Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's competency assessment records, competency assessment policy, and interview with the technical supervisor (TS) at the time of the validation survey on 5/8/2023, the laboratory failed to have policies to assess the competency of 1of 1 technical supervisor (TS) and 5 of 5 general supervisors (GS) on their supervisory responsibilities listed in Subpart M from 2021 through the time of the survey. Findings include: 1. According to the CMS 209 form provided at the time of the validation survey, the laboratory has 1 of 1 TS (CMS 209 personnel # 3) and 5 of 5 GS (CMS 209 personnel #4, #5, #6, #7, #8) performing the responsibilities listed in Subpart M. 2.The laboratory competency assessment policy reviewed at the time of the validation survey did not include the procedure for assessing the competency of 1 of 1 TS, and 5 of 5 GS for their supervisory responsibilities. 3. On the day of the survey, 05/08/2023 at 11:48 am, the laboratory could not provide records of competency assessments performed for TS and GS from 2021 through the time of the survey. 4. The TS interviewed on 5/10/23 around 01:00 pm confirmed the findings above. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials 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 -- for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's differential stain quality control (QC) records and interview with the technical supervisor (TS), the laboratory failed to document the QC performed each day of patient testing for the intended reactivity of the Quick Dip Stain used for manual differential examinations for 3 of 25 days from 11/28/2022 to 12 /22/2022. Finding Include: 1. On the day of the survey, 05/08/2023 at 11:00 am, review of the laboratory's manual differential QC stain records revealed the laboratory did not document the QC performed each day of patient testing for manual blood cell differential examinations stained using the Quick Dip Stain for the following 3 of 25 days from 11/28/2022 to 12/22/2022: - 11/28/2022: 1 manual differential examination performed - 12/20/2022: 4 manual differential examinations performed - 12/22/2022: 3 manual differential examinations performed 2. The TS confirmed the findings above on 05/08/2023 around 01:00 pm. D6020 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 the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's microscopic urinalysis quality control (QC) records, patient result log, electronic medical record, and interview with the Technical Supervisor (TS) at the time of the validation survey on 5/8/2023, the laboratory director (LD) failed to ensure the QC established for the microscopic urinalysis examinations performed on 8 of 8 patient specimens on 11/23/2022 using Alta Diagnostic urinalysis QC materials covered all results reported for patient testing. Findings include: 1.The microscopic urinalysis patient result log, and electronic medical record reviewed at the time of the survey revealed that 8 of 8 patient specimens were tested on 11/23/2022. The patient log also revealed that the laboratory reported white blood cells, red blood cells, bacteria, squamous epithelial cells, mucous, casts, and crystals for patient specimens. 2. The microscopic urinalysis QC log reviewed revealed that the laboratory only performed 1 level of QC on the microscopic cells seen. 3. The TS interviewed at 12:30 pm on 05/08/23 confirmed that the laboratory only performs QC on microscopic cells seen. -- 2 of 2 --