CLIA Compliance and Laboratory Safety

CHAPTER 40 CLIA Compliance and Laboratory Safety Learning Outcomes Cognitive Domain 1. Spell and define the key terms 2. Explain the significance of CLIA and describe how to maintain compliance in the physician office laboratory 3. Discuss the practices physician office laboratories must define to assure good performance of waived testing 4. Using CLIA guidelines, identify laboratory tests that are and are not within the scope of practice for a medical assistant 5. Identify disease processes that are indications for CLIA-waived tests 6. Identify the consequences of practicing outside CLIA guidelines 7. Identify the role of the Centers for Disease Control regulations in health care settings 8. Define critical values and document the proper notification to the health care professional 9. Identify results that require follow-up and document action in chart 10. Identify how to handle all test results whether inside or outside the reference interval and document on a flow sheet 11. Identify and use quality control methods 12. Define proficiency testing and describe why CLIA requires it to maintain laboratory quality 13. Identify the source of instrument maintenance and calibration instructions 14. Analyze charts, graphs, and/or tables in the interpretation of health care results 15. Define OSHA and state its purpose 16. Discuss the application of standard precautions with regards to: a) all body fluids, secretions, and excretions; b) blood; c) nonintact skin; and d) mucous membranes 17. Identify safety techniques that can be used to prevent accidents and maintain a safe work environment 18. List the types and uses of personal protective equipment 19. Identify safety signs, symbols, and labels 20. Describe the reasons to file an incident report 21. Describe the Needlestick Safety and Prevention Act and list its requirements Psychomotor Domain 1. Practice standard precautions 2. Participate in training on standard precautions 3. Comply with safety signs, symbols, and labels 4. Evaluate the work environment to identify safe versus unsafe working conditions 5. Screen and follow up test results and document laboratory results appropriately (Procedure 40-1) 6. Use methods of quality control (Procedure 40-2) 725

726 PART IV The Clinical Laboratory 7. Document accurately 8. Perform routine maintenance of clinical equipment (Procedure 40-3) 9. Perform patient screening using established protocols 10. Assist with patient care ABHES Competencies 1. Define scope of practice for the medical assistant, and comprehend the conditions for practice within CLIA regulations 2. Document accurately 3. Understand the various medical terminology for each specialty 4. Comply with federal, state, and local health laws and regulations 5. Apply principles of aseptic techniques and infection control 6. Screen and follow up patient test results 7. Use standard precautions 8. Advise patients of office policies and procedures 9. Practice quality control 10. Dispose of biohazardous materials

CHAPTER 40 CLIA Compliance and Laboratory Safety 727 Name: Date: Grade: COG MULTIPLE CHOICE 1. What body regulates nonresearch laboratory testing in the United States? a. The Centers for Disease Control and Prevention b. The Centers for Medicare and Medicaid Services c. The Food and Drug Administration d. The Department of Labor e. Congress 2. A laboratory must have a written quality assurance policy that: a. is communicated to all staff. b. is stored neared the site of use. c. includes all HazCom requirements. d. includes all MSDSs supplied by the manufacturers. e. is updated once a week. 3. A pronounced and immediate change in test performance is known as a: a. control. b. trend. c. reagent. d. flow. e. shift. 4. What might the yellow quadrant of the National Fire Safety Association diamond indicate? a. Health hazard b. Fire hazard c. Reaction hazard d. Biological hazard e. Natural hazard 5. OSHA is a federal agency within the: a. Department of the Interior. b. Department of Health and Human Services. c. Department of Labor. d. Department of Commerce. e. Department of the Treasury. 6. All hazardous chemicals must be: a. placed on top shelves out of a patient s reach. b. placed near a sink in case a person s skin is exposed. c. labeled with a warning and statement of the hazard. d. used only by medical professionals while wearing heavy boots. e. stored away from sunlight. 7. The best source of normal values for the POL is: a. the Physicians Desk Reference. b. the manufacturer s packaging insert. c. the ICD-9 CM. d. the Laboratory Procedure Manual. e. the CLIA certificate. 8. The presence of a panic value in test results indicates: a. an outbreak of a contagious virus. b. imminent death of the patient. c. general good health. d. a potentially life threatening situation. e. negligence on the part of the laboratory. 9. Who provides quality control instructions for a given test? a. FDA b. CLSI c. Laboratory director d. Manufacturer e. OSHA

728 PART IV The Clinical Laboratory 10. What document describes the appropriate methods for performing every test offered by a laboratory? a. Quality assurance plan b. CLIA certificate c. Laboratory Procedure Manual d. Flow sheet e. Material safety data sheet 11. Which of the following does OSHA require the employer to make available to the medical assistant in the laboratory? a. Health insurance b. Hepatitis B vaccine c. Prescription refills d. Performance evaluations e. Measles vaccine 12. Hazardous waste materials include a. Supply packaging b. Laboratory reports c. Used needles and sharps d. Unopened supplies e. Documents in the patient s chart 13. Urine dipsticks and pregnancy tests are examples of a. Waived tests b. Moderately complex tests c. Provider performed microscopy d. High complexity tests e. Referral tests 14. What CLIA-waived test may be ordered on a patient presenting with a sore throat? a. Hematocrit b. Urine dipstick c. Glucose meter measurement d. Rapid strep test e. CBC 15. The laboratory receives a patient report from the referral laboratory. What is the next responsibility of the medical assistant? a. Place the results in the patient s chart. b. Place the results on the physician s desk. c. Screen and follow up the test results. d. Ask Medical Records to follow up. e. Phone the results to the patient. 16. The physician orders a urine dipstick test on a patient. What is required before reporting the test results to the physician? a. Acceptable quality control results b. The test to be duplicated c. A microscopic evaluation d. A signed release from the patient e. Review of the results with the patient 17. You bring your lunch to work and need to refrigerate it. You would: a. store it in the laboratory refrigerator. It is nearest to you while you work. b. store it in the refrigerator in the break room. That refrigerator does not have a biohazard label. c. store it in the refrigerator with drugs and vaccines. d. store it in a drawer in the laboratory. e. store it in an empty drawer in the procedure room. 18. How do you choose the shoes you wear in the laboratory? a. It is summer so you choose sandals. b. Your canvas sport shoes are so comfortable. c. You choose a completely closed shoe to protect from physical and chemical hazards. d. You choose a clog. You have heard they are really ergonomic. e. You do not wear scrubs in your office, so you wear a casual, open-toed shoe with your casual work outfit.

CHAPTER 40 CLIA Compliance and Laboratory Safety 729 19. You are just getting over a cold and have a lingering cough. How do you protect your patients? a. Turn your head when you cough. b. Wear a mask. c. Call in sick. d. Cough into your arm. e. Open a lozenge and slip it in your mouth so you won t cough while collecting a patient s specimen. 20. You are cleaning the laboratory counters at the end of the day. What is the cleaning product of choice? a. Boiling water b. Dish soap and warm water. c. Ammonia d. Full strength bleach e. A 10% bleach solution COG MATCHING Grade: Match each key term with its defi nition. Key Terms 21. aerosol 22. calibration 23. biohazardous waste Definitions a. an additional more specific test performed to rule out or confirm a preliminary test result to provide a final result b. a device or solution used to monitor the test for accuracy and precision c. life-threatening test results 24. blood-borne pathogens 25. chemical hygiene plan (CHP) 26. confirmatory test 27. control 28. critical values 29. external control 30. flow sheet 31. internal control d. a form used to collect important data regarding a patient s condition e. similar results if asked to repeat the test f. control built into the testing device g. control that acts just like a patient specimen h. particles suspended in gas or air i. the manufacturer s instructions for storage, handling, and disposal of the chemical j. pathogens when present in human blood cause disease k. infectious waste or biomedical waste l. a method provided by the manufacturer to standardize a test or laboratory instrument m. a part of the HazCom standard that must address chemical hazards present in the medical office 32. material safety data sheet (MSDS) 33. precision

730 PART IV The Clinical Laboratory COG MATCHING Grade: Match each key term with its defi nition. Key Terms Definitions 34. proficiency testing a. testing programs provide unknown samples to test as if they were patient specimens 35. qualitative test b. a substance that produces a reaction with a patient specimen so the analyte can be 36. quantitative test detected or measured c. the test result range the physician wants for the patient 37. reagent d. test has positive or negative results 38. reconstitution e. tests are measured and reported in a number value 39. sensitivity f. when QC results make an obvious change g. when results increase or decrease over time 40. shifts h. used in medical offices to reduce the risk for transmission of pathogens 41. specificity i. human blood and most body fluids are handled as if they are infectious for HIV, hepatitis B virus, hepatitis C virus, and other blood-borne pathogens 42. standard precautions j. adding water to bring a material back to its liquid state 43. therapeutic range k. the lowest concentration of an analyte that can reliably be detected or measured by a test system 44. trends l. the ability of a test to detect a particular substance or constituent without 45. universal precautions interferences or false reactions by other substances COG IDENTIFICATION Grade: For each listed purpose, identify the organization, law, or standard initiating the purpose. Organization, Law, or Standard Purpose 46. regulatory program that sets standards for the quality of laboratory testing 47. regulates all laboratory testing performed on humans 48. U.S. government s agency for protecting the health of all Americans and providing essential human services 49. works to protect public health and safety 50. responsible for protecting and promoting public health through the regulation and supervision of blood transfusions products 51. works to support the health care industry by providing knowledge and resources for maintaining quality laboratory operations 52. required by any group that performs even one test, including a waived test

CHAPTER 40 CLIA Compliance and Laboratory Safety 731 53. state agency requiring notification of the occurrence of a reportable disease 54. establishes rules to ensure the safety, standards, and integrity of all testing performed on human specimens 55. standards protect workers by eliminating or minimizing chemical, physical, and biological hazards and preventing accidents 56. requires all medical employers to provide training for their employees in techniques that will protect them from occupational exposure to infectious agents, including blood-borne pathogens 57. the right to know law 58. a part of the HazCom standard that must address potential chemical exposure by the employee 59. requires medical offices to keep an injury log to record the details of sharps injuries COG IDENTIFICATION Grade: Identify laboratory tests that a medical assistant (MA) can perform and those that must be performed by a medical technologist/clinical laboratory scientist (MT/CLS). 60. Urine dipstick 61. Urine microscopic 62. Hematocrit 63. WBC differential 64. Thyroid panel 65. Specific gravity 66. Glucose by glucose meter 67. Pregnancy test by waived kit 68. Rapid strep by waived kit 69. Strep identification by microbiology culture

732 PART IV The Clinical Laboratory COG IDENTIFICATION Grade: Identify requirements to maintain CLIA compliance in the POL. Note required (R) or not applicable (NA). 70. Test complexity 71. CLIA certification 72. Quality assurance plan 73. Critical values 74. Personnel training 75. Personnel Competency Assessment 76. Screen and follow up test results 77. Maintain flow sheets 78. Proficiency testing 79. Patient test management 80. Laboratory Procedure Manual 81. Quality control 82. Report communicable diseases 83. Reagent management 84. Instrument calibration and maintenance 85. Documentation

CHAPTER 40 CLIA Compliance and Laboratory Safety 733 COG IDENTIFICATION Grade: Identify the waived test used in the identification of the disease process. Answers may be used more than once. 86. Strep throat: A. Erythrocyte sedimentation rate 87. Pregnancy: B. Urine HCG test 88. Mononucleosis: C. Hematocrit 89. Glycosuria: D. Mono test 90. Hypoglycemia: E. Rapid Strep test 91. Inflammation: F. Urine dipstick 92. Anemia: G. PT/INR meter 93. Proteinuria: H. Glucose meter 94. Bilirubinuria: 95. Hyperglycemia: COG AFF SHORT ANSWER Grade: 96. Why did the Needlestick Safety and Prevention Act become law, and what are its requirements? 97. Define proficiency testing and describe why CLIA requires it to maintain laboratory quality?

734 PART IV The Clinical Laboratory 98. Identify the source of instrument maintenance and calibration instructions. 99. Describe the difference between a flow sheet and a patient history. 100. In the context of laboratory medical testing, what is the purpose of a control? 101. Explain the difference between qualitative and quantitative tests. 102. How do you identify whether patient values are inside or outside the reference interval?

CHAPTER 40 CLIA Compliance and Laboratory Safety 735 103. In reviewing patient results, how do you determine patient values requiring followup? 104. Give four reasons an incident report may be needed. 105. Using the hazardous materials rating system, give the type of hazard identified by the following colors. a. Blue: b. Red: c. Yellow: 106. A bottle of sodium hydroxide, a common alkali, has the diamond-shaped symbol of the National Fire Protection Association printed on it. The number 3 is printed in the blue quadrant. What does this number indicate?

736 PART IV The Clinical Laboratory COG IDENTIFICATION Grade: Identify safety techniques that can be used to prevent accidents and maintain a safe work environment. Identify each action as S (safe) or NS (not safe). 107. Eating, drinking, or smoking in the laboratory area. 108. Touching your face, mouth, or eyes with your gloves or with items, such as a pen or pencil used in the laboratory. 109. Wash your hands prior to inserting your contact lens in the laboratory. 110. Label all specimen containers with biohazard labels. 111. Store all chemicals according to the manufacturer s recommendations. 112. Wash hands frequently for infection control. 113. Wear gloves to protect from needlestick accidents. 114. Wear gloves to protect yourself and the patient from biohazard contamination. 115. Do not discuss a work injury or biohazard exposure to minimize concern. COG IDENTIFICATION Grade: For each item of personal protective equipment listed, describe the type of protection provided. 116. Gloves: 117. Lab coats: 118. Masks:

CHAPTER 40 CLIA Compliance and Laboratory Safety 737 119. Goggles and face shields: 120. Respirators: COG PSY AFF CASE STUDIES FOR CRITICAL THINKING Grade: 1. The Levey-Jennings QC Chart for a test commonly performed in your office appears to suggest that the test is producing progressively higher results. How would you go about researching this phenomenon? What information should you present to the physician? 2. A test is showing systematically low results; that is, in each case, the result is proportionately lower than expected. The results are precise, but inaccurate. What must you do to ensure proper results? Document this appropriately in the QC log and in the patient s chart.

738 PART IV The Clinical Laboratory 3. You are performing a glucose test on your patient using a glucose meter. The patient s glucose result is below the level the meter can detect. The glucose meter can detect values as low as 40 mg/dl. What kind of value is this? What steps should you take with the test results? Using the space below, demonstrate recording this information in the patient s chart. 4. Patient Jacob Wisliki is on coumadin therapy following a stroke. Dr. Wilson requests that you maintain a flow sheet on this patient. Today is November 11, 2012. Mr. Wisliki s INR is 1.8. His current medication dose is 2 mg qd. Dr. Wilson orders weekly INR testing. Maintain Mr. Wisliki s flow chart using the information provided below. Mr. Wisliki s INR is below Dr. Wilson s target range today, so Dr. Wilson increases Mr. Wisliki s dose to 2.5 mg qd. You instruct Mr. Wisliki to return in a week as Dr. Wilson ordered. Mr. Wisliki returns. His INR today is 2.1. This is in Dr. Wilson s therapeutic range, but Dr. Wilson would like to see the value run higher. He increases Mr. Wisliki s dose to 3.5 mg qd. You instruct Mr. Wisliki to return in a week as Dr. Wilson ordered. Mr. Wisliki returns the following week. His INR today is 3.5. This value is higher than Dr. Wilson s therapeutic range, so he decreases Mr. Wisliki s dose to 3.0 mg qd. You instruct Mr. Wisliki to return in a week as Dr. Wilson ordered. Mr. Wisliki returns on schedule. His INR today is 3.1. Dr. Wilson is concerned that Mr. Wisliki s INR did not respond as usual to the decrease in the dose. He asks Mr. Wisliki about any changes in his diet. Mr. Wilson says that he has been eating more spinach lately because it is ripe in his garden. Dr. Wilson tells Mr. Wisliki that eating green leafy vegetables will cause the anticoagulant to not work as well in his body and can cause increased INR. He instructs Mr. Wisliki to avoid eating green leafy vegetables while on anticoagulant therapy. Dr. Wilson does not change Mr. Wisliki s dose as he expects the INR to go down when Mr. Wisliki stops eating as much green leafy vegetables. You instruct Mr. Wisliki to return in a week as Dr. Wilson ordered. Mr. Wisliki is back for his weekly INR check. Today his INR is 2.5. This is exactly where Dr. Wilson wants Mr. Wisliki s INR to be so he does not change his dose today. You instruct Mr. Wisliki to return in a week as Dr. Wilson ordered. Mr. Wisliki is back for his INR. Today his INR is 2.5. As Mr. Wisliki s INR is stable, Dr. Wilson does not change his dose. You instruct Mr. Wisliki to return in a week as Dr. Wilson ordered. Anticoagulation Flowsheet Patient s name: _Jacob Wisliki Date of Birth: _03/20/1940 Target International Normalized Ratio (INR): 2.0 3.0 2.5 3.5 Other: Date Current Dose INR Complications New Dose Next INR Initials 11/23/2011 2 mg qd 1.8 2.5 mg qd 2.1 3.5 mg qd 3.2 3.0 mg qd 3.1 3.0 mg qd 2.5 3.0 mg qd 2.5

CHAPTER 40 CLIA Compliance and Laboratory Safety 739 PSY PROCEDURE 40-1 Screen and Follow Up Test Results and Document Laboratory Results Appropriately Name: Date: Time: Grade: EQUIPMENT/SUPPLIES: Patient laboratory results, critical values list for offi ce, patient s chart, telephone (as needed) STANDARDS: Given the needed equipment and a place to work, the student will perform this skill with % accuracy in a total of minutes. (Your instructor will tell you what the percentage and time limits will be before you begin practicing.) KEY : 4 = Satisfactory 0 = Unsatisfactory NA = This step is not counted PROCEDURE STEPS SELF PARTNER INSTRUCTOR 1. Review laboratory reports received from reference laboratory. 2. Note which reports may be placed directly on the patient s chart and which require immediate notification due to critical results. 3. Notify the physician of the result. Take any immediate instructions from the physician. 4. Follow instructions and document notification and follow-up. 5. Chart remaining reports appropriately. CALCULATION Total Possible Points: Total Points Earned: Multiplied by 100 = Divided by Total Possible Points = % PASS FAIL COMMENTS: Student s signature Partner s signature Instructor s signature Date Date Date

CHAPTER 40 CLIA Compliance and Laboratory Safety 741 PSY PROCEDURE 40-2 Quality Control Monitoring Using a QC Chart Name: Date: Time: Grade: EQUIPMENT/SUPPLIES: Instrument test results, quality control charts STANDARDS: Given the needed equipment and a place to work, the student will perform this skill with % accuracy in a total of minutes. (Your instructor will tell you what the percentage and time limits will be before you begin practicing.) KEY : 4 = Satisfactory 0 = Unsatisfactory NA = This step is not counted PROCEDURE STEPS SELF PARTNER INSTRUCTOR 1. Assemble the charts and data. 2. On the QC chart, plot the control results obtained for the test run. 3. Evaluate chart for acceptability of results. 4. If results are within accepted limits, report patient results. 5. If results are not within accepted limits, do not report patient results. Troubleshoot the test. Repeat testing on the patient and control specimens. 6. If results are within accepted limits, report patient results. Document corrective action and acceptable control results. 7. If results are not within accepted limits, notify the physician of test malfunction. Arrange to have patient specimen referred for testing or store the specimen appropriately until repairs can be made. 8. Troubleshoot within manufacturer s guidelines for operator troubleshooting. Document in the maintenance log. If this is not successful, arrange repairs for the instrument. Document any manufacturer-supplied repairs in the maintenance log. 9. Keep physician informed of testing status. 10. Before returning the instrument to service, validate calibration and quality control. Document appropriately. CALCULATION Total Possible Points: Total Points Earned: Multiplied by 100 = Divided by Total Possible Points = % PASS FAIL COMMENTS: Student s signature Partner s signature Instructor s signature Date Date Date

CHAPTER 40 CLIA Compliance and Laboratory Safety 743 PSY PROCEDURE 40-3 Perform Routine Maintenance of Clinical Equipment Name: Date: Time: Grade: EQUIPMENT/SUPPLIES: Laboratory instrument to be maintained, instrument manual from manufacturer, instrument maintenance log, maintenance supplies as indicated in the instrument manual, personal protective equipment, hand sanitizer, surface sanitizer, contaminated waste container STANDARDS: Given the needed equipment and a place to work, the student will perform this skill with % accuracy in a total of minutes. (Your instructor will tell you what the percentage and time limits will be before you begin practicing.) KEY : 4 = Satisfactory 0 = Unsatisfactory NA = This step is not counted PROCEDURE STEPS SELF PARTNER INSTRUCTOR 1. Wash your hands. Put on gloves. 2. Read or review the maintenance section of the instrument manual. 3. Follow the manufacturer s step-by-step instructions for maintaining the instrument. 4. Turn on the instrument and ensure that it is calibrated. 5. Perform the test on the quality control material. Record results. Determine whether QC is within control limits. If yes, proceed with patient testing. If no, take corrective action and recheck controls. Document corrective action. Proceed with patient testing when acceptable QC results are obtained. 6. Document maintenance procedures performed in instrument maintenance log. 7. Properly care for or dispose of equipment and supplies. 8. Clean the work area. Remove personal protective equipment, and wash your hands. CALCULATION Total Possible Points: Total Points Earned: Multiplied by 100 = Divided by Total Possible Points = % PASS FAIL COMMENTS: Student s signature Partner s signature Instructor s signature Date Date Date