The Honorable James Jeffords
United States Senate
Washington, DC 20510
Dear Chairman Jeffords:
The American Association for Clinical Chemistry (AACC), representing nearly 11,000 professional laboratory scientists, welcomes the opportunity to comment on your bill, S.1921, the Health Care Personal Information Nondisclosure Act of 1998. In general, we support your efforts to expand patient control over medical data, maintain the integrity of health care research and minimize the administrative burdens on health care entities. We hope that our comments, which follow, will help make this an even better bill.
Section 101 Inspection and Copying of Protected Health Information
S.1921 states that an individual has the right to inspect and copy his or her own ‘protected’ health information, as long as he or she agrees to pay the costs associated with inspecting and copying the document. The bill also states that the provider has 30 days to comply with this request. AACC recommends that providers be given 60 days to respond to the initial request, when the records are stored off premises or are not readily available.
Sections 101(d) Statement Regarding Request; 102 (b)&(c) Amendment of Protected Health Information
The legislation would also permit individuals to request that the health care provider amend their medical records. If the provider denies the request, the individual could file a statement with the provider disputing the decision. In any subsequent disclosure of the disputed information, the provider would be required to include a copy of the patient’s statement and, if requested, the provider’s reasoning for not adding the supplemental information to the medical record. AACC recommends that the applicability of this section be more narrowly defined.
We agree that patients who perceive errors in their medical records, should be able to request and obtain a correction to their records. However, the laboratory is not the appropriate provider for maintaining supplemental information. Currently, many laboratories transfer such data to microfilm once the patient transaction is completed. Permitting patients to add supplemental information to their laboratory records would therefore require the establishment of a separate, parallel filing system. This would be both impractical and costly for many laboratories, while not improving the confidentiality of patient results.
More important, without the patient’s complete medical record, the laboratory is unable to confirm whether a patient’s request is valid or not. The only person who can make that determination is the primary care physician. We therefore recommend that the supplemental data option be limited to the primary care provider (whether in private practice or in the hospital), who is the primary source of most such inquiries and who can best determine whether the patient’s request is valid.
Section 102(a)(3) Amendment of Protected Health Information
Section 102 (a)(3) states that a provider, after amending the patient’s record, "must make reasonable efforts to inform any person to whom the unamended portion of the information was previously disclosed, of any non-technical amendment that has been made." AACC recommends that this provision be modified so that the provider has the discretion, based on the medical relevancy of the information, to determine whether the "amended" section of the patient record should be sent to the individuals who previously received the protected health information.
Section 102 Rules of Construction
AACC recommends that you include a provision, stating that a health care provider does not have to delete or alter the original medical information, even though the patient may request that such a change be made.
Section 112 (a)(1) Accounting for Disclosures
This section states that a health care provider "shall establish and maintain, with respect to any protected health information disclosure, a record of such disclosure in accordance with regulations issue by the Secretary." Although AACC agrees with the intent of this provision, we believe that a reasonable phase-in period is necessary to accomplish this task. The only feasible method for documenting the disclosure of test results is through electronic means. However, not all laboratories have electronic records systems. In addition, many existing electronic systems will need to be modified to capture this information. AACC therefore recommends that laboratories be given five years, from the effective date of any subsequent regulation, to comply with this provision.
Section 112 (b) Record of Disclosure & 202 (d) Record of Individual’s Authorizations and Revocations
These sections stipulate that each person collecting or storing personally identifiable health information shall maintain such records of each authorization and revocation for seven years,, and that such data will become part of the person’s identifiable health information. We recommend that you change these provisions to make them consistent with the Medicare conditions of participation for hospitals, which require hospitals to maintain patient records for five years. (emphasis added)
Section 202 (c)(3) Actions
This provision states that "an individual may not maintain an action against a person for disclosure of protected health information made in good faith reliance on the individual’s authorization at the time disclosure was made." AACC recommends that this protection be expanded to cover the health care entity, as well as the individual. Thus, Section 202 (c)(3) should be modified to read: "…an action against a person or entity for disclosure." (Underlined words represent the change to the provision.)
Section 205 Emergency Services
The draft bill states that "any person who creates or receives protected health information under this title may disclose protected health information in emergency circumstances when necessary to protect the health or safety of the individual." The legislation further states that release of such information, in good faith, is not punishable by this Act. AACC strongly supports this flexibility. We believe it is essential that health care providers be able to focus their attention on helping the patient and not have to worry about possible legal ramifications for doing so.
Section 208 Health Research
S. 1921 requires that health researchers remove or destroy patient identifiers associated with specimens unless they get approval from an institutional review board (IRB). We agree with this recommendation. However, we are concerned that the current language may have an unintended, adverse effect a laboratory’s ability to comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA’88).
The CLIA regulations require that laboratories "verify or establish," for each test method, the accuracy of the test, the normal range of results and other performance specifications. To meet these requirements, laboratories review patient records, note their test results and identify those individuals diagnosed with a particular disease. This process permits the laboratory to establish the ‘normal range’ for healthy individuals and validate the accuracy of the test.
Although laboratorians do not consider this health research, it may considered so under your legislation. Thus, laboratories could be required to get IRB approval to validate each test method. This would be very costly, onerous and time consuming for laboratories, especially smaller hospitals and laboratories that do not have IRBs. We recommend that you specifically exclude such activities from the definition of health research.
By way of background, AACC is the principal association of professional laboratory scientists--including MDs, PhDs and medical technologists. AACC’s members develop and use chemical concepts, procedures, techniques and instrumentation in health-related investigations and work in hospitals, independent laboratories and the diagnostics industry nationwide. The AACC's objectives are to further the public interest and educational activities and to help maintain high professional standards.
If you have any questions or we may be of any assistance, please call me at (708) 216-4725 or Vince Stine, Director, Government Affairs, at (202) 835-8721.
Stephen Kahn, PhD, DABCC