Validating Autologin....

Issues & Legislative Committee Report

May 2004

JCAHO Update

An audio conference was held on 3/17 with three hospitals talking about having recently gone through the JCAHO survey. The presenters said it was a process-oriented, five day survey and less focused on actual errors. Survey results are stressing standards compliance as opposed to a final score. (JCAHO is doing more of a pass/fail now.) They have a healthcare staffing certification program that was approved in 11/2003.

Of JCAHO's seven National Patient Safety Goals, #5 Infusion Pumps and #6 Alarm Systems are the two areas that will be more focused on the materials management end.

Group Purchasing Organizations (GPO)/Code of
Conduct Principles

HIGPA just endorsed the Global Location Number (GLN) supported by the Coalition for Healthcare eStandards (CHeS) and introduced by the Uniform Code Council (UCC).

Single-Use Devices

Needlesticks, Needlesafe Devices - The ECRI has a 2nd edition reference available on needlestick devices/sharp safety, which is available at www.ecri.org.

Disaster Preparedness

There was AHRMM representation at a Medical Materiel Coordinating Group (MMCG) created by Health & Human Services and facilitated by MITRE, a federally funded research and development center. The MMCG was created to: define information that is mutually beneficial to share, establish a communications process, and establish an emergency operations process by bringing together the government and the private sector (including distributors, manufacturers, and materials managers). AHRMM's participation would support our Materials Managers by providing educational and reference research for professionals working on their facilities disaster plan or working with the local community.

eCommerce/Bar Coding

On February 26, 2004, the FDA published (in the Federal Register) and made final their '”ar Code Label Requirement for Human Drug Products and Blood” for those items used in direct patient care in the acute care setting. Sixty (60) days hence, the regulation will go into effect, April 26, 2004. For existing FDA-approved products, there is a two-year compliance period, but for newly approved products (FDA-approved after 4/26/04), the compliance period is shortened to 60 days from date of FDA product approval.

A big concern by many is that the regulation stopped short of requiring the inclusion of lot number and expiration date on bar coded products. But, in the marketplace, many companies are making plans to embed that data into their bar codes and thereby give themselves a competitive edge. "It is eventually going to be required" is the generally accepted opinion. For Materials Managers, very little affect will be noticed immediately on the way they do business. However, it will affect the pharmacies and labs. In the not too distant future, we will probably see addendums to this regulation or subsequent stand-alone, but related regulations, that will require on nearly all products used in patient care (and especially sterile products) a bar code at the lowest unit of measure; that which is the unit of 'use' on a patient.

Radio Frequency Identification (RFID)

DoD will require RFID tags on items at the pallet and case level, and on individual items valued over $5,000 beginning January 1, 2005. In October 2004, they will send out new contract language for incorporation into all new contracts and existing contracts which will require this tagging. 

DoD is leading an intra-governmental council on RFID standardization. The goal is to have a single standard within the federal government which will help drive standardization in the civilian sector as well. The fear is that we don't want one standard at DoD and another at Department of Energy or Agriculture.

On the civilian sector side, it seems Accenture is leading the effort with several pilot programs. Most currently seem to be focused on pharmaceuticals looking at lot, batch, expiration information, shipping/receiving info, returns processing, and product security and consumer safety. Pharmaceuticals seems to be the initial focus of RFID where counterfeiting is prevalent.

There are two main identification methods called UID (Unique Identification) and EPC (Electronic Product Code). Most commercial items will have an EPC on them, but many unique DoD non-commercial may only have an UID. There is work underway to be sure that EPC and UID can be read by the same scanner. It has to do with length of field and encryption levels, but the DoD lead Mr. Alan Estevez has pledged they will work to make the system compatible.

Safety Issues

The Institute for Safe Medication Practices reports that, according to a survey released in March 2004, perceived intimidation in the workplace could lead to situations that compromise patient care. The survey respondents were mainly nurses and pharmacists who stated they believe they are ignored or verbally abused by physicians and their peers. As a result, respondents said, they are more likely to not question a physician's order, avoid interacting with an intimidating prescriber, and assume an order is correct even though questionable.

The U.S. FDA has released its final bar code ruling for human drug products and biologics. New medications covered by the rule must comply with 60 days of their approval. Previously approved drugs and all blood and blood products are required to be in compliance with two years. According to FDA estimates, the new ruling will result in 500,000 fewer adverse events over the next 20 years.

The Association of Professionals in Infection Control and Epidemiology (APIC) has expressed opposition to OSHA's proposed TB standard that imposes new requirements by enforcing the General Industry Respiratory Protection Standard. In a letter to John Henshaw, an OSHA administrator, APIC outlines its opposition with the following: 

Complimentary and Alternative Medicine

The five emerging models for delivery of complimentary and alternative medicine are as follows:

There seems to be disconnect between what patients seek and what hospitals offer. The top therapy sought by American consumers is relaxation techniques, followed by herbal medicine, massage, and chiropractics. The top services offered are massage, stress management, yoga, and relaxation. Only 13% of hospitals surveyed offer herbs in the hospital pharmacy and chiropractics is all but nonexistent.

Alternate Care Market Trends

Medicinal plants are a key component of medical care in many countries and cultures. Although their use in the United States is not as wide spread, recent studies have shown that about 25% of the economic market for dietary supplements in America consists of botanicals. For the most part, botanicals have not been rigorously studied. Even though many of them have been used for centuries, there are many reasons to conduct further research on their use for medicinal purposes. For example, some botanicals have been found to be toxic. Some have been found to interact with other botanicals or with medications (whether prescription or over-the-counter), which has caused adverse patient outcomes. Often the ingredients that are active medicinally in a botanical are unknown or not well understood.

National Center for Complementary and Alternative Medicine (NCCAM) Director Stephen E. Straus, M.D. says, "Exploring how and why botanicals act in the body is a key step in evaluating their safety and effectiveness." Herbal and medicinal plant therapy is becoming more common practice throughout the United States and increased research is being done by a variety of expert sources to determine their overall effectiveness in treating a multitude of illnesses. 

Health Insurance Portability & Accountability Act (HIPAA)

There has been a lot of activity focusing on the pitfalls of HIPAA. California hospital UCSF outsourced data transcription to a vendor in Florida who then outsourced to a vendor in India. The company in India wasn't paid for these services so they threatened to publish the information about patients. There is a continuing need to be vigilant about disclosure and disposal when patients' names are attached to devices and equipment.

Hospitals for Healthy Environment (H2E)

H2E is challenging all Partners to become a Making Medicine Mercury Free (MMMF) Award Winner by 2005. You can apply at any time to join the ranks of H2E MMMF Award Winners that have virtually eliminated mercury and developed policies to sustain the elimination. Facilities must fulfill the criteria listed below to be considered for this honorable distinction. Evaluation criteria includes:

Award application materials become the property of H2E - they will not be returned. MMMF Award Applications will be accepted throughout the year. Applications will be reviewed and awarded on a rolling basis. H2E will provide winners with an award plaque and packet of materials. Winners will also be recognized as part of the official 2005 award ceremonies.