 EXAMINATION (ANALYTICAL FACTORS)

QUALITY MANAGEMNET SYSTEM OF THE HISTOPAHOLOGY

LABORATORY  Grossing of tissues
 Processing
 Procedure reliability using technical manuals
 QUALITY CONTROL-“ Is a set of procedures or technical activities on fulfilling quality
 Reagent integrity & efficiency
requirements”  Cutting of paraffin sections
 QUALITY ASSURANCE-“ Is a set of procedures or technical activities on fulfilling quality  Staining
requirements”  Slide labeling
 QUALITY MANAGEMENT SYSTEM-“ Is a set of procedures or technical activities on  Equipment reliability
fulfilling quality requirements”  Adequate calibration
 Proficiency of personnel and continuous education
 Good internal quality control
 It is concerned with good sampling, tissue processing with quality reagents,
providing supplies and equipment, receiving, documenting and validating  POST-EXAMINATION(POST-ANALYTICAL FACTORS)
results.
To ensure an effective QMS, the histopathology laboratory should have the After the proper examination, the histotechnologist prepares the slides for
following: evaluation by the pathologist. Usually, the pathologist records the findings
 Skilled histotechnologist/histotechnicians and diagnosis on the correct requisition slip clearly.
 Proper specimen collection
 Proper diagnosis of the case
 Proper processing of specimen
 Preparation of accurate report
 Efficient processing results  Timely release of the report
 High quality of reagents and equipment  Clinical interpretation of the report
 Preventive maintenance of equipment  Treatment of the patient
 Continuous professional education of staff
 Documentation and control  Quality management system consists of:
 Proper coordination  Management Responsibility(managers, compliance; quality manual; org
chart)
 Timely customer’s feedback
 FACTORS AFFECTING THE THREE PHASES OF EXAMINATION  Human Resource Management
 There are 3 phases of examination in a histopathology laboratory. Each ( policies of obtaining only high qualified personnel; job descriptions of
phase is affected by different factors. personnel)
1. Pre-examination
2. Examination  Physical facilities (safety of personnel. Storage space)
3. Post-examination
 Equipment (acquisition, installation, calibration, validation, preventive
maintenance)
 PRE-EXAMINATION(PRE-ANALYTICAL FACTORS)
1. Calibration – quantitative measuring or metering to assure
The collection of specimen starts in the operating room. accurate operation throughout its measuring limits
2. Validation – steps taken to confirm & record the proper
 Collection of the right specimen operation of the equipment)
 Proper fixation of the specimen 3. Preventive maintenance – inspection, repairs
 Correct identification of the specimen
 The timely transportation of the specimen  Reagents & Supplies (QC – at least weekly,
new lot of reagents)

Jaira Clydenn T. Ramayla, RMT, MLS(ASCPi)CM Page 1

  Continual Quality Improvement Activities
(Quality plan, EQAS, NEQAS)

 Document control management (request form, patient’s report, incident

reports, safety records

 4 types of reports sent by the lab:

 Telephone reports
 Preliminary reports (Pending results)
 Final reports (test is completed)
 Corrected reports (notification of physician)

 QUALITY ASSURANCE AND DOCUMENTATION

I.HISTOPATH REPORTS
1. Surgical Pathology
2. Cytopathology Report
3. Autopsy Report

Number of copies prepared for report:

- 3 copies
1. Doctor
2. Patient
3. File
II. SIGNATURES
A. Request forms (patient doctors)
B. Result forms (pathologist)
III. SPECIMEN HANDLING
1. FIX first!!!
II. Label immediately
IV. ROUTINE TURNOVER OF RESULTS
Surgical pathology & cytology – 24 hours
Frozen sections – 5 to 15 minutes
Autopsy report – 1 week
IV. STORAGE:
A. Specimen : 1 month to 1year
B. Tissue blocks: 3 years to 10 years
C. Slides: Indefinitely

Jaira Clydenn T. Ramayla, RMT, MLS(ASCPi)CM Page 2