Springfield Clinic - Mohs/ Attn Labo Director

Summary Statement of Deficiencies D0000 A recertification survey was conducted on May 19th, 2026 by the State of Illinois Department of Public Health. The laboratory was found to be out of compliance with CLIA regulations (42 CFR Part 493) for the following condition- level deficiencies: D6168 - 42 C.F.R. 493.1487 Condition: Laboratories performing high complexity testing; Testing personnel 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, and interview with the laboratory representative, the laboratory failed to ensure one of four testing personnel met the educational requirements of 493. 1489 for 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 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 -- 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 the CMS-209 (Laboratory Personnel Report) Form, laboratory personnel records, and interview with the laboratory representative, the laboratory failed to ensure one of four testing personnel met the educational requirements of 493. 1489 for the subspecialty of Histopathology. Findings include: 1. Review of the CMS- 209 (Laboratory Personnel Report) Form revealed four testing personnel (TP) performing high complexity testing in the subspecialty of histopathology. 2. Review of personnel educational documentation revealed one of four TP (TP#4) failed to meet the educational requirements to qualify as a high complexity testing personnel. TP #4 failed to have the required 6 credit hours in chemistry and failed to have the required 12 additional hours in any combination of biology, chemistry, or medical laboratory science. 3. Interview with the laboratory representative on 05/19/2026, at 10:30 am, confirmed one of four TP, TP #4, failed to meet educational requirements to qualify as a high complexity TP. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on lack of documentation, laboratory policy and procedure manual, and interview with testing personnel (TP) #2; the laboratory failed to establish policies and procedures to assess employee competency for Mohs histopathology testing. Findings Include: 1. Review of the laboratory's policy and procedure manuals found the laboratory lacked a competency assessment policy for Mohs histopathology testing. 2. On survey date 10-07-2024, at 11:30 am, TP#2 confirmed the laboratory failed to establish a competency assessment policy for Mohs histopathology testing. 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 direct observation of laboratory testing supplies and interview with laboratory testing personnel (TP) #2; five of ten lots of marking dyes for the inking /grossing of Mohs histopathology specimens were expired. Findings Include: 1. During a tour of laboratory on 10-07-24 at 11:53 am the surveyor observed five of ten marking dye reagents that had exceeded the expiration date. a. Avantik Red Marking 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 -- Dye Lot #:133856 EXP date: 12-31-23 b. Avantik Blue Marking Dye Lot #:141560 EXP date: 02-29-24 c. Avantik Black Marking Dye Lot #:139190 EXP date:01-31-24 d. Avantik Green Marking Dye Lot #:135894 EXP date: 12-31-23 e. Avantik Yellow Marking Dye Lot #:136800 EXP date: 12-31-23 2. On survey date 10-07-24, at 11:54 am TP#2 confirmed the marking dyes identified were expired. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with testing personnel (TP) #2; the laboratory director failed to establish and follow written policies and procedures for monitoring, assessing, and correcting problems for Mohs histopathology testing. Findings Include: 1. No documentation of a written quality assessment plan was available for review by surveyors on date of survey 10-07-24. 2. On survey date 10-07-24, at 09:30 am TP#2 confirmed the laboratory director failed to establish a quality assessment plan for Mohs histopathology testing. D6126 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(vi) The procedures for evaluation of the competency of the staff must include, but are not limted to assessment of problem solving skills. This STANDARD is not met as evidenced by: Based on review of the laboratory's competency assessment records and interview with laboratory testing personnel (TP) #2; the technical supervisor failed to evaluate and document problem solving skills as part of the competency assessment for Mohs histopathology testing for four of four competency assessments reviewed. Findings Include: 1. Review of the laboratory's records identified the competency assessment form titled, "Mohs competency assessment Springfield clinic", which included 15 skills to be assessed for TP competency but failed to include assessment of problem- solving skills. 2. Review of four of four competency assessment records from 2022 through 2024 for TP #2 failed to include an assessment of problem solving skills. 3. Interview with TP #2 at 11:30 am on 10-07-2024 confirmed the lab failed to assess personnel problem solving skills as part of the competency assessments. -- 2 of 2 --