1. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins Chapter 4: Urinalysis Clinical Laboratory Operations Graff’s Textbook of Urinalysis and Body Fluids, Third Edition Mundt, L. & Shanahan, K. Chapter 4: Urinalysis Clinical Laboratory Operations Graff’s Textbook of Urinalysis and Body Fluids, Third Edition Mundt, L. & Shanahan, K.

2. Copyright © 2016 Wolters Kluwer All Rights Reserved Chapter Outline Regulations and Regulatory Agencies Quality Assessment Laboratory Safety

3. Copyright © 2016 Wolters Kluwer All Rights Reserved Regulations and Regulatory Agencies Introduction Clinical laboratories must continually assess, update, and adjust services to achieve optimal patient outcomes. Laboratory professionals need both scientific, medical and technical expertise comprehension of governmental regulations and safety requirements. Laboratory leaders are responsible for compliance to governmental rules, regulations, and laws, disseminating this knowledge to laboratory staff ensuring compliance

4. Copyright © 2016 Wolters Kluwer All Rights Reserved Federal Regulations and Regulatory Organizations CLIA ’88 law mandates quality assessment and sets these levels of clinical lab testing: –Provider performed microscopy –Waived testing –Moderate complexity testing –High complexity testing

5. Copyright © 2016 Wolters Kluwer All Rights Reserved Federal Regulations and Regulatory Organizations Public Health Service Act Department of Health and Human Services –Centers for Medicare and Medicaid Services (CMS) –Commission on Office Laboratory Accreditation ( COLA) OSHA (Occupational Safety and Health Administration) –Worker safety issues, MSDS sheets EPA (Environmental Protection Agency) –Regulates medical laboratory waste

6. Copyright © 2016 Wolters Kluwer All Rights Reserved Federal Regulations and Regulatory Organizations FDA (Food and Drug Administration) –Approval of diagnostic tests CDC (Centers for Disease Control) –Implements public health regulations, monitors reportable diseases and trends, categorizes lab tests DOT (Department of Transportation) –Regulates packaging and transport of biological hazards and HAZMATS NRC (Nuclear Regulatory Commission) –Regulates the handling and disposal of radioactive materials

7. Copyright © 2016 Wolters Kluwer All Rights Reserved External Accreditation and Inspection Accreditation agencies (with deeming authority from the federal CMS) CAP (College of American Pathologists) COLA (Commission on Office Laboratory Accreditation) JCAHO (Joint Commission on Accreditation of Healthcare Organizations)

8. Copyright © 2016 Wolters Kluwer All Rights Reserved External Accreditation And Inspection AOA (American Osteopathic Association) AABB (American Association of Blood Banks) ASHI (American Society for Histocompatibility and Immunogenetics)

9. Copyright © 2016 Wolters Kluwer All Rights Reserved Laboratory Standards CLSI (Clinical Laboratory Standards Institute) –Formerly NCCLS –Publishes national and international standard documents on a variety of laboratory testing procedures and policies for guidance on achieving better testing outcomes.

10. Copyright © 2016 Wolters Kluwer All Rights Reserved Additional Legal and Ethical Concerns Informed Consent –Ensure patient’s understanding of procedures –Provides a right to refuse procedures Standard of Care –Care that a reasonable laboratory professional would give Confidentiality –HIPAA (Health Insurance Portability and Accountability Act)

11. Copyright © 2016 Wolters Kluwer All Rights Reserved Additional Legal and Ethical Concerns Specimens for Legal Cases –Chain of custody Ethical Considerations –Show respect –Keep informed –Follow established procedures and policies –Demonstrate compassionate patient care

12. Copyright © 2016 Wolters Kluwer All Rights Reserved Quality Assessment Variables Affecting the Quality of Laboratory Testing Establishing a Quality Assessment Program Performing Quality Control Tests Participating in Proficiency Testing

13. Copyright © 2016 Wolters Kluwer All Rights Reserved Variables Affecting the Quality of Laboratory Testing PREANALYTICAL ERRORS ANALYTICAL ERRORSPOSTANALYTICAL ERRORS Patient identification errors Technologist errorComputer result entry error Improper patient preparation Instrument Calibration error Test interpretation errors Inappropriate ordersReagent deteriorationIllegible report Incorrect containerPipetting errorsFailure to deliver report Specimen labeling errorsInstrument bias or failure Incorrect patient information Improper specimen collection or handling Test procedure not followed Transcription errors Improper timing of collection Timing errors while running tests Delayed report Hemolyzed or contaminated specimen Instrument not operated correctly Failure to phone correctly critical results

14. Copyright © 2016 Wolters Kluwer All Rights Reserved Quality Assessment (cont.) Establishing a Quality Assessment Program Ensures –effective communication –adherence to established policies –accurate and thorough documentation practices –use of delta checks –timely verbal reporting of all critical values

15. Copyright © 2016 Wolters Kluwer All Rights Reserved Quality Assessment (cont.) Process Improvement –System that looks at a laboratory’s processes and how they affect patient outcomes –Discovery of weaknesses in processes –Implementation of changes monitored –Ultimate goal is to ensure quality of care

16. Copyright © 2016 Wolters Kluwer All Rights Reserved Quality Assessment (cont.) Quality Control –A set of procedures and practices to monitor the testing process and verify the reliability, accuracy, and precision of the test. –You must monitor each test with standards and controls (at least two levels) –New tests must be validated

17. Copyright © 2016 Wolters Kluwer All Rights Reserved Quality Assessment (cont.) Proficiency testing –External proficiency testing is mandated by CLIA ‘88 –Unknowns from CAP or other approved lab –Internal proficiency testing is also helpful for quality

18. Copyright © 2016 Wolters Kluwer All Rights Reserved Safety in the Clinical Laboratory Compliance: –Local regulations –State regulations –Federal safety laws Protects: –Healthcare workers –Patients –Visitors

19. Copyright © 2016 Wolters Kluwer All Rights Reserved Safety in the Clinical Laboratory Safety Labeling Common safety symbols. Copyright © 2016 Wolters Kluwer All Rights Reserved

20. Safety in the Clinical Laboratory Safety Policies –Accessible safety manuals –Designated safety officer –Use of incident reporting

21. Copyright © 2016 Wolters Kluwer All Rights Reserved Clinical Laboratory Hazards Safety Hazards in the Laboratory –Physical hazards –Electrical hazards –Radioactive hazards Protection, wear a film badge to monitor cumulative radiation exposure –Fire/ explosive hazards Know the acronyms RACE and PASS

22. Copyright © 2016 Wolters Kluwer All Rights Reserved Classes of Fire Extinguishers and Their Uses CLASSUSEWATER EXTINGUISHER DRY EXTINGUISHER AOrdinary combustible materials, paper YES BFlammable liquidsNO (spreads liquid and gases and fire) YES CElectrical equipmentNO (risk of shock) YES DCombustible metalsNO (intensifies fire) NO (Use sand or special extinguishing agents)

23. Copyright © 2016 Wolters Kluwer All Rights Reserved Chemical Hazards Chemical Hygiene Plan –SDS (Safety Data Sheets) –available to all –Use as guide on OSHA requirements Required PPEs Storage Handling Disposal Spill clean up

24. Copyright © 2016 Wolters Kluwer All Rights Reserved Chemical Hazards (cont.) Chemical Labeling –NFPA (National Fire Protection Agency) –Globally Harmonized System (GHS) –Hazardous Materials Identification System (HMIS)

25. Copyright © 2016 Wolters Kluwer All Rights Reserved Chemical Hazards (cont.) Globally Harmonized System (GHS) –Pictogram –Signal word –Hazard statement –Precautionary statement

26. Copyright © 2016 Wolters Kluwer All Rights Reserved Chemical Hazards (cont.) Oxidizer Acute toxicity Carcinogen (severe) Respiratory sensitizer Reproductive toxicity

27. Copyright © 2016 Wolters Kluwer All Rights Reserved Chemical Hazards (cont.) National Fire Protection Agency (NFPA) symbol Copyright © 2016 Wolters Kluwer All Rights Reserved

28. Chemical Hazards (cont.) Hazardous Materials Identification System (HMIS) label.

29. Copyright © 2016 Wolters Kluwer All Rights Reserved Chemical Hazards (cont.) Chemical handling –PPE (personal protective equipment) Gloves, apron, goggles, respirator Face shield or table-top splash shield

30. Copyright © 2016 Wolters Kluwer All Rights Reserved Chemical Hazards (cont.) Chemical Spills –Remove contaminated clothing as soon as possible –Use shower and eye wash if necessary –Quickly neutralize spill

31. Copyright © 2016 Wolters Kluwer All Rights Reserved Chemical Hazards (cont.) Chemical Exposure Limits –Follow OSHA limits on exposure to toxic chemicals Threshold limit values (TLVs) Permissible exposure limits (PELs)

32. Copyright © 2016 Wolters Kluwer All Rights Reserved Standard precautions PPE/barrier protection –gloves, gowns, bandages, facial barriers, respiratory Hand washing Decontamination of work surfaces and instruments Specimen labeling Spill clean-up Engineering controls Immunizations Protection from the aerosolization Exposures to infectious agents Specimen transport and shipping Biohazard Risks

33. Copyright © 2016 Wolters Kluwer All Rights Reserved Biohazard Risks (cont.) Minimize exposure by adhering to laboratory cleanliness practices.

34. Copyright © 2016 Wolters Kluwer All Rights Reserved Biological waste Policies for Hazardous Materials (HAZMATS) –Hazmat team for larger incidents Exposure Control Plan Other Safety Issues Specifically Related to Urinalysis and Body Fluids –Hepatitis, HIV, cytomegalovirus Biohazard Risks (cont.)

35. Copyright © 2016 Wolters Kluwer All Rights Reserved Clinical / Medical laboratories are held to high standards. Laboratory personnel must : –be aware of and comply with regulatory policies and laws at the local, state, and national levels. –ensure that the quality of laboratory testing is assessed and corrective measures are taken. –adhere to personal and patient safety practices. Summary