News/Issues

Issues & Legislative Committee Reports

May 14, 2009

Vendor Credentialing / Supplier Access

There are two documents which are new in my monthly search for information related to HCIR Credentialing/Vendor Access and The Joint Commission standards. There has been no change to the standards and the proposed standard, LD.3.40 has not been published. I have included links to the source documents below:

Question related to HCIR Standard posted to the TJC website on April 15, 2009
American Society of Health-System Pharmacists (ASHP) Board of Directors Report for the Council of Pharmacy Management. Select the Board of Directors Reports on Councils under the Action and Agenda Items

Health Care Industry/Vendor Representatives
April 15, 2009

Q. Does The Joint Commission have requirements related to credentialing health care industry/vendor representatives who are involved in care, treatment, and services provided by professional staff in accredited health care organizations?

A. The Joint Commission does not have any standards that specifically address health care industry/vendor representatives who are involved in care, treatment, and services provided by professional staff in accredited health care organizations. This is due to the fact that at this time there are no accepted national standards on competence for the tasks performed by these health care industry/vendor representatives. Currently, there is also no specific licensure, certification, or registration for health care industry/vendor representatives who are involved in care, treatment, and services provided by professional staff in accredited health care organizations.

There are several Joint Commission standards that are relevant to any individual that enters a health care organization who directly impacts the quality and safety of patient care. In order to protect patient safety, accredited health care organizations need to be aware of who is entering their organization and what these individuals are doing in their organization (EC.02.01.01). Accredited health care organizations need to take steps to ensure patient rights are respected (RI.01.01.01), and that infection control precautions (IC.02.01.01) and other organization-specific policies and procedures are followed.

Additionally, The Joint Commission has several standards related to anyone who can impact the quality and safety of patient care; many of which are located in the Leadership chapter. Some of the requirements located in the Leadership chapter are LD.03.06.01 EP4 (competence of anyone who works in the organization), LD.04.01.05 EPs 1 and 3 (leaders oversee operations, and administrative and clinical direction responsibilities are defined), and LD.04.04.05 EPs 1, 3, and 4 (the development and implementation of a patient safety program).

Although The Joint Commission does not have any specific credentialing requirements for health care industry/vendor representatives who are involved in care, treatment, and services provided by professional staff, please note that some professional organizations are recommending general credentialing requirements for these individuals. For more information, you may want to contact AdvaMed whose website is www.advamed.org.

Quality / Medication Errors / Safety Issues

Quality:

“FDA to review medical devices marketed prior to 1976”
Healthcare Purchasing News, May 2009, pg. 6

The FDA announced that manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and effectiveness information to the agency so that it may evaluate the risk level for each device type. Devices found by the FDA to be of high risk to consumers will be required to undergo the agency’s most stringent premarket review process.

These 25 device types, which are listed in the Federal Register announcement, were marketed in the U.S. prior to the Medical Device Amendments to the FDA Act of 1976. That law authorized the FDA to review new medical devices. This announcement is the first step towards completing the review of Class III devices types predating the 1976 law, as was recommended by the U.S. Government Accountability Office (GAO) in a January 2009 report to Congress. Class III devices represent the highest level of risk and generally require a showing of safety and effectiveness before they may be marketed. These include: heard valves and intraocular lenses. After 1976, the FDA classified these 25 device types into Class III (premarket approval). Under the law, these devices were not immediately required to undergo the premarket approval process. The law required the FDA to issue a rule subjecting the devices to that requirement. Until that time, new devices within those device types have been cleared through the premarket notification process, in which the agency determines whether they are substantially equivalent to legally marketed devices not requiring premarket approval.

Devices that present a new intended use or include new technology that presents new questions of safety or effectiveness may not be found substantially equivalent and require premarket approval. Manufacturers of the 25 remaining devices types must submit the requested information within 120 days to the FDA, for review. Regulations will be issued for each device type that either will require manufacturers to submit premarket applications or will re-classify the devices into Class I or Class II.

http://edocket.access.gpo.gov/2009/pdf/E9-8022.pdf

http://www.fda.gov/bbs/topics/NEWS/2009/NEW0 1990.html

“APIC supports coalition to improve healthcare quality”
Healthcare Purchasing News, May 2009, pg. 6

APIC announced its support of Stand for Quality, a diverse coalition of more than 165 healthcare organizations who recently announced a plan to improve the quality and affordability of healthcare for all patients through a public-private partnership (www.standforquality.org).

Since 2006, APIC has been promoting a Targeting Zero philosophy – the viewpoint that every healthcare institution should be working toward a goal of zero HAIs. While not all HAIs are preventable, APIC believes that all organizations should strive for zero infections.

“Dennis Quaid opens HIMSS with medication errors reality talk”
Healthcare Purchasing News, May 2009, pg. 6

Actor Dennis Quaid focused on his recent experience with medication errors at HIMSS. Quaid was the featured keynote speaker, Sunday, April 5. Quaid told his emotional story about the medication errors that almost killed his twin babies at Cedars Sinai Hospital. After his twins were born, they were diagnosed with an infection and their doctor put them in the hospital on IV antibiotics. When changing the IV solution, the nurse in charge gave the twins 10,000 USP of Heparin instead of 10 USP Hep-Loc. A group of nurses the following morning made the same error. Quaid blames the manufacturer on not differentiating the bottles and labels which were almost identical. He also blamed the fact that it got past the pharmacy and nurse double check systems. He says what is needed is a “hospital technological backup” that would protect from human factors that cause errors in the event that human checklists were ignored. Quad and his wife have started the Quaid Foundation to reduce medical error. Since the errors occurred at Cedars, the hospital has adopted bar-coding, special pharmaceutical cabinets and other safety measures. HIMSS has donated $10,000 to their foundation to help facilitate safety measures. Quaid ended his talk by saying the next step for healthcare should be to make all of these system interoperable and that systems must be uses friendly. He stated that we need to make bar-coding, CPOE and electronic record keeping common in hospitals.

Supply Chain Standards – GS1/HSCSC

AHRMM continues to support GS1 standards for the healthcare supply chain and has representation on all of the workgroups including the Global Location Number (GLN) Work Group, the Global Trade Item Number (GTIN) Work Group, the Global Data Synchronization (GDSN) Work Group, the Traceability Work Group, the Adoption and Implementation Work Group, and the GS1 Healthcare US Leadership Team. The Leadership Team and GLN and GTIN work groups continue to work to ready the industry for adopting universal data standards and eliminating custom account numbers by 2010 (GLN) and custom product numbers by 2012 (GTIN). The plan involves the adoption of the GLN for standardized account/location identification and the GTIN® for standardized product identification by all healthcare providers and suppliers. This industry-wide initiative to adopt GS1 standards for account/location and product identification will help to ensure that the correct products are delivered to correct locations at the correct time – creating a safer, more efficient, and less expensive supply chain. The Adoption and Implementation Work Group are in the final stages of creating a C-Suite collateral piece that presents the benefits of data standards at a high level to assist with the “top down” approach to getting the standards adopted by healthcare providers. In addition, GS1 Healthcare and GS1 Healthcare US worked on joint comments and submitted a response to the FDA’s request for comments on the Draft Guidance for a Standardized Numerical Identification (SNI) / a unique (serialized) identifier for pharmaceuticals.The next GS1 Healthcare US Work Group Forum is scheduled for October, however work groups meet by phone on a weekly basis.