Imagine, for a moment, that there are no uniform traffic regulations in the United States and the design of signs, lights, lane markings and all other infrastructure is left to the whim of local officials. No two towns, cities or municipalities have the same rules. A cross-country drive would be a safety nightmare filled with delays, missed turns and a stack of traffic tickets for local laws that you were unaware you were violating. Fortunately, uniform traffic regulations and standards were created long ago and our ability to travel is, depending upon traffic tie-ups, unhindered.
Representatives who work for medical device manufacturing and distribution companies live in a world far closer to the chaotic one above as they attempt to be credentialed for access to hospitals. For instance, a medical device sales representative attempting to demonstrate a product to hospitals in Miami Dade, Florida, must satisfy all the prerequisites listed in a 13-page contract that - among other things - requires that he/she be registered with the county as a lobbyist; have a confirmed appointment before any visit; have a yearly-renewable identity badge along with a daily visitor's badge; meet with staff only in designated areas; deliver any supplies/samples through the hospital supply chain and must have any training program pre-approved by the hospital administration.
In a hospital in the Carolinas vendor representatives must be medically prescreened prior to providing services at facilities. Vendors are asked to go through extraordinary efforts when increasing prices, such as having to obtain written permission from a Senior Vice President of the organization after 30 days notice. In addition, vendors must carry commercial general and products liability insurance limits of $2-$10 million and are asked to sign their coverage over to the hospital without regard to fault, by naming the institution as an additional insured.
In another hospital, medical device representatives must register with the Materials Management office (which might be offsite); schedule appointments between the hours of 6:30 to 5:00 pm; may not use facility telephones; and must provide proof of indemnity and core competency training for their devices and compliance with OSHA standards, for example: blood borne pathogens, hepitatis awareness, infection control principles and submit to health screening.
These examples are not unique but very much the norm. No two independent hospitals or health associations appear to have the same policies, procedures or credentialing guidelines. With over 5,700 hospitals in the US the need for standardized credentialing is acute, if not critical.
The field of credentialing came about slowly over time. It is a reaction to many things including patient privacy, increased litigation, Joint Commission Accreditation of Healthcare Organizations (JCAHO) requirements, abuse (such as representatives in physical contact with patients in the OR, theft of patients' goods, etc.) Hospitals claim to have little knowledge of their vendors' backgrounds and the resultant efforts to create control systems have led to missing or outdated information as reps enter and leave their positions. Hospitals increasingly want to exercise oversight that, in addition to the traditional issuance of badges, would also include orientation and training regarding the facility, HIPAA compliance, conduct and attire in the OR, aseptic principles, infection control, occupational safety and other applicable practices.
These fundamental issues are not disputed by the medical devices industry, but rather the lack of standardization that has created burdensome and inconsistent vendor access policies. Medical device companies, both large and small, spend vast amounts of time and money in an attempt to keep up with the myriad of demands from hospitals around the country. Adding even more to their difficulties is that hospital policies are sometimes applied to both clinical/sales and to non-clinical/administrative medical technology personnel and, in extreme situations, to delivery personnel.
The patchwork set of "solutions" currently in play include a growing number of subscription web-based services (REPtrax, Vendormate,VendorClear; etc.) that offer to collect the credentials of vendor reps who meet each hospital's requirements.
These firms offer their credential tracking services for "free" to the hospitals and clinics, if the hospital gives them an "exclusive" preferred provider status directing the medical device vendors to them. They claim to make the process more efficient to help maximize the supply chain, but online forums posted by vendors are rife with complaints about incorrect or conflicting information, high fees (per employee/per year) and wasted time, equating the process to a mild form of extortion. Some medical device firms may have 3-4 different employees (sales/marketing, equipment service/calibration and clinical training) going into a single hospital.
In addition, hospitals frequently add documents to the sites which are, in effect, contracts that create liability issues for vendors. The problem is exacerbated by confusion over who registers: the sales representative or an officer of the vendor.
Salespeople are not generally authorized nor empowered to agree to policies that would create liabilities for their employees.
Yet it is the salesperson who is supposed to register, as it is he/she who needs the badge.
Further compounding the overall problem is that most health organizations don't agree on what specific credentialing criteria are necessary; much less show any desire to standardize the process.
AdvaMed, the world's largest medical technology association has proposed a uniform set of credentialing requirements to be considered as the national standard.
In this proposal three major roles of health care industry representatives are defined and a clear set of credentialing requirements lised, along with specifics on the renewal frequency and responsible party. Key requirements include training documentation; product liability insurance; patient confidentiality; code of conduct; background verification and hospital unit orientation. Medmarc, the medical technology industry-created products liability insurance company, supports AdvaMed's position and offers its policyholders advice about the liability implications associated with signing credentialing agreements with hospitals that include "hold harmless" provisions.
To that end AdvaMed and Medmarc welcome any opportunity for meaningful dialogue with the nation's health care institutions. The standardization of credentialing will benefit everyone concerned and contribute significantly toward greater patient care.
It is clear that the credentialing is here to stay and will continue to evolve, particularly with JCAHO involvement. Until a uniform process is agreed to by hospitals, clinics, and medical device manufacturers we suggest device manufacturers' and distributors minimize these growing costs in the following ways:
- Adopt the Advamed Code of Ethics
- Subject employee credentialing documents to a legal review.
- Determine if the insurance coverage and limits are appropriate for the work being performed (often insurance brokers provide these types of reviews).
- Determine if medical malpractice errors and omissions exposure potentials exist in addition to product liability risks and secure coverage if necessary.
- Comply with related OSHA requirements.
- Document core product competencies; clinical, service and product sales.
For instance when one individual is responsible for training and another for calibrating and installation both should understand their limitations and not attempt to go beyond their proficiency levels.
- Instruct on-site employees to not sign documents or agreements that contain certification language that is outside their scope of competency.
- Alert your HR departments of these requirements that employees may encounter.
- Become involved in the process through correspondence with elected officials, or by joining, supporting, and participating in an advocacy organization like AdvaMed and IMDA that can make forward progress for the benefit of all.
- Advise your on-site staff of these evolving credentialing requirements.
- Advise visiting staff to guard patient confidentiality requirements.
Les Jackson is a science writer and radio host.
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Medmarc is a part of ProAssurance Group, a family of specialty liability insurance companies. The product material is for informational purposes only. In the event any of the information presented conflicts with the terms and conditions of any policy of insurance offered from ProAssurance, its subsidiaries, and its affiliates, the terms and conditions of the actual policy will apply.
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