In-Hospital Risk Standardized Mortality for Percutaneous Coronary Intervention (excluding cardiogenic shock and cardiac arrest)

The data elements required to generate this measure are abstracted from a medical record by someone other than person obtaining original information (e.g., chart abstraction for quality measure or registry). All data elements are available in defined fields in electronic clinical data (e.g., clinical registry). This measure uses clinical data from the NCDR CathPCI Registry.  

Availability:
Participating hospitals report patient demographics, medical history, risk factors, hospital presentation, initial cardiac status, procedural details, medications, laboratory values and in-hospital outcomes as the key activity of participating in the NCDR CathPCI registry. The majority of the 21 required data elements are routinely generated and acquired during the delivery of standard cardiac care to this patient population. Electronic extraction of data recorded as part of the procedure expedites data collection. This strategy offers point of care data collection and minimizes time and cost. Institutions can manually report using a free web-based tool or automate the reporting by using certified software developed by third-party vendors. The data elements required for this measure are readily available within the patient’s medical record or can be attained without undue burden by the hospital. Most data elements exist in a structured format within patient’s electronic health record. 

Sampling:
There is no sampling of patient data allowed within the contractual terms of participation in the NCDR CathPCI Registry. The registry is designed to include 100 percent of consecutive adult patients who undergo PCI at participating institutions. Section 2.b of the NCDR Master Agreement with participants includes ‘Participant Responsibilities’: “b. Use of ACCF Data Set and ACCF-Approved Software. Participant will submit a data record on each patient who receives medical care and who is eligible for inclusion in the Registries in which Participant is participating under this Agreement.” Adult patients, ages 18 years and older, who undergo a diagnostic cardiac catheterization and/or PCI. Eligible diagnostic catheterizations are characterized by the passage of a catheter into the aortic root for pressure measurements and/or angiography, and can include Left Ventricle (LV) pressure measurements, LV angiography, coronary angiography, and coronary artery bypass angiography. Eligible PCI procedures include those that involve passage or attempted passage of a coronary device across one or more coronary lesions for purposes of increasing the intraluminal diameter of the vessel and/or restoring or improving circulation. Patients are selected for inclusion by reviewing existing medical records and no direct interaction with the patient is required outside of the normal course of care. There is no discrimination or bias with respect to inclusion on the basis of sex, race, or religion. 

Patient confidentiality:
The CathPCI Registry dataset was created by a panel of experts using available ACC-AHA guidelines, data elements and definitions, and other evidentiary sources. Protected Health Information (PHI) as such term is defined by the Health Insurance Portability and Accountability Act of 1996 (HIPAA), such as social security number, is collected. The intent for collection of PHI is to allow for registry interoperability and the potential for future generation of patient-level drill downs in Quality and Outcomes Reports. Registry sites can opt out of transmitting direct identifiers to the NCDR, enabling inclusion of direct identifiers in the registry to be at the discretion of the registry participants themselves. When using the NCDR web-based data collection tool, direct identifiers are entered but a partition between the data collection process and the data warehouse maintains the direct identifiers separate from the analysis datasets. The minimum level of PHI transmitted to the ACCF when a participant opts out of submitting direct identifiers meets the definition of a Limited Data Set as such term is defined by HIPAA. All analyses are performed by contracted data analytic centers who conduct such analysis on a Limited Data Set. 

Data collection within the NCDR conforms to laws regarding PHI Each participant signs a Business Associate Agreement with the ACCF permitting the use and disclosure of PHI. Patient confidentiality is of utmost concern with all metrics. The proposed measure does not currently include a patient survey. There is no added procedural risk to patients through involvement in the CathPCI Registry. No testing, time, risk, or procedures beyond those required for routine care are imposed. The primary risk associated with this measure is the potential for a breach of patient confidentiality. The ACCF has established a robust plan for ensuring appropriate and commercially reasonable physical, technical, and administrative safeguards are in place to mitigate such risks.

Data are maintained on secure servers with appropriate safeguards in place. The project team periodically reviews all activities involving PHI to ensure that such safeguards including standard operating procedures are being followed. The procedure for notifying the ACCF of any breach of confidentiality and immediate mitigation standards that need to be followed are communicated to participants. ACCF limits access to PHI , and to equipment, systems, and networks that contain, transmit, process or store PHI, to employees who need to access the PHI for purposes of performing ACCF’s obligations to participants who are in a contractual relationship with the ACCF. All PHI are stored in a secure facility or secure area within ACCF’s facilities which has separate physical controls to limit access, such as locks or physical tokens. The secured areas are monitored 24 hours per day, 7 days per week, either by employees or agents of ACCF, by video surveillance, or by intrusion detection systems. 

Each participant who has access to the NCDR website must have a unique identifier. The password protected webpages have implemented inactivity time-outs. Encryption of wireless networks, data transmission and authentication of wireless devices containing NCDR Participant’s information is required. PHI may only be transmitted off of ACCF’s premises to approved parties, which shall mean: A subcontractor who has agreed to be bound by the terms of the Business Associate Agreement between the ACCF and the NCDR participant. 
Overall there is no added procedural risk to patients through their hospital’s involvement in the CathPCI Registry. No testing, time, risk, or procedures beyond those required for routine care will be imposed.