Skin Care Ctr Of Southern Illinois

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory's clinic manager JB; the laboratory failed to follow it's policy and procedure for specimen handling in the specialty of pathology for three of six sets of patient slides reviewed for Mohs histopathology. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the procedure, "Mohs Overview", which stated the following under the "Sectioning" section on page two of three: "1. Labe each slide with patient name, case number, stage, and section number." 2. During the survey on 10-21-2021 at 1:10 pm, direct observation of three of six sets of patient slides for Mohs histopathology testing were not labeled as indicted in the laboratory's procedure, "Mohs Overview". a. Patient Identification: P1 - Three of Four slides were improperly labeled P2 - One of Two slides were improperly labeled P9 - Seven of Nine slides were improper labeled 3. On survey date 10-21-2021 at 1:20 pm the clinic manager JB confirmed the procedure for Mohs slide labeling was not followed for three of six sets of patient slides reviewed. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must 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 -- be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to document reactivity of hematoxylin and eosin (H&E) staining for four of four patient testing dates reviewed. Findings Include: 1. Review of the laboratory procedure, "Quality Assurance Procedure", states H&E staining quality is checked daily. 2. Review of the "Mohs Maintenance" logs found a qualified testing personnel/technical supervisor failed to document H&E staining acceptability for four of four patient testing dates reviewed. Patient Identification Date P1 09-22-2021 P2 08-25-2021 P3 08-11-2021 P11 10-08-2021 4. Interview on 10-21-2021, at 11:00 am, the LD confirmed the facility failed to document the H&E staining acceptability each time of use in 2021 by a qualified testing personnel/technical supervisor. 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 records and interview with the clinic manager JB; the laboratory failed to have 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 histopathology. Findings Include: 1. The laboratory failed to ensure one of four testing personnel (TP) were qualified for high complexity histopathology testing. 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 have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical -- 2 of 3 -- laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (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; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the clinic manager JB; the laboratory failed to ensure one of four testing personnel were qualified for high complexity histopathology testing. Findings Include: 1. Review of educational documentation for one of four testing personnel identified on the CMS-209 (Laboratory Personnel Report) failed to meet the educational requirements for high complexity testing. a. TP#3 -Associates Degree in Histotechnology, no transcripts provided. 2. On survey date 10-21-2021, at 1:20 pm, the above findings were confirmed by the the clinic manager JB. -- 3 of 3 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to perform bi-annual method accuracy evaluations for histopathology testing in 2017 and 2018. Findings Include: 1. Review of proficiency testing documentation revealed the laboratory only documented histopathology method accuracy evaluations once in both 2017 and 2018. a. 2017 Dermatopathology Proficiency Test - 10-20-2017 b. 2018 Dermatopathology Proficiency Test - 01-29- 2018 2. Interview with the LD on 06-18-2019, at 12:50 pm, confirmed that the laboratory failed to perform bi-annual method accuracy verifications for histopathology testing in 2017 and 2018. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to have a procedure manual for histopathology testing. Findings Include: 1. Review of laboratory records revealed the laboratory failed to 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 -- have a procedure manual for histopathology testing. 2. On survey date 6-18-2019, at 12:50 PM, the LD confirmed the procedure manual had been misplaced and no histopathology procedure manual was available for review. -- 2 of 2 --