Rahul Gupta, MD; Konstantinos Dean Boudoulas, MD FSCAI; and Nainesh C. Patel, MD FSCAI

Introduction

As interventional cardiologists, we perform a wide range of procedures in the cardiac catheterization laboratory (CCL), and due to the invasive nature of these procedures, complications may occur. While there is increased emphasis on the clinical management of these patients to improve patient outcomes and mitigate procedural complications, appropriate documentation in certain instances may be lacking. Inadequate documentation not only can affect the clinical management of patients, but it may fail to capture the severity of illness in any particular patient, resulting in an unfavorable risk stratification in reported registries. In this Tip of the Month, we focus on the specific documentation that should be performed in the CCL to increase the quality of reporting.

Salient Points for Procedural Documentation

1. Appropriate comorbidities of the patient should be captured to risk stratify a patient accurately. This includes documentation of clinical conditions such as the presence of heart failure, shock, cardiac arrest, and frailty, among others.
2. The time-out protocol should be documented with a focus on the patient’s consent, patient’s medical history and presenting symptoms, pertinent lab results, available imaging data, antiplatelet and anticoagulation regimen and tolerance, and preprocedural risk assessment.¹
3. A description about the technique used for vascular access should be provided, and all products (e.g., sheaths, catheters, guidewires, among others) used in the procedure should be charted, including any identifying information and lot numbers.
4. The method of vascular hemostasis should be documented, including whether a closure device—and what type—was utilized.
5. For any medication given in the CCL, it is critical to document the name, dose, site, route, and time of administration. For any administered blood products, documentation of the staff members checking the products should be made.
6. Hemodynamic data and tracings should be recorded. The transvalvular gradient and valve area should be reported, where appropriate.²
7. A visual diagram of the coronary tree with vascular anatomy and lesion location would be helpful to include.
8. A summary of the procedure with a final diagnosis, final impression of the results, and recommendations based on those results should be noted.
9. Notification of the findings to the patient, family, and referring physician(s) should be performed and documented.

A preliminary report should be generated immediately postprocedure and included in the patient's chart before transferring the patient to the next level of care. The report should be finalized ideally within 24 hours of the procedure. The American College of Cardiology (ACC)/ American Heart Association (AHA)/SCAI Health Policy Statement has recommended structured reports as the optimal format for generating procedure reports, with the first section containing high-value clinical information; the second section dedicated to the graphical representation of the findings; and the final section containing remaining data presented as a series of structured, formatted tables.^{3, 4} This builds on the fact that that the information should be captured as data rather than prose, and the final report should be concise, well organized, consistent, reproducible, understandable, and in a format that is flexible to accommodate evolutionary procedural changes and documentation requirements.

Documentation of Critical Events/Complications

Complications are an unfortunate outcome for some patients who receive medical treatment. These events can occur and compromise the outcome of a case despite the execution of a procedure based on accepted best practices. Documentation of critical events or complications during the procedure is another area with need for significant improvement in quality metrics. While the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) has made it easier to code complications, the documentation should clearly state whether the event is an expected outcome of the procedure or the patient’s disease process or if it is an actual procedural complication. Important rules to follow when it comes to documentation of critical events include the following:

• Not all procedural conditions are complications. There should be a cause-and-effect relationship between the procedure performed and the condition. 
• Procedural complications are defined as “unexpected” or “unusual outcomes” that occur during care.
• Provider documentation should choose these words with caution: “due to,” “resulted from,” or “the result of.”
• An incident report should be made for any unexpected event involving a patient that resulted in injury or could have resulted in injury.⁵ Accurate documentation of the events with the precise date and time of each event is required in the report.
• Key elements to include are clinical indicators, positive findings, the physical exam, the treatment provided, and an assessment regarding whether any other information is missing or unclear. Frequency and acuity are important determinants as well.

Appropriate documentation can be a major contributing factor in improving the quality of patient care and to alleviate any harm. In creating a comprehensive record, the proceduralist should review the differential reasons why an event may have occurred in the particular patient. Each of the potential reasons for the complication should be excluded and the most probable reason clearly identified and addressed with a treatment plan. An outline of the routine procedure and processes that were in place to ensure the safety of the patient can be critical. In short, the documentation process is a subtle reminder for the steps that need to be taken and reinforces the interventionalist’s desire to take every reasonable step to avoid a critical event, detect the complication as early as possible, and develop a management plan to allow the patient the optimal opportunity for recovery.

Mitigating the Risk of Complications

To minimize the rate of complications and to prepare and lessen the effects of future complications, the following processes should be adopted by each hospital:

• Utilize risk-adjusted models to put success rates and observed in-hospital outcomes in perspective.⁶
• Participate in national or regional quality improvement registries such as the National Cardiovascular Data Registry (NCDR) or Cath-Percutaneous Coronary Intervention (CathPCI) Registry to meet quality standards.⁷
• Have physicians participate in quarterly quality improvement, peer-review, and/or morbidity and mortality (M&M) meetings with cine reviews as well as random case reviews for the evaluation of procedural appropriateness.

Summary

A procedure report is a legal medical record that is an essential component of any procedure and should be of the highest quality. As it is said, “To err is human, to document divine.” Quality documentation is a vital component of overall quality improvement that is imperative in providing patients with quality care, assisting physicians in the decision-making process, and improving overall health outcomes.

References

1. Naidu SS, Abbott JD, Bagai J, et al. SCAI expert consensus update on best practices in the cardiac catheterization laboratory: This statement was endorsed by the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society (HRS) in April 2021. Catheter Cardiovasc Interv, 2021 Aug 1;98(2):255–276.
2. Bashore TM, Bates ER, Berger PB, et al. American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on cardiac catheterization laboratory standards. A report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol. 2001 Jun 15;37(8):2170–214.
3. Sanborn TA, Tcheng JE, Anderson HV, et al. ACC/AHA/SCAI 2014 health policy statement on structured reporting for the cardiac catheterization laboratory: a report of the American College of Cardiology Clinical Quality Committee. J Am Coll Cardiol. 2014 Jun 17;63(23):2591–2623.
4. Dehmer GJ, Badhwar V, Bermudez EA, et al. 2020 AHA/ACC Key Data Elements and Definitions for Coronary Revascularization: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Clinical Data Standards for Coronary Revascularization). J Am Coll Cardiol. 2020 Apr 28;75(16):1975–2088.
5. Kern M. Cath Lab Documentation: What should go into a cath report? Cath Lab Digest, 2008 Jun. https://www.hmpgloballearningnetwork.com/site/cathlab/articles/cath-lab-documentation-what-should-go-a-cath-report#:~:text=For%20any%20medication%20given%20in,type%20of%20IV%20is%20helpful.
6. Singh M, Holmes DR, Lennon RJ, et al. Development and validation of risk adjustment models for long-term mortality and myocardial infarction following percutaneous coronary interventions. Circ Cardiovasc Interv. 2010 Oct;3(5):423–30.
7. Brindis RG, Fitzgerald S, Anderson HV, et al. The American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR): building a national clinical data repository. J Am Coll Cardiol. 2001 Jun 15;37(8):2240–5.