Clinical Lab 1

• Clinical Laboratory


  • essential component of the health institutions
  • place where specimens are processed, analyzed, preserved, and properly disposed.
  • MAIN TASK : provide accurate and reliable information
• Medical technologists


  • person that plays a significant role in the performance of laboratory testing and ensuring the reliability of results
• Department of Health


  • requires the hospital laboratory to be actively involved in research, community outreach programs... etc
• Classification of Clinical Lab acc. to function

  • Clinical Pathology
  • Anatomic Pathology
• According to Function : Clinical Pathology


  • focuses on the areas of clinical chemistry, immuno-hematology and blood banking, medical microbiology, immunology ... etc
• According to Function : Anatomic Pathology


  • focuses on the areas of histopath, immmunohistopath, cytology, autopsy and forensic path
  • concerned with diagnosis of diseases through microscopic examination of tissues and organs
• According to Institutional Characteristics

  • Institution-based
  • Free-standing
• Acc. to Institutional Characteristics : Institution-based


  • operated within the premises or part of an institution such as a hospital or school
• Acc. to Institutional Characteristics : free-standing


  • not part of an established institution
• Acc. to Ownership

  • government-owned
  • Privately-owned
• Acc. to Ownership : Government-owned


  • owned by government either wholly or partially, by national or local government units
• Acc. to Ownership : Privately-owned


  • established , owned, operated by an individual, corporation, association or organization
• According to Service Capability

  • Primary category
  • Secondary Category
  • Tertiary Category
• According to Service Capability : Primary Category


  • basic routine lab tests only
  • 10sq.m.
• According to Service Capability : Secondary Category


  • All lab test done with routine clinical chem
  • 20sq.m.
• According to Service Capability : Tertiary Category


  • all lab test performed
  • atleast 60 sq.m
• Republic act No. 4688


  • clinical lab act of 1966
  • an act regulating the operation and maintenance of clinical laB and requiring its registration with the DOH
• Sections 1 - 5 of R.A. 4688

  1 - All lab shall register and secure license annually

  2 - It shall be unlawful for any person to be in-charge unless he is a licensed physician

  3 - SEC shall be charged with the responsibility of enforcing the provisions of this act

  4 - all who violates shall be punished.

  • Imprisonment - not less than 1 month but not more than 1 year
  • Fine - not less than 1 thousand pesos nor more than 5 k pesos

  5 - if any section of this act shall be adjudged by any court, the judgement shall not affect or invalidate the remaining section.
• Administrative order No. 59 s. 2001


  • an act about the rules and regulations governing the establishment, operations and maintenance of clinical lab in the Phil.
• Renewal of License

  • filled within 90 days before the expiry date of license
• Penalty

  • 1 thousand pesos for late renewal
  • more than 2 months expired, 100 pesos every month plus 1 thousand pesos penalty
• Clinical Lab shall be inspected every 2 years or as necessary
• Transferring of license

  • write at least 15 days before actual transfer
  • inform CHD
  • Failure to do this will cause revocation of license
• Extension lab shall have separate license
• Violations for the ff.

  • if without certified pathologist or without registered medtech
  • change of ownership, location, head of lab or personnel without informing CHD
  • refusal to allow inspection
• True or false

  All clinical lab should have functional Quality assurance program

  TRUE
• Internal Quality Control Program


  • there shall be documented continuous competency assessment program for personnel, which includes updates on lab methods, equipments and reagents, and proper maintenance and monitoring of all equipments
• External Quality Control Program


  • all clinical lab shall participate in this given by NRL, and refusal to participate can be basis for suspension/ revocation of license
• True or False

  lab reports should be filed and stored at least 1 yr but anatomic and forensic pathology result shall be kept permanently in the lab!

  TRUE
• Types of Specimen used in Clinical lab

  • blood
  • urine
  • sputum
  • feces

  others:

  • CSF
• 3 phases of Lab Testing Cycle

  • pre-analytic
  • analytic
  • post-analytic
• Pre-analytic phase


  • phase includes the receipt of lab request, patients preparation, specimen collection, and proper transport and processing of specimens to clinical lab
• Analytic phase


  • deals with the actual testing of the submitted/collected specimen
• Post-analytic phase


  • includes the transmission of test results to the medical doctor
  • diagnosis and treatment
• Internal Quality Assurance System 


  • includes day to day activities that are undertaken in order to control factors or variables that may affect test results
• External Quality Assurance System 


  • a system for checking performance among clinical lab and is facilitated by designated external agencies
  • NRL (National Reference Lab) - DOH designated EQAS
• Designated NRL-EQAS

  • NKTI (national kidney and transplant institute) - hematology coagulation
  • RITM (research institute for tropical medicine) - microbiology and parasitology
  • LUNG CENTER OF THE PHIL. - clinical chem
  • EAMC (east avenue Medical center ) - drugs of abuse
  • San lazaro - HbsAg, HIV, HCV