Appalachian Wellness, Llc

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing (PT) scores obtained from the national database and verified with the PT 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 (PT) desk review of the Certification and Survey 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 -- Provider Enhanced Reporting-0155 and American Proficiency Institute 2024 records (1st and 2nd events), the laboratory failed to successfully participate in a PT program. The laboratory failed to successfully participate in the specialty of Hematology for Red Blood Cell, Hemoglobin, and White Blood Cell Count for 2 of 2 testing events. Refer to D2130 and D2131. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 (PT) desk review of the Certification and Survey Provider Enhanced Reporting (Casper)-0155 and American Proficiency Institute (API) 2024 records (1st and 2nd events), the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in 2 of 2 consecutive testing events in Hematology for Red Blood Cell (RBC), Hemoglobin (HGB), and White Blood Cell Count (WBC Count). The findings include: 1.Review of the CASPER -0155 report revealed the following: Hematology 2024- 1st Event Laboratory received an unsatisfactory score of 40% for RBC. Hematology 2024- 2nd Event Laboratory received an unsatisfactory score of 0% for RBC. Hematology 2024- 1st Event Laboratory received an unsatisfactory score of 60% for HGB. Hematology 2024- 2nd Event Laboratory received an unsatisfactory score of 0% for HGB. Hematology 2024- 1st Event Laboratory received an unsatisfactory score of 60% for WBC Count. Hematology 2024- 2nd Event Laboratory received an unsatisfactory score of 0% for WBC Count. 2. A PT desk review from API 2024 PT records confirmed the above findings. 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 a proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 and American Proficiency Institute (API) 2021 records (1st and 2nd events), the laboratory failed to achieve overall satisfactory performance (80% or greater) for 2 of 2 consecutive events in the specialty of Hematology. The findings include: 1. Review of the Casper-0155 report revealed the following: Hematology 2024- 1st Event Laboratory received an unsatisfactory score of 73% for the Hematology. Hematology 2024- 2nd Event Laboratory received an unsatisfactory score of 0% for the Hematology. 2. A PT desk review from API 2024 PT 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. -- 2 of 3 -- 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 (PT) desk review of the Certification and Survey Provider Enhanced Reporting-0155 and American Proficiency Institute 2024 records (1st and 2nd events), it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services to ensure successful PT participation of the specialty of Hematology, Red Blood Cell, Hemoglobin, and White Blood Cell Count during 2 of 2 testing events. 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 (PT) desk review of the Certification and Survey Provider Enhanced Reporting-0155 and American Proficiency Institute 2024 records (1st and 2nd events), the laboratory director failed to ensure that the PT samples were tested as required under Subpart H during 2 of 2 testing events. Refer to D2130 and D2131. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Recertification Survey was initiated and concluded on 08/15/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on review of laboratory documentation, proficiency testing records, personnel records, and staff interview, the technical consultant failed to ensure the laboratory completed training for the moderate complexity hematology testing prior to patient testing for one (1) of two (2) Testing Personnel (TP) #1 employed by the laboratory. The Findings include: Review of the "CMS-209", completed by the Laboratory Director, dated 08/09/2023, revealed two (2) employees held the title of TP. According to the Laboratory Personnel Report, TP #1 performed moderate complexity testing. Review of Proficiency testing records from American Proficiency Institute for 2022 hematology Event #3, revealed "For all [Proficiency Testing] results, an attestation statement must be signed by testing personnel and the laboratory director and retained for a minimum of two (2) years." The Attestation Statement for the hematology sample tested was signed by TP #1 on 12/15/2022, and by the Laboratory Director on 12/20/2022. Review of TP #1's "Personnel File Checklist" revealed TP #1's initial training was not completed until 02/03/2023. During an interview, on 08/15 /2023 at 12:29 PM, TP #1 stated she was hired at the laboratory on 09/05/2022. TP #1 stated she did not receive training until February 2023 and acknowledged she performed proficiency testing for Event 3 in December 2022. During an interview, on 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 -- 08/15/2023 at 1:02 PM, the Technical Supervisor (TS) stated he was responsible for the training and competency of all employees. Further, the TS acknowledged the laboratory failed to ensure TP #1 completed an initial training to ensure she knew how to perform the job before she used the instruments. -- 2 of 2 --