SS-MIX Japan Ministry s standardized storage and applications Michio

SS-MIX: Japan Ministry's standardized storage and applications Michio Kimura, MD, Ph. D, FACMI Hamamatsu University, Japan HL 7 Japan chair IMIA vice-president

PART 1 DISASTER PREPAREDNESS AND SS-MIX STORAGE Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine

11 March 2011 East Japan Earthquake z Magnitude 9. 0 earthquake, followed by 12 meter high Tsunami on March 11 y 25, 000 casualties, 90, 000 in refugee stations z Fukushima nuclear plant not cooled down, yet y. Evacuation zone: 20 km+ diameter z Tokyo is 250 km away: slight short of electricity z We sincerely appreciate all the helps from 135 countries, 15 int’l organizations y. From search dog to aircraft carrier Ronald Reagan Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine

Electricity failure by day Source: Report of Japan Soc. of Civil Eng. Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine

Failed stations of 3 Cell-phone companies by day Source: Report of Japan Soc. of Civil Eng. Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine

Healthcare provider operation at Iwate Prefecture by week Source: Report of Iwate Physicians Assoc. Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine

Recovery z. Each element recovery saturates in a week y. Electricity, Network, Restoration, Staffs y. Severely broken facilities takes much longer z. Healthcare provider operation is based on all of them ysaturates in a month Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine

What was needed? z We suffer from earthquake + something y+ fire, house crash : Kobe 1994: Surgical help y+ tsunami : Tohoku 2011: Chronic, Psychiatric z Most doctors went into the area said: “Past prescription history would have helped to keep the continuity of care” y. Atropine for chemical disaster, after atropine? y. Double-sheet copy paper could be the best solution x. One for record, one in patients’ hand, only with which continuity of care can be kept in refugee station. Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine

Priority of medical record contents Interview Survey by Healthcare, Welfare for dispatch team application working group z. High: y. Severity of injury/disease, Prescription history, Type of injury/disease z. Middle: y. Images of the patient (visible or X-ray), Past disease history (incl. examination results), Past progress notes z. Low: y. Past health checkup record. Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine

Does internet/SNS help? z. Telephone: requires both party at the same time (push-type) y. Congestion rate: 1 to 10 -20 y. Satellite cell-phone was reliable, and has RJ 45 net port(384 kb/s) z. Internet: pull for readers y. E-mail: one-to-one y. SNS: Easy to broadcast x. However, mountain of aide material arrived to few refugee stations which was on “broadcast” while neighboring Ph. D, FACMI, had nothing. School of Medicine Michio Kimura, MD, station Hamamatsu University,

Disaster network, N-STAR, Inmarsat z. How to get power? y. Hybrid car? Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine

Does EHR help? z. Medical records at each provider y. Scattered in many meanings x. Have to have back up archive y. Ishinomaki municipal hospital and Yamagata general medical center (82 km from Ishinomaki) mutually stored their reimbursement claim data x. Ishinomaki restored patient demographics in a month. y. All other information would be useful, only if they had time to download and read x. When? Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine

Can we use reimbursement claim for recovery? z. Reimbursement claim data y. Fee for service contents in Japan yare at insurer (J-Energy insurance organization to Ishinomaki fishermen mutual) yare collected at Ministry, but unlinkablely anonymized y. JAMI advised Ministry to relax the inquiry process to each insurer x. Ministry took action to relax process. Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine

JAMI had made recommendation in 2000, but… z Double layer copy paper for on-site record y. Some team had them (Japan red cross) z Satellite phone y. Few installed y. Defense force had them, without PC z Disaster preparedness public interest y. Half life: 2 years z Should be combined with more frequent, advocate “disaster” y. System down, network trouble. Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine

Lessons learned (again) z. Initial one week y. Prescription history xby easy operation for dispatch team xbut, could be with no electricity nor network z. Medical record restoration after then y. HIS SE is a precious resource to share z. To keep concern y. Network failure, system replace, can be disastrous. Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine

Solution: HL 7 based SS-MIX storage z. Ministry project z. Imports prescription, lab results, diagnosis in HL 7 v 2. 5 from HIS z. No DB engine needed z 1059 hospitals can export HL 7 z 358 hospitals has SS-MIX storage Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine

Hospitals with SS-MIX Storage 358 hospitals, as of 6/2014 (140 at 6/2013) Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine

Ministry of Health Project: SS-MIX: HL 7 standardized clinical information storage Wide variety of applications z We have patient demographics, prescriptions & injections, lab results, diagnosis classifications in HL 7 v 2. 5 y PHR, repository for EHR y Making documents, including case cards y Clinical database y Interoperability with peripheral departmental systems y Backup for disaster, including replacing & upgrading HIS. SS-MIX Storage 標準化 準 each HIS Backup for Disaster, 災害時、リプレース 時バックアップ System replace Px Peripheral Departmental Systems in Hospital HL 7 socket interface データ取込 Data pickup Data sent Formatted Document System 標準化 データ取込 Data pickup CD for Patients Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine 診断書、 Diagnosis Certificates ケースカード、 Case Cards 疾病対策 AE Reports

SS-MIX viewer demo Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine

SS-MIX Storage root folder Patient ID, first 3 digits Patient ID, remaining digits z Patient ID Full patient ID y birth date xcontents z Filesystem directory service only z No DB Another engine miscellaneous storage needed ybut, quick retrieval directory for files other than HL 7 v 2. 5 Transaction date, YYYYMMDD HL 7 event message identifier. i. e. OML-01 HL 7 v 2. 5 message files, (lab results, Px, ) Same structure, and Transaction date, YYYYMMDD Contents identifier (Metadata) Contents, (JPEG files, CDA's, ) Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine

How many people covered by SS-MIX storage? z 358: storing prescription and lab results z. Average hospital (250 beds) stores 2 years of data, first year 20, 000 plus second year increase 7, 000 z 27, 000*358=9, 666, 000 z. Possible duplication deducted: 8, 000. Michio Kimura MD Ph. D FACMI Hamamatsu University School of Medicine 21

Ministry projects on SS-MIX storage z. Mo. H and PMDA's MIHARI and MID-NET (Japan Sentinel) z. Mo. H's regional healthcare information sharing (Noto, Urasoe, Miyako, 100+) z. METI(Economics, Trade, Industry)'s "My Hospital, Everywhere" project (Noto) z. Mo. E's 42 national university hospital EMR backup. Michio Kimura MD, Ph. D, FACMI, Hamamatsu University School of Medicine

SS-MIXは 2か所へ、フルバックアップは遠い方 1か所へ SS-MIX フルバックアップ データセンター （東日本） データセンター （西日本） SS-MIX 病院情報 システム フルバックアップ 徳島　医療情報部長会資料 国立大学病院 23

Portal site for National Univ Hosp. Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University

Prescriptions 25

Lab results 26

20 SS-MIX storage in PC can provide Px, lab, Dx without power, network At Hamamatsu Univ. Hosp. Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine

SS-MIX software is available with no charge z. Visit here for English documents and requests http: //www. jami. jp/english/ Michio Kimura MD Ph. D FACMI Hamamatsu University School of Medicine 28

To use SS-MIX server software z. Software is available free y. Does not need database engine z. Hardware and installation required y. In Japan, about 10000 -20000 USD z. Prescription and lab results in HL 7 v 2. 5 y. In Japan, they are from CPOE y. Alternatives can be: Local pharmacy system, Lab exam company z. To collect and evaluate contents, drug and lab. Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine exam codes should be standardized.

PART 2 APPLICATIONS EXCEPT FOR DISASTER ARCHIVE Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine

Case cards z. Made by hand z. But, most of the data are in CPOE y. Prescription history of the drug y. Concurrent drugs y. Lab results Michio Kimura MD Ph. D FACMI Hamamatsu University School of Medicine 31

Prescription history of the case card pre-populated Michio Kimura MD Ph. D FACMI Hamamatsu University School of Medicine 32

Adverse event reports are ready in PDF Michio Kimura MD Ph. D FACMI Hamamatsu University School of Medicine 33

Clinical Information Retrieval System: D*D demo 10 years, 73, 709, 298 records of prescription, lab results, diagnosis classifications at Hamamatsu Univ. Hosp. Searchable in time sequence in a few minutes Michio Kimura MD Ph. D FACMI Hamamatsu University School of Medicine 34

Search example Listing up of patients, with AST: 30 -180 one week before the first prescription of “Crestor” (Rosuvastatin, anti-hyperlipidemia), then AST elevated to 180 -500 within one week 35 Michio Kimura MD Ph. D FACMI Hamamatsu University School of Medicine

Other examples at Hamamatsu Univ. Hosp. z In 2007, patients recorded Hb. A 1 c=6. 6 -8. 0, and re-examined within 3 weeks y-5. 8: 55 cases, 5. 9 -6. 5: 289 cases, 6. 6 -8. 0: 657 cases, 8. 1+: 192 cases z Gemzar (Gemcitavin for cancer) first prescription: 181 cases in 2007 y. Then, diagnosed as interstitial pneumonia (ICD-10 J 84. x) : 7 cases z Stroke onset, and recurrence within 3 years? y“Stroke” is a disease used for the reason to examine CT or MRI, which includes full of noises. Michio Kimura MD Ph. D FACMI Hamamatsu University School of Medicine 36

Hospital performance indicators z. Hb. A 1 c control of diabetes patients by the year St. Luke Tokyo Hospital 2004 2005 2006 2007 2008 2009 Hamamatsu Univ. Hosp. 0. 0% 20. 0% 40. 0% 60. 0% 80. 0% Hb. A 1ｃ<7. 0 Michio Kimura MD Ph. D FACMI Hamamatsu University School of Medicine 37

A New HIS Network Project by MHLW/PMDA (MID-NET project) z Drug safety assessment and validation from 10, 000 patients (hopefully) z Budget 110 M yen($1. 1 M) for 2011 y 3 year total 260 M yen y. Planned to install the clinical search system D*D, which was based on MIHARI in Shizuoka to 10 core hospitals including Hamamatsu University hospital y 2012 Tokyo Univ. , 2013 6, 2014 3 y. Trial use starts April 2014 z "CPOE based" means AE can be detected real time without delay. 38 Michio Kimura MD Ph. D FACMI Hamamatsu University School of Medicine

Michio Kimura MD Ph. D FACMI Hamamatsu University School of Medicine 39

本事業の拠点医療機関 n 10医療機関を拠点として 　データの検索・調査を行い、 　副作用を分析・評価する。 n平成 23年度は東大病院の 　システムの開発に着手。 　24、25年度に順次、 　9拠点病院のシステムを開発。 PMDAや 研究者に よる活用 拠点医療機関（7箇所） 東北大 拠点医療ｸﾞﾙｰﾌﾟ（3ｸﾞﾙｰﾌﾟ） 九大 NTT病院 徳洲会 佐賀大 東大 香川大 千葉大 浜松医大 北里研 Michio Kimura MD Ph. D FACMI Hamamatsu University School of Medicine 40

医療情報データベースの基本構成 システム構成の概要 協力医療機関 ＰＭＤＡ 暗号化送信 承認・処理開始 病院A スクリプト レセプトDB 医事DB DPC-DB オーダリング 電子カルテDB 　等 抽出 スクリプ ト 統合データ ソース SS-MIX 2 抽出 システム 1次統計処理 システム 承認ベースによる 画面転送での処理 分析インタフ ェース システム 統計指標 中間処理 結果 抽出後 個票 （IDなし） 分析結果を確認 SS-MIX拡張 　ストレージ 標準ストレージ 化 システム DB変換統合 化 システム 抽出後 個票 （IDあり） 分析用データセット 集計結果データ ※分析用データの送付は 　PMDA、医療機関相互の 　合意がある場合に可能 分析データ 標準化 データ構造データ抽出 変換 匿名化 集計結果データ 分析用データセット Michio Kimura MD Ph. D FACMI 統計処理 複数施設 統合処理系 複数施設 統合処理 システム 統合データソースから抽出した集計結果情報（主に、発生 頻度、件数、記述統計、クロス集計結果等） 統合データソースから抽出した分析用データセット（主に、 データをマージ・ソート処理が必要な統計処理等） 複数施設統合 41 データ処理センタ Hamamatsu University School of Medicine

Setting script: Creatinine< 1. 17, then Pravastatine (Mevalotine. R)(any titer) prescribed, Creatinine< 2. 0 within 1 week Michio Kimura MD Ph. D FACMI Hamamatsu University School of Medicine 42

Control (Pravastatin prescribed): 253 cases Case (Creatinine<1. 17 then CRE>2. 0): 1 case Michio Kimura MD Ph. D FACMI Hamamatsu University School of Medicine 43

Demographics of Case and Control (mean, SD, min, max, age, sex, , ) Michio Kimura MD Ph. D FACMI Hamamatsu University School of Medicine 44

End of presentation z Presenter: z kimura@mi. hama-med. ac. jp OECD, Paris, France Michio Kimura, MD, Ph. D, FACMI, Hamamatsu University, School of Medicine