Difference between revisions of "LII:The Comprehensive Guide to Physician Office Laboratory Setup and Operation/Education, staffing, accreditation, and other considerations"

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===General staffing and education===
===General staffing and education===
Subpart M of the [[Clinical Laboratory Improvement Amendments]] (CLIA) details requirements and responsibilities for laboratory personnel, consultants, supervisors, and directors.<ref name="CLIARegsM">{{cite web |url=http://www.ecfr.gov/cgi-bin/text-idx?SID=f1d85c34dbb66a6dd7f7821c3c4f99f6&mc=true&node=pt42.5.493&rgn=div5 |title=Title 42: Public Health, Part 493 — Laboratory Requirements |publisher=U.S. Government Publishing Office |date=03 August 2015 |accessdate=05 August 2015}}</ref> The exception to this is a laboratory with a certificate of waiver, where personnel requirements and proficiency testing is not required. However, manufacturers' instructions must still be carefully followed, and only CLIA-waived tests may be performed by the personnel.


For non-waived laboratories, the following resources provide paraphrasing of [http://www.ecfr.gov/cgi-bin/text-idx?SID=f1d85c34dbb66a6dd7f7821c3c4f99f6&mc=true&node=pt42.5.493&rgn=div5#sp42.5.493.m CLIA Subpart M]:
* [http://www.aafp.org/practice-management/regulatory/clia/personnel.html American Academy of Family Physicians - Personnel Requirements]
* [http://www.aafp.org/practice-management/regulatory/clia/personnel.html American Academy of Family Physicians - Physician Office Laboratory (POL) Director Duties]
* [https://clients.cola.org/files/pdf/LabGuide4.pdf Commission on Office Laboratory Accreditation (COLA) - Personnel for Non-waived Testing] (PDF)
* [http://www.laboratorystartupconsultants.com/#!laboratorystatelicense/c14ce Laboratory Start-Up Consultants - Laboratory State License and Personnel & Facility License Info]
In some cases, state governments apply additional regulations and responsibilities to clinical laboratories and their personnel. According to consultancy Laboratory Start-Up Consultants, the following states have staffing, education, and licensing requirements beyond that of CLIA<ref name="LSUCLic">{{cite web |url=http://www.laboratorystartupconsultants.com/#!laboratorystatelicense/c14ce |title=Laboratory State License - Personnel & Facility License Info |publisher=Lighthouse Recruiting, LLC |accessdate=05 August 2015}}</ref>:
* California: [http://www.cdph.ca.gov/programs/lfs/Pages/default.aspx Department of Public Health - Laboratory Field Services]
* Connecticut: [http://www.ct.gov/dPh/cwp/view.asp?a=3115&q=468182 Department of Public Health - Regulation & Licensure]
* Florida: [http://floridasclinicallabs.gov/licensing/ Board of Clinical Laboratory Personnel - Licensing] and [http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Laboratory_Licensure/index.shtml Agency for Health Care Administration - Laboratory Licensure Unit]
* Georgia: [https://dch.georgia.gov/healthcare-facility-regulation-0 Georgia Department of Community Help - Healthcare Facility Regulation]
* Hawaii: [http://health.hawaii.gov/statelab/ Department of Health - State Laboratories Division]
* Louisiana: [http://www.lsbme.la.gov/licensure/clinical-laboratory-personnel State Board of Medical Examiners - Clinical Laboratory Personnel]
* Montana: [http://bsd.dli.mt.gov/license/bsd_boards/cls_board/board_page.asp Department of Labor and Industry - Montana Board of Clinical Laboratory Science Practitioners]
* Nevada: [http://dpbh.nv.gov/Reg/MedicalLabs/Medical_Laboratories_-_Home/ Nevada Division of Public and Behavioral Health - Medical Laboratory Services]
* New Jersey: [http://www.nj.gov/health/phel/ Department of Health - Public Health and Environmental Laboratories]
* New York: [http://www.wadsworth.org/labcert/clep/clep.html Department of Health - Clinical Laboratory Evaluation Program] and [http://www.op.nysed.gov/prof/clt/ Education Department - Clinical Laboratory Technology]
* North Dakota: [http://www.ndclinlab.com/ North Dakota Board of Clinical Laboratory Practice]
* Rhode Island: [http://www.health.ri.gov/licensing/healthcare/#clincallab Department of Health - Healthcare Licensing]
* Tennessee: [http://tn.gov/health/topic/ML-board1 Department of Health - Medical Laboratory Board]
* Washington: [http://www.doh.wa.gov/LicensesPermitsandCertificates/FacilitiesNewReneworUpdate/LaboratoryQualityAssurance Department of Health - Laboratory Quality Assurance]
* West Virginia: [http://www.dhhr.wv.gov/healthprep/programs/laboratory/Pages/default.aspx Department of Health and Human Resources - Office of Laboratory Services]
==References==
<references />


===List of certification programs===
===List of certification programs===

Revision as of 20:48, 5 August 2015

Operation of a physician office laboratory (POL) requires expertise, just like any other laboratory. But how should they be staffed, and what sort of education requirements should the staff have? This chapter addresses those questions and also provides additional resources for staffing a POL.

This sixth chapter on the topic of staffing and education has five sections.

-----Return to the beginning of this guide-----

6. Staffing and Education Requirements

General staffing and education

Subpart M of the Clinical Laboratory Improvement Amendments (CLIA) details requirements and responsibilities for laboratory personnel, consultants, supervisors, and directors.[1] The exception to this is a laboratory with a certificate of waiver, where personnel requirements and proficiency testing is not required. However, manufacturers' instructions must still be carefully followed, and only CLIA-waived tests may be performed by the personnel.

For non-waived laboratories, the following resources provide paraphrasing of CLIA Subpart M:

In some cases, state governments apply additional regulations and responsibilities to clinical laboratories and their personnel. According to consultancy Laboratory Start-Up Consultants, the following states have staffing, education, and licensing requirements beyond that of CLIA[2]:

References

  1. ↑ "Title 42: Public Health, Part 493 — Laboratory Requirements". U.S. Government Publishing Office. 3 August 2015. http://www.ecfr.gov/cgi-bin/text-idx?SID=f1d85c34dbb66a6dd7f7821c3c4f99f6&mc=true&node=pt42.5.493&rgn=div5. Retrieved 05 August 2015. 
  2. ↑ "Laboratory State License - Personnel & Facility License Info". Lighthouse Recruiting, LLC. http://www.laboratorystartupconsultants.com/#!laboratorystatelicense/c14ce. Retrieved 05 August 2015. 

List of certification programs

List of organizations and professional certifications

List of educational programs

List of staffing agencies

References


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