Ashley Clinic

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 the review of proficiency testing (PT) records from American Proficiency Institute (API) and interview, the laboratory failed to successfully participate in PT for the analytes: Hematology, RBC (Erythorocyte Count), Hematocrit (Non-Waived), Hemoglobin (Non-Waived), WBC (Leukocyte Count), and Platelet Count for two out of three consecutive proficiency testing events: 2022 Event 2 and 2023 Event 1 (refer to D2131). D2131 HEMATOLOGY CFR(s): 493.851(g) 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 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: A PT desk review and phone interview on 5/4/23 revealed the laboratory failed to successfully particiate in PT from API for the analytes: 0760 Hematology, 0775 RBC (Erythrocyte Count), 0785 Hematocrit (Non-Waived), 0795 Hemoglobin (Non- Waived), 0805 WBC (Leukocyte Count) and 0815 Platelet Count. Findings: 1. Review of the 2022 API 2nd Event with a score of 0% and 2023 1st Event revealed a score of 65% for (0760) Hematology. 2. Review of the 2022 API 2nd Event with a score of 0% and 2023 1st Event revealed a score of 40% for (0775) RBC. 3. Review of the 2022 API 2nd Event with a score of 0% and 2023 1st Event revealed a score of 60% for (0785) Hematocrit (Non-Waived). 4. Review of the 2022 API 2nd Event with a score of 0% and 2023 1st Event revealed a score of 60% for (0785) Hemoglobin (Non-Waived). 5. Review of the 2022 API 2nd Event with a score of 0% and 2023 1st Event revealed a score of 60% for (0805) WBC (Leukocyte Count). 6. Review of the 2022 API 2nd Event with a score of 0% and 2023 1st Event revealed a score of 60% for (0815) Platelet Count. 7. Phone interview 5/4/23 at 1:30 p.m. confirmed, the laboratory failed to successfully particiate in PT from API for the analytes: 0760 Hematology, 0775 RBC (Erythrocyte Count), 0785 Hematocrit (Non-Waived), 0795 Hemoglobin (Non-Waived), 0805 WBC (Leukocyte Count) and 0815 Platelet Count. -- 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 the review of proficiency testing (PT) records from American Proficiency Institute (API), the laboratory failed to successfully participate in PT under the specialty Routine chemistry for the regulated analyte: sodium. (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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing (PT) from the provider API for Chemistry, and phone interview, the laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events for the regulated analyte: sodium. Findings: 1. Review of API PT scores for 2022 Event 3 revealed a 60% performance score for sodium. 2. Review of the API PT scores for 2023 Event 1 revealed a 60% performance score for sodium. 3. Phone interview with the chief operations officer on 4/5/23at 11:30 a.m. confirmed, the laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events for the regulated analyte: sodium. -- 2 of 2 --

Summary Statement of Deficiencies 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 the available documentation and confirmed during interview with the Chief Finance Officer (CFO), the laboratory failed to have the current Individualized Quality Control Plans (IQCP)s approved, signed, and dated by the current laboratory director (LD) before use. Findings: 1. Upon review of the laboratory IQCP procedures, the current laboratory director did not approve, sign, and date the laboratory IQCPs for: 9 of 9 IQCP procedures in the laboratory at time of survey. 2. The following are IQCPs were identified without the current LD approval signature and date: a. Biofire Respiratory Panel 2.1 b. Hgb A1C, Afinion, Abbott c. Mycoplasma, Immuncocard, Meridian Bioscience d. Prothrombin Time (PT), Hemochron, IL e. Serum HCG, Consult, McKesson f. Helicobacter pylori (H. pylori), Consult, McKesson g. Microalbumin, Clinitek Status, Siemens h. Erythrocyte Sedimentation Rate (ESR), Excyte mini, ELITechGroup i. Vaginal Panel (Candida species, Gardnerella vaginalis, Trichomonas vaginalis), Affirm, BD 2. Interview with the CFO on June 28, 2021 at 10:30 a.m. confirmed, the laboratory failed to have 9 of 9 IQCP procedures approved, signed, and dated by the current laboratory director before 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 1 --