C P C Pathology

Summary Statement of Deficiencies D5637 CYTOLOGY CFR(s): 493.1274(d)(1)(ii) (d)(1)(ii) Each individual's workload limit is reassessed at least every 6 months and adjusted when necessary. This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with the laboratory representative; the laboratory failed to review and reassess the workload limit of three of three testing personnel (TP) performing primary screenings of nongynecologic cytology slides at least every six months. Findings include: 1. Review of laboratory records revealed a lack of documentation of the review and reassessment of workload limits at least every six months for three of three TP (TP #2, TP #3, and TP #4) performing primary screenings of nongynecologic cytology slides. 2. Interview with the laboratory representative on 11/05/2025, at 11:45 am, confirmed the laboratory failed to review and reassess the workload limit of three of three TP performing primary screenings of nongynecologic cytology slides at least every six months. D5639 CYTOLOGY CFR(s): 493.1274(d)(2)(i) (d)(2) The maximum number of slides examined by an individual in each 24-hour period does not exceed 100 slides (one patient specimen per slide; gynecologic, nongynecologic, or both) irrespective of the site or laboratory. This limit represents an absolute maximum number of slides and must not be employed as an individual's performance target. In addition-- (d)(2)(i) The maximum number of 100 slides is examined in no less than an 8-hour workday; 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with the laboratory representative; the laboratory failed to establish a maximum workload limit for three of three testing personnel (TP) performing primary screening of nongynecological cytology slides irrespective of the site or laboratory. Findings include: 1. Review of laboratory records revealed three TP (TP #2, TP #3, and TP #4) performed primary screenings of nongynecologic cytology slides at Laboratory A. 2. Interview with the laboratory representative on 11/05/2025, at 11:38 am, revealed TP #2 and TP #3 also performed primary screenings of nongynecologic cytology slides at Laboratory B. 3. Review of laboratory records revealed a lack of documentation of the screening time of nongynecologic cytology slides TP #2, TP #3 and TP #4 screened irrespective of the site or laboratory. 4. Interview with the laboratory representative on 11/05/2025, at 11:45 am, confirmed the laboratory failed to establish a maximum workload limit for three of three TP performing primary screening of nongynecological cytology slides irrespective of the site or laboratory. 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 the CMS-209 (laboratory Personnel Report) Form, laboratory personnel records, lack of documentation, and interview with the laboratory representative; the laboratory failed to ensure 2 of 15 testing personnel were qualified for high complexity testing in the subspecialty of histopathology. 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) -- 2 of 3 -- 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 the CMS-209 (laboratory Personnel Report) Form, laboratory personnel records, lack of documentation, and interview with the laboratory representative; the laboratory failed to ensure 2 of 15 testing personnel (TP) were qualified for high complexity testing in the subspecialty of histopathology. Findings include: 1. Review of the CMS-209 (Laboratory Personnel Report) Form revealed 15 TP performing high complexity testing in the subspecialty of histopathology. 2. Review of personnel educational documentation revealed 2 of 15 TP (TP #11 and TP #13) failed to meet education requirements to qualify as high complexity TP. 3. Interview with the laboratory representative on 11/05/2025, at 11:30 am, confirmed the laboratory failed to ensure 2 of 15 testing TP were qualified for high complexity testing in the subspecialty of histopathology. -- 3 of 3 --