Clear Choice Dermatology Lab Salem

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 review of the current CMS 209 form, the CMS 209 form from the previous survey dated 12/12/2023, and interview with the Laboratory Manager, the Laboratory Director (LD) failed to ensure that a procedure for assessing all personnel who are listed on the CMS 209 form as holding a Federal Title (TC, Technical Consultant, TS, Technical Supervisor, GS, General Supervisor) was established and that competency assessment of those personnel holding such titles was performed annaully or as stated in the procedure for Federal Title Assessments. Findings include: 1. Upon request for a procedure for assessing personnel who hold a federal title, none could be produced. 2. Upon request for documentation for assessment for all personnel listed on either CMS 209 forms, holding a federal title (TS), none could be produced. 3. The CMS 209 form from the survey conducted 12/12/2023 listed one (1) person as a TS. (TS #1). The CMS 209 form from current survey listed one (1) person as the TS. This is not the same person as listed on the previous survey's CMS 209 form. (TS #2). 4. Interview with the Lab Manager confirmed that there was no procedure or policy for assessing laboratory personnel who hold a federal title of TS, TC, or GS, nor was he aware of any competencies by federal title of the personnel in question (TS #1 and TS #2). 5. The laboratory reports performing 31,990 histological stains and grossing procedures annually. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of competency assessments, laboratory procedures, peer review records and current CMS 209 form, the Laboratory Director (LD) failed to fulfill the duties of the LD. Findings include: 1. See D6093, D6103, D6107 D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and 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 the lack of peer review documentation for each Pathologist reading and interpretting histological slides, interview with the Lab Manager and interview with the Laboratory Director (LD) by phone 01/15/2026, the LD failed to ensure that each Pathologist listed on the CMS 209 form for surveys dated 12/12/2023 and 01/06/2026 had written evidence of peer review at least twice per year. Findings include: 1. Upon request for twice yearly peer review documentation for three (3) individuals listed on the 12/12/2023 CMS 209 form for reading and interpretting histological slides for 2024 & 2025, none could be produced for TP #5 & TP #6. One (1) documented peer review in 2025 was reviewed for TP#4, none could be produced for 2024. 2. Upon request for twice yearly peer review documentation for the four (4) individuals listed on the 01/06/2026 CMS 209 form, (TP #4, TP #5, TP #7 and TP #8) for reading and interpretting histological slides for 2024 and 2025, some could not be produced. TP #6 had no testing in 2024 & 2025, according to the LD by phone 01/15/2026 at 3:00 pm. a. TP # 4 lacked documentation for twice annually peer review for 2024 and one for 2025. b. TP # 5 lacked documentation for twice annually peer review for 2024 ( on leave for 2025). c. TP # 7 lacked training documentation and evidence of twice annually peer review for 2025. d. TP #8 lacked documentation for twice annually peer review for 2024 & 2025. (TP #8 left this facility for Alaska 12/2025). 3. Interview with the Lab Manager at 1:30 pm confirmed that there was no other peer review documentation to his knowledge. 4. Phone interview with the LD on 01/15/2026 at 3: 00 pm confirmed that there were missing peer review competencies for all of the seven (7) TP reading and performing histological slide interpretation for 2024 and 2025. 5. The laboratory reports performing 31,990 histological stains and grossing procedures annually. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) (e)(13) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) competency assessments submitted for review during survey, lack of a detailed procedure for the assessment of TP performing grossing on human tissues, TP performing interpretation of stained histological tissues on slides and interview with the Lab Manager, the Laboratory Director (LD) failed to ensure approved written policies and procedures for the assessment of all testing personnel (TP) involved with any of the three (#) phases of laboratory testing were established and being followed. Findings include: 1. Upon review of the procedure manual, competency assessments submitted for review during survey for TP performing grossing or microscopic interpretation of histological slides the LD failed to ensure all TP had access to a competency assessment procedure for all persons performing high complexity testing, including initial training and written records of cases reviewed and used in assessment applicable to this training and that it was being followed. 2. Review of the competency assessments for the six (6) TP currently performing grossing revealed no detail as to how competency was determined for each of the six (6) elements for personnel performing grossing on human tissues. Further review revealed an unqualified person was performing the competency assessments for grossing TP, including his own competency assessment. 3. Request for a written policy or procedure for monitoring TP who perform grossing on human tissues failed to yield such policy or procedure. 4. Requests for bi-annual peer review policy and 2024 & 2025 peer review records for the four (4) providers listed on the CMS 209 form failed to yield two (2) peer review documents / year for each TP for 2024 & 2025. See D6093 5. No written record of cases reviewed for each of the six (6) individual's performing grossing prior to being allowed to do grossing un-assisted could be produced. 6. Interview with the Lab Manager at 12:30 pm confirmed that there was no procedure or policy for performing competencies on persons performing grossing nor was there a specific number of cases required to be performed for grossing, before that specific TP was approved to gross on his or her own. 7. Interview by phone with the LD on 01/15/2026 at 3:00 pm confirmed there was no policy or procedure that stated the required number of successful grossing cases required for competence and be deemed competent to gross human tissues without oversight. 8. The laboratory reports performing 31,990 histological stains and grossing annaully. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) (e)(15) Specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of personnel documents, CMS form 209 and interview with the Lab Manager, the Laboratory Director (LD) failed to provide a current and complete list of all persons involved in any of the three (3) phases of laboratory testing, including pre- analytic, analytic and post analytic and to what extent each person is allowed to perform the test and if oversight or supervision is required, since last survey 12/12 -- 3 of 4 -- /2023. Findings include: 1. This is a repeat citation. 2. A current list of all laboratory personnel, including lab assistants, performing any phase of testing and "who was allowed to do what" since the last survey could be produced. 3. Interview with the Lab Manager at 1230 pm confirmed that the requested document could not be found. 4. The laboratory reports performing 31,990 histological stains and grossing of human tissues annaully. -- 4 of 4 --

Summary Statement of Deficiencies D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) educational documentation, competency assessments and interview with the Laboratory Director (LD), the LD failed to ensure that the person listed on the CMS 209 form as General Supervisor (GS) and as a testing personnel (TP) had the requisite education and documentation required by CLIA on file for this laboratory. Findings include: 1. While on site for survey 12/12 /2023, the LD could not produce educational documentation or clinical experience for TP 1, listed on the CMS 209 form as a TP and as the General Supervisor (GS). 2.The LD and GS / TP1 confirmed during interview 12/12/2023 at 12:15 pm that they did not have the competency assessments for the person listed on the CMS 209 formTP2 readily available for my review. 3. Upon review of the grossing competency assessments for TP2 submitted to me after the survey 12/12/2023 by email 12/15 /2023, the grossing competencies dated 4/14/2023 and 10/3/2023 failed to include the 6 elements of assessment required for competency assessment for those performing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- moderate and high complexity testing, in this case, grossing of human tissues.. 4. The laboratory reports performing 880 Mohs surgical procedures and 7975 Histopathology specimens processed and interpreted annually D6100 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(10) The laboratory director must ensure that a general supervisor provides on-site supervision of high complexity test performance by testing personnel qualified under 493.1489(b)(4). This STANDARD is not met as evidenced by: Based on review of educational documents and competencies produced for my review during survey and interview with testing personnel (TP1) and the Laboratory Director (LD), the LD failed to ensure the person listed on the CMS 209 form as the General Supervisor (GS) was qualified to perform the duties of a GS, by education and / or experience. Findings include: 1. Upon review of the educational documents provided for my review during survey, no documentation of education or experience for the GS (also TP1) could be produced. 2. When asked to provide evidence of education for the GS /TP1 twice (2x) post survey, the laboratory failed to provide evidence of education or experience within the 10 day post survey time line. 3. Interview with the LD during survey at 12:15 pm confirmed the laboratory did not have evidence of education or experience for GS/TP1 listed on the CMS 209 form. 4. Received by email from TP1 on 12/20/2023, GS/TP1 confirmed that she had no evidence of education or experience to provide to me. 5. The laboratory reports performing 880 Mohs surgical procedures and 7975 Histopathology specimens processed and interpreted annually. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual provided for my review during survey and interview with the General Supervisor (GS, / TP 1) and the Laboratory Director (LD), the LD failed to ensure an approved and current procedure manual, signed and dated indicating his approval was available to all testing personnel (TP). Findings include: 1. Upon review of the current procedure manual presented for my review during survey, I could not find a current LD approval signature/date for any of the following procedures located within this procedure manual for testing personnel use: 1. General Laboratory Safety 2. Procedure for Labeling and Storage of Chemicals 3. Quality Assessment 4. Macroscopic Tissue Processing (aka Grossing) 5. Specimen Collection 6. Microtomy 7. Tissue Embedding 2. Review of the signatures on the documents above and interview with the GS/TP1, the GS/TP1 confirmed the signatures were those of the previous LD. 3. Interview with the GS / TP1 and LD at 1230 pm 12/12/2023 confirmed that the current LD had not reviewed the procedure manual nor had he approved any of it's contents since the last survey 03/23/2023. 4. The laboratory reports performing 880 Mohs surgical procedures and 7975 Histopathology specimens processed and interpreted annually. -- 2 of 4 -- D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of laboratory records indicating the duties and responsibilities of all staff performing any phase of laboratory testing and interview with the General Supervisor (GS / TP1) and the Laboratory Director (LD), the LD failed to ensure the duties and responsibilities of all laboratory personnel involved in the testing process were approved and current. Findings include: 1. Review of the job descriptions for each position described for high complexity testing in the manual presented for review during survey, the LD failed to ensure a current, signed and approved job description for each TP performing CLIA regulated testing was approved and in place for this laboratory. 2. Interview with the LD and GS / TP1 at 12:30 pm confirmed that no such current, approved and dated personnel job descriptions and policy for TP for this lab was available for review. 3. The laboratory reports performing 880 Mohs surgical procedures and 7975 Histopathology specimens processed and interpreted annually. 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 -- 3 of 4 -- 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 patient test reports and interview with the Laboratory Director (LD), the LD failed to ensure that testing personnel (TP 2), who is performing anatomical grossing on human tissue specimens received from other satellite Clear Choice laboratories, had his gross assessment of tissues reviewed by the Technical Supervisor (TS), or the LD or another CLIA qualified individual within 24 hours and documenting this in writing. Findings include: 1. Upon review of the grossing done by TP 2, no evidence of TS or LD review within 24 hours of performing the grossing could be provided. 2. Interview with the LD at 1:00 pm confirmed that the laboratory was not performing grossing review within 24 hours of TP 2 performing the gross assessment of human tissue samples submitted for histological interpretation by a CLIA qualified individual as described in 493.1449 (b) or (l). 3. The laboratory reports performing 880 Mohs surgical procedures and 7975 Histopathology specimens processed and interpreted annually. -- 4 of 4 --