HLT-24-15-00006-A Patient Access of Laboratory Test Results
12/23/15 N.Y. St. Reg. HLT-24-15-00006-A
NEW YORK STATE REGISTER
VOLUME XXXVII, ISSUE 51
December 23, 2015
RULE MAKING ACTIVITIES
DEPARTMENT OF HEALTH
NOTICE OF ADOPTION
I.D No. HLT-24-15-00006-A
Filing No. 1032
Filing Date. Dec. 07, 2015
Effective Date. Dec. 23, 2015
Patient Access of Laboratory Test Results
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
Amendment of Parts 34 and 58 of Title 10 NYCRR.
Statutory authority:
Public Health Law, section 576 and 587
Subject:
Patient Access of Laboratory Test Results.
Purpose:
To give patients a right to access medical records directly from clinical, including completed lab. test reports.
Text or summary was published
in the June 17, 2015 issue of the Register, I.D. No. HLT-24-15-00006-P.
Final rule as compared with last published rule:
No changes.
Text of rule and any required statements and analyses may be obtained from:
Katherine Ceroalo, DOH, Bureau of House Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.ny.gov
Assessment of Public Comment
Comment:
One comment generally supported the right of patients to access patient information but also expressed reservations about clinical laboratory test results being immediately available to patients prior to being seen or signed off by the ordering physician. The commenter thought this could be detrimental when the testing was for difficult or life-threatening diagnoses. The commenter asks that wording be included in the regulation to allow the physician who ordered the testing the opportunity to review the results prior to the patient having access to them. This would give the doctor the ability to speak to the patient and clarify what the test results mean before the patient sees the report.
Response:
The Federal Department of Health and Human Services (HHS) addressed this concern in responses to public comments received on the newly adopted federal rule. HHS emphasized that the rule does not alter the role of the ordering or treating provider in reporting and explaining test results to patients. HHS expects that patients will continue to obtain test results and advice about what those test results mean through their ordering or treating providers.
HHS also noted that under 45 CFR § 164.524(b)(2)(i), laboratories are not required to provide individuals with access to their laboratory test reports immediately; laboratories can wait up to 30 days. HHS believes 30 days is generally sufficient to allow the ordering or treating provider to receive the test report in advance of the patient’s receipt of the report, and to communicate the result to the patient, and counsel the patient as necessary with regard to the result. HHS emphasized that laboratories will not be responsible for providing interpretations of laboratory test results to patients.
Comment:
A comment requested information regarding how the proposed rule would be implemented given the requirements in PHL § 2781(5) for persons ordering HIV related tests to communicate test results to the subject of the test.
Response:
This regulation will have no effect on such requirements. Persons ordering HIV related tests will continue to be required to comply with PHL § 2781(5) in exactly the same manner.
Comment:
Some commenters requested that language be removed from 10 NYCRR § 34-2.11 that requires a clinical laboratory to direct patient inquiries regarding the meaning or interpretation of the test results to the referring health services purveyor, because this language prohibits a clinical laboratory pathologist from conferring with a patient on the interpretation of laboratory/pathology test results.
Response:
Removal of the language in 10 NYCRR § 34-2.11 is not consistent with the Department’s goal of aligning its regulations with the federal requirements. Additionally, the requirement that a clinical laboratory direct patient inquiries regarding the meaning or interpretation of the test results to the referring health services purveyor applies to all clinical laboratory directors, including those individuals who are not pathologists. The Department of Health is planning on meeting with stakeholder groups to obtain additional feedback on conferrals between pathologists and patients.
Comment:
One comment generally supported the right of patients to access patient information but requested that language be removed from 10 NYCRR § 34-2.11 that requires a clinical laboratory to advise a patient that test results have already been, or are simultaneously being, communicated to the referring health services purveyor. The commenter stated that the current regulations would require a clinical lab to make customized statements on their reports for NYS patients indicating that that the provider has, or is receiving, results. This additional language on reports issued to NYS patients would be administratively burdensome and costly due to the need for additional programming of their reporting systems. They also stated that these requirements are of no therapeutic benefit to the patient.
Response:
The Department does not believe it is necessary to change the regulation as it does not specifically require that a statement be made on a patient report.
