Doctors Care City Of Columbia

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted at Doctors Care, City of Columbia on 02/07 /2024. The laboratory was found not to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. 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 review of the Centers for Medicare and Medicaid (CMS) 209 form laboratory policies, personnel records, and confirmed in staff interview, the laboratory failed to establish and follow a policy to assess responsibilities for one of one technical consultant. Findings included: 1. The laboratory's submitted CMS-209 form listed one Technical Consultant (TC). 2. Review of the laboratory's policies revealed the laboratory failed to establish a competency assessment policy for the technical consultant's responsibilities. 3. Review of the laboratory's personnel records revealed no documentation of competency assessment for the technical consultant. 4. In an interview on 02/07/2024 at 11:50am in the laboratory office, the clinic manager was asked to provide documentation of competency assessment for the technical consultant. No documentation was provided. She further stated that the laboratory did not have a policy for TC competency assessment. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: During an onsite recertification survey on 01/24/2019, based on procedure manual review, proficiency testing review, and testing personnel review, the laboratory failed to ensure that proficiency testing (PT) for complete blood count (CBC) testing were routinely tested the same number of times as patient samples for 1 of 7 PT eventsreviewed from 2017 to 2019 (2018 Event 3). Findings include: 1. The laboratory procedure defined the following values as panic values: a. WBC (white blood cell count) less than 3 or greater than 15 b. Hgb (hemoglobin) less than 10 or greater than 20 c. Plt (platelet count) less than 100 or greater than 600 d. Hct (hematocrit) less than 30 or greater than 60 The procedure manual stated that all panic values would be rerun to ensure accuracy. 2. Review of the American Proficiency Institute (API) proficiency testing events from 2017 to 2019 revealed the following proficiency testing events with critical values that were reported and not repeated according to laboratory policy. a. 2018, Event 3: i. sample 12- WBC 17.0; ii. sample 14- WBC 2.8; Hgb 6.0; Hct 17.7; Plt 64 3. Testing personnel confirmed during an onsite interview on 01/24/2019 at 1:00pm that the laboratory failed to ensure that proficiency testing samples were routinely tested the same number of times as patient samples. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. 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 -- This STANDARD is not met as evidenced by: During an onsite recertification survey on 01/24/2019, based on proficiency testing record review, and testing personnel interview, the laboratory failed to review and evaluate proficiency testing results for 1 of 7 proficiency testing events reviewed from 2017 through 2019 (2018, Event 3). Findings include: 1. Review of proficiency testing results revealed the following scores: a. 2018, Event 3; 0% for vaginal wet prep identification There was no documentation of director review and evaluation or