ehr onc final certification - Department of Health Care Services
ehr onc final certification - Department of Health Care Services ehr onc final certification - Department of Health Care Services
may result in disparities with the official record of test results. These commenters wanted to ensure that the laboratory's record would be the same as the record maintained in the EHR. One commenter stated that paragraph (g)(4) could imply process and system behavior that we did not intend to require. The commenter stated that it is common practice in a hospital setting for lab results to be transmitted in high volume from a lab system to an EHR and made available for review to the clinician through the EHR, without a need for a user to review each transaction before updating the EHR to make the results available. Another commenter made a similar point and questioned whether an “update” meant manual intervention, which they stated would be impracticable in a hospital setting. One commenter stated that most EHR technology already links orders to lab results in an established way. The commenter also indicated that the certification criterion we adopted requires changes to a process that most EHR developers have already implemented and introduces inefficiencies for both EHR developers and health care providers. Response. We appreciate the issues raised by commenters on this specific capability and have revised this part of the certification criterion to more clearly express our expectation for Certified EHR Technology and to be responsive to and consistent with commenters’ suggestions. We intended for an update to mean, as indicated by the meaningful use objective and measures, that a laboratory test result would be incorporated in Certified EHR Technology with the originating laboratory order or with a patient’s record in any one of the methods specified. Accordingly we have revised this specific capability to more clearly reflect our intent. We believe this addresses commenters’ concerns and requests for clarification and would permit batches of Page 72 of 228
laboratory test results to be electronically linked to laboratory orders or patient records without manual intervention. Comments. Some commenters noted that small and medium size practices have had a difficult time working with commercial laboratory vendors to provide interfaces from which they can receive lab test results. These commenters noted that laboratory vendors typically charge too much for their services and do not prioritize establishing connections with small and medium size practices because they do not have the same volume of laboratory referrals as large practices. Response. This certification criterion requires as a condition of certification that Certified EHR Technology be capable of supporting electronic laboratory interfaces. We understand the concerns raised by commenters pertaining to the difficulty of certain practices being able to obtain laboratory interfaces and note that the meaningful use Stage 1 measure associated with this certification criterion is included in the “menu set” specified by CMS which we believe should help assuage some commenters’ concerns. We do not believe that the ability of a practice (regardless of size) to obtain an interface or other type of connection is an issue that is within the scope of this final rule to address. Comment. One commenter recommended that we revise this certification criterion to require that laboratory domain expertise be exhibited when laboratory information is displayed. The commenter further elaborated by stating that laboratory results are not homogeneous, and that specific laboratory domain expertise is necessary to design the ways in which the data associated with certain laboratory results (e.g., microbiology, molecular pathology) are displayed in EHR systems to ensure appropriate presentation and interpretation. Page 73 of 228
- Page 21 and 22: program established by the National
- Page 23 and 24: criteria adopted by the Secretary a
- Page 25 and 26: Comment. In the context of the defi
- Page 27 and 28: y the certification criteria for a
- Page 29 and 30: commenters asked whether we meant t
- Page 31 and 32: adopted by the Secretary. The secon
- Page 33 and 34: Response. We would like to make cle
- Page 35 and 36: Response. In the Interim Final Rule
- Page 37 and 38: could be a health care professional
- Page 39 and 40: standard for certain purposes. In s
- Page 41 and 42: e voluntary and would not be requir
- Page 43 and 44: already existing regulatory require
- Page 45 and 46: setting). We also include, where ap
- Page 47 and 48: clarification on why the number of
- Page 49 and 50: more clearly specify this capabilit
- Page 51 and 52: Response. While we do not require t
- Page 53 and 54: that check, the functionality show
- Page 55 and 56: Response. The comments are correct
- Page 57 and 58: enable the user to electronically r
- Page 59 and 60: longitudinal care, or whether the E
- Page 61 and 62: EHR and EHR Module developers to pr
- Page 63 and 64: suggestions for different age range
- Page 65 and 66: Record smoking status for patients
- Page 67 and 68: 23) during the EHR reporting period
- Page 69 and 70: laboratory test results are receive
- Page 71: commenters reasoned that because a
- Page 75 and 76: or outreach Generate patient lists.
- Page 77 and 78: months). We believe that these revi
- Page 79 and 80: that the PQRI 2009 Registry XML spe
- Page 81 and 82: To better align this certification
- Page 83 and 84: the capability specified by the cer
- Page 85 and 86: vendors were unwilling or unable to
- Page 87 and 88: the concerns expressed by some comm
- Page 89 and 90: Page 89 of 228 electronically compa
- Page 91 and 92: (1) The standard (and applicable im
- Page 93 and 94: for the purposes of demonstrating c
- Page 95 and 96: Guide for Immunization Messaging Re
- Page 97 and 98: Response. We clarify for commenters
- Page 99 and 100: serve as a limiting factor, however
- Page 101 and 102: Page 101 of 228 Unchanged Comment.
- Page 103 and 104: Comment. One commenter suggested th
- Page 105 and 106: Response. We appreciate the thought
- Page 107 and 108: Complete EHRs or EHR Modules design
- Page 109 and 110: Response. We disagree. As stated ab
- Page 111 and 112: Response. As discussed above, we ha
- Page 113 and 114: SHA-1 and other secure hash algorit
- Page 115 and 116: misinterpreted our example and stat
- Page 117 and 118: Other commenters also expressed con
- Page 119 and 120: eferenced in FIPS 140-2 Annex A, wh
- Page 121 and 122: of the most secure encryption algor
may result in disparities with the <strong>of</strong>ficial record <strong>of</strong> test results. These commenters<br />
wanted to ensure that the laboratory's record would be the same as the record maintained<br />
in the EHR. One commenter stated that paragraph (g)(4) could imply process and system<br />
behavior that we did not intend to require. The commenter stated that it is common<br />
practice in a hospital setting for lab results to be transmitted in high volume from a lab<br />
system to an EHR and made available for review to the clinician through the EHR,<br />
without a need for a user to review each transaction before updating the EHR to make the<br />
results available. Another commenter made a similar point and questioned whether an<br />
“update” meant manual intervention, which they stated would be impracticable in a<br />
hospital setting. One commenter stated that most EHR technology already links orders to<br />
lab results in an established way. The commenter also indicated that the <strong>certification</strong><br />
criterion we adopted requires changes to a process that most EHR developers have<br />
already implemented and introduces inefficiencies for both EHR developers and health<br />
care providers.<br />
Response. We appreciate the issues raised by commenters on this specific<br />
capability and have revised this part <strong>of</strong> the <strong>certification</strong> criterion to more clearly express<br />
our expectation for Certified EHR Technology and to be responsive to and consistent<br />
with commenters’ suggestions. We intended for an update to mean, as indicated by the<br />
meaningful use objective and measures, that a laboratory test result would be<br />
incorporated in Certified EHR Technology with the originating laboratory order or with a<br />
patient’s record in any one <strong>of</strong> the methods specified. Accordingly we have revised this<br />
specific capability to more clearly reflect our intent. We believe this addresses<br />
commenters’ c<strong>onc</strong>erns and requests for clarification and would permit batches <strong>of</strong><br />
Page 72 <strong>of</strong> 228
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