Summary:
Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's staining solutions, and interview with the staff on February 14, 2023, at 3:20 pm, the laboratory failed to label the Mohs slide staining solution with the identity and expiration date. The findings include: 1. The laboratory used an outside service to prepare Mohs slides in house. The outside company brings the staining solution. However, the staining solutions were not labeled. It is the laboratory's responsibility to make sure that the outside company did not use expired reagents while processing slides on site. This deficient practice may have compromised the quality of the service provided and thus harmed patient. 2. The laboratory staff on February 14, 2023, at 3:20 pm, affirmed that the Mohs technician did not label the staining solutions with the identity and expiration dates. 3. The laboratory's testing declaration form, signed by the laboratory director on 2/14/2023, stated that the laboratory performs approximately 2,600 tests, annually. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory 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 -- director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's staining solutions, and interview with the staff on February 14, 2023, at 3:20 pm, it was determined that the laboratory director failed to assure the compliance with the applicable regulations. The findings include: See D5415. -- 2 of 2 --