Tri-Cities Skin & Cancer

Summary Statement of Deficiencies D0000 During a recertification survey performed on August 10, 2026, the laboratory was found out of compliance with the following conditions: D6168 42 C.F.R. 493.1487 Condition: Laboratories performing high complexity testing; Testing Personnel D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) (e)(12) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), lack of records, and interview with testing personnel three (TP3), the laboratory director failed to ensure testing personnel four (TP4) had been evaluated and demonstrated accuracy before performing grossing of patient tissue removed during histopathology procedures, with approximately 800 cases done since TP4 began testing on 05.18.2026 until the date of the survey on 08.10.2026. The findings include: 1. Review of the Form CMS-209 revealed that TP4 was listed as a high complexity testing person. 2. No record of documented evaluation of competency or accuracy of test performance for grossing of patient tissue samples removed during histopathology procedures for TP4 by the laboratory director. 3. Interview on 08.10.2026 at 12:15 p.m. with TP3 confirmed the above survey findings. A subsequent interview via electronic communication on 08.18.2026 at 1:34 p.m. confirmed that TP4 performed approximately 800 grossing procedures from 05.18.2026 to the survey date, 08.10.2026. D6168 TESTING PERSONNEL 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 -- 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 a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), review of education documents, and staff interview, testing personnel five (TP5) did not qualify as a high-complexity testing person (Refer to 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 observation of the laboratory, review of testing personnel education -- 2 of 3 -- documents, and staff interview, testing personnel number five (TP5) listed on the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209) failed to meet the high complexity regulatory education requirements for performing grossing of tissue removed during histopathology procedures, with approximately 1500 grossing procedures performed from 03.09.2026 through the survey date of 08.10.2026. The findings include: 1. Observation of the laboratory on 08.10.2026, at 9:30 a.m., revealed one grossing station in use for histopathology testing procedures. 2. Review of education documents revealed that TP5 did not meet the minimum education requirements for performing high complexity testing for grossing of tissue removed during histopathology procedures. 3. Interview on 08.10.2026 at 12:15 p.m. with TP3 confirmed the above survey findings. A subsequent interview via electronic communication with TP3 on 08.18.2026 at 1:34 p.m. confirmed that TP5 performed approximately 1500 grossing procedures from 03.09.2026 to the survey date, 08.10.2026. -- 3 of 3 --

Summary Statement of Deficiencies 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 laboratory observation, review of patient test records, and staff interviews, the laboratory failed to ensure that it did not use potassium hydroxide (KOH) and Chlorazol Black E reagents beyond their expiration for the fungal testing of 55 patients from December 2023 through the survey date (11.12.2024). The findings include: 1. Observation of the laboratory on 11.12.2024 at 9:20 a.m. revealed two bottles of Delasco 10% potassium hydroxide (Lot: K20BC1) with an expiration date of 11.30.2023 and one bottle of Delasco Chlorazol Black E (Lot: K236K3) with an expiration date of 06.30.2024 used for dermatological fungal exams. 2. A review of patient test records revealed the laboratory performed KOH testing on 18 patients from 12.01.2023 to the survey date (11.12.2024) using expired 10% potassium hydroxide reagent and 37 patients from 07.01.2024 to the survey date (11.12.2024) using expired Chlorazol Black E reagent. 3. An interview with the lead histotechnician on 11.12.2024 at 11:45 a.m. confirmed the above survey findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. 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 -- This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report form (CMS-209), the laboratory's Competency Assessment policy, testing personnel (TP) records, and staff interviews, the technical consultant failed to evaluate annual competency for five of seven moderately complex testing personnel performing Potassium Hydroxide (KOH) and Direct Wet Mount patient testing in 2023. The findings include: 1. A review of the CMS-209 revealed seven persons (TP1, TP2, TP3, TP4, TP5, TP6, and TP7) who perform moderately complex patient testing. 2. A review of the "Competency Assessment" policy revealed the following statement: -"To ensure that all laboratory staff members are performing their job duties and responsibilities accurately and proficiently, an annual competency assessment will be performed." 3. A review of the laboratory's testing personnel records revealed no documentation of 2023 annual competency assessments for moderately complex testing personnel, TP1, TP2, TP3, TP5, and TP7, that performed KOH and Direct Wet Mount patient testing in 2023. 4. An interview with the lead histotechnician on 11.12.2024 at 11:45 a.m. confirmed the above survey findings. -- 2 of 2 --