Efficient Clinical Document Management
Simplify your compliance and operations documentation with expert management services
Efficient Clinical Document Management
Simplify your compliance and operations documentation with expert management services
Simplify your compliance and operations documentation with expert management services
Simplify your compliance and operations documentation with expert management services
I'm an ASCP certified Medical Laboratory Scientist with over a decade of experience handling laboratory documentation and quality assurance for all clinical departments. I've worked for hospitals and reference laboratories; creating document solutions tailored to their unique requirements. As a Lean Six Sigma Black Belt, I strive to make all solutions efficient, concise, and easy to implement and maintain.
I offer a comprehensive range of document management services, including standard operating procedures, proficiency testing failure investigation reports, NCA/CAPA, quality control documentation, bench aids, flow charts, and so much more. Since no two labs are exactly the same, all services are custom made to meet the unique needs of each laboratory.
All documents are delivered in standard formats compatible with MS Office software (.docx, .xls, .vsdx, etc.), PDF, and standard image formats (.png, .jpg, etc.)
Using my templates or yours, every document is designed and created with your laboratory's needs in mind. All document are not write protected and are completely modifiable by you if desired. Your company or facility logo is used as needed on every document provided.
From informal how-to guides to CAP-compliant bench references, I can create supplemental information from almost any procedure to make workflow easier and more efficient for your staff.
As laboratories and compliance become more complex, online and cloud-based platforms are becoming the norm. As a trained MediaLab admin, I can turn your stack of package inserts into documents ready for approval by you and your medical director.
Please reach us at chris@clinicallabdocs.com if you cannot find an answer to your question.
Clinical labs of all sizes are subject to the same accreditation requirements regardless of how well staffed the lab is. As a laboratorian, I intimately understand what it's like to have stacks of procedures, logs, competencies, and calibration/QC data to review--while attempting to work the bench at the same time. Clinical Laboratory Documentation Services can handle all the tedious document review so you're free to focus on providing top-quality patient care.
Labs accredited by the College of American Pathologists (CAP) understands COM.10000 (requirement for a procedure manual) and COM.10100 (requirement for procedure review at least every two years). Since facility, equipment, staff, and workflows are unique to each laboratory, every procedure is custom made for the requirements of your lab. From one procedure to an entire procedure manual, I can turn your stack of package inserts into complete procedures ready for submission to laboratory leadership and the medical director. I'm also available for periodic procedure review, so if you get an updated package insert (or it's just due for review), send it to me and I'll handle it for you.
I write all documents with your laboratory in mind. Send me a copy of your template and that's what will get used. Your template, your logo, your documents. If you need your established procedure manual reviewed, I can do that as well and make any changes you require. If you don't have a template, I can use my own or work with you to create one to meet your requirements.
No. Some of the generic wording of procedures can be similar across institutions, but your templates, logos, and other company information are never given out to other clients unless you request it.
Absolutely not! Your documents are your documents. I make every effort to return files in whichever format you request. I typically use MS Office products, so as long as you have the ability to edit those files, you'll be able to make any changes you wish. Flowcharts can be difficult to integrate into procedures in any format other than an image. In all cases where a flowchart or diagram is required, you'll get all .vsdx files along with the images for easy editing in the future.
Yes. I'm a veteran of well over two dozen CAP inspections and know what it's like as an inspector and the one being inspected. All documents are written to comply with all CAP requirements. I'm available to answer any document-related questions or be a second pair of eyes to review things prior to your inspection. My extensive background in QA and compliance also means I'm able to assist with other areas of the inspection process.
I make every effort to get documents returned as soon as possible. Simple procedures can be done in less than 24 hours and more complex ones may take slightly longer. Large jobs like full procedure manuals or quality management plans can vary depending on size and scope. I'm always upfront about time estimates and rush service is available if needed.
I'm not affiliated with MediaLab in any way, however I have several years of experience as a MediaLab admin. I've worked to migrate complete procedure manuals into MediaLab including document linking and approval workflows. With access, I'm able to create manuals, sub-manuals, upload documents, link, and assign them as needed.
No. I do not have the ability to safely handle PHI and request that you do not send it to me. When writing validation summaries, deficiency investigations, or other documents which may include PHI, I ask that you include anonymized data. All documents are returned editable by you, so if you need to include PHI for internal use, you're more than free to add it at that point.
Absolutely. I've written many quality management procedures with the needs of the laboratory in mind. I'll work with you to create custom solutions that work for your laboratory.
If you have absolutely any questions about Clinical Laboratory Documentation Services, feel free to email me at chris@clinicallabdocs.com or fill out the form below and I'll reply promptly!
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