Republic of the Philippines

Department of Health
OFFICE OF THE SECRETARY

MAR 01 2022
ADMINISTRATIVE ORDER
No. 20244, 4083-0007

SUBJECT: Philippine Standards on the Retention Period of Documents,

Records, Slides and Specimens 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 RA 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 Period 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) dated Jengary5-202+.

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 for Health Laboratories stipulated
under DO 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 the Philippine
Center for Disease Control and Prevention.

Il, OBJECTIVES

A. General Objective:

This Order shall provide guidance on the national standards on the minimum
retention period of documents, records, slides and specimens all clinical and public in
health laboratories.

Building 1, San Lazaro Compound, Rizal Avent

Direct Line: 711-9502; 711-9503 Fax: 743- 1829 @ URL:
¢
funk Line 651-7800 loc. 1 1 B,1108, 1135
hitp:/Avww.doh.gov.ph; e-mail: ftduque@doh.gov.ph
4
 B. Specific Objectives:

1. To establish retention period guidelines on documents, records, slides and

specimens according to its storage condition 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 inlicensing a clinical laboratory by HFSRB.

HI. 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 from the human body
patient for the
to obtain information about the health status of a
prevention, diagnosis and treatmentof 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. Recerds — 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 of time 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 flat 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 as a
whole.

Vv. GENERAL GUIDELINES

A. The DOH shall institutionalize the minimum standard retention period of

documents, records, slides, and specimens in
clinical laboratories in the country as

Le
 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 RA 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.

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 ofretained specimens
for the biosafety and biosecurity 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

D.
specimens as patterned to this Order;
The head of laboratory shall ensure institutional policies for all documents,
records, slides and specimens are maintained and available for the particular time
frames as specified in this Order if the Clinical Laboratory ceasesits operation;
E. A dedicated space in the health facility shall be ensured 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, provided that 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 provided that it is accessible and retrievable by the
authorized user.

VII. ROLES AND RESPONSIBILITIES

A. Office for 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 for issuance or renewal
of LTO of clinical laboratories

C. Clinical and Public Health Laboratories shall:

= Include the provisions of this issuance in their respective SOPs;

2. Adopt the time period 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.

VI. EFFECTIVITY

This Order shall take effect fifteen (15) days after publication by 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.

ISCO Tf
DUQUE III, MD, MSc
Secretary of Health
 [ANNEX A]

List of Retention Period based on

its category:
A. DOCUMENTS AND Retention Period Remarks
RECORDS:

Active Storage Total

1 Analytical Systems and

Quality Improvement Files:
Annual Review of Policies, 2 years 2 years
Processes and Procedures
Records

Equipment and Instrument 2 years 2 years After equipment

Preventive Maintenance has been returned
Records / rendered
unserviceable

Inspection, Audit and 5 years 5 years

Assessment Records

Management Review Records 2 years 2 years

Method Manuals (Work 2 years 2 years

Instructions) and Laboratory After procedure
Worksheet has been

/
discontinued
Method Process Validation 2 years 2 years
Records

Qualification, Competency 3 years 3 years After last day of

and Training of Laboratory employment
Staff Records

Quality Control Records 2 years 2 years

Qualification System 5 years 5 years

Assessment and Proficiency
Testing Records (e.g. NEQAS)

Reagents, Materials and 2 years 2 years

Supplies Records

Registration and Referral 2 years 2 years

Records

Specimen Rejection Records 1

year 1
year

Supplier Qualification Records 2 years 2 years

Waste Disposal Records 2 years 2 years

Clinical Laboratory Files:

Blood Bank Records:

a. Donor 5 years 5 years 10 years

b. Recipient and other 5 years 5 years 10 years
Patients

c. Permanent Deferral Permanent**

Donor

Clinical Laboratory 2 years 3

years 5 years After updated
Employees’ Signature Initials

Laboratory Test Filled-Out 2 years 2 years

Requisition Forms (Clinical
Laboratory Request)
Record Book: After date of last
entry

a. General Laboratory 5 years 5 years

Test Results

b. General Patient 5 years 5 years 10 years

Registry (Accession)

Laboratory Test Reports:

Clinical Laboratory 2 years 2 years

Cytogenetics 10 years 10 years 20 years

Cytology 5 years 5 years 10 years

Drug Test Reports:

a. Negative 2 years 2 years

b. Positive with Permanent**

Medico-legal Concerns

Medico-legal Permanent**

Surgical Pathology 5 years 5 years 10 years

 4| Special Laboratory Files:

Flow Cytometry Histograms 5 years 5 years 10 years

and Dot Plots

Electrophoresis 1
year 1
year

Cytogenetic Diagnostic 10 years 10 years 20 years

Images (Digitized, Prints 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 DepartmentCircular 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 Retention Period

1 Anatomic Pathology:

Forensic Autopsy Stained Slides and Paraffin Blocks Permanent

Surgical Pathology and Immunohistochemistry Stained Slides and 10 years

Paraffin Blocks

Tissue Frozen Section Stained Slides and Stained Smears 10 years

2 Cytogenetics:

Permanently Stained Slides 3 years

3 Cytology:

Cytology Negative / Unsatisfactory Stained Slides 5 years

Cytology Positive / Suspicious Stained Slides 10 years

Fine Needle Aspiration Biopsy Stained Slides 10 years

Gynecologic Stained Slides 5 years

4 Hematology:

Bone Marrow Smears 10 years

Bone Marrow Tissue Biopsy Slides and Paraffin Blocks 10 years

tr
Malaria Stained Smears 1
year
Other Body Fluids Slides for Cell Counting 7 days

Peripheral Blood Slides (Abnormal) 1

year
Peripheral Blood Slides (Normal) 7 days

Microbiology:
AFB-stained Smears 1
year
Grams and Trichome Stained Slides 7 days

KOH Slides 7 days

SPECIMENS Retention Period

Anatomic Pathology:

Body Fluids for Cytology 7 days,

Refrigerated
Formalin-fixed representative tissues suitable for DNA Analysis Permanent

Thin Prep Aliquot Tubes 30 days, Room

Temperature

Wet and Formalin-fixed Tissues for Forensic Autopsy 1

year after
completion of final
report
Wet and Formalin-fixed Tissues for Routine Histopathology (Benign) 2 weeks after
completion of final
report
Wet and Formalin-fixed Tissues for Routine Histopathology 4 weeks after
(Malignant) completion of final
report

Blood Banking and Transfusion Medicine:

ABO Blood Typing (EDTA-Whole Blood and Serum) 7 days

Crossmatch Unit Segments from blood donor units and recipients 7 days
post-transfusion

Direct Antiglobulin Test 7 days

Serum with positive antibody screening test 1

year, Frozen

At
“a
Clinical Chemistry and Immunology

Immunofixation Gels
/ Serology
1
year, Room
Temperature

Other Body Fluids (Pleural / Peritoneal / Pericardial Fluid) 1

week,
Refrigerated

Serum / Plasma 1
week,
Refrigerated

Clinical Microscopy:

24-hour Urine, aliquot 1

day, Refrigerated

Drug Testing and Toxicology:

Body fluids and tissues for toxicology (with medico-legal concerns) Permanent

Urine (Negative Screening Test) 5 days, Frozen

Urine (Positive Screening Test) 1

year, Frozen

Hematology:

Anti-coagulated (Heparinized or EDTA) Whole Blood 24 hours, Room

Temperature

Plasma for Coagulation Testing 24 hours, Room

Temperature

Microbiology:
Blood cultures 7 days inside the
machine

Culture Swabs 1
day, Room
Temperature

Sputum 1
day, Refrigerated

Urine for culture 1

day, Refrigerated

Molecular Laboratory:

Nasal and Oropharyngeal Swabs (Abnormal) 30 days, Frozen

Nasal and Oropharyngeal Swabs (Normal) 1

day, Frozen

ran 5
Other Tissue Swabs for viral isolation 30 days,
Refrigerated

Serum / Plasma 1
week,
Refrigerated
 [Annex B]
References:

1. College of American Pathologists Retention of Laboratory Records and Materials

(2010). Retrieved from
https:/Avww.ncleg.gov/documentsites/committecs/PMC-LRC2011/December%205,%

College of American Pathologists Policy. Minimum Period of Retention of

Laboratory Records and Materials (2020). Retrieved from:
sulelss. cap.org, clssiShowPro ert fnodeP ath LUCMCON/Contribution%20F older

CLIA Regulations: Retention Requirements (2011). Retrieved from:

hitps://www.ncleg. ov/documentsites/committees/PMC- ERC2011/December’2.05,

\pdt
McPherson, R. A. , Pincus, M. R. (2017). Henry’s Clinical Diagnosis and
Management by Laboratory Methods. St. Louis, Missouri, Elsevier. 23rd edition.
Fung, M. K., Grossman, B. J., Hillyer, C. D (2014). American Association of Blood
Banks Technical Manual. Bethesda, Maryland, AABB. 18" ed.
World Health Organization: Introduction to Documents and Records. Retrieved from:
https:/Awww.who. int/ihr/traming/laboratory_ quality/16 b content doc _rec.pdfua=1
Joint Commission on Accreditation of Healthcare Organizations. Records and
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htt s/iwww.jointcommissionintemational. org/-/media/jci/jci-documents/accreditation

Joint Commission International Accreditation Standards for Laboratories (4" edition).

Retrieved from:
leap
$2
SA, Ielileominiss oniusteaiion org/-/me jci/jci-documents/accreditation
lia
Blanchard Valley Health System “Laboratory Specimen Retention Policy (2016).
Retrieved from:
hittp://Avwww.bvhealthsystem.org/media/file/(K_%20Laborato
tion%20and%20Add%200n%20Policy.pdf
10. Ontario Association of Medical Laboratories: Guidelines for the Retention of
Laboratory Records and Materials. (2006). Retrieved from:
https://oaml.com/wp-content/uploads/2016/05/Guideline-for-the-Retention-of- Record
s-Materials-Junc-06.pdf, CLP020-001
11 . RA 9165: Dangerous Drugs Act of 2002. Manual of Operations on Drug Testing
12. RA 9470. National Archives of the Philippines (NAP) Act of 2007
13. Department of Health - Records Disposal Schedule (RDS), 1996
14. RITM BRMO COVID-19 Specimen Storage and Disposition Guidelines, Ver. 1