PMLS

• Pre-examination Variables


  • Variables that occur to sample before being tested
  • Sometimes called PREANALYTICAL ERRORS, referring to errors that occur before the analytical portion of the testing occurs
• Pre-examination Variables


  • Patient identification
  • Tourniquets/hemoconcentration
  • Exercise and posture
  • Fasting and Timed samples
• Keeping the tourniquet on for longer than one minute

  Can result in hemoconcentration and a change in test results
• Compliance


  Formalized monitoring of an organization's adherence to laws and regulations
• Exercise


  1. Will change cell permeability, causing an increase in various analytes

  2. Hemoglobin will increase with exercise
• The laboratory should have a compliance plan that follows the regulations of the government agency
• Office of Inspector General


  Has been at the forefront of Nation's efforts to fight waste, fraud and abuse and to improve the efficiency of Medicare, Medicaid and more than 100 other Department of Health & Human Services (HHS) programs
• Compliance is essential to prevent overcharging
• Fasting samples after 10- to 12-hour fast


  Will give the best results for certain tests that are influenced by food intake
• Overcharging can be of the patient, Medicare, Medicaid, or the insurance carrier
• Anti Kickback Law


  Prohibits the knowing and willful payment or offer of any remuneration directly or indirectly in return for inducing, referring, or soliciting services, including laboratory testing paid for by a federal health program
• Timed samples


  Are collected for those analytes that follow diurnal (24hrs) or circadian (depends on body clock) rhythms
• Stark Law


  Forbids physician from referring sample to laboratory in which physician or immediate family member has financial interest (Medicare or Medicaid)
• Incorrect or improperly filled evacuated tube

  • Hemolysis with syringe draws
  • Cleaning with Betadine or Iodine solutions - Can cause increase in potassium, phosphorous, and uric acid
  • Incorrect order of draw
  • Samples that must be chilled
• The reason for the Stark Law was to prevent unnecessary medical testing that could raise the government's overall healthcare costs
• False Claims Act


  • Prohibits knowingly presenting false claim to government
  • Prohibits changing billing code (upcoding) to increase reimbursement
• Order of draw for evacuated tubes


  Will cause a carryover of additives from one tube to the next, resulting in compromised test results
• False Claims Act


  • Billing for lab tests that are not medically necessary for diagnosis and treatment
• Civil Monetary Penalties Law


  Prohibits claims for service not provided as claimed
• Certain tests, such as Ammonia, Catecholamines, Lactic Acid, and pH/Blood gases

  Require samples to be chilled
• Many states have their own set of laws that prohibit the payment of referral fees as well as the referral of the laboratory tests to a laboratory in which the physician has a financial interest
• State laws are not limited to the Medicare and Medicaid programs
• Penalties vary depending on state
• Chilling sample


  By placing in cup of ice and water
• Clinical Laboratory Improvement Act (CLIA)


  Includes specifications for quality control, quality assurance, patient test management, and personnel and proficiency testing
• CLIA includes some of the regulations that direct the laboratories in how the phlebotomist is proven to be competent in his or her job performance
• Certain samples must be kept warm after collection

  Cold Agglutinins and Cryoglobulin specimens often require the specimen to be kept warm after collection with a heel warmer
• Protected Health Information (PHI)


  Phlebotomist has the responsibility to patient to keep the patient's PHI confidential
• Health Insurance Portability and Accountability Act (HIPAA)


  • Protects health insurance coverage for workers and their families when they change or lose their jobs
  • Provided standards for the transfer of electronic health data
  • Restricts dissemination of health information on patient
  • Each health care worker will only have access to information that is determined to be necessary to treatment and care of that patient
• Laboratories should have a compliance plan to ensure they are not outside the law in any policies
• Elements of the compliance plan

  • Standards of conduct
  • Medical necessity
  • Billing
  • Reliance on standing orders
  • Compliance with applicable HHS fraud alerts
  • Marketing
  • Prices charged to physicians
  • Retention of records
  • Compliance as an element of a performance plan
• Protect samples from light

  If a sample cannot be exposed to light, it is best to place the sample in an amber tube or wrap the tube in aluminum foil (bilirubin, carotene, ascorbic acid, vitamin a)
• Phlebotomy-related compliance policies


  • Requisition design
  • Client supplies and equipment
  • Courier services
  • Hazardous and infectious wastes
  • In-office Phlebotomist
  • Questionable test requests
  • Release of test information
• Malpractice


  Failure of a professional person to offer a standard of care, resulting in injury or harm to the patient
• Best practices


  The most efficient and effective way of accomplishing a task, process, or activity based on repeatable procedures that have proven themselves over time for large numbers of people
• When test results are not consistent with previous test results, it is always recommended to redraw and run the test again
• Complications of phlebotomy that can result in legal action

  • Consent to perform venipuncture
  • Fainting or convulsing patient
  • Hematoma
  • Accidental arterial puncture
  • Nerve damage
  • Mislabeled/unlabeled sample
  • Exposure of the patient to blood-borne pathogens of another patient
• Sample Transport


  Transportation of samples from the phlebotomist location to the testing laboratory may use various methods that will contain a spill or breakage of the sample
• To prevent lawsuits, phlebotomists should follow established procedures and practices and be observant of patient
• Ethics


  • Moral philosophy of acting responsibly
  • Varies by individual, religion, social status, or heritage
  • In performing their jobs, phlebotomists must treat patients as they would like to be treated themselves
  • Phlebotomists see many patients at their worst, which can make it difficult to be ethical and professional