology No LD signature 2019-3 Microbiology No LD signature 2019-3 Immunohematology No LD signature 2020-2 Hematology / Coagulation No TP signature 5. In an interview on 10/29/30 at 13:30 p.m., TS 3 confirmed the above finding. . D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 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 document review and interview with laboratory personnel, the laboratory failed to investigate an unacceptable Coagulation proficiency testing (PT) result for 1 analyte in 2020. Findings are as follows: 1. The laboratory performed Coagulation testing as confirmed by the Technical Supervisor 3 (TS3) during a tour of the laboratory on 10/29/20 at 8:10 a.m. 2. The laboratory performed proficiency testing (PT) using the American Proficiency Institute (API) and College of American Pathologists (CAP) PT providers. 3. The laboratory received unacceptable PT result in the API 2020 Chemistry Core 1st event for the analyte listed below. Sample Test CM- 04 D Dimer 4. Investigation of unacceptable results was required as established in the Proficiency Testing policy located in the Laboratory Policies & Procedures manual. 5. An investigation of the unacceptable PT result was not found during review of laboratory records. The laboratory was unable to provide investigation documentation upon request. 6. In an interview on 10/29/30 at 13:30 p.m., TS 3 confirmed the above finding. . 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). This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of one 2018, one 2019 and one 2020 proficiency testing (PT) score when the PT program did not obtain the agreement required for scoring. Findings are as follows: 1. The laboratory performed Hematology, Urinalyis, Parasitology and Chemistry testing as confirmed by the Technical Supervisor 3 (TS3) during a tour of the laboratory on 10/29/20 at 8:10 a.m. 2. The laboratory performed proficiency testing (PT) using the American Proficiency Institute (API) and College of American Pathologists (CAP) PT providers. 3. The following PT events / samples / test results were not graded by API due to lack of consensus. See below. Event Sample ID Analyte Heme / Coag BCI-10 Blood Cell ID 2018 / 2nd Heme / Coag US- 02 Urine Sediment 2019 / 1st VKP-01 Vaginal Wet Prep (KOH) Chemistry Core CH- 01 Creatinine 2020 / 1st 4. The API report referred the laboratory to the expected result data summary for evaluation of the non-graded test results. The data summary for the above analytes were not present in laboratory records. Evaluation of the non- graded results were not found in laboratory records. The laboratory was unable to provide an evaluation of the non-graded results upon request. 5. In an interview on 10 /29/30 at 13:30 p.m., TS 3 confirmed the above finding . -- 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 review of proficiency testing reports from the American Proficiency Institute, the laboratory failed to successfully participate in proficiency testing for pO2 testing under the specialty of Chemistry. Findings are as follows: D2087 - the laboratory failed to obtain a PT score for pO2 testing of at least 80 percent in two testing events D2096 - the laboratory failed to achieve satisfactory performance for pO2 testing in two out of three consecutive testing events D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on a review of proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to obtain a PT score for pO2 testing of at least 80 percent which resulted in unsatisfactory performance for the analyte. Unsatisfactory PT performance of pO2 testing was obtained in the following events. - 2017 3rd event: 40% - 2018 2nd event: 20% D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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. This STANDARD is not met as evidenced by: . Based on a review of proficiency testing (PT) reports from the American Proficiency Institute (API) provider, the laboratory failed to achieve successful performance for pO2 testing in two out of three consecutive PT events. Findings are as follows: The laboratory failed pO2 testing in two out of three consecutive PT events. Two out of three consecutive PT failures for the same analyte constitutes unsuccessful performance. PT reports from API listed the following unsatisfactory pO2 scores. - 2017 3rd event: 40% - 2018 2nd event: 20% -- 2 of 2 --

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 document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of a non-regulated Chemistry analyte at least twice annually. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory on 07/31 /18 at 8:10 a.m. 2. Beta Hydroxybutyrate was added to the laboratory test menu on 03 /15/17 as indicated in the performance verification records for the analyte and confirmed by the General Supervisor during the tour. 3. Twice annual verification of accuracy documents for Beta Hydroxybutyrate were not found during review of laboratory proficiency testing records from 2017 through date of survey, 07/31/18. The laboratory was unable to provide verification of accuracy documents upon request. 4. The laboratory was given an opportunity to provide the missing documents within 7 days from the survey date. 5. In an email received on 08/05/18 at 8:36 a.m., the TC confirmed the accuracy of Beta Hydroxybutyrate testing had not been verified in 2017 or 2018. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. 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 observation and interview with laboratory personnel, the laboratory failed to label a secondary container used for gram staining. Findings are as follows: 1. The laboratory performed Microbiology testing as as confirmed by the Technical Consultant (TC) during a tour of the laboratory on 07/31/18 at 8:10 a.m. 2. One glass jar containing a dark liquid labeled "7/26/18" was observed in the gram staining area of the laboratory during the tour. A bottle of Gram Crystal Violet was adjacent to the glass jar. 3. In an interview on 07/31/18 at 8:15 a.m., the TC confirmed the jar was not labeled. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to demonstrate two new analytes could obtain all performance characteristics comparable to those established by the manufacturer prior to testing patient specimens. In addition, the laboratory failed to verify the performance of laboratory test systems after relocating the laboratory to new location. Findings are as follows: The laboratory performed Microbiology, Chemistry, Hematology, and Immunohematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory on 07/31/18 at 8:10 a.m. A. Procalcitonin 1. An Abbott Architect i1000 chemistry analyzer was observed as present and available for use during the tour of the laboratory. The laboratory began Procalcitonin testing using this analyzer on 02/20/18 as indicated in the performance verification documents and confirmed by the General Supervisor during the tour. 2. Laboratory performance verification (PV) studies completed to verify the reportable range of Procalcitonin (PCT) did not reach the upper limits of the adopted reportable range for the analyte found in the Procalcitonin Architect 1 System procedure. See below. Analyte PV Adopted PCT 0.02-159.97 0.02-1000 3. In an interview on 07/31/18 at 2:05 p.m., the TC confirmed the laboratory's PV did not verify the upper limit of the adopted reportable ranges. B. Beta Hydroxybutyrate 1. An Abbott Architect c4000 chemistry analyzer was observed as present and available for use during the tour of the laboratory. The laboratory began Beta Hydroxybutyrate testing using this analyzer on 03/15/17 as indicated in the performance verification documents and confirmed by the General Supervisor during the tour. 2. Laboratory performance verification (PV) studies completed to verify the reportable range of Beta Hydroxybutyrate (BHB) did not reach the upper or lower limits of the adopted reportable range for the analyte found in the Beta Hydroxybutyrate Architect C System procedure. See below. Analyte PV Adopted BHB 0.06-9.50 0.0-11.81 3. Laboratory PV studies completed to verify the precision of BHB testing included testing of three levels of quality control material on one day, 10/28/16. Additional activities to verify precision were not -- 2 of 3 -- found. 4. In an interview on 07/31/18 at 2:10 p.m., the TC confirmed the laboratory's PV did not verify the upper and lower limits of the adopted reportable ranges and no further activities were performed to verify precision. C. Performance verification after relocation 1. The entire laboratory moved to a new location on 05/17/17 as indicated by the TC. 2. Documentation of PV studies performed on non-waived test systems to confirm the relocation did not affect test performance was not found in laboratory records. The laboratory was unable to provide relocation PV documentation upon request. 3. In an interview on 07/31/18 at 5:05 p.m., the TC stated performance verifications were completed after test systems were relocated but the records could not be located. D6151 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463(b)(3)(4) (3) The director or technical supervisor may delegate to the general supervisor the responsiblity for providing orientation to all testing personnel; and (4) Annually evaluating and documenting the performance of all testing personnel. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to ensure all training and initial competency assessments for 2 of 2 new testing personnel was documented. Findings are as follows: 1. The laboratory performed Hematology and Immunohematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory on 07/31/18 at 8:10 a.m. 2. Two testing personnel (TP) began employment with the laboratory since the previous survey in 2016. See below for month of hire. The General Supervisor (GS) confirmed at 8:45 a.m. on date of survey that both employees currently performed Hematology and Immunohematology testing independently in the laboratory. TP Hired TP2 September 2017 TP3 January 2018 3. Documentation of all initial training and competency assessments for the two new employees was not found during review of laboratory records. See below for missing documents. The laboratory was unable to provide these documents upon request. TP Missing documents TP2 Coagulation, Immunohematology TP3 Coagulation 4. In an interview on 07/31/18 at 9:35 a.m., the GS confirmed the above finding. The GS explained the missing initial training and competency assessment for TP2 and TP3 had been completed but could not be located. -- 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 review of proficiency testing reports from the American Proficiency Institute, the laboratory failed to successfully participate in proficiency testing for Blood Cell Identification testing under the specialty of Hematology. Findings are as follows: D2121 - the laboratory failed to obtain a PT score for Blood Cell Identification of at least 80 percent D2127 - the laboratory failed to participate in the 2nd Hematology/Coagulation proficiency testing event in 2017 D2130 - the laboratory failed to achieve successful performance for Blood Cell Identification testing in two consecutive PT events. 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 -- D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on review of proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to obtain a PT score for Blood Cell Identification of at least 80 percent which resulted in unsatisfactory performance for the analyte. Unsatisfactory PT performance of Blood Cell Identification was obtained in the following API events. -2017 2nd event 0% -2017 3rd event 60% D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: . Based on a review of proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to participate in the 2nd Hematology/Coagulation testing event in 2017 which resulted in a score of 0 for all analytes. Findings are as follows: 1. Review of PT results from API revealed that the laboratory failed to participate in the 2nd Hematology/Coagulation testing event of 2017. 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. This STANDARD is not met as evidenced by: . Based on review of proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to achieve successful performance for Blood Cell Identification testing in two consecutive PT events. Findings are as follows: The laboratory received unsatisfactory scores for Blood Cell Identification testing in two consecutive PT events. Two consecutive PT failures for the same analyte constitutes unsuccessful performance. PT reports from API listed the following unsatisfactory Blood Cell Identification scores. -2017 2nd event 0% -2017 3rd event 60% -- 2 of 2 --