President Barack Obama has declared the spreading H1N1 swine flu virus to be a national emergency and has signed a proclamation that gives hospitals more flexibility if they need to handle large numbers of flu patients. The proclamation is included in its entirety below:
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.
Provisions of 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 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 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 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 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)
Questions and Answers
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: 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.
Provisions that 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:
- 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))
- The requirement to honor a request to opt out of the facility directory (45 CFR 164.510(a))
- The requirement to distribute a notice of privacy practices (45 CFR 164.520)
- The patient's right to request privacy restrictions (45 CFR 164.522(a))
- 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:
- In the emergency area and for the emergency period identified in the public health emergency declaration.
- To hospitals that have instituted a disaster protocol. The waiver would apply to all patients at such hospitals.
- 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).
OSHA Seeks Comments on Combustible Dust Standard
“It’s time for workers to stop dying in preventable combustible dust explosions,” said U.S. Secretary of Labor, Hilda L. Solis. “Workplace safety is not a slogan. It’s a priority clearly embodied in our laws.”
“Last year, 14 workers lost their lives in a combustible dust explosion at Imperial Sugar in Port Wentworth, Georgia. Since 1980, more than 130 workers have been killed and more than 780 injured in combustible dust explosions,” added acting Assistant Secretary of Labor for OSHA, Jordan Barab.
The NEP has resulted in an unusually high number of general duty clause violations, indicating a strong need for a combustible dust standard. The general duty clause is not as effective as a comprehensive combustible dust standard would be at protecting workers. Responses to questions posed in the ANPR will help the agency propose an effective combustible dust standard.
Support for a combustible dust standard came from the U.S. Chemical Safety Board in 2006 and again in 2008 during a congressional hearing when the board said a new standard, combined with enforcement and education, could save workers’ lives.
Combustible dusts are solids ground into fine particles, fibers, chips, chunks, or flakes that can cause a fire or explosion when suspended in air under certain conditions. Types of dust likely to combust include metal (aluminum and magnesium), wood, plastic or rubber, coal, flour, sugar and paper.
The public has 90 days to comment on the proposed ANPR. The agency also will conduct stakeholder meetings and will analyze all information and comments received from the public in developing a proposed rule on combustible dust.
Construction Workers Must Wear High-visibility Warning Garments
“Highway construction workers should not suffer serious or fatal injuries simply because they could not be seen,” said acting Assistant Secretary of Labor for OSHA, Jordan Barab. “Requiring the use of reflective vests is essential to help prevent workers from being injured or killed.”
In 2004, OSHA issued a letter of interpretation about the use of high-visibility apparel in highway construction. The letter emphasized that section 5(a)(1) of the OSH Act requires workers in highway work zones to wear high-visibility apparel.
However, the Occupational Safety and Health Review Commission ruled that OSHA’s 2004 letter indicated a more limited position, that high-visibility garments were only required where the Federal Highway Administration’s Manual on Uniform Traffic Control Devices (MUTCD) mandates their use.
Therefore, OSHA is issuing a new letter stating that all highway and road construction workers must wear high-visibility apparel regardless of whether the MUTCD requires them to do this or not. OSHA considers road and construction traffic a well-recognized hazard to highway/road construction workers. The Bureau of Labor Statistics reinforced the need for using safety apparel when data from 2003 to 2007 showed there were 425 road construction work zone fatalities.
OSHA to Review all State Plan Programs and Issues Report on Nevada’s State Occupational Safety and Health Program
The comprehensive evaluation of the Nevada OSHA plan points to an urgent need for corrections in oversight and changes in all phases of its workplace safety and health program.
Twenty-five workers were killed in construction accidents at sites along the Las Vegas strip from January 2008 through June 2009. Those deaths, in addition to extensive media coverage revealing Nevada OSHA’s poor handling of the fatality investigations and several serious complaints filed with federal OSHA about Nevada’s state plan administration, compelled OSHA’s investigation.
“The safety of workers must be priority one, and the U.S. Department of Labor is stepping up review of state OSHA plans to ensure that is the case,” said Secretary of Labor Hilda L. Solis. “I am pleased that Nevada OSHA cooperated fully throughout the evaluation process and that the state agency’s new leadership has pledged to take prompt corrective action.”
Between July and August 2009, OSHA monitors evaluated Nevada’s workplace fatality investigations, as well as information from all Nevada OSHA inspections conducted from January 2008 through June 2009. OSHA identified a number of systemic issues that caused great concern including:
- Identified hazards were not cited,
- Families of deceased workers were not notified of fatality investigations nor provided opportunities to speak to investigators—though family members may provide information pertinent to a case, and
- Nevada OSHA investigators demonstrated limited knowledge of construction safety hazards.
The details of OSHA’s Nevada report raised concerns about OSHA’s monitoring of all state plan states. Jordan Barab, the Labor Department’s acting Assistant Secretary for OSHA, added, “As a result of the deficiencies identified in Nevada OSHA’s program and this administration’s goal to move from reaction to prevention, we will strengthen the oversight, monitoring and evaluation of all state programs.”
Barab also pointed out the benefits of state programs, including that, “Many state programs have shown they have the flexibility to deal with workplace hazards that are sometimes not addressed by federal OSHA, and we strongly support their initiative and dedication.”
Owner of Training Company Indicted for Issuing Sham Certificates
A federal grand jury indicted Rogelio (aka Roger) Lowe yesterday with two counts of mail fraud and nine counts of making or using a false document or writing, United States Attorney Joseph P. Russoniello announced.
Lowe, of Thornton, Calif., is charged with engaging in a scheme to defraud in connection with issuing certificates to asbestos removal workers despite knowing that he had not provided them with the proper training, and charging their employers the full price of the training. Lowe is also charged with making and using false documents in connection with his scheme.
Federal law prohibits any person from removing asbestos from schools and public and commercial buildings unless that person has been trained under a program either approved by the United States Environmental Protection Agency or an accredited State program. Asbestos is classified as a hazardous substance and known carcinogen. To become a certified asbestos worker, an individual must, at a minimum, complete a four-day, eight hours per day, training course. The training course must include lectures, demonstrations, at least 14 hours of hands on training and individual respirator fit testing. The student must then pass a closed-book examination. Once a person receives a certificate, he or she must then take an annual refresher course.
Lowe was the owner and operator of E&D Environmental Safety Training Inc., a safety consulting company that, according to its Web site, provides occupational training in asbestos work, lead abatement and mold remediation. According to the indictment, starting at an unknown date, but no later than 2008, Lowe provided asbestos removal courses that did not comply with federal law. As part of the scheme, Lowe did not teach the course for the required number of hours—including holding classes that were no more than 25 minutes in length—provided answers to the closed-book examinations, and forged tests for students that did not attend a test day. Lowe would then issue certificates to students and charge their employers accordingly.
The indictment further states that Lowe also submitted class rosters to the California Division of Industrial Relations, Division of Occupational Safety and Health, (Cal/OSHA), reflecting that these students had successfully completed the training and passed the closed-book examination when he knew they had not. Cal/OSHA used and relied on these rosters to add the names of students to its state list of qualified asbestos workers. According to the indictment, Lowe issued certificates for both initial asbestos training and annual refresher courses without providing the required training in violation of law.
Lowe made an initial appearance this morning in front of U.S. Magistrate Judge Elizabeth LaPorte and was released on a $400,000 bond. The matter has been assigned to the U.S. District Judge Jeffrey S. White. Lowe is scheduled to make an initial appearance in front of Judge White on Nov. 12, 2009 at 2:30 p.m.
The maximum statutory penalty for each count of violating Title 18 U.S.C. ? 1341—Mail Fraud—is 20 years and a fine of $250,000. The maximum statutory penalty for each count of violating Title 18 U.S.C. ? 1001—Making False Statements—is five years and a fine of $250,000. However, any sentence following conviction would be imposed by the court after consideration of the U.S. Sentencing Guidelines and the federal statute governing the imposition of a sentence, 18 U.S.C. ? 3553.
Stacey Geis is the Assistant U.S. Attorney who is prosecuting the case with the assistance of Rayneisha Booth. The prosecution is the result of a two-year investigation by the Federal Bureau of Investigation and the United States Environmental Protection Agency’s Criminal Investigative Division. The case was referred to the EPA and the FBI by Cal/OSHA, who provided assistance throughout the course of the investigation.
An indictment contains only allegations against an individual and, as with all defendants, Mr. Lowe must be presumed innocent unless and until proven guilty.
CSB to Examine Fire at Tesoro Refinery in Salt Lake City
. According to refinery officials, liquid hydrocarbons were released from a flare stack during an effort to restart the refinery’s crude unit. The hydrocarbons were ignited in a pool fire that extended from the base of the stack and damaged a trailer and other equipment that were positioned nearby.
CSB Chairman Bresland said the CSB inquiry would seek to determine if there are any similarities to the 2005 accident at the BP Texas City refinery, which occurred when flammable liquid erupted from a blowdown stack during a unit startup, leading to a massive vapor cloud explosion that killed 15 workers in nearby trailers and injured 180 others. The CSB recommended numerous changes to regulations, enforcement, and industry safety practices following that accident.
“Nearly four years after the disaster in Texas City, there continues to be a disturbing number of fires, explosions, and releases at the nation’s refineries. These events endanger workers and the public and can disrupt the supply of needed transportation fuels,” said Chairman John Bresland. “A sudden release of flammable liquid from a flare or blowdown stack poses a potential risk to people, equipment, and the environment and warrants a close look.”
No injuries were reported in the fire at Tesoro, but smoke and flames were visible over a wide area in Salt Lake City, and an interstate highway and a commuter rail line were closed temporarily. Refinery and municipal firefighters extinguished the blaze within an hour.
The CSB continues to investigate the serious flash fire that occurred in January 2009 at the Silver Eagle refinery in nearby Woods Cross, Utah, with a final report expected early in 2010.
For more information, contact Daniel Horowitz with the CSB at 202-261-7613 or 202-441-6074 (cell).
CSB Investigative Team Deploying to Caribbean Petroleum Corporation Tank Explosion in Puerto Rico
A six-person team from the U.S. CSB has deployed to the site of a major explosion and fire at a petroleum storage facility near San Juan, Puerto Rico, that occurred early Friday, October 23, 2009. Reports indicate that a number of large petroleum storage tanks are on fire at the Caribbean Petroleum Corporation facility in Bayamon.
Strike Force Finds Commercial Drivers in Violation of Drug and Alcohol Rules
The Federal Motor Carrier Safety Administration (FMCSA) announced 77 commercial bus and truck drivers are off the road and over 80 carriers face enforcement action as a result of FMCSA’s first national drug and alcohol strike force.
From September 8 to September 18, 2009 FMCSA safety investigators examined the drug and alcohol safety records of commercial drivers employed by bus companies, including school bus drivers, interstate passenger carriers, hazardous material transporters and general freight long-haul trucking companies.
“Safety is the number one priority for the Department of Transportation. Parents need to know when they put their child on a school bus that the driver will get them there safely and that they are drug and alcohol free,” said U.S. Transportation Secretary Ray LaHood. “Violators of our drug and alcohol policies have no business driving a commercial vehicle. Programs like the drug and alcohol strike force are helping remove the most dangerous offenders from our roadways.”
The 77 commercial drivers who face the prospect of civil penalties for failing to adhere to federal drug and alcohol regulations can no longer operate a commercial motor vehicle and will likely face a monetary fine. Additionally, 84 commercial carriers face pending enforcement action for violations such as using a driver that has tested positive for illegal drugs and for not instituting a drug and alcohol testing program.
The goals of the strike force were to identify motor carriers in violation of federal drug and alcohol testing requirements and to remove from the road commercial truck and bus drivers who jump from carrier to carrier to try and evade federal drug and alcohol testing and reporting requirements.
Both drivers and carriers will have an opportunity to contest the alleged violations and the amount of the civil penalties.
OSHA Proposes $254,000 in Fines for Lead Hazards at New Hampshire Foundry
OSHA has cited Franklin Non-Ferrous Foundry Inc., for 17 alleged willful and serious violations of workplace health and safety standards. The Franklin, New Hampshire, foundry faces a total of $254,000 in fines following comprehensive OSHA inspections that began in April.
“Chief among the hazards identified in the foundry are inadequate or absent protections for workers whose duties expose them to airborne concentrations of lead,” said Rosemarie Ohar, OSHA’s area director in New Hampshire. “Lead is a subtle and insidious hazard that can seriously damage the blood-forming, nervous, urinary and reproductive systems. This reality makes it imperative that employers monitor their workers’ lead exposure levels, provide effective respiratory protection and promptly remove workers from exposure when necessary.”
OSHA determined that the foundry did not provide the required biological monitoring for workers exposed to lead in the course of their duties, and did not properly fit-test and ensure adequate respiratory protection for those workers. In addition, it did not provide required benefits for a worker who was medically removed from work due to lead overexposure.
The foundry has been cited several times over the past decade for similar violations. These latest conditions resulted in OSHA issuing three willful citations with $210,000 in proposed fines. OSHA defines a willful violation as one committed with plain indifference to or intentional disregard for employee safety and health.
“The sizable fines proposed in this case reflect the fact that this employer well knows these safeguards are required to protect the health of its workers, yet has repeatedly refused to provide them,” said Ohar.
OSHA also issued the foundry 14 serious citations, with $44,000 in fines, for damaged and lead-contaminated respirators, and an erroneous and outdated lead compliance program, as well as for various confined space, forklift, machine guarding and electrical hazards. OSHA issues serious citations when death or serious physical harm is likely to result from hazards about which the employer knew or should have known.
OSHA Cites Alabama Construction Company with Repeat and Serious Safety Violations and Issues $146,000 in Penalties
OSHA is proposing $146,000 in penalties against T&C Construction in Hoover, Alabama, for safety violations. The inspection was initiated based on a Regional Emphasis Program on falls when an OSHA compliance officer observed that employees laying brick on a residential house were exposed to a fall hazard.
T&C Construction is being cited with 11 repeat violations with proposed penalties of $131,200. The violations include the company’s lack of a safety program; employees not wearing personal protective equipment; an extension cord being made with parts for permanent installation being on the ground; employees using electrical branch circuits that did not have a ground-fault circuit interrupter; several deficiencies in scaffolding procedures; and the employer’s failure to develop, implement or maintain a written hazard communications program for employees working with mortar or cement.
The employer also is being cited with five serious safety violations and $14,800 in proposed penalties. These violations include no guards on the gear or pulleys on the mixing machine, using an extension cord that had the grounding prong removed, scaffold planking that was not designed by a qualified person, damaged planking that was not replaced or removed, no guardrails installed on a ramp being used, and frames of the fabricated scaffold were not joined together with coupling or stacking pins.
“Previous to this inspection, T&C Construction was made aware of what needs to be addressed to protect its workers from injury, but the company choose not to act and continue to put its employees at risk,” said Roberto Sanchez, director of OSHA’s Birmingham Area Office. “They should not wait for death or serious injury to occur to one of their employees before they make the necessary changes.”
OSHA Proposes $112,300 in Fines for Electrical and Other Hazards at Armored Car Company
OSHA has cited Dunbar Armored Industries Inc., Dunbar Cash Vault Services, and Coin Wrap Inc., for 33 alleged violations of safety and health standards at Dunbar Armored’s New Britain, Connecticut facility. The three employers face combined penalties of $112,300, chiefly for electrical-related hazards, following OSHA inspections opened in April in response to a complaint.
“Electricity moves—and can kill or injure—at the speed of light. It doesn’t give you a second chance,” said C. William Freeman III, OSHA’s area director in Hartford. “That’s why it is vitally important that each employer at this workplace ensure that all electrical equipment, wiring and cords be properly and safely used and maintained on a continuing basis.”
Dunbar Armored Industries Inc., which operates the armored car service, was issued 17 serious citations, with $55,500 in proposed fines, for improperly grounded electrical equipment, blocked access to electrical panels, misused electrical equipment, damaged and misused power cords, unguarded openings in electrical boxes, a damaged electrical conduit, and failing to provide the company electrician with PPE and training in electrical safe-related work practices. It was also cited for a fire extinguisher that had not been tested in five years, improper compressed gas storage, unlabeled containers of hazardous chemicals, an unguarded grinder, and stair hazards.
Dunbar Cash Vault Services, which provides cash management services at the facility, was issued 12 serious citations, with $42,300 in fines, for blocked and unmarked exits, a leaking battery on a fork truck, misused electrical equipment, a broken electrical conduit, misused power cords, improperly grounded electrical equipment and other electrical hazards.
Coin Wrap Inc., which provides coin wrapping services at the facility, was issued four serious citations, with $14,500 in fines, for storing metal items atop electrical boxes, using power cords in place of permanent wiring, unguarded moving parts of a coin wrapping machine, and blocked access to electrical boxes.
OSHA Fines Steel Mill $82,500 for Willful and Repeat Violations
OSHA has cited steel mill Republic Engineered Products Inc., in Lorain with one alleged willful and one alleged repeat citation of federal workplace safety and health standards. Proposed fines total $82,500.
OSHA began a follow-up safety inspection at the Lorain site in April to verify that previous violations had been corrected and that the company remained in compliance with OSHA standards. The inspection revealed a willful violation for fall hazards and a repeat violation for failure to conduct inspections necessary for the control of lead exposure.
“Steel mills remain a dangerous place to work, and it is inexcusable to fail to correct serious dangers, particularly after they’ve already been identified by OSHA,” said OSHA Area Director Jule Hovi in Toledo, Ohio. “Falls are a leading cause of serious injury and fatalities in the workplace, and the destructive dangers of lead to working people and their families has been well documented. We expect better. I believe that all of us share a common interest and desire in seeing that every worker goes home safe and healthy at the end of every work shift.”
Republic Engineered Products Inc., previously has been inspected by OSHA 44 times nationwide since 1991, including three fatality investigations, and has received a total of 183 citations. From October 1999 through July 2002, the Lorain site was inspected eight times, including one fatality investigation, under the ownership of Republic Technologies Inc. From November 1989 through January 1999, the Lorain site was inspected 19 times, including five fatality/catastrophe investigations, under the ownership of U.S.S. Kobe Steel Co. There are currently 150 workers at the Lorain site and a total of 500 workers companywide.
OSHA issues repeat violations when a substantially similar violation of any standard, regulation, rule or order is found at any other facilities in federal enforcement states.
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