Community Clinic - Rogers Medical

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Through observation and interview the laboratory failed to assure that supplies were not used when they have exceeded their expiration date. Findings follow: A) During a tour of the laboratory on 9/24/26 at 09:10 am, one of one bottle of Potassium Hydroxide Solution Lot # 5908-00 with an expiration date of 2026-06-30, was observed in the microscopy room . B) In an interview on 09/24/26 at 09:10 am, laboratory staff member (# 3 on the form CMS 209) confirmed that the bottle was available for use, and had exceeded the expiration date. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. 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 -- This STANDARD is not met as evidenced by: Through review of instrument calibration records, instrument user's manual, laboratory policy and procedure manual, lack of documentation, and interview it was determined that the laboratory failed to calibrate the Cell-Dyn Emerald hematology instrument every 6 months. Findings follow: A.)The manufacturer user manual for the Cell-Dyn Emerald Hematology analyzer and the laboratory policy and procedure manual both state that the instrument should be calibrated every 6 months. B) Review of the calibration documentation for the Cell Dyn Emerald hematology instrument revealed calibration was performed on 3/29/24, 3/17/25, 11/14/25, and 6/11/26. C) Upon request, the laboratory could not provide record of calibration of the Cell-Dym Emerald hematology analyzer between 03/29/24 and 3/17/25. D) In an interview on 9 /24/26 at 10:45 am the laboratory staff member (number 3 on the form CMS 209) confirmed that the calibration of the Cell-Dyn Emerald hematology analyzer had not been Performed every six months as required by the instrument manufacturer and laboratory policy. -- 2 of 2 --

Summary Statement of Deficiencies D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Through a lack of policy and procedure and interview it was determined that the laboratory director did not establish written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the laboratory. Findings follow: A. Upon request, the laboratory could not produce written policies and procedures for quality assessment. B. In an interview on September 12, 2024 9: 50am the laboratory director verified that policies and procedures defining quality assessment were not available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 --