THE HISTOPATHOLOGY LABORATORY

• Aims:
• To process tissues adequately, to report a complete and
accurate histologic diagnosis, and to provide safekeeping of
tissue archives and reports.
• Requirements:
• Equipment/ machines with technical support and preventive
maintenance.
• Technically-skilled histotechnologists.
• Anatomic pathologists.
• Safety measures and a system of rational waste. Disposal.
RECEIVING OF SPECIMEN
• Complete patient and clinical data.
• Ensures prompt evaluation and reporting.
• Include patient / doctor contact information.
• Out-patient referrals and slide review cases requirements:
• Tissue sample/s and/or paraffin block/s, slide/s and
histopathology report.
• Doctor request (for clinical impression and/ or special
preparation/ fixation required)
• Assessment of charges.
SPECIMEN REJECTION
• Discrepancy between requisition and specimen label.
• Unlabeled or mislabeled specimens
• Contaminated specimen/ leaking container.
• No clinical data/ history.
• Pathologist cannot accurately predict clinical data from glass
slides alone.
• Inappropriately identified specimen.
CHECKING OF SPECIMEN
• Check completeness of specimen.
• Compare if type of sample and number of samples are
compatible with surgery done laterality.
• Check for fixation.
• If unfixed: put formalin (surgical) or alcohol (cytology).
• If inadequate or ‘wrong’ fixative: add or replace fixative.
SPECIMEN COLLECTION AND CONTAINERS
• Large samples should placed in a wide mouth container or a
thick plastic bag with 10% neutral buffered formalin immediately.
• Volume of formalin is 20x the size of specimen. Very large
specimens such as leg are sent to the laboratory as it is
immediately.
• If culture are also desired put 1 part in sterile container and send
to the laboratory immediately. The other part of the specimen is
immediately immersed in 10% neutral buffered formalin.
LOGGING OF SPECIMEN
• Provide a unique histopathologic accession number per case.
• S-07-000X for surgicals and C-07-000X for cytology.
• Not good practice to use patient name as unique accession
(confidentiality).
• All samples from 1 surgery equals 1 specimen accession
number.
• Make for a homogenous single evaluation and reporting.
GROSS EVALUATION SPECIMEN
• Ideally, tissue must be fixed for 6-48 hours and sectioned in
order for fixative to penetrate well.
• Gross worksheet.
• Accession number, number of sections and block taken per
case, manner of embedding.
• Sample for gross description only.
• Specimen submitted for documentation purposes.
• No microscopic examination is performed and no
histopathologic diagnosis is issued.
• Special requests:
• Abortus or calculi to be returned to patient.
TISSUE FOR GROSS DESCRIPTION ONLY
• Prepuce/ foreskin • Lens cataracts
• Vaginal mucosa • Nasal Septum (rhinoplasty)
• Scars/cicatrix • Calculi, stones
• Foreign bodies (e.g., bullets, • Eyelid
ortho, medical devices , • Placenta from normal
silicone implants) spontaneous delivery
• Hair , fingernails, and toenails • Teeth
removed for cosmetic reasons.
• Fetuses
CUTTING AREA CONSIDERATIONS
• If specimen is entirely submitted for processing, save specimen
containers in one area until case is signed-out
• Problems with labels laterality, lost sample.
• Save biohazard waste bag from gross processing room for an
extra day to allow for recovery of lost specimens or cassettes if
needed (inadvertently).
TISSUE PROCESSING CONSIDERATIONS
• Tissue processing worksheet.
• To account for all sections/ blocks submitted.
• Sections with staples should never be submitted for tissue
processing.
• At least 2 levels of about 20 – 25um apart may unmask other
pathology.
• Tissue ribbon simply repeats adjacent histology.
• Step sections appropriate for minute samples.
TISSUE PROCESSING CONSIDERATIONS
• Floaters or pick-ups
• Clean tools and dissection area/ case, wrap small fragments in
filter paper, change solution, periodically clean water baths.
• Check cutting face of paraffin block.
• Check other cases for similar lesion type.
• Additional sections from remaining fixed tissue or deeper levels
from paraffin block.
• Slide: Circling and tagging as folder.
• If floater disappears on slide from deeper cuts discard previous
slide with floater.
• Need not include floater in the final report.
CASE EVALUATION AND REPORTING
• Ideal to have laboratory information system.
• To know if patient has previous surgery or diagnosis and to know
his/her other laboratory work-ups.
• Turn around time (from specimen receipt to case reporting)
• Ideal: 24 hours for clear-cut cases: 2-3 days for cases of
moderate complexity.
• Reasonable: 7 -14 days
• Step sections appropriate for minute samples.
• Diagnosis
• Check for completeness typographical errors and specimen
laterality.
NOTICE OF PENDING DIAGNOSIS
• Preliminary report addressed to the attending physician of the
patient.
• To let the MD know that there will be a delay.
• To let the MD know the reason/s for the delay.
1. Additional sections or deeper levels taken
2. Clinical and radiologic information needed
3. Difficult case: needs referral to other pathologists.
4. Difficult case: needs special stains and/ or
immunohistochemistry studies.
• The notice must have a working pathologic diagnosis or
differential diagnoses.
CASE/ SLIDE REVIEW
• Requirements:
• Photocopy of the histopath report.
• Paraffin block (submit all) and H&E slides of the above paraffin
block.
• Written request from the doctor, if available.
• Previous report is necessary:
• To verify that the item submitted (paraffin block and slide)
belongs to the patient.
• To determine the source as well as the gross description of the
specimen.
• To know the pathologist who read the previous reports
CASE/ SLIDE REVIEW
• Screening of material by trainee/ consultant pathologist:
• In cases wherein there is a discrepancy on the specimen
submitted and the report, the matter should be discussed well to
the bearer. And inform him/ her what is lacking and still need to
be submitted, writes it on the request form.
• Ideally, once official report is released, a copy of it should be
mailed to the Pathologist who read the histopath report.
ARCHIVING
• Paraffin blocks, histopathology slides and reports are important
materials that have to be kept for future references.
• Paraffin Blocks
• Kept in a transparent plastic bag (prevent access of pests)
indicating the beginning and ending numbers on the contents.
• It should be kept in a cool dry place (avoid melting of paraffin).
• Histopathology Slides
• Arranged according to the year and sequence of accession
numbers in designated drawers.
• It should be kept in a cool dry place.
RECORDS AND SPECIMEN RETENTION
• Request forms and logbooks: 1-2 years
• Gross specimens & blood smears (routine): 714 days after report
issued.
• Body fluids (specimen): 48 hours
• Surgical pathology reports: 10 years or indefinitely
• Autopsy/forensic reports: indefinitely
• Cytogenetics report/ diagnostics images: 20 years
• Cytogenetics slides: 3 years
• Surgical pathology slides: At least 10 years
• Paraffin blocks: at least 10 years or indefinitely.
• Instrument maintenance: 2 years
• Quality control: 2 years
STORAGE BLOCKS/ SLIDES FOR REVIEW/
SPECIAL PROCEDURES
• The requesting party should be informed of the laboratory policy
regarding storage and disposal of theses items.
• A copy of consent form the disposal is signed by the requesting
party:
• Name of the patient, specimen/ Accession No.
• Number of slide/s & or block/s submitted.
• Number of submitted
• Unclaimed materials will be subject for disposal after one year.
• Items are filed in designated drawers, arranged in alphabetical
order, and kept in a cool dry place
PARAFFIN BLOCKS AND SLIDES
HISTOPATHOLOGY SECTION
Received from patient __________, are ________ paraffin
block (s) labeled as _____________ for the following examination(s).
_________________________________________________________
Please be informed that the above item(s) must be retrieve
upon claiming of official result. The institute is no longer responsible
if the item(s) is are lost or misplaced if not claimed in 30 days.
Conforme,
_________________________ Date: _______________
Signature Over Printed Name
Received by: _______________________
SURGICAL PATHOLOGY SPECIMEN –
INFORMED CONSENT
I hereby authorize (name of hospital) to:
[ ] Store the following specimen obtained from myself or my
_______________ for maximum of 5 days.
In the event I fail to pick-up the specimen myself or by my representative. I shall
not hold (name of hospital) liable for its action in managing it in accordance with
public health regulations.
[ ] Manage the specimen in accordance with health regulation as I am not interested in
retrieving it.
SPECIMEN: _________________ S.P. No. -- __________________________
(description) (to be filled by pathology)
____________________________ DATE: __________________________
PATIENT NAME AND SIGNATURE
Witnessed by: _________________________ (PRINTED NAME AND SIGNATURE)
IMPORTANT: Authorization must be signed by the patient or by the nearest relative in
case of a minor or when a patient is physically or mentally handicapped.
___________________________ DATE: __________________________
SIGNATURE OF THE PATIENT’S REPESENTATIVE
___________________ REALATION TO PATIENT
Witnessed by: ___________________________ (PRINTED NAME/ SIGNATURE)
BORROWING OF SLIDES AND BLOCKS
• It is the prerogative of the patient and his/ her doctor to borrow
slides and blocks for outside review.
• For Histopathology
• Obtain recuts for laboratory’s own file in case materials
borrowed are not returned.
• Additional slides must be.
• For cytology
• If >1 slide has lesion, retain 1 or 2 slides for filing.
PACKAGING OF SAMPLES, SLIDES AND
BLOCKS
• Sliding and blocks
• Place material in sturdy plastic/ reinforced box.
• “Pakidala” – patient, relatives or friends carry the material to the
laboratory.
• Don’t put too much mounting medium on slide.
• Allow the mounting medium on slides
• Allow the mounting medium on slides to dry before putting the
slides in containers.
• Tissues:
• If with fixatives, ensure that leakage will be prevented during
transport.
SENDING MATERIAL OVERSEAS
CERTIFICATION
December 25, 2006
TO WHOM IT MAY CONCERN:
This is to certify that the 5 slides and 2 paraffin blocks labeled
as 06-17481 with St. Luke’s Medical Center Institue of Pathology are
chemically inert, non – infectious and do not contain animal products.
This material is being sent to the United States for review as requested.
Thank you.

Francisco V. Narciso, MD
Director, Institute of Pathology
St. Luke’s Medical Center
COSTING
• Cost of supplies = Transport and collection + processing.
• Cost of labor: estimated to be equal to the total cost of supplies.
• Total direct cost of test = Supplies + Labor
• Total test cost without profit = Total direct cost + Overhead
• Overhead: typically runs between 40-50% of total costs; cost of
running QC part of overhead.
• Total test cost with profit = Total test cost + Profit:
• Profit: determined by the institution and is usually between 3%
and 10%.
SHORT CUTS FOR COST CUTS
• Are good if quality is maintained
• Rapid tests mean faster turn-around-time.
• Quality of slides and blocks
• Reflects technique
• Depends on the quality of reagents
• Slides and blocks may be sent abroad for review or further
testing.
• Food for thought: If the specimen in question were yours or your
relatives, will you be satisfied to have it processed and evaluated
poorly.
MAINTENANCE
• Proper documentation of maintenance charts.
• Monitoring of temperature
• Proper labeling of coplin jars used for special stains
• Standard of labeling of shelves, hanging cabinets, filing cabinets
and logbooks.
• Appropriate use and handling of reagents. “First in - first out
"policy should be observed.
• Develop a more organized and effective filing system for paraffin
system for paraffin blocks and slides.
CHAIN-OF-CUSTODY FORM (MEDICO-LEGAL)
INSTITUTE OF PATHOLOGY
Patient Name: Date:
Specimen:
Name of associate delivering the specimen:
Specific time delivered to laboratory: Signature:
Received pathologist who received the specimen:
Received pathologist who received the specimen (gross) :
Date and specific time released to the police:
Name of the receiving police officer:
Unit: Detachment: Tel. No.:
Signature Over Printed Name: Police Officer and 2 witnesses
Associate who released the specimen to the police
QC IN HISTOPATHOLOGY
• Quality in Control on Fixation
• pH of formalin solution should not drop below pH 6 (formation of
formic acid can be prevented by the use of neutral buffered
formalin).
• Between pH 5.6 and 6, or under pH 5.6, DNA and RNA are
poorly preserved and acid mucopolysaccharides are more
soluble.
QC IN HISTOPATHOLOGY SERVICE
• Quality in Control on Routine H & E staining
• Check pH of hematoxylin.
• When slides come out of the bluing agent (lithium carbonate or
ammonia water), check the slide under the microscope to make
sure that hematoxylin has stained the nuclei and the excess
hematoxylin removed from those structures it should not stain.
• After completion of H & E staining and mounting, check slides
microscopically for:
1. Proper staining of nuclei and cytoplasm.
2. Bubbles, dirt, debris, or precipitate on slide
3. Proper labeling
4. Proper tissue orientation in embedding.
QC IN HISTOPATHOLOGY SERVICE
• Quality in Control on Record
• Storage of records (histopath reports, slides, paraffin blocks)
must be organized to facilitate retrieval.
QC IN HISTOPATHOLOGY SERVICE
• Quality in Control on the System
• Turn around time (TAT) factors involved.
1. Prosector (“go back to specimen”)
2. Quality of slide preparation
3. Complexity of the case
4. Secretarial Component
• Use “in-time/date” stamp when tissue is received; time/date of
distribution of report.
• By sampling reports each month, TAT averages can be
determined and compared with predetermined goals. Efficient
laboratories achieve TAT of 24 hours for simple cases and 48-72
hours for simple cases, and 48-72 hours for complicated
problems.
QC IN HISTOPATHOLOGY SERVICE
• Quality in Control on the System
• The Secretarial Component. The secretarial staff is responsible
for the typing, filing and coding of surgical pathology data.
• The product is continually monitored since the pathologist
usually proofreads and correct the reports before signing them.
• Each month, however, random samples of surgical pathology
reports should be examined to determined quality and accuracy.
QC IN HISTOPATHOLOGY SERVICE
• Process Control Procedures
• A schedule and a record for equipment maintenance and
service.
• Records of solution changes (note date on the container)
• Record of paraffin bath temperature; checked and noted daily.
• Controls run on every special stain.
PERFORMANCE INDICATORS
• Waiting time.
• Results processing: in patient and out-patient
• Cancelled procedures due to :
• Equipment breakdown, availability of supplies
• Equipment uptime
• Autotechbicon, Microstainer, Cryostat, Embedding Center, Gross
Station.
• Errors corrected prior to releasing (% error)
• Pre-analytical: pre-procedural, specimen collection, ID
• Technical Phase
• Post-analytical: typographical error.