LAB-QM-004 — Scope of Service and Laboratory User Information Policy

1.0 Purpose

To define, document, control, and periodically review the range of laboratory activities and examinations performed by the Clinical Laboratory of Tarangnan Community Hospital.

This policy establishes the laboratory's approved Scope of Service as the authoritative basis for determining:

• which laboratory activities and examinations are performed in-house;
• which examinations are outside the laboratory's scope;
• which examinations require referral to an external laboratory;
• which laboratory procedures and resources are applicable;
• which services may be represented as laboratory services of TCH; and
• how additions, removals, or other changes to the laboratory's scope are evaluated, approved, implemented, and controlled.

The laboratory shall not claim to perform or report examinations outside its approved scope.

To establish the requirements for providing accurate, current, accessible, and appropriate information about the Clinical Laboratory and its services to patients, requesting physicians, hospital departments, and other laboratory users.

This policy ensures that users are provided with the information they need to access laboratory services, including laboratory location and operating schedule, examination requesting and specimen collection arrangements, expected availability of results, applicable patient and user requirements, advisory and communication arrangements, and the process for raising complaints or concerns.

The laboratory's approved range of laboratory activities and examinations shall be controlled separately under LAB-QM-004 Laboratory Scope of Service Policy. User-facing information describing laboratory services shall be derived from the current approved scope and applicable operational procedures and shall not establish or independently modify the laboratory's scope.

In this merged policy, the approved scope is stated in Sections 5.1–5.9 and the laboratory user-information requirements in Sections 5.10–5.20.

2.0 Scope

This policy applies to all sections and personnel of the Clinical Laboratory involved in accepting, performing, referring, reporting, managing, or changing laboratory examinations and related laboratory activities.

It applies to:

• the establishment of the laboratory's examination menu;
• definition of in-house and referred activities;
• identification of examinations outside the laboratory's scope;
• addition or removal of examinations;
• review and approval of scope changes;
• communication of the approved scope to relevant users;
• maintenance of the documented scope; and
• periodic review of the Scope of Service.

Detailed examination procedures, patient-preparation requirements, specimen-collection requirements, analytical procedures, and reporting requirements are controlled by their respective laboratory policies and procedures.

This policy applies to all personnel responsible for preparing, maintaining, communicating, distributing, or providing laboratory information to patients, requesting physicians, hospital departments, and other users of the Clinical Laboratory.

It covers general laboratory service information, including:

• laboratory location and contact information;
• operating hours and applicable after-hours arrangements;
• procedures for requesting laboratory examinations;
• general specimen collection and submission information;
• information concerning patient preparation and other pre-examination requirements;
• expected availability of laboratory results;
• availability of laboratory advisory services;
• applicable consent requirements;
• factors that may significantly affect examination performance or result interpretation;
• general referral laboratory information;
• complaint and feedback channels; and
• maintenance, distribution, and updating of user-facing laboratory information.

Detailed examination-specific technical requirements shall remain controlled under the applicable pre-examination, examination, post-examination, or other laboratory procedures.

3.0 Definitions

3.1 Scope of Laboratory Activities

The documented range of laboratory activities and examinations that the Clinical Laboratory performs and for which it may claim conformity with applicable requirements.

3.2 Scope of Service

The approved range of examinations and related laboratory services provided by the Clinical Laboratory, including defined in-house activities and identified exclusions.

3.3 In-House Examination

An examination performed within TCH's Clinical Laboratory using the laboratory's authorized personnel, equipment, methods, and resources.

3.4 Referred Examination

An examination requested through TCH's Clinical Laboratory but performed by an external referral laboratory.

3.5 Examination Menu

The controlled list of examinations currently approved for performance by the Clinical Laboratory.

3.6 Scope Change

Any addition, removal, suspension, expansion, restriction, or other change affecting the laboratory's approved range of activities or examinations.

3.7 Laboratory Information

Information provided by the Clinical Laboratory to patients, requesting physicians, hospital departments, and other users to support appropriate access to and use of laboratory services.

3.8 User

A person or organization using or requesting laboratory services, including patients, physicians, hospital departments, and other authorized healthcare personnel or organizations.

3.9 Patient

The individual from whom a specimen is collected or for whom a laboratory examination is requested.

3.10 User-Facing Service Information

Controlled information made available to laboratory users describing the laboratory and its services, including information contained in a laboratory brochure, service manual, test directory, patient instruction, or equivalent communication material.

3.11 Laboratory Scope of Service

The documented range of laboratory activities and examinations that the Clinical Laboratory is authorized and capable of performing within its approved scope, controlled under LAB-QM-004 Laboratory Scope of Service Policy.

3.12 Patient Preparation

Instructions or conditions that a patient is required to observe before specimen collection to support the suitability and integrity of the specimen and the validity of the examination.

4.0 Responsibility

4.1 Hospital Director

• Approves the laboratory's Scope of Service.
• Approves additions, removals, or significant changes to the approved examination scope.
• Ensures appropriate organizational support for the provision of laboratory information to users (standing governance and policy approval duties are defined in Organization and Governance).

4.2 Pathologist

• Reviews proposed changes to the examination menu for clinical appropriateness.
• Provides professional advice concerning the suitability of examinations proposed for addition, modification, suspension, or removal.
• Provides professional guidance when laboratory information may affect clinical use, interpretation, or appropriate utilization of examinations (standing governance and policy review duties are defined in Organization and Governance).

4.3 Chief Medical Technologist / Laboratory Quality Manager

• Maintains the documented Scope of Service.
• Ensures that the examination menu remains current and accurate.
• Ensures examinations are performed and reported only within the approved scope.
• Initiates review of proposed scope changes.
• Evaluates technical and operational implications of proposed changes.
• Coordinates Pathologist review and Hospital Director approval.
• Ensures affected policies, procedures, records, user information, and other controlled documents are reviewed when the scope changes.
• Ensures the current approved scope is communicated to relevant laboratory personnel and reflected in user-facing service information.
• Ensures implementation of this policy.
• Ensures that laboratory information provided to users is accurate, current, appropriate, and consistent with approved laboratory policies and procedures.
• Ensures that user-facing information describing laboratory examinations is derived from the current approved scope under LAB-QM-004.
• Coordinates the preparation, review, approval, distribution, and updating of controlled laboratory service information.
• Ensures that obsolete user-facing information is withdrawn or replaced.
• Ensures that applicable patient-preparation and specimen-collection information is communicated through appropriate user-facing materials.
• Coordinates correction of inaccurate or conflicting laboratory information.
• Ensures appropriate records of distribution, revision, and updating are maintained.

4.4 Medical Technologists

• Perform examinations only within the approved laboratory scope.
• Identify requests for examinations that are outside the approved scope.
• Refer out-of-scope examination requests through the applicable referral process.
• Notify the Chief Medical Technologist / Laboratory Quality Manager of circumstances that may affect the laboratory's ability to perform an examination within its approved scope.
• Provide laboratory information to users within the limits of their authority and assigned duties.
• Use only current approved laboratory information when advising patients, physicians, or hospital personnel.
• Follow applicable policies and procedures when providing information regarding specimen collection, preparation, examination requests, results, referrals, and other laboratory services.
• Report inaccurate, outdated, or conflicting information to the Chief Medical Technologist / Laboratory Quality Manager.

4.5 Laboratory Aides

• Perform only assigned non-technical support activities.
• Do not determine whether an examination is within or outside the laboratory's scope.
• Refer scope-related questions or requests to an authorized Medical Technologist or the Chief Medical Technologist / Laboratory Quality Manager.
• Provide only information within their assigned non-technical responsibilities and authority.
• Refer technical, clinical, examination-specific, or patient-preparation questions to an authorized Medical Technologist or the Chief Medical Technologist.
• Use only current approved user-facing information when performing assigned support activities.

5.0 Policy / Procedure

5.1 Documented Scope Requirement

The Clinical Laboratory shall specify and document the range of laboratory activities and examinations it performs.

The laboratory shall perform and report only examinations included within the current approved Scope of Service.

An examination not included in the approved scope shall not be represented as an in-house laboratory examination.

Where an examination requested by a user is outside the laboratory's scope, the request shall be managed through the applicable referral process when referral is available and appropriate.

5.2 Approved Examination Scope

The Clinical Laboratory is a primary-level laboratory.

Its current approved examination scope comprises the following:

The two H. pylori examinations are distinct examinations performed on different specimen types:

• H. pylori stool antigen — Fecalysis;
• H. pylori serum antibody — Serology.

Urinalysis method (confirmed): TCH performs the microscopic examination component of Routine Urinalysis by the manual microscope method (technologist-performed microscopic sediment examination), not by an automated urine microscopy analyzer. This is confirmed TCH practice and is stated here to prevent any future Microscopy SOP from being built around an automated-analyzer workflow that does not apply at TCH.

The examination menu in this section is the authoritative laboratory scope. User-facing service information shall derive its scope statements from this approved list.

5.3 Examinations Not Offered In-House

The following activities are outside the current approved in-house scope:

• Microbiology culture and sensitivity;
• full Blood Bank / Transfusion Service activities, including crossmatching, component preparation, and donor screening;
• Histopathology and Cytology; and
• Molecular testing.

Basic ABO/Rh determination remains within the Hematology scope and does not constitute a full Blood Bank or Transfusion Service.

Examinations outside the approved scope shall not be performed or reported as in-house TCH laboratory examinations.

Where appropriate, requests for examinations outside the scope shall be managed according to the Referral Laboratory Policy.

5.4 Relationship Between Scope and Operational Procedures

Inclusion of an examination in the Scope of Service does not by itself authorize performance outside the applicable approved procedures.

Each examination within scope shall be supported, as applicable, by appropriate:

• pre-examination procedures;
• specimen collection requirements;
• analytical procedures;
• quality-control requirements;
• equipment and reagent requirements;
• result review and reporting procedures; and
• applicable records.

The examination shall be performed only when the laboratory has the required personnel, equipment, methods, materials, and other resources necessary for the examination.

5.5 Changes to the Scope of Service

Any proposed addition, removal, suspension, or significant modification of an examination or laboratory activity shall be evaluated before implementation.

The change shall:

• be initiated and evaluated by the Chief Medical Technologist / Laboratory Quality Manager;
• undergo appropriate technical review;
• undergo Pathologist review for clinical appropriateness;
• receive Hospital Director approval before implementation;
• undergo applicable document-control action;
• include review of affected laboratory procedures and records;
• include review of applicable equipment, reagents, personnel competency, quality-control, and other resource requirements; and
• result in updating applicable user-facing laboratory service information.

An examination shall not be represented or reported as an approved in-house service until the required scope-change process has been completed.

5.6 Temporary Suspension or Restriction of an Examination

Where an examination within the approved scope cannot temporarily be performed because of circumstances such as equipment failure, reagent unavailability, personnel limitations, quality-control failure, or other operational conditions, the laboratory shall manage the affected examination according to applicable nonconformity, contingency, and referral procedures.

Temporary inability to perform an examination shall not automatically constitute permanent removal from the approved scope.

Where a permanent change is intended, the formal scope-change process in Section 5.5 shall apply.

5.7 Review of the Scope of Service

The Scope of Service shall be reviewed at least annually and whenever a significant change may affect the laboratory's range of activities.

Review shall consider, as applicable:

• examination demand and service requirements;
• laboratory capability;
• personnel competency and availability;
• equipment and instrumentation;
• reagents and supplies;
• quality-control performance;
• referral arrangements;
• regulatory requirements;
• changes in hospital services;
• changes in clinical needs; and
• the continuing appropriateness of the examination menu.

The result of the review shall be documented and any approved changes shall be managed through document control.

5.8 Communication of the Approved Scope

The current approved Scope of Service shall be made available to relevant laboratory personnel and shall form the authoritative basis for user-facing descriptions of laboratory services.

The laboratory shall not maintain a second independent examination menu in another policy.

Where a brochure, test directory, service manual, or other user-facing material lists examinations offered by the laboratory, its scope-related information shall be derived from this policy and kept consistent with the current approved scope.

5.9 Referral of Out-of-Scope Examinations

Requests for examinations outside the approved in-house scope shall be managed in accordance with the Referral Laboratory Policy.

Referral arrangements shall identify the appropriate external laboratory and applicable requirements for referral, specimen handling, documentation, reporting, and result communication.

Referral of an examination does not change the examination's status as outside the TCH in-house scope.

Information for Laboratory Users (Sections 5.10–5.20). The following subsections carry over the laboratory user-information requirements formerly controlled under LAB-QM-004 General Laboratory Information Policy, merged into this policy under approved consolidation item 47.

5.10 Relationship to the Laboratory Scope of Service

The approved examination menu and range of laboratory activities shall be controlled exclusively under LAB-QM-004 Laboratory Scope of Service Policy.

LAB-QM-004 shall not reproduce the complete examination menu or independently define which examinations are within or outside the laboratory's scope.

Any user-facing statement concerning the examinations or services offered by the laboratory shall be based on the current approved scope under LAB-QM-004.

Where a discrepancy is identified between user-facing information and the approved Scope of Service, the approved scope under LAB-QM-004 shall be treated as the controlling source pending correction of the user-facing information.

5.11 Provision of Laboratory Information

The Clinical Laboratory shall make appropriate information available to patients and laboratory users to enable them to understand and appropriately access laboratory services.

Information provided to users shall be:

• accurate;
• current;
• sufficiently detailed for its intended purpose;
• consistent with approved laboratory policies and procedures;
• available in an appropriate form and manner; and
• maintained under document-control requirements where the information constitutes controlled documented information.

5.12 General Laboratory Service Information

The laboratory shall make applicable information available concerning:

• laboratory location and contact information;
• operating hours;
• after-hours or emergency arrangements, where applicable;
• procedures for requesting laboratory examinations;
• specimen submission and collection arrangements;
• applicable patient-preparation requirements;
• expected availability of results or applicable turnaround-time information;
• available advisory services;
• applicable consent requirements;
• factors known to significantly affect examination performance or result interpretation;
• referral arrangements for examinations not performed by the laboratory; and
• the process for complaints, feedback, or concerns.

Public posting of operating hours, services, and prices. The following shall be posted in a conspicuous area visible to clients (the reception/specimen-collection area), and shall also be available on request:

• the Laboratory's operating hours, including after-hours arrangements; and
• the list of laboratory services offered (consistent with Scope of Service and Laboratory User Information Policy Section 5.2) with their corresponding prices.

Prices are those in the hospital's current approved schedule of fees. The Laboratory does not set prices; it ensures the posted list matches the current approved schedule. The posted list is updated whenever a service is added, suspended, or withdrawn, or a price changes.

This implements DOH A.O. 2021-0037, Annex A, Section V.B.10, Annex B1, Item 22, and the AO's general guideline that all clinical laboratories make their prices accessible to the public as mandated by the UHC law.

5.13 Patient Preparation and Pre-Examination Information

The laboratory shall ensure that users receive applicable information necessary for appropriate patient preparation and specimen collection.

Patient-preparation requirements shall be established and controlled through the applicable pre-examination procedures and examination-specific requirements.

This policy governs the provision and communication of such information and does not replace the technical procedure defining the actual preparation requirement.

Examples may include, as applicable:

• fasting requirements;
• timing of specimen collection;
• medication-related instructions;
• required specimen type;
• specimen quantity;
• collection container;
• special collection conditions; and
• other factors that may affect specimen suitability or examination performance.

Where an examination-specific preparation requirement changes, the applicable controlled procedure and corresponding user-facing information shall be reviewed and updated.

5.14 User-Facing Laboratory Service Information

The laboratory shall maintain appropriate user-facing information describing its services.

The laboratory service information may be provided through a controlled brochure, laboratory service manual, test directory, patient instruction, request information, or equivalent approved communication material.

As applicable, user-facing service information shall include:

• laboratory services available;
• applicable patient-preparation requirements;
• specimen requirements;
• collection or submission instructions;
• applicable transport requirements;
• expected availability of results;
• relevant referral information; and
• other information necessary for appropriate use of the laboratory service.

The detailed examination information shall be derived from the applicable authoritative laboratory documents and shall not create requirements that are inconsistent with those documents.

5.15 Distribution and Accessibility

Current laboratory information shall be made available to intended users through appropriate channels.

Distribution may include:

• laboratory-issued brochures or service information;
• hospital departments;
• requesting physicians;
• patient-facing instructions;
• laboratory request or collection materials; and
• other approved communication channels.

Where controlled distribution is required, records of issuance or distribution shall be maintained.

5.16 Review and Updating of User Information

User-facing laboratory information shall be reviewed and updated when necessary to ensure continued accuracy.

Review shall be initiated when there is a relevant change in:

• laboratory scope of service;
• examination availability;
• operating hours;
• specimen collection requirements;
• patient-preparation requirements;
• referral arrangements;
• reporting arrangements;
• regulatory requirements; or
• other information that may affect laboratory users.

Changes affecting the laboratory's examination menu shall originate from the approved scope-control process under LAB-QM-004 and applicable document-control requirements.

Obsolete information shall be withdrawn from active use and replaced with the current approved information.

5.17 Ordering and Request Information

The laboratory shall provide users with appropriate information concerning examination requests.

Examinations shall be requested through the approved laboratory request process.

Detailed requirements for specimen collection, identification, acceptance, rejection, and other pre-examination activities shall be governed by the applicable laboratory procedures.

Telephone or other non-standard requests shall be managed and documented according to the applicable laboratory policy and procedure.

5.18 Reporting and Result Availability Information

The laboratory shall provide users with appropriate information concerning the availability and reporting of laboratory results.

Information provided to users shall be consistent with the approved Laboratory Reporting Policy and applicable post-examination procedures.

Critical-value communication, result authorization, confidentiality, and release of results shall be governed by their respective controlling policies and procedures.

5.19 Referral Laboratory Information

When an examination is not performed within the laboratory's approved scope, users shall be provided with appropriate information regarding the applicable referral arrangement.

The referral process itself shall be controlled under the Referral Laboratory Policy.

User-facing information shall not imply that a referred examination is performed in-house.

5.20 Complaints and Feedback

Users shall be provided with an appropriate means of communicating complaints, concerns, or feedback regarding laboratory services.

Complaints shall be managed according to the laboratory's applicable complaint, nonconformity, and quality-improvement processes.

5.21 Complaints, Client Feedback and Customer Satisfaction

5.21.1 Complaint and Feedback Channels

The laboratory shall provide the following channels through which clients may submit complaints and feedback regarding laboratory services:

• a suggestion box, visible and accessible to clients at the reception area;
• the Client Feedback, Satisfaction Survey, and Complaint Form (F-QM-004-A-V0), available at the reception area;
• verbal complaints or feedback; and
• written or electronic submissions.

5.21.2 Complaint Handling and Resolution

Every complaint received through any channel in Section 5.21.1 shall be received and logged in the Client Feedback, Satisfaction Survey, and Complaint Form / Register (F-QM-004-A-V0) and acknowledged to the complainant within 2 days of receipt.

The complaint shall be resolved — including its investigation, the action taken, the response to the complainant, and closure — within 7 days of receipt.

Where a complaint cannot be resolved within 7 days of receipt, the complainant shall be informed of the reason and of the expected resolution date, and the extension shall be approved by the Chief Medical Technologist / Laboratory Quality Manager.

A complaint that reveals a quality problem shall also be reported and managed as an occurrence under LAB-QM-010; where corrective action is warranted, it shall be managed under LAB-QM-011.

5.21.3 Customer Satisfaction Survey

The laboratory shall measure customer satisfaction using the Client Feedback, Satisfaction Survey, and Complaint Form (F-QM-004-A-V0), which shall be available at the reception area.

A customer satisfaction survey shall be conducted for at least one survey period per year.

Survey results shall be consolidated and analysed by the Customer Relations / Complaints Officer designated under Section 5.21.4, and shall be reported to Management Review (LAB-QM-013).

5.21.4 Customer Relations / Complaints Officer

The Hospital Director shall designate in writing, by signed designation, a Customer Relations / Complaints Officer. The designation is by default given to the Chief Medical Technologist / Laboratory Quality Manager or to a Medical Technologist.

The Customer Relations / Complaints Officer shall:

• receive and log complaints and client feedback in F-QM-004-A-V0;
• acknowledge complaints to complainants within 2 days of receipt;
• coordinate the investigation of complaints;
• respond to complainants and close complaints within 7 days of receipt, applying the extension rule in Section 5.21.2 where needed;
• consolidate and analyse customer satisfaction survey results;
• report survey results and complaint trends to management; and
• promote customer satisfaction.

5.21.5 Records

The records generated under this Section — the Client Feedback, Satisfaction Survey, and Complaint Form (F-QM-004-A-V0) and the Hospital Director's signed written designation of the Customer Relations / Complaints Officer — are listed and controlled under Section 6.0.

6.0 Records

Additional records generated under this policy include:

• Approved versions and reviews of the Scope of Service, test directory, and user-facing brochures/instructions; and
• The Hospital Director's signed written designation of the Customer Relations / Complaints Officer.

All records generated under this policy shall be controlled in accordance with Control of Records and retained per Laboratory Retention Schedule Policy.

7.0 References

• DOH-Philippines QMS Tool, 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
• ISO 15189:2022, Section 5 — Structural and Governance Requirements; Section 7 — Process Requirements
• WHO LQMS Handbook, Chapter 13 — Customer Service

Companion policies:

• Document Control Policy — document control for test directory, service brochures, and user notices
• Confidentiality Policy — confidentiality and protection of patient service requests and records
• Specimen Collection Policy — specimen collection instructions and user information requirements

Controlled visual annex:

• IG-04 — Test Menu — 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-04-Test-Menu-LAB-QM-004.png (PNG, print PDF, and editable HTML).