Northshore Dermatology Center

Summary Statement of Deficiencies D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on record review and an interview with general supervisor (GS1), the laboratory failed to ensure the information transcribed or entered into the laboratory's information system (LIS) is transcribed or entered accurately, affecting 7 out of 7 patients. Findings Include: 1. The patients' requisitions, final reports, and laboratory manual were reviewed. 2. The 7 randomly selected patients' requisitions and final reports revealed the following: * 7 out of 7 requisitions failed to list the correct name of the laboratory performing the Histopathology testing. 3. The laboratory's manual failed to include a policy and procedure which would establish an ongoing process that would ensure the accuracy of the information entered manually into the electronic medical records (EMR) by personnel. 4. On an Initial survey conducted on 11/24 /2020 at 1:00PM, the GS1 confirmed the above findings. 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 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 -- acceptability. This STANDARD is not met as evidenced by: Based on record review and an interview with the general supervisor (GS1); the laboratory failed to ensure test reports indicate the name of the laboratory where the Histopathology tests was performed. Findings include: 1. The laboratory's patient test logs and final reports from the electronic medical records (EMR) were reviewed. 2. The name of the testing laboratory performing tissue processing, staining and Histology slide interpretation is "Northshore Dermatology Center". 3. The final reports of 7 patients selected from the test log revealed the name of the testing laboratory as "sherwood labs internal". 4. The laboratory failed to ensure the final reports of 7 out of 7 patients stated the correct name of the laboratory performing the tests. 5. On an Initial survey conducted on 11/24/2020 at 1:00PM, the GS1 confirmed the above findings. -- 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 record review and an interview with the testing personnel (TP1); the laboratory failed to establish and follow written procedures that meet the requirement to assess employees performing grossing and tissue processing for Histopathology, affecting 1 out of 1 testing personnel (TP). Findings include: 1. The procedures manual and personnel records were reviewed. 2. The laboratory failed to have a written competency procedure that includes the following requirements: *If applicable, the review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; *The direct observation of performance of instrument maintenance and function checks. *The assessment of problem solving skills. 3. The personnel records revealed that the laboratory failed to train and evaluate the competency of TP1, prior to processing patients specimens. 4. TP1 confirmed the findings on 03/14/2019 at 2:30 PM and stated that they were unaware the laboratory had a competency procedure. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on record review and an interview with testing personnel (TP1); the laboratory failed to establish written policies and procedures for specimen submission, handling, and referral, prior to receiving patient specimens for Histopathology. Findings include: 1. The laboratory procedures manual was reviewed. 2. The manual failed to included the following written policies and procedures: * Patient preparation. * Specimen collection. * Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. * Specimen storage and preservation. * Conditions for specimen transportation. * Specimen processing. * Specimen acceptability and rejection. * Specimen referral. 3. Further review of the "General Laboratory Policies and Procedures Manual" revealed it was not written or signed by the laboratory director (LD); the LDs name was hand written on the signature page by the TP1. 4. On 03/14/2019 at 1:30 PM, the TP1 confirmed the manual given to them was from the previous laboratory and not signed by the new laboratory director, and did not reflect the actual specimen processing procedure that is performed currently in the laboratory. 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 record review, the lack of documentation, and an interview with the testing personnel (TP1); the laboratory failed to follow written quality control procedures for the Hematoxylin and Eosin (H&E) staining procedure performed. Findings include: 1. The laboratory procedures manual was reviewed. 2. Both the Pathologist and histotechnologist are required to document the daily evaluation (or check) of the routine H&E stained slides. 3. Documents revealed H&E slides were produced on the following dates: 2/05/2019, 2/11/2019, 2/14/2019, 2/21/2019, 2/27/2019, 2/28/2019, 3 /07/2019, and 3/13/2019. 4. Further, review revealed no documentation of H&E stain quality checks performed on the above dates. 5. TP1 stated during the interview on 03 /14/2019 at 2:30 PM that they were unaware of the quality control check procedure and created their own quality control procedure. 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. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on record review and an interview with the testing personnel (TP1); the laboratory failed to ensure test reports indicate the name of the laboratory where the test was performed. Findings include: 1. The requisitions and final reports of slides sent to a reference laboratory were reviewed. 2. The requisitions reviewed were from the following dates: 2/05-06/2019; 2/08-09/2019; and 2/19-21/2019; which totaled 24 patients. 3. The patients' slides from the above dates were sent to the reference laboratory for interpretation. 4. The final reports from the reference laboratory for 24 out of 24 patients failed to state the correct name of the laboratory that submitted the slides. 5. TP1 confirmed the findings on 03/14/2019 at 2:15 PM. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 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 laboratory records and an interview with the testing personnel (TP1). 1. The laboratory director (LD) failed to be accessible to provide onsite consultation when needed (See D6080). 2. Failed to establish quality assurance (QA) programs for the laboratory's processes and procedures (See D6094). 3. Failed to ensure laboratory personnel was trained and competent, prior to testing patients (See D6102). 4. Failed to have an approved standard operating procedure manual available to all personnel (See D6106). D6080 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(c) The laboratory director must be accessible to the laboratory to provide onsite, telephone or electronic consultation as needed. This STANDARD is not met as evidenced by: Based on direct observation, record review and an interview with the testing personnel (TP1); the laboratory director (LD) failed to be accessible to provide onsite telephone or electronic consultation as needed affecting 1 out of 1 TP. Findings: 1. The laboratory manual, maintenance logs, quality control (QC) record, and personnel documents were reviewed. 2. The laboratory begin tissue processing for Histopathology on 02/01/2019. 3. Review of the procedures manual revealed the LD failed to establish written policies and procedures for all aspects of the testing process. Refer to D6106 and D6094. 4. The LD failed to be available to perform quality control checks on H&E stained slides prior to shipping to reference laboratory. 5. During the laboratory walkthrough on 03/14/2019, the surveyor observed maintenance logs for the following equipment: Refrigerator, Freezer, Reagents, Microtome, Tissue- Tek, and embedding station. Further review of the logs revealed the LD failed to review and monitor these instruments which are used in the grossing, and production of tissue slides. 6. Documents showed the LD failed to train and evaluate the competency of TP1, prior to grossing and producing tissue slides. 7. During survey -- 3 of 5 -- date 03/14/2019 at 2:15 PM, the surveyor's findings were confirmed by TP1, who also stated that they had not heard from the LD since they were hired as testing personnel on 02/01/2019. 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 record review and an interview with the testing personnel (TP1); the laboratory director (LD) failed to establish quality assurance (QA) programs for the laboratory. Findings include: 1. The laboratory's standard operating procedures manual was reviewed. 2. The LD failed to establish an ongoing review process that encompasses all facets of the laboratory's technical and non-technical functions for the following phases of the testing process: *Preanalytic - assessing practices/issues related to test requests, specimen submission, handling and referral. *Analytic - assessing:practices/issues related to test procedures; accurate and reliable test systems; equipment, instruments; reagents; materials; and supplies; specimen and reagent storage condition; equipment/instrument/test/system maintenance and function checks; control procedures; comparison of test results;

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's procedures manual, direct observation, and an interview with the testing personnel (TP) and the technical supervisor (TS), the laboratory failed to establish, when maintenance and function check protocols are not provided by the manufacturer, a maintenance protocol that ensures equipment, instrument, and test system performances are accurate and reliable. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. Findings: 1. On 07/27/2018 at 11:30 AM during a tour of the laboratory, the surveyor observed the following equipment, instruments, and test systems in the laboratory: 1). An Incubator, embedding station, and refrigerator; 2). A Biological hood used for tissue staining; 3). Microscope 2. The procedures manual does not include a maintenance and/or function check policy and procedure for the following equipment, instruments, and test systems: 2). Calibration of Thermometers used in incubators, water baths (embedding station), and refrigerator; and 4). Filter changes for the Biological hood used for tissue staining. 5). Preventative maintenance and service for microscope. 3. No documentation was provided as evidence that the maintenance and function checks listed in "Findings #2" were ever performed in the laboratory. 4. On a Validation survey conducted on 07/27 /2018 at 1:30 PM, the TP and technical supervisor (TS) 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 5 -- D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on the surveyor's review of the Laboratory Personnel Report (CMS 209), the laboratory's policies, procedures and records, and an interview with the technical supervisor (TS), the TS failed to evaluate and document the performance of individuals performing Histopathology testing at least annually, affecting 2 out of 2 testing personnel (TP). Findings: 1. The CMS 209 lists 2 laboratory employees, TP- KL3 (listed on line 2) and TP-M6B (listed on line 3) performing Histopathology grossing in the laboratory. 2. The personnel records presented revealed the following: a). The last documented competency for TP-M6B was performed on 03/14/2016, and b). No competency assessments were performed for TP-KL3 during the years of 2016 through 2018. 3. The laboratory's competency policy states that laboratory personnel are to be evaluated annually for competency. 4. On a Validation survey conducted on 07/27/2018 at 1:30 PM, the TS confirmed the above findings. D6141 GENERAL SUPERVISOR CFR(s): 493.1459 The laboratory must have one or more general supervisors who are qualified under 493.1461 of this subpart to provide general supervision in accordance with 493.1463 of this subpart. This CONDITION is not met as evidenced by: Based on the surveyor's review of the Laboratory Personnel Report (CMS-209), employee files, and an interview with the laboratory staff, the laboratory director (LD) failed to employ individuals who meet the qualification requirements of 493.1461 for general supervisor (GS). Finding: 1. The laboratory failed to ensure laboratory personnel meet the qualification requirements for GS, who provide day-to-day supervision of testing personnel and reporting of test results in an high complexity laboratory. See D6143. D6143 GENERAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1461 (a) The general supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The general supervisor must be qualified as a-- (b)(1) Laboratory director under 493.1443; or (b)(2) Technical supervisor under 493.1449. (c) If the requirements of paragraph (b)(1) or paragraph (b)(2) of this section are not met, the individual functioning as the general supervisor must-- (c)(1)(i) 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 -- 2 of 5 -- technology from an accredited institution; and (c)(1)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing; or (c)(2)(i) Qualify as testing personnel under 493.1489(b)(2); and (c)(2)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing; or (c)(3)(i) Except as specified in paragraph (3)(ii) of this section, have previously qualified as a general supervisor under 493.1462 on or before February 28, 1992. (c)(3)(ii) Exception. An individual who achieved a satisfactory grade in a proficiency examination for technologist given by HHS between March 1, 1986 and December 31, 1987, qualifies as a general supervisor if he or she meets the requirements of 493. 1462 on or before January 1, 1994. (c)(4) On or before September 1, 1992, have served as a general supervisor of high complexity testing and as of April 24, 1995-- (c) (4)(i) Meet one of the following requirements: (c)(4)(i)(A) Have graduated from a medical laboratory or clinical laboratory training program approved or accredited by the Accrediting Bureau of Health Education Schools (ABHES), the Commission on Allied Health Education Accreditation (CAHEA), or other organization approved by HHS. (c)(4)(i)(B) Be a high school graduate or equivalent and have successfully completed an official U.S. military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician). (c)(4)(ii) Have at least 2 years of clinical laboratory training, or experience, or both, in high complexity testing; or (c) (5) On or before September 1, 1992, have served as a general supervisor of high complexity testing and-- (c)(5)(i) Be a high school graduate or equivalent; and (c)(5) (ii) Have had at least 10 years of laboratory training or experience, or both, in high complexity testing, including at least 6 years of supervisory experience between September 1, 1982 and September 1, 1992. (d) For blood gas analysis, the individual providing general supervision must-- (d)(1) Be qualified under 493.1461(b)(1) or (2), or 493.1461(c); or (d)(2)(i) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (d)(2)(ii) Have at least one year of laboratory training or experience, or both, in blood gas analysis; or (d)(3) (i) Have earned an associate degree related to pulmonary function from an accredited institution; and (d)(3)(ii) Have at least two years of training or experience, or both in blood gas analysis. (e) The general supervisor requirement is met in histopathology, oral pathology, dermatopathology, and ophthalmic pathology because all tests and examinations, must be performed: (e)(1) In histopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l)(1); (e)(2) In dermatopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l) or (2); (e)(3) In ophthalmic pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(1)(3); and (e)(4) In oral pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(m). This STANDARD is not met as evidenced by: Based on the surveyor's review of the Laboratory Personnel Report (CMS-209), employee files, and an interview with the laboratory staff, the laboratory director (LD) failed to employ individuals who meet the qualification requirements of 493.1461 for general supervisor (GS). Finding: 1. Review of the employees' files and the CMS 209 revealed the following: a). The CMS 209 reports 1 GS (listed on line 2) in the laboratory; b). The GS received a Bachelor's of Arts degree in Philosophy in 2011, and has a transcript that shows the completion of 4 credit hours of Environmental Biology, 4 credit hours Contemporary Chemistry and 3 credit hours in Oceanography in November of 2014. c). No other documentation was provided to show that the employee had met the GS education requirement prior to supervising the laboratory. -- 3 of 5 -- 2. No documentation was provided as evidence the GS position had been delegated to any other qualified personnel in the laboratory. 3. On a Validation survey conducted on 07/27/2018 at 1:30 PM, the TP and technical supervisor (TS) confirmed the above findings. 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 the surveyor's review of the Laboratory Personnel Report (CMS 209), the laboratory's personnel files, records, and an interview with the laboratory staff, the laboratory director (LD) failed to ensure the laboratory has 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 highly complex tests performed for Histopathology. Findings: 1. The laboratory failed to ensure laboratory staff meet the education criteria specified in 493.1489(b) (1). 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 -- 4 of 5 -- 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 the surveyor's review of the Laboratory Personnel Report (CMS-209), employee files, test records, and an interview with the laboratory staff, the laboratory failed to ensure laboratory employees meet the qualification requirements for performing highly complex testing in the specialty of Histopathology. Findings: 1. The CMS 209 list 2 testing personnel (TP) performing tissue grossing in the laboratory. 2. The education credentials of the 2 laboratory employees revealed that 2 out of 2 does not meet the education requirement as defined 493.1489(b) (1) - (7) due to the following: a). TP-KL3 (listed on line 2) has received a Bachelor's of Arts degree in Philosophy in 2011, and a transcript that shows the completion of 4 credit hours of Environmental Biology, 4 credit hours Contemporary Chemistry and 3 credit hours in Oceanography in November of 2014; and b). TP-M6B (listed on 3) has 31 continuing education credit hours through the American Society for Clinical Pathology (non-ASCP) and received a Bachelors of Liberal Arts and Sciences with a major in Communication. The transcript provided shows that the curriculum fulfilled by TP-M6B for this degree does not include the requirement of, "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. 3. The competencies and test records reviewed showed that TP-M6B and TP-KL3 are tissue grossing in the laboratory. 4. On a Validation survey conducted on 07/27/2018 at 1:30 PM, the TP and technical supervisor (TS) confirmed the above findings. -- 5 of 5 --