Summary:
Summary Statement of Deficiencies D0000 A Recertification survey was performed on March 21, 2022 at Dermatology Associates of SWLA, LLC, CLIA ID # 19D2062017. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 observation by surveyor and interview with personnel, the laboratory failed to ensure supplies did not exceed expiration date. Findings: 1. Observation by surveyor during the laboratory tour on March 21, 2022 at 1:29 pm revealed the following expired items: Cancer Diagnostic, INC Red Tissue Marking Dye, Lot 9203, Expiration Date: 2021-07-01, Quantity: one (1) bottle (located on counter, in-use) Cancer Diagnostic, INC Blue Tissue Marking Dye, Lot 9252, Expiration Date: 2021- 09-30, Quantity: one (1) bottle (located on counter, in-use) Cancer Diagnostic, INC Black Tissue Marking Dye, Lot 9253, Expiration Date: 2021-09-30, Quantity: one (1) bottle (located on counter, in-use) Cancer Diagnostic, INC Green Tissue Marking Dye, Lot 9254, Expiration Date: 2021-09-30, Quantity: one (1) bottle (located on counter, in-use) Cancer Diagnostic INC Yellow Tissue Marking Dye, Lot 9252, Expiration Date: 2021-09-30, Quantity: two (2) bottles (located in drawer) Cancer Diagnostic INC Violet Tissue Marking Dye, Lot 9246, Expiration Date: 2021-09-30, Quantity: two (2) bottles (located in drawer) Cancer Diagnostic INC Orange Tissue Marking Dye, Lot 9255, Expiration Date: 2021-09-30, Quantity: one (1) bottle (located on counter, in-use) Cancer Diagnostic INC Red Tissue Marking Dye, Lot 9249, Expiration Date: 2021-09-30, Quantity: one (1) bottle (located in drawer) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Cancer Diagnostic INC Green Tissue Marking Dye, Lot 9360, Expiration Date: 2021- 12-31, Quantity: one (1) bottle (located in drawer) Formalin, Prep date: 5/15/18, Expiration Date: 2/2022, Quantity: one (1) gallon bottle Leica Surgipath Clearium Mounting Medium, Lot 042219, Expiration Date: 2021-04-22, Quantity: seven (7) bottles 2. In interview on March 21, 2022 at 1:35 pm, Testing Personnel 1 confirmed the identified marking dyes were expired. Testing Personnel 1 further stated she fills the in -use bottles with marking dyes located in the drawer. Surveyor did not observe secondary labeling on the expired marking dyes. 3. In further interview on March 21, 2022 at 1:45 pm, Testing Personnel 1 stated the formalin is received from from Pathology department. Testing Personnel 1 stated the laboratory does not use the Clearium mounting medium. Testing Personnel 1 confirmed the items identified were expired. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of maintenance logs and interview with personnel, the laboratory failed to ensure monthly maintenance for the air vent was performed as required for twenty four (24) of twenty six (26) months reviewed. Findings: 1. Review of the laboratory's "Fume Hood/Air Vent Log" revealed the following instructions: a) "The air vent of fume hood shall be turned on as soon as the lab is open for operation, shall remain on during operating hours. At all times the stains are to remain under the hood (if applicable)." b)" Dust air vent monthly, document by using the letter D" c) "Replace filter as required by manufacture [sic], document" d) "Grounding to be checked and documented annually" 2. Review of the laboratory's "Fume Hood/Air Vent Log" for 2020, 2021, and 2022 revealed the laboratory did not document the air vent monthly maintenance for the following months: 2020: January through June and September through December 2021:January through December 2022: January and February 3. In interview on March 21, 2022 at 2:45 pm, Testing Personnel 1 stated she had not been documenting the monthly air vent maintenance. 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