10 Core CAP-Compliant SOP Frameworks: General Laboratory Policies, Document Control, Safety & Quality Procedures Editable Word PDF
$197.00
★ 10 INSTITUTIONAL-GRADE CAP-COMPLIANT STANDARD OPERATING PROCEDURES (SOPS) ★
Designed specifically for Hospital Laboratories, Diagnostic Reference Centers, and Pathology Practices preparing for a College of American Pathologists (CAP) Laboratory Accreditation Program (LAP) on-site inspection.
Writing laboratory policy and procedure manuals from scratch takes 40+ hours per binder. Worse, document control citations—such as procedures lacking Medical Director approval or failing to match current manufacturer package inserts—are among the most common Phase II deficiencies cited by peer inspectors.
This turn-key suite delivers 10 fully editable Microsoft Word (.docx) SOP frameworks mapped directly to the CAP General Laboratory (GEN) checklist standards, complete with pre-built biennial Director sign-off tables, staff acknowledgement blocks, and regulatory crosswalks.
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WHAT’S INCLUDED IN THIS $197 PACKAGE
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1. SOP-GEN-001: DOCUMENT CONTROL & BIENNIAL PROCEDURE MANUAL REVIEW
• Aligned with CAP GEN.20100, GEN.20200, GEN.20375 & 42 CFR § 493.1251.
• Protocol for authoring, versioning, annual/biennial Director approvals, and 2-year document retention rules.
2. SOP-GEN-002: NONCONFORMANCE, OCCURRENCE MANAGEMENT & CAPA
• Aligned with CAP GEN.13806, GEN.20300 & 42 CFR § 493.1282.
• Structured occurrence reporting, 5-Why Root Cause Analysis (RCA), and 30-day corrective action resolution workflows.
3. SOP-GEN-003: QUALITY MANAGEMENT PLAN & QUALITY INDICATOR MONITORING
• Aligned with CAP GEN.13806, GEN.16902 & 42 CFR § 493.1200.
• Pre-analytic, analytic, and post-analytic indicator tracking, quarterly QM committee review, and annual Director appraisals.
4. SOP-GEN-004: PROFICIENCY TESTING HANDLING & ANTI-REFERRAL OVERSIGHT
• Aligned with CAP GEN.40000, GEN.40100, GEN.40500 & 42 CFR § 493.801.
• Strict prohibition of external referral, routine technologist rotation, attestation countersignatures, and 30-day investigation protocols for scores < 100%.
5. SOP-GEN-005: PERSONNEL COMPETENCY ASSESSMENT (ALL 6 MECHANISMS)
• Aligned with CAP GEN.54400, GEN.54750 & 42 CFR § 493.1413 / § 493.1451.
• Step-by-step procedures to assess and document all 6 CMS/CAP evaluation mechanisms semi-annually (year 1) and annually thereafter.
6. SOP-GEN-006: CHEMICAL HYGIENE, BIOSAFETY & HAZARDOUS WASTE
• Aligned with CAP GEN.70000, GEN.73700, GEN.76100 & OSHA 29 CFR 1910.1450.
• PPE enforcement, Safety Data Sheet (SDS) accessibility, weekly 3-minute eyewash flushing, and biohazard transport manifests.
7. SOP-GEN-007: CRITICAL RESULTS IMMEDIATE NOTIFICATION & READ-BACK
• Aligned with CAP GEN.41316, GEN.41320 & 42 CFR § 493.1291.
• Mandatory 15-minute notification window, verbal read-back verification protocol, and audit logbook documentation.
8. SOP-GEN-008: EQUIPMENT PREVENTIVE MAINTENANCE & CALIBRATION VERIFICATION
• Aligned with CAP GEN.40100, GEN.41200 & 42 CFR § 493.1252 / § 493.1254.
• Routine daily/weekly PM checks, 6-month calibration verification (AMR checks), and continuous storage temperature excursion handling.
9. SOP-GEN-009: LIS DOWNTIME, BUSINESS CONTINUITY & RECOVERY
• Aligned with CAP GEN.43000, GEN.43825, GEN.43900 & 42 CFR § 493.1291.
• Manual requisition workflows, emergency verbal results, and systematic post-restoration data reconciliation.
10. SOP-GEN-010: REFERENCE LABORATORY SEND-OUT & REFERRAL OVERSIGHT
• Aligned with CAP GEN.41350, GEN.41400 & 42 CFR § 493.1242.
• Accreditation verification of referral labs, cold-chain transport tracking, and report transcription auditing.
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SAVE $190: UPGRADE TO THE COMPLETE MASTER SUITE
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Need the complete turnkey compliance infrastructure? Check out our "Complete CAP Inspection Readiness Master Suite" ($397.00), which includes all 10 SOPs PLUS:
• CAP GEN Checklist & Mock Audit Workbook ($149 solo value)
• Inspection Day War Room Protocol & Defense Playbook ($97 solo value)
• 30-Day Phase I & Phase II CAPA Remediation Pack ($99 solo value)
• Inspector Presentation Binder & 6-Tab Divider Print Kit ($49 solo value)
Total Value: $591.00 — Get everything in the master suite and save 33%!
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SPECIFICATIONS & COMPATIBILITY
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• Delivered in 100% Unlocked Microsoft Word (.docx) & Google Docs compatible format
• Fully customizable: simply insert your facility name, CLIA number, and specific analyzer models
• Pre-formatted in standardized CLSI-style headings with built-in Director approval blocks
• Instant Download — Lifetime Access & Updates
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