Ridgeview Professional Building-Specialty Clinic

Summary Statement of Deficiencies D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to document the time patient specimens were received into the laboratory for 2021 and 2022. Findings are as follows: 1. The laboratory performes Mohs Micrographic Surgery under the subspecialty Histopathology as confirmed by the Mohs Histotechnician (M-HT) during a tour of the laboratory at 10:40 a.m. on 01/11 /23. 2. In an interview during the tour of the laboratory at 10:50 a.m. on 01/11/23, M- HT confirmed the time each specimen is received into the laboratory is not documented on the Mohs map or elsewhere. He confirmed there is a spot on the Mohs map for this to get documented however it is not being filled out by laboratory staff. 3. Requirements for documentation of patient specimen (tissue) receipt time into the laboratory were not found in the Mohs Procedure Manual. 4. The time of tissue receipt into the laboratory was not documented in testing records for four of four cases reviewed on date of survey. For each case there was a space on the Mohs Surgical Map to document the "time in" for each stage (patient tissue specimen). The spaces were left blank. See below: Patient Accession # Date of test # of Stages M21-142 06 /22/2021 1 M21-329 11/23/2021 2 M22-98 04/14/2022 2 M22-234 09/01/2022 1 5. In an interview on at 11:52 a.m., the M-HT confirmed the above findings. The laboratory performs Mohs on approximately 410 patients annually. The number of patient tissue samples (stages) varies with each patient. 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 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 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 2 of 2 Histopathology tissue processing personnel met the qualification criteria to perform highly complex 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 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 -- 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 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 with laboratory personnel, the laboratory failed to ensure 2 of 2 Histopathology tissue processing personnel met the qualification criteria required to perform high complexity testing. Findings are as follows: 1. The laboratory performed Mohs Micrographic surgery under the subspecialty of Histopathology as confirmed by Testing Personnel 5 (TP5) during a tour of the laboratory at 1:05 p.m. on 05/12/21. 2. During the tour, TP5 stated she and 1 other testing personnel (TP) prepared tissue obtained during the Mohs Micrographic surgery procedure and began performing the highly complex tissue inking component on 03/23/21. 3. Education credentials reviewed on date of survey indicated the TP performing tissue inking did not meet the minimum educational requirements needed to perform high complexity testing. See below. TP Education credential TP5 Registered Medical Assistant TP6 Certified Medical Assistant 4. Laboratory records -- 2 of 3 -- indicated inking was performed by unqualified personnel on 32 patients between 03/23 /21 and 05/11/21. 5. In an interview at 2:00 p.m. on 05/12/21, TP5 confirmed the above finding. -- 3 of 3 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to ensure the address of the performing laboratory on a test report was accurate. Findings are as follows: 1. The laboratory performed Dermatopathology testing as confirmed by the Histotechnician during a tour of the laboratory on 1/25/19 at 8:05 a. m. 2. A patient test report reviewed on date of survey did not include the correct address of the performing laboratory: Case #: 18-349 Patient: Female / 86 yrs Date of Service: 12/4/2018 Correct Address: 560 South Maple Street, Waconia, MN 55387 Address as Shown: 111 Hundertmark Road, Chaska, MN 55318 3. In an interview on 1/25/19 at 9:45 a.m., the Histotechnician confirmed the above findings. . 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 --