Pinnacle Dermatology

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Through observation, lack of documentation and interview it was determined the laboratory failed to monitor room temperature in one of two rooms in which supplies with storage temperature requirement were stored. Findings follow: A) During a tour of the laboratory on 02/24/20 at approximately 10:30 AM, 250 BD SST Blood Collection Tubes Lot # 8274451, expiration date 2020-9-30, 350 BD EDTA Blood Collection Tubes Lot # 9260566 expiration date 2021-1-31 and 300 BD Red Top blood collection tubes lot # 8278809 expiration date 2020-9-30, all with a storage temperature requirement of 4 degrees C. to 25 degrees C. were observed stored in a storage room separate from the laboratory . B) Upon request, the laboratory was unable to provide records of room temperature in the separate storage room. C) In an interview on 02/24/20 at approximately 11:00 AM, the technical consultant, identified as number three on the CMS 209 form, stated that the laboratory did not monitor the room temperature in the storage room identified above. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other 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 -- supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Through observation, interview and review of the "MOHS Surgery" log it was determined that the laboratory utilized expired staining supplies for five months during which 72 MOHS surgery procedures were performed. Findings follow: A) During a tour of the laboratory on 2/24/20 at approximately 10:30 AM, one of one bottle of Avantic UltraClear lot # 1708164 with an expiration date of 8/19 was observed in the flammable storage cabinet in the laboratory. B) In an interview on 2/24 /20 at approximately 10:30 AM, the laboratory staff member, identified as number 1 on the separate staff identification list, confirmed that the Avantik UltrClear identified above was currently in use and had been in use before August 2019 and since. C) Review of the MOHS Surgery log revealed that 72 MOHS surgery procedures had been performed including slide staining since August 2019 to date. D) In an interview on 2/24/20 at approximately 11:00 AM, the technical consultant, identified as number 3 on the CMS 209 form, confirmed that the laboratory had been using Avantik UltraClear in their staining process after its date of expiration and staining was performed on 72 patients after the product expired. 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

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: . Through a review of Histology patient staining logs, lack of documentation, as well as interviews with staff, it was determined the laboratory failed to document staining quality for Hematoxylin and Eosin (HE) stain on each day of patient testing. As evidenced by: A. A review of patient logs for December 29, 2017 thru July 12, 2018 revealed that HE stains were performed on sixty-eight patients without documentation of HE stain quality controls. Patients tested include patient # 17-001 and patient # 17- 002 tested on 12/29/2017: patient # 18-005, patient # 18-006 and patient #18-007 tested on 2/9/18; patient #18--018, patient #18-019 and patient #18-020 tested on 03 /23/18; patient #18-024, patient #18-025, patient #18-026, and patient #18-027 tested on 04/13/18: patient #18-039, patient #18-040, patient #18-041, patient #18-042 and patient #18-043 tested on 05/11/18: patient # 18-059, patient #18-060, patient #18- 061, patient #18-062, patient #18-063 and patient #18-064 tested on 06/22/18. B. In an interview on 7/12/2018 at 11:30, the technical consultant (as listed on form CMS 209) confirmed the laboratory did not document HE stain quality on the days patients were tested. 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 --