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Welcome to the NYS DOH Office Based Surgery Adverse Event Report Database

Overview

In accordance with New York State Public Health Law Section 230-d, all physicians, physician assistants (PA), specialist assistants (SA), and podiatrists privileged to perform ankle surgery by the State Education Department, must report specific adverse events (https://www.health.ny.gov/professionals/office-based_surgery/) occurring in relation to the performance of office-based surgery (OBS) to the Office of Health Services Quality and Analytics (OHSQA), formerly the Office of Quality and Patient Safety (OQPS), of the NYS Department of Health. Such reportable adverse events shall be reported to OHSQA within three business days of the occurrence of the event; suspected transmission of bloodborne pathogens must be reported within three days of becoming aware of a suspected transmission.

Failure to report this information falls within the definition of professional misconduct identified in Section 6530(48) of NYS Education Law.

Who Must Report Adverse Events:

  • ALL Licensed physicians, PA's, SA's and podiatrists directly or indirectly involved in the OBS procedure must file an adverse event report. Mandated reporters involved in the OBS procedure, usually this includes the proceduralist and the sedation/anesthesia provider, may file a single report or each licensee may file separate reports.
  • It is the personal responsibility of each mandated reporter to ensure that an adverse event report has been filed.
  • ANY physician, PA and/or SA, or podiatrist in a hospital or other setting who believes or becomes aware of a patient complaint, complication, condition, emergency department visit, hospital admission or death that occurred status post an OBS procedure

Event Reporting:

  • OBS MDs, PAs and/or SAs, or podiatrists should provide all information requested on the form.
  • Non-OBS reporters should provide all the information that they have when submitting a report.
  • All licensed physicians, PA and/or SA, or podiatrist directly involved in the OBS procedure should be advised of the adverse event report submission.

Please do not close this browser window or tab until the AER is submitted. Please review the form before beginning, an offline version may be printed for use as a worksheet in collecting the necessary information.

Training Videos

Training video for mandated reporters who are a member of the OBS practice:

Training video for mandated reporters who are NOT a member of the OBS practice:

1.0 Mandated Reporter

A mandated reporter is any physician, physician assistant or specialist assistant, or podiatrist directly or indirectly involved in an OBS procedure associated with a reportable adverse event. Mandated reporters are expected to complete the OBS adverse event form within 72 hours of the occurrence of the adverse event and/or within 72 hours of becoming aware of these events.

1.1 Type of Report

1.2 Mandated Reporter Information

Complete the fields below to identify the mandated reporter for this adverse event.

2.0 Practice Information

2.1 Accreditation Information

Private physician practices that perform office-based surgery as defined by PHL §230-d require accreditation by an agency designated by the New York State Department of Health.

Provide the accreditation information for the practice site where the procedure was performed.

2.2 Practice Information

Provide the practice site information where the procedure was performed.

3.0 Event Detail

Provide specified information pertaining to all reportable adverse event types that occurred.

3.1 Date of Discovery

3.2 Adverse Event Type and Details

Check all adverse event types that apply. Complete the corresponding fields for each type selected.

Place of Death Information

Select all serious adverse event types that apply and provide the date the event occurred.

Patient death or serious injury associated with:

Hospital(s) Information

Provide the hospital information where the patient was attended to.

3.3 Observed Signs and Patient Symptoms

3.4 Suspected or Known Complications

4.0 Procedure

Complete the following sections regarding pre-procedure, procedure, and follow-up information.

4.1 Pre-procedure Information

4.2 Procedure Information

What were the CPT/HCPCS code for procedures scheduled and/or performed for this case?

Click here to search for CPT codes (opens in new window/tab)

Length of procedure (Time into the procedure room to time out of procedure room.)

Length of recovery (Time from arrival in the recovery room until discharge from OBS Practice.)

4.3 Discharge and Follow-up Information

5.0 Sedation/Anesthesia

Please complete the fields below regarding the medications, sedation and/or anesthesia provided during the pre-procedural, intra-procedural, and post-procedural periods.

5.1 Pre-Procedure Information

5.2 Sedation/Anesthesia Technique

Provide the type(s) of anesthetic, sedation and/or anesthesia administered.

Provide local medication information:

5.3 Intra-Procedural Sedation/Anesthesia Medications

Indicate all sedation/anesthesia medications administered to the patient including dose and units.

Inhalational Anesthetic Agents:

5.4 Other Intra-Procedural and Post-Procedural Medications

Indicate all other medications administered to the patient during and after the procedure including dose and units.

5.5 Additional Intra-Procedural and Post-Procedural Medications

Provide name of all additional medications administered to the patient both during and after the procedure.

6.0 Participating Staff

Please complete the sections below for all who participated in the procedure, including MDs, CRNAs, NPs, PAs and other staff.

6.1 Proceduralist

Provide the practice information the proceduralist is affiliated with.

6.2 Assisting Proceduralist

Provide the practice information the assisting proceduralist is affiliated with.

6.3 Sedation/Anesthesia Prescriber

Provide the practice information the sedation/anesthesia prescriber is affiliated with.>

6.4 Sedation/Anesthesia Administrator

Provide the practice information the sedation/anesthesia is affiliated with.

6.5 Other Participating Staff

7.0 Patient Demographics

Complete the fields below regarding the patient involved in the adverse event.

7.1 Patient Name

7.2 Patient Address

7.3 Patient Demographics

8.0 Patient's Health History

Provide the patient’s health history by completing the fields the below.

8.1 Patient Height and Weight

Please fill out patient's height and weight.

8.2 Medical History

Select all pertinent medical conditions for the patient in the sections below and provide additional details when applicable.

Check None if patient has no past medical history or Unknown if the patient’s history is not known to the reporter.

8.2.1 Cardiovascular

Check the boxes for past cardiovascular conditions.

8.2.2 Respiratory

Check the boxes for past respiratory conditions.

8.2.3 Gastrointestinal/Genitourinary

Check the boxes for past Gastrointestinal/Genitourinary conditions.

8.2.4 Endocrine/Hematology/Neuromuscular

Check the boxes for past Endocrine/Hematology/Neuromuscular conditions.

8.2.5 OB/GYN

Check the boxes for past OB/GYN conditions.

8.2.6 Other Pertinent Conditions

Check the boxes for past Other Pertinent Conditions.

9.0 Home Medications

Please provide both the patients prescription and over-the-counter home medications.

9.1 Home Medications

Provide the home medications, both prescriptions and over-the-counter, taken by the patient.

Select all medication types/classes that apply and enter the name of each medication in the space provided to the right.

Examples of medication names are available by hovering over the “?”.

Check None if the patient is not taking any home medications.

9.2 Medication(s)

Please check all Medication Type/Class boxes that apply to indicate the patients current home medications. Enter the name of each medication in the space provided. Examples of medication names are available by hovering over the ? mark.

Description of Medication Type/Classes Name of medication(s). (List all medications for each Medication Type/Class)
CARDIOVASCULAR
Used to treat high blood pressure (hypertension), heart failure, chest pain, angina, kidney disease in diabetes, migraines, and abnormal heart rhythms (i.e. atrial fibrillation).
Ace Inhibitors
Angiotensin II Receptor Antagonists (ARB)
Antiarrhythmics
Beta Blockers
Calcium Channel Blockers
Nitrates
Thiazide Diuretics & Diuretics
RESPIRATORY
Used to treat asthma and chronic obstructive pulmonary disease (COPD)
Bronchodilators
Corticosteroids
ENDOCRINE
Used to treat diabetes, parathyroid, and thyroid disease (hyperthyroid/hypothyroid)
Insulin
Oral Hypoglycemic Agents (diabetic medications)
Antithyroid
Thyroid Hormones
GASTROINTESTINAL/GENITOURINARY
Used to treat acid reflux, gastrointestinal reflux disease (GERD), peptic ulcers, duodenal ulcers, and h-pylori.
H2 Antagonists
Proton Pump Inhibitors (PPI)
Pain
Nonsteroidal Anti-inflammatory Drugs (NSAIDs)/Aspirins (ASA)
Used to treat pain, arthritis, headache, fever
Opiates
Used to treat pain
Other
Anticoagulants/Antiplatelet
Used to reduce the risk of blood clots (i.e. pulmonary embolism, deep vein thrombosis)
Steroids
Used to treat arthritis, autoimmune diseases, skin conditions
Benzodiazepines
Used to treat anxiety, insomnia, seizures, restless leg syndrome, symptoms of alcohol withdrawal
Other Home Medications - Please specify

10.0 Quality Improvement

Indicate the factors that contributed to the complication(s) for this event and improvement opportunities identified in the review of the adverse event.

10.1 Contributing Factors

Severity Assessment of the Adverse Event:

What factors contributed to the complication(s)?

Check all that apply.

Specify the specific patient factors:

10.2 Quality Improvement

11.0 Supporting/Additional Documents

Additional documentation regarding this adverse event may be included by uploading documents here (optional). Examples of documentation helpful in the review of reported adverse events are: history & physical, pre-procedure assessments, intra– op and post procedure documentation, anesthesia/sedation records, and discharge documentation.

The NYS DOH OBS Program frequently requests medical records as part of the review of Adverse Event Reports. The type of events for which medical records are most frequently requested are:

  • Death or Serious Physical Injury
  • Cardiac/Respiratory Arrest
  • Need for Rescue; Airway Management, Unanticipated Cardiovascular and Hemodynamic Management, or Pharmaceutical Management
  • Altered Level of Consciousness; Loss of Consciousness
  • Hemorrhage class II or higher
  • Unplanned return to OR prior to discharge from the OBS practice
  • Unplanned return to the OR after discharge from an OBS office for a procedure related to the OBS procedure
  • Any adverse event defined by the +National Quality Forum's (NQF) Serious Reportable Event for Surgery or Invasive procedures
  • Malignant Hyperthermia
  • Bloodborne Pathogen Transmission

12.0 Contact

Please complete the fields below to identify the primary contact person for any necessary follow-up on this adverse event report.

13.0 Attestation

Before submitting the Adverse Event Report, the attestation statement below must be completed.

Please read the attestation statement below and enter the full name of the person completing the form and attesting to the accuracy of the information submitted.

I hereby attest that the information submitted on this adverse event report is true, accurate, and complete to the best of my knowledge.