Clinical Laboratories PDF

**CLINICAL LABORATORIES** BASIC CONCEPTS: - A place establishment or institution organized and operated primarily for the performance of bacteriological, biochemical, microscopical, serological or parasitological tests. - Practical application of fundamental sciences to human body sam...

**CLINICAL LABORATORIES** BASIC CONCEPTS: - A place establishment or institution organized and operated primarily for the performance of bacteriological, biochemical, microscopical, serological or parasitological tests. - Practical application of fundamental sciences to human body samples using specialized equipment and methods to gather data that helps determine health status. - A clinical laboratory must be built to ensure it is safe for patients, staff, and the public, with no risks or hazards. - The laboratory must be strong enough to handle heavy load and environmental conditions. - Must have enough lighting and good airflow to ensure that staff can work effectively and that everyone remains comfortable. - Floors, walls, ceilings, fixtures, and furniture in the lab must be made of strong, durable materials that are easy to clean and resistant to fire and acids. - There shall be measures for detecting fire such as fire alarms in walls, peepholes in doors or smoke detectors in ceilings. There shall be devices for quenching fire such as fire extinguishers or fire holes that are easily visible and accessible in strategic areas. - Proper maintenance shall be provided to prevent untimely breakdown of building and equipment. - Liquid waste shall be discharged into an approved public sewerage system, and solid waste shall be collected, treated and disposed of in accordance with applicable codes, laws or ordinances. ---------------------------------- **TYPES OF CLINICAL LABORATORY** ---------------------------------- ----------------------------- **ACCORDING TO FUNCTIONS:** ----------------------------- 1. **Clinical Pathology** - A clinical laboratory based on function which includes hematology, clinical chemistry, microbiology, parasitology, mycology, immunology & serology. 2. **Anatomic Pathology** - A clinical laboratory based on function which includes surgical pathology, immunohistopathology, cytology, autopsy, and forensic pathology. ---------------------------- **ACCORDING TO OWNERSHIP** ---------------------------- **[Government ]** - Operated and maintained, partially or wholly, by the national government, with local government unit, any other political unit. **[Private ]** - Owned, established and operated by any individuals, corporation, association, organization ------------------------------------- **ACCORDING TO SERVICE CAPABILITY** ------------------------------------- - Primary Laboratory - Secondary Laboratory - Tertiary Laboratory **[Primary laboratory ]** - 10 sq. m - Traditional Laboratory - Initial step in establishing a clinical laboratory if the patients are from a small community, a barangay or within vicinity. - Laboratory examinations: Routine hematology, urinalysis, fecalysis, gram staining, blood typing **[Secondary laboratory ]** - 20 sq. m - Conventional laboratory with partially/ semi-automated instruments - Caters to larger groups of community residents, and can be a hospital-based or school-based laboratory. - Laboratory examinations: routine hematology tests, routine chemistry tests (glucose, uric acid, cholesterol, urea nitrogen, creatinine) urinalysis, fecalysis, gram staining, blood typing, serological tests, bacteriological analysis, crossmatching - Lab equipments: refrigerator **[Tertiary Laboratory ]** - 60 sq. m - Sophisticated laboratory with fully automated machines. - Complete laboratory including all those in secondary laboratory and comprising six to eight sections. - Clinical Chemistry, Hematology, Clinical Microscopy, Immunohematology and blood bank, immunology and serology, microbiology, histopathology ------------------------------------------ **ACCORDING TO INSTITUTIONAL CHARACTER** ------------------------------------------ **[Institution based ]** - A laboratory that operates within the premises and as part of an institution, such as but not limited to hospital, medical clinic, school, medical facility for OFW **[Free standing ]** - A laboratory that does not form part part of any other institution. ----------------------------- **CLINICAL LABORATORY LAW** ----------------------------- **[RA 4688 ]** - "Clinical Laboratory Law of 1966" - Approved on June 18, 1966 **[A.O No.59 s. 2001]** - Implementing guidelines of RA 4688 which is titled: Rules and Regulations Governing the Establishment, Operation, and Maintenance of Clinical Laboratory in the Philippines. **[A.O No. 27 s. 2007]** - Revised rules and regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines. Revised IRR Governing the Establishment, Operation, and Maintenance of Clin Lab. **[Section 1 ]** - All labs should be licensed and regulated by the DOH (except government labs doing minimum lab exams) **[Section 2 ]** - Licensed physicians should be in-charge of the labs. **[Section 3 ]** - DOH-BRL is the one in-charge with the implementation of this act and to issue rules and regulations. **[Section 4 ]** - Punishment for violators ( 1 month -- 1 year imprisonment, 1000-5000 pesos fine) **[Section 5 ]** - Separability clause **[Section 6 ]** - Php 50,000 from the National Treasury are appropriated to carry out this act. **[Section 7 ]** - Repealing clause **[Section 8 ]** - Effectivity ( May 19, 1966) --------------------------------------------- **QUALITY CONTROL, ACCURACY AND PRECISION** --------------------------------------------- **Quality control** -- Insurance of a method to remain valid over time **Accuracy** -- Nearness of the result to the true value **Precision** -- Nearness of the result to one another. ------------------------------------------ **CYCLE OF CLINICAL LABORATORY TESTING** ------------------------------------------ **[Pre-analytical phase ]** - Phase of quality assurance where most errors occur and which includes test ordering, patient preparation, patient ID, specimen collection, transport and processing. **[Analytical Phase ]** - Phase where test analysis, quality control, calibration, and preventive maintenance. **[Post-Analytical Phase ]** - Phase where verification of calculations and reference ranges, review of results, reporting of result, test interpretation and follow-up patient and checking for error. **QUALITY MANAGEMENT** -------------------------------------- **APPROACHES TO QUALITY MANAGEMENT** A. **Total Quality Management** B. **Continuous quality improvement (CQI)** C. **Six Sigma** D. **Lean** **Total Quality Management (TQM)** - Focuses on teams, processes, and statistics, - Aims to meet or exceed customer expectations. **Continuous Quality Improvement ( CQI)** - A part of TQM - Strives to continually enhance practices beyond just meeting standards. **[Six Sigma ]** **Steps:** **Define :** Identify the problem **Measure:** Collect data **Analyze**: Examine data to find causes **Improve:** Implement solutions **Control** : Monitor and sustain improvements **[Lean ]** - Focuses on reducing waste ( non-value-added activities) - Aims to improve customer satisfaction. ----------------------- **QUALITY ASSURANCE** ----------------------- - Focuses on preventing defects by improving processes and ensuring they are designed to meet quality standards. --------------------- **QUALITY CONTROL** --------------------- **Quality Control/ Statistical process Control samples** - The measurement procedure by assaying QC materials for which the correct result is known in advance; monitors the overall reliability of laboratory results in terms of accuracy and precision. ------------------- **REFERENCE LAB** ------------------- **CC**: Research Institute for Tropical Medicine ( RITM) **Hematology** : National Kidney and Transplant Institute (NKTI) / St. Luke's Medical Center **Microbiology** : Research Institute for Tropical Medicine (RITM) / Philippine Genome Center **Immunology and Serology** ; Department of Health -- National Reference Laboratory ( DOH -NRL) **Microbiology and Parasitology** : UP-Philippine General Hospital (PGH) --------------------- **QUALITY CONTROL** --------------------- 1. Accuracy 2. Precision 3. Internal QC 4. Delta Check 5. External QC / Proficiency testing ------------------------------------ **CONTINUOUS QUALITY IMPROVEMENT** ------------------------------------ - use to reduce waste, increase efficiency, and increase internal ( meaning, employees) and external (meaning, customer) satisfaction. - Ongoing process that evaluates how an organization works & ways to improve its processes.