Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Khadijah Jordan, MD PC on April 4, 2018 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: 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 a review of the proficiency testing (PT) documentation, and an interview, the laboratory failed to retain documentation of the chemistry analyzer results for two (2) of six (6) PT events reviewed. Findings include: 1. Review of the laboratory's 2016 American Academy of Family Physicians (AAFP) and 2017 American Proficiency Institute (API) PT documentation, a total of six (6) events, revealed no Abbott Architect Plus i1000 instrument result records were retained for: 2016 AAFP Event B: Follicle Stimulating Hormone (FSH), Luteininzing Hormone (LH), Prolactin, Testosterone, Progesterone -PT