Ssm Health Dermatology

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/29/2021. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the Mohs technician at the conclusion of the survey. 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 a review of records and interview with the Mohs technician, the laboratory failed to document the reactivity of the H&E (Hematoxylin & Eosin), stain each day of testing for 1 of 10 days. Findings include: (1) On 01/29/2021 at 09:50 am, the Mohs technician stated to the surveyor the laboratory performed microscopic interpretations of histology (Mohs and skin biopsies) specimens that had been stained with H&E (Hematoxylin & Eosin) stain; (2) The surveyor reviewed test records for 10 days of patient testing (microscopic interpretations) performed from 03/29/2019 through 11/30/2020. There was no evidence the reactivity of the stain had been observed for acceptability for the 1 of the 10 days. The specific date of testing was 12 /12/2019; (3) The surveyor reviewed the findings with the Mohs technician, who stated on 01/29/2021 at 11:20 am, there was no documentation to prove the reactivity of the stain had been observed. 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 D0000 The findings were reviewed with the histotechnician at the conclusion of the survey. 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: Based on a review of records, manufacturer's instructions, and interview with the histotechnician, the laboratory failed to ensure the manufacturer's environmental specifications were met. Findings include: (1) At the beginning of the survey, the histotechnician stated to the surveyor, the laboratory performed frozen sections of tissues obtained during Mohs surgical procedures and from biopsies. The tissues were processed using two Avantik Cryostat QSII cryostats and stained with H&E (Hematoxylin and Eosin) and examined microscopically for diagnosis; (2) The surveyor reviewed the manufacturer's environmental requirements for the cryostats. The manufacturer required a humidity of less than 60%; (3) Records were reviewed from 14 months (July, August, September, and December 2016; January, April, May, June, July, October, and December 2017; and February, March and April 2018) and the surveyor identified 3 days of patient testing when the humidity was unacceptable at 60%: (a) July 2016: Day 22 (b) August 2016: Day 4 (c) July 2017: Day 31 (4) Although