Va League Planned Parenthood Richmond Health Ctr

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Virginia League for Planned Parenthood on 03/08/22 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D6063 - 42 C.F.R. 493-1421 Condition: Laboratory Testing Personnel. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on a review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), available testing personnel (TP) records, test logs, and interview, the laboratory failed to retain documentation of personnel qualifications for one of two new testing personnel from 3/01/20 to the date of survey 03/08/22. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an 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 -- accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), available testing personnel (TP) records, test logs, and interview, the laboratory failed to retain documentation of personnel qualifications for one of two new testing personnel responsible for reporting patient test results from 3/01/20 to the date of survey 03/08/22 (24-months). Findings include: 1. Review of the CLIA CMS 209 Form revealed two new TP identified as performing non-waived immunohematology (Rh Anti-D) procedures. 2. Review of the education documents for TP A revealed a 2015 university diploma from Venezuela. The inspector requested to review US equivalent education credentials for TP A. The documentation was not available for review. See Personnel Code Sheet. 3. Review of TP A training records revealed that TP A's initial training was verified/signed by the lab director on 2/28/20. Review of patient test logs revealed TP A as performing patient immunohematology procedures from March 2020 to the date of the survey, a 24-month timeframe. 4. An exit interview with the quality assurance manager on 03/08/22 at 1200 confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Virginia League for Planned Parenthood on December 9, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) records, lack of documentation, and interview with the lab director and quality assurance manager, the lab director failed to review and sign two (2) of 10 final PT results. Events of record review included all 6 events in 2018 and 4 events in 2019. Findings include: 1. Review of the American Proficiency Institute (API) PT revealed the lack of documentation by the lab director for review and signature of the 2018 Hematology 1st event final API PT results and the 2019 Immunology 1st event final API PT results. 2. An interview with the lab director and quality assurance manager at approximately 3:25 PM confirmed the findings. 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 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 -- 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 the review of proficiency testing (PT) records, lack of documentation, and interview with the lab director and quality assurance manager, the lab failed to maintain the attestation statement for one (1) of 10 PT events reviewed. Events of record review included all 6 events in 2018 and 4 events in 2019. Findings include: 1. Review of the American Proficiency Institute (API) PT records revealed lack of documentation of the 2018 Hematology 2nd event Attestation statement. The inspector requested to review the attestation statement. The document was not available for review. 2. An interview with the lab director and quality assurance manager at approximately 3:25 PM confirmed the findings. -- 2 of 2 --