PMLS LEC MODULE 8 AND 10

• It is very important that phlebotomists adhere to the best practices and the guidelines set by standard and regulatory agencies, beginning from the pre-analytical phase, during the analytical phase, up to the post-analytical phase, to ensure that we deliver utmost care to our patients and produce the most accurate results
• Imagine a patient whose test was wrongly done, or a patient with a falsely normal result which was supposed to be an elevated result because you did not follow the proper procedure in doing the venipuncture. It could actually hinder the diagnosis of the patient, and consequently lead to the mismanagement of the patient's case
• The Joint Commission, College of American Pathologists, Clinical Laboratory Improvement Amendments of 1988 (CLIA '88), and Clinical and Laboratory Standards Institute play key roles in bringing quality assessment review techniques to health care
• Quality Assurance (QA)


  A program that guarantees quality patient care by tracking outcomes through scheduled reviews in which areas of the health care organization look at the appropriateness, applicability, and timeliness of patient care
• QA Indicators


  • Guides to monitor all aspects of patient care
  • Must be measurable, well-defined, objective, specific, and clearly related to an important aspect of care
  • Can measure quality, adequacy, accuracy, timeliness, effectiveness or patient care, customer satisfaction, and so on, designed to look at areas of care that tend to cause problems
• Quality System Essentials (QSEs)


  • 12 fundamental components that can be used in any order desired to develop a quality management process
  • Each requires that processes, policies, and procedures be written and monitored
• The 12 Quality System Essentials (QSEs)


  • Organization
  • Facilities and Safety
  • Personnel
  • Equipment
  • Purchasing and Inventory
  • Process Control
  • Documents and Records
  • Information Management
  • Occurrence Management/Nonconforming Event Management
  • Assessments: External and Internal
  • Customer Service
  • Process Improvement
• The Joint Commission requires that Laboratory Requisitions must include specific information
• Threshold value


  A level of acceptable practice beyond which quality patient care cannot be assured
• Data sources


  Include patient records, laboratory results, incident reports, patient satisfaction reports, and direct patient observation
• Action plan


  Defines what will change and when that change is expected
• To improve an outcome, the process must be reviewed, following it from start to finish. It means standardizing the way performance is measured and activities are evaluated
• Quality Control (QC)


  • A component of QA program and a form of procedure control
  • The use of checks and controls, to ensure that the same process is always followed
  • Involves using all available quality control checks on every operational procedure to make certain it is performed correctly
• The Lean System


  Focuses on the elimination of waste to allow a facility to do more with less and at the same time increase customer and employee satisfaction
• The 6S tasks in the Lean System for phlebotomy


  • Sort
  • Straighten
  • Scrub
  • Safety
  • Standardize
  • Sustain
• Six Sigma methodology


  Utilizes the acronym DMAIC: Define goals and current processes, Measure current processes and collect data, Analyze the data for cause and effect information, Improve the process using the date collected, Control the correction of concerns displayed in the data
• Quality assurance in laboratory testing actually starts before the specimen is collected, in the preanalytical stage
• The phlebotomist and others involved in specimen collection must stay current concerning testing in order to answer inquiries correctly
• Specimen Identification


  • Most important aspect of specimen collection
• Puncture Devices


  • Ensure the quality and sterility of every needle and lancet for patient safety
  • All puncture devices come in sealed, sterile containers and should be used only once
  • If the seal has been broken, the device should be put in a sharps container and a new one obtained
  • Manufacturing defects in needles, such as barbs and blunt tips, can be avoided before use by quickly inspecting the needle after unsheathing
• Evacuated Tubes


  • Manufacturers print expiration
• Quality assurance


  Starts before the specimen is collected, in the preanalytical stage
• Phlebotomist and others involved in specimen collection


  • Must stay current concerning testing in order to answer inquiries correctly
• Specimen identification


  Most important aspect of specimen collection
• Puncture devices


  • Ensure the quality and sterility of every needle and lancet for patient safety
  • All puncture devices come in sealed, sterile containers and should be used only once
  • If the seal has been broken, the device should be put in a sharps container and a new one obtained
  • Manufacturing defects in needles, such as barbs and blunt tips, can be avoided before use by quickly inspecting the needle after unsheathing
• Evacuated tubes


  • Manufacturers print expiration dates on each tube for quality assurance
  • Outdated tubes should not be used because they may not fill completely: dilution of the sample, distortion of the cell components, erroneous results
  • Anticoagulants in expired tubes may not work effectively, instead allowing small clots to form and thereby invalidating hematology and immunohematology results
  • All new lots of evacuated tubes should be checked for adequate vacuum and additive, integrity of the stopper, ease of stopper removal, tube strength during centrifugation
• Labeling


  • Inaccuracies, such as transposed letters or missing information, will result in the specimen being discarded
  • Even with correct label (especially for computer-generated labels), it should be placed on the correct patient's specimen, and the date, time of draw, and ID of the person collecting the sample must be noted
• Phlebotomy technique


  • Proper phlebotomy technique must be carefully taught by a professional who understands the importance of following national standards and the reasons for using certain equipment
  • A periodic review of their technique is necessary for quality assurance and performance improvement
• Collection priorities


  • The importance of knowing how to recognize which specimen request is the most critical or when a specimen involves special collection criteria (e.g., renin or therapeutic drug monitoring [TDM]) can save the patient unnecessary medication or additional testing
  • It may even shorten the patient's stay in the hospital because, in many instances, therapy is based on test values from specimens assumed to have collected at the right time and in the proper manner
• Delta checks


  • It compares current results of a lab test with previous results for the same test on the same patient
  • Some variation in the results is to be expected, but a major difference in results could indicate error and requires investigation
• Labeling must be exact!
• When a phlebotomist understands the rationale for maintaining the standards, high-quality specimens are ensured
• Documentation


  A major part of a QA program
• Documentation required by the Joint Commission


  • A detailed procedure manual
  • Identification of variables associated with the procedures
  • Policies to control and monitor variables
  • Reference manuals provided to nursing and other nonlaboratory staff who collect samples
  • Competency assessments and continuing education records
• Patient's record


  • The most important documentation
  • A chronologic documentation of the medical care given to the patient
  • Every notation in the patient's medical or clinical record should be legible, precise, and complete
• Reasons for maintaining accurate, up-to-date medical records


  • To provide an aid to the practice of medicine
  • To provide an aid to communications between the physician and others involved with the patient's care
  • To serve as a legal document that may be used in a court of law
  • To serve as a very valuable tool for helping the hospital to evaluate performance outcomes
• Collection manuals


  • Detail how to prepare the patient and collect a high-quality sample
  • Contain, in chart form, the type and minimum amount of specimen needed for testing, special handling required, reference values for the test, the days testing is available, and the normal turnaround time (TAT)
  • Include updates and a copy of the notification of these changes to the persons who will be affected
  • Describe patient preparation and other special instructions for specimen collection
• Procedure manual


  States the policies and procedures that apply to each test or practice performed in the laboratory
• Information found in a procedure manual


  • Purpose of the procedure
  • Policy
  • Specimen type and collection method
  • Equipment and supplies required
  • Detailed step-by-step procedure
  • Limitations and variable of the method
  • Corrective actions
  • Method validation
  • Normal values and references
  • Review and revision dates
  • Approval signatures and dates
• Safety manual


  Contains procedures related to chemical, electrical, fire, and radiation safety; exposure control; and disaster plans as well as complete details on how to handle hazardous materials