Help Doc
1. GETTING STARTED
Welcome to MobiLab! This help guide provides step-by-step instructions for operating the MobiLab clinical chemistry analyzer and MobiLab Connect software platform.
1.1 Login & Security
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1. Open MobiLab app on your tablet
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2. Enter your username (provided by facility administrator)
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3. Enter your password
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4. Tap 'Login' → Dashboard displayed
AUTO-LOGOUT POLICY (UPDATED)
For security and regulatory compliance (ISO 13485, CDSCO MDR 2017), you will be AUTOMATICALLY LOGGED OUT after 12 Hours OF INACTIVITY. This protects patient data and maintains audit trail integrity. If you step away from the tablet, your session will end and you must log in again upon return.
2. PATIENT BOOKING
2.1 Creating a Booking
From Dashboard → 'New Booking' → Select test type → Enter patient details (following validation rules in Section 2.1a) → Select test panels → Review summary → Confirm booking.
2.1a DATA ENTRY VALIDATION RULES (NEW)
The MobiLab app enforces validation rules to prevent data entry errors and ensure patient safety:
PATIENT NAME (MANDATORY)
Maximum 100 characters. Allowed: A–Z, 0–9, spaces, hyphens. Not allowed: Special symbols. Error if invalid characters entered: 'Invalid character in name field'
DATE OF BIRTH (MANDATORY)
Valid past date (DD/MM/YYYY). Used to calculate patient age for test eligibility and reference range selection. Error if future date: 'Date cannot be in the future'
GENDER (MANDATORY)
Select: Male / Female / Other / Prefer not to say. Required because many reference ranges vary by gender.
HEIGHT (cm) & WEIGHT (kg) (OPTIONAL but RECOMMENDED)
Validated ranges: Height 30–250 cm, Weight 0.5–200 kg. Used for BMI calculation and test result interpretation. Out-of-range values rejected with message: 'Height/Weight outside acceptable range'
AGE-BASED TEST ELIGIBILITY
Age-inappropriate tests (e.g., Lipid Panel for patient <10 years) trigger YELLOW WARNING. You can cancel the test or override with documented clinical reason.
2.2 Managing Bookings
From Dashboard: View pending bookings, edit 'Pending' status bookings, cancel bookings with reason, view booking history
3. DEVICE CONNECTION
3.1 DUO Analyzer (UPDATED)
Connect DUO Analyzer to tablet via USB, turn on device. App auto-detects and displays: Device ID, Battery %, Firmware version. Status indicator: GREEN = Ready, ORANGE = Warning, RED = Error.
FIRMWARE UPDATES (UPDATED)
When an update is available, app displays a notification. Apply within 7 days. Do NOT disconnect during update (3–10 min). Plan updates outside testing hours.
OUTDATED FIRMWARE WARNING (NEW)
If firmware >3 months outdated, RED WARNING appears: 'Device firmware outdated. Update required.' You CANNOT conduct patient tests until updated. Outdated firmware causes inaccurate calibration and fails regulatory audits.
FIRMWARE UPDATE PROCESS (NEW)
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1. Connect DUO via USB
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2. Tap 'Update Available' or Settings → Device → Update
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3. Review update notes
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4. Tap 'Proceed with Update'
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5. Device indicator blinks BLUE (in progress)
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6. Wait for completion — do NOT unplug
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7. Device restarts → Indicator GREEN
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8. Confirmation: 'Firmware update successful'
4. CONDUCTING TESTS
4.1–4.3 Test Types
MobiLab supports: Biochemistry (glucose, urea, creatinine, electrolytes, liver/cardiac markers), FIA, Urine Analysis, Serology, Blood Group, ESR, Electrolyte Panel, Thyroid Panel. Refer to device manual for specific sample preparation procedures.
4.4 RESULT REVIEW & APPROVAL WORKFLOW (NEW)
[NEW SECTION - Required for CDSCO compliance] After test completion, results transition to 'In Review' status. A QA Reviewer (facility-assigned) performs comprehensive review before results are finalized and released to patients.
4-STEP REVIEW PROCESS:
STEP 1 — Verify patient identity (name, DOB, patient ID match booking exactly)
STEP 2 — Check flagged results (RED status = out-of-QC-range; requires investigation)
STEP 3 — Review operator notes (e.g., 'Sample hemolyzed; second attempt taken')
STEP 4 — Approve or Reject with reasoning
APPROVE → Status 'Approved' → Final report generated → Released to patient → Result LOCKED
REJECT → Status 'Rejected' → Moves to Retest tab → Operator receives rejection reason
All approvals timestamped with reviewer name, date, time. Logged for audit compliance. Results locked after approval to ensure data integrity.
5. REAGENT AND LOT SELECTION
Before testing, select the correct reagent lot with a non-expired date. Each result linked to a lot used (required for traceability and regulatory compliance).
6. RETEST FLOW
If the QA Reviewer rejects the result or QC fails, the test appears in the 'Retest' tab. Retest using a fresh sample and new reagent lot.
7. QUALITY CONTROL (QC) (EXPANDED)
Quality Control ensures the analyzer functions accurately and produces reliable results. QC uses known-value control samples to verify measurements within acceptable limits.
7.1 Introduction to QC
Every clinical analyzer must perform regular QC to detect measurement drift, reagent degradation, and calibration issues. Poor QC practices result in inaccurate patient results, failed audits, and patient safety risks.
7.2 Performing QC
Dashboard → 'Quality Control' → Select test panel → Insert QC sample → Device analyzes → Compare results to expected ranges (GREEN = PASS, RED = FAIL).
7.3 QC FREQUENCY & REQUIREMENTS (NEW)
[NEW SUBSECTION - Required for ISO 13485 §8.2.4] QC frequency depends on your facility's protocols, determined by your Medical Director:
DAILY QC: When opening a new reagent lot or after device maintenance. Confirms device ready for patient testing.
WEEKLY MAINTENANCE QC: Once per week (e.g., Monday morning). Confirms ongoing device accuracy.
PER-SESSION QC: Some tests require QC at the start of each session. Administrator specifies which tests.
Administrator assigns QC tasks in the app calendar. Follow the schedule strictly. QC must PASS (GREEN) before patient testing begins.
7.4 QC FAILURE HANDLING (NEW)
[NEW SUBSECTION] If QC falls outside acceptable range (±2 Standard Deviations), RED status appears:
WHEN QC FAILS: RED status, Patient testing BLOCKED, Affected reagent lot flagged 'Under Investigation', Alert sent to Supervisor
REQUIRED ACTIONS: (1) STOP patient testing, (2) Contact Supervisor to investigate, (3) Possible causes: Reagent degradation, device drift, operator error, expired control
CORRECTIVE ACTIONS: Recalibrate device with fresh control sample, Replace reagent lot with new unexpired lot, Retrain operator if technique incorrect, Check control sample storage conditions
RESUME PATIENT TESTING: After corrective action, RETEST QC immediately. If QC GREEN (pass), patient testing may resume. Document QC failure, cause, corrective action in QC log. Patient results NOT released until QC passes.
7.5 QC RECORDS & TRACEABILITY (NEW)
[NEW SUBSECTION] All QC results stored in QC Reports section, linked to: Reagent lot number/expiry, QC date/time, Operator name, Device serial number, PASS/FAIL status, operator notes.
QC records retained per facility retention policy (typically 3–5 years per CDSCO guidelines). Records essential for regulatory inspections and internal audits.
8. TRAINING CENTER
All operators must complete training before conducting patient tests. Training includes video tutorials, MCQ assessments, theory assessments, and practical demonstrations. The supervisor assigns training modules based on your role.
9. VIEWING REPORTS
Once approved by QA Reviewer, view the final patient report by tapping 'Reports' on Dashboard. Reports show test values, reference ranges, interpretation flags. Print or email as needed per facility procedures.
10. ABHA / ABDM INTEGRATION (EXPANDED)
MobiLab integrates with India's Ayushman Bharat Health Account (ABHA) and Ayushman Bharat Digital Mission (ABDM). Patients can access results via ABDM app with explicit consent.
10.1 ABHA LINKAGE & CONSENT (NEW)
[NEW SUBSECTION - Required for DPDPA 2023 compliance] When a patient provides ABHA ID, confirm EXPLICIT CONSENT to share results via ABDM.
CONSENT PROCESS: Patient (or legal guardian if minor) verbally or in writing confirms: 'I consent to share results through ABDM'. App records: ABHA ID, patient name, date/time, operator name. Consent stored securely. Without explicit consent, ABHA linkage NOT permitted.
10.2 DATA SHARING (NEW)
[NEW SUBSECTION] Only specific test data eligible for ABDM sharing:
SHARED: Test result values, reference ranges, interpretation flags, test name/date, facility name | NOT SHARED: Operator name, internal notes, facility ID
When generating report for ABHA-linked patient, app displays checkbox: ☐ Share to ABDM (only if ABHA linked + consent on file). If checked → Results encrypted to ABDM. If unchecked → Results stay in MobiLab only.
10.3 PRIVACY & DATA SECURITY (NEW)
[NEW SUBSECTION - Required for DPDPA 2023 compliance] Results shared to ABDM protected by:
ENCRYPTION: In transit (TLS 1.2) + At rest (AES-256)
PATIENT CONTROL: Patient can revoke ABHA anytime via ABDM app. Once revoked, future results are NOT shared. Previously shared results remain in the patient's ABDM record.
RIGHT TO BE FORGOTTEN (DPDPA 2023): Patient requests deletion → Facility contacts ABDM with consent → ABDM removes results (subject to retention requirements) → MobiLab retains per CDSCO policy
AUDIT TRAIL: All sharing actions logged (date/time, patient ID, sharing status, operator)
IMPORTANT: Never share without explicit consent. Unauthorized sharing violates DPDPA 2023 and causes regulatory penalties and loss of patient trust.
11. TROUBLESHOOTING
Device not detected: Reconnect USB cable, try different USB port, restart device/tablet. | Red status in result: Review by QA operator; may indicate specimen issue or calibration drift. | QC Fails: Contact supervisor, recalibrate device, replace reagent, retest QC before resuming. | Login failed: Verify credentials, reset password, contact IT if account locked.
12. DEMO MODE
Demo mode allows practice without affecting patient data. Demo results marked 'DEMO', never released. Demo data segregated from production, cannot sync accidentally.
13. DATA SECURITY BEST PRACTICES
Never share login credentials. Never leave the tablet unattended while logged in. Log out when leaving the workstation (auto-logout after 30 min). Report suspected breaches immediately. Only view results if clinically necessary. Do not screenshot results on personal devices. Do not discuss results in public areas.
14. SUPPORT AND CONTACT
Email: support@primaryhealthtech.com | Phone: 7042750444
APPENDIX A: USER ROLES & ACCESS CONTROL MATRIX (NEW)
[NEW APPENDIX - Required for ISO 13485 §4.2.3 compliance] This matrix defines user roles and permissions. All user actions logged for audit compliance.
OPERATOR
✓ Login, conduct tests, create bookings, perform QC, view own results | ✗ Cannot edit results, approve results, assign roles | Auto-logout after 30 min inactivity
QA REVIEWER
✓ Review 'In Review' results, approve/reject, access audit logs | ✗ Cannot conduct tests, modify values (approve/reject only) | Timestamp recorded
SUPERVISOR
✓ All operator permissions + retrain operators, assign reagent lots, audit activity, override with reason, investigate QC failures | ✗ Cannot approve results (QA Reviewer only)
ADMIN
✓ Create/delete accounts, reset passwords, configure settings, manage backups, access audit logs, manage firmware | ✗ Cannot approve results, conduct tests
GENERAL SECURITY: Passwords ≥8 characters (upper/lower/number/symbol), changed every 90 days. MFA required if enabled. Auto-logout 30 min inactivity. All actions logged with timestamp/action/data.