Primary Care Of Elizabethton

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the submitted Centers for Medicare and Medicaid Services (CMS) 209 form, laboratory's policy, personnel records, and staff interview, it was revealed the laboratory's policy failed to include initial training and semi-annual competency evaluation as required in Subpart M of the State Operations Manual (SOM) Appendix C and failed to have documentation of initial training and/or semi- annual competency for two of four testing personnel. Findings included: 1. A review of the submitted CMS-209 form listed four testing personnel for moderate complexity testing. 2. A review of the laboratory's Quality Assurance Plan policy revealed the policy failed to include initial training and semi-annual competency assessments for testing personnel performing moderate complexity testing. 3. A review of laboratory personnel records revealed the following: -No documented initial training or semi- annual competency assessment for testing personnel three of four as listed on the CMS-209 -No documented semi-annual competency assessment for testing personnel four of four as listed on the CMS-209 4. An interview on 04.11.2024 at 11:15 a.m. with the Technical Consultant confirmed the above survey findings. 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) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the manufacturer control package insert, and interview with the lab liaison, the laboratory failed to label three of three control vials used for performing quality control on the Complete Blood Count (CBC) analyzer with a corrected expiration date on the date of the survey. The findings include: 1. Observation of the laboratory on 04.11.2024, at 9:45 a.m., revealed the Sysmex XN-300 CBC analyzer (serial # 12504) in use for patient testing. Also observed were three levels (L1, L2, and L3) of Sysmex XN-L Check CBC controls (L1-Lot 40121401, L2-Lot 40121402, and L3-Lot 40121403) that were not labeled with the corrected expiration date. 2. A review of the manufacturer control package insert revealed the following: "Open vials and vials which have been sampled by cap piercing will retain stability for 15 days if stored at 2-8 degrees C after being recapped". 3. An interview with the lab liaison on 04.11.2024, at 9:45 a.m. confirmed that the laboratory failed to label CBC controls with the corrected expiration date for three of three control vials observed on the date of the survey (04.11.2024). Word key: degrees C = degrees Celsius D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: =================================== Based on review of proficiency testing (PT) record's attestation statements for 2020-2021 and an interview with the technical consultant, the laboratory failed to ensure testing person number seven (TP#7) listed on the Center for Medicare and Medicaid Services Personnel Report (CMS-209) signed PT attestation pages for hematology wet prep examinations in 2020 and 2021. Findings include: 1. Review of PT attestation statements for hematology wet prep examinations for 2020 and 2021 revealed there were no signatures for TP#7. 2. In an interview on April 6, 2022, at 11:00am, the technical consultant confirmed TP#7 was the only testing person for hematology wet prep examinations and confirmed there were no signatures for TP#7 on the PT attestation statements for the hematology wet prep examination for 2020 and 2021. =================================== 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 --