Shoreline Skin Corporation

Summary Statement of Deficiencies 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 surveyor review of laboratory records and interview with staff, the laboratory has not documented and retained records of reagents and stains used in testing including lot numbers and expiration dates. Findings include: 1. Review of laboratory records showed reagent inventory logs that were not completed. No reagent inventory records were available for the last two years. 2. Interview with staff A on August 16, 2021 at 10:15 AM confirmed the laboratory did not document lot numbers and expiration dates of reagents and stains used for testing in the laboratory. Further interview confirmed the laboratory had no records to show when the eosin or hematoxylin stains or 95 % alcohol had expired. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other 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: Based on surveyor observation of laboratory supplies and interview with staff, the laboratory used several expired supplies for slide staining and preparation. Findings include: 1. Observation of stains and supplies in the laboratory on August 16, 2021 at 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 -- 10:20 AM revealed one bottle of Cover Safe, lot 16012934 with an expiration date of March 29, 2018 was available for use with the stain line. No supply of hematoxylin or eosin stain and no 95% alcohol was available in the laboratory. 2. Interview with laboratory personnel, staff A, on August 16, 2021 at 10:20 AM confirmed the Cover Safe was expired and in use. Further interview confirmed the hematoxylin and eosin stain and 95% alcohol had expired and were discarded. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of quality assurance records and interview with the laboratory director, the laboratory did not perform twice annual accuracy verification in 2018 for Mohs procedures. Findings include: 1. Review of quality assurance records showed no evidence the laboratory performed accuracy verification for Mohs testing in 2018. 2. Interview with the laboratory director on August 14, 2019 at 9:00 AM confirmed the laboratory did not complete accuracy verification procedures in 2018. This is a repeat deficiency previously cited on August 2, 2017. 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 --