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Quality Management and Quality Audit According to GxP/GMP Requirements - Webinar

  • ID: 4899768
  • Webinar
  • April 2019
  • Region: Global
  • 90 Minutes
  • Compliance Online
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Why Should You Attend:

CMS created a tag number to house the major section regarding standing order requirements in the medical record chapter under Tag 457. There are a total of four separate sections in the hospital CoP manual that regulate this issue. This has been confusing for hospitals because two of the sections did not link to the other requirements in the CMS manual. CMS also moved most of the standing order requirements from tag 405 into the new section on tag 457. Standing orders must address well defined clinical scenarios. Standing orders related to medications must be approved by the Medical staff and nursing and pharmacy leadership. When CMS rewrote all the radiology standards in July of 2015 and there are many required radiology protocols and policies.

The development of protocols and standing orders is best described as a journey. This online training will provide the history of each of the four sections and what each section requires hospitals to do. This webinar will clarify this confusing area and make the requirements understandable for hospitals. This is especially important as hospitals move toward a complete electronic medical record. It is important that any order in the electronic medical record populate the entire order in the order section.

Areas Covered in the Webinar:

Introduction
What are the CoPs
How to locate a copy of the CoP
Survey and Certification website for changes
Definitions
Joint Commission standards on standing orders
Examples
CMS required radiology protocols
History
History and development
Tag 450 Changes
A new tag number 457 was created
final interpretive guidelines
Tag 457
Use of pre-printed and electronic standing orders, order sets and protocols for patient orders and what criteria is met
Medical staff approval
Orders based on national guidelines and evidenced based practice
New tag number created under tag 457
Tag 405 content moved to 457
Orders and protocols review and approved by the medical staff
Review by hospital’s nursing and pharmacy leadership
Consistency with nationally recognized and evidenced based guidelines
Periodic and regular review of orders and protocols by the Medical Staff and the hospital’s nursing and pharmacy leadership to determine the continuing usefulness and safety of the orders and protocols
Dates, times, and authenticated in the medical record by the ordering physician or another physician who is responsible for the care of the patient
The person signing off the order must be acting according to their scope of practice and in accordance with state law
Tag 405
Most of the sections moved to tag 457
Order needed for all drugs and biologicals
Tag 406
Drugs and biologicals prepared on the orders contained in standing orders, protocols, and electronic standing orders
Vaccines may be administered per physician-approved hospital policy after an assessment of the contraindications (MEC must approve the protocol)
Orders for drugs and biologicals requirements
Order for vaccine must later be signed by the physician
An exception to having the order signed off (dated and timed) is flu and pneumovax
Need to have an order for all drugs and biologicals
Scope of practice issue
CMS Memo on Standing Orders in Hospitals
Documenting as an order in the patient’s chart
Requirements for signing off an order
Requirements for a written set of orders, or is using a preprinted order set
Physician or practitioner must identify the total number of pages
documenting additions to preprinted orders, strike outs or deletions
an electronic signature requirements for electronic orders
State law and scope of practice requirements
Protocols used to standardize and optimize patient care in accordance with clinical guidelines or standards of practice
Implementation of evidenced based protocols or order sets to be used with patients diagnosed with MI, CHF, pneumonia, or who are undergoing certain surgical procedures
Formal protocols with code team or rapid response teams
Pre-printed orders requirements
All orders must be signed off, dated, and timed
Tag 450
All entries in the medical record must be legible and complete
Every entry must be signed, dated, and TIMED
Last page of the order sheet must identify the total number of pages, be dated, timed, and signed off or authenticated
The practitioner must initial every deletion, addition, strike out to preprinted orders.
Same principles apply to electronic order sets as far as signed, dated, and time
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Eleonora Babayants - Founder and President Galaxy Consulting, is a documentation management professional and hands-on consultant with over 25 years of experience in documentation and records management, document control, regulatory compliance, internal and external auditing, electronic document management systems, information governance, and change management.

Eleonora’s past work includes development and implementation regulatory compliance processes and procedures, leading implementation and administration of document control systems in full compliance with regulatory requirements, enabling enterprise search, improving systems information architecture, creating and implementing users training programs.

She led electronic document management systems selection and deployment, administered and supported these systems, web information portals, knowledgebase applications, recommended and implemented re-structuring of the content and the information architecture of these systems. She worked very closely with IT to do feasibility assessment and to capture users’ requirements. She wrote technical documents and created documents templates.

Eleonora’s experience spans multiple industries including biomedical, pharmaceutical, medical devices, food and beverages companies.
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