Summary:
Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory procedure, 2024 Hematoxylin and Eosin (H & E) quality control (QC) logs and 2024 patient testing logs 02/03/25, the laboratory failed to document QC for the H & E testing approximately 2 of 40 days in which patient testing was performed. Findings: Review of laboratory procedure "MOHS H & E STAIN PROCEDURE - MANUAL" revealed "3....When the Q.C. slide is finished review for quality of stain, document on the Q.C. Stain Setup Sheet,...". Review of 2024 H & E QC logs revealed the laboratory failed to document QC on 2 of approximately 40 days; 05/09/24 and 11/12/24. Review of 2024 patient testing logs revealed 2 patients were tested on 05/09/24 and 1 patient was tested on 11/12/24. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory personnel records and interviews with 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 3 -- Director (LD) and Testing Personnel (TP) 02/03/25, TP #2 does not meet the educational requirements to perform grossing of dermatopathology specimens; high complexity testing. Findings: See D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; or (b)(2)(i) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(2)(ii) Be qualified under the requirements of 493.1443(b)(3) or 493.1449(c)(4) or (5); or (b)(3)(i) Have earned an associate degree in a laboratory science or medical laboratory technology from an accredited institution or (b)(3)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes (b)(3)(ii) (A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either (b)(3)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(3)(ii)(A)(2) 24 semester hours of science courses that include (b)(3)(ii)(A)(2)(i) 6 semester hours of chemistry; (b)(3)(ii)(A)(2)(ii) 6 semester hours of biology; and (b)(3)(ii)(A)(2)(iii) 12 semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(3)(ii)(B) Have laboratory training that includes: (b)(3)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES or the CAAHEP (this training may be included in the 60 semester hours listed in paragraph (b)(3)(ii)(A) of this section); or (b)(3)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing; or (b)(4) Successful completion of an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and having held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(5) Notwithstanding any other provision of this section, an individual is considered qualified as a high complexity testing personnel under this section if they were qualified and serving as a high complexity testing personnel in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. (b)(6) For blood gas analysis (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3), (4), or (5) of this section; or (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b) (6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution. (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (f) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records and interviews with Laboratory Director (LD) and Testing Personnel (TP) 02/03/25, TP #2 does not meet the educational requirements to perform the grossing of dermatopathology specimens - high complexity testing. Findings: Review of laboratory personnel records revealed TP #2 has an associates degree in medical assisting. The associates degree does not meet the education requirements to perform the grossing of dermatopathology specimens - high complexity testing. Interview with TP #2 at approximately 10:30 a. m. confirmed their highest level of education is an associates degree in medical assisting. During exit interview at approximately 12:00 p.m. the LD stated TP #2 has been trained to perform grossing, but they were unaware that an associates degree in -- 2 of 3 -- medical assisting did not qualify TP #2 to perform grossing of dermatopathology specimens - high complexity testing. -- 3 of 3 --