Laboratory Result Submission for Complex Patients
For patients with complex medical histories or multiple medications, laboratory results must be submitted with comprehensive contextual information including patient identifiers, medication history, specimen collection details, test methodology, reference ranges appropriate to the patient's specific conditions, and interpretive guidance—all communicated through secure, timely channels with clear action items for abnormal findings. 1
Essential Information Required on All Laboratory Reports
Patient and Specimen Identification
- Patient's full name and unique identifiers (date of birth, medical record number) 1
- Date and time of specimen collection and laboratory receipt (distinguished from test request date) 1
- Referring clinician's name who ordered the test 1
- Reason for testing as provided on requisition (critical for result interpretation in complex patients) 1
Clinical Context for Complex Patients
- Complete medication history, including prescription drugs, over-the-counter medications, and herbal supplements (essential as these can affect test results and interpretation) 1
- Relevant past medical history, particularly chronic conditions like renal disease, liver disease, or conditions affecting test interpretation 1
- Previous test results when available, especially baseline values for comparison 1
- Information about family members' test results when relevant for genetic or inherited conditions 1
Test Result Reporting Requirements
Core Result Elements
- Analytes tested and specific test methodology used 1
- Results in appropriate measurement units with current standard nomenclature 1
- Reference intervals or normal ranges individualized to the patient's demographics (age, sex, population) and clinical conditions 1
- Performance specifications including limits of detection, quantification, and analytic specificity 1
- Clear notation of whether results are preliminary, final, amended, or corrected 1
For HIV Viral Load Testing (Example of Standardized Reporting)
- Results must be reported in both copies/mL and log10 transformation (e.g., 500,000 copies/mL and log10 = 5.7) 1
- Test kit name, manufacturer, and version must be specified 1
- Values below detection limits reported as "less than" the lower limit (e.g., <400 copies/mL) 1
- Values above detection limits reported as "greater than" the upper limit (e.g., >750,000 copies/mL) 1
Interpretation and Clinical Guidance
Required Interpretive Information
- Interpretation of results for complex tests, profiles, and carrier status testing, linked to the reason for testing 1
- Name of laboratory personnel providing interpretation 1
- Recommendations for additional testing of patient or family members when appropriate 1
- Recommendation for consultation with specialists (e.g., genetics professionals) when indicated 1
- References to relevant literature if applicable 1
For Patients on Multiple Medications
- Interpretive guide or reference to aid in understanding how medications may affect results 1
- Limitations of the test method that affect clinical use, particularly drug interactions 1
- Clear statement of intended use and technical limitations 1
Communication Protocols for Abnormal Results
Immediate Notification Requirements
- Critical abnormal results require immediate telephone notification to both the primary provider and designated specialist, followed by written/electronic confirmation 1
- For tuberculosis: positive AFB smears, culture growth, M. tuberculosis identification, and drug resistance results must be reported immediately 1
- Turnaround time standards: AFB microscopy within 24 hours, culture growth within 14 days, organism identification within 21 days, susceptibility testing within 30 days 1
Out-of-Range Result Communication
- Pediatric subspecialist resource information with telephone numbers for consultation 1
- Information about suspected diagnosis and consequences if untreated 1
- Required actions including repeat screening, confirmatory testing, clinical actions, and evaluation with specific timelines 1
- Instructions for when provider cannot contact patient or when provider changes 1
- Contact information for follow-up personnel (name, phone, email, fax) 1
Electronic Reporting Systems
Implementation Requirements
- Systems must accommodate all recommended report elements including complex interpretive information 1
- Follow Health Level Seven International (HL7) messaging standards for electronic result transmission 1
- Quality assurance procedures must be established for electronic reporting systems 1
- Ensure accessibility and security compliance with HIPAA privacy requirements 1
Common Pitfall to Avoid
Electronic alerts can be missed or ignored when providers receive excessive notifications unrelated to critical results 2. Laboratories should limit electronic alerts to truly abnormal or actionable results and ensure critical alerts are displayed prominently with tracking mechanisms 2.
Confidentiality and Information Sharing
Patient Information Protection
- Establish procedures ensuring appropriate access, documentation, storage, release, and transfer of confidential information 1
- Prohibit unauthorized or unnecessary access or disclosure 1
- When family member information is needed for test interpretation, obtain patient authorization before releasing results to other providers 1
Requests from Other Providers
- Release patient test information only to authorized persons: the ordering clinician, designated care providers, or the referring laboratory 1
- If a provider caring for a family member requests results, obtain patient authorization first 1
- Laboratory directors must approve circumstances for information release in compliance with federal, state, and local requirements 1
Record Retention
- Maintain all records including test requests, procedures, analytic system records, performance specifications, proficiency testing, and quality assessments for minimum 2 years (longer if required by state law or accreditation) 1
- Retention policies must comply with CLIA requirements, state laws, and accrediting organization standards 1
Special Considerations for Complex Patients
When Diagnostic Uncertainty Remains
- Additional (Tier 2-4) laboratory tests should be guided by the patient's individual medical, neuropsychiatric, and risk profile 1
- Use a deliberate, personalized approach rather than broad-based "shotgun" testing 1
- Consider specialist consultation for interpretation of complex test panels 1