Skin Cancer Center Of Fairfield County

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to follow their established policies and procedures in the subspecialty of mycology. Findings Includes: 1. Record review on 02/11/2025 of the laboratory's 'KOH Proficiency and Review' binder revealed lack of documentation of 2 proficiency testing reviews by 2 of 5 testing personnel for 2024. 2. Record review on 02/11/2025 of the laboratory's 'KOH/Scabies Training, Competency & Proficiency Review Policy' revealed 'Employees performing KOH testing will complete 2 proficiency reviews annually which will be read and signed by another person qualified to read KOHs the same day'. 3. Staff interview on 02/11/2025 at 11:30 AM with testing personnel #1 confirmed the above findings. 4. The laboratory performs 16 potassium hydroxide preparation/scabies tests annually in the subspecialty of mycology. 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 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 and staff interview, the laboratory failed to use in date reagents. Findings include: 1. Surveyor observation of the laboratory's Potassium Hydroxide (KOH) reagent on 6/14/21 at 10:45 AM revealed, the HealthLink KOH 10% (Cat# 1815) and lot # 1904311 reagent expired on 2/12/20. 2. Record review on 6 /14/21 of the laboratory's KOH billing records revealed the laboratory performed 23 KOH tests in 2020 and 17 KOH tests to-date in 2021 in the sub-specialty of Mycology. 3. Staff interview with testing personnel #2 on 6/14/21 at 11:15 AM confirmed the above findings. D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview the laboratory failed to document and maintain records of patient test results. Findings include: 1. Surveyor observation on 6/14/21 at 11:00 AM of the Potassium Hydroxide (KOH) test log revealed 2 of 3 testing personnel (TP) failed to document patient KOH test results in 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 -- the log. 2. Record review of the KOH test log on 6/14/21 revealed records of patient KOH test log was not available in 2020 and prior to 3/15/21. 3. Record review on 6/14 /21 of the laboratory's KOH billing records revealed the laboratory performed 23 KOH tests in 2020 and 17 KOH tests to-date in 2021 in the sub-specialty of Mycology. 4. Staff interview with TP#2 on 6/14/21 at 11:15 AM confirmed the above findings. -- 2 of 2 --