Skin Care Drs Pa

Summary Statement of Deficiencies D0000 The Skin Care Doctors, PA laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on July 10, 2024. The following condition-level deficiency was cited: 493.1487 Laboratories performing high complexity testing: testing personnel The following standard-level deficiencies were cited: 493.1451 Technical supervisor responsibilities 493.1489 Testing personnel qualifications . D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Technical Supervisor failed to ensure an initial competency assessment was competed for one of one testing personnel in 2024. Findings are as follows: 1. The laboratory performed Mohs Micrographic surgery under the subspecialty of Histopathology as confirmed by the Practice Administrator (PA) during a tour of the laboratory at 1:05 p.m. on 07/10 /24. Mohs Micrographic surgery was suspended September 2022 through December 2023 and reinstated on 01/24/24. 2. Testing Personnel 1 (TP1) performed the high complexity tissue inking component as confirmed by TP1. 3. TP1 obtained a Mohs training certificate in January 2023. Documentation provided on 07/17/24 indicated TP1 did not possess the required education to perform high complexity testing. See D6171. 4. A tissue inking competency assessment procedure was not found in the 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 -- Mohs Policy and Procedure Binder. The laboratory was unable to provide the missing procedure upon request. 5. Initial competency assessment documentation for tissue inking was not found for TP1. The laboratory was unable to provide the missing record upon request. 6. In an interview at 1:00 p.m. on 07/10/24, the PA confirmed the above finding. . 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 education documents and interview and email communication with laboratory personnel, the laboratory failed to ensure personnel performing high complexity testing meet the qualification requirements of 493.1489. Findings are as follows: The laboratory failed to ensure one of one Histopathology testing personnel met the qualification criteria to perform high complexity 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 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 -- 2 of 3 -- 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 document review and interview and email communication with laboratory personnel, the laboratory failed to ensure one of one Histopathology tissue processing personnel met the qualification criteria required to perform high complexity testing in 2024. Findings are as follows: 1. The laboratory performed Mohs Micrographic surgery under the subspecialty of Histopathology as confirmed by the Practice Administrator (PA) during a tour of the laboratory at 1:05 p.m. on 07/10/24. Mohs Micrographic surgery was suspended September 2022 through December 2023 and reinstated on 01/24/24. 2. Testing Personnel 1 (TP1) performed the high complexity tissue inking components confirmed by TP1. 3. TP1 obtained a Mohs training certificate in January 2023. Additional education credentials were not available on date of survey. The laboratory was given five days to provide TP1's education credentials. 4. In an interview at 1:00 p.m. on 07/10/24, the PA confirmed the above finding. 5. In an email received at 9:12 a.m. on 07/17/24, the PA provided TP1's Medical Assistant Associate of Applied Science Degree. This degree did not include the required education to perform high complexity testing. 6. In an email received at 10:11 am on 07/17/24, the PA acknowledged this finding. . -- 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 document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of the single Histopathology test performed in the laboratory at least twice annually in 2021. Findings are as follows: 1. The laboratory performed Mohs micrographic surgery with microscopic examination under the specialty of Histopathology as confirmed by the Histotechnician (HT) during a tour of the laboratory at 1:00 p.m. on 09/13/22. 2. Cases completed by the Mohs surgeon were sent for evaluation twice annually to verify accuracy as established in the Proficiency Testing procedure located in the Mohs Lab Policies and Procedures manual. 3. Documentation of 2021 Mohs case evaluations was not found during review of laboratory records. 4. The laboratory performed approximately 75 Mohs micrographic surgery procedures annually as indicated in laboratory records and listed on Form CMS-116 Clinical Laboratory Improvement Amendments (CLIA) Application for Certification provided by the laboratory on date of survey. 5. In an interview at 1:25 p.m. on 09/13/22, the HT confirmed the above finding. . Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's 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 document review and interview with laboratory personnel, the laboratory failed to document Histopathology quality control (QC) performance for Periodic Acid-Schiff staining each day of use. Findings are as follows: 1. The laboratory performed Histopathology testing using Periodic Acid-Schiff (PAS) stain as confirmed by Histotechnician 1 (HT1) during a tour of the laboratory on 10/10/18 at 10:00 a.m. 2. Policy #380, Periodic Acid-Schiff Stain, located in the Standard Operating procedures manual, indicated the Dermatopathologists documented PAS stain quality in each patient pathology report. 3. Documentation of PAS stain quality was not included in the patient pathology report for case DRS18-658 reviewed on date of survey. 4. In an interview on 10/10/18 at 12:10 p.m., HT1 confirmed the performance of the PAS stain had not been documented in the patient pathology report. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 document review and interview with laboratory personnel, the laboratory failed to perform and document activities used to verify the accuracy of Microbiology test procedures at least twice annually in 2017. Findings are as follows: 1. The laboratory performed Microscopic Examinations for fungus and parasites under the specialty of Microbiology as confirmed by the Histotechnician (HT) during a tour of the laboratory on 06/18/18 at 10:05 a.m. 2. Laboratory records indicated 5 fungal examinations and 1 parasite examination had been performed in 2017. 3. Documentation of 2017 Microscopic Examination verification of accuracy was not found in laboratory records. The laboratory was unable to provide verification of accuracy documentation from 2017 upon request. 4. In an interview on 06/18/18 at 12: 00 p.m., the HT confirmed Microscopic Examination accuracy had not been verified in 2017. 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: 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 -- . Based on document review and interview with laboratory personnel, the laboratory failed to include a procedure for microscopic examinations in the procedure manual. Findings are as follows: 1. The laboratory performed Microscopic Examinations for parasites under the specialty of Microbiology as confirmed by the Histotechnician (HT) during a tour of the laboratory on 06/18/18 at 10:05 a.m. 2. A written procedure for the microscopic examination of parasites was not found during review of the Skin care Doctors Mohs Lab Sartell Policy and Procedure manual. The laboratory staff was unable to provide a procedure upon request. 3. In an interview on 06/18/18 at 12:05 p. m., the HT confirmed the above finding. -- 2 of 2 --