Data Manager Orientation and Training

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Introduction

The orientation and training section introduces new data managers to the policies and procedures set by the Department of Public Health and the Massachusetts Data Analysis Center (Mass-DAC) for hospitals participating in the Massachusetts Quality of Cardiac Care Study. It highlights the critical procedures necessary to complete quarterly Mass-DAC data harvests and provides overviews of reports and forms used throughout the year. All hospitals performing cardiac surgery and percutaneous coronary interventions in the Commonwealth of Massachusetts must submit data to Mass-DAC.

The Mass-DAC web site provides links to the most current versions of all downloadable forms referenced or reproduced as exhibits in the PDF version of the orientation and training manual.

Download the PDF version of the manual.

Table of Contents

Introduction
History
Contacts: Hospital personnel working with Mass-DAC
Websites
Mass-DAC websites
Data security
Data submissions and harvest periods
Adjudication of medical records
Reports
Merging Mass-DAC registry data with external sources

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History

The Massachusetts Data Analysis Center (Mass-DAC), a data-coordination center established in 2002 in response to a state mandate, provides expert evaluation of cardiac surgery and angioplasty data in the Commonwealth of Massachusetts. Mass-DAC collects and validates patient-specific clinical data from all Massachusetts hospitals that provide cardiac surgery or percutaneous coronary interventions. This data is used to monitor the quality of cardiac care delivered in the Commonwealth to improve the level of care provided. Mass-DAC is under the direction of Sharon-Lise Normand, PhD, professor of health care policy (biostatistics) in the Department of Health Care Policy at Harvard Medical School and in the Department of Biostatistics at the Harvard School of Public Health.

In 2012, Dr. Normand received the Distinguished Scientist award from the American Heart Association due to her national and international leadership in the development of innovative statistical methods for health services and outcomes research. She has also been an active contributing member in several prominent medical committees including,

Massachusetts enacted legislation in 2000, section 428 of Chapter 159 of the Acts of 2000, (see excerpt on history page), establishing that a cardiac care quality advisory commission “develop standards and criteria to be used by the department of public health for the purpose of collecting, monitoring and validating patient specific outcome data for all hospitals in the commonwealth that perform open heart surgery or angioplasty.” Following a 2001 report filed by the Massachusetts Cardiac Care Quality Commission, the State legislature mandated the Massachusetts Department of Public Health collect patient specific outcome data, and evaluate all surgery and angioplasty programs in the Commonwealth.

Regulations were passed in April 2002 requiring all Massachusetts hospitals providing cardiac surgery and/or angioplasty to collect patient data using the Society of Thoracic Surgeons (STS) National Cardiac Surgery Database Instrument, in the case of cardiac surgery, and the American College of Cardiology’s National Cardiovascular Data Registry (ACC-NCDR) Instrument, in the case of coronary intervention procedures. All data are submitted electronically to the Massachusetts Data Analysis Center (Mass-DAC), the data-coordinating center that is under the direction of Sharon-Lise Normand and located in the Department of Health Care Policy at Harvard Medical School. Mass-DAC is advised by an external Cardiac Advisory Committee. In addition to the data submissions to Mass-DAC, hospitals are required to submit data to the national STS and ACC data registries. Implementation of data collection for cardiac surgery began January 1, 2002. Implementation of data collection for coronary interventions using the ACC-NCDR Instrument began April 1, 2003.

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Contact information for participating hospital

The hospital’s primary point of contact with Mass-DAC is the data manager, who is the hospital’s hub for getting critical data to Mass-DAC and disseminating information received from Mass-DAC. The data manager keeps Mass-DAC apprised of changes to key hospital personnel who need to communicate with Mass-DAC.  Having the most current information on hospital personnel ensures correspondence about data and reports are sent to the appropriate people.

Key hospital personnel includes the data manger, backup data manager, directors, chiefs, technical support staff, and other key administrative staff that Mass-DAC needs to communicate with. Mass-DAC maintains several different correspondence lists for dissemination of information. The data mangers are usually the best person to notify Mass-DAC of any changes. To update, add, or remove staff contact information, please use the Mass-DAC contact update form:

ContactUpdateForm.pdf.

The PDF form uses fields that may be filled in before saving and sending to Mass-DAC. To use the form fields, the free Adobe Acrobat reader version 8 or higher must be used, (available at http://get.adobe.com/reader/). The form may be either e-mailed or faxed (617-432-5428) to the Mass-DAC Program Manager-Ann Lovett, or Project Assistant – Caroline Wood.

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Websites

Mass-DAC maintains two external websites to disseminate information to the general public and transfer high risk confidential data and reports to participating hospitals.

Public home: www.massdac.org

The public home website, accessible by anyone with access to the internet, provides general information about Mass-DAC, our reports, policies, and services. It is designed to be responsive to device type, adapting to smart phones, tablets, laptops, and workstation  monitors. Information on the site is categorized into five major areas of interest:

  • Data Managers
  • Physicians
  • General public
  • Reports – Annual published and description of other types created
  • Research – using Mass-DAC registry data

The home page presents recently posted articles, page updates, and a list of coming events, conferences, and due dates.  All pages share common menus with the top-level menu structured by major areas of interest and sub-menus focusing on specific topics for each group. The second-level menu adds links to information of interest to all groups, such as calendar of events, frequently asked questions, and links to external websites of related interest.

Secure document repository:

The secure document repository is behind the Harvard Medical School (HMS) secure socket layer virtual private network (VPN), and is only accessible to staff who have accounts on the HMS VPN. This site is not available to the general public and is used primarily to transmit encrypted high risk confidential information (HRCI). The HMS VPN provides a secure connection, creating a virtual tunnel for data to travel from your computer, over the internet, to the VPN hardware at HMS. The VPN tunnel protects transmitted data from being “overheard” as it passes over the internet and makes your computer appear as if it were directly connected at HMS.

The Mass-DAC secure document repository is the primary mode that hospitals and other Mass-DAC participants use to exchange HRCI, such as data submissions and hospital feedback reports. The use of the repository for HRCI has been approved by the Harvard Medical School Internal Review Board, and meets Harvard University’s Enterprise Security Policy, as well as both state and federal guidelines.

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Data security

The Massachusetts Data Analysis Center security policies comply with the Information Security Policy standards developed by Harvard University and integrate additional requirements mandated by the state of Massachusetts, the Massachusetts Department of Public Health (DPH), and federal regulations, (e.g., Health and Human Services HIPAA privacy and security rules). Mass-DAC and Harvard University continually review and update the security policies.  These reviews ensure that electronic records, physical records, and infrastructure housing high risk confidential information (HRCI) and utilized by Mass-DAC are protected and secure.

Most of the data shared between Mass-DAC and the hospitals contains HRCI data.  When transmitting electronic HRCI data, the data must be transferred through the Harvard Medical School (HMS) Virtual Private Network (VPN) to the Mass-DAC Secure Document Repository The HMS VPN uses a secure socket layer to encrypt all data transmitted through the site and has been approved by the Harvard Medical School IRB.  All files with HRCI,  (e.g., data submission files, data quality reports), should also be encrypted with PGP public key cryptography according to best-practices recommended in applicable federal and state regulations.

PGP and Public Key Cryptography

Public key cryptography provides a more secure method of encryption than using pass-phrases alone which must be shared by both the sender and receiver (symmetric encryption). Public key cryptography utilizes two distinct keys, a public key used by the sender to encrypt files and a private key held by the receiver to decrypt files (asymmetric encryption). Using asymmetric encryption allows Mass-DAC and participants to exchange messages securely since all communications involve only public keys, and no private keys are ever transmitted or shared. The process is similar to owning a bank safe deposit box, which can only be opened with two keys present, one the bank holds (private), and one the box owner holds (public).

The three things you will do with PGP on a quarterly basis are outlined in the walk-through documents listed below. These will help you to generate a new PGP key to share with Mass-DAC and import the Mass-DAC PGP keys. If you need additional help, please feel free to contact the Mass-DAC Senior Data Manager  with any questions on using PGP for Mass-DAC files.

    • Creating and sharing PGP keys – Commonly done for new data managers, new software installs, or periodic updates of new keys.
    • Creating a PGP archive – This needs to be done with all HRCI data and data submissions
    • Extracting files from a PGP archive – To view documents decrypted by PGP Desktop, the files must be saved to a local disk, then opened by the parent application. PGP Desktop does not allow documents to be viewed within PGP.

Mass-DAC and most hospitals utilize PGP encryption software from Symantec, either Symantec Endpoint Encryption or File Share Encryption.  A free alternative is GnuPG is a public implementation of the OpenPGP standard as defined by RFC4880 (also known as PGP).  The free version requires more information technology support to implement and is only used by two of the hospitals in Massachusetts.

Data submissions and harvest periods

All Massachusetts hospitals that perform cardiac surgeries or percutaneous coronary interventions (PCI) must submit patient and physician specific data to Mass-DAC on a quarterly basis. Mass-DAC collects this data for both cardiac surgery and PCI programs for all patients 18 years of age or older.

  • The cardiac surgery cohort includes surgeries on the heart and the thoracic great vessels. Examples of cardiac surgery include coronary artery bypass grafts, heart valve repair or replacement, heart transplantation, surgery of the thoracic aorta, repair of congenital heart defects, and minimally invasive heart surgery.

  • The PCI cohort includes the placement of an angioplasty guide wire, balloon, or other device into a native coronary artery or graft for the purpose of mechanical coronary revascularization. It is a non-surgical procedure designed to open and maintain the patency of obstructed coronary vessels. This treatment is an invasive procedure performed in the cardiac catheterization lab (i.e., outside of an operating room) by an interventional cardiologist in which a balloon, stent, or other device is delivered to the affected vessel to open and maintain its patency.

Data is collected utilizing instruments developed by the Society of Thoracic Surgeons (STS) national registry and the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) with supplements created by Mass-DAC for Massachusetts specific data elements. All data fields must be collected with no exclusions, including identifying demographic information on both patient and physician.  Each hospital must use a software vendor approved by STS or ACC-NCDR to collect the data and to create data extracts to be sent to Mass-DAC.  The cardiac surgery and PCI cohorts use the most recently published version of the national registry data collection instruments:

  • STS Adult Cardiac Surgery (July 2014 – version 2.81)
  • ACC-NCDR CathPCI (July 2009 – version 4)

All data fields must be collected with no exclusions, including identifying demographic information on both patient and physician.  Each hospital must use a software vendor approved by STS or ACC-NCDR to collect the data and to create data extracts to be sent to Mass-DAC.  Specifications for Massachusetts data elements and documents on how to submit data to Mass-DAC are accessed through the menus for the cohort specific website pages:

Mass-DAC receives the data extracts submitted by each hospital during four quarterly (3 month) harvest periods each year. Each harvest is open for 4 months, after which no new submissions are accepted without prior approval from Mass-DAC. Each harvest must include all surgeries or procedures performed during the months for the harvest period.  To see the high-level workflow for a harvest let’s look at the  June 2013 harvest:

  • Prepare data for records with dates of surgery/procedure from January 1, 2013, through March 31, 2013,
  • The first data submission for the harvest must be received by Mass-DAC by the 1st business day of the harvest month via the secure document repository,
  • A data quality report will be returned to the hospitals, noting any issues to address,
  • Data resubmissions with corrections must be uploaded in within 30 days after receiving the data quality report,
  • The last possible date a submission may be uploaded is October 1, 2013.

Every data submission received during the harvest period generates a data quality report for the hospital. Details and samples of these reports are located on the Surgery Data and PCI Data pages. These pages include all forms and Mass-DAC documentation you need to successfully complete a data submission.  The files include:

  • Mass-DAC supplemental data specifications,
  • Submission verification form,
  • Check list of tasks, and
  • Massachusetts hospital numbers needed for the transfer in and discharge to fields.

All data submissions must be uploaded quarterly to the Mass-DAC Secure Document Repository via the Harvard Medical School (HMS) secure virtual private network (VPN). Uploaded files containing HRCI should be encrypted with a PGP encryption key or with a new 90-day encryption password on a zip file if PGP is unavailable at your site. The data submissions are due 2 months after the last day of the harvest (e.g., the Jan-Mar harvest period will be due June 1st).  The current timeline is available on the Data Manger-Data Submissions page and menu.

To transfer a file with Mass-DAC you must log-in through two websites:

  1. Log-in to the HMS VPN, https://secure.med.harvard.edu/.
  2. Once behind the HMS VPN, click on the MASSDAC link to go to the secure document repository.

Additional details on how to use the Mass-DAC Secure Document Repository are available in the user guide:

 

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Adjudication of medical records

Mass-DAC performs two adjudications each fiscal year to verify coding of variables submitted.  Hospitals must submit medical record documentation that supports the submitted coded values. The types of medical records Mass-DAC needs may change slightly each year, but generally, the table below outlines the most commonly requested information. PCI compassionate use and exceptional risk cases require additional documentation in addition to the types noted in the table.

Adjudication Record Types

Cardiac SurgeryPCI
Emerg. Dept. recordsEmerg. Dept. records
History and physical examHistory and physical exam
Documentation in the record of statusCath lab reports including vital signs during the procedure
Documentation of shock if you coded yes to shock just prior to the surgery along with vital signs and medications and any other treatment for shockDocumentation in the record of status
Echo and /or current or prior cath if doneDocumentation of cardiac arrest prior to PCI if you coded yes to that variable
OR notes including anesthesia record and surgeon notesDocumentation of shock if you coded yes to shock just prior to the PCI along with vital signs and medications and any other treatment for shock
Notes that document VS for shock or statusEcho or current or prior cath showing severity of AS
Discharge summaryEKGs or labs that diagnosed a STEMI
Any other documentation that would support the coding of these variables such as progress notes, labs, etc.Discharge summary
Any other documentation that would support the coding of these variables such as progress notes, labs, etc.
Procedure audits, to confirm case is not an isolated CABG:CD or DVD of all PCI procedures for:
  • operative notes including surgeon notes
  • discharge summary
  • mortalities
  • exceptional risk
  • compassionate use extreme anatomic risk

Adjudication committees:

Mass-DAC has two adjudication committees that review patient medical records to validate patient-specific data elements submitted during the data harvests. The cardiac surgery committee reviews records in the Mass-DAC cardiac surgery STS based registry, while the PCI committee reviews records in the Mass-DAC adult percutaneous coronary interventions ACC-NCDR CathPCI based registry. The committees are consist primarily of physicians, but also include clinical data managers who are well-versed in the intricacies of the variable definitions for each registry.

Reasons why we need physician expertise
  • Validating key data used in analytic models
  • Reducing coding inconsistencies among all hospitals
  • With your help, the Massachusetts data has become the gold standard for the national registries
Benefits for the physicians and hospitals
  • Learn nuances of the definitions
  • Colleague interaction

Physician volunteers:

Physicians are needed to help validate Mass-DAC data and review analytic results. The three areas Mass-DAC needs physician’s expertise in include:

  • Medical records adjudicators
  • Hospital outlier review
  • Physician oversight/outlier review

For record adjudication, Mass-DAC requests that every hospital in Massachusetts provide a physician volunteer. All volunteer reviewers must sign a confidentiality agreement with Mass-DAC and DPH.  The reviewers examine medical records requested by Mass-DAC from each hospital and validate the coded registry data. Hospitals are notified of any disagreement that the adjudicators find may appeal any adjudication decision by sending in additional supporting documentation. The appeals are reviewed by a second physician on the  Adjudication Committee, which will determine the appropriate coding for the variable.  All adjudication changes made to 100% sample census variables will be updated in the final analytic Mass-DAC data set.

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Reports

Mass-DAC generates three types of periodic reports for each hospital. Quarterly reports are generated documenting the quality of data submitted, highlighting important data issues. On a semi-annual basis, feedback reports are distributed comparing the hospital’s data to all other Massachusetts hospital data. Custom reports may also be requested and submitted for approval through DPH. Each hospital may request one ad-hoc custom report per year with additional requested charged an analysis fee. Additional details and examples of reports are outlined below and available under the Reports or Data Manager menus.

Data submission quality reports:

Each data submission received is processed for completeness (e.g., all values filled in, only records for the quarter), validation (e.g., values in correct range), and consistency of related variables (e.g., city name and zip code agree with postal service tables).  If there are problems with the data, the hospitals will utilize the report to find the records and variables that either need corrected values or verification, and then resubmit to Mass-DAC. In addition to the quality checks, the following summaries are provided:

  • Type of records submitted, compared to the verification form,
  • Physician volumes by procedure type,
  • If multiple files are submitted, merge results are highlighted,
  • Physician volumes by case type; hospital should validate against independent source,
  • Detailed lists for all cases under the age of 18, mortalities, and for PCI compassionate use and exceptional risk,
  • Feedback frequency tables for most variables, excluding key fields that are unique to each record,
    • PCI registry data, 300+ variables,
    • Cardiac surgery registry data, 700+ variables.

Samples of the data quality reports are located on the Reports-Data Quality Reports page and on the Data Manager-Data Submission cohort pages.

Feedback reports:

Feedback reports are generated only once or twice a year and are usually sent back directly to the hospital. Additional feedback reports prepared for presentation at data manger or advisory committee meetings. Below is a list of the types of feedback reports Mass-DAC creates:

  • Fiscal year bivariate report of risk factors and other key registry variables,
  • Preliminary fiscal year hospital standardized mortality incidence rates (SMIR),
  • Multi-year trend reports comparing hospital averages to state averages,
  • National Quality Forum measures at the state level comparing all hospitals, de-identified,
  • Physician-specific 3-year computed SMIRs sent to individual physicians,
  • Merged death dates to patient records,
  • Expected risk adjusted mortality results at the patient level corresponding to the annual report.

Samples of some of the data feedback reports are located on the Reports-Hospital Feedback Reports page.

Custom reports:

Custom reports and data extracts may be requested by participants in the cardiac surgery study.  Each request must be approved by DPH before work on the extract or report can begin.  Each hospital may make one special request per fiscal year at no cost.  Additional request will be charged a fee.  Recent examples include:

  • Robotic surgeries compared to state average,
  • Complication risks,
  • Volumes for all STEMIs by fiscal year,
  • Risk adjusted mortalities at the patient level.

 

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Merging Mass-DAC registry data with external sources

Massachusetts Acute Hospital Case Mix Data

Acute Hospital Case Mix data includes case specific, diagnostic discharge data that describe socio-demographic characteristics of the patient, the medical reason for the admission, treatment and services provided to the patient, the duration and status of the patient’s stay in the hospital, and the full, undiscounted total and service-specific charges billed by the hospital to the general public. Mass-DAC requests inpatient, outpatient observation room and emegency department data each year from the Massachusetts Center for Health Information and Analysis (CHIA). Mass-DAC uses patient date of birth, episode of care dates and procedure codes, and medical record number to validate and discover PCI and coronary artery bypass graft procedures done during the fiscal year. Any inconsistencies found are shared with the hospital data managers before making any changes to the Mass-DAC registry.

Massachusetts Registry of Vital Records

Massachusetts mortality date information for Mass-DAC registry patients is obtained in July each year from the Massachusetts Registry of Vital Records. A list of Mass-DAC patients is linked to the registry data to find deaths occurring in the Commonwealth. While the primary source for in-hospital and 30-day mortality rates is the hospital-reported information, the mortality database is employed as a verification and discovery tool.

Using a confidential and secure transmission procedure, Mass-DAC submits one record for each unique set of patient identifiers to the Registry of Vital Records. The following patient identifiers are used: patient names, date of birth, Social Security number, and gender. The Registry of Vital Records returns to Mass-DAC a list of potential matched records. Mass-DAC then utilizes a conservative algorithm to determine exact matches minimizing false positives (patients alive, found dead) and false negatives (patients found dead, but are alive)

National Death Index (NDI) from the CDC

In 2014, the NDI made available an early release (99% complete) version of the death index for calendar year 2013. This new file enabled Mass-DAC to request a search of fiscal year 2013 data before the final public report is released. In the past, the final file would not be available until March or later after the published report. Mass-DAC only submits registry patients that are known not to be a Massachusetts resident, about 7% of our records. A list of Mass-DAC patients is linked to the NDI data to find possible deaths for non-Massachusetts residents. While the primary source for in-hospital and 30-day mortality rates is the hospital-reported information, the NDI database is employed as a verification and discovery tool.

Using a confidential and secure transmission procedure, Mass-DAC submits one record for each non-Massachusetts resident unique set of identifiers to the NDI. The following patient identifiers are used: patient names, date of birth, Social Security number, gender, race and last known alive date. NDI returns to Mass-DAC a list of exact matched, probablistic matched and potential matched records. Mass-DAC then utilizes a conservative algorithm to determine exact matches minimizing false positives (patients alive, found dead) and false negatives (patients found dead, but are alive).

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