Labs Must Comply With New OSHA Standard

Arevised labeling standard issued by the U.S. Department of Occupational Safety and Health Administration (OSHA) has implications for clinical and anatomic pathology laboratories that must certify compliance in order to participate in federal health care programs. The revised Hazard Communication Standard (HCS) contains two important changes that will affect laboratories. The revised standard changes the labeling elements and the format of the Material Safety Data Sheets, including shortening the name to Safety Data Sheets (SDSs). Implementation will be phased in over several years (Dec. 1, 2013, to June 1, 2016), with the first implementation requirement deadline Dec. 1, 2013. What does this have to do with laboratory compliance? When a laboratory completes its 855b Medicare Enrollment Application, it certifies that it meets all federal and state requirements for the type of supplier for which the application is being submitted. The clinical laboratory is required to meet OSHA chemical hygiene and OSHA bloodborne pathogen regulations. If the laboratory is not meeting those standards, it could lose its ability to participate in the Medicare program. The first compliance date for the revised HCS, Dec. 1, 2013, requires that laboratories and other covered parties must have trained their workers on the new label elements in the SDS format. OSHA believes the training should occur early in the transition process because workers are already beginning to see the new labels and the revised SDSs is in their workplace. In an OSHA fact sheet published in February 2013 the requirements of the training are laid out in a list format. The training focuses on new label elements, which must include information the employees would expect to see on the labels, including product identifier, signal word (hazard alert), and pictograms that describe the nature of the hazard. According to OSHA, the new labels must also include “precautionary statements which describe recommended measures to minimize or prevent adverse effect resulting from exposure. The training should include information on how employees might use the labels to help them properly store chemicals and locate information on first aid. The second part of the training should include information on the new format of SDSs and must include information on the standardized 16 section format and how the information on the new label relates to the information in the SDS.” Specific information on the revised standard, published in March 2012, can be found on the OSHA Web site (www.OSHA.gov) by searching for “revised hazard communication.” Click on the first item that comes up in the list titled “revised hazard communication standard (aligned with GHS).” OSHA Compliance and Medicare Enrollment While many labs focus their compliance efforts on the anti-kickback law, Stark statute, and privacy and security requirements, the fact is that OSHA compliance is just as important. This issue was highlighted recently when LabCorp was cited by OSHA for alleged repeat and serious health violations. An article in the June 11 issue of National Intelligence Report describes how the laboratory has been cited more than once for similar violations and how the standard applies to all of the laboratory’s locations where federal enforcement standards are in place, even in other states. The violations centered around the company not providing mandatory training for its employees before they were required to participate in job-related duties that exposed them to health and safety risks. Repeated violations are often considered neglectful and put the laboratory in the position of being seen as a company that is neglecting its requirements to protect its employees and meet federal and state laws and regulations. In this era of heightened scrutiny on compliance issues and Medicare and Medicaid fraud and abuse concerns, a laboratory could find itself under the microscope because of a violation of a law that it perceives has nothing to do with compliance as described in the various OIG compliance guidance documents. When a laboratory violates OSHA laws and regulations, it is not meeting the certification it attested to in its enrollment form and could have its billing privileges revoked. Lack of Useful Statistics The OSHA Web site contains a large variety of statistical information parsed and provided in different ways and formatted in different ways. Even with all of these statistics, it is difficult to find information specific to laboratories about the number of complaints, inspections, and violations that have occurred so it is impossible to estimate the frequency of OSHA complaints and violations for clinical laboratories. Keep in mind, however, that OSHA laws and regulations exist at both the federal and state levels and this serves to increase the risk. Many OSHA inspections occur as a result of employee complaints and in some cases can come from a disgruntled employee. Two private industry sectors experienced declines in the rate of injuries and illnesses in 2011 compared to 2010—health care and social assistance (driven by declines both in hospitals and in nursing and residential care facilities). While this bodes well for the health care industry, it is not necessarily helpful for estimating risk associated with OSHA violations in clinical laboratories. Actions Laboratory administrators and compliance professionals are responsible for ensuring that these rules are followed. There are two actions that can be taken to minimize risk of the kinds of problems experienced at LabCorp. The compliance officer should include compliance with all mandatory training requirements, including OSHA, in periodic audits and reviews. Most of these trainings occur on an annual basis but others may be conducted as needed when a new requirement is published. At that time, affected employees will need to be trained and the annual training will need to be revised to reflect the new requirement. The compliance officer’s responsibility is to make certain the training occurs and the annual training materials are updated. The second recommended action is to design and conduct an audit prior to the effective date of the new requirement, and at an appropriate interval after the effective date, to ensure compliance has occurred. In this audit, do not vary the critical aspects of the audit, unless absolutely necessary, so results can be compared. If the audit needs redesign, redesign it after the second audit and before it is conducted again.