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Lesson 13: Quality Assessment and Laboratory Management Questions With Complete Solutions Laboratory Quality It is defined as accuracy, reliability and timeliness of reported test results. Quality A form or degree of excellence 'conformance to the requirements' In 1960, a man wrote _________________________' as the definition of the quality in his paper 1 Pre-examination/Pre-analytical area 2 Examination/ analytical area 3 post-examination/post-analytical area What are the three distinct areas of clinical laboratory? Pre-examination/Pre-analytical Area It includes the reception, the phlebotomy department, and samples receiving. Pre-examination/Pre-analytical Area It collects and prepares the sample. Examination/Analytical Area
where the MedTechs work to analyze the sample. Post-examination/Post-analytical Area reports the released results. Quality Control and Quality Assurance When we speak of quality in the clinical laboratory, what terms are always present? Quality Control It involves procedures to ensure that acceptable standards are being met while the procedures are being performed Quality Control Employs the use of standards, instrument calibrators, and controls. Quality Control Focuses specifically on the testing process, or analytical phase of the lab process. Quality Control Limited to a test or procedure. Quality Assurance It is the overall process or guaranteeing quality patient care which includes the methods used for patient preparation,
The purpose or goal of the phlebotomy quality assurance are to: Laboratory Testing an important part of patient diagnosis and is a major part of patient care. Controls Substances that contain and establish amount of the substance being tested, which is the analyte. Controls It validates the reliability of the test system, and to evaluate the operator's performance and environment conditions that might impact results Controls It is tested at the same time and in the same way as patient's samples. Calibrators solutions with specified defined concentrations that are used to set an instrument kit or system before testing is began standards Calibrators are sometimes called _________________, but the term calibrator is preferred. They usually do not have thesame consistency as patient's samples
Standard it is used to calibrate a method Standard control or standard calibrator Standard has known values although it is usually used as ____________________ or __________________ F The terms quality assurance and quality assessment are usually interchangeable. T or F The terms quality assurance and quality control are usually interchangeable T T or F Calibrators are often provided by the manufacturer of an instrument. F T or F Calibrators can be used as controls. samples received The quality of laboratory testing is absolutely dependent on the quality of the ______________________ Documentation
Clinical and Laboratory Standards Institute Global, non-profit standards developing organization with representatives from the profession, industry, and government. Clinical and Laboratory Standards Institute Its goal is to develop best practices in clinical and laboratory testing and promote their use throughout the world. Clinical and Laboratory Standards Institute Its goal is to use process that balances the viewpoints of the industry, government, and the healthcare professions. International Organization for Standardiization International standard-setting body composed of representatives from various national standards organizations International Organization for Standardiization Its goal is to develop worldwide standardization by promoting adoption of international quality standards ISO 9001 provides guidance for quality in service industries. ISO 15189: 2007 requirements for quality and competence in Medical Laboratories. LTO or "License to Operate"
The regulator agencies require specific documentations to be accomplished by the health-related facilities before they are granted with __________________________________ 1 Detailed procedure manual 2 Identification of variables associated with the procedures 3 Policies to control and monitor variables 4 Reference manuals provided to non-laboratory staff who collect samples 5 Competency assessments and continuing education records Documentations which are part of the quality assurance program are? 1 Procedure Manuals 2 Equipment Check form 3 Internal Reports Documentation Requirements Procedure Manuals State policies and procedures that apply to each test or practice performed. Procedure Manuals Must be accessible by the laboratory staffs, and present at all times in the laboratory sections. Procedure Manuals
Forms used to record equipment checks used in the laboratory. Equipment Check Forms Accreditation standards agencies require the laboratory to show documentation on QC checks and activities. Equipment Check Forms Verification of new lot numbers (tube additives, vacuum strength, and expiration dates). Equipment Check Forms Refrigerator and freezer temperatures monitoring sheets. Equipment Check Forms Centrifuge maintenance checklist. Confidential Incident Report This form is filled out when a problem occurs. 1 Injur 2 Errors in handling and processing of samples 3 Insubordination and other misdemeanors Instances where IR is given: T T or F Function of the IR is not to place the blame on the personnel but to identify what took place and administer corrective actions
1 Identify the problem 2 State the consequences 3 Describe Corrective Action An IR must: pre-examination variables Anything that can be changed or altered Pre-examination Patient Client prep Pre-examination Sample collection Pre-examination personnel competency test evaluations Pre-examination Sample receipt and accessioning Pre-examination sample transport Examination quality control testing Post-examination record keeping
Records Determine if changes to the manual are needed Records Reduce the number of errors Records Decrease number of STAT requests Records Justify staffing and evaluate if additional trainings for phlebotomists are required or changes in staffing schedule 1 Hand-held computer system 2 Nurse Verificaion (IPD) 3 Patient Verification Methods employed by some institutions (to minimize errors in ordering tests): Hand-held computer system barcoding system Hand-held computer system The barcode on the patient's ID band is scanned, and this will provide the patient's ID and his/her test requests Hand-held computer system
Once you're done with phlebotomy, a second scan of the barcode will print out labels with the identification of a patient. Nurse verification - IPD the test requisition slips are printed in the lab, and the phlebotomist will have it verify the nurse-in-charge based on the patient's chart Patient verification he phlebotomist will have it to verify directly from the patient and verify against the doctor's order Patient Identification most important step in specimen collection 1 Patients must be actively involved in the identification process. 2 Ask 2 patient identifiers 3 having the patient spell out their last name. 4 Match these against the laboratory requisition form. 5 check the ID band or bracelet. How do we identify patients? (if barcode readers are not available) T T or F Verification of the patient must be done at all times even if you know the patient personally.
T
T or F Misidentification is a serious offense. Grounds for malpractice lawsuits. First in, first out system
- where we use the evacuated tube with the shortest expiration dates first 1 Adequate vacuum and additive 2 Integrity of stopper removal 3 Tube strength Evacuated Tubes should be checked for: fasting, allergies and medications Patient Preparation: Phlebotomists should be aware of patient's__________________________ Patient Identification Any errors or differences must be resolved before collection may vary slightly from one. Patient Identification Identification protocol may vary slightly from one institution to another Patient Identification
Usually facilitated by "auto verification" Patient misidentification Grounds for malpractice lawsuits. Phlebotomy Equipment Ensure sterility and quality of needles and puncture devices Phlebotomy Equipment Ensure stability of evacuated tubes and their additives Phlebotomy Equipment QC all new lots of evacuated tubes should be checked for adequate vacuum and additive, integrity of stopper removal, and tube strength. Phlebotomy Equipment When all is done checking, document everything. For any defects detected, notify the manufacturer, or the distributor for the product placement. Phlebotomy Equipment Ensure safety of the phlebotomist and patient with the use of appropriate disposal containers and safety devices. Patient Preparation Phlebotomists should be aware of patient's fasting, allergies, and medications.
1 Hematoma 2 Edematous Area 3 Arms adjacent to masectomies 4 Arms receiving intravenous fluids 4 areas to avoid because of possibility of contamination: procedure manual. If you are not sure of the fasting requirements, you can always check with the ___________________ 1 Burned or scarred area 2 Arms adjacent to masectomy 3 Arms with fistulas and shunts 4 back of the heel 5 previous dermal puncture site 6 arteries 6 areas to avoid to prevent injury to the patient: infection Improper cleansing of the phlebotomy site can cause an
Blood culture contamination the most frequently encountered variable of site cleansing Microbiology department It records contamination incidents.
Cleansing the Site Increase in contamination rates are investigated and documented Blood culture contamination Corrective actions: in-service training of personnel collecting blood culture samples Performing Venipuncture A phlebotomist must understand the rationale for maintaining standards and the reasons for using certain techniques Performing Venipuncture Patient's impression is heavily influenced by phlebotomist 1 Wrong tube collection 2 Fialure to mix the sample adequately 3 Failure to follow correct order of draw 4 Failure to maintain proper blood: anticoagulant ratio 5 excessive dilution Variables in technique will affect both sample quality and patient safety: Performing Venipuncture Frequent poor techniques will be documented as IR Performing Venipuncture Phlebotomists must strive not to become another bad memory.
