LAB-QM-008 — Organization and Governance Policy

1.0 Purpose

This policy establishes the organizational and governance framework of the Tarangnan Community Hospital (TCH) Clinical Laboratory Quality Management System (QMS), defining leadership authority, accountability, reporting lines, regulatory notifications, and the formal delegation of duties and leave coverage across laboratory operations.

2.0 Scope

This policy applies to all organizational levels and personnel of the Clinical Laboratory, including the Hospital Director, Pathologist, Chief Medical Technologist / Laboratory Quality Manager, Medical Technologists, and Laboratory Aides.

TCH operates a flat laboratory structure without separate section heads or deputy supervisors; all technical and administrative coordination consolidates into the Chief Medical Technologist / Laboratory Quality Manager under the clinical oversight of the Pathologist and executive authority of the Hospital Director.

3.0 Definitions

• Governance — the system by which the Clinical Laboratory is directed, controlled, and held accountable for achieving its quality objectives and regulatory obligations.
• Authority and Accountability — Authority is the legitimate power to make decisions, allocate resources, and direct work within defined limits; Accountability is the obligation to answer for the performance of assigned responsibilities and results achieved.
• Delegation of Authority — the documented assignment of specific duties and decision-making power to a qualified subordinate while the delegating authority retains ultimate accountability.
• Organizational Chart — the controlled diagram (F-QM-008-A-V0) defining the laboratory's positions, reporting relationships, and lines of authority.

4.0 Responsibility

4.1 Hospital Director

• Provides executive leadership, direction, and resources for the Clinical Laboratory, and holds ultimate institutional accountability for laboratory governance and operation.
• Grants final approval for all Clinical Laboratory policies, SOPs, and forms prior to implementation.

4.2 Pathologist

• Provides clinical and technical oversight for laboratory operations and examination quality, and reviews and concurs on all technical and quality policies, SOPs, and forms prior to approval.
• Reviews and signs relevant SOPs within two (2) months of any new appointment to the role (including acting capacity), and reviews any formal delegation of clinical or technical duties made under this policy.
• Conducts a physical supervisory visit to the Clinical Laboratory at least once a week, as required for a hospital-based DOH-licensed clinical laboratory under DOH A.O. 2021-0037, Annex A, Section II.A.4, and documents each visit as required under Section 5.1.1 of this policy.

4.3 Chief Medical Technologist / Laboratory Quality Manager

• Serves as the day-to-day leadership position responsible for the overall technical, clinical, and administrative operation of the Clinical Laboratory.
• Develops, maintains, and posts the controlled Organizational Chart (F-QM-008-A-V0), documents any formal delegation of duties or leave coverage using F-QM-008-B-V0, and escalates matters exceeding laboratory-level authority to the Pathologist and Hospital Director.

4.4 Medical Technologists

• Perform assigned technical and quality duties within the authority of their position and verified competence, and report quality concerns, risks, and nonconformities through established channels.
• Accept and document any formally delegated duties or leave coverage on F-QM-008-B-V0, operating strictly within the limits of that delegation.

4.5 Laboratory Aides

• Perform assigned non-technical support duties within the limits of their role and report observed problems to a Medical Technologist or the Chief Medical Technologist / Laboratory Quality Manager.
• Accept and document any delegated non-technical duties as assigned, and never perform, verify, interpret, or release laboratory examinations or collect patient specimens.

5.0 Policy / Procedure

5.1 Governance Structure

The Clinical Laboratory shall establish and maintain an organizational structure that clearly defines authority, responsibility, accountability, reporting relationships, and communication pathways necessary for the effective operation of the Quality Management System.

The governance hierarchy of the TCH Clinical Laboratory is:

• Hospital Director
• Pathologist
• Chief Medical Technologist / Laboratory Quality Manager
• Medical Technologists
• Laboratory Aides

The Hospital Director and the Pathologist are separate roles with distinct authorities: the Hospital Director holds institutional and executive approval authority; the Pathologist provides clinical review and professional oversight. Neither role subsumes or replaces the other.

Leadership shall provide direction, resources, oversight, and support so that laboratory services are delivered in accordance with approved policies, regulatory requirements, accreditation standards, and professional practice.

5.1.1 Pathologist Supervisory Visits

The Head of the Laboratory (Pathologist) shall conduct a physical supervisory visit to the Clinical Laboratory at least once a week. This is the schedule that DOH A.O. 2021-0037, Annex A, Section II.A.4 sets for a hospital-based DOH-licensed clinical laboratory. The alternative schedule in the same section — one physical visit a month combined with at least twice-weekly supervisory calls or videoconferences — applies to laboratories that are not hospital-based and shall not be used for this laboratory.

Each supervisory visit shall be well documented. The Chief Medical Technologist / Laboratory Quality Manager shall record every visit in a supervisory visit log stating the date and time of the visit, the areas and concerns reviewed, the decisions made and the actions agreed, and the name and signature of the Pathologist. Supervisory calls or videoconferences held between visits shall also be entered in the same log and marked as remote. The log shall be filed and controlled per Control of Records and retained per Laboratory Retention Schedule Policy.

5.2 Organizational Chart

The Clinical Laboratory shall maintain a controlled Organizational Chart (F-QM-008-A-V0) defining authority, responsibility, reporting relationships, supervisory and functional relationships, and communication pathways. The chart shall be reviewed whenever significant organizational changes occur. Detailed responsibilities of each position shall be maintained in the applicable Human Resource Management documents and approved Position Descriptions per Recruitment Qualification and Appointment Policy.

The current, updated Organizational Chart (F-QM-008-A-V0) shall be posted in a conspicuous area, showing names, latest pictures (at least passport-size), and designation, per DOH A.O. 2021-0037 Annex B1, Item 1.

5.2.1 DOH License to Operate (LTO) Posting

The Clinical Laboratory's current, valid DOH License to Operate (LTO) shall be posted in a conspicuous area visible to clients, per DOH A.O. 2021-0037 Annex B1, Item 3.

5.2.2 Notification of Changes to DOH

The Health Facilities and Services Regulatory Bureau (HFSRB) or the Center for Health Development – Regional Licensing and Enforcement Division (CHD-RLED) shall be informed in writing of any change in:

• Ownership of the Clinical Laboratory;
• Location of the Clinical Laboratory;
• Head of the Laboratory (Pathologist); or
• Laboratory personnel (appointment, separation, or replacement).

Making such a change without informing HFSRB/CHD-RLED is a prohibited act under DOH A.O. 2021-0037 Annex C, Item B.5.

The Chief Medical Technologist / Laboratory Quality Manager shall identify the change (including personnel changes under Recruitment Qualification and Appointment Policy) and prepare the notification for signature and submission by the Hospital Director (or designated licensing focal person) within fifteen (15) calendar days of the change, per DOH A.O. 2021-0037, Section VII.B.11. A copy of each notification and proof of receipt shall be filed with the current LTO.

5.3 Authority and Accountability

Authority shall be assigned based on organizational position, professional qualifications, demonstrated competence, training, experience, and applicable legal and regulatory requirements. Personnel shall be accountable for the quality, accuracy, completeness, and timeliness of activities performed under their assigned responsibilities, including compliance with approved policies and procedures, protection of confidential information, accurate documentation, reporting of nonconformities, and participation in quality improvement activities.

Delegation shall not relieve higher levels of management of overall accountability for the effectiveness of the QMS.

5.4 Delegation of Duties and Leave Coverage

• General Principles: Delegation of authority empowers a qualified subordinate to act within prescribed limits in compliance with laboratory policies, while the delegating authority retains ultimate accountability. A person cannot delegate authority they do not possess, nor delegate the entirety of their authority. Authority once delegated may be modified or withdrawn at any time.
• Written Delegation and Leave Coverage (F-QM-008-B-V0): The Chief Medical Technologist / Laboratory Quality Manager may delegate specific operational or technical functions (such as QC review, method verification, PT monitoring, equipment oversight, occurrence review, or LIS administration) or temporary leave coverage to a qualified, competent staff member using the Official Delegation of Duties, Authority & Leave Coverage Form (F-QM-008-B-V0).
• Leave Processing Rule: Any delegation for leave coverage shall identify the qualified staff member assuming the duties and shall remain effective for the duration of the leave. A leave request requiring formal delegation shall not be processed unless accompanied by a completed F-QM-008-B-V0 identifying the assumption of duties.

5.5 Leadership, Communication, Ethics, and Risk-Based Decision-Making

• Leadership and Communication: Laboratory leadership shall establish quality objectives, allocate resources, participate in internal audits (Internal Audit) and Management Review (Management Review), and maintain open internal communication (through staff meetings, memoranda, and briefings) so information on patient safety, risks, nonconformities, quality indicators, and management decisions reaches personnel promptly. Personnel shall be free to report quality concerns in good faith without fear of retaliation.
• Ethical Conduct and Competence-Based Assignment: All personnel shall perform their duties honestly and impartially in accordance with Internal Laboratory Rules and Regulations Policy. Responsibilities shall be assigned only to personnel holding verified qualifications and competence under the Human Resource series (Orientation Policy, Competency Assessment Policy, Recruitment Qualification and Appointment Policy, and Personnel Records Policy).
• Risk-Based Decision-Making and Evaluation: Management decisions affecting patient safety, examination quality, new services, or resource allocation shall be supported by objective evidence, risk assessment (Risk Management), and appropriate clinical/technical consultation. Governance effectiveness shall be reviewed periodically during Management Review (Management Review) and improved under Continual Improvement and Performance Improvement Program Policy.

6.0 Records

F-QM-008-A-V0 embeds the current Organizational Chart posted per Section 5.2. F-QM-008-B-V0 documents both standing/special delegations of duties and temporary leave coverage per Section 5.4. All records generated under this policy, including the supervisory visit log under Section 5.1.1, DOH notifications and LTO files, shall be controlled per Control of Records and retained per Laboratory Retention Schedule Policy.

7.0 References

• DOH-Philippines QMS Tool, Section 1 — Management Review; Section 2 — Resource Management; Section 3 — Service Delivery; Section 4 — Monitoring Performance
• DOH Administrative Order No. 2021-0037, Annex A — General Guidelines; Annex B1 — Technical Standards for Clinical Laboratories; Annex C — Prohibited Acts
• ISO 15189:2022, Section 5 — Structural and Governance Requirements
• WHO LQMS Handbook, Chapter 18 — Organization
• Republic Act No. 4688, Clinical Laboratory Act of 1966
• Republic Act No. 5527, Philippine Medical Technology Act of 1969

Companion policies:

• Quality Management Manual — overall Quality Management System framework and strategic planning
• Internal Laboratory Rules and Regulations Policy — internal laboratory rules, impartiality, and professional conduct
• Management Review — executive evaluation of laboratory governance and QMS performance

Controlled visual annex:

• IG-09 — Who Does What — one-page visual annex to this policy, controlled under Document Control Policy Section 5.2.6 and registered in F-QM-002-B-V0. Master files: infographics/IG-09-Who-Does-What-LAB-QM-008.png (PNG, print PDF, and editable HTML).