Summary:
Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory's Individualized Quality Control Plan (IQCP) for a Chemistry test failed to include an evaluation of all risk factors. Findings are as follows: 1. The laboratory performed Human Chorionic Gonadotropin (hCG) testing under the Chemistry specialty as confirmed by the Technical Consultant (TC) during a tour of the laboratory on 11/29/18 at 10:05 a.m. 2. Quidel QuickVue hCG Combo Test kits were observed as present and available for use during the tour. 3. The QuickVue One-Step hCG Combo Test procedure found in the Hinckley Procedure Manual indicated quality control testing was performed at the hospital laboratory on new lots and shipments of test kits. Test kits approved for use were then shipped to the clinic location. 4. The laboratory's IQCP Risk Assessment for the Quidel QuickVue hCG Combo Test did not include test kit transport from the hospital to the clinic. 5. The laboratory was unable to provide a risk assessment for test kit transport from the hospital to the clinic upon request. 6. In an interview on 11/29/18 at 12:05 p.m., the TC confirmed the above finding. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES 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 -- 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 document review and interview with laboratory personnel, the technical consultant (TC) failed to complete required Microbiology, Hematology, and Chemistry competency assessment elements for all testing personnel (TP) in 2017. Required elements include; 1) Direct observation of test performance, 2) Monitoring the recording and reporting of test results, 3) Review of intermediate test results or worksheets and records, 4) Direct observation of instrument maintenance, 5) Assessment of test performance with previously analyzed specimens, and 6) Assessment of problem solving skills. Findings are as follows: The laboratory performed Microbiology, Hematology and Chemistry testing as confirmed by the TC during a tour of the laboratory on 11/29/18 at 10:05 a.m. A. Microbiology 1. The laboratory performed the following tests under the Microbiology specialty; Vaginal Wet Preparations, KOH microscopic examinations, and Throat Cultures. 2. The 2017 Annual Competency records for 3 of 3 tenured TP reviewed on date of survey were incomplete. See below. Vaginal Wet Preparations TP Missing elements TP2 5 KOH Microscopic examinations TP Missing elements GS* 1, 2 TP1 1,2 Throat Cultures TP Missing elements GS 5 TP1 2 TP2 5 3. In an interview on 11/29/18 at 11:20 a.m., the TC confirmed the 2017 Microbiology competency assessments were incomplete for the GS, TP1 and TP2. B. Hematology 1. A Sysmex XS-1000i hematology analyzer was observed as present and available for use during the tour. The TC indicated the laboratory performed Complete Blood Count with an automated 3 part differential using this analyzer. In addition, the laboratory performed Manual Differentials, Erythrocyte Sedimentation Rate (ESR), Prothrombin and International Normalized Ratio (PT/INR), Post-Vasectomy and Fern testing under the Hematology specialty. 2. 2017 hematology competency assessment records for 3 of 3 tenured TP reviewed on date of survey were incomplete. See below. Sysmex XS-1000i TP Missing elements TP2 1, 2, 3, 4, 5 Manual Differential TP Missing elements TP2 1, 2, 5 ESR TP Missing elements TP2 5 PT/INR TP Missing elements GS 1, 2, 3 Post-Vasectomy TP Missing elements GS 1, 2, TP1 1, 2 Fern TP Missing elements GS 2 TP1 1, 2, 5 TP2 1, 2, 5 3. In an interview on 11/29/18 at 11:20 a.m., the TC confirmed the 2017 Hematology competency assessments were incomplete for the GS, TP1 and TP2. C. Chemistry 1. The laboratory performed the following tests under the Chemistry specialty; Urine sediment microscopic examinations and Serum Human Chorionic Gonadotropin (hCG). 2. 2017 Chemistry competency assessment records for 2 of 3 tenured TP reviewed on date of survey were incomplete. See below. Urine sediment TP Missing elements TP2 5 Serum hCG TP Missing elements TP1 1, 2 3. In an interview on 11/29/18 at 11:20 a.m., the TC confirmed the 2017 Chemistry competency assessments were incomplete for TP1 and TP2. *Note GS - General Supervisor -- 2 of 2 --