Psoriasis And Eczema Treatment Center

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager, the laboratory failed to document the evaluation of unsatisfactory results and

Summary Statement of Deficiencies D5006 MYCOLOGY CFR(s): 493.1203 If the laboratory provides services in the subspecialty of Mycology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1263, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on record review and interview with the Office Manager, the laboratory failed to meet the subspecialty of mycology requirements as specified in 493.1230 through 493.1256, 493.1263, and 493.1281 through 493.1299. Findings include: 1. The laboratory failed to follow written procedures for the use of Dermatophyte Test Media (DTM). Refer to D5401. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 interview with the Office Manager, the laboratory failed to follow written procedures for the use of Dermatophyte Test Media (DTM) for 2 (Patients 19132 and 62188) of 4 patient test records reviewed. Findings include: 1. A review of the laboratory's "Laboratory Procedure Fungal Culture" revealed a section titled "Test Procedure" stating, "examine the culture before 2 weeks for color and growth." 2. A review of the "ACU-DTM Dermatophyte Test Media Directions For 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 -- Use" revealed a section titled "Results" stating, "The test medium may be examined for color change from yellow to red after 24 hours. Most pathogenic dermatophytes will produce full color change in 3-7 days." and "Color interpretation of the test is questionable after 14 days due to the possibility of false positives." 3. A review of patient test records revealed the following patients with more than 14 days between collection and reading: a. Patient 19132 was collected on 5/1/19 and reported on 5/20 /19 with the reported result of negative. b. Patient 62188 was collected on 1/23/20 and reported on 3/27/20 with the reported result of positive. 4. An interview on 1/26/21 at 11:01 am with the Office Manager confirmed the laboratory did not read the cultures for the patients listed above according to their policy. -- 2 of 2 --

Summary Statement of Deficiencies D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to retain the authorization requisition for the histopathology testing and the gross description of the biopsy specimen for six (1-2 and 6-9) of nine patient charts audited. Findings include: 1. On June 21, 2018 at 1:10 PM, record review for six (1-2 and 6-9) of nine patient charts audited revealed the laboratory failed to retain on-site the authorization requisition for the histopathology testing and the gross description of the biopsy specimen. 2. On June 21, 2018 at 1:10 PM, the laboratory was given to the end of the survey to supply the necessary documents and the documents were not received. 3. During the interview on June 21, 2018 at 1:10 PM, the office staff confirmed the authorization requisition was not available on the day of the survey. 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 --