Opans, Llc

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 upon review of 2022 and 2023 CAP-PT(College of American Pathologists)- (Proficiency Testing) records and interview with the LD(Laboratory Director) on 3/5 /24, the laboratory did not assess the accuracy of 27 of 85 urine toxicology analytes twice annually. Findings: Review of 2022 and 2023 CAP-PT records revealed the following: 1. The laboratory is enrolled in the CAP DMPM (Drug Monitoring for Pain Management) module. 2. The DMPM module contains 27 of the 85 urine toxicology analytes performed in the laboratory. In interview at approximately 11:30 a.m., the LD confirmed the laboratory's CAP enrollment is the only activity performed to verify the accuracy of urine toxicology analytes. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: 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 -- Based upon review of the laboratory's policy, review of 2022, 2023 and 2024 laboratory records and interview with TP#2 (Testing Personnel) on 3/5/24, the laboratory failed to document its incubator temperature each day of patient testing. Findings: Review of the laboratory's Analytical Test Method policy revealed in Section: "Specimen, QC and Analytical Standards Preparation: Plate preparation: Step 6. Mix gently and heat at 60 degrees Celsius for approximately 30 minutes." Review of 2022, 2023 and 2024 laboratory records revealed the absence of documentation of the incubator temperature each day of patient testing. In interview at approximately 2: 15 p.m., TP#2 confirmed that he does not document the incubator's temperature. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based upon review of two patient test reports (1284494 and 1319094) and interview with the Laboratory Director on 3/5/24, the laboratory does not disclose the cut off values of 30 drug classes included in their dried blood and urine toxicology screening profiles. Findings: Review of two patient test reports (1284494 and 1319094) revealed the absence of cut off values for 30 drug classes contained in the dried blood and urine toxicology screening profiles. In interview at approximately 3:30 p.m., the Laboratory Director confirmed the findings. -- 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153 and 155 on 9/5/19 and desk review of 2018 and 2019 CAP (College of American Pathologists) proficiency testing records 11/20/19, the laboratory failed to successfully participate in proficiency testing for Total Bilirubin and Iron in two consecutive proficiency testing events. See the deficiency cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153 and 155 on 9/5/19 and desk review of 2018 and 2019 CAP (College of American Pathologists) proficiency testing records 11/20/19, the laboratory failed to achieve satisfactory performance for Total Bilirubin and Iron in two consecutive proficiency testing events, resulting in unsuccessful performance. Findings: A. Total Bilirubin Desk review of CMS Casper 155D and 2018 and 2019 CAP proficiency testing results revealed: 1. The laboratory provided unacceptable responses for 2 of 5 samples and received a score of 60% for Total Bilirubin on the 2018 C-C event. 2. The laboratory provided unacceptable responses for 2 of 5 samples and received a score of 60% for Total Bilirubin on the 2019 C-A event. B. Iron Desk review of CMS Casper 155D and 2018 and 2019 CAP proficiency testing results revealed: 1. The laboratory provided unacceptable responses for 5 of 5 samples and received a score of 0% for Iron on the 2018 C-C event. 2. The laboratory provided unacceptable responses for 5 of 5 samples and received a score of 0% for Iron on the 2019 C-A event. 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153 and 155 on 9/5/19 and desk review of 2018 and 2019 CAP (College of American Pathologists) proficiency testing records 11/20/19, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. See the deficiency cited at 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153 and 155 on 9/5/19 and desk review of 2018 and 2019 CAP (College of American Pathologists) proficiency testing records 11/20/19, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: A. Total Bilirubin Desk review of CMS Casper 155D and 2018 and 2019 CAP proficiency testing results revealed: 1. The laboratory provided unacceptable responses for 2 of 5 samples and received a score of 60% for Total Bilirubin on the 2018 C-C event. 2. The laboratory provided unacceptable responses for 2 of 5 samples -- 2 of 3 -- and received a score of 60% for Total Bilirubin on the 2019 C-A event. B. Iron Desk review of CMS Casper 155D and 2018 and 2019 CAP proficiency testing results revealed: 1. The laboratory provided unacceptable responses for 5 of 5 samples and received a score of 0% for Iron on the 2018 C-C event. 2. The laboratory provided unacceptable responses for 5 of 5 samples and received a score of 0% for Iron on the 2019 C-A event. -- 3 of 3 --

Summary Statement of Deficiencies D6026 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(8) 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)(8) Ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, review of random patient test reports, and interview with the director on 3/7/18, the laboratory director failed to ensure that the laboratory's PSA (Prostatic Specific Antigen) and Free PSA (Prostatic Specific Antigen) test reports included the identity of the assay used. Findings: 1. The laboratory performs Prostatic Specific Antigen (PSA) testing using the IMMULITE 2000 PSA solid-phase, chemiluminescence immunometric assay. The manufacturer's product insert (PIL2KPTSD-2, 2014-01-16) for this test reads in the section entitled, "Caution: ...The concentration of PSA in a given specimen determined with different assays can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the assay used...". 2. The laboratory performs Free Prostatic Specific Antigen (PSA) testing using the IMMULITE 2000 Free PSA solid-phase, sequential chemiluminescence immunometric assay. The manufacturer's product insert (PIL2KPFD-27, 2015-04-20) for this test reads in the boxed section, "...The concentration of Free PSA in a given specimen determined with different assays can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the assay used...". 3. Review of a random computer generated patient reports for PSA (#17000201751); and, PSA - free (#2018014001) revealed that the test reports did not include the 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 -- method used for PSA or Free PSA. 4. During interview at approximately 10:15 a.m., the laboratory director confirmed that the PSA and Free PSA methods were not included in te patient test reports reported to the physicians. -- 2 of 2 --