News/Issues

Issues Legislative Committee Meeting

March 12, 2009

Association & Board Update

The group reviewed the AHRMM Board Meeting Overview from the February 7 meeting.

The Board Members introduced themselves since this was the first board meeting of the year and there are 4 new board members at the table.
AHRMM President Jay Kirkpatrick gave a presentation focused on AHRMM's strategic priorities which include supply chain standards, SCMetrix(tm), networking and engaging healthcare supply chain executives, and educating members in supply chain excellence.
AHRMM presented a 2009 Contingency Budget due to the economic climate to address the projected decrease in revenue from attendance and participation in education programs and the expected expense reduction.
American Hospital Association (AHA) Vice President of the Professional Membership Groups (PMGs) gave a presentation on the AHA structure, the PMG structure, and two of AHA's top initiatives Health For Life and the Pursuit of Excellence.
The AHRMM Board reviewed the Strategy Map to ensure the association is moving in the right direction. As a group, the board agreed to continue with the Strategy Map and that the process of strategic planning should not be viewed as an event that takes place ever three years but as a dynamic process.
The AHRMM Board spent time discussing the current economy and how that will impact healthcare supply chain professionals and will present a White Paper addressing the economy and steps a supply chain professional can take by the end of February.
The AHRMM Board discussed the Certified Materials & Resource Professional program and the benchmarking project SCMetrix(tm) and the importance of both to the membership and industry as a whole. Both initiatives need the support of the membership and the industry to be successful.
The Executive Director presented an association and financial report. The 2008 Financial Report will be available on the AHRMM website in late March.
The meeting ended with Jay Kirkpatrick's closing remarks.

AHRMM, W.P. Carey School of Business release SCMetrix™
AHRMM Association for Healthcare Resource & Materials Management (Chicago, IL) and the W.P. Carey School of Business at Arizona State University released the first SCMetrix™ dashboards for participating hospitals. The online tool was developed in response to the healthcare industry’s request for a benchmarking program that would allow hospitals to benchmark their supply chain performance against other like facilities that are similar in size, scope of service, procedure, geographic location, and more, within and outside of their own system. For more information on SCMetrix, visit www.scmetrix.org or www.ahrmm.org.

FDA's UDI initiative
I’m sure you are wondering what AHRMM has been doing in regards to the FDA's UDI initiative and call for response. Click here for the AHRMM response, and a response from the APSC.

The Unique Device Identifier mandate is gaining traction. AHRMM, the American Hospital Association (AHA), and the Advancing Patient Safety Coalition, support the UDI and the use of GS1 Healthcare US Global Location Number (GLN) and GTIN (Global Trade Item Number (GTIN) as the means to achieve this mandate.

Please feel free to share these documents , or discuss them with our NESHMM members at the educational meeting this month, and, or post them on the NESHMM website. AHRMM and its leadership team members have been vocal proponents and actively engaged in the development and implementation of the GS1 standards with the desired aims of improving patient safety and streamlining our supply chain services operations.

Vendor Credentialing / Supplier Access

This opening page of this report is basically a repeat of my initial report from back in 2008. The healthcare industry continues to wait for the TJC release of a standard on Credentialing of Industry Representatives/Vendor Representatives. This continues to be a topic seen in healthcare industry publications and even on our AHRMM ListServe. The current Standard from The Joint Commission, E.C.2.10, requires hospitals to “identify and manage its security risks”. As providers, this standard continues to be one of our main reasons for putting in place some type of credentialing/tracking process, internally or through an outsourced company. We continue to hear that this standard will be addressed more specifically to IR’s by The Joint Commission in the 2009 however until then we are tasked with compliance based on the interpretation of this standard by our industry. I have included the TJC Standard below;

Joint Commission Standard EC.2.10

The hospital identifies and manages its security risks.

Rationale for EC.2.10

It is essential that a hospital manages the physical and personal security of patients, staff (including the potential for violence to patients and staff in the workplace), and individuals coming to the hospital’s buildings. In addition, security of the established environment, equipment, supplies, and information is also important.

Elements of Performance for EC.2.10

The hospital develops and maintains a written management plan describing the processes it implements to effectively manage the security of patients, staff, and other people coming to the hospital’s facilities.
The hospital identifies a person(s), as designated by leadership, to coordinate the development, implementation, and monitoring of the security management activities.
The hospital conducts proactive risk assessments that evaluate the potential adverse impact of the external environment and the services provided on the security of patients, staff, and other people coming to the hospital’s facilities.*
The hospital uses the risks identified to select and implement procedures and controls to achieve the lowest potential for adverse impact on security.
The hospital identifies, as appropriate, patients, staff, and other people entering the hospital’s facilities.
The hospital controls access to and egress from security-sensitive areas, as determined by the hospital.
The hospital identifies and implements security procedures that address actions taken in the event of a security incident.
The hospital identifies and implements security procedures that address handling of an infant or pediatric abduction, as applicable.
The hospital identifies and implements security procedures that address handling of situations involving VIPs or the media.
The hospital identifies and implements security procedures that address vehicular access to emergency care areas.

The AHRMM ListServ continues to provide a place for discussions related to this as well as other current issues and we would encourage subscribing to this useful ListServe. For this months March update, I have included links below to recently published information, which have varied points of view related to this topic and the TJC standard. (I apologize for the extensive use of links however the ability to copy and republish these article’s without the site’s permission can be difficult to determine so please access them by the links) My recent Google search found these articles related to Healthcare Industry Representative Credentialing:

Check out an article in the November 2008 AORN Connections titled;Exploring a shared solution, AORN is working with industry, hospitals, medical associations and accrediting organizations to develop ways to improve the credentialing process for healthcare industry representatives by Carina Stanton Senior News Editor.
An interesting “White Paper” published by HCPro.com from ePharmaceuticals which is described as the Life Sciences division of HCPro, the nation’s leading provider of integrated information, education, training, and consulting services in the healthcare regulatory and compliance arenas. It is from December 2008 and discusses the credentialing and speaks to the burdensome and inconsistent vendor access policies and the vast amounts of time and money being spent in an attempt to keep up with the myriad demands from hospitals around the country.
The NCI GPS January 2009 Newsletter article which represent’s a Distributor’s perspective of the impact the vendor credentialing requirements are having on this segment of the healthcare industry.
This additional link is from the same NCI site; however it is from a GPO perspective written by Dee Ann Cross - Director, Operations - Novation LLC.
Lastly, for those who haven’t seen this I have included this link to the AvaMed’s (Advanced Medical Technology Association) comment to The Joint Commission regarding the proposed standard on Health Care Industry Representative credentialing.

Technology / Merging Technologies Impact

Healthcare Innovation and Technology Congress

Connect with renowned health care and technology leaders in an interactive setting to discover how your organization can evolve in an ever-changing information age. The 5th Annual World Healthcare Innovation and Technology Congress (WHIT v.5.0) addresses precedent issues facing the industry today in regards to the future information technology to engage providers, payers and consumers in the next generation of health care delivery.

WHIT v.5.0 not only gathers thought leaders in this space to speak and to share their stories, but also provides delegates with networking opportunities through interactive discussions within the agenda and informal meetings during gala receptions and invitational dinners.

Just announced: Over the last three years, the World Health Care Congress Leadership Summit Series successfully hosted the Leadership Summit on The Road to Interoperability. Annually, the Summit addressed the role of interoperability to solve issues regarding patient safety, clinical quality, access to care, privacy, investment and ROI. Due to popular demand, the Summit will be combined with WHIT v.5.0 to provide an opportunity for delegates to attend ONE meeting to gain all the knowledge needed to understand the health care IT space.

Issues under development for WHIT v.5.0:

Eye on the prize: President Obama's health care initiatives for wireless nation
Understanding the 3 IIIs: Informatics, Innovation, Interoperability
The Expansion of the Connectivity and New Media Movement: Where does your organization fit?
Military health and its relation to the health information technology movement
Understanding open source and why it matters sooner rather than later

To secure your seat, register now or sign up to receive a printed brochure

Call for Papers: Submit Abstract for Presentations

The 5th Annual World Healthcare Innovation and Technology Congress (WHIT v.5.0) is now accepting abstract submissions for 2009! Submissions should be sent no later than Friday, March 29, 2009. Click here for details.

Survey Info: http://www.zoomerang.com/Survey/?p=U2BNUJQANEUF

Tissue Tracking Takes on New Interest at Joint Commission

Since enacting the tissue standards in July 2005, Joint Commission has been increasing the rigor of the standards. Effective Jan. 2009, Joint Commission pulled the tissue standards out from the huge Provision of Care (PC) and Quality Control (QC) chapters in the Accreditation Manual and created the new Transplant Safety chapter. Coupled with unannounced surveys, this action will certainly standardize the surveying process relative to the tissue standards and increase scrutiny on hospitals’ adherence to the tissue standards because the surveyors now must evaluate tissue management.

Biomedical Synergies, Inc.’s TRACS4Life™ software uses manufacturers’ barcodes to track and trace human tissue products through a hospital’s supply chain. This data entry into a centralized database allows for extensive reporting that manual systems do not. This reporting is essential for patient safety, Joint Commission compliance, and reduction of hospital liability.

As an update, a new feature of TRACS 4 Life™ will provide notification of tissue and implant recalls directly in the program. This recall notification feature prevents delays in the appropriate departmental notification and allows for proper handling of manufacturers’ recalls, both of which helps to ensure that affected inventory is pulled immediately and that affected patients are notified promptly.

Smart Phone for patients and Docs

Special iPhone/iTouch application helps busy patients remember to take medications; provides vital info for physicians

Indianapolis-based Community Health Network launched its “ myCommunity Pillbox” application for the Apple iPhone and iTouch at the 2nd Annual Leadership Summit on Consumer Connectivity this February 23-24 in Carlsbad, Calif., showcasing an innovative, user-friendly method for patients to manage medications and important medical information.

Mesh manufacturers go Au Natural….

In February a member asked this question…. Saw the announcement this week.

There seems to be a lot of interest fom Docs, and all of the major mesh manufactuers are selling these products, none of which are on contract with GPOs

There are currently several “biologic” meshes available for hernia repair on the market. When I first started, I think there were only two and now there are at least 7. I anticipate that over the next few years, the chatter in the market will increase. There are almost no head-to-head comparison studies and certainly no large, randomized studies. Therefore, it is extremely difficult for the surgeon to make a decision as to which mesh is the appropriate mesh. To make it even more complicated, there is a huge cost variation between the available options. I have had an interest in this for years and that is why I have decided to collect as much information as I can, try to assimilate it in an understandable fashion, and present it to the surgeons using these meshes. Below I have listed the meshes that I know of, the company that sells it, the source of tissue, whether or not the collagen is cross-linked, and whether or not the product needs to be hydrated.

Other information that I am gathering is: sizes available, cost per cm2, shelf life, storage requirement, length of time on market, number of human studies, length of follow-up time, operative findings at reoperation (ie adhesions, etc), wound complication, etc. If you can think of some other information that I should be collecting, please email me. Also, if you know of other biologics on the market for hernia repair, please email the name.

Product name	company	source	cross-linked	need to hydrate
Surgisis	Cook	porcine	yes	yes
Alloderm	LifeCell	human	no	yes
Strattice	LifeCell	porcine	no	?
Permacol	Covidian	porcine	yes	no
FlexHD	Ethicon	human	no	no
Allomax	Bard	human	yes	yes
Collamend	Bard	porcine	yes	yes

Biomerix receives FDA clearance for REVIVE

Biomerix Corporation (Fremont, CA) received FDA (Rockville, MD) 510(k) clearance to market REVIVE™, used for soft tissue repair procedures, including the repair of inguinal hernias. REVIVE is constructed from Biomerix Biomaterial™ and acts as a tissue scaffold to help reinforce and support the surrounding tissue. The product also minimizes the scarring response that results from implantation of a mesh, which sometimes leads to persistent groin pain in some patients.

San Antonio Community Hospital deploys Leksell Gamma Knife

San Antonio Community Hospital (Upland, PA) deployed the Leksell® Gamma Knife Perfexion™, manufactured by Elekta AB (Norcross, GA). The alternative to traditional open-brain surgery and daily radiation treatment delivers focused doses of radiation without an incision and is used to treat brain tumors and other brain disorders.

No, it’s not a space heater. This device is a Room Sterilizer.

TRU-D

MercyHospitalFolsom acquires TRU-D advanced germicidal technology

After its participation in a pilot study to test TRU-D Rapid Room Sterilizer, an advanced automated disinfection device, Mercy Hospital of Folsom (Folsom, CA) adopted the disinfection protocol. The TRU-D Rapid Room Sterilizer, manufactured by Lumalier Corporation (Memphis, TN), uses a measured dose of intense germicidal UV energy to sterilize the host environment. Mercy expects that a more thorough disinfection process will reduce environmental reservoirs of infectious pathogens, thereby lowering the risk of hospital acquired infections. More information is available at www.lumalier.com.

New Anto Microbial dressing gets fast tracked by FDA

Quick-Med Technologies (Boca Raton, FL) received FDA marketing approval to sell the NIMBUS barrier gauze wound care dressing, developed by scientists at the University of Florida (Gainesville, FL). The NIMBUS dressing was approved using a rare FDA clearance process used only for medical devices for which there is no existing equivalent FDA-cleared wound dressing. The antimicrobial agents remain permanently bonded to the gauze, allowing the dressing to retain its antimicrobial properties and to prevent bacteria from migrating back into the wound.

New Cancer Detection Imaging System Approved

SpectraScience (San Diego, CA), a manufacturer of medical devices, received FDA (Rockville, MD) clearance to manufacture its LUMA® Cervical Cancer Imaging System. The noninvasive LUMA Cervical Imaging System is used on tissue samples to determine within seconds the presence of normal, pre-cancerous, or cancerous cells, significantly improving detection of high-grade pre-cancerous cervical abnormalities that could become invasive cancer.

Quality / Medication Errors / Safety Issues

Medication Errors:

"Five Steps to Prevent deadly IV medication errors" , Hospital and Health Networks, February 2009, pg 490.

Intraveneous medication errors are twice as likely to cause harm to patients as medicatins administered as tablets or liquids. This is according to the American Society of Health-System Pharmacists. A consortium of healthcare organizations identified best practices for IV use and short-and long-term recommendations (December 2008). The following recommendations are for the next one to three years and include:

Universally standardizing concentrations of "high-alert" IV medications (those most likely to cause harm if an error occurs).
Streamlining the process to being ready-to-administer standardized infusion concentrations to market.
Using "intelligent" IV pumps (those with safety features that help prevent unsafe rates and doses.)
Making the business case for IV safety to hospital leadership.
Establishing multidisciplinary medication safety committees in hospitals to address the prevention of IV medication errors.

Safety:

"APIC program strives to halt unsafe needle practices" , Materials Management in Healthcare, February 2009, pg 3-4

The Association for Professionals in Infection Control and Epidemiology (APIC) is setting its signs on needle safety, in the wake of evidence about increasing risk of hepatitis from unsafe needle use. The January 2009 "Annals of Internal Medicine" identified 33 injection-related outbreaks of hepatitis B or C in U.S. outpatient clinics during the past 10 years.APIC will provide educational materials and infectino control expertise for HONOReform, a national coalition formed to help stop unsafe needle practices in outpatient centers. HONOReform was founded by a breast cancer survivor who received chemotherapy at an ambulatory care center and was infected with Hepatitis C because the clinic reused syringes. Because of the increasing number of patients being seen in outpatient settings, more will be put at risk unless clinicians are educated and consistently adhere to infection prevention measures. Clinics should also be concerned about the new and more virulent pathogens such as MRSA.

FDA Reviews / Government Updates

On health care reform, the American people are too often offered two extremes -- government-run health care with higher taxes or letting the insurance companies operate without rules. President Obama and Vice President Biden believe both of these extremes are wrong, and that’s why they’ve proposed a plan that strengthens employer coverage, makes insurance companies accountable and ensures patient choice of doctor and care without government interference.

The Obama-Biden plan provides affordable, accessible health care for all Americans, builds on the existing health care system, and uses existing providers, doctors, and plans. Under the Obama-Biden plan, patients will be able to make health care decisions with their doctors, instead of being blocked by insurance company bureaucrats.

Under the plan, if you like your current health insurance, nothing changes, except your costs will go down by as much as $2,500 per year. If you don’t have health insurance, you will have a choice of new, affordable health insurance options.

Make Health Insurance Work for People and Businesses -- Not Just Insurance and Drug Companies.

Require insurance companies to cover pre-existing conditions so all Americans regardless of their health status or history can get comprehensive benefits at fair and stable premiums.
Create a new Small Business Health Tax Credit to help small businesses provide affordable health insurance to their employees.
Lower costs for businesses by covering a portion of the catastrophic health costs they pay in return for lower premiums for employees.
Prevent insurers from overcharging doctors for their malpractice insurance and invest in proven strategies to reduce preventable medical errors.
Make employer contributions more fair by requiring large employers that do not offer coverage or make a meaningful contribution to the cost of quality health coverage for their employees to contribute a percentage of payroll toward the costs of their employees' health care.
Establish a National Health Insurance Exchange with a range of private insurance options as well as a new public plan based on benefits available to members of Congress that will allow individuals and small businesses to buy affordable health coverage.
Ensure everyone who needs it will receive a tax credit for their premiums.

Reduce Costs and Save a Typical American Family up to $2,500 as reforms phase in:

Lower drug costs by allowing the importation of safe medicines from other developed countries, increasing the use of generic drugs in public programs, and taking on drug companies that block cheaper generic medicines from the market.
Require hospitals to collect and report health care cost and quality data.
Reduce the costs of catastrophic illnesses for employers and their employees.
Reform the insurance market to increase competition by taking on anticompetitive activity that drives up prices without improving quality of care.

The Obama-Biden plan will promote public health. It will require coverage of preventive services, including cancer screenings, and increase state and local preparedness for terrorist attacks and natural disasters.

A Commitment to Fiscal Responsibility: Barack Obama will pay for his $50 - $65 billion health care reform effort by rolling back the Bush tax cuts for Americans earning more than $250,000 per year and retaining the estate tax at its 2009 level.

Supply Chain Standards – GS1/HSCSC

GS1 Healthcare US hosted a workgroup meeting in early March. There are workgroups for each of the GS1 standards (GLN, GTIN, GDSN) as well as a Traceability workgroup. AHRMM is represented on each of the workgroups. Progress reports were given on the adoption efforts going on and the proposed sunrise dates for GLN and GTIN. GS1 Healthcare US continues to periodically host a free “Basics” session via webinar to help providers become better acquainted with the standards. AHRMM promotes these webinars and has them listed on the website. Also, the provider toolkit is available for download, visit http://www.ahrmm.org/ahrmm_app/ext/standards/ to get a copy.