Gerald A. Hoeltge, MD, FCAP, quality officer, Pathology and Laboratory Medicine Institute, Cleveland Clinic
Since their implementation, the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations have presented some challenges to clinical lab professionals.
However, a September 14, 2011, Centers for Medicare and Medicaid Services (CMS) Proposal to amend CLIA may be, if implemented, one of the most challenging yet, says Rochelle P. Stewart, MBA, CLS, MLS(ASCP)CM, QLC(ASCP), CLC/MT(AMT), founder, president, and CEO, rpl Laboratory Solutions® Inc, Southern California, a laboratory consulting firm that helps clients handle complex state and federal regulatory and accreditation requirements for waived and nonwaived lab testing. To be assured consideration, comments had to have been received by November 14, 2011.
Gerald A. Hoeltge, MD, FCAP, quality officer, Pathology and Laboratory Medicine Institute, Cleveland Clinic, says the CMS Proposal was to revise its CLIA regulations to facilitate patients’ access to the laboratory test results. If adopted, 42 CFR 493.1291(f)(1) would read, “Upon a patient’s request, the laboratory may provide access to completed test reports that, using the laboratory’s authentication process, can be identified as belonging to that patient.”
According to Hoeltge, “The Proposed Rule goes along with today’s trend of allowing patients to control their health care choices and medical records. As the use of electronic medical records becomes more common, patients’ desire to have unfiltered, immediate access to their test results is understandable. Those of us who work in the laboratory and generate those test results want our patients to benefit from the information contained in accurate, reliable testing.”
CHALLENGES FOR CLINICAL LABS
Rochelle P. Stewart, CEO, rpl Laboratory Solutions® Inc
This is not the first or only challenge presented to clinical labs by CLIA, Stewart notes. “In the physician and group practice settings, I’d have to say that understanding all the specifics of the regulations and how to translate the requirements into a simple process is probably the biggest challenge for the practices,” she says. “As a result, the practices tend to shy away from lab services, not because it isn’t a feasible and integral part of patient care. But rather the concern of not making the grade when it comes to inspections, getting cited by a government agency, even though they are trying their best, is a real fear. It’s unfortunate because with qualified, expert assistance, setting up and maintaining an operational, compliant lab focused on quality patient testing is a relatively simple process. And the physician should be able to control the provision of lab testing for his/her patients.”
But the new patient data Proposal has stirred concerns. Some feel it will be a time drain on lab workers, setting in motion issues revolving around releasing results to the incorrect or unauthorized end user and exposing them to questioning by the patients for interpretation of the results. Laboratorians’ training and scope of practice do not include clinical assessment, and mechanisms already exist to provide patients with results and qualified interpretation. However, others acknowledge the need for a new rule and are even already offering wider patient access. Stewart says the new Proposal is starting a strong wave of discussion within the industry, noting that with most new Proposals there is polarization. “Making it a rule versus allowing practices to move forward on their own initiative can create a resistance,” Stewart says. “Right now a large number of facilities provide direct patient access to their lab results online or by mailing them the report once completed.
“It’s mostly an issue when a patient walks into the facility and requests the reports in person,” Stewart says. “Then it’s a matter of filling out form(s) and waiting. I think that if the industry is left to its own resources, direct access to results is just one of the many services of transparency that the medical facilities will provide.
“Health care is still a competitive business,” Stewart says. “Once a medical facility [read: competitor] comes up with an innovative and sought-after patient [read: consumer] service, other facilities will move in the same direction to remain competitive and on the cutting edge.”
Stewart says she’s not certain this proposed rule was truly required. “Society today is very informed and has a wealth of knowledge and information at its collective fingertips through the Internet,” she says. “People are also less timid about speaking out. Some may say that I’m a little naïve on this, but I’m a strong believer in free market and individual enterprise. The market will drive the services that patients want and/or need, including removing barriers to patient access.”
Neil M. Desai, Quest Diagnostics
CONSIDERATIONS FOR LABS
Hoeltge says there are three aspects of this Proposal to be thought through. First, the rule would deny the laboratory discretion in the release of those test results. Although the proposed rule reads “may provide,” existing HIPAA regulations grant the right of access to electronic records to patients or their representatives. The combination of the CMS Proposed Rule plus the HIPAA rules would force laboratories to develop policies and procedures to give patients their laboratory test results directly upon request. This may include substantial modifications to existing forms and software.
Second, laboratories will need to be able to identify the patient. Only the patient or his representative is authorized to receive the test result. Unlike the patient’s physician, the laboratory rarely has a personal relationship with the patient. How is the lab to authenticate such a request? The Proposal provides no guidance, Hoeltge says.
Last—and most important from the aspect of quality patient care—test results must be personalized to the patient’s health picture to be interpretable. “Test results given outside of a conversation with the attending physician can harm the patient,” Hoeltge says. “A cancer diagnosis, for example, is a life-changing event. When the surgeon shares the pathologic diagnosis with the patient, the impact of that news is discussed, and the patient’s questions are answered.
“Other test results—particularly, genetic test results—are difficult to interpret, or must be combined with other test results to be understood,” Hoeltge says. “Physicians may need to consult with colleagues before talking to the patient about a test result. No laboratory wants to impose upon the doctor-patient relationship that is so fundamental to healing.”
DIRECT ACCESS FOR PATIENTS
Some providers have anticipated the need to facilitate patients’ access to their testing data in a thoughtful way, he notes. “At the Cleveland Clinic, we give our patients access to their information through an interactive and secure patient health record called MyChart©,” Hoeltge says. “It is secure because it is password-protected. The software authenticates the recipient of the information. Patients have rapid access to many routine laboratory test results.
“Laboratory test results routinely released to MyChart without discussion may include lipid profiles, blood glucose, and hemoglobin A1c determinations,” Hoeltge says. “First, our physicians review their patients’ results to determine whether the release to MyChart would have the potential to cause confusion, fear, or undue anxiety. In cases where a physician feels that the potential for fear or anxiety exits, the physician contacts the patient directly to review the results and then releases them to MyChart for the patient to review.”
Hoeltge notes that CMS has received many helpful comments on this Proposal. “All of us who live and work in the clinical laboratory trust that the Final Rule will be in the very best interest of our patients and their families,” he says.
Neil (Nilesh) M. Desai, executive director, enterprise architecture and technology, Quest Diagnostics, Madison, NJ, who leads its Gazelle mobile health app, agrees that providing laboratory results directly to patients is vital to the movement toward increased transparency, patient participation, and consumerism in health care.
“Providing direct data access will help foster patient-physician dialogue so patients will be more engaged in decisions affecting their health,” Desai says. “It will help them to see trends in their own lab data that may spur healthier lifestyles. For instance, a patient with diabetes can track her or his A1c diabetes test results, which in turn may spur greater interest in losing weight or otherwise exercising more.”
The rule, if adopted, will also encourage health record portability, a key element of health care reform for improving quality and cost efficiencies, Desai says.
ROLE OF HEALTH INFORMATION TECHNOLOGY
Desai says it is impossible to discuss direct patient-data access without also discussing health care information technology. To a great extent, the Internet and mobile devices are drivers in the movement to give patients greater access to their data. Quest Diagnostics is a leader in adopting health care information technology to improve health care information exchange with physicians, patients, and other groups, Desai says.
“About 200,000 physicians and clinicians now use our Care360 connectivity platform for lab orders and results,” he says. “Quest Diagnostics also offers the Gazelle mobile health app, which facilitates patient access to test results while also providing the ability to manage other health data, like physician contact information and medication lists. While we only released the app about a year ago, user interest is growing strongly and it is routinely among the top 25 downloaded health apps on the Apple store.
“We believe Quest Diagnostics is the only laboratory company in the US providing both electronic health systems for physicians and hospitals, through Care360 and other tools, and electronic patient health records for patients, through Gazelle,” Desai says. “In fact, physicians who use our Care360 electronic system and patients who use our Gazelle mobile health app can seamlessly connect electronically to facilitate direct patient access.”
In terms of the Proposal’s impact on the lab industry, Desai says that because some states already facilitate direct patient access, some labs may already have systems in place for fulfilling requests. “Quest Diagnostics has made considerable investments in health care information technology, including Care360 and Gazelle,” Desai says. “We already provide data access to patients in many states, so we expect the transition would largely involve extending current systems into new states.” Quest currently facilitates about a million requests for lab data from patients each year.
CHANGING PHYSICIAN-PATIENT DYNAMICS
Perhaps the biggest potential impact of the rule on the health care industry will be in changing the dynamic of interactions between physicians and patients, Desai says. “I’m concerned that some physicians do not understand how strongly many patients want to be able to access their own data,” he says. “As one patient who uses Gazelle recently told us, ‘It’s my health and my results; I should be able to get them as easily as possible.’ “
The laboratory industry can help educate physicians, hospital pathologists, and others about this keen patient interest in direct data access, Desai says. “The labs, physicians, and hospitals that do a good job of facilitating direct data access will have a potent advantage in gaining patient loyalty in the future,” he adds.
There’s interest in increased patient access to results. As previously reported in CLP, on October 26, 2011, Ortho Clinical Diagnostics, Raritan, NJ, in partnership with the National Association of Chronic Disease Directors (NACDD), Atlanta, unveiled new consumer survey results and a report revealing the state of blood test health literacy in the United States with strategies to support much-needed patient education and empowerment. The first step: ensuring patient access to and understanding of blood test results, a critical component to maintaining health and wellness.
The survey found that although nearly 90% of people would prefer to discuss blood test results during a physician’s visit, only about 40% have discussed their results in person, primarily because the results were either mailed or e-mailed to the patient or the patient never received the results. Some respondents reported that providers told them to assume everything was OK if the physician did not notify them about the results.
Based on these findings, the “Know Your Numbers” campaign was developed to help patients realize the importance of blood test results in maintaining their health, and encourage them to take a more active role in obtaining and engaging with their health care providers to understand blood test results. Key to achieving the goals of the campaign is ensuring that laboratories can get results directly to patients and their health care providers, currently a limiting factor in 39 states.
“Diagnostic test results are your personal health care report card, influencing 60% to 70% of health care decision-making,” says John Robitscher, CEO, NACDD. “It is crucial that people are able to obtain blood test results in a timely manner and understand the basic information provided to have a meaningful conversation with their doctors. Empowering patients to understand the connection between their blood tests and lifestyle may help prevent the onset of a chronic disease, as well as help reduce unnecessary health care costs attributed to inadequate health literacy.”
AUTHENTICATING PATIENTS’ ID
In the HIPAA requirements, laboratories have an obligation to authenticate the individual making the request for data, Desai says, noting that Quest Diagnostics already does that in states where it is giving patients access to their data; Quest Diagnostics currently services patients who want direct patient access in three ways:
- Physicians: When a physician orders a lab test, the patient may ask the physician to indicate on the requisition that Quest Diagnostics should also send her or him a copy of the test results. Most tests take between 1 to 10 days to complete. If the patient wants a copy of previous test results, she or he can ask the physician to send a copy.
- Patient Service Center: Quest Diagnostics has about 2,000 patient service centers across the country where patients provide specimens for testing. If a patient asks if they can access their data, Quest reviews the request with respect to the state in which they are located. If it is permitted for their state, Quest asks the patient to fill out a brief form. The form asks for their name, contact information, and birth date, but not a social security number. Once this is complete, results are typically provided to the patient electronically via fax. The whole process before the patient gets her/his results is about 30 days.
- Gazelle: The other approach is through Quest’s Gazelle mobile health app. When a user downloads Gazelle, she has the option to request data rights. Again, the patient fills out a brief form, and if she is in a state that permits it, Quest can provide the access. Quest employs a third-party authorization technology that verifies that the patient is who she says she is. It does this by asking for personal information only the patient would know—such as, “What was your first car?”
Desai adds that peer-reviewed studies published in respected journals provide evidence that direct patient-data access may improve both quality and patient engagement:
- A study published in the Annals of Internal Medicine in 2009 found that patients are not informed of approximately 7.1% of abnormal lab results.
- A study published in LabMedicine in 2007 found that “patients want information on their lab results, an understanding of their results and that understanding the purpose of their tests and their relationship to their conditions would increase their satisfaction with the health care system.”
Gary Tufel is a contributing writer for CLP.
