LAB-QM-PRE-002 — Referral Laboratory Policy

1.0 Purpose

To describe the process for selecting, evaluating, and monitoring reference (referral) laboratories used for examinations TCH's Laboratory does not perform in-house, and to describe how send-out specimens are requisitioned, tracked, and reported.

2.0 Scope

This policy applies to all Medical Technologists and Laboratory Aides in sections involved in identifying, preparing, dispatching, and tracking send-out specimens, and to the Chief Medical Technologist/Laboratory Quality Manager responsible for selecting and evaluating referral laboratories.

3.0 Definitions

• Referral laboratory / Reference laboratory — an external laboratory to which a sample is submitted for an examination TCH does not perform in-house.
• Turnaround time (TAT) — the time interval encompassing the entire examination process, from when a result is needed to when it is available to act upon; for send-out testing, this includes the time from specimen dispatch to the referral laboratory until the result is returned to TCH.
• Send-out log — the tracking record (physical logbook, consistent with TCH’s paper-based system; see Laboratory Information Management Policy) documenting each specimen referred out, the test(s) requested, dispatch date/time, and result-return date.

4.0 Responsibility

4.1 Hospital Director

• Approves the referral laboratory relationship and any formal lab-to-lab contract/MOA (see Section 5.2 below) (standing governance and policy approval duties are defined in Organization and Governance).

4.2 Pathologist

• Reviews the selection and periodic re-evaluation of the referral laboratory(ies) for clinical appropriateness (standing clinical oversight per Organization and Governance).

4.3 Chief Medical Technologist / Laboratory Quality Manager

• Identifies TCH's referral testing needs (tests not performed in-house - see Scope of Service and Laboratory User Information Policy).
• Leads selection and periodic re-evaluation of TCH's referral laboratory(ies), consulting institutional medical staff and hospital administration as needed.
• Obtains and maintains SPH's license/accreditation documentation on file (see Section 5.4 below).
• Reviews reference-lab performance data at least annually.

4.4 Medical Technologists

• Prepare, label, and log send-out specimens per Section 5.5 below.
• Perform the final visual invoice-vs-log verification before courier/ transport pickup.

4.5 Laboratory Aides

• Assist with non-technical send-out packaging and specimen transport preparation under Medical Technologist supervision.
• Do not perform, verify, authorize, interpret, or release technical send-out records or examinations.

5.0 Policy / Procedure

5.1 Policy Statement

It is TCH Laboratory's goal to provide high-quality testing.

For examinations that cannot be performed on-site given TCH's current primary-level scope (see Scope of Service and Laboratory User Information Policy), the Chief Medical Technologist/Laboratory Quality Manager and hospital administration are responsible for ensuring that a referral laboratory capable of high-quality, cost-effective testing is selected, and that patients are informed, where applicable, of any relationship between the referring physician and the referral laboratory.

5.2 TCH's Current Referral Arrangement

TCH's Laboratory currently refers tests it does not perform in-house to Samar Provincial Hospital (SPH).

As of this writing, this is a patient-level referral relationship only — the patient (or the requesting unit, on the patient's behalf) is referred to SPH for the test, rather than TCH's Laboratory operating a formal specimen send-out arrangement under a lab-to-lab contract or Memorandum of Agreement (MOA) with SPH.

The Laboratory shall formalize a lab-to-lab Memorandum of Agreement (MOA) with SPH governing a formal specimen send-out arrangement. This MOA is currently under development and has not yet been executed; this policy states the requirement and readies the governing procedure (Sections 5.3–5.5) in advance of the MOA's completion — it does not represent that the MOA already exists.

Per DOH A.O. 2021-0037, Annex A, Section VII and Annex B1, Item 32, every referral arrangement shall meet the following:

• The referral laboratory shall be a DOH-licensed clinical laboratory. A copy of its current DOH-LTO shall be kept on file and replaced on each renewal.
• The MOA shall be notarized and shall prescribe the accountabilities of each party, including collection, transport, processing of specimens, and release of results.
• A separate MOA is required for referred tests that are not within TCH's service capability, unless the referral is part of the equipment-breakdown contingency plan (Section 5.2.1 item 2).
• Referral is permitted only (a) for a test that is not part of the service capability expected for TCH's licensed category, or (b) as part of the equipment-breakdown contingency plan, within the time limit in Section 5.2.1 item 2.

5.2.1 Referral Categories

The Laboratory distinguishes two categories of referral, each with a different trigger and expected duration:

• Ongoing capability-gap referral — for a test that is not, and is not expected to become, part of TCH's current scope of service (see Scope of Service and Laboratory User Information Policy). This referral is ongoing for as long as the test remains outside TCH's scope.
• Equipment-breakdown/downtime referral — a short-term referral activated when an in-house test cannot be performed because of equipment breakdown or another unanticipated interruption of on-site testing, per Equipment Management Policy Section 6.7.1 and Section 6.8.4. This referral shall be temporary, limited to the duration of the equipment downtime, and shall end once in-house testing capability is restored — it is not a substitute for returning the test to TCH's normal scope of service. An equipment-breakdown referral shall not last more than 3 months from the date it is activated (DOH A.O. 2021-0037, Annex A, Section VII.D.2), and shall be documented: activation date, test(s) affected, reason, and the date in-house testing resumed, recorded in the send-out log (Section 5.5 item 4) and cross-referenced to the Equipment Downtime Log (F-QM-ANA-005-A-V0). If in-house testing has not been restored within 2 months of activation, the Chief Medical Technologist / Laboratory Quality Manager shall notify the Pathologist and the Hospital Director in writing so that repair, replacement, or a formal scope change under Scope of Service and Laboratory User Information Policy Section 5.5 is decided before the 3-month limit is reached.

Both categories are referred under the same send-out requisitioning/labeling/tracking procedure (Section 5.5) and the same MOA once executed (Section 5.2 above); they are distinguished in the send-out log (Section 5.5 item 4) by reason for referral so that equipment-breakdown referrals can be trended and reviewed alongside Equipment Management Policy Section 6.8's monthly downtime trend review.

5.3 Selection Criteria for a Referral Laboratory

Once TCH's Laboratory does operate a formal specimen send-out arrangement (with SPH or any future referral laboratory), selection and periodic re-evaluation are based primarily on quality and cost effectiveness of services, considering:

• Quality of service — facilities/equipment appropriate to the scope and volume of testing; participation in External Quality Assessment (EQA)/proficiency testing with a documented corrective- action process for out-of-range results; personnel qualifications (licensure, certification, continuing education); internal quality control records; instrument maintenance records; client satisfaction.
• Applicable certification/accreditation status in effect for the specialty/subspecialty of the referred testing (DOH-Philippines licensure at minimum; other accreditation as applicable).
• Cost effectiveness.
• Efficiency of service — scope of available testing, specimen collection/handling instructions, defined transportation method and schedule, published turnaround time, and a defined critical-value/results-reporting mechanism.

Reasons a referral laboratory relationship may be needed include: a unique or infrequently-requested test not offered in-house; backup service during an instrument breakdown or unanticipated interruption of on-site testing; or a routine test not currently within TCH's scope (see Scope of Service and Laboratory User Information Policy).

5.4 Referral Laboratory Evaluation

Where a formal referral relationship is established, the Chief Medical Technologist/Laboratory Quality Manager documents an on-site or correspondence-based evaluation covering (at minimum): licensure/ accreditation/certification status and expiry; qualifications of the laboratory's technical director and staff; internal quality control program documentation; EQA/proficiency testing participation and results; client references; scope of testing offered; specimen collection/handling/rejection criteria; transportation arrangements; published turnaround times; communication/reporting mechanisms (including critical-value notification); and policy on corrected/ amended reports.

This evaluation is repeated periodically (at minimum on contract renewal, or annually where no formal contract exists) and approved by the Chief of Hospital/Medical Director.

5.5 Send-Out Specimen Requisitioning, Labeling, and Tracking

• Send-out specimens are labeled with at least two patient identifiers (full name and MRN) plus the date/time of collection, following the same identification and labeling requirements as Specimen Collection Policy.
• The Technologist preparing the send-out aliquot labels the container and requisition with the two identifiers, collection date/time, and any additional information required by the referral facility.
• A copy of the request/invoice for the send-out test is placed with the requisition; before dispatch, the send-out test(s) on the invoice are visually verified against the send-out/shipping log by the staff member responsible for final dispatch — any discrepancy is resolved before the specimen leaves TCH's custody.
• All send-out specimens are recorded in the send-out log section of the Referral Laboratory Register, Annual Evaluation & Send-Out Log (F-QM-PRE-002-A-V0; physical logbook, per TCH's current paper-based process — see Document Control Policy for form-control requirements), noting: patient identifiers, test(s) referred, dispatch date/time, result-return date, and referral category (ongoing capability-gap or equipment-breakdown/downtime, per Section 5.2.1). Recurring delays or discrepancies in returned results may warrant a corrective action (see Corrective and Preventive Action Policy).
• Specimen packaging and transportation to the referral laboratory follow Specimen Handling Packaging Transportation Policy (see Figure 1).

Figure 1 — Referral laboratory specimen packaging, dispatch, and result release flow

5.6 Communication of Results

Critical (imminently life-threatening) values returned by the referral laboratory are communicated to the ordering physician immediately, per Reporting Critical Values Policy. Other unexpected or unusual results are communicated in a timely fashion consistent with the clinical context. Reports from the referral laboratory indicate the name of the referral laboratory and, where applicable, reference ranges.

Referral results shall be released to the requesting unit on the referral laboratory's own report (the original, or a copy certified by the referral laboratory). Results performed by another laboratory shall not be transferred, transcribed, or re-typed onto a TCH result form.

This is a prohibited act under DOH A.O. 2021-0037, Annex C, Item A.7 (see Laboratory Reporting Policy Section 5.4 item 2). A copy of the referral report is filed in the patient's chart, and its return is recorded in the send-out log (Section 5.5 item 4).

5.7 Patient Notification

Where applicable, patients are informed of any relationship between the requesting physician and the referral laboratory, consistent with transparency expectations under DOH-Philippines and JCI standards.

6.0 Records

7.0 References

• DOH QMS Tool for Clinical Laboratories (2024), Section 3 — Service Delivery
• DOH Administrative Order No. 2021-0037, Annex A Section VII, Annex B1 Item 32, and Annex C Item A.7
• ISO 15189:2022, Clause 6.8 — Externally provided products and services
• WHO Laboratory Quality Management System Handbook, Chapter 11 — Purchasing and inventory
• JCI Accreditation Standards for Hospitals, AOP.5.10 — Reference and contract laboratories
• CLSI QMS05-A2, Qualifying, Selecting, and Evaluating a Referral Laboratory

Companion policies:

• Scope of Service and Laboratory User Information Policy — defines examinations referred out of TCH
• Specimen Collection Policy — send-out specimen requisition, labeling, and patient identification
• Specimen Handling Packaging Transportation Policy — send-out specimen packaging and transport

Controlled visual annex:

• IG-24 — Referral Specimens — 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-24-Referral-Specimens-LAB-QM-PRE-002.png (PNG, print PDF, and editable HTML).