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 anatomy/physiology, immunology, genetics/molecular biology, microbiology, organic/biochemistry, and statistics. 2. Pre-analytical, analytical, and post-analytical components of laboratory services, such as hematology, hemostasis, chemistry, microbiology, urinalysis, body fluids, molecular diagnostics, immunology, phlebotomy, and immunohematology. This includes principles and methodologies, performance of assays, problem-solving, troubleshooting, techniques, interpretation of clinical procedures and results, statistical approaches to data evaluation, and continuous assessment of laboratory services for all major areas practiced in the contemporary clinical laboratory. Standard 22B is continued on next slide.

4. Standard 22B • The standard states (continued): • The curriculum must include: 3. Principles and practices of quality assurance/quality improvement as applied to the pre-analytical, analytical, and post-analytical components of laboratory services. 4. Application of safety and governmental regulations and standards as applied to laboratory practice. 5. Principles of interpersonal and interdisciplinary communication and team-building skills. 6. Principles and application of ethics and professionalism to address ongoing professional career development. 7. Education techniques and terminology sufficient to train/educate users and providers of laboratory services. 8. Knowledge of research design/practice sufficient to evaluate published studies as an informed consumer. 9. Concepts and principles of laboratory operations must include: a. Critical pathways and clinical decision making; b. Performance improvement; c. Dynamics of healthcare delivery systems as they affect laboratory service; d. Human resource management to include position description, performance evaluation, utilization of personnel, and analysis of workflow and staffing patterns, and; e. Financial management: profit and loss, cost/benefit, reimbursement requirements, materials/inventory management.

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 MLS 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 MLS

6. Standard 22B.1 • Standard 22B.1 • The program must insure the scientific content of courses such as anatomy/physiology, immunology, genetics/molecular biology, microbiology, organic/biochemistry and statistics is either: • Taught as part of the MLS program curriculum Or • Taught as a prerequisite university/college course prior to entry into the MLS 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 • Across the curriculum, the program must insure the pre-analytical, analytical and post-analytical components are taught. • Pre-analytical – all aspects of specimen integrity from the time the physician places the laboratory orders to the time the specimen is received in the laboratory • Analytical – all processes associated with specimen testing once received in the clinical laboratory • Post-analytical – all processes involved with result reporting and delivery

9. Standard 22B.2 • For all major areas of the clinical 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 • 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

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 • Principles and practices of quality assurance/quality improvement as applied to the pre-analytical, analytical and post-analytical components of laboratory services • 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 • Application of safety and governmental regulations and standards as applied to laboratory practice • 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) • NAACLS • Others • Occupational Safety and Health Administration (OSHA) • Environmental Protection Agency (EPA)

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 of interpersonal and interdisciplinary communication and team-building skills • 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

17. Standard 22B.6 • Principles and application of ethics and professionalism to address ongoing professional career development • Opportunities or examples: • Introduction to professional organizations • ASCP, ASCLS, CLMA, ASM, AACC, others • Attendance of a national, state or local professional meetings • Continuing education • Journals, seminars, workshops, webinars, professional meetings, formal academic training, etc. • Certification and continuing education maintenance

18. Standard 22B.6 • Opportunities or examples (continued): • Networking • Mentoring • Presentation at a professional meeting • Participation in a professional organization • Committees, board of directors, officers, student representative • Specialist examinations • Professional ethics • Hospital medical ethics committee • Program policies such as plagiarism and honesty • Licensure

19. Standard 22B.7 • Education techniques and terminology sufficient to train/educate users and providers of laboratory services • Opportunities or examples: • Create and present an in-service for the clinical laboratory personnel • Critique the objectives and evaluations for a course within the MLS program • Create and present a recruitment session for a grade school, high school or college • Develop competency assessment tools • Create an educational poster presentation for non-laboratory personnel or the public

20. Standard 22B.8 • 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

21. Standard 22B.9 • Concepts and principles of laboratory operations must include: • 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

22. Standard 22B.9 • Performance improvement • Opportunities and examples: • Review performance measures in place and note trends • Attend a quality oversight laboratory or hospital meeting • Review quality methodologies such as Six Sigma, LEAN or ISO • Identify changes made due to quality indicators in place and note the effect of the changes • Review the CAP accreditation guidelines as they relate to performance improvement

23. Standard 22B.9 • Dynamics of healthcare delivery systems as they affect laboratory service • Opportunities and examples: • Review the laboratory’s mission, vision and value and strategic plan and determine how it supports those of the hospital • Review the laboratory’s business plan • Develop an advertising campaign for promotion of laboratory services • Review data from survey tools related to customer service • Spend the day in the laboratory’s customer service area • Visit an outreach clinic and reference laboratory • Propose ways to work with other departments or facilities to expand services • Review policies for continuity of operation during a disaster • Investigate the effect of standardization of testing across a system of hospitals

24. Standard 22B.9 • Human resource management to include position description, performance evaluation, utilization of personnel, and analysis of workflow and staffing patterns • Opportunities or examples: • Attend a new co-worker orientation • Review the laboratory units of service, operating and capital budgets with the laboratory director/manager • Examine laboratory job descriptions and performance evaluation tools • Review training and competency assessments • Create a resume • Work with a supervisor to build a department work schedule • Set up a mock interview for a laboratory position • Given the laboratory’s test ordering pattern, determine the number of co-workers needed each shift

25. Standard 22B.9 • Financial management: profit and loss, cost/benefit, reimbursement requirements, materials/inventory management. • Opportunities or examples: • Review a laboratory capital and operating budget • Review CPT coding for the laboratory test menu • Review a laboratory test order requisition for compliance issues • Review a laboratory budget for variance(s) or trends • Examine a vendor equipment or supplies contract • With a supervisor or manager, review the processing of costing out a test • Select a new test to add to the laboratory menu and determine the potential impact to workload volume • Assist with ordering supplies for a laboratory area

26. 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

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

28. Assessment Screening an expectorated sputum specimen for the presence of squamous epithelial cells is considered a/an __________ component of the total testing process. • Pre-analytical • Analytical • Post-analytical

29. Assessment Providing MLS students education on the sensitivity and specificity of the rapid Group A Streptococcus throat screen would help meet the NAACLS MLS curricular requirement for __________ in Microbiology. • Continuous assessment of laboratory services • Performance of assays • Principles and methodologies • Statistical approaches to data evaluation

30. Assessment MLS students are provided the opportunity to meet with a 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

31. Assessment A clinical laboratory is considering implementing LEAN/Six Sigma principles at the facility where MLS students complete their chemistry clinical rotation. The Six Sigma black belt instructor offers to present a lecture to the students on LEAN and Six Sigma. This would be a example of curriculum in the area of: • Process improvement • Human resource management • Principles and methodologies • Application of safety and governmental regulations