NEW YORK STATE DEPARTMENT OF HEALTH OFFICE-BASED SURGERY UPDATE ON REPORTING REQUIREMENTS AND ADVERSE EVENT REPORTING
As continued follow-up to our clients regarding the full implementation of the Office Based Surgery Law in New York State, we want to take this opportunity to provide you with an update regarding discussions through the New York State Department of Health. Specifically, on Friday, January 23, 2009, Dr. John Morley, Medical Director of the New York State Department of Health’s Office of Health Systems Management presented an update to the Public Health Council of the State of New York relative to the current status of the adverse reporting requirement and current information relative to the status of physicians gaining their requisite accreditation through the three (3) accrediting agencies (Joint Commission, AAAHC or AAAASF). It warrants emphasis that practicing OBS in an unaccredited facility on or after July 14, 2009 constitutes medical misconduct.
As you are aware, the OBS Law established two (2) implementation timeframes. The first was related to the reporting of adverse effects that went into effect on January 14, 2008 and the second was related to the requirement that full accreditation had to be in place as of July 2009. Regarding the issue of accreditation, Dr. Morley reported that based on his discussions with representatives of the accrediting bodies; there were still a majority/significant number of applicable practices/physicians who had not initiated the accreditation process. He indicated that the State Health Department was “going to get the word out” on the topic. Dr. Morley was assured by the accrediting bodies that any request to initiate the accreditation process after March/April 2009, would not guarantee that the practice would be accredited in time for the July 2009 OBS Law mandate.
Regarding adverse reporting events, for the required period in 2008, there were a total of 548 adverse event reports broken down by the following medical conditions or type of procedures reported to the State Health Department:
| MEDICAL CONDITION OR PROCEDURE TYPE | TOTAL NUMBER |
| Colonoscopy/Sigmoidoscopy | 194 |
| End Stage Renal Disease which includes Thrombectomy, Venous PTA, Fistulagram, Catheter Exchange or Insertion | 95 |
| Upper Endoscopy includes EGD and Gastroscopy | 67 |
| Vascular includes angiogram, aortagram, venogram, angioplasty and stent | 34 |
| ESWL | 32 |
| Termination of Pregnancy | 29 |
| Plastic Surgery includes breast augmentation, abdominoplasty, liposuction, rhinoplasty | 20 |
| Green Lite Laser | 12 |
| Nerve Block | 7 |
| CT Scans | 5 |
| Cystoscopy | 5 |
| Other | 31 |
| Not Specified | 17 |
For informational purposes, adverse events are defined as:
- Patient death within 30 days of the OBS procedure;
- Unplanned transfer to a hospital;
- Unscheduled hospital admission within 72 hours of the OBS procedure; or
- Any other serious or life-threatening event.
The adverse event reporting is done to the New York State Department of Health’s Patient Safety Center. Effective September 2, 2008, there are new adverse reporting requirements for any suspected health care disease transmission (defined as originating in an OBS practice, the transmission of any reportable communicable disease that is bloodbourne from a health care professional to a patient or between patients). Bloodborne pathogens are microorganisms that when present in human blood can cause disease (these include the Hepatitis B virus, Hepatitis C Virus and HIV).
If you have any questions about this topic or any other legal issue, please feel free to call Scott Einiger, Esq. at Abrams, Fensterman, Fensterman, Eisman, Formato, Ferrara & Einiger, LLP at (212) 279 9200.
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