Waco Gastroenterology Associates Pa

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the laboratory's reagent logs, interview, and pre-survey paperwork, the laboratory failed to retain the open date for the chemicals and stains used in the laboratory for histopathology microscopic interpretation for 22 of 22 months reviewed. Findings follow. A. Review of the Reagent Lot Verification log also used as the reagent log from 10/18/2021 - 08/30/2023 showed no documentation of the open date. B. Interview with the PathLab Supervisor on August 30, 2023 at 1600 hours confirmed they have not retained the open date of chemicals and stains used in the laboratory. C. Review of the CMS Form 116 showed the estimated annual testing volume was 22,960 blocks and special stains. 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 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 policies and procedure, quality control records, patient reports, review of the CMS 116 application and interview of facility personnel, the laboratory failed to define intended reactivity to ensure predictable staining characteristics of Hematoxylin & Eosin (H&E) stain for each day of patient testing in 2018 and 2019. Findings included: 1. Review of the laboratory's written procedure titled Quality control found on pp 2-3 under the heading "QC of Histology Staining: 2. H&E: Is the nuclear and cytoplasm material clearly discernible? Is the chromatin hazy or clear? 2. Review of Daily QA Sheets(used to record acceptability of stains) found no definition of intended reactivity for H&E staining to ensure predictable staining characteristics. The laboratory recorded QC in the appropriate boxes as: October 9, 2018 Eosin ; Lab QC - A Pathologist QC - A Hematoxylin - Lab QC - A Pathologist QC - A October 11, 2018 Eosin ; Lab QC - A Pathologist QC - + Hematoxylin - Lab QC - A Pathologist QC - + October 23, 2018 Eosin ; Lab QC - A Pathologist QC - 3+ Hematoxylin - Lab QC - A Pathologist QC - 3+ September 9, 2019 Eosin ; Lab QC - A Pathologist QC - + Hematoxylin - Lab QC - A Pathologist QC - + September 10, 2018 Eosin ; Lab QC - (Check mark) Pathologist QC - + Hematoxylin - Lab QC - (Check mark) Pathologist QC - + September 23, 2019 Eosin ; Lab QC - A Pathologist QC - A Hematoxylin - Lab QC - A Pathologist QC - A A key at the bottom of the Daily QA sheet designated A= Acceptable, U= Unacceptable, += Positive. 3. Review of laboratory reports found under microscopic description: :Slide quality, stains and 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 -- controls are satisfactory. 4. Review of the CMS 116 application provided during the inspection found the laboratory reported an annual volume of 15,131 histology tests. 5. Interview of testing person 6 on the CMS report 209 Laboratory Personnel Report confirmed the laboratory did not define the predictable staining characteristics of the H&E stain in their policy, documentation of quality control performance or the patient final reports D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of policies and procedure, quality control records, patient reports, review of the CMS 116 application and interview of facility personnel, the laboratory failed to define intended reactivity to ensure predictable staining characteristics of the Giemsa and Alc Blue /PAS stains for each day of patient testing in 2018 and 2019. Findings included: 1. Review of the laboratory's written procedures found: a. Quality Control (revision 12/29/2019) - on pp 2-3 under the heading "QC of Histology Staining: 4. Special Stains: Is the +ve control slide clearly discernable? Is the counter stain too light/dark? Stain on label? Type of stain done clearly labeled? b. AB/PAS (Revision 12/29/2019) - page 4 under the heading Quality Control and Quality Assurance: 1. Control materials to be used: a. A Candida Albicans control along with a known positive patient tissue is used for control. 2. Instructions for preparing and handling control materials: a. A 3 micron paraffin embedded section of the known control is made, cut and placed on Candida Albicans Control. b. WGA Path Lab will perform one positive control slide every day that AB/PAS slides are stained. 3. Establishment of tolerance limits for controls: a. Stain as expected. 4.