intellispace perinatal rev. h - philips

Patient Monitoring

Meaningful Use Addendum

IntelliSpace Perinatal

Rev. H.00

4535 644 63491Software revision H.00.20Published in Germany 10.2013Internal Code: 20131022

1Table Of Contents
1 Introduction 1
Meaningful Use Stage 2 1

2 Meaningful Use Stage 2 Technical Addendum 3

Meaningful Use (MU) Installation Requirements 3

Setup Requirements 3

Value Table Configuration Requirements 3

End User Device Encryption - 170.314 (d)(7) 4

Auditable Events and Tamper Resistance - 170.314 (d)(2) 4

Integrity - 170.314 (d)(8) 5

Demographics - Preferred Language Tables 5

3 Meaningful Use Stage 2 IfU Addendum9

Documenting Demographics 9

Vitals Signs, Body Mass Index and Growth Charts 10

Medication List 10

Allergy List 11

Smoking Status 11

Authentication, Access Control and Authorization 12

Amendments 12

Emergency Access 13

Audit Reports 13

Automatic Log Off 13

Automated Numerator Recording 14

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1

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1Introduction

1.1 Meaningful Use Stage 2IntelliSpace Perinatal revision H.00.20 provides functionality to support compliance with the sixteen Meaningful Use Stage 2 objectives outlined below.

You will require a special initial setup and Value Table Editor (VTE) configuration. Some of the criteria will require a change in how you document a field, some will require the use of a specified IntelliSpace Perinatal feature, and others will require no change to your workflow or documentation.

Your system will only comply with certification guidelines if it is implemented and configured as described in this document, and you use the workflows and features as described here.

The information is divided into a technical addendum for the system administrator and an addendum to the Instructions for Use (IfU) for the end users, Super Users and System Managers.

Objective Reference to Information

170.314(a)(3) Demographics see “Documenting Demographics” on page 9

170.314(a)(4) Vital signs, body mass index, and growth charts

see “Vitals Signs, Body Mass Index and Growth Charts” on page 10

170.314(a)(6) Medication List see “Medication List” on page 10

170.314(a)(7) Medication Allergy List see “Allergy List” on page 11

170.314 (a)(11) Smoking Status see “Smoking Status” on page 11

170.314 (d)(1) Authentication, access control, and authorization

see “Authentication, Access Control and Authorization” on page 12

170.314 (d)(2) Auditable Events and Tamper Resistance

see “Auditable Events and Tamper Resistance - 170.314 (d)(2)” on page 4

170.314 (d)(3) Audit Report(s) see “Audit Reports” on page 13

170.314 (d)(4) Amendments see “Amendments” on page 12

170.314 (d)(5) Automatic log off see “Automatic Log Off” on page 13

170.314 (d)(6) Emergency access see “Emergency Access” on page 13

170.314 (d)(7) End User Device Encryption see “End User Device Encryption - 170.314 (d)(7)” on page 4

170.314 (d)(8) Integrity see “Integrity - 170.314 (d)(8)” on page 5

170.314 (g)(1) Automated Numerator Recording see “Automated Numerator Recording” on page 14

170.314 (g)(3) Safety Enhanced Design Compliancy is based on the validation process used.

170.314 (g)(4) Quality Management System Philips’ Product development process is compliant.

1 Introduction Meaningful Use Stage 2

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2Meaningful Use Stage 2Technical Addendum

2.1 Meaningful Use (MU) Installation Requirements

The system must be installed following the details outlined in the sections Setup Requirements and Value Table Configuration Requirements.

2.1.1 Setup RequirementsDuring IntelliSpace Perinatal setup, select the following System Settings:

• Meaningful Use certification

• Storage

• Patient record attachment management

The External Database must be set up, and word and excel template printing using Microsoft Office must be configured in the system.

Copy the meaningful use stage 2 excel template from the distribution medium :\OB TraceVue\Configuration\Meaningful Use, to the Internal Server \tv2_templates\customer\maternal\excel\manual folder, or, if you intend to automatically print the template, copy the file to \tv2_templates\customer\maternal\excel\auto. For details about MU template automation refer to the System Administration and Configuration Guide, chapter 6.4.8 Meaningful Use Template.

2.1.2 Value Table Configuration RequirementsDelete all items from the following folders in the Value Table Editor (VTE):

• \\Maternal\Forms\Demographics\Race / Ethnicity

• \\Maternal\Forms\Demographics\Preferred Language

Delete the following folders from VTE Folder \\Maternal\Forms\Admission\Table\Smoking Status:

• Current every day smoker

• Current some day smoker

• Former smoker

• Never smoker

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2 Meaningful Use Stage 2 Technical Addendum End User Device Encryption - 170.314 (d)(7)

• Smoker, current status unknown

• Unknown if ever smoked

Delete the length measurement(s) from the following VTE folders:

• \\Newborn\Forms\Admission\Measurements\

• \\Newborn\Forms\Discharge\Measurements\

Select Merge file from Value Table Editor. Then browse to the distribution medium :\OB TraceVue\Configuration\Meaningful Use, and merge all folders from the provided VTE default files.

Choose which configuration to merge:

Both files contain all the Meaningful use relevant value table defaults; the difference is in the list of languages only.

• MUBaseLang.tvt:

Base Language Value Table: contains the most popular languages in the U.S., for details refer to the chapter demographics.

• MUAllLang.tvt:

Full Language Value Table: contains all languages from the standard, for details refer to the chapter demographic.

2.2 End User Device Encryption - 170.314 (d)(7)End users work with IntelliSpace Perinatal on thin or thick clients only (not on the Internal or External Server). On these clients the application does not store patient health information, so that encryption of end user devices is not required.

2.3 Auditable Events and Tamper Resistance - 170.314 (d)(2)

When the Meaningful use system setting is selected, the audit logging functionality is always turned on and cannot be turned off by any user.

All audit information is stored in the archive on episode closure. The system audit trail is automatically stored every day at midnight in the archive.

The archive is only accessed by the retrieve operation that reads the episode data. The data cannot be changed, overwritten or deleted by IntelliSpace Perinatal as it uses a read operation only. Also, every re-open or correction activity to an existing episode will create a new archive episode. This protects history episodes in the archive from being changed, overwritten or deleted.

If an archive package is modified from outside the application, the retrieve operation detects the tampering using a Philips hash algorithm and reports an error message.

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Integrity - 170.314 (d)(8) 2 Meaningful Use Stage 2 Technical Addendum

2.4 Integrity - 170.314 (d)(8)This function is provided by a CheckSumVerifier Add-In. In order to detect unintended changes of template content after document creation, a checksum using the SHA-2 secure hash algorithm can be generated and verified.

For details about the checksum functionality refer to the Site Preparation Guide and IT Specification Guide, Chapter 5.4.1.5 Installing Check Sum Verification Add-In, and the System Administration and Configuration Guide, Chapters 5.3.3.1 Enabling/Disabling SHA-2 Check Sum Generation and 5.3.3.2 Perform Check Sum Verification.

2.5 Demographics - Preferred Language TablesThe languages are derived from the ISO standard 639-2.

Base Language Value Table:

Full Language Value Table:

ISO 639-2 Code Name ISO 639-2 Code Name ISO 639-2 Code Name

eng English guj Gujarati pol Polish

spa Spanish hat Haitian por Portuguese

ara Arabic heb Hebrew rus Russian

hye Armenian hin Hindi srp Serbian

zho Chinese ita Italian tgl Tagalog

hrv Croatian jpn Japanese tha Thai

fra French kor Korean urd Urdu

deu German nav Navajo vie Vietnamese

ell Greek, Modern (1453-)

fas Persian yid Yiddish

X Declined to specify


eng English ces Czech ndo Ndonga

spa Spanish dan Danish nep Nepali

ara Arabic div Divehi sme Northern Sami

hye Armenian nld Dutch nor Norwegian

zho Chinese dzo Dzongkha nno Norwegian Nynorsk

hrv Croatian epo Esperanto oci Occitan (post 1500)

fra French est Estonian oji Ojibwa

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2 Meaningful Use Stage 2 Technical Addendum Demographics - Preferred Language Tables


deu German ewe Ewe ori Oriya

ell Greek, Modern (1453-)

fao Faroese orm Oromo

guj Gujarati fij Fijian oss Ossetian

hat Haitian fin Finnish pli Pali

heb Hebrew ful Fulah pan Panjabi

hin Hindi gla Gaelic por Portuguese

ita Italian glg Galician pus Pushto

jpn Japanese lug Ganda que Quechua

kor Korean kat Georgian ron Romanian

nav Navajo grn Guarani roh Romansh

fas Persian hau Hausa run Rundi

pol Polish her Herero rus Russian

por Portuguese hmo Hiri Motu smo Samoan

rus Russian hun Hungarian sag Sango

srp Serbian isl Icelandic san Sanskrit

tgl Tagalog ido Ido srd Sardinian

tha Thai ibo Igbo sna Shona

urd Urdu ind Indonesian iii Sichuan Yi

vie Vietnamese iku Inuktitut snd Sindhi

yid Yiddish ipk Inupiaq sin Sinhala

X Declined to specify gle Irish slk Slovak

abk Abkhazian jav Javanese slv Slovenian

aar Afar kal Kalaallisut som Somali

afr Afrikaans kan Kannada sot Sotho, Southern

aka Akan kau Kanuri sun Sundanese

sqi Albanian kas Kashmiri swa Swahili

amh Amharic kaz Kazakh ssw Swati

arg Aragonese kik Kikuyu swe Swedish

asm Assamese kin Kinyarwanda tah Tahitian

ava Avaric kir Kirghiz tgk Tajik

ave Avestan kom Komi tam Tamil

aym Aymara kon Kongo tat Tatar

aze Azerbaijani kua Kuanyama tel Telugu

bam Bambara kur Kurdish bod Tibetan

bak Bashkir lao Lao tir Tigrinya

eus Basque lat Latin ton Tonga (Tonga Islands)

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Demographics - Preferred Language Tables 2 Meaningful Use Stage 2 Technical Addendum


bel Belarusian lav Latvian tso Tsonga

ben Bengali lim Limburgan tsn Tswana

bih Bihari languages lin Lingala tur Turkish

bis Bislama lit Lithuanian tuk Turkmen

nob Bokmål, Norwegian lub Luba-Katanga twi Twi

bos Bosnian ltz Luxembourgish uig Uighur

bre Breton mkd Macedonian ukr Ukrainian

bul Bulgarian mlg Malagasy uzb Uzbek

mya Burmese msa Malay ven Venda

cat Catalan mal Malayalam vol Volapük

khm Central Khmer mlt Maltese wln Walloon

cha Chamorro glv Manx cym Welsh

che Chechen mri Maori fry Western Frisian

nya Chichewa mar Marathi wol Wolof

chu Church Slavic mah Marshallese xho Xhosa

chv Chuvash mon Mongolian yor Yoruba

cor Cornish nau Nauru zha Zhuang

cos Corsican nde Ndebele, North zul Zulu

cre Cree nbl Ndebele, South

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2 Meaningful Use Stage 2 Technical Addendum Demographics - Preferred Language Tables

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3Meaningful Use Stage 2IfU Addendum

If your institution is using IntelliSpace Perinatal to support your meaningful use (MU) objectives, this can require changes to your workflow in some areas. This addendum to the Instructions for Use covers those changes.

3.1 Documenting Demographics For maternal and newborn demographics there is an MU objective (170.314 (a)(3))that requires that you record the patient’s sex, race, ethnicity, preferred language and date of birth. For race, ethnicity and preferred language you must also be able to record that a patient declined to specify or that state law prohibits recording this data.

You can do this on the Demographics page. For each field, except for date of birth, there is a drop-down menu with the choices, including Declined to specify, where required. For Race, multiple choices can be made. When MU is configured, you cannot type information into these fields.

Depending on how your system has been set up, you may have the short list of languages (the 30 most common languages) or the complete list.

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3 Meaningful Use Stage 2 IfU Addendum Vitals Signs, Body Mass Index and Growth Charts

3.2 Vitals Signs, Body Mass Index and Growth Charts

Growth charts are an optional certification criterium and are not included in IntelliSpace Perinatal.

The MU objective 170.314 (a)(4) requires vital signs for maternal patients only. To meet this requirement, the blood pressure must be charted in the patient’s flow chart.

To meet the BMI requirement for maternal patients, the height and weight must be entered in the Exam page, either at a prenatal visit or at admission. The BMI is then calculated automatically.

To meet the BMI requirement for newborn patients, the weight and length must be entered in the Measurements section of the newborn Admission page. The BMI is also calculated here automatically.

3.3 Medication ListThe MU objective 170.314 (a)(6) requires that you record the patient’s active medication list and medication history. This can be done using the standard functionality on the Meds page.

If the patient has no medications, this must also be recorded. You can record “no medications” on the Meds page by checking the box in the Show in summary column (marked !) when no medications have been entered.

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Allergy List 3 Meaningful Use Stage 2 IfU Addendum

3.4 Allergy ListThe MU objective 170.314 (a)(7) requires that you record the patient’s active medication allergy list and medication allergy history. This can be done using the standard functionality on the Allergies page.

With the Mark all others negative key you can automatically make entries in all categories indicating that there are no known allergies.

3.5 Smoking StatusThe MU objective 170.314 (a)(11) requires that you record the smoking status using a list of standard responses. You can do this on the Admission page, by checking Meaningful Use Smoking Status and selecting the appropriate response from the dropdown list.

If you type another response in here, instead of selecting one from the list, you will not be compliant with this requirement.

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3 Meaningful Use Stage 2 IfU Addendum Authentication, Access Control and Authorization

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3.6 Authentication, Access Control and Authorization

The MU objective 170.314 (d)(1) requires that access to the system is limited and that users are assigned specific permissions according to their role. In IntelliSpace Perinatal, the Super User or System Manager can define user log-in names and passwords and define whether the user has permission to view patient data and to edit patient data.

3.7 AmendmentsThe MU objective 170.314 (d)(4) requires the capability to attach an amendment to a patient’s record at their request, or to record that their request to attach an amendment was denied. You can do this on the Attachments page of the appropriate form, for example Admission, Prenatal Visit or Discharge.

You can select Amendment accepted or Amendment denied in the dropdown list for Category.

Emergency Access 3 Meaningful Use Stage 2 IfU Addendum

3.8 Emergency AccessThe MU objective 170.314 (d)(6) requires that users can gain access to data in an emergency. In IntelliSpace Perinatal, the Super User or System Manager can set up an additional user account for the nominated users. For example, a user that does not have patient data view permission, could in the event of an emergency, switch to an emergency user which grants patient view permission. The emergency user account is set up with the same settings as the original user account, with the following additions:

• append “EMR” to the user name

• add the permission to view patient data

3.9 Audit ReportsThe requirements of MU objective 170.314 (d)(3) are met by the standard system audit trail functionality in IntelliSpace Perinatal. Refer to the Understanding Audit Trails chapter in the Instructions for Use for details.

3.10 Automatic Log OffThe MU objective 170.314 (d)(5) requires that user sessions be ended automatically when inactive, to avoid open sessions being used by unauthorized personnel. In IntelliSpace Perinatal, the Super User or System Manager must set 1 minute as the period of inactivity, after which the user should be logged off and the session closed, in the PC configuration. As 1 minute is not included in the dropdown list, it must be typed into the field.

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3 Meaningful Use Stage 2 IfU Addendum Automated Numerator Recording

3.11 Automated Numerator RecordingThe MU objective 170.314 (g)(1) requires that data on the number of cases that fulfill specific requirements from the objectives is collected automatically and made available, for example in the form of a report. In IntelliSpace Perinatal the Meaningful Use Excel template is provided to create a report for the required objectives.

Following the standard procedures for printing statistics you select the Meaningful Use statistical report. Once this is open, navigate to the Evaluation Period pane to select the appropriate reporting interval, stage and measure. Below is an example of the Evaluation Period pane:

You can also use the Excel file to check which cases do not yet meet the requirements by selecting the Not Met Log tab at the bottom of the screen:

NOTE The IntelliSpace Perinatal external database is designed as a rolling database, with data purge recommended at the latest after 2 years to keep performance at an acceptably high level. In order to keep the generated logs and reports for longer periods of time, store them in a safe location.

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intellispace perinatal rev. h - philips

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