Summary:
Summary Statement of Deficiencies 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: Through a review of 2020 and 2021 temperature records for refrigerators, freezers, and rooms in the laboratory, and through interviews with laboratory staff, it was determined the laboratory quality assurance failed to identify temperatures documented on days that do not exist. Survey findings follow: A. A review of the Temperature Recording Chart labeled "Sendout Frig" for 2021 revealed temperatures documented on 6/31/2021, 9/31/2021, and 11/31/2021. The three dates, of 368 dates listed on the form, do not occur on a calendar. B. Through a review of the Temperature Recording Chart labeled "Sendout Frig" for 2021 it was determined the technical consultant (employee #19 as listed on the form CMS-209), as part of her quality assurance review, had signed the months with temperatures documented on nonexistent dates. There was no documentation that improper temperatures or dates had been identified in the quality assurance records. C. During an interview, at 10:55 on 2/16/2022, with laboratory employees #11 and #19 (as listed on the form CMS- 209), it was confirmed the laboratory documented temperatures on days that do not exist on the calendar and that it wasn't identified in quality assurance reviews. 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 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 -- 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 the CMS 209 form, review of personnel records, lack of documentation and interview it was determined that the laboratory director failed to provide written authorization to perform Arterial Blood Gas (ABG) analyses with or without supervision for one of three testing personnel surveyed. Findings follow: A) Review of the CMS 209 form revealed that the testing person , identified as number 17 on the CMS 209 form, was listed as a testing personnel for moderately complex testing procedures. B) Review of personnel records revealed that no written authorization to perform moderately complex procedures was provided for the testing person, identified as number 17 on the CMS 209 form. C) Upon request, the laboratory was unable to provide written authorization signed by the laboratory director authorizing the testing person, identified as number 17 on the CMS 209 form, to perform moderately complex ABG analysis either with or without supervision. D) In an interview on 2/15/22 at 03:15 PM, the laboratory staff member, identified as number 12 on the CMS form, confirmed that the testing person, identified as number 17 on the CMS 209 form, performed ABG analysis without supervision and there was no written authorization from the laboratory director authorizing that testing person to perform ABG analysis. -- 2 of 2 --