Book:The Comprehensive Guide to Physician Office Laboratory Setup and Operation

Title: The Comprehensive Guide to Physician Office Laboratory Setup and Operation

Edition: Second edition

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: June 2022

This guide provides an in-depth discussion of the physician office laboratory (POL) and its place in the clinical laboratory world. Though a lot has changed in regards to the POL and the role it plays in clinical testing—including a pandemic—the POL remains an important part of the clinical testing culture today and deserves discussion. This guides discusses that clinical environment, as well as the testing domains typical to the POL, the data management considerations it must make, and the regulatory and quality assurance issues that come with the territory. Also included are a great many useful, POL-friendly resources like CLIA-waived test vendors, education programs for laboratorians, and more.

This second edition, among other things, updates numerous statistics, adds new findings related to POLs, and reorganizes the structure to be more consistent with current LIMSwiki guides. Trends concerning reimbursement for tests, molecular testing, pharmacy labs, and more were added to the guide, as was more up-to-date information about return on investment, data management practices, and quality assurance. All reference resources in the guide were also refreshed for this update to show the latest education programs, CLIA-waived offerings, and more.

(NOTE: The PDF output of this guide fails to properly list the references. To see the original document, with references, see here.)

About this book

Introduction

1. The clinical environment

1.1 The POL as a clinical laboratory

1.2 Good laboratory practices

1.3 Laboratory safety

1.4 Regulatory compliance: HIPAA and PPACA

1.5 Regulatory compliance: CLIA

1.6 Point-of-care testing

1.7 Provider-performed microscopy testing

1.8 CLIA market and industry trends

1.9 Economic issues related to the POL

1.10 Data management

2. Primary laboratory testing domains in the POL

2.1 Urinalysis

2.2 Hematology and blood collection

2.3 Clinical chemistry

2.4 Immunology

2.5 Toxicology and pain management

2.6 Molecular diagnostics

3. Data management

3.1 Workflow and functional requirements

3.2 LIS integration with software and instruments

3.3 Best practices and standard operating procedures

3.4 Other workflow requirements

4. Education, staffing, accreditation, and other considerations

4.1 Education and training

4.2 Educational programs

4.3 Certification and accreditation

4.4 Other considerations for the POL

5. Final thoughts and additional resources

5.1 Final thoughts

5.2 Further reading

5.3 CLIA-waived instrument and test kit vendors

5.4 Other diagnostic instrument and test kit vendors

5.5 Instrument and equipment distributors

5.6 Consultants serving the POL market

5.7 Consumables and supplies used in the POL

5.8 Staffing agencies

5.9 Laboratory billing and revenue enhancement