LAB-QM-POST-001 — Laboratory Reporting Policy

1.0 Purpose

To describe how the Laboratory reviews, releases, and distributes results/reports to requesting clinicians and patient care areas.

To describe the procedure for identifying, correcting, and documenting any previously reported incorrect laboratory result.

2.0 Scope

Applies to all Laboratory technical staff involved in result review, release, and distribution.

3.0 Definitions

• Corrected Report — one that replaces a previously reported incorrect result, reference range, or interpretation after it has already reached the patient or requesting clinician.
• Manual result — a result handwritten or manually entered by the reporting Technologist (given TCH's non-interfaced, Excel-based LIS, this describes the great majority of TCH's results); reviewed by a second Technologist where staffing allows, with final authorization by the Pathologist (see Section 5.2).
• Reporting error — an incorrect or erroneous result or information reported to a healthcare provider.
• Reported — the result/information has become available to the healthcare provider (includes results verified in the system or given verbally by phone).
• Clerical error — a result not correctly transcribed from worksheet to report, incorrect units, or a misplaced decimal point.
• Methodological problem — instrument- or reagent-related (e.g. calibration/function checks outside range, reagent/standard manufacturing problem, carry-over).
• Technical problem — relates to technique (e.g. inaccurate manual pipetting, result released before verification).
• Sample problem — relates to specimen quality as received (e.g. improper transport, hemolyzed, insufficient volume, mislabeled).

4.0 Responsibility

4.1 Hospital Director

• Exercises executive oversight and provides institutional reporting resources (standing governance and policy approval per Organization and Governance).

4.2 Pathologist

• Reviews the content/format of laboratory reports for clinical appropriateness prior to approval.
• Provides final authorization for release of laboratory results, following performance and initial verification by the assigned Medical Technologist (see Section 5.2). (Standing clinical oversight per Organization and Governance).

4.3 Chief Medical Technologist / Laboratory Quality Manager

• Reviews and approves the content/format of laboratory reports at least every 2 years, and any modification to final reports.
• Ensures compliance with applicable regulatory, accreditation, national, and international standards.
• Reviews/approves this policy at least annually; authorizes and approves corrections made on erroneous reports.
• Reviews the type and severity of the error; provides retraining where indicated.
• Uses error-type data for quality improvement; notifies the Chief of Hospital/Medical Director if an erroneous result impacted patient care; reviews related incidents and recommends quality-improvement action (see Corrective and Preventive Action Policy).

4.4 Medical Technologists

• Type/encode or handwrite results; perform the initial on-screen/ on-paper review of encoded results; verify and finalize reports.
• Perform secondary review of results before release, where staffing allows.
• Ensure critical results are identified, reported immediately, and documented per Reporting Critical Values Policy.
• Follows this policy; notifies the requesting physician/healthcare provider that an error occurred and a corrected report will follow, with the notification read back to confirm understanding; makes the correction.

4.5 Laboratory Aides

• Hand-carry printed reports to requesting units per Section 5.3.
• Do not perform, verify, interpret, or release laboratory results.
• Do not authorize or perform corrections to reported results.

5.0 Policy / Procedure

5.1 Policy Statement

It is Laboratory policy that patient specimens are properly and positively identified, processed, and analyzed, and that results are released in accordance with applicable Philippine laws, accreditation standards, and professional ethics. This section describes the procedure for reviewing, releasing, reporting, and distributing Laboratory results.

5.2 Results Review

Given TCH's confirmed non-interfaced, Excel-based LIS (see Confidentiality Policy Section 5.1 item 6), essentially all results at TCH are manually encoded results, reviewed and authorized for release as follows: performed and initially verified by the assigned Medical Technologist; secondary review by a second Medical Technologist where staffing allows; final authorization by the Pathologist (per Section 4.2).

Laboratory Aides are excluded from authorizing or releasing results; their role is limited to non-technical support (e.g., hand-carrying printed reports per Section 5.3) and does not include result review, authorization, or release. Section-specific detail is found in each section's own quality management program (see Figure 1).

Figure 1 — Result verification, release, and amended report recall flow

This is distinct from the Chief Medical Technologist / Laboratory Quality Manager's periodic (at least every 2 years) review and approval of report content/format under Section 4.3, which is a document-level review, not a per-result authorization.

5.2.1 Result Validation Before Release

Before a result is released, the reporting Medical Technologist shall verify: (a) correct patient/specimen identification against the requisition; (b) that the result is plausible against the applicable data-integrity checks of Laboratory Information Management Policy Section 5.4; and (c) that any critical, unusual, or referral result is routed per Section 5.4 before the report is printed and released.

This verification shall be documented on the Official Laboratory Result Report & Amended/Corrected Report Form (F-QM-POST-001-A-V0, see Section 6.0).

5.3 Distribution of Results

TCH's confirmed result-distribution process: once a result is finalized and printed from the Lab-LIS, the Laboratory Aide hand-carries the printed report to the requesting unit:

• Inpatient (IP) results are carried to TCH's Nurse Station, in the IP building, which is staffed 24/7.
• Outpatient (OPD) results, during OPD hours (8:00 AM–5:00 PM): are carried to TCH's Doctor's Office, in the OPD building.
• Outpatient (OPD) results finalized after OPD hours (after 5:00 PM): the entire OPD Building — including all physicians and staff — operates 8:00 AM–5:00 PM only and is not staffed after that time. Any patient who would otherwise be seen in OPD is instead accommodated in the ER section of the IP Building after hours. The printed report is therefore carried to the IP Building's ER section rather than to the (closed) OPD Doctor's Office.

TCH currently has only one Nurse Station (IP, 24/7) and one Doctor's Office (OPD, 8:00 AM–5:00 PM only), so this routing — by patient type, and for OPD results, by time of day — covers all requesting units.

5.4 Special Types of Reports

• Critical/panic values are handled per Reporting Critical Values Policy.
• Referral laboratory results (received from SPH or any future referral laboratory per Referral Laboratory Policy) are reviewed for clerical errors, proper patient identification, and completeness, and are then 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, as this is a prohibited act under DOH A.O. 2021-0037, Annex C, item A.7 (see Referral Laboratory Policy Section 5.6). A copy of the referral laboratory report is filed in the patient's chart. Every step is documented on the Referral Laboratory Register, Annual Evaluation & Send-Out Log (F-QM-PRE-002-A-V0, owned by Referral Laboratory Policy — not duplicated here).
• Corrected results carry a fixed comment per Section 5.8.
• Unusual results and critical values are handled per Reporting Critical Values Policy.
• HIV-positive and other notifiable-disease results are handled per Reporting Critical Values Policy, which reflects Philippine RA 11332/RA 11166 requirements.

5.5 Report Content

Each report includes, at minimum: TCH's name and official logo; patient identification (full name, medical record number, age, sex); ordering physician identification; patient location (ward/unit, where applicable); date/time of specimen collection and specimen source; received date; report date/time; test result(s) and reference interval(s); interpretation where appropriate; unit of measurement; any comment on primary-sample quality that may affect the result (e.g. lipemic, hemolyzed, low volume); and flags for critical/abnormal results where applicable.

Patient results are confidential (see Confidentiality Policy).

Signatories. Every report shall also bear:

• the name, PRC registration number, and original signature of the Medical Technologist(s) who performed the examination; and
• the name, PRC registration number, and signature of the Pathologist, who is accountable for the reliability of the results.

This is required by DOH A.O. 2021-0037, Annex A, Section V.B.5 and Annex B1, Item 26. The TCH result form templates shall carry fixed fields for both signatories. A report missing any of these elements shall not be released.

5.6 Results Release Follow-Up

Delayed results — whatever the cause — are communicated to the requesting doctor or patient care area, documented on the Technical Delay & TAT Monitoring Log (F-QM-POST-003-A-V0, shared with Turnaround Time and Stat Testing Policy — not duplicated here).

5.7 Other Reporting Requirements

Printing/releasing results without the signatories required by Section 5.5 is prohibited. Patient data is accessible only to authorized Medical Technologists (see Laboratory Computer System Security Policy). Each Technologist's initials/ID serve as the tracking mechanism identifying who performed or completed a test (see Turnaround Time and Stat Testing Policy).

Any modification or deletion of an entered result made before the report is printed and released shall not be erased outright; it shall be corrected by a single-line strikethrough of the original entry (leaving it legible), with the corrected value, the reason for the change, and the initials/date of the Medical Technologist making the correction, entered on the same worksheet/result form.

This is distinct from a correction to a result after release, which is handled under Section 5.8. No separate log is created for this pre-release correction; it is captured on the existing paper worksheet already retained per Laboratory Retention Schedule Policy and referenced in Laboratory Information Management Policy Section 5.3.

Electronic/digital signature (future state). TCH's confirmed Excel-based Lab-LIS has no individual per-user login and does not currently generate an electronic or digital signature (see Confidentiality Policy Section 5.1 item 6); the signatures required by Section 5.5 are presently handwritten signatures with printed names and PRC registration numbers only.

Should TCH's Lab-LIS be upgraded to a system capable of applying an electronic or digital signature, any such signature shall comply with the Philippine Electronic Commerce Act (Republic Act No. 8792) and applicable DICT/Philippine National Public Key Infrastructure (DICT-PNPKI) requirements for a valid electronic signature.

No electronic or digital signature capability currently exists at TCH; this clause states the requirement to be met if and when that capability is implemented and does not represent that it is in place today.

5.8 Corrected and Revised Reports

5.8.1 Policy Statement

Any result verified with inaccurate information is corrected immediately upon identification of the error.

When the Laboratory discovers an incorrect reported result, a corrected report is generated as promptly as possible, and the error is communicated directly to the ordering clinician or other authorized individual. Both the original and corrected reports are retained, and the corrected report includes the previous (incorrect) result in a comment.

5.8.2 Correction Procedure

• When an incorrect reported result is identified, the correct result is made available and the requesting physician (or designee/ responsible nurse) is notified within 30 minutes, using the Official Laboratory Result Report & Amended/Corrected Report Form (F-QM-POST-001-A-V0), which documents at minimum: patient name and MRN; test name; date/time of request; the old (incorrect) result with date/time; the new (correct) result with date/time; and the reporting staff member's signature with date/time.
• The treating physician or designee acknowledges having read the corrected result by signing the amended report section of F-QM-POST-001-A-V0.
• Error correction details are documented on the amended report section of F-QM-POST-001-A-V0, selecting the applicable error category: Technical, Methodological, Clerical/Transcription, Sample, or Wrong Interpretation of Results.

5.8.3 Correction Mechanics (TCH's Manual Workflow)

Given TCH's paper/Excel-based LIS, a correction is made by drawing a single line through the incorrect entry (never erasing or obscuring it), writing the correct result beside it, and initialing/dating the change, consistent with Control of Records.

The corrected report issued to the requesting physician always carries the comment: "This result was previously reported as [ ] and corrected to be [ ]; Dr. [ ] is informed of the corrected result and read-back verification is confirmed."

5.8.4 Performance Monitoring

Evidence tracked includes: annual policy review; and records of all corrected/revised results (recurring error-type patterns may warrant a formal corrective action — see Corrective and Preventive Action Policy).

6.0 Records

Send-out results use the Referral Laboratory Register, Annual Evaluation & Send-Out Log (F-QM-PRE-002-A-V0); delayed-result notifications use the Technical Delay & TAT Monitoring Log (F-QM-POST-003-A-V0) owned by Turnaround Time and Stat Testing Policy.

7.0 References

• DOH QMS Tool for Clinical Laboratories (2024), Section 5 — Quality Improvement Activities and Section 6 — Information Management System
• DOH Administrative Order No. 2021-0037, Annex A Section V.B.5–V.B.6, Annex B1 Item 26, and Annex C Item A.7
• ISO 15189:2022, Clause 7.4 — Post-examination processes
• ISO 15189:2022, Clause 8.4 — Control of records
• JCI Accreditation Standards for Hospitals, AOP.5.4 — Timely availability of laboratory results
• Republic Act No. 8792, Electronic Commerce Act of 2000

Companion policies:

• Reporting Critical Values Policy — critical-value reporting and notifiable-disease communication
• Turnaround Time and Stat Testing Policy — turnaround time monitoring and delay notifications
• Laboratory Retention Schedule Policy — retention schedule for laboratory reports, worksheets, and amendment records

Controlled visual annex:

• IG-21 — Amended Reports — 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-21-Amended-Reports-LAB-QM-POST-001.png (PNG, print PDF, and editable HTML).