Module GLP-35 · Version 1.0
Budgeting, Inventory, and Operational Decisions
A guided walkthrough of how a laboratory forecasts test volume, sizes reagent orders, sets a reorder point and safety stock, prices a test with fixed and variable costs, compares owning an instrument to reagent rental, and makes a bounded, defensible decision during a reagent shortage.
Your next section
Start section 1Read without an account. Sign in to save.
Who this module is for
Medical laboratory scientists, laboratory supervisors, and trainees who place or approve reagent and supply orders
Learning objectives
- Distinguish fixed, variable, direct, indirect, capital, and quality costs in a laboratory budget
- Calculate test-level reagent and consumable use and apply reorder-point and safety-stock concepts to an inventory decision
- Evaluate a budget or shortage tradeoff using service, risk, quality, and workforce impact, and recommend a bounded, defensible action
How completion works
Mark every required section done and answer every knowledge check in those sections correctly. The final save completes the module automatically.
Sources
13 sources
1. Clinical Laboratory Improvement Amendments, 42 CFR Part 493, Subparts J ("Facility Administration for Nonwaived Testing," 493.1101), K (general laboratory systems), and M (493.1407, director responsibilities), U.S. Centers for Medicare & Medicaid Services, current eCFR text.
Source note · federal regulation
2. CLSI QMS20, The Cost of Quality in Medical Laboratories, 2nd edition, Clinical and Laboratory Standards Institute, published November 9, 2020.
Source note · consensus standard
3. CLSI QMS21, Purchasing and Inventory Management, 1st edition, Clinical and Laboratory Standards Institute, published November 30, 2016, reaffirmed June 2021.
Source note · consensus standard
4. College of American Pathologists, Laboratory General/Common accreditation checklist requirements on reagent inventory, expiration control, and new-lot/shipment verification, drawn from CAP's publicly posted sample checklist and educational webinar handout material.
Source note · accreditation standard
5. College of American Pathologists, "CAP Publishes Strategies to Mitigate National Shortage of 'Blue Top' Test Tubes," CAP Newsroom, 2021.
Source note · professional society guidance
6. U.S. Food and Drug Administration, Medical Device Shortages List and "Supply and Shortages of Medical Devices: Frequently Asked Questions," Center for Devices and Radiological Health, current pages.
Source note · federal regulation
7. U.S. Food and Drug Administration, Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices, Guidance for Industry and FDA Staff.
Source note · federal regulation
8. U.S. Centers for Disease Control and Prevention, "Lab Alert: Sodium Citrate Blood Specimen Collection Tubes in Short Supply," June 14, 2021.
Source note · federal regulation
9. Becton, Dickinson and Company, BD Vacutainer Blood Collection Tubes Substitutes (US region), manufacturer supply-disruption substitution table, 2021-2022.
Source note · manufacturer labeling
10. Association of Public Health Laboratories, A Practical Guide for Public Health Laboratory Leaders, 2nd edition, 2015, "Administrative Functions in the Laboratory" (financial management, cost categories, budget variance), pp. 14-17.
Source note · professional society guidance
11. NC State Poole College of Management, Supply Chain Resource Cooperative, "Safety Stock Analysis in Inventory Management: A Tutorial."
Source note · peer-reviewed literature
12. U.S. Internal Revenue Service, Publication 946, How To Depreciate Property (2025), for straight-line/MACRS depreciation concepts; general accounting practice for capital-vs-lease cost comparison.
Source note · federal regulation
13. General cost-accounting practice for comparing capital-equipment ownership cost per test against bundled reagent-rental cost per test, consistent with standard managerial-accounting break-even analysis; not a laboratory-specific regulatory source.
Source note · laboratory reference