2. CHAPTER © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 1 Laboratory and Equipment Safety

3. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-2 Introduction Laboratory testing – integral part of patient care Medical assistant must know –Common laboratory equipment –Safety in the laboratory –Steps to prevent accidents CLIA ’88 – impact on laboratory setting –Quality assurance –Quality control procedures –Required record keeping

4. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-3 Role of Laboratory Testing in Patient Care Analysis of blood, urine, and other body fluids –Regular monitoring to identify diseases or other problems –Confirm initial diagnosis –Determine and monitor dosage of a medication

5. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-4 Role of Laboratory Testing (cont.) Kinds of laboratories –Reference laboratory Owned and operated by an organization outside the practice Have technological resources beyond the POL –POL Quicker turnaround Eliminates need for patient travel to other test location Some managed care companies require their subscribers to use a specific reference laboratory.

6. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-5 Role of Laboratory Testing (cont.) Purpose of POL –Accurate and timely processing of routine tests –Reporting test results to physician –Tests Chemical analysis Hematologic tests Microbiologic tests Urinalysis

7. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-6 Apply Your Knowledge Compare a reference laboratory and the POL. ANSWER: A reference laboratory is a lab facility usually run by an organization separate from the practice. It has technologies beyond the POL. Patients have to travel to this facility. A POL provides quicker turnaround on results but is limited in the testing that can be performed. Patients are able to have testing done during an appointment without leaving the office. Super!

8. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-7 Medical Assistant’s Role Processing tests done in POL –Preparing the patient –Collecting the sample –Completing the test –Reporting and documenting the results –Communicating information about the test

9. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-8 Medical Assistant’s Role (cont.) Additional responsibilities –Understand regulations –Accident prevention –Waste disposal –Housekeeping and maintenance –Quality assurance and control –Record keeping –Inventory and order equipment and supplies –Use reference materials –Screen and follow-up results

10. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-9 Apply Your Knowledge What are the duties of a medical assistant related to testing done in the POL? ANSWER: The medical assistant duties may include preparing the patient, collecting the sample, running the test, reporting the results, and, once the physician has reviewed the results, communicating the results to the patient.

11. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-10 Use of Laboratory Equipment You may routinely use the following: –Autoclave –Centrifuge –Microscope –Electronic equipment –Equipment used for measurement

12. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-11 Use of Laboratory Equipment (cont.) Autoclave – sterilizes surfaces of instruments and equipment Centrifuge – spins and separates specimen into its component parts

13. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-12 Use of Laboratory Equipment (cont.) Optical microscope –Uses light, concentrated through a condenser and focused through the object, to project an image –Compound microscope – two lenses magnify the image created by condensed light

14. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-13 Microscope Oculars –Eyepieces Monocular Binocular –Contain a magnifying lens – magnify image 10 times (10X lens) Objectives –Contain another magnifying lens –Moved under ocular when needed –Three objectives Two dry One oil-immersion Microscope

15. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-14 Microscope (cont.) Arm and focus controls –Arm – attaches oculars and objectives to body –Focus controls – used to focus the object Light source –Under stage and substage –Adjustable intensity Stage and substage –Stage – platform for slide –Substage – condenser Specimen slides/ coverslip Microscope

16. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-15 Parts of the Microscope Eyepieces Nosepiece Objectives Slide Clips Stage Condenser Iris Light Source Fine Adjustment Coarse Adjustment Base Arm 5. 6. 7. 8. 9. 10. 11. 12. 2. 3. 4. 1. Back

17. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-16 Use of Laboratory Equipment (cont.) Using an optical microscope –Operate correctly –Care and maintenance Clean after each use Store under plastic cover Move by holding arm and supporting the base

18. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-17 Use of Laboratory Equipment (cont.) Electronic equipment and software –Used to create and maintain clinical data –More accurate, safer, and more efficient than manual methods –Photometer – measures light intensity Equipment used for measurement –Pipettes –Flasks or beakers –Hemocytometer –Thermometers

19. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-18 Apply Your Knowledge Matching: ___ Measures light intensity A.Focus controls ___ Platform for slideB.Hemocytometer ___ Contains magnifying lensC.Stage ___ One is an oil-immersion D.Photometer ___ Condenser to concentrate lightE.Ocular ___ Move body tube up and downF.Substage ___ Calibrated to count cellsG.Objective ANSWER: G F E D C B A Nice Job!

20. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-19 Safety in the Laboratory Primary concern OSHA –Protection of employees in the workplace –Specific guidelines –General duty clause If no specific guidelines Workplace free from recognized hazards –Enforces guidelines from CDC

21. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-20 OSHA Guidelines Standard Precautions Hazard communication standards OSHA Bloodborne Pathogens Standard Hazardous Waste Operations and Emergency Response Final Rule Needlestick Safety and Prevention Act

22. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-21 Standard Precautions Assume that all blood, blood products, human tissue, and body fluids are contaminated PPE guidelines –Gloves –Eye protection Use equipment appropriately Proper biohazard disposal

23. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-22 Hazard Communication Biohazard labels Material Safety Data Sheets (MSDS) Hazard labels –Name of material –Hazardous effects

24. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-23 Safety in the Laboratory (cont.) OSHA Bloodborne Pathogens Standard –Written OSHA Exposure Control Plan –Training Blood-borne pathogens PPE Universal Precautions Prevention of exposure –Hepatitis B vaccination

25. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-24 Safety in the Laboratory (cont.) Hazardous waste –Dispose in proper containers Sharps Other biohazardous waste –Location of containers –Reduce spillage Needlestick Safety and Prevention Act –Revision of Bloodborne Pathogen Standard –Use of devices to reduce risk

26. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-25 Accident Prevention Guidelines Physical safety –Common sense –PPE –Manufacturers’ guidelines Fire and electrical safety –Fire drills –Fire extinguishers –Reduce electrical hazards

27. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-26 Safety in the Laboratory (cont.) Chemical safety –MSDS –PPE Biologic safety –Standard Precautions –Disinfection –Waste disposal Accident reporting –Office procedures –Ensure safety/ first aid –Clean up

28. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-27 Safety in the Laboratory (cont.) Housekeeping –Reduce risk of disease transmission –Guidelines Written policies and procedures Clean up spills/splashes immediately Clean equipment after use Dispose of waste correctly

29. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-28 Apply Your Knowledge What information must be included on the MSDS? ANSWER: MSDS must include:  Name of the product  Chemical and common name of ingredients  Chemical characteristics of the products  Physical hazards  Health hazards  Guidelines for safe handling  Emergency and first-aid procedures for exposure

30. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-29 Quality Assurance Programs Monitor the quality of patient care –Ensure safety of workers –Assess the quality of tests performed Clinical Laboratory Improvement Amendments (CLIA) –Regulation of laboratories –Test categories Certificate of Waiver Moderate complexity High complexity

31. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-30 CLIA Certificate of Waiver Tests –Pose insignificant risk to the patient if they are performed or interpreted incorrectly –Simple and accurate, so the risk of obtaining incorrect results is minimal –Approved by the FDA for home use

32. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-31 CLIA (cont.) Moderate-complexity tests –75% of tests –Qualified laboratory personnel –Random inspections High-complexity tests –Tests for specialties and subspecialties –Qualified laboratory personnel –Random inspections

33. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-32 Components of Quality Assurance Quality control program –Adherence to procedures –Careful documentation Instrument and equipment maintenance Proficiency testing Training and continuing education Standard operating procedures documentation

34. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-33 Quality Control and Maintenance Ensure accuracy in test results by carefully monitoring test procedures Procedures –Equipment calibration –Use control samples –Perform reagent controls –Maintain equipment –Documentation of above procedures

35. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-34 Quality Control and Maintenance (cont.) Equipment maintenance –Manufacturer’s guidelines –Troubleshooting a problem – investigating the cause using a systematic approach Documentation –Quality control log –Reagent control log –Equipment maintenance log –Reference laboratory log –Daily workload log

36. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-35 Proficiency Testing Proficiency testing program –Accuracy of test results –Adherence to standard operating procedures Control sample, documentation sent to proficiency testing organization –Pass – continue performing test –Fail – discontinue performing tests

37. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-36 QA Programs Training, continuing education, and documentation –Employer responsibility –Reference material MSDS/safety manuals/SOPs Manufacturers’ user or reference guides Clinical Lab Technical Procedure Manuals Regulatory documentation (OSHA, CLIA ’88) Maintenance and housekeeping schedules

38. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-37 QA Programs (cont.) Requisition forms –Medical assistant’s responsibility –Complete information –Include with specimen or send with patient to laboratory

39. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-38 Apply Your Knowledge What is the purpose of a quality assurance program for a laboratory? ANSWER: The purpose of a QA program for a lab is to monitor the quality of patient care, ensure safety of workers, and assess the quality of tests performed. Quality Answer!

40. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-39 Communicating with the Patient Before testing –Patient preparation –Verification of patient preparation During specimen collection –Proper patient identification –Verbal and nonverbal After specimen collection –Postprocedure instructions –Schedule for further testing, if needed

41. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-40 Communicating with the Patient (cont.) Test results –Report to physician for interpretation –Report to patient, if instructed to by the physician –Patient questions Answer if within your scope Refer to physician

42. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-41 Record Keeping Quality control and equipment maintenance Inventory control Record test results in patient records Tracking of specimens

43. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-42 Record Keeping (cont.) Patient records –Identify unusual findings –Follow office procedures Specimen identification –Patient information –Person who collected specimen –Physician Patient: Jason Jones DOB: 10/22/0000 Date / time: 04/14/0000 @ 9:00 AM Collected by: shf Physician: M. Welby

44. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-43 Apply Your Knowledge 1. Mr. Jones called for his laboratory results but the physician has not reviewed the results. What should the medical assistant do? ANSWER: The medical assistant should tell Mr. Jones that the physician has to review the results before releasing them to the patient. She should also tell Mr. Jones that she or the physician will call with the results once they are reviewed. 2. When she reviews Mr. Jones’ laboratory results, she notes that his glucose is elevated. What should the medical assistant do? ANSWER: She should identify the test result that is out-of-range by circling or underlining it based on office policy. Bravo!

45. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-44 In Summary 45.1The physician’s office laboratory (POL) is responsible for accurate and timely processing of routine tests and for reporting test results to the physician. 45.2The medical assistant’s duties in an office laboratory include preparing the patient for the test, collecting the sample, completing the test, reporting the results to the physician, and communicating information about the test to the patient. 45.3Common laboratory equipment includes autoclaves, centrifuges, microscopes, electronic equipment and software, and equipment used for measurement.

46. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-45 In Summary (cont.) 45.4Follow specific steps for operating a microscope, including plugging it in, cleaning the lenses, placing the slide on the stage, adjusting the focus, examining the image, and cleaning the lens before storage. 45.5Regulatory controls governing the physician’s office laboratory include Standard Precautions, Hazard Communication Standard, OSHA Bloodborne Pathogens Standard, Hazardous Waste Operations and Emergency Response Final Rule, and the Needlestick Safety and Prevention Act.

47. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-46 In Summary (cont.) 45.6Preventing accidents in the physician’s office laboratory should include physical, fire and electrical, chemical, and biologic safety measures. 45.7The goal of a quality assurance program in a physician’s office laboratory is to monitor the quality of the patient care that a medical laboratory provides. 45.8The medical assistant might be responsible for recording information about quality control and equipment maintenance, inventory control, test results in patient records, and tracking every specimen that he or she handles.

48. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-47 In Summary (cont.) 45.9Hazardous waste must be disposed of in properly constructed and labeled containers. Containers for sharps must be puncture-proof, leak-resistant, and rigid, and needles should be dropped into the sharps container without bending, breaking, or recapping them. 45.10Quality assurance and quality control programs serve to reduce testing errors and provide for the safety of laboratory personnel. 45.11Accurate quality control documentation in a physician’s office laboratory includes a reference laboratory log and a daily workload log.

49. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-48 In Summary (cont.) 45.12Common reference materials used while performing procedures in a physician’s office laboratory include Material Safety Data Sheets, standard operating procedures, safety manuals, equipment manufacturers’ user or reference guides, Clinical Laboratory Technical Procedure Manuals, regulatory documentation, and maintenance and housekeeping schedules. 45.13It is the medical assistant’s responsibility to ensure that patients understand what is expected of them before a test. Providing clear pretest instructions in both oral and written form is an essential part of the test procedure.

50. © 2011 The McGraw-Hill Companies, Inc. All rights reserved. 45-49 End of Chapter 45 Quality is not an act, it is a habit. ~ Aristotle