Just as drivers cannot plead ignorance of the law when being ticketed for speeding, nor can labs plead ignorance of federal regulations when being inspected. And, on the flip side, just as following the rules of the road can improve one’s driving skills, adhering to the CAP Laboratory General Checklist allows a lab to build a sound data-management program.
That’s the message of a recent CAP audioconference, titled “External Regulations Pertinent to LIS Functionality,” presented by John Sinard, MD, PhD. Dr. Sinard, a member of the CAP Diagnostic Intelligence and Health Information Technology Committee and director of pathology informatics at Yale University Medical School, noted that labs tend to underestimate the number of HIPAA and CLIA requirements that apply to laboratory information systems. Consequently, the volume of LIS-related questions in the CAP Laboratory General Checklist can overwhelm them.
It’s important to remember that those questions “are based on the requirements of existing CLIA regulations and address many of the issues contained in HIPAA,” as well as promote sound data-management practices, he told CAP TODAY.
The LIS-related questions in the CAP Laboratory General Checklist are divided into two phases. Phase I questions promote what the College deems to be sound data-management practices, while phase II questions address requirements for CAP accreditation. The checklist, in part, addresses the computer facility, LIS procedure manual, hardware and software, system maintenance and security, patient data, autoverification, data retrieval and preservation, interfaces, and networks.
Of particular importance is the need for documentation. “It’s a big theme here,” Dr. Sinard says. “Documentation is key, and it’s required on many levels.” The checklist instructs lab directors to establish policies that document how the laboratory is meeting federal requirements. It also directs lab personnel to record policy compliance in logs and mandates that designated employees sign off on policies and logs. “[CAP] inspectors will say that if something is not documented, then it was not done,” Dr. Sinard adds.
The audioconference also highlights the checklist requirement that a laboratory with LIS functionality housed at a remote site verify that the hosting facility meets CAP standards, even if that facility is in a different state. For example, the checklist requires that the hosting facility have appropriate fire-fighting equipment and protection against power outages and interruptions. It also strongly recommends that the laboratory document that the host facility is clean and environmentally controlled and has properly protected wires and cables.
While laboratories may have limited control over the operations of a host facility, “it remains the responsibility of the laboratory director to assure that laboratory operations are not compromised by inadequate hosting services,” Dr. Sinard says. “It’s not acceptable to say, ‘I don’t know,’ about an issue at an off-site facility,” he adds. “The bottom line is that the guidelines in the checklists govern appropriate management of these facilities because inappropriate management there can compromise patient care. The aim of this requirement is to ensure that the system will be available when you need it.”
To promote compliance with this requirement, Dr. Sinard suggests that a laboratory give the facility hosting its LIS a copy of the checklist and stipulate in its contract with the host facility that the latter must meet CAP checklist requirements. Most reputable, large companies that specialize in hosting LIS functionality are familiar with the checklist and comply with it, he says, but a lab could unknowingly contract with an unscrupulous or uniformed firm.
Also discussed in the audioconference were checklist interfacing requirements. According to the checklist, a lab must validate annually against each system connected to its LIS. “What if the LIS is interfaced to 50 different systems? Must the lab validate against all of them? The answer is still yes, you validate them all every year,” Dr. Sinard says.
The days of an LIS sending results to one or two other systems in the same hospital are gone, he points out. Now labs may get samples from hundreds of physician offices, and they need to send results on paper and via computers.
“Directors are responsible for making sure that results going to other treating physicians are accurate,” he says. “Clinicians are making treatment decisions based on viewing lab results on their own office systems. If that office system doesn’t display normal ranges, or if its interface drops a decimal point, the lab is still responsible for an accurate result. The lab director can’t just say, ‘I sent it correctly.’ Correctness is defined not by what information went out, but by what information is received.”
“View the CAP checklist questions for LIS not as a burden, but rather as tools for promoting best practices,” Dr. Sinard adds. The questions, which were written largely by members of the CAP Diagnostic Intelligence and Health Information Technology Committee, take into account “the realities of practicing pathology in today’s environment.”
The checklist authors understand that many pathology departments don’t have direct control over their LIS, he says. “In many institutions, the hospital information system has control over functionality.” In such situations, he continues, the CAP checklist can be a valuable tool for providing pathology departments leverage for making sure that best practices are being met by the institution’s information systems group.
The electronic health records marketplace gained ground last month with passage of the American Recovery and Reinvestment Act of 2009. The new law addresses what is perceived to be the largest barrier to EHR adoption—cost.
Under the legislation, providers, including independent pathologists, are eligible for a $15,000 incentive payment for adopting certified medical records, starting in 2011. Incentive payments are available, in decreasing amounts, until 2015. The money will be dispensed through the Medicare and Medicaid programs.
To be eligible for the incentive, providers must demonstrate “meaningful use” of certified EHR technology, according to the legislation, such as using e-prescribing and connecting to outside entities via health information exchanges. Details of how criteria are to be met and measured were not included in the law.
Hospital-based pathologists are not eligible for the incentive payment as policymakers were concerned it could lead to double payment. The legislation allocates health information technology incentives directly to hospitals instead.
The Congressional Budget Office estimates that passage of the act will dramatically increase EHR adoption and that approximately 90 percent of physicians and 70 percent of hospitals will be using comprehensive electronic health records within the next decade.
Aperio Technologies and Cerner Corp. have developed an interface between Aperio’s Spectrum digital pathology information management system and Cerner’s CoPathPlus anatomic pathology information system.
With the interface, pathologists will be able to archive, analyze, and examine slides digitally via Spectrum while accessing patient information and other data in CoPathPlus.
DSS Inc., a developer of enhancements to VistA, the Veterans Administration’s electronic health record, announced it will open source the code for its vxVistA, an enhanced version of VistA designed for the commercial market.
“VistA deployments in the private sector have demonstrated that VistA can provide private hospitals and clinics with the highest quality electronic health record in the shortest amount of time for a fraction of the cost of competing products,” says Mark Byers, president and CEO of DSS. “We can lower the cost of health care while significantly increasing the quality of that care by implementing VistA across the United States.”
To this end, DSS has joined the Open Health Tools Foundation, an umbrella nonprofit organization for open-source projects in health care.
The College of American Pathologists has released its CAP Electronic Cancer Checklists in XML format.
“XML was chosen for its universal acceptance, ease of use, and its ability to facilitate the sharing of structured information across different information systems, particularly via the Internet,” says Cory Hall, director of the CAP Diagnostic Intelligence and Health Information Technology Department. “XML supports the transformation of information into multiple electronic formats for ease of integration into existing pathology and cancer registry systems,” he adds.
The electronic checklists are synoptic or structured summary reports intended to provide clinicians with comprehensive, consistent information about tumor findings. They are encoded with the international health care terminology standard SNOMED CT.
The Amsterdam-based publisher Elsevier recently introduced two medical research Web sites, SciTopics and eClips Consult.
SciTopics, www.scitopics.com, is a free site for medical, scientific, and technical research collaboration. The site initially offers 650 pages of content from more than 800 scientists. It is intended as a starting point for scientific research and provides a content publishing platform that has search and collaboration functions. Users can conduct keyword searches. Authors posted on the site offer a list of references and suggested Web resources.
Elsevier’s new subscription service, eClips Consult, www.eclips.consult.com, provides access to clinical research from 350 medical journals and journal abstract databases. The Web site and e-mail service provide article recommendations from more than 280 medical specialists. Daily e-mails can be customized to display links to articles of interest
The Center for Cell Phone Applications in Healthcare, developed by the Medical Records Institute to promote the use of mobile technologies, is being re-established as an independent, nonprofit organization called mHealth Initiative.
MHealth is open to organizations, vendors, groups, and individuals interested in the development and use of mobile technologies for health care purposes.
“Through mHI, we will create a road map for the new health ecosystem based on mDevices, new software, new interoperability solutions, and secure wireless transmission,” says Claudia Tessier, president of mHealth Initiative and former vice president of the Medical Records Institute.
Tessier will work alongside Peter Waegemann, who is leaving his post as founder and CEO of the Medical Records Institute to become executive director of mHI.
Geisinger Health System, Danville, Pa., has contracted to purchase Sunquest Information Systems’ Outreach Advantage connectivity product to facilitate communication between its laboratory, community physician offices, and patients.
Aspyra has entered into an agreement with Diamond Reference Laboratory, Diamond Bar, Calif., to upgrade the lab’s LIS to the most current release of Aspyra’s CyberLab laboratory information system, version 7.2. Aspyra will also implement its CyberPath anatomic pathology module at Diamond.
Clara Maass Medical Center, a member of the St. Barnabas Health Care System, Belleville, NJ, has selected Axolotl Corp. to provide technology and services for its health information exchange.
Global Med Technologies’ Wyndgate Technologies division has licensed its eDonor, ElDorado Donor, and Donor Doc integrated donor-management systems to the South Texas Blood & Tissue Center, San Antonio. The center serves more than 100 hospitals and clinics in 43 south Texas counties, operates a certified tissue bank, and is a National Marrow Donor Program registration site.
Dr. Aller is director of automated disease surveillance and team lead for disaster preparedness Focus B, Los Angeles County Department of Public Health. He can be reached at email@example.com. Hal Weiner is president of Weiner Consulting Services, LLC, Florence, Ore. He can be reached at firstname.lastname@example.org.