Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on procedure manual review, lack of documentation, and interview with staff, the laboratory lacked a written procedure manual for 1 of 2 test methods in use (microscopy testing). Findings include: 1. The laboratory procedure manual failed to include written procedures for 5 of 5 microscopy tests performed--Fern Test, Microscopic Urinalysis, Potassium Hydroxide (KOH), Wet Mounts, and Semen Analysis (presence/motility). 2. The laboratory stated on 08/12/2019 at approximately 12:00 PM, 2 providers at the facility were performing microscopy testing. 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 laboratory test request review, laboratory test report review, and interview with staff, the laboratory failed to establish an ongoing mechanism to monitor and correct, when indicated, problems in performing the test ordered for 2 of 3 complete 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 -- blood count (CBC) tests reviewed. Findings include: 1. Test orders for patient 1157292 tested on 04/19/2019 and patient 406677 tested on 05/31/2019 state to perform a CBC with White Blood Cell Count Differential (Diff). 2. Test reports for Patient 1157292 tested on 04/19/2019 and patient 406677 tested on 05/31/2019 did not have results for the Diff. 3. The technical consultant stated on 08/12/2019 that Diffs were not performed for patients 1157292 and 406677. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on lack of documentation, and interview with staff, the technical consultant failed to evaluate the competency of 2 of 2 employees performing microscopy testing. The laboratory started patient testing in 03/2019 and performs 5 microscopy tests. Findings include: 1. The laboratory lacked documentation personnel performing microscopy testing had been evaluated by the technical consultant for competency to perform testing. 2. The Director confirmed on 08/12/2019 at approximately 12:00 PM that 2 providers performed microscopy testing (Fern Tests, Potassium Hydroxide exams, Microscopic Urinalysis, Semen Analysis {post vasectomy}, and Wet Mounts). -- 2 of 2 --