Axis Clinicals Llc

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 Center for Medicare and Medicaid Services reports and proficiency testing reports from the College of American Pathologists (CAP), the laboratory failed to successfully participate in proficiency testing for Beta human chorionic gonadotropin (BHCG) testing under the specialty of Chemistry. Findings are as follows: 1. The CASPER Report 0155D, reviewed on 12-10-21, indicated the the laboratory failed to successfully participate in BHCG testing in 2021. Unsatisfactory PT performance in BHCG testing was obtained in the following Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- events. -2021 1st event 20% -2021 3rd event 0% 2. The CASPER Report 0155D indicated the laboratory failed to obtain a BHCG PT score of at least 80 percent in two out of three consecutive testing events in 2021. See D2087 and D2096. . D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 a review of proficiency testing (PT) reports from the College of American Pathologists (CAP), the laboratory failed to obtain a PT score for Beta human chorionic gonadotropin (BHCG) testing of at least 80 percent which resulted in unsatisfactory performance for the analyte. Unsatisfactory PT performance for BHCG testing was obtained in the following events. -2021 1st event 20% -2021 3rd event 0% . 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 College of American Pathologists (CAP) provider, the laboratory failed to achieve successful performance for Beta human chorionic gonadotropin (BHCG) testing in two out of three consecutive PT events. Findings are as follows: The laboratory failed BHCG 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 CAP listed the following unsatisfactory BHCG scores. -2021 1st event 20% -2021 3rd event 0% . -- 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 observation, document review, and interview with laboratory personnel, the laboratory failed to verify the accuracy of one non-regulated analyte at least twice annually in 2020. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 8: 05 a.m. on 09/23/21. 2. An Ortho Vitros ECi chemistry analyzer was observed as present and available for use during the tour. 3. The laboratory performed Follicle Stimulating Hormone (FSH) testing on this analyzer beginning on 04/12/19 as indicated on the test listing provided by the laboratory. 4. Enrollment in Proficiency Testing (PT) for each analyte tested by the laboratory was required as established in the Proficiency Testing procedure found in the Toxicology and Clinical Laboratory SOP Binder. The laboratory utilized the College of American Pathologists (CAP) and the American Proficiency Institute (API) as the PT providers in 2019 and utilized CAP as the PT provider in 2020. 5. Verification of accuracy documents for FSH were not found during review of CAP and API PT records from 2019 and 2020. The laboratory was unable to provide FSH verification records upon request. 6. FSH testing was performed on zero patient specimens in 2019 and 71 patient specimens in 2020 as indicated on a laboratory report provided by TP1 on 09/23/21 that included all FSH testing from 04/12/19 - 09/23/21. 7. In an interview at 2:45 p.m. on 09/23/21, TP1 confirmed the above finding. . . D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) 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 -- 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 verify the reportable range for 2 of 3 new analytes implemented by the laboratory in 2021. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by Testing Personnel 1 (TP1)) during a tour of the laboratory at 8:05 a.m. on 09/23/21. 2. A Sysmex CA-620 coagulation analyzer was observed as present and available for use during the tour of the laboratory. 3. Performance verification (PV) activities for Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) tested on the CA-620 analyzer were completed in August 2021. The laboratory began testing patient specimens using this analyzer on 08/24/21 as indicated by laboratory records. 4. Reportable range verification was required for new analytes as established in the Calibration Procedure located in the Toxicology and Clinical Laboratory SOP Binder 5. The reportable range verification for PT and aPTT was not found during review of PV records. The laboratory was unable to provide the missing documentation upon request. 6. In an interview at 2:05 p.m. on 09/2/21, TP1 confirmed the above finding. 7. Testing was performed on 34 PT patient specimens and 37 aPTT patient specimens since date of implementation through date of survey, 08/24/21- 09/23/21, as indicated on a laboratory report provided by TP1 on 09/30/21. . D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Technical Consultant failed to ensure an annual competency assessment was performed for 1 testing personnel in 2020. Findings are as follows: 1. The laboratory performed Immunology, Chemistry, and Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 8:05 a.m. on 09/23/21. 2. The Competency Assessment and Training procedure located in the Toxicology and Clinical Laboratory SOP Binder indicated personnel were evaluated for competency annually. 3. The 2020 annual competency assessment for TP1 was not found during review of personnel records. 4. The laboratory was unable to provide the missing annual competency assessment upon request. 5. In an interview at 10:00 a.m. on 09/23/21, TP1 confirmed the above finding. *This deficiency was previously cited during the 10/18/19 survey.* -- 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 one occasion in 2018 and 4 occasions in 2019. Findings are as follows: 1. The laboratory performed Chemistry, Toxicology, Endocrinology, Urinalysis, and Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 10/18/19 at 8:25 a.m. 2. The laboratory performed proficiency testing (PT) using the College of American Pathologists (CAP) PT provider. 3. The Laboratory Director and Testing Personnel were required to sign the attestation statements as established in the Proficiency Testing procedure located in the Toxicology & Clinical Laboratory Personnel Quality Assessment 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 1 of 11 CAP PT events in 2018, and 4 of 18 CAP PT events in 2019. See below. Year Event 2018 Chemistry - C 2019 Urine Drug Adulterant /Integrity Testing - B Viral Markers - B Urine Drug Confirmation - B Urine Drug Confirmation - C 5. In an interview on 10/18/19 at 12:30 p.m., the GS confirmed the above finding. . D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to establish a written competency assessment procedure which included the following requirements found in Subpart M, and failed to establish a competency assessment process / documentation form for the testing areas of Hematology and Drugs of Abuse Confirmatory Testing. 493.1451 (b)(8)(i) Direct observation of routine test performance; (b)(8)(ii) Monitoring the recording and reporting of test results; (b)(8)(iii) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records; (b)(8)(iv) Direct observation of performance of instrument maintenance and function checks; (b) (8)(v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and (b)(8)(vi) Assessment of problem solving skills. Findings are as follows: 1. The laboratory performed Chemistry, Toxicology, Endocrinology, Urinalysis, and Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 10/18/19 at 8:25 a.m. 2. A competency assessment procedure was not found during review of laboratory policies and procedures. The laboratory was unable to provide a competency assessment procedure upon request. 3. A documentation system for recording the competency assessment of personnel performing testing in the areas of Hematology and Drugs of Abuse Confirmatory Testing was not found. The laboratory was unable to provide the competency assessment documentation forms upon request. 4. In an interview on 10/18/19 at 10:45 a.m., the GS confirmed the above finding. . 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 document review and interview with laboratory personnel, the laboratory failed to review and evaluate proficiency testing (PT) results for 4 of 11 events in 2018 and 6 of 18 events in 2019. Findings are as follows: 1. The laboratory performed Chemistry, Toxicology, Endocrinology, Urinalysis, and Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 10/18/19 at 8:25 a.m. 2. The laboratory performed proficiency testing (PT) using the College of American Pathologists (CAP) PT provider. 3. Results of the following PT events were found in the laboratories records. Evidence that these results were reviewed or evaluated by the laboratory was not found. Year Survey / Event 2018 Urine Drug Adulterant/Integrity Testing - B Urine Drug Screen - C Urine Drug Confirmation - C Urine Drug Confirmation - D 2019 Urine Drug Adulterant/Integrity Testing - B Viral Markers - B Urine Drug Screen - B Urine Drug Confirmation - A Urine Drug Confirmation - B Urine Drug Confirmation - C 4. In an interview on 10/18/19 at 12: 30 p.m., the GS confirmed the above finding. . D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) -- 2 of 6 -- 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 document review and interview with laboratory personnel, the laboratory director failed to ensure proficiency testing (PT) results were evaluated to identify problems that required