View source for The Comprehensive Guide to Physician Office Laboratory Setup and Operation/Data management/Best practices and standard operating procedures

===3.3 Best practices and standard operating procedures===
[[File:ISO logo.png|right|200px]]It's not enough for physician office staff to choose and implement information management tools in the practice. Like a stethoscope or a diabetes test kit, information management software is a tool requiring knowledge of how to effectively use and manage it in order to achieve the best results; it won't improve patient and test management all on its own. As such, any physician office or POL adding data management tools should also implement a set of best practices that will better guarantee cleaner, more secure patient and test data. Proper health information management (HIM) practices have the potential to yield higher staff productivity levels, "improve reimbursement by helping create quality records that substantiate the care that physicians bill ... [and] reduce denied claims through better documentation."<ref name="HeubuschPhys08">{{cite journal |url=https://library.ahima.org/doc?oid=82949 |title=Physician Practices and Information Management: HIM Professionals Offer Value in Changing Practices |journal=Journal of AHIMA |author=Heubusch, Kevin |volume=79 |issue=8 |pages=18–22 |year=August 2008 |accessdate=17 May 2022}}</ref>

But who's going to take responsibility for developing and maintaining information management best practices in the physician office and its associated laboratory? In larger POLs, a HIM professional may be dedicated to practice and data management duties.<ref name="HeubuschPhys08" /> However, with 70.6 percent of non-exempt POLs in the U.S. running on a CLIA certificate of waiver<ref name="CMS14Enroll">{{cite web |url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf |format=PDF |title=Enrollment, CLIA exempt states, and certification of accreditation by organization |author=Centers for Medicare and Medicaid Services, Division of Laboratory Services |date=May 2022 |accessdate=17 May 2022}}</ref>, a majority of POLs tend to be quite small, overseen not by a laboratory director but rather a person operating as the practice manager. That may be an office manager or a physician in the practice, who in reality may not have a lot of experience with information management procedures and technologies. As such, an information management system's ease-of-use and dependability is often viewed as vital to POL staff who are only just beginning to learn how to effectively develop and implement an effective information management plan.

Standards like [[ISO 15189]] ''Medical laboratories — Requirements for quality and competence'' suggest the development of standard operating procedures (SOPs) for the laboratory. These SOPs and best practices also apply to the use of information management tools in the POL. As such, it helps to look at the responsibilities that the office manager or physician will have as part of SOP and best practice development. They may<ref name="HeubuschPhys08" /><ref name="SmithImp03">{{cite journal |url=http://www.aafp.org/fpm/2003/0500/p37.html |title=Implementing an EMR System: One Clinic’s Experience |journal=Family Practice Management |author=Smith, Paul D. |volume=10 |issue=5 |pages=37–42 |year=May 2003 |accessdate=17 May 2022}}</ref>:

* document and assess POL and practice workflow;
* select and implement an EHR, LIS, and/or middleware;
* create and maintain health records, including transitioning old data to the new system; 
* manage the creation and implementation of quality system documentation and training material; 
* manage privacy, confidentiality, and sharing policies for test and patient data; and
* manage quality and compliance reporting duties.

These tasks and duties help shape how SOPs for information management are developed. Defining POL and practice workflow before choosing an information management system, for example, helps clarify what system functionality is necessary and how data entry procedures will potentially alter that workflow upon system implementation. Thinking about a practice's existing privacy, confidentiality, sharing, and reporting duties and how they'll be affected by adding information management tools helps drive post-implementation SOP development. 

The practice/data manager requiring additional guidance in developing a POL's data management SOPs may turn to other laboratories' existing SOPs. One such example is Johns Hopkins University's Safety Monitoring in International Laboratories (SMILE) program, which offers at least elementary tools towards developing information management policy in the form of an SOP Checklist.<ref name="MaddenCheck13">{{cite web |url=http://www.niaid.nih.gov/labsandresources/resources/daidsclinrsrch/documents/labstudydata.doc |archiveurl=https://web.archive.org/web/20160105213800/http://www.niaid.nih.gov/labsandresources/resources/daidsclinrsrch/documents/labstudydata.doc |format=DOC |title=Checklist for Site SOP Required Elements: Quality Management Plan |author=Madden, Jaclyn; Hanes, Heidi (ed.) |publisher=Johns Hopkins University |date=18 January 2013 |archivedate=05 January 2016 |accessdate=17 May 2022}}</ref> (Original .doc archived [https://web.archive.org/web/*/http://www.niaid.nih.gov/labsandresources/resources/daidsclinrsrch/documents/labstudydata.doc here]) Pages seven and eight offer insights into information management considerations such as patient confidentiality, electronic information access and use, reporting, results modification, communication of changes, and data storage and integrity. 

Other options for POL staff to gain insight into SOP development include:

* reviewing the chosen data management system's documentation;
* taking certified courses on health information technology, for example through the American Medical Informatics Association (AMIA)<ref name="AMAHIT">{{cite web |url=https://amia.org/education-events/education-catalog/amia-health-informatics-essentials-health-information-systems |title=AMIA Health Informatics Essentials: Health Information Systems |publisher=American Medical Informatics Association |accessdate=17 May 2022}}</ref> (found [https://amia.org/education-events/education-catalog/amia-health-informatics-essentials-health-information-systems here]);
* reading implementation stories from other physician offices and POLs.<ref name="SmithImp03" /><ref name="CongdonThe12">{{cite web |url=https://www.healthitoutcomes.com/doc/the-reality-of-ehr-use-in-the-physicians-practice-0001 |title=The Reality Of EHR Use In The Physicians Practice |author=Congdon, Ken |work=Health IT Outcomes |publisher=Jameson Publishing |date=02 October 2012 |accessdate=17 May 2022}}</ref>; and
* hiring a consultant or part-time HIM professional to fill in knowledge gaps.<ref name="HeubuschPhys08" />