Administrative Order No.

2022 – 0007

01 March 2022

PHILIPPINE STANDARDS ON THE

RETENTION PERIOD OF
DOCUMENTS, RECORDS, SLIDES
AND SPECIMEN IN CLINICAL
LABORATORIES

I. RATIONALE
Cognizant of its role to provide an effective and
efficient Quality Management System (QMS) in
Clinical Laboratories and to set a framework to
strengthen the development, implementation, and
evaluation of the health policies, programs, and
plans by R.A. No. 11223 or “Universal Health Care
Act,” the Department of Health (DOH)
promulgated this Order by providing a
comprehensive set of quality standards on the
retention of documents, records, slides, and
specimens in Clinical Laboratories. In addition to
the mandate of the National Archives of the
Philippines Act of 2007 to review and update all
health records, policies shall be developed to
protect all public documents, records, and other
pertinent materials of archival value prior to its
disposal. Thus, meetings with the Technical
Working Group (TWG) established through DPO
2018 – 1602 entitled “Creation of a TWG to
Formulate AO on the Establishment of Retention
Period for Documents, Records, Slides, and
Specimen in Clinical Laboratory” were held to
establish the national standards on the minimum
retention period referenced from international
laboratory standards such as temporary storage in
accessible and suitable environment to ensure a
secure, safe–keeping repertoire. This also cites the
recently issued Records Disposition Schedule by
the National Archives of the Philippines (NAP)
date 26 May 2021.
Provisions under this Order comply with the
requirements stated in the assessment and
inspection tool for the issuance and renewal of
license to operate (LTO) of clinical laboratories by
the Health Facilities and Services Regulatory
Bureau (HFSRB) pursuant to A.O. No. 2021 –
0037, “New Rules and Regulations governing the
Regulation of Clinical Laboratories in the
Philippines.” Further, this order also follows the
roles and responsibilities of the Office of Health
Laboratories stipulated under D.O. No. 2021 –
0421 entitled “Creation of the Office for Health
Laboratories under the Health Facilities and
Infrastructure Development Team to
Institutionalize the Philippine Health Laboratory
System,” pending the enactment of Center for
Disease Control and Prevention.

II. OBJECTIVES
A. General Objective:
This order shall provide guidance on the national
standards on the minimum retention period of
documents, records, slides, and specimens in all
clinical and public health laboratories.
B. Specific Objectives:
1. To establish retention period guidelines on
documents, records, slides, and specimens
according to its storage conditions and to prevent
overloading of the storage capacity of
laboratories; and
2. To ensure compliance of retention protocols as
part of the minimum standards and inspection tool
in licensing a clinical laboratory by HFSRB.

III. SCOPE AND COVERAGE

This order shall apply to all clinical and public
health laboratories in the country, including
government– and private–owned, clinical and
anatomic pathology, institution–based and free–
standing, general and special laboratory, primary,
secondary, or tertiary laboratories, and
laboratories with limited-service capability.

IV. DEFINITION OF TERMS

1. Clinical Laboratory – refers to a facility that is
involved in the (a) pre–analytical, (b) analytical,
and (c) post–analytical procedures, where tests
are done on specimens form human body to obtain
information about the health status of a patient for
the prevention, diagnosis, and treatment of
diseases. These tests include but are not limited to
the following disciplines: clinical chemistry,
hematology, immunohematology, microbiology,
immunology and serology, clinical microscopy,
histopathology (cytology), toxicology,
endocrinology, molecular and nuclear diagnostics.
2. Documents – refer to written information
regarding policies, processes, and procedures in
the clinical laboratory to communicate effectively
to all laboratory staff and users, which need to be
updated or maintained when necessary.
3. Records – refer to the collected information
produced by the laboratory in the process of
performing and reporting laboratory tests that are
permanent and are easily retrieved by the
laboratory staff.
4. Retention Period – refers to the specific period
established by the DOH as the lifespan of
documents, records, slides, and specimens after
which they are deemed ready for permanent
storage or disposal in accordance with the
statutory and regulatory requirements.
5. Slides – refer to thin pieces of glass used to hold
a portion of tissues or body fluids for examination
under the microscope.
6. Specimens – refer to portions of human body
fluids or tissues taken for examination, study, or
analysis of one or more quantities assumed to
apply.

V. GENERAL GUIDELINES
A. The DOH shall institutionalize the minimum
standard retention periods of documents, records,
slides, and specimens in clinical laboratories in the
country as stated in Annex A of this Order and as
guided by the approved Records Disposition
Schedule (RDS) by the National Archives of the
Philippines as disseminated through the
Department Circular 2021 – 0226 entitled
"Dissemination of the Approved Records
Disposition Schedule (RDS).”
B. All clinical laboratories shall establish their own
archive to safeguard its documents, records,
slides, and specimens, including paraffin blocks, in
a safe environment, protected from loss and
destruction and secured from theft and tampering.
For records, slides, and specimens classified for
permanent preservation, a repository shall be
made available for permanent storage of
important data.
C. Pursuant to R.A. No. 10173 or the Data Privacy
Act of 2012, all clinical laboratories shall ensure
privacy or confidentiality by allowing authorized
personnel only for clinical laboratory management
on accessing laboratory documents and records.

VI. SPECIFIC GUIDELINES

A. All clinical laboratories shall implement the
guidelines on the retention period as stated in this
issuance.
B. The clinical laboratories shall conduct a regular
inventory of retained specimens for the biosafety
and biochemistry of the laboratory.
C. The clinical laboratories shall create their own
institutional policies and procedures and adopt
them to their respective Standard Operating
Procedures (SOPs) based on the minimum
retention period of documents, records, slides, and
specimens as patterned to this order.
D. The head of laboratory shall ensure institutional
policies for all documents, records, slides, and
specimens are maintained and available for the
time frames as specified in this order if the
Clinical Laboratory ceases its operation.
E. A dedicated space in the health facility shall
ensure for a suitable archive for placement of
documents, records, slides, and specimens within
the premises or an off–site area within the vicinity
of the Clinical Laboratory, if it is stated in their
own internal policies.
F. The DOH together with the NAP shall permit
the use of electronic laboratory documents and
records if it is accessible and retrievable by the
authorized user.

VII. ROLES AND RESPONSIBILITIES

A. Office of Health Laboratories (OHL) shall:
1. Provide technical assistance in the development
and updating of standards on retention period of
clinical laboratory documents, records, slides, and
specimens; and
2. Coordinate with HFSRB, NAP and the different
clinical and public health laboratories in
implementing and updating this Order, as deemed
necessary.
B. Health Facilities and Services Regulatory
Bureau (HFSRB) shall:
1. Enforce compliance to the retention period of
documents, records, slides and specimens and its
manner of disposal during inspection of issuance
or renewal of LTO of clinical laboratories.
C. Clinical and Public Health Laboratories shall:
1. Include the provisions of this issuance in their
respective SOPs.
2. Adopt the time for retention of their laboratory
documents, records, slides, and specimens based
on Annex A of this issuance.
3. Provide a suitable archive of documents,
records, slides, and specimens within the clinical
laboratory premises as to prevent damage,
deterioration, loss, and misuse of clinical
laboratory information pursuant to the Data
Privacy Act of 2012.
4. Document an inventory or reports of laboratory
documents, records, slides, and specimens
periodically as part of their own SOPs; and
5. Comply with the standards of the retention
period of documents, records, slides, and
specimens to ensure efficient and effective QMS in
Clinical Laboratories and as part of the
requirements of issuance and renewal of LTO and
inspection tool by the HFSRB.

VIII. EFFECTIVITY
This order shall take effect fifteen (15) days after
publication the DOH, or in a newspaper of general
circulation, and upon filing of three (3) certified
copies of this order with the Office of the National
Administrative Register of the University of the
Philippines Law Center.

FRANCISCO T. DUQUE III, MD, MSc

Secretary of Health

LIST OF RETENTION PERIOD BASED ON ITS

CATEGORY
A. DOCUMENTS AND RECORDS
1. Analytical Systems and Quality Improvement
Files
Activ Stora Tota Remarks
e ge l
Annual Review 2 2
of Policies,
Processes, and year
years
procedure s
records
After
Equipment and equipment
Instrument 2 has been
2
Preventive year returned /
years
Maintenance s rendered
Records unservicea
ble
Inspection, Audit 5
5
and Assessment year
years
Records s
2
Management 2
year
Review Records years
s
Method Manuals After
(Work 2 procedure
2
Instruction) & year has been
years
Laboratory s discontinue
Worksheet d
Method/Process 2 2
Validation years year
Records s
2
Quality Control 2
year
Records years
s
Qualification
System
Assessment and 5
5
Proficiency year
years
Testing Records s

(e.g., NEQAS)
Reagent,
2
Materials and 2
year
Supplies years
s
Records
Specimen
1 1
Rejection
year year
Records
Supplier 2
2
Qualification year
years
Records s
Waste Disposal 2
2
Records year
years
s
2. Clinical Laboratory Files
Blood Bank
Records
a. Donor 10
5 5
year
years years
s
b. Recipient and 10
5 5
other patients year
years years
s
c. Permanent
Permanent**
Deferral Donor
Clinical
Laboratory 5
2 3 After
Employee’s year
years years updated
Signature s
Initials
Laboratory Test
filled–out
2
Requisition 2
year
Forms (Clinical years
s
Laboratory
Request)
Record Book After Date
of Last
 Entry
a. General 5
5
Laboratory Test year
years
Results s
b. General 10
5 5
Patient Registry year
years years
s
3. Laboratory Test Reports
Clinical 2
2
Laboratory year
years
s
Cytogenetics 20
10 10
year
years years
s
Cytology 10
5 5
year
years years
s
Drug Test
Reports:
a. Negative 2
2
year
years
s
b. Positive with Permanent**
Medico–legal
concerns
Medico–legal Permanent**
Surgical 10
5 5
Pathology year
years years
s
4. Special Laboratory Files
Flow Cytometry 10
5 5
Histograms and year
years years
Dot Plots s
Electrophoresis 1 1
year year
Cytogenetic
Diagnostic 20
10 10
Images year
years years
(Digitized, Prints s
or Negatives)
Forensic
Autopsy Gross
Permanent**
Photographs or
Negatives
*Adopted from the approved Records Disposition
Schedule (RDS) by the National Archives of the
Philippines as disseminated through the
Department Circular 2021 – 0226
** Permanent records are those with enduring
value and classified in the Records Disposition
schedule that have been selected for permanent
preservation (National Archives of the
Philippines).

B. SLIDES, SMEARS AND PARAFFIN

BLOCKS
1. Anatomic Pathology
Retention
Period
Forensic Autopsy Stained Slides
Permanent
and Paraffin Blocks
Surgical Pathology and
Immunohistochemistry Stained 10 years
Slides and Paraffin Blocks
Tissue Frozen Section-Stained
10 years
Slides and Stained Smears
2. Cytogenetics
Permanently Stained Slides 3 years
3. Cytology
Cytology Negative /
5 years
Unsatisfactory Stained Slides
Cytology Positive / Suspicious
10 years
Stained Slides
Fine Needle Aspiration Biopsy-
10 years
Stained Slides
Gynecologic Stained Slides 5 years
4. Hematology
Bone Marrow Smears 10 years
Bone Marrow Tissue Biopsy
10 years
Slides and Paraffin Blocks
Malaria Stained Smears 1 year
Other Body Fluids Slides for Cell
7 days
Counting
Peripheral Blood Slides
1 year
(Abnormal)
Peripheral Blood Slides (Normal) 7 days
5. Microbiology
AFB–stained Smears 1 year
Grams and Trichome Stained 7 days
Slides
KOH Slides 7 days
C. SPECIMENS
1. Anatomic Pathology
7 days,
Body Fluids for Cytology
refrigerated
Formalin–fixed representative Permanent
tissues suitable for DNA Analysis
30 days,
Thin Prep Aliquot Tubes Room
Temperature
1 year after
Wet and Formalin–fixed tissues completion
for Forensic Autopsy of final
report
2 weeks
Wet and Formalin–fixed tissues after
for Routine Histopathology completion
(Benign) of final
report
Wet and Formalin–fixed tissues 4 weeks
for Routine Histopathology after
(Malignant) completion
 of final
report
2. Blood Banking and Transfusion Medicine
ABO Blood Typing (EDTA – 7 days
Whole Blood and Serum)
Crossmatch Unit Segments from 7 days post –
blood donor units and recipients transfusion
Direct Antiglobulin Test 7 days
Serum with positive Antibody 1 year,
Screening Test Frozen
3. Clinical Chemistry and Immunology /
Serology
Immunofixation Gels 1 year, Room
Temperature
Other Body Fluids 1 week,
(Pleural/Peritoneal/Pericardial Refrigerated
Fluid)
Serum/Plasma 1 week,
Refrigerated
4. Clinical Microscopy
24–hour Urine, aliquot 1 day,
Refrigerated
5. Drug Testing and Toxicology
Body Fluids and Tissues for Permanent
Toxicology
(with medico–legal concerns)
Urine (Negative Screening Test) 5 days,
Frozen
Urine (Positive Screening Test) 1 year,
Frozen
6. Hematology
24 hours,
Anti–coagulated (Heparinized or
Room
EDTA) Whole Blood
Temperature
24 hours,
Plasma for Coagulation Testing Room
Temperature
7. Microbiology
7 days inside
Blood Cultures
the machine
1 day, Room
Culture Swabs
Temperature
1 day,
Sputum
Refrigerated
 1 day,
Urine for Culture
Refrigerated
8. Molecular Laboratory
Nasal and Oropharyngeal Swabs 30 days,
(Abnormal) Frozen
Nasal and Oropharyngeal Swabs 1 day,
(Normal) Frozen
Other Tissue Swabs for viral 30 days,
isolation Refrigerated
Serum / Plasma 1 week,
Refrigerated