Summary:
Summary Statement of Deficiencies D0000 Community Clinic Rogers Medical Laboratory is in compliance with the applicable Standards and conditions of 42 CFR Part 493, Laboratory Requirements. The following standard level deficiencies were cited on current survey: D5481: CFR 493.1256(f) - The laboratory failed to ensure quality control met criteria for acceptability prior to reporting patient results, D6046: CFR493.1413 - The technical consultant failed to evaluate the competency of testing personnel as required. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through review of quality control policy and procedure, quality control reports, patient results, and interview it was determined that the laboratory reported patient results for complete blood cell analysis before quality control were performed on 10 of 23 days of testing in March 2018 affecting 33 patients. Findings follow: A. Review of quality control policy and procedure revealed that quality control "should be performed at the start of each work day". B. Review of quality control reports for March 2018 and patient result printed reports revealed that: * On 3/5/18 quality control was performed at 02:41 PM and complete blood cell analyses were performed and reported on patient identified as number 1 on the patient identification list at 09: 32 AM, patient identified as number 2 on the patient identification list at 11:16 AM and patient identified as number 3 on the patient identification list at 12:07 AM ; * On 3/8/18 quality control was performed at 02:27 PM and complete blood cell analyses were performed and reported on patient identified as number 4 on the patient identification list at 09:26 AM, patient identified as number 5 on the patient identification list at 10:06 AM; * On 3/9/18 quality control was performed at 02:58 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 -- PM and complete blood cell analyses were performed and reported on patient identified as number 6 on the patient identification list at 12:03 PM and patient identified as number 7 on the patient identification list at 01:35 PM; * On 3/12/18 quality control was performed at 11:24 AM and complete blood cell analyses were performed and reported on patient identified as number 8 on the patient identification list at 07:22 AM and patient identified as number 9 on the patient identification list at 08:13 AM; * On 3/13/18 quality control was performed at 02:43 PM and complete blood cell analyses were performed and reported on patient identified as number 10 on the patient identification list at 08:38 AM, patient identified as number 11 on the patient identification list at 07:48 AM, patient identified as number 12 on the patient identification list at 10:02 AM, patient identified as number 13 on the patient identification list at 11:11 AM, patient identified as number 14 on the patient identification list at 01:46 PM; * On 3/14/18 quality control was performed at 03:15 PM and complete blood cell analyses were performed and reported on patient identified as number 16 on the patient identification list at 08:46 AM, patient identified as number 17 on the patient identification list at 09:29 AM, patient identified as number 18 on the patient identification list at 10:19 AM, patient identified as number 19 on the patient identification list at 10:32 AM, patient identified as number 20 on the patient identification list at 10:35 AM, patient identified as number 21 on the patient identification list at 11:11 AM, patient identified as number 22 on the patient identification list at 12:09 PM and patient identified as number 23 on the patient identification list at 02:18 PM; * On 3/15/18 quality control was performed at 11:10 AM and complete blood cell analyses were performed and reported on patient identified as number 24 on the patient identification list at 09:07 AM, patient identified as number 25 on the patient identification list at 08: 17 AM, patient identified as number 26 on the patient identification list at 08:56 AM, patient identified as number 27 on the patient identification list at 10:11 AM, and patient identified as number 28 on the patient identification list at 10:13 AM; * On 3 /16/18 quality control was performed at 02:55 PM and complete blood cell analyses were performed and reported on patient identified as number 20 on the patient identification list at 10:20 AM and patient identified as number 30 on the patient identification list at 02:48 PM; * On 3/20/18 quality control was performed at 02:40 PM and complete blood cell analyses were performed and reported on patient identified as number 31 on the patient identification list at 09:35 AM, patient identified as number 32 on the patient identification list at 01:40 PM and patient identified as number 33 on the patient identification list at 02:00 PM; * On 3/26/18 quality control was performed at 10:36 AM and complete blood cell analysis was performed and reported on patient identified as number 34 on the patient identification list at 08:59 AM. D. In an interview on 7/10/18 at approximately 11:45, the laboratory director identified as number 1 confirmed that patient results for white blood cell analyses were performed and reported prior to quality control being performed on the dates identified above. 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: Through a review of the CMS-209 form, a lack of docmentation, and through -- 2 of 3 -- interviews with laboratory staff, it was determined the technical consultant failed to evaluate the competency of four of ten testing personnel. Survey findings follow: A. Review of personnel records for testing personnel listed on the CMS 209 form revealed that no competency evaluations were present for testing personnel identified as numbers 9 through 12 on the form B. In an interview at appriximately 11:16 on 7/10 /18, the laboratory director identified as number 1 on the CMS 209 form confirmed that the testing personnel identified above performed moderately complex microscopy procedures and that annual competencies had not been evaluated for the testing personnel. -- 3 of 3 --