Ashley Clinical Diagnostic Lab Inc

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 8/8/2024, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and AAB-Medical Laboratory Evaluation records (2024-1 and 2024-2), the laboratory failed to successfully participate in a proficiency 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 2 -- 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 subspecialty of Routine Chemistry for the analyte Calcium, Total resulting in a unsuccessful performance. Refer to D2097. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(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 desk review of Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB-Medical Laboratory Evaluation reports, the laboratory failed to achieve satisfactory performance for three of three events proficiency events in 2024 for analyte Calcium, Total.. The finding include 1. The laboratory received the following scores: 0% on the 2024 Ca first event 0% on the 2024 Ca second event 2. A review of the 2024 proficiency Testing scores from AAB-Medical Laboratory Evaluation reports 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 155 report AAB records for 2024-1 and 2024-2 events, the laboratory director failed to provide overall management and a 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 CASPER 155 report AAB records for 2024-1 and 2024-2 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2097 . -- 2 of 2 --

Summary Statement of Deficiencies D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(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 the America Association of Bioanalysts (AAB) proficiency testing records, eight (8) randomly selected patients from 10/23/2018 to 2/18/2021, and interview with the laboratory director (LD); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for General Immunology. The findings included: 1. The AAB reported the following for General Immunology: Event Analyte Score Reported Q3-2018 ANA 40% Q3-2019 RA/RF 60% Q3-2020 RA/RF 60% 2. Based on the laboratory's annual testing declaration for 2020 the laboratory analyzed and reported approximately 60,550 General Immunology tests during the time the laboratory had unsatisfactory proficiency testing results. 3. The LD affirmed 02/24/2021 at approximately12:15 p.m. that the laboratory received the above unsatisfactory proficiency testing score. 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 review of the American Association of Bioanalysts (AAB) proficiency testing records and interview with the laboratory director (LD) and testing personnel (TP); it was determined that the laboratory failed to attain a score of at least 80 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 -- percent of acceptable responses for multiple Chemistry Analytes of proficiency testing (PT) for the first event in 2019 (Q1-2019). The finding included: 1. Based on review of PT records for Q1-2019, AAB reported unsatisfactory scores for the following analytes: Analyte Score % Albumin 0 Bicarbonate 60 Calcium 20 Cholesterol Total 0 Glucose 60 Protein Total 0 Urea Nitrogen 40 Uric Acid 0 Magnesium 20 2. Based on the laboratory testing declaration submitted at the time of the survey on 02/24/2021 the laboratory analyzed and reported approximately 3,650 tests during the time the laboratory had unsatisfactory proficiency testing results. 3. The LD and TP affirmed 02/24/2020 at approximately 12:30 p.m. that the laboratory received the above unsatisfactory proficiency testing scores. 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 the laboratory's American Association of Bioanalysts (AAB) testing records, eight (8) random patients sampling, and interview with the laboratory director (LD); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Hematology for the third event of 2018 (Q3- 2018 ). The findings included: 1. The AAB proficiency program gave an unsatisfactory score of 60% for Blood Cell Identification and 60% as well for Coagulation PT Fibrinogen INR for Q3-2018. 2. Based on the laboratory's annual testing declaration submitted on the day of the survey February 24, 2021, the laboratory analyzed and reported approximately 500 Hematology tests, during the time the laboratory had unsatisfactory proficiency testing results. 3. The LD confirmed on 2/24/2021 at approximately 12:00 pm. that the laboratory received the above proficiency Hematology proficiency testing results described in 1. D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on direct observation of the facilities layout, observation of the of the laboratory's COVID-19 Polymerase Chain Reaction (PCR) testing, and interviews with the laboratory director (LD) and testing personnel (TP) on February 24, 2021 for its molecular amplification procedure; it was determined that the laboratory failed to ensure that the molecular amplification procedures which are not contained in closed systems have a uni-directional flow with separate areas for specimen preparation, reagent preparation, RNA extraction, amplification, and RNA detection. The findings included: 1. The laboratory performs PCR testing for the presumptive detection of SARS-CoV-2 using the ABI7500 and Automatic Quant Studio 9600. 2. During the laboratory tour on 02/24/2021 at approximately 11:10 a.m. the examiner observed that storage and preparation of reagents and PCR reaction using the QuantStudioand ABI7500 were all performed in the same area without unidirectional flow. 3. The LD -- 2 of 3 -- and TP confirmed by interview on February 24, 2021 at approximately 11:45 a.m. that the laboratory's molecular PCR testing for the presumptive detection of SARS-CoV-2 RNA was not set up in unidirectional flow areas. 5. Based on laboratory records, the laboratory performed and reported approximately 60,000 SARS-CoV-2 Real time PCR molecular diagnostic tests annually. D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. This STANDARD is not met as evidenced by: Based on surveyors direct observations of the laboratory's SARS-CoV-2 testing processes and interview with the laboratory director and testing personnel on February 24, 2021; the laboratory director failed to ensure that the physical plant and environmental conditions of the laboratory were appropriate for the testing performed. Findings include: See D3005. -- 3 of 3 --