Advanced Biomedical Dba United Diagnostic Lab

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The laboratory was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER)-0155 and American Proficiency Institute (API) 2022 records (2nd event) and 2023 records (1st event), the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Routine Chemistry for the Bilirubin (Bili, TOTAL) analyte. (Refer to D2096). 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 proficiency testing desk review of the CASPER-0155 and API records 2022 (2nd event) and 2023 (1st event), the laboratory failed to achieve satisfactory performance (80% or greater) for two (2) of three (3) testing events in the specialty of Routine Chemistry for the BILI TOTAL analyte. 1. Review of the Casper -0155 report revealed the following: Routine Chemistry 2022- 2nd event Laboratory received an unsatisfactory score of 20% for the BILI TOTAL analyte. Routine Chemistry 2023- 1st Event Laboratory received an unsatisfactory score of 0% for the BILI TOTAL analyte. 2. A review of proficiency testing records from API 2022 and 2023 proficiency testing records confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER-0155 Individual Laboratory Report and API 2022 records (2nd event) and 2023 records (1st event), the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that 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 desk review of the CASPER-0155 and API 2022 -- 2 of 3 -- records (2nd event) and 2023 (1st event), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey and an abbreviated survey investigating complaint KY37964 were conducted on 11/07/2022. There were no deficiencies related to the complaint. The facility failed to meet the requirements below during the recertification survey, with deficiencies cited. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on interview and review of the facility's policies and procedures, the laboratory failed to ensure the updated laboratory procedure manual was signed and dated by the laboratory director. The findings include: Review of the laboratory's policies and procedure manual revealed that the manual was updated on 01/01/2022; however, the laboratory director had not signed or dated the updated manual. Interview with the Owner, on 11/07/2022 at 3:10 PM, revealed that the laboratory director visited the facility quarterly to perform reviews and had not yet visited for the current quarter. Further interview revealed the the updated procedure manual was dated 01/01/2022 prior to the current quarter, and still had not been signed or dated by the laboratory director. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 chemistry and Hematology proficiency testing results from the American Association of Bioanalysts (AAB) proficiency testing agency on 08/11 /2021, the laboratory failed to successfully participate in two (2) consecutive testing events for Cholesterol HDL, Cell ID or WBC Differential and Hematocrit (HCT). See: D2131, and 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 2 -- 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 Chemistry proficiency testing results from the American Association of Bioanalysts (AAB) testing agency on 08/11/2021, the laboratory failed to successfully achieve satisfactory performance for the Cholesterol HDL analyte in two (2) consecutive testing events. Findings include: 1. The laboratory failed to achieve a satisfactory score for the Cholesterol HDL analyte in the first (1st) testing event of 2021 with a score of twenty percent (20%). 2. The laboratory failed to achieve a satisfactory score for the Cholesterol HDL analyte in the second (2nd) testing event of 2021 with a score of zero percent (0%). 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. This STANDARD is not met as evidenced by: Based on the desk review of proficiency testing results from the American Association of Bioanalysts (AAB) on 8/11/2021, the laboratory failed to achieve satisfactory overall Hematology testing event scores in two (2) consecutive testing events. Findings include: 1. The laboratory failed to achieve a satisfactory score for the Cell ID or WBC Differential in the first (1st) testing event of 2021 with a score of zero percent (0%). 2. The laboratory failed to achieve a satisfactory score for the Cell ID or WBC Differential in the second (2nd) event of 2021 with a score of zero percent (0 %). 3. The Laboratory failed to achieve a satisfactory score for the Hematocrit (HCT) in the first (1st) testing event of 2021 with a score of sixty percent (60%). 4. The laboratory failed to achieve a satisfactory score for the Hematocrit (HCT) in the second (2nd) event of 2021 with a score of zero percent (0%). -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on record review and staff interview on 08/05/2019, the laboratory failed to follow manufacturer's requirements for reconstitution of Beckman Coulter Lyophilized calibration material used on the AU 480 chemistry analyzer for the calibration of creatinine. Findings include: 1. The manufacturer's instructions for storage and stability of reconstituted Beckman Coulter Lyophilized Chemistry Calibrators Level 1 and Level 2 state "Reconstituted calibrator materials are stable for seven days from the date of reconstitution when stored at 2-8 degrees C, except for Total and Direct Bilirubin which are stable for four days." 2. The Technical Supervisor acknowledged in an interview at 11:20 AM on 08/05/2019, calibration material used to calibrate creatinine was reconstituted every fourteen days. 3. The Technical Supervisor acknowledged the laboratory failed to have a system in place to ensure the manufacturer's instructions were followed for the reconstitution and storage of calibration materials. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of personnel records and staff interview on 06/06/2019, the laboratory director failed to ensure appropriate training for services offered was documented for Testing Personnel #2 listed on the Laboratory Personnel Report 209 prior to the start of patient testing 04/27/2019. Findings include:Analyzer 1. Review of personnel records revealed the hire date for Testing Personnel #2 was 03/26/2019. 2. There was no documentation of initial training on the Medonic Hematology Analyzer prior to 04/27/2019. 3. There was no documentation of initial training on the Instrumentation Laboratory ACL Coagulation Analyzer prior to 04/27/2019. 4. There was no documentation of initial training on the Beckman Coulter AU 480 Chemistry Analyzer prior to 04/27/2019. The Technical Supervisor acknowledged in an interview at 9:50 AM on 06/06/2019, the laboratory failed to have a system to ensure initial training was documented on each testing personnel prior to performing patient testing. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --