2013 Legislative, Regulatory and Policy Update
|Copyright 2014 by Virgo Publishing.|
|Posted on: 01/03/2013|
By Kelly M. Pyrek
Essential to the viability of infection prevention and control efforts is advocacy work undertaken by healthcare professionals. Whether grassroots or association-driven, forming and maintaining solid relationships with representatives in local and state government is critical to advancing the healthcare-associated infection HAI prevention agenda. We look at the efforts of three associations to further the causes that uphold patient safety.
IAHCSMM Advocates for Certification of Sterile Processing and Central Service Technicians
One of the legislative priorities of the International Association of Healthcare Central Service Materiel Management (IAHCSMM) is maintaining that every patient deserves to have a certified central service technician reprocessing his/her instruments, as well as actively promoting laws and regulations to ensure certification of central sterile supply personnel at the state level.
In its model legislation, IAHCSMM is asking that individuals who work as a central service technician in a healthcare facility should not be employed unless the person either 1) holds and maintains the Certified Registered Central Service Technician (CRCST) credential; or 2) provides evidence that the person was employed or otherwise contracted for the services as a central service technician in a healthcare facility on or in the two years immediately prior to the designated effective date; or 3) is a student or intern performing the functions of a central service technician if the student or intern is under the direct supervision of an appropriately licensed or certified healthcare professional and is functioning within the scope of the student or intern’s training. IAHCSMM says that a central service technician who does not meet these requirements has 12 months from the date of hire to obtain the Certified Registered Central Service Technician credential or the Certified Sterile Processing and Distribution Technician credential. In addition, the technician must annually complete 10 hours of continuing education to remain qualified to function as a central service technician.
While it was pushing hard for this model legislation in a number of states in 2012, IAHCSMM was focusing a tremendous amount of resources and attention on New York; however, the New York governor vetoed IAHCSMM's CS certification bill on Oct. 3, 2012, as well as vetoed the surgical technologists’ certification bill, according to Josephine Colacci, IAHCSMM's government affairs director.
In June 2012, IAHCSMM's bill passed unanimously out of the Assembly and Senate. "We had no opposition from other organizations," said Colacci in a recent statement to IAHCSMM members. "Moreover, we received letters of support from CBSPD, AST, AORN, NY State Nurses Association, NY Chapter of the American College of Surgeons, APIC, and SEIU/1199. We even obtained a neutral letter from the New York Hospital Association. Our members, APIC members, and SEIU/1199 members sent an overwhelming number of letters and phone calls to the governor’s office to support our bill. After all of this, the governor vetoed it."
The governor issued a combined veto memo to IAHCSMM's bill, the surgical technologist bill, and a bill that would have certified the nurse anesthetists; the language from the veto memo: "All of the above bills seek, in one way or another, to govern the practice of certain 'professions' in the healthcare field. However, the bills fail to clearly address critical issues, such as scope of practice, supervision, and the oversight of role and regulatory jurisdiction of the affected agencies, namely the State Education Department and Department of Health. These omissions create a risk of inconsistent standards and confusion to consumers. The administration will work with the sponsors to address these issues of public concern, but for the above-mentioned reasons I cannot approve these bills."
As Colacci said in the statement to the IAHCSMM membership, "I cannot thank our members in New York enough for their time and dedication to this issue. We will prevail! Sometimes, it just doesn’t happen on the time frame that we want."
AORN Champions RN Circulator Legislation
Based on recommendations from the National Legislative Committee and the president-elect, each year the Association of periOperative Registered Nurses (AORN) board of directors establishes legislative priorities for its government affairs department to pursue in legislative and regulatory arenas nationwide. Going into 2013, ensuring that there is a perioperative registered nurse in the role of circulator in every operating room is AORN's top legislative priority, says Amy Hader, JD, AORN's director of government affairs.
"Making sure that there is an RN circulator in every room for every patient for the duration of the surgery has been our national priority and will stay the same going into the new year," Hader emphasizes. "We saw a few bills pass in the last few years but we still have 27 states with either no protection or weak protection for surgery patients that don't mandate an RN circulator be with each patient for the duration of the procedure. The OR is a very busy place and these are the people responsible for everything in the OR. We're not giving up on this and we are making encouraging progress. We tend to focus on two to three states per year with grassroots engagement of legislators."
In its RN Circulator Legislative Policy Statement, AORN asserts that "it is the right of the patient to receive the highest quality nursing care. No other person is more knowledgeable or qualified to handle the multiple critical issues surrounding patient safety in the operating room than the registered nurse (RN) who is specifically trained in perioperative nursing. The perioperative RN, through professional and patient-centered expertise, is the primary patient advocate in the operating room and is responsible for monitoring all aspects of the patient’s condition. The presence of the RN in the circulating role throughout each surgical procedure is essential for timely delivery of quality surgical care and optimal patient outcomes." The statement adds further, "One perioperative RN is dedicated to the patient during that patient’s entire intraoperative experience. During surgery, most patients are anesthetized or sedated and are powerless to make decisions on their own behalf. By employing critical thinking, assessment, diagnosing, outcome identification, planning, and evaluation skills, RN circulators direct the nursing care and coordinate activities of the surgical team for the benefit of the patient, whose protective reflexes or self-care abilities are compromised by the procedure. These critical nursing functions of the RN circulator are not delegable in the operating room."
According to AORN, at least 23 states have laws or regulations in place that are specific to having a registered nurse serve as the circulator in hospitals, and there are 16 states with similar language for ambulatory surgery centers. Many state boards of nursing and the Center for Medicare & Medicaid Services affirm through public directives, advisory opinions, practice guidelines, or regulations that the circulating role belongs to the perioperative RN.
As the RN Circulator Legislative Policy Statement notes, "The role of the RN in the perioperative setting is vital to the provision of optimal and safe patient care. The perioperative RN is the healthcare practitioner with the knowledge, training, and skills to successfully perform circulating duties in the surgical setting. Using sound nursing judgment, critical thinking skills, and interpersonal communication skills, the RN circulator is able to assess and evaluate individual patient needs and to ensure positive patient outcomes. To ensure that patients receive the highest quality and standard of nursing care, it is essential that there is a perioperative registered professional nurse in the role of the circulator throughout every operative or invasive procedure."
"Everyone agrees that having an RN as circulator is a best practice, but the disagreement seems to come in on whether there is a necessity for legislation or regulation on the topic, and the opposition varies by state," Hader says. "What we are hearing is a disagreement on need for legislation protecting a practice that everyone agrees is best. Our answer to that is, we think it's a best practice and to our knowledge everyone is staffing with an RN circulator but as cost pressures keep hitting hospitals, we don't want any departure from that high standard happening in hospitals today. So we view legislation as a safeguard going into the future."
Hader says that infection preventionists can partner with perioperative nurses to not only champion patient safety and infection control, but to help advocate for RN circulator legislation.
"The circulating nurses are responsible for a lot before, during and after the procedures -- one of those jobs is maintaining infection control throughout the surgery, so I see room for infection preventionists to work with perioperative nurses and with AORN to promote safety and optimal outcomes for all surgery patients," she says. We all want the same thing. We work hard to empower nurses to feel confident to be advocates not just for their profession, but for their patients. Nurses are the voices of the surgery patients. The surgical team, in collaboration with all healthcare providers, is important for safeguarding patient safety. In a state without an RN circulator law, nursing and infection prevention staff can work together to create a hospital policy that requires an RN circulator to be with every patient in every room for the duration of the surgical procedure."
APIC Unveils State Advocacy Toolkit
In October 2012, the Association for Professionals in Infection Control and Epidemiology (APIC) unveiled its Voice for Infection Prevention (VIP) Advocacy Toolkit as a guide for infection preventionists' visits with their state legislators.
In a foreword to the toolkit, Nancy Hailpern, APIC's director of regulatory affairs, and Lisa Tomlinson, APIC's senior director of government affairs, explain, "As the amount of legislation and regulation governing the practice of infection prevention increases, it becomes more important for policymakers to hear from experts to help guide them through the intricacies of the profession and provide advice on evidence-based practices that lead to increased patient safety without overburdening providers. Infection preventionists are ideally suited to provide this information to state policymakers. However, the idea of visiting legislators can be intimidating. The Voice for Infection Prevention (VIP) Advocacy Toolkit: a Guide for Visits to State Legislators is a multi-component toolkit designed to facilitate planning for visits to state legislators by APIC chapters. We hope that your chapter will consider planning visits with your state legislators. Since many legislators may not be familiar with your profession, a good place to start would be a 'meet and greet' visit to provide basic information about APIC and infection prevention, so that if the issue does arise in the legislature, legislators will have the names of experts to contact for additional information."
The toolkit was borne out of the experiences of two members of APIC Chapter 73 (Greater St. Louis) during the planning and execution of a legislative day -- Cassandra Landholt, epidemiology technician at Barnes-Jewish Hospital, and Jeanne Yegge, RN, BSN, MPH, CIC, infection prevention consultant at BJC Learning Institute.
"The advocacy day was the idea of our chapter's legislative representative Jeanne Yegge," explains Landholt. "I was excited to get involved because I hadn't met our state legislators yet. We wanted to get our names and faces out there, and determine the level of infection prevention knowledge that our state legislators had, as well as to see if they were aware of APIC, what we needed to educate them about, and lay the groundwork for interactions to come." Landholt adds, "We met face to face with the chairs and vice chairs of the healthcare committee, and with so many of them being clinicians, they were very aware of APIC and of healthcare-associated infections. In fact, one of them we met with helped write the HAI Action Plan, so it was good to know they had that framework. We kept our conversation basic, focusing on what APIC is, who infections preventionists are and what we do -- the essential groundwork to ensure we are all on the same page."
The toolkit provides checklists designed to take the guesswork out of a legislative visit, covering purpose, planning and logistics, as well as helpful hints for effective follow-up with legislators and their staff. The toolkit also suggests a number of talking points for legislative visits, such as the scope of HAIs, the work in which infection preventionists engage daily, and ways to partner for the future. Additionally, the toolkit contains sample brochures as well as templates for appointment request letters, follow-up letters, and "sorry we missed you" letters for legislators.
First-time jitters can be calmed with a little preparation, Landholt says. "I had never done any kind of advocacy day work previous to my visit to the state capitol, but Jeanne Yegge was with me and her level of prior legislative-visit experience was comforting. Planning is critical to the success of a legislative visit. If you are not prepared, with certain conversations in mind, you could easily become overwhelmed in a place like a state capitol. I had to learn where to start and what to think about, and planning is essential."
Infection preventionists may be concerned about the time required for advocacy work, but Landholt says it's a matter of "divide and conquer." She adds, "If you can gain the support of your chapter and get everyone to pitch in an hour or two, that would make the planning easier and quicker for everyone involved. In terms of balancing workload, we have a lot of support from our managers and use small bits of our work time. mostly an hour after work here and there -- probably 18 to 20 hours for planning and we each took the day off from work for the actual advocacy day. We are very fortunate that in St. Louis, most of the hospitals have the support from upper management to promote infection prevention and have face time with legislators and other venues for advocacy."
"We're very excited about how the Voice for Infection Prevention (VIP) Advocacy Toolkit can help our members," says Hailpern. "We're hoping it will encourage our chapters to conduct state-level advocacy similar to what the St. Louis chapter is doing, without having to be afraid of what to do or how to get started. We also hope APIC members will use it as a starting point and they will call us for more information so we can help them with their advocacy efforts. And as more chapters start conducting advocacy work, we anticipate they will report back on what they have experienced so that others will see that it's not such a daunting thing to do. Maybe chapters can even meet with legislators as a get-to-know-you endeavor instead of lobbying on a particular issue of piece of legislation. The more they do advocacy work and see that other chapters are doing it too, it might seem less intimidating."
Hailpern says she recently made a presentation to a quarterly meeting of the California APIC Coordinating Council, an intrastate group comprised of 12 APIC chapters in that state, explaining the toolkit and advising how it can be used in the council's advocacy efforts.
"It's good to know our experiences, through the creation of the toolkit, are benefitting others," says Landholt. "We are looking forward to hearing about other infection preventionists' experiences with their advocacy work and their interaction with their legislators."
FDA Examines Labeling of Medical Devices
The Food and Drug Administration (FDA) is currently examining the content and format of labeling for medical devices, and seeking insight from healthcare professionals about what is important and useful information for prescribing and using medical devices. Presently, there are few regulations that define and describe requirements for medical device labeling, including the instructions for use. The FDA is taking a closer look at what details should be provided with medical devices, as well as how that information should be organized and communicated.
The impetus for this effort began several years ago when an FDA official, also a nurse, began investigating home use of medical devices. "I was looking at the safe migration of medical devices into the home and being used by lay caretakers," says Mary Weick-Brady, MSN, RN, senior policy analyst in the Office of the Center Director, Center for Devices and Radiological Health at the FDA. "From my personal experiences, having been a home care nurse years ago, I knew it was sometimes difficult to find the labeling -- it would either get lost or the device would be transferred from one person to another and the labeling wouldn't go with it."
Weick-Brady explains that when talking about "labeling," it means the package insert or the instructions for use for the end user -- not the package label itself, nor the operator/service manual. Section 201(k) of the Federal Food, Drug and Cosmetic Act (FFDCA) -- the law under which the FDA takes action against regulated products -- defines "label" as a "display of written, printed, or graphic matter upon the immediate container of any article." The term "immediate container" does not include package liners. According to the FFDCA, any word, statement or other information appearing on the immediate container must also appear on the outside container or wrapper of the retained package of such article, or is easily legible through the outside container of the wrapper. Section 201(m) of the FFDCA defines 'labeling' as "all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article' at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce. The term "accompanying" is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. "Accompanying" also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce, according to the FFDCA.
"As we looked into the labeling issue, it wasn't just happening in the home environment," Weick-Brady says. "People with medical devices were coming into the emergency department of the hospital and the treating healthcare professional would not know how to operate that particular device because they didn't have the right labeling. People coming into the ED were very sick and couldn't show clinicians how to operate the device, whether it was an insulin pump or a pacemaker. When we checked even further, we found that a lot of people in clinical environments were unable to find the labeling -- it was either in the biomedical engineer's office or it was in the nurse educator's office, they weren't really sure. Clinicians want access to medical device labeling information but they didn't want to have to root through a lot of other information to get to what they specifically needed. They were saying, 'I need good, usable labeling, and if it is not usable, it is not useful.'"
Weick-Brady explains that the oversight of the Center for Devices and Radiological Health runs the gamut of medical devices -- meaning anything from a heating pad, to a ventilator to an implant of any kind, to hemodialysis. "Depending on the type of device, labeling increases in complexity," she says. "Over-the-counter device labeling, or what we would call the package insert, could easily fit on the back of the label itself, of the package labeling. Whereas if you have a hemodialysis machine, for either the home or in the clinic, you probably have several hundred pages of user instructions. Labeling for a device such as an infusion pump, where you can program it many ways depending on the drug and the time it needs to be infused, you would have an increased level of complexity and an increased number of alarms you would need to look for, and probably things to look for in trouble-shooting the device -- so that means a very complex labeling that is essential for users to have."
Weick-Brady says she is in the process of determining the viability of an online repository for all medical device labeling information. "The FDA would like to know if this repository would be beneficial to those who actually use the labeling -- one place as a source for all labeling information," she says. "Unlike drugs, devices are out there for many years, and they go form one person to another. Manufacturers, justifiably so, want to sell newer products, so frequently they will support on their websites the newer product labeling and not necessarily the older product labeling. I can't fault them for that, but the problem is that labeling still must be out there for people to use. People come to love their devices and they don't want to switch them out, so having access to the older product labeling would be part of this particular labeling repository. Information would be archived and users could easily look up products."
In August 2012, the FDA partnered with RTI International to conduct a survey of healthcare professionals as part of the aforementioned labeling efforts. "In the first phase of this study we conducted focus groups," Weick-Brady says. "We asked physicians, nurses and technicians working infusion therapy, respiratory therapy and wound care -- all the people who use device labeling in one way or another -- what their experiences were with labeling. What we kept hearing from them is, 'I don't have time to read all of that labeling -- all I want is information to find out how to operate this device safely and effectively, learn what the alarms are, and what I need to do when those alarms sound.' They also said, 'I need to know how to clean this device, I need to know how to put this device together, I need to know what kind of accessories might be needed.' We also heard that labeling is all over the place, unlike drug labeling where you know where your indications are going to be -- there is no standard content or format for medical device labeling. They told us 'I want to know if I am looking at labeling, whether for a pump or a ventilator, I want to know where the warnings are, I don't want to go looking throughout the whole document.' It was clear that clinicians are looking for standard format and content on labeling."
Weick-Brady continues, "Because of that feedback I put together the second phase of the survey where we developed a shortened version of generic labeling for an infusion pump and offered three different versions of this labeling for people to look at. We wanted people to respond to these labeling templates to see if this is what they are looking for, would they help clinicians -- because if we are going to undertake this online medical device labeling repository, we need as much feedback as possible."
The Food and Drug Administration (FDA) has released a proposed rule that most medical devices distributed in the United States carry a unique device identifier (UDI). Congress passed legislation in 2007 directing the FDA to develop regulations establishing a unique device identification system for medical devices. A UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date. According to the FDA, a UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the agency identify product problems more quickly, better target recalls and improve patient safety.
The FDA is also creating a database that will include a standard set of basic identifying elements for each UDI, and will make most of it available to the public so that users of a medical device can easily look up information about the device. The UDI does not indicate and FDA’s database will not contain any information about who uses a device, including personal privacy information.
In developing the proposed rule, the FDA worked closely with industry, the clinical community and patient and consumer groups, and conducted four pilot studies. The final rule is scheduled for release in May 2013.
When fully implemented, the UDI system may:
A number of organizations have submitted comments to the FDA about UDI.
Premier healthcare alliance says it "strongly supports the implementation of a UDI system and commends the FDA for issuing the proposed rule. UDI is the missing link to protect patient safety. Enabling healthcare providers to track medical devices electronically in the supply chain will improve the speed and accuracy of product recalls, as well as adverse event reporting. In addition, automating the now manual process of tracking of medical devices is projected to save the healthcare industry approximately $16 billion each year from greatly improved efficiencies." Among other comments, Premier emphasized in its comments to the FDA that the proposed seven-year implementation timeframe is too long, especially since the medical community has already waited five years for UDI. Premier explains, "The seven-year timeline applies to unclassified devices, many of which play roles akin to those of class II or III devices and raise important patient safety issues. Premier comments that such unclassified devices should not be treated any differently than comparable class II or III devices. Premier’s comments stress that the recently enacted FDA Safety and Innovation Act clearly demonstrates Congressional interest in seeing relatively prompt implementation of UDI requirements. Premier urges FDA to complete the implementation of UDI requirements for all affected devices (with respect to labels/packaging) within two years of the effective date of the final rule."
Premier also noted that items in convenience kits need UDIs: "FDA proposes that a combination product whose primary mode of action is that of a device would be subject to UDI labeling requirements, and each device constituent part of a combination product would need to have its own UDI unless it is not possible for the device constituent part to be used except as part of the use of the combination product. FDA also proposes to require a UDI on the label and device package of each convenience kit, as well as a distinct UDI for each device in a convenience kit, unless an included device is intended for a single use. To ensure patient safety, any item within a combination product that may be used independently or any item within a convenience kit that may be used more than once (whether or not intended for single use) should be individually labeled with a UDI." To read the proposed rule, visit: http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0090-0001
AAMI Announces Launch of Quality Systems for Device Reprocessing Working Group
The Association for the Advancement of Medical Instrumentation (AAMI) is seeking volunteers to help with the creation of a new standard: AAMI ST90: Reprocessing of reusable medical devices -- Quality management systems for reprocessing for healthcare delivery organizations.
The organization is seeking participation from users (such as sterile processing professionals, nurses and other clinicians), healthcare technology managers, device manufacturers, independent service organizations, quality systems experts, hospital leadership, purchasing organizations, regulatory agencies, and any other interested parties.
Applications are invited both from current standards committee participants and from new participants. In addition, AAMI invites nominations for user/general interest and industry co-chairs for both groups. Self-nominations are acceptable. Nominations can be sent to firstname.lastname@example.org.
This document will specify minimum requirements for quality management systems where an organization needs to demonstrate its ability to effectively, efficiently and consistently reprocessing (clean, decontaminate, disinfect, sterilize) reusable medical devices in order to prevent infections, pyrogenic reactions or other adverse patient events.
This standard will be developed by ST/WG 86, Quality systems for device reprocessing working group, under the auspices of the AAMI Sterilization Standards Committee. To apply to this working group, visit http://www.aami.org/CommitteeCentral/Committee/ShowMembershipForm.cfm and select AAMI/ST/WG 86 from the drop down menu in Item #5.
Healthcare Personnel Influenza Vaccination Reporting to Begin
Healthcare personnel flu vaccination reporting that is mandated by the Centers for Medicare and Medicaid Services (CMS) via the CDC's National Healthcare Safety Network (NHSN) begins on Jan. 1, 2013. Beginning in January for the 2012-2013 influenza season, acute-care hospitals participating in the CMS Inpatient Prospective Payment System (IPPS) Hospital Inpatient Quality Reporting Program are required to submit data on influenza vaccination of healthcare workers via NHSN; however, use of this measure for payment determination will not begin until FY 2015.
The NHSN module for this reporting mandate has been available since mid-September 2012, with the CDC making available various training materials, protocol, forms and instructions.
Hospitals are expected to report vaccinations received by healthcare workers at the facility, vaccinations received outside the facility, medical contraindications and declinations. Data must be reported for all employees on payroll, licensed independent practitioners (who are physicians, advanced practice nurses and physician assistants affiliated with the hospital but not on payroll), and students, trainees, and volunteers aged 18 or older. Only healthcare personnel physically working in the facility for at least 30 days between Oct. 1 and March 31 should be counted.
Acute-care hospitals planning to report healthcare personnel influenza vaccination summary data should make sure their facility is enrolled in NHSN, the Healthcare Personnel Safety Component is activated, and that personnel who will be entering these data for the hospital (e.g. employee health staff) are given user rights to the component. Within the Healthcare Personnel Safety Component, monthly reporting plans must be created or updated to include healthcare personnel influenza vaccination summary reporting before data can be entered.
Quality, Readmissions, Hospital-Acquired Conditions Among CMS FY 2013 IPPS Performance Measures
On Aug. 1, the Centers for Medicare & Medicaid Services (CMS) issued its fiscal year (FY) 2013 Medicare inpatient prospective payment system (PPS)/long-term care hospital (LTCH) PPS final rule. In the rule, CMS projects that Medicare operating payments to acute-care hospitals for discharges occurring in FY 2013 would increase by 2.3 percent. This includes, among other adjustments, a restoration to the base rates of 2.9 percent to ensure that a prior documentation and coding adjustment does not continue to cut hospital payments into the future. Also included are several new provisions related to quality measure reporting and payment updates based on hospitals' performance.
- Hospital value-based purchasing (VBP) program and reduced payment for readmissions
- Hospital-acquired condition (HAC) payment policy
- Hospital inpatient quality reporting (IQR) proposed measures