Laboratory Quality Management System, Schemes and Mind Maps of Law

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LABORATORY QUALITY

MANAGEMENT SYSTEM

ATTY. FRANCIS C. BRION, RMT INSTRUCTOR

LABORATORY QUALITY

• Accuracy, reliability, and timeliness of reported results
• Challenge: reduce the level of inaccuracy as much as possible
• Errors: unnecessary treatment, treatment complications, delay in diagnosis, additional and unnecessary diagnostic testing
• Need: perform all processes and procedures in the lab in the best possible way

QUALITY CONTROL

• Target: accurate results
• Samples with known expected results are tested before or along with patient samples
• If the expected QC results are obtained
  • All the patients’ unknown results are likely to be accurate
• NOTE: QC only targets the analytical part of the workflow
• Requirements for the type and frequency of QC
  • Specified in operation manuals, package inserts, and regulation standards

QUALITY ASSURANCE

• A set of planned actions to provide confidence that

processes are working as expected

• Answers the question: How does the laboratory

know it is delivering a high-quality service to its

customers?

• Assesses how well the laboratory workflow (pre, ana,

post) is functioning

EQUIPMENT

• Calibration: adjustments are done to ensure accuracy

and precision

• Preventive Maintenance: systematic and routine

cleaning, adjustment and replacement of equipment

parts at scheduled intervals.

• NOTE: Everyone who uses the equipment should be

trained in calibration and daily maintenance.

• Purchase, install, calibrate, verify, and validate

EQUIPMENT

• All staff must be trained on the operation of equipment
• Troubleshooting
  • Identify the source of the problem
  • Check manufacturer instructions
  • No correction: backup instruments, replacement

instrument during repair, send samples to another lab

PROCESS MANAGEMENT

• Laboratory handbook/policy and procedure manual
  • contact names and telephone numbers of key personnel;
  • name and address of the laboratory;
  • hours of operation of the laboratory;
  • list of tests that can be ordered;
  • detailed information on sample collection requirements;
  • sample transport requirements, if any;
  • expected turnaround times;
  • description of how urgent requests are handled—this should include a list of what kinds of tests are done on an urgent basis, what are the expected turnaround times, and how to order these tests.

TEST REQUISITION

• specifies all the information that will be needed for proper handling and reporting
• patient identification;
• tests requested;
• time and date of the sample collection;
• source of the sample, when appropriate;
• clinical data, when indicated;
• contact information for the health care provider requesting the test.

SAMPLE COLLECTION

REQUIREMENTS

• Type of container: blood tubes, microbiology samples transport
• Sample labeling
• Special handling: immediate refrigeration, protection from light or prompt delivery to the laboratory

ASSESSMENTS

• systematic examination of some part (or sometimes all)

of the quality management system to demonstrate to

all concerned that the laboratory is meeting regulatory,

accreditation and customer requirements

• Types:
  • Internal audit
  • External audit
  • External quality assessment

INTERNAL AUDIT

• staff working in one area of the laboratory conduct assessments on another area of the same laboratory
• ISO: The main elements of the quality management system should normally be subject to internal audit once every twelve months.

EXTERNAL QUALITY ASSESSMENT

• Proficiency testing : external provider sends unknown

samples for testing (processed by normal testing methods

and by the usual personnel)

• Rechecking (AFB) or retesting (HIV rapid test): slides that

have been read are rechecked by a reference

laboratory; samples are retested for interlaboratory

comparison

• On-site evaluation : if proficiency testing and rechecking

are difficult to conduct

STANDARDIZATION

• ISO: International Organization for Standardization
  • Develops standards to ensure quality, safety, and efficiency of products, services, and systems
• CLSI: Clinical Laboratory Standards Institute
  • promotes the development and use of voluntary consensus standards and guidelines within the health care community
• WHO: World Health Organization
  • Disease-specific diagnostic laboratories

CERTIFICATION AND

ACCREDITATION

• Certification
  • an independent body gives written assurance that a product, process or service conforms to specific requirements
  • inspection team checks for physical presence of texts, procedures and documents
• Accreditation
  • authoritative body gives formal recognition that a body or person is competent to carry out specific tasks
  • observe laboratory staff to ensure that they perform functions and duties correctly and competently
• Licensure
  • Legal requirement for operation