Community Clinic Fayetteville Medical

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 confirmed by interview with laboratory staff it was determined that one of three blood culture bottles that had exceeded its date of expiration was present and available for use in the outpatient phlebotomy area. Findings follow: A. During a tour of the laboratory on 11/13/20 at approximately 12: 00 PM one of three BD Bactec blood cultaure collection vials , Lot # 9318978 expiration date 2020-08-31 was observed on a phlebotomy tray in the outpatient phlebotomy area. B. In an interview on 11/13/20 at approximately 12:00 PM, the laboratory staff member, identified as number one on the CMS 209 form, confirmed that the item identified above had expired and was available for use. 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. 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 the laboratory's "Quality Control Policy," quality control summary reports, lack of documentation, "Result Listing" report for 11/4/19, and interview, it was determined that the laboratory failed to perform quality controls for hematology CBC testing on one of one days of testing in November 2019. Survey findings follow: A. Review of the laboratory's "Quality Control Policy" showed that "controls will be run each day of testing before patient results are reported." B. Review of November 2019 quality control summary reports for the Cell Dyne CBC analyzer showed that no quality control results were listed for November 4, 2019. C. Upon request, the laboratory was unable to produce quality control results for the Cell Dyne CBC analyzer for November 4, 2019. D. Review of the "result listing" report showed that CBC testing performed on the Cell Dyne CBC analyzer was reported on one patient, identified as number one on a separate patient identification list. E. In an interview on November 13, 2020 at approximately 10:30 AM, the laboratory staff member identified as number one on the CMS 209 form, confirmed that Cell Dyne CBC quality control was not performed on November 4, 2019 and a patient results were reported. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Through review of instrument manufacturer's manuals, laboratory humidity records, and interview it was determined that the laboratory failed to monitor humidity in one of one room in which an intrument with operating humidity requirement was used. Findings follow: A. Review of the instrument manufacturer's manual for the Emerald hematology analyzer revealed that the instrument had an operating humidity requirement of less than 80%. B. Review of laboratory humidity records revealed that on 58 of 58 days in January, February, and March of 2018, in which the laboratory was open, humidity level was recorded as 67% with no variation. C. On a tour of the laboratory on 3/28/18 at approximately 1130 the hygrometer was observed with a reading of 67% with a sub-script stating "MAX". D. Review of the manufacturer's users manual for the hygrometer revealed that if the hygrometer had a subscript of "MAX" that it was displaying the maximum humidity level since the instrument was last set and that the re-set button had to be pressed again to see the current humidity level. E. On the tour, the instrument was re-set, the "MAX" subscript disappeared and the hygrometer displayed a humidity level of 54%. F. In an interview on 3/28/18 at approximately 1145, the laboratory director identified as number one on the CMS 209 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 -- form confirmed that the hygrometer had not been used according to the manufacturer's instructions and humidity records for 2018 could not be considered accurate. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Through review of personnel records, lack of documentation, and interview it was determined that the laboratory failed to have written authorization to perform testing for six of six testing personnel listed on the CMS 209 form. Findings follow: A. Upon review of personnel records, no written authorization to test was found for testing personnel identified as numbers two through seven inclusive on the CMS 209 form. B. Upon request, the laboratory could not produce a written authorization to test for the personnel mentioned above. C. In an interview on 3/28/18 at approximately 1145 the laboratory director identified as number 1 on the CMS 209 form confirmed that no written authorization to test was available for the testing personnel identified as numbers two through seven inclusive on the CMS 209 form and that those personnel did perform moderate complexity testing. -- 2 of 2 --