ehr onc final certification - Department of Health Care Services

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ambulatory setting be required to receive HL7 2.5.1 formatted laboratory test results and those designed for an inpatient setting be required to receive HL7 2.3.1 formatted laboratory test results. One commenter suggested that our objectives could be better supported if we stated that in this certification criterion a requirement that laboratory results must be received electronically using HL7 transactions with implementation guidance. Response. While we understand the intent of these commenters’ suggestions, we do not believe that it is within the scope of this rule to dictate the standard by which laboratories transmit test results. The scope of this rule is the adoption of certification criteria that specify required capabilities of Certified EHR Technology (in this case, receiving laboratory information in structured format) and not, in this instance, specifying the standard by which laboratories must transmit test results. Comment. A commenter requested that we clarify how this certification criterion is applicable to hospital settings. The commenter asked whether we intended for the capability of receiving laboratory test results to include results obtained during a patient’s stay at the hospital or if we meant to also include the receipt of laboratory test results from other time periods. They suggested requiring only those laboratory test results obtained during the patient stay. Response. For the purposes of demonstrating compliance with this certification criterion, we do not specify the contexts (e.g., a patient stay) under which laboratory test results are received. Rather, consistent with the meaningful use objective and measure and the capabilities required by this certification criterion, we specify that when Page 68 of 228
laboratory test results are received in structured format by Certified EHR Technology, that the results can be incorporated. Comment. One commenter requested that we clarify whether the structured data requirement applies to all laboratories (including reference labs, hospital labs, physician office labs, and physicians performing their own lab tests). Response. This certification criterion requires Complete EHRs and EHR Modules to provide the capability to receive clinical laboratory test results in a structured format as a condition of certification. It does not speak to how laboratories must send the test results. Comments on 170.302(g)(2) Comments. Some commenters requested clarification on this specific capability within the certification criterion regarding what needed to be displayed in the context of LOINC codes. These commenters suggested that we not require the display of the actual LOINC code, but the description associated with the LOINC code. A commenter suggested that we identify a subset of common LOINC codes instead of requiring that tens of thousands of LOINC codes be supported for the purposes of certification. Other commenters suggested that we offer guidance in the form of a “starter set” of LOINC codes to encourage the use of the standard. One commenter requested that we confirm its understanding of this specific part of the certification criterion, which is that Certified EHR Technology must demonstrate the capability to import LOINC coded results from an external source. Finally, one commenter noted that the heading for the standard at §170.205(a)(2)(iii) should just refer to “laboratory test results” and not “laboratory orders and results.” Page 69 of 228
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DEPARTMENT OF HEALTH AND HUMAN SERV
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HHS Department of Health and Human
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5. Definition of Qualified EHR 6. D
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technology. Section 3004(b)(1) of t
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esolve identified technical challen
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Some commenters appear to have misi
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efficiencies and desired quality im
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codes must be used “inside” an
Page 17 and 18: not necessarily have applied to our
Page 19 and 20: 3. Definition of Implementation Spe
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: 23) during the EHR reporting period
Page 71 and 72: commenters reasoned that because a
Page 73 and 74: laboratory test results to be elect
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
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eferenced in FIPS 140-2 Annex A, wh
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of the most secure encryption algor
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the disclosure was made (recipient)
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Use CPOE for medication orders dire
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equire EHRs to build custom interfa
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esult, we do not believe that this
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was needed before RxNorm could be a
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• MDDB - Medi-Span Master Drug Da
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Response. We do not believe that it
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Send reminders to patients per pati
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specified data elements and CMS’s
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what would qualify as a "response."
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Comment. A commenter recommended th
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in accordance with one of the adopt
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Comments. Many commenters suggested
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flexibility in this certification c
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productive, confusing, time-consumi
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include in this initial set. Accord
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to the HITSP C32 implementation spe
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Response. Again, we do not believe
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e achieved without these and recomm
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electronically record, store, retri
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EHRs and EHR Modules designed for a
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§170.205(a)(2)(iii); and (v) The s
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Response. We disagree, as doing so
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Dental Terminology as a condition o
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However, we do not preclude Complet
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ability of CCD and CCR to support t
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ability to receive these reports. M
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commenters acknowledged and express
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a meaningful use objective they wou
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CMS and ONC had worked together to
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The eligible professional or eligib
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EHR technology with the needs of us
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The RFA requires agencies to analyz
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values seemed low and that the gap
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commenter provided), our assumption
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absolute low we estimated for a per
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number of previously CCHIT-certifie
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for Certification Low High Page 197
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Finally, the third type of cost we
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2012 15% $10.10 $30.80 $20.45 3-Yea
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The RFA requires agencies to analyz
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The Office of Management and Budget
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The standards and implementation sp
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The Secretary adopts the following
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any edition other than that specifi
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(e) Regenstrief Institute, Inc., LO
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4. Revise subpart C to read as foll
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smoker; current some day smoker; fo
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(2) Generate audit log. Enable a us
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(3) Medication allergy list; (4) De
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§170.205(a)(1) or §170.205(a)(2).
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(d) Electronic copy of health infor
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specifications) specified in §170.
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