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Chapter 26, 27 and 32

Chapter 26, 27 and 32. Safety and Regulatory Guidelines In the Medical Laboratory/Introduction to Laboratory. CLIA ‘88. Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) Federal regulations designed to set safety policies and procedures that protect patients

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Chapter 26, 27 and 32

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  1. Chapter 26, 27 and 32 Safety and Regulatory Guidelines In the Medical Laboratory/Introduction to Laboratory

  2. CLIA ‘88 • Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) • Federal regulations designed to set safety policies and procedures that protect patients • 1967—misread Pap smears caused Congress to become more involved with regulating laboratories (CLIA ’88)

  3. CLIA ‘88 • Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) • States can seek exemptions from CLIA standards and have state standards apply instead • Accrediting bodies granted “deemed status”

  4. CLIA ’88 Overview • Is designed to protect public by regulating all laboratory tests performed on humans • Is based on complexity of tests performed • Affects all aspects of the laboratory

  5. CLIA ’88 Overview • Specifies type of test performed, training and education of personnel involved in testing, and quality control

  6. CLIA ’88 Testing Categories • Click to play the video

  7. CLIA ’88 Testing Categories • Waived tests • Simple, unvarying, and require minimum of judgment and interpretation • Moderate-complexity tests • Physician-performed microscopy procedures (PPMP) tests • High-complexity tests

  8. CLIA ‘88 Consequences • Contents of the law • List of analytes on the CLIA ’88 waived list • Types of CLIA certificates

  9. CLIA ‘88 Consequences • CLIA ’88 regulations for quality control in automated hematology • Required procedures • Calibration • Control samples • Proficiency testing • Check manufacturer’s recommendations for particular piece of equipment

  10. CLIA ‘88 Consequences • Aftermath of CLIA ’88 • Has led to concerns about overload of paperwork it produces • Developments regarding postponements and funding problems • Recent findings of errors, gaps in quality in physician’s office laboratories (POLs)

  11. CLIA ’88 and MAs • Covers all laboratories even if they perform a few basic tests • Documentation by medical assistants is important • Responsibility of medical assistants to teach and assist others who may not be trained

  12. CLIA ’88 and MAs • Where to find more information regarding CLIA ’88 • Guidelines available from Federal Register and online

  13. OSHA Regulations • Occupational Safety and Health Administration (OSHA) • Intend for employees to have safe and healthful work environment • Present requirements employer must follow to ensure employee safety and health

  14. OSHA Regulations • Two standards comprise the regulations • The Bloodborne Pathogen Standard • Standards for Occupational Exposure to Hazardous Chemicals in the Laboratory • Purpose is to heighten employee awareness of risks linked with chemical dangers • Involves employee training and identification of hazardous chemicals

  15. Chemical Hygiene Plan • Core of the OSHA safety standard • Written plan specifies training and information requirements of standard • Describes requirements of standard

  16. Chemical Hygiene Plan • Written CHP and program must be operational if chemicals are stored in facility and handled by employees • Describes three primary goals an employer must accomplish to be in compliance with OSHA standard for chemical exposure • Requirements of CHP

  17. Chemical Hygiene Plan • Importance of chemical standards to medical assistants • All employees must comply or face penalties • All employees have right to know about hazards at work site and how to handle, store, and dispose of hazardous substances

  18. OSHA Regulations and Students • Students do not fall under the OSHA guidelines but should take precautions

  19. The Laboratory • POL collects and tests specimen • Specimen collected at POL and transported from physician’s office to separate lab for testing • Collected and tested at separate lab

  20. Purposes of Lab Testing • To record an individual’s state of health • Routine physical examination • Provides reference values for comparison • To satisfy employment, insurance, and legal requirements • Employment-required drug and alcohol testing • Research statistics and clinical trials

  21. To detect asymptomatic conditions or diseases • Routine screening in another area reveals disorder • No symptoms associated with disease process • To confirm a clinical diagnosis • Diagnosis determined through subjective and objective information • Tests given to confirm diagnosis

  22. To differentiate between two or more diseases • Perform simplest and least invasive test • Rule out a disease • To diagnose • If symptoms are vague • Profile ordered • Narrows field for diagnosis

  23. To determine the effectiveness of treatments • To prevent diseases/disorders • To prevent the exacerbation of diseases • Patients with chronic conditions • May need to adjust diet or medication

  24. Types of Laboratories • Procurement stations • Satellite laboratories • Hospital-based • Reference laboratories

  25. Point-of-care testing (POCT) • Bedside testing • Rapid, accurate results • POLs • Types of tests commonly performed • Use of self-contained tests • At-home test kits

  26. Laboratory Departments • Hematology • Urinalysis • Clinical chemistry • Immunology • Serology • Microbiology

  27. Virology • Parasitology • Cytology • Histology • Toxicology • DNA testing

  28. Laboratory Tests • Panels of laboratory tests • Tests categorized into related groups • Formerly called “profiles” • CMS-approved organ- and disease-oriented panels

  29. Quality Controls/Assurances • Control tests • Have known value/outcome • Proficiency testing • Compare with results of patient’s test • Minimizes human error • Checks reagents/chemicals

  30. Preventive maintenance • Manufacturer’s recommended maintenance • Temperature checks on refrigerators, freezers, and incubators

  31. Instrument validations • Check calibration and accuracy of instruments and machines • Ensure accurate results

  32. The medical assistant’s role • Perform administrative office duties • Prepare patients • Collect specimens • Perform waived tests

  33. The medical assistant’s role • Four aspects of quality laboratory testing for accurate results • Prepare patient properly • Obtain specimen as expertly as possible • Reagents and equipment in best condition and calibration possible • Test performed by trained professional

  34. Lab Requisitions • Preprinted • Computer-generated • Features of requisition • Physician’s information • Patient’s name, address, phone numbers • Patient’s billing information

  35. Features of requisition • Unique patient identifier • Patient’s age/date of birth and gender • Source of specimen • Time and date of specimen collection • Test requested

  36. Features of requisition • Medications patient is taking • Clinical diagnosis • Urgency of results • Special collection/patient instructions • Other doctor(s) to receive copies of report

  37. Lab Requisitions andReports and the TPMS

  38. Lab Written Reports • Features: • Laboratory name, address, and phone numbers • Referring physician’s name and identification numbers • Patient’s name, ID number, age, and gender

  39. Features • Date specimen was received by laboratory • Date and time specimen was collected • Date laboratory reported results • Test name, results, and normal reference ranges

  40. Attach to patient’s chart • Notify physician of abnormal results • Computerized laboratory report >>

  41. Specimen Collection • Proper procurement, storage, and handling • Obtain from independent laboratories • Instruction manual • Guidelines • Patient preparation instructions

  42. Microscopes • One of the most used pieces of equipment in laboratory • Parts • Light source • Eyepiece • Objectives • Condenser • Diaphragm

  43. Types of microscopes • Compound • Phase contrast • Fluorescent • Electron

  44. How to use a microscope • Adjusting focus with coarse and fine adjustments • Raising and lowering of platform while viewing slide from the side • Control intensity of light with condenser and iris diaphragm • Oil-immersion lens

  45. How to care for a microscope • Proper way to handle

  46. How to care for a microscope • Follow manufacturer’s and clinic’s rules • Cover microscope when not in use • Clean lenses with special lens paper after each use • Always focus away from lens to prevent lens from coming into contact with slide • Use oil only with oil-immersion lens

  47. Questions • ?

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