Oak Grove Medical Clinic

Summary Statement of Deficiencies D0000 A Certification Survey was performed on October 22, 2020 at Oak Grove Medical Clinic, CLIA ID # 19D0674920. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation, record review and interview with personnel, the laboratory failed to document weekly, bi-weekly, and monthly maintenance for the Horiba Medical ABX Micros 60 Hematology analyzer. Findings: 1. Observation by surveyor during the laboratory tour on October 22, 2020 at 11:30 am revealed the laboratory utilizes the Horiba Medical ABX Micros 60 Hematology analyzer for Complete Blood Count (CBC) testing. 2. Review of the laboratory's Micros 60 Maintenance Log revealed the laboratory performs the following maintenance: a) Daily: Check Reagents Start-up Passed Standby (end of day) b) Weekly: Backflush X3 Concentrated Clean c) Bi-Weekly: Change Controls d) Monthly: Change Reagents Print Graphs/Statistics 3. Review of the laboratory's maintenance logs for January 2019 through September 2020 revealed the laboratory did not perform the following maintenance: a) Weekly: February 3, 2019 through February 8, 2019 February 26, 2019 through February 28, 2019 March 4, 2019 through March 8, 2019 March 18, 2019 through March 22, 2019 April 1, 2019 through April 5, 2019 April 15, 2019 through April 18, 2019 August 5, 2019 through August 9, 2019 October 1, 2019 through October 4, 2019 October 14, 2019 through October 18, 2019 October 28, 2019 through October 31, 2019 February 24, 2020 through February 28, 2020 March 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 -- 9, 2020 through March 13, 2020 June 8, 2020 through June 12, 2020 September 21, 2020 through September 25, 2020 b) Bi-Weekly: January 2019 February 2019 March 2019 April 2019 June 2019 July 2019 August 2019 c) Montly: January 2019 February 2019 March 2019 June 2019 October 2019 November 2019 December 2019 February 2020 March 2020 April 2020 May 2020 June 2020 August 2020 4. In interview on October 22, 2020 at 11:05 am, Personnel 6 stated that the maintenance is being performed because the instrument requires it before continuing but the laboratory personnel is not documenting when completed. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and interview with personnel, the laboratory failed to follow their established procedures to monitor, assess, and correct problems, identified with the analytic system. Findings: 1. Review of the laboratory's policy and procedure manual under "Quality Assurance" revealed the following: a) Specific Objectives: * Monitor and evaluate the overall quality of the total testing process, which includes 3 phases: pre-analytic, analytic, and post-analytic * Evaluate the effectiveness of established policies and procedures * Provide guidelines for identifying and correcting problems, documentation of

Summary Statement of Deficiencies D0000 A Certification Survey was conducted on April 17, 2018 at Oak Grove Medical Clinic - CLIA # 19D0674920. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, 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: I. Based on record review and interview with personnel, the laboratory failed to ensure written policies and procedures to assess competency for the Technical Consultant were complete. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed Personnel 7 and 8 serves as Technical Consultants. 2. Review of the laboratory's policies and procedures revealed the laboratory did not have a policy for competency assessment of Technical Consultant. 3. Review of personnel records revealed competency assessments for the duties of Technical Consultant on Personnel 7 and 8 were not documented. 4. In interview on April 17, 2018 at 9:30 am, Personnel 8 stated that competency assessements were not performed for the Technical Consultants. II. Based on record review and interview with personnel, the laboratory failed to ensure detailed written policies and procedures were established to assess competency for testing personnel. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory did have a policy to address competency; however, it did not include the following six (6) procedures as a minimal requirement for assessing the competency of the testing personnel: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 2. In interview on April 17, 2018 at 9:30 am, Personnel 8 confirmed the laboratory did not have detailed policies and procedures for personnel competency assessments. 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, 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)