Infection Control Articles

Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010 

SUMMARY

The 2010 influenza recommendations include new and updated information.  Highlights of the 2010 recommendations include:

1. a recommendation that annual vaccination be administered to all persons aged≥6 months for the 2010-11 influenza season
2. a recommendation that children aged 6 months-8years whose vaccination status is unknown or who have never received seasonal influenza vaccine before (or who received seasonal vaccine for the first time in 2009-10 but received only 1 dose in their first year of vaccination) as well as children who did not receive at least 1 dose of an influenza A (H1N1) 2009 monovalent vaccine regardless of previous influenza vaccine history should receive 2 doses of a 2010-11 seasonal influenza vaccine (minimum interval: 4 weeks) during the 2010-11 season
3. a recommendation that vaccines containing the 2010-11 trivalent vaccine virus strains A/California/7/2009 (H1N1)-like (the same strain as was used for 2009 H1N1monovalent vaccines), A/Perth/16/2009 (H3N2)-like and B/Brisbane/60/2008-like antigens be used
4. information about Fluzone High-Dose, a newly approved vaccine for persons aged ≥65 years
5. information about other standard-dose newly approved influenza vaccines and previously approved vaccines with expanded age indications.

Vaccination efforts should begin as soon as the 2010-11 seasonal influenza vaccine is available and continue through the influenza season.  These recommendations also include a summary of safety data for U.S.-licensed influenza vaccines.  These recommendations and other information are available at CDC’s influenza website (http://www.cdc/gov/flu) ; any updates or supplements that might be required during the 2010-11 influenza season also will be available at this website.  Recommendations for influenza diagnosis and antiviral use will be published before the start of the 2010-11 influenza season.

To obtain a copy of this entire publication visit: www.cdc.gov/mmwr

Reference:  MMWR, Prevention and Control of Influenza with Vaccines, Recommendation of the Advisory Committee on Immunization Practices (ACIP, 2010

What is Eastern equine encephalitis (EEE)?

EEE is a rare disease that is caused by a virus spread by infected mosquitoes.  EEE virus (EEEV) is one of a group of mosquito-transmitted viruses that can cause inflammation of the brain (encephalitis).  Tn the United States, approximately 5-10 EEE cases are reported annually.

How do people get infected with EENV?

EEEV is transmitted through the bite of an infected mosquito.  Disease transmission does not occur directly from person to person.

Where and when have most cases of EEE occurred?

Most cases of EEE have been reported from Atlantic and Gulf Coast states.  Cases have also been reported from the Great Lakes region.  EEE cases occur primarily from late spring through early fall, but is subtropical endemic areas (e.g., the Gulf States), rare cases can occur in winter.

Who is at risk for infection with EEEV?

Anyone in an area where the virus is circulating can get infected with EEEV.  The risk is highest for people who live in or visit woodland habitats, and people who work outside or participate in outdoor recreational activities, because of greater exposure to potentially infected mosquitoes.

How soon do people get sick after getting bitten by an infected mosquito?

It takes 4-to 10 days after the bite of an infected mosquito to develop symptoms of EEE.

What are the symptoms of EEV disease?

Severe cases of EEV infection (EEE, involvin encephalitis, an inflammation of the brain) begin with the sudden onset of headache, high fever, chills, and vomiting.  The illness may then progress into disorientation, seiures, and coma.  Approximately a third of patients who develop EEE die, and many of those who survive have mild to severe brain damage.

How is EEE diagnosed?

Diagnosis is based on tests of blood or spinal fluid.  These tests typically look for antibodies that the body makes against the viral infection.

What is the treatment for EEE?

There is no specific treatment for EEE.  Antibiotics are not effective against viruses, and no effective anti-viral drugs have been discovered.  Severe illnesses are treated by supportive therapy which may include hospitalization, respiratory support, IV fluids, and prevention of other infections.

How can people reduce the chance of getting infected with EEEV?

Prevent mosquito bites.  There is no vaccine or preventive drug.

• Use insect repellent containing DEET, picaridin, IR3535 or oil of lemon eucalyptus on exposed skin and/or clothing.  The repellent/insecticide permethrin can be used on clothing to protect through several washes.  Always follow the directions on the package.
• Wear long sleeves and pants when weather permits.
• Have secure, intact screens on windows and doors to keep mosquitoes out.
• Eliminate mosquito breeding sites by emptying standing water from flower pots, buckets, barrels, and other containers.  Drill holes in tire swings so water drains out.  Keep children’s wading pools empty and on their sides when they aren’t being used.

Waht should I do if I think a family member might have EEE?

Consult your healthcare provider for proper diagnosis.

Reference: www.cdc.gov/EasternEquineEncephalitis/gen/qa.html

Eastern equine emcephalitis virus (EEEV) is transmitted to humans by the bite of an infected mosquito.  Eastern equine encephalitis (EEE) is a rare illness in humans, and only a few cases are reported in the United States each year.  Most cases occur in the Atlantic and Gulf Coast states. Most persons infeced with EEEV have no apparent illness.  Severe cases of EEE (incolving encephalitis, an inflammation of the brain) begin with a sudden onset of headache, high fever, chills, and vomiting.  The illness may then progress into disorientation, seizures, or coma.  EEE is one of the most severe mosquito-transmitted diseases in the United States with approximately 33% mortality and significant brain damage in most survivors.  There is no specific treatment for EEE; care is based on symptoms.  You can reduce your risk of being infected with EEEV by using insect repellent, wearing protective clothing, and staying indoors while mosquitoes are most active.  If you think you or a family member may have EEE, it is important to consult you healthcare provider for proper diagnosis.

Dengue transmission has been increasing to epidemic levels in many parts of the tropics and subtropics where it had previously been absent or mild.  Dengue affected areas are widely distributed throughout Africa, Asia, Pacific, the Americas and the Caribbean.  This calendar year, more than 50 countries have reported evidence of dengue transmission; including 17 countries in Asia, 17 in the Americas, 10 in Africa, seven in the Caribbean, and one in the Pacific.  With an extensive dengue outbreak occurring in Puerto Rico and evidence of continued transmission in Key West, Florida, travel to certain domestic locations may also pose a risk for the traveler.  The mosquitoes known to transmit dengue virus, Aedes aegypti and Aedes albopictus, are present throughout much of the southeastern United States and infected returning travelers may pose a risk for initiating local transmission.

SYMPTOMS

Dengue virus infections can manifest as a subclinical infection or DF, and may develop into potentially fatal DHF. DF is a self limiting febrile illness that is characterized by high fever plus two or more of the following: headache, retro-orbital pain, join pain, muscle or bone pain, rash, mild hemorrhagic manifestations (e.g., bleeding of nose or gums, petechiae, or easy bruising), and leukopenia.  Because the incubation period for dengue infection ranges from 3 to 14 days, the patient may not present with illness until after returning from travel. 

Clinical management of DF consists of symptomatic treatment (avoid aspirin, NSAIDS and corticosteroids, as they can promote hemorrhage) and monitoring for the development of severe disease at or around the time of defervescence.  A small proportion of patients develop DHF, which is caracterized by presence of resolving fever or a recent history of fever, lasting 2-7 days, any hemorrhagic manifestation, thrombocytopenia (platelet count≤100,000/mm³), and increased vascular permeability, evidenced by hemoconcentration, hyposlbuminemia or hypoproteinemia, ascites, or pleural effusion. DHF can result in circulatory instability or shock.  Adequate management requires timely recognition and hospitalization, close monitoring of hemodynamic status, and judicious administration of intravascular fluids.  There is no antiviral drug or vaccine against the dengue virus.

Updated guidelines for the management of dengue can be found at http://whqlibdoc.who.int/publications/2009/9789241547871_eng.pdf

LAKEWOOD RANCH, FLORIDA - A consultant says Lakewood Ranch Medical Center is the first hospital in the world to have some of its staff try a new medical garment that combats infections with a germ-killing ingredient woven into it.

Orlando-based Vestagen Technical Textiles has manufactured scrub tops, pants, lab coats, isolation gowns, sheets for patient’s beds, cubicle curtains and T-shirts under the Vestex brand name that not only have an antimicrobial woven in to repel microbes, but a nano-particle barrier that can repel body fluids, said Linda Spaulding, an international infection control consultant.

Spaulding, a registered nurse who lives in Lakewood Ranch, has done consulting for Lakewood Ranch Medical Center and is on the advisory board for Vestagen Technical Textiles, which enabled her to get the products to Lakewood Ranch Medical Center recently for a test, she said.

“I think this could revolutionize the way health care works,” Spaulding said.

How it works is perhaps a little hard to understand for non-scientists, but the company Web site, www.vestagen.com, explains the clothing lines uses a “nanoparticle hydrophobic barrier” to repel fluids of all kinds. The antimicrobial agent imbedded in the fabric is what can be a barrier against infections, Spaulding said.

“If drool or blood splashes on it, it won’t adhere,” Spaulding said.

Wilma Schmidt, a registered nurse at Lakewood Ranch Medical Center, plans to wear Vestex clothing while working during an upcoming trip to Haiti.

Vestagen has offered to provide free scrubs to Schmidt and seven others from her church group who are going to Haiti soon, Schmidt said.

“It’s going to make working in those conditions more bearable since we won’t be soaking wet with sweat all day long,” Schmidt said.

Spaulding laughed when it was suggested the outfits could be used for staying clean while eating spaghetti at a restaurant, but she said the company could consider that, and perhaps a line of children’s clothing.

The company’s Web site quotes statistics compiled by the Centers for Disease Control and Prevention that state that infections kill nearly 100,000 yearly and add roughly $30 billion to the nation’s health care tab.

The outfits seem to cost only a few dollars more than non-antimicrobial garments.

Traditional scrub pants, for example, run about $19 while the new material pants cost $24, Spaulding said.

Other garments are also $4 to $6 more, Spaulding said.

The whole hospital has not converted over to the new scrubs, but the surgery manager of the hospital is wearing the new gear as well as the emergency room staff, Spaulding said.

“I’ve had pregnant women say they want these scrubs,” Spaulding said. “I currently have a lab coat made of the new textile that I wear every day. It’s hard to go back once you realize you are protected.”

Read the full article now at the Bradenton Herald website

VESTAGEN is a company worth taking a look at this year.  This Orlando Company has developed a new technology designed to help combat Hospital-Acquired Infections. 

Dec. 7, 2009 - Vestagen Technical Textiles announced its entry into the advanced performance textile arena with the introduction of the first of a new class of Nanotechnology-Based Healthcare Specialty Textiles.  The Orlando-based company will provide apparel and textile products for use in environments where biological contamination of clothing can occur.  Vestex, designed exclusively for the healthcare market, made its debut at the Institute for Healthcare Improvement’s 2009 National Forum.

Vestagen holds exclusive North American license to three patented Swiss technologies.  For the first time, these technologies have been blended to create a unique combination that can be applied to any single layer of fabric.  Vestex personal and professional wear repels fluids; has documented and registered antimicrobial properties impregnated in the clothing to resist contamination; rapidly kills microbes; is highly durable; minimizes odor and is naturally self cleaning.

“Infections are becoming more widespread in our society, and nowhere is that more evident than in our nation’s hospitals,” said Richard P. Wenzel, M.D., professor and former chairman of the Department of Internal Medicine at Virgina Commonwealth University Medical Center.  “This innovative nanotechnology-based textile may prove to be an important component in a hospital’s infection control efforts.”

According to the Centers for Disease Control and Prevention (CDC), health care-associated infections (HAIs) affect two million patients and claim nearly 100,000 lives each year.  With a per-patient cost of $15,000, these dangerous and preventable infections add approximately $30 billion annually to our nation’s health care tab.

“There is a clear and urgent need for our technology in America’s hospitals,” said Ben Favret, founder and CEO of Vestagen.  “It is well documented that medical textiles can become contaminated with dangerous pathogens, including the bacterium Methicillin Resistant Staphylococcus aureus (MRSA).”

In recent months, the issue of HAIs has come to the forefront of the health care debate.  In October, the U.S. Department of Helath & Human Services announced the award of $17 million to fund projects to fight HAIs.  The CDC and other government agencies has also called for more resources to focus on reducing and eliminating infections, one of the most common complications of hospital care.  Simultaneously, the American Medical Association is debating the future of doctors’ white coats, which have been criticized for unwittingly spreading infectous bacteria to patients.

“Vestagen is committed to providing advanced, antimicrobial, nanotechnology-based helathcare specialty textile products for our nation’s health care workers,” said Favret.  “We intend for Vestex, which combines protection, quality and comfort with traditional, identifiable styles of medical wear, to set a new technical standard for health care worker uniforms.”

The first line of Vestex apparel will include scrub pants and tops in a variety of colors, long sleeved T-shirts and lab coats.  They will be available in limited quantities this fall with a national roll-out in spring 2010.

About Vestagen Technical Textiles LLC

Vestagen Technical Textiles is an Orlando-based marketer and manufacturer of advanced performance textiles.  Vestagen is led by a skilled management team with nearly a century of combined experience in the health care, textile and apparel industries.  Backed by V-Ten Capital Partners, Vestagen is committed to creating innovative textile solutions.  For more information, visit www.vestagen.com

1. The cleared SS1’s circulation pump was a [redacted] pump. In 1999, the pump was changed to [redacted] pump. According to internal Steris documents, the original circulation pump failed for low flow performance and seal leakage that resulted in decreased SS1 reliability and consumer complaints. The change to [redacted] pump altered the flow rate, the now characteristics, and the flow through the lumen of the device. These changes significantly impact the function and delivery of the sterilant to and through an instrument.

2. The cleared SS1’s high pressure pump was an [redacted] pressure pump with a flow rate of [redacted]. In 1992, you developed a new model SS1, Model 90. This new model had a [redacted] high pressure pump with a flow rate of [redacted]. In 1995, as a result of consumer complaints of the Model 89 series high pressure pump leaking, your firm began installing pressure switches in the pumps to monitor the function of the high pressure pump. In 1998, your firm developed an “HP Pump Enhancement Kit,” and in 1999, began replacing the [redacted] high pressure pumps in the Model 89A1 and 90B1 series with the new [redacted] high pressure pumps. The changes to the high pressure pump altered the flow rate and flow characteristics in the SSI and through the lumen of the device. Therefore, these pump changes significantly impact the function and delivery of the sterilant to and through the device being processed.

3. In December 1996, your finn made changes to the original software used in the device as cleared in 1989, in response to reports that customers were receiving high pressure pump alarms due to low facility water pressure. In response, you changed the software program to limit the operation of the high pressure pump to the sterilant exposure phase and the final drain. Because of this software change, the high pressure pump no longer runs during the final rinse phase. This action may affect removal of chemical residues from the processed devices and may pose a risk to the patient.

4. On August 19, 2002, your firm sent correspondence to all of your customers stating that it had changed the connector design on the Quick Connect Kits from individual components to one unit, in which all of the components are tethered together. The design change was initiated following microbiological testing failures related to the older, individual-component connectors. Additionally, new connectors were developed to facilitate the adaptation of the flow unit to the instrument to be processed. These changes to the connectors have a significant effect on the sterile fluid pathway and delivery of the sterilant.

5. The cleared SSI’s chamber volume was [redacted] After 510(k) clearance, your firm increased the chamber volume to [redacted] and then to [redacted] Along with this large increase in the chamber volume, the Sterilant 20 formulation was altered, with the intent of maintaining the final peracetic acid (PAA) concentration given the larger chamber volume. This large increase in chamber volume, which apparently also prompted a change in sterilant formulation, could significantly affect the ability of the system to sterilize by altering how sterilant is delivered and the concentration of ingredients in the sterilant.

6. Following the clearance of the 510(k), your firm added five additional [redacted] ingredients [redacted] and [redacted] to the formulation of the Sterilant 20. This change to the sterilant formulation could significantly affect safety or effectiveness of the device, specifically, the effectiveness of the active ingredient and its ability to sterilize, and by altering the stability of the sterilant.

FDA Notice: Concerns About the Steris System 1 Processor, Components, and Accessories, and FDA Recommendations

Issued: December 3, 2009

Dear Healthcare Facility Administrator and Infection Control Practitioner:

The Food and Drug Administration (FDA) is providing this notice to inform you of important information regarding the regulatory status of the STERIS System 1 Processor (SS1) and actions that you should take if you have this medical device in your facility. The SS1 is typically used in surgical and endoscopy suites for reprocessing, i.e., sterilizing or disinfecting, medical devices.

STERIS Corporation (STERIS) has significantly modified the SS1, and FDA has not approved or cleared this modified product. Thus, FDA has not determined whether the SS1 is safe or effective for its labeled claims, including claims that it sterilizes medical devices. Use of a device that is promoted to sterilize or disinfect a medical or surgical device, but that does not properly perform these functions, poses risks to patients and users. Improperly disinfected or sterilized instruments may transmit pathogens to patients and healthcare staff, or expose them to hazardous chemicals. Improper sterilization or disinfection may also adversely affect the quality and functionality of reprocessed instruments.

FDA has received some reports of malfunctions of the SS1 that had the potential to cause or contribute to serious injuries to patients, such as infections. Infections that occur after a procedure using a medical device reprocessed in the SS1 may be difficult to attribute to the SS1 and may go unreported. There have also been reports of injuries, mostly burns from exposure to the sterilant solution, to healthcare facility staff operating the device.

On May 15, 2008, FDA issued a Warning Letter advising STERIS that its changes to the SS1 caused it to be adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act (see http://www.fda.gov/ICECI/ EnforcementActions/WarningLetters/ 2008/ucm1048303.htm).As FDA stated in the Warning Letter, the changes made to the SS1 could significantly affect the safety or effectiveness of the device.

In response, STERIS stated that it would work with its customers to transition them to legally‑marketed replacements for the SS1. On January 20, 2009, STERIS advised its customers of this commitment and the steps that it would take to respond to FDA’s concerns. However, based on a recent inspection of STERIS and meetings with the firm, FDA is not satisfied that the firm has been working effectively to transition its customers to replacements for the SS1. FDA is therefore sending this letter to make recommendations on actions that you should take.

FDA Recommendations

If you have an acceptable alternative to the SS1 to meet your sterilization and disinfection needs, you should transition to that alternative as soon as possible to ensure continued patient safety. If you do not have an acceptable alternative to the SS1, you should promptly assess your facility’s patient-care needs and sterilization and disinfection requirements and take steps to obtain legally-marketed substitutes for the SS1.

For additional information, including information on FDA cleared or approved medical devices, see the “Questions and Answers” document on the FDA web site.

Please note that user facilities, including hospitals, are required to report suspected device-related deaths to FDA and the manufacturer, and serious injuries to the manufacturer or to FDA, if the manufacturer is unknown (see http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/PostmarketRequirements/ ReportingAdverseEvents/default.htm ). Also, FDA solicits voluntary reports of adverse events from healthcare professionals (see http://www.fda.gov/Safety/MedWatch/HowToReport/ucm085568.htm ).

Contacting FDA

Answers to many of your questions are contained in FDA’s “Questions and Answers” document. In addition, FDA will host a call during the week of December 7 for healthcare facilities using the SS1. Healthcare facilities that wish to participate in this call should contact Heidi Marchand, Office of Special Health Issues, by phone at 301-827-4460 or by email at heidi.marchand@fda.hhs.gov. These facilities may also send an email to the NewsHealthCareProfs@fda.hhs.gov. E-mails and voice-mail messages should include the name of the healthcare facility, a point of contact at the facility, and a contact phone number and E-mail address.

Questions can also be directed to Candace McManus, DrPH, at the Office of Compliance, CDRH, 10903 New Hampshire Avenue, WO66, Silver Spring, Maryland, 20993, by email at candace.mcmanus@fda.hhs.gov, or by telephone message at 1-877-260-3731.

Sincerely,

Timothy A. Ulatowski
Director, Office of Compliance
Center for Devices and
Radiological Health
Food and Drug Administration

 Authority

Section 1135 of the Social Security Act [42 USC §1320b–5] permits the Secretary of Health and Human Services to waive certain regulatory requirements for healthcare facilities in response to emergencies.  Two conditions must be met for the Secretary to be able to issue such “1135 waivers”:  first, the Secretary must have declared a Public Health Emergency; second, the President must have declared a National Emergency either through a Stafford Act Declaration or National Emergencies act Declaration.  If these conditions are met, then healthcare facilities may petition for 1135 waivers in response to particular needs, and only within the geographic and temporal limits of the emergency declarations.

Under Section 1135:

The Secretary may tailor authorities granted under Section 1135 waivers to match the specific situational needs, but the requirements that may be waived include those related to Medicare, Medicaid or the Children’s Health Insurance Program (CHIP), the Emergency Medical Treatment and Active Labor Act (EMTALA), and the Health Insurance Portability and Accountability Act (HIPAA).  These requirements provide important protections for patients during normal day-to-day operations, but they may impede the ability of healthcare facilities to fully implement disaster operations plans that enable appropriate care during emergencies.  For example, requirements under the Emergency Medical Treatment and Active Labor Act (EMTALA) would prohibit hospitals from certain rapid triage or sorting activities and prevent the establishment of off-site, alternate care facilities that could off-load emergency department demand.

• Waivers are permitted only to the extent they ensure that sufficient health care items and services are available to meet the needs of Medicare, Medicaid, and CHIP beneficiaries in the emergency area during the emergency period.  The “emergency area” and the “emergency period” are the geographic area, in which, and the time period, during which, the dual declarations exist. 
• Permitted actions include the waiver or modification of conditions of participation, other certification requirements, program participation requirements, pre-approval requirements for health care providers; waiver of sanctions for certain directions or relocations and transfers that otherwise would violate the Emergency Medical Treatment and Labor Act (EMTALA); waiver of sanctions related to Stark self-referral prohibitions; modifications to deadlines and timetables for the performance of required activities; and waiver of sanctions and penalties arising from noncompliance with certain Health Insurance Portability and Accountability Act (HIPAA) privacy regulations.

Examples of use of waivers:

• Hospitals request to set up an alternative screening location for patients away from the hospital’s main campus (requiring waiver of the Emergency Medical Treatment and Labor Act-EMTALA)
• Hospitals request to facilitate transfer of patients between ERs and inpatient wards between hospitals (requiring waiver of both EMTALA and HIPAA regulations)
• Critical Access Hospitals requesting waiver of 42 CFR 485.620, which requires a 25-bed limit and average patient stays less than 96 hours
• Skilled Nursing Facilities requesting a waiver of 42 CFR 483.5, which requires CMS approval prior to increasing the number of certified beds in a distinct part

Past instances where authority to grant Section 1135 waivers was enabled for recent disaster events include

• Hurricane Katrina (2005)
• 56th Presidential Inauguration (2009)
• Hurricanes Ike and Gustav (2008)
• North Dakota flooding (2009)

Q:  Why do this now; why can’t we wait until a hospital or region needs these 1135 Waivers?

            A:  The H1N1 epidemic is moving rapidly.  By the time regions or healthcare systems recognize they are becoming overburdened, they need to implement disaster plans quickly.  1135 Waivers still require specific requests be submitted to HHS and processed, and some State laws may need to be addressed as well.  Adding a potential delay while waiting for a National Emergency Declaration is not in the best interest of the public, particularly if this step can be done proactively as the President has done today. 

Q:  Has the authority to grant 1135 waivers been granted before?

            A:  Yes, there are several instances where 1135 Waiver authority has been granted under the Stafford Disaster Relief and Emergency Assistance Act (vice National Emergencies Act) to help healthcare facilities cope with large patient burdens.  Recent examples include Hurricane Katrina (2005), Hurricanes Ike and Gustav (2008), and the North Dakota flooding (2009).  In addition, 1135 waiver authority has been granted previously as a precautionary measure, as in the case of the recent 56th Presidential Inauguration (2009).

Q:  Specifically, what will this NEA Declaration enable and what will this allow hospitals to do, if a waiver is requested and granted?

            A:  An NEA Declaration fulfills the second of the two conditions required for the Secretary of HHS to be able to grant 1135 waivers.  If requested, and HHS grants an 1135 waiver, healthcare facilities will be able to utilize alternate care sites, modified patient triage protocols, patient transfer procedures, and other actions that occur when they fully implement disaster operations plans.

Q:  Is the HIPAA Privacy Rule suspended during a national or public health emergency?

            A (from the HHS Office for Civil Rights website):  No; however, the Secretary of HHS may waive certain provisions of the Rule under the Project Bioshield Act of 2004 (PL 108-276) and section 1135(b)(7) of the Social Security Act.

What provisions may be waived

If the President declares an emergency or disaster and the Secretary declares a public health emergency, the Secretary may waive sanctions and penalties against a covered hospital that does not comply with certain provisions of the HIPAA Privacy Rule:

1. the requirements to obtain a patient’s agreement to speak with family members or friends involved in the patient’s care (45 CFR 164.510(b))
2. the requirement to honor a request to opt out of the facility directory (45 CFR 164.510(a))
3. the requirement to distribute a notice of privacy practices (45 CFR 164.520)
4. the patient’s right to request privacy restrictions (45 CFR 164.522(a))
5. the patient’s right to request confidential communications (45 CFR 164.522(b))

When and to what entities does the waiver apply

If the Secretary issues such a waiver, it only applies:

   1. In the emergency area and for the emergency period identified in the public health emergency declaration.

   2. To hospitals that have instituted a disaster protocol.  The waiver would apply to all patients at such hospitals.

   3. For up to 72 hours from the time the hospital implements its disaster protocol.

When the Presidential or Secretarial declaration terminates, a hospital must then comply with all the requirements of the Privacy Rule for any patient still under its care, even if 72 hours has not elapsed since implementation of its disaster protocol. 

Regardless of the activation of an emergency waiver, the HIPAA Privacy Rule permits disclosures for treatment purposes and certain disclosures to disaster relief organizations. For instance, the Privacy Rule allows covered entities to share patient information with the American Red Cross so it can notify family members of the patient’s location.  See 45 CFR 164.510(b)(4).

Learn More:  * See http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/emergency/katrinanhipaa.pdf for information on sharing information in emergency situations.

All employers are required to have an Exposure Control Plan which identifies job classifications, tasks, and procedures where there is occupational exposure to Bloodborne pathogens. This plan must be available to employees and reviewed and updated annually.

Safety Devices: Employer must evaluate medical devices with enginerred sharps injury protections otherwise known as safety devices. Employers must use appropriate, effective, and commercially available safety devices. Front-line employees are to be involved in the evaluation and selection process of safety devices.

Hepatitis B Vaccination: Employers must offer free hepatitis B vaccinations to all employees with occupational exposure to blood or other potentially infectious materials (OPIM).

Other Controls: Employers must ensure that employees comply with Standard Precautions (also know as universal precautions). Provide and ensure the use of appropriate personal protective equipment, such as gloves, gowns, lab coats, face shields or masks and eye protection, and mouthpieces, resuscitation bags, pocket masks, or other ventilation devices. And ensure that contaminated sharps are disposed of in proper sharps disposal containers.

Post-Exposure Incident Procedures: Employers must establish a procedure for post-exposure evaluation and follow-up. Documentation of exposure must include: the route of exposure and other circumstances, and identify the source individual where feasible. Employers must offer post-exposure medical evaluation by a healthcare professional at no cost to employees and must test the source individual’s blood for BBPs where possible, and test the exposed employee’s blood after consent is obtained. Employers must ensure the provision of post-exposure medication when medically indicated and as recommended by the treating physician in accordance to the most recent CDC guidelines.

Training: The training of employees with occupational exposure must include the following elements: 1) An accessible copy of the BBP standard (29 CFR 1910.1030); 2) Information on the epidemiology and symptoms of bloodborne diseases; 3) Information on modes of transmission of BBPs; 4) Description of employer’s Exposure Control Plan and how to get a copy; 5) How to recognize tasks that may involve exposure to blood or OPIM; 6) Use and limitations of methods to reduce exposure, including enginerring controls, work practices, and personal protective equipment; 7) Information on the hepatitis B vaccine; what to do and whom to contact after an exposure; 9) information on post-exposure evaluation and follow-up; 10) an opportunity for interactive questions and answers.

Need assistance putting all of the components together for you healthcare facility call InCo and Associates International. We can put the pieces together for you.