Summary:
Summary Statement of Deficiencies 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 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 quality control records, patient specimen logs, and interview of facility personnel, the laboratory failed to document the negative and positive reactivity of quality control slides for Hematoxylin and Eosin (H and E) staining on each day of patient testing between January 2022 and November 7, 2022. The findings included: 1. Based on review of H and E stain quality control logs between January 2022 and November 7, 2022 the laboratory documented acceptability of stain reactivity on 10 dates as follows: January 13, 2022 February 14, 2022 March 10, 2022 April 22, 2022 May 20, 2022 June 9, 2022 July 11, 2022 August 12, 2022 September 12, 2022 October 21, 2022 2. Based on review of patient test logs from July 1, 2022 through November 1, 2022, The laboratory documented 140 patient specimens collected on these dates without documentation of negative and positive quality control procedures on the date of testing: July 1, 2022 2 patient specimens July 5, 2022 2 patient specimens July 6, 2022 2 patient specimens July 8, 2022 1 patient specimen July 12, 2022 4 patient specimens July 13, 2022 2 patient specimens July 15, 2022 4 patient specimens July 18, 2022 1 patient specimen July 19, 2022 4 patient specimens July 20, 2022 1 patient specimen July 22, 2022 3 patient specimens July 9, 2022 1 patient specimen July 26, 2022 4 patient specimens July 27, 2022 4 patient specimens August 2, 2022 1 patient specimen August 3, 2022 3 patient specimen August 6, 2022 2 patient specimens August 9, 2022 1 patient specimen August 10, 2022 3 patient specimens August 12, 2022 4 patient specimens August 15, 2022 4 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 -- patient specimens August 16, 2022 2 patient specimens August 17, 2022 2 patient specimens August 20, 2022 4 patient specimens August 23, 2022 3 patient specimens August 24, 2022 3 patient specimens August 26, 2022 3 patient specimens August 29, 2022 1 patient specimen August 30, 2022 4 patient specimens August 31, 2022 1 patient specimen September 2, 2022 1 patient specimen September 6, 2022 3 patient specimens September 7, 2022 7 patient specimens September 9, 2022 1 patient specimen September 12, 2022 1 patient specimen September 13, 2022 3 patient specimens September 14, 2022 2 patient specimens September 16, 2022 3 patient specimens September 19, 2022 2 patient specimens September 20, 2022 2 patient specimens September 21, 2022 3 patient specimens September 27, 2022 2 patient specimens September 28, 2022 2 patient specimens October 3, 2022 1 patient specimen October 4, 2022 2 patient specimens October 7, 2022 4 patient specimens October 4, 2022 2 patient specimens October 11, 2022 1 patient specimen October 12, 2022 1 patient specimen October 17, 2022 3 patient specimens October 18, 2022 3 patient specimens October 19, 2022 2 patient specimens October 21, 2022 3 patient specimens October 25, 2022 3 patient specimens October 26, 2022 3 patient specimens October 28, 2022 1 patient specimen October 29, 2022 1 patient specimen November 1, 2022 3 patient specimens 3. During interview of the laboratory director conducted on November 7, 2022 at 2:21 PM, he stated he did not document quality or acceptability of staining each day of patient testing. -- 2 of 2 --