Summary:
Summary Statement of Deficiencies 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 a review of the stain quality control records, a review of the policy and procedure manual, a review of patient reports, and an interview with the laboratory supervisor, the surveyor determined the laboratory failed to document quality control results for special stains used on 1/20/2017 for three patient cases. This affected one day and potentially three patient reports for the survey period of 2017 through 2018. 1. A review of the laboratory's policy and procedure manual indicated the quality control of the immunohistochemical stains were reviewed on a daily basis. 2. A review of the quality control records (Special Stain Log) revealed the quality control was not documented for the following: a) On 1/20/2017 for Case #S17475 [AFB (Acid Fast Bacilli), Gram, PAS (Periodic Acid Schiff), GMS (Gomori Methenamine- Silver) stains] b) On 1/20/2017 for Case #S17455 (Iron, Trichrome stains) c) Case #S17424 (GMS, PAS, AFB stains) 3. In an interview on 2/07/2019 at 12:20 PM, the laboratory supervisor reviewed the special stain quality control log with the surveyor and confirmed the controls had not been documented on 1/20/2017 for the cases listed in paragraph 2. At this time, the surveyor requested the patient cases (reports) for 1/20 /2017 be pulled for review. 4. A review of the three patient reports revealed of the three reports, the report for Case #S17475 included the following under, Microscopic Description: "Microscopic examination is performed. A PAS, GMS, AFB and gram stain are performed with appropriate tissue controls." The pathologists failed to 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 -- document the reactivity of the quality control for these special stains, performed on 1 /20/2017 for the three cases afore-mentioned. 5. The above noted findings were discussed with Testing Personnel #1, the laboratory supervisor and three hospital administrators, during the exit summation on 2/07/19 at 2:40 PM. D5667 CYTOLOGY CFR(s): 493.1274(h) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of Cytology (non-gynecological) quality control logs and an interview with the laboratory supervisor, the surveyor determined the laboratory testing personnel (the reviewing pathologists) failed to document quality control for stains performed on Cytology specimens for seven cases (seven days) for the survey review period of 2017 through 2018. The findings include: 1. A review of the Daily Stain QA (Quality Assurance) and Pathologist Workload for Cytology revealed seven days when the quality control of the stain was not documented. The following cases and dates were described as: 12/14/2018, C18-1150; 9/27/17, C17-710, 7/20/17, C17- 488, 7/12/17, C17-470, 5/8/17, C17-305, 3/3/17, C17-142, and 4/21/17, C17-267. 2. On 2/07/2019 at 12:20 PM, the surveyor reviewed the logs with the laboratory supervisor. The laboratory supervisor confirmed the quality control had not been documented. When asked about the quality control for the patient slides, the laboratory supervisor explained the quality control as being an "internal quality control," because it is included within the patient specimen (slide). The laboratory supervisor further stated no determinations had been made on how or if any patients had been affected. 3. The above noted findings were discussed with Testing Personnel #1, the laboratory supervisor and three hospital administrators, during the exit summation on 2/07/19 at 2:40 PM. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of