Standard 22B Instructional Areas

1. Standard 22BInstructional Areas

2. Recommended Materials • Guide to Accreditation • NAACLS Glossary of Terms

3. Standard 22B • The standard states: • The curriculum must include: 1. Scientific content (either prerequisite or as an integral part of the curriculum) to encompass areas such as organic and/or biochemistry, genetics, cell biology, microbiology, Immunology, diagnostic molecular biology. 2. Principles, methodologies, and applications of molecular microbiology (infectious diseases), molecular pathology (hematology/oncology), and molecular genetics. Techniques of molecular science must include at least two techniques in each of separation and detection, amplification, and sequence analysis. Standard 22B is continued on next slide.

4. Standard 22B • The standard states (continued): • The curriculum must include: 3. clinical significance of laboratory procedures in diagnosis and treatment. 4. principles and practices of quality management. 5. principles and practices of laboratory administration, supervision, safety, and problem solving; 6. principles and practices of computer science; 7. acquisition and evaluation of laboratory information systems, and 8. principles and practices of professional conduct; 9. principles and practices of applied study design, implementation and dissemination of results.

5. Standard 22BLearning Outcomes Upon completion of this unit of instruction and review of additional resources, the learner shall be able to: • Identify the scientific content required for the DMS curriculum as defined by the NAACLS standards • Classify a topic/task as a pre-analytical, analytical or post-analytical laboratory component • Categorize examples of curriculum topics/experiences into the appropriate instructional areas for DMS

6. Standard 22B.1 • Standard 22B.1 • The program must insure the scientific content of courses such as Organic/biochemistry, genetics, Cell biology, Microbiology, Immunology, Diagnostic molecular biology is either: • Taught as part of the DMS program curriculum Or • Taught as a prerequisite university/college course prior to entry into the DMS program

7. Standard 22B.1 • A matrix, unique to each discipline, is available in section IV of the “New Guide for Accreditation” at http://naacls.org/accreditation/newguide_accreditation.asp • The matrix helps the program document where the required scientific content is provided

8. Standard 22B.2 • Principles, methodologies, and applications of molecular microbiology, molecular pathology, and molecular genetics are covered and techniques of molecular science must include at least two techniques in each of separation and detection, amplification, and sequence analysis. • Molecular microbiology – all aspects of molecular infectious diseases testing focusing on identification and load that includes minimal of two techniques of detection, amplification, and sequence analysis. • Molecular pathology – all aspects of molecular hematology/oncology that includes minimal of two techniques of detection, amplification, and sequence analysis. • Molecular genetics – all aspects of molecular pre/post natal testing that includes minimal of two techniques of detection, amplification, and sequence analysis.

9. Standard 22B.2 • For all major areas of the diagnostic molecular laboratory, the program must insure the curriculum includes: • Principles and methodologies • Performance of assays • Problem solving and trouble-shooting • Techniques • Interpretation of clinical procedures and results • Statistical approaches to data evaluation • Continuous assessment of laboratory services

10. Standard 22B.2 • Two areas within Standard 22B.2 that are often difficult to grasp include: • Statistical approaches to data evaluation • Opportunities or examples in the clinical laboratory: • Sensitivity • Specificity • Confidence interval • Positive and negative predictive values • Delta checks • Trends • Standard deviation

11. Standard 22B.2 • Continuous assessment of laboratory services is another component that is often overlooked in a program. It needs to be discussed in each major testing area of the diagnostic molecular laboratory. • Knowledge of research design/practice sufficient to evaluate published studies as an informed consumer • Opportunities or examples: • Using a procedure, review the reference(s) cited and then research for possible updates • Perform a literature search • Develop a hypothesis and perform a literature review • Research a new instrument or test and develop a proposal for or against its use • Review a research paper to insure its validity

12. Standard 22B.3-9 • While some of the instructional areas described in Standard 22B.3-9 can be taught throughout the curriculum, others may be better approached as topics within a separate course such as management. • Writing behavioral objectives for these topic areas tend to lend themselves better to taxonomy levels I and II. • Level III taxonomy levels may be more difficult to achieve if time is a limiting factor for the program • Measurable objectives are required to document achievement of the appropriate knowledge and skills for each topic area • These topics can be reinforced by having the student participate in various projects, such as writing a procedure, during applied education where many of the examples provided occur each day. • The opportunities or examples provided are designed to stimulate ideas for potential inclusion in the curriculum and are not required specifically by the NAACLS MLS standards.

13. Standard 22B.3 • Clinical significance of laboratory procedures in diagnosis and treatment; • Opportunities or examples: • Review of quality control for a clinical area and resolution of outliers • Review and assess the quality assurance monitors in the clinical laboratory • Attend a laboratory quality committee meeting • Determine how the laboratory fits into the hospital quality improvement (QI) program • Review QI monitors that cross over into other non-laboratory departments • Using the CAP accreditation checklist, review the quality management system of a laboratory • Review of proficiency testing data

14. Standard 22B.4 • Principles and practices of quality management • Opportunities or examples: • Review of quality control for a clinical area and resolution of outliers • Review and assess the quality assurance monitors in the clinical laboratory • Attend a laboratory quality committee meeting • Determine how the laboratory fits into the hospital quality improvement (QI) program • Review QI monitors that cross over into other non-laboratory departments • Using the CAP accreditation checklist, review the quality management system of a laboratory • Review of proficiency testing data

15. Standard 22B.4 • Opportunities or examples (continued) • Department of Transportation (DOT) • Nuclear Regulatory Commission (NRC) • Compliance • Health Insurance Portability and Accountability Act (HIPAA) • Stark and anti-kickback laws • Medicare/Medicaid reimbursement • CPT coding • Medical necessity • Advanced beneficiary notice • ICD9 coding soon to transition to ICD10 • Fraud and abuse

16. Standard 22B.5 • Principles and practices of laboratory administration, supervision, safety, and problem solving • Opportunities or examples: • Discussion of Accreditation • Clinical Laboratory Improvement Amendments (CLIA) • The Joint Commission (TJC formerly JCAHO) • College of American Pathologists (CAP) • American Association of Blood Banks (AABB) • American College of Medical Genetics (ACMG) • NAACLS • Others • Occupational Safety and Health Administration (OSHA) • Environmental Protection Agency (EPA)

17. Standard 22B.6 • Principles and practices of professional conduct • Opportunities or examples: • Conflict management skills • Verbal, nonverbal and paraverbal (tone, pitch, pace and inflection of voice) communication • Telephone etiquette • Customer service • Business communication such as an email, memo, proposal, etc. • Team building exercises

18. Standard 22B.7 • Principles and practices of applied study design, implementation and dissemination of results: • Critical pathways and clinical decision making • Opportunities and examples: • Review the laboratory test menu and use tools available to determine testing overuse, misuse and underuse by physicians • Using evidence based research, make suggestions for changes to the test menu • Research benchmarks for current best practices • Review order sets, care pathways and algorithms in place • Review reflexive testing available

19. Standard 22B.7 b. Opportunities or examples: • Reflexive testing • Algorithms and practice guidelines • Test and instrument evaluation • Costs versus benefit • Sensitivity and specificity • Value provided for physician and patient • Turn around time • Training and proficiency testing required • Screen versus confirmatory results • Effect on length of stay • Test evaluation and validation • Test utilization by physicians • Use of evidence based medicine • Benchmark against best practices

20. Standard 22B • While not required specifically by NAACLS, additional topics/experiences for inclusion in a management course might include: • Write a procedure using Clinical and Laboratory Standards Institute format • Laboratory information management and technology • Steps in the critical thinking and problem-solving process • Time management skills • MLS in a consultative role in the hospital • Shadow a laboratory manager or director for a day • Perform a mock CAP inspection of a clinical laboratory area • Capstone project or professional portfolio • Volunteerism and community service • Professional advocacy

21. Assessment Based on the NAACLS MLS standards, which of the following is considered required curriculum? • Physics • Organic chemistry • Ecology • College algebra

22. Assessment Extracting the buffy coat containing the WBCs from a whole blood sample for DNA extraction is considered a/an _________________ component of the total laboratory testing process. • Pre-analytical • Analytical • Post-analytical

23. Assessment Providing DMS students education on the sensitivity and specificity of the HCV viral load assay would help meet the NAACLS DMS curricular requirement for ______________ in Molecular Infectious Diseases Testing.  • Continuous assessment of laboratory services • Performance of assays • Principles and methodologies • Statistical approaches to data evaluation

24. Assessment DMS students are provided the opportunity to meet with a molecular clinical laboratory pathologist and discuss physician utilization of laboratory testing.  This is an example of education in the curricular area of: • Problem-solving and trouble-shooting • Financial management • Critical pathways and clinical decision making • Performance improvement

25. Assessment All of the following can be considered as part of the molecular infectious disease testing curriculum EXCEPT: • HCV viral load test • HIV genotype test • Mycobacterium genotype test • Gram stain