New York State Surgical and Invasive Procedure Protocol (NYSSIPP) - Frequently Asked Questions
Topics
- Applicability
- Scheduling
- Consent
- Pre-Operative/Pre-Procedural Verification Process
- Site Marking
- Wrist Band
- Time Out
Applicability
Is the New York State Surgical and Invasive Procedure Protocol (NYSSIPP) considered a standard of care within NYS?
New York State Surgical and Invasive Procedure Protocol (NYSSIPP) became the standard of care within NYS, on March 1, 2007, for Hospitals, Diagnostic and Treatment Centers, Ambulatory Surgery Centers, and individual practitioners.What is the scope of the New York State Surgical and Invasive Procedure Protocol (NYSSIPP)?
The New York State Surgical and Invasive Procedure Protocol (NYSSIPP) applies to all operative and invasive procedures including endoscopy, general surgery, or interventional radiology. Other procedures that involve puncture or incision of the skin, or insertion of an instrument or foreign material into the body, are within the scope of the protocol. This protocol also applies to those anesthesia procedures either prior to a surgical procedure or independent of a surgical procedure such as spinal facet blocks. Certain "minor" procedures such as venipuncture, peripheral IV placement, insertion of nasogastric tube, and foley catheter insertion are not within the scope of the protocol.Is an Extracorporeal Shockwave Lithotripsy (ESWL) procedure considered invasive?
Yes. The New York State Surgical and Invasive Procedure Protocol (NYSSIPP) applies to ESWL.What are the accountability expectations of the DOH with respect to the protocol?
The New York State Surgical and Invasive Procedure Protocol (NYSSIPP) is considered a standard of care, which can involve alternative processes that meet or exceed the standards in the protocol.What are the expectations of the New York State Surgical and Invasive Procedure Protocol (NYSSIPP) for smaller hospitals?
These standards of care should be followed by all Article 28 facilities regardless of size.Does the New York State Surgical and Invasive Procedure Protocol (NYSSIPP) mandate compliance monitoring?
Facilities should make routine compliance monitoring of areas that perform applicable procedures an integral part of their quality improvement activities, including addressing non-compliance.Is the surgeon responsible for making sure the correct procedure is scheduled? If not, who is?
This is determined by the facility. The intent of the New York State Surgical and Invasive Procedure Protocol (NYSSIPP) is not to micromanage these processes.During the scheduling process, what information regarding an implant or device to be placed or removed should be included?
As much that is known about the implant or device should be included at the time of scheduling such as name of device, brand name, size, etc. as applicable.Does the information for scheduling need to be verified by the scheduler?
Yes. The person responsible for accepting scheduling requests should verify the information provided by the surgeon/proceduralist.Should information on surgical approach be included for scheduling?
Yes. The entire procedure including the exact site, level, etc. should be written out. Example: If the approach for a laparoscopic or open cholecystectomy is known at the time of scheduling, the approach should be included.The New York State Surgical and Invasive Procedure Protocol (NYSSIPP) language regarding scheduling says that the entire procedure with exact site, level, digit, side/laterality with no abbreviations should be indicated. Does that apply to the consent form only? Procedures such as electroconvulsive therapy (ECT), esophagogastroduodenoscopy (EGD), or coronary artery bypass graft (CABG) are commonly referred to by the acronym in verbal and written communication.
Acronyms and/or abbreviations should not be used on the consent form and schedule except as noted (C-Cervical, T-Thoracic, L-Lumbar, or S-Sacral).Can you verify what information should be included on the schedule regarding "donor/recovery sites?" Example: skin grafting, the surgeon may not have identified recovery site at the time of booking.
It should include "donor/recovery sites." If it is not known at the time of scheduling, it can be added later with confirmation from the physician's office and scheduler.Does the reservation/booking form have to have the same wording or description of the procedure as the wording on the consent form? Example: scheduled for a McBride procedure and consent states cutting of bone and tissue and internal fixation device.
What you are referring to is the document used to schedule a procedure and the document used to obtain patient consent for performance of the procedure. The consent document must include the name and description of the procedure in terms that are understandable to the patient with correct site/side, level, and digit with the side spelled out as "left," "right," or "bilateral." In your example, the consent should say "left" or "right," joint name, "McBride procedure - cutting of the bone and tissue with internal fixation device," plus all of the other specifications under consent. The document to schedule the procedure and the operating room schedule can have technical terminology but the consent should have both, the technical procedure/surgical name and the laypersons's terms.What should be done if there is a minor change that needs to be made to the consent?
The consent form should be redone, even for a minor change.How should the name and description of the surgery or procedure be handled on the consent form?
The medical terminology should be listed first – then the layperson's term for the procedure. For example, left femoral herniorrhaphy – repair a weakness of the wall of the left groin.The clinical name of the procedure also needs to be included on the consent form for the purpose of correct coding, so would it be acceptable to include a line on the form, in the area where the procedure is written, that states, "The terms describing this procedure listed in this consent form have been explained and are understood by the patient"?
No. The medical terminology and the layperson's term for the procedure should both be documented on the consent form. Examples: 1) herniorrhaphy – repair of a weakness in the wall of the groin. 2) laminectomy – removal of a piece of bone in the spine. 3) abdominoperineal resection – removal of the large intestine, rectum and anus with an opening placed in the abdominal wall.For recovery or donor sites, on consents, the final determination is not always known pre-operatively. How specific is the requirement?
As much as is known at the time of consent should be written about the donor site(s). If it is known that they are going to take a saphenous vein graft (SVG) from either leg then it should state "saphenous vein graft (SVG) from left, right or both legs." If the right radial artery is going to be the donor graft then write "right radial artery donor graft." For skin grafts: "Split thickness donor skin grafts from left thigh, any other potential place that the grafts may be taken from, etc."With reference to the word "implant," how specific does the information for the consent document need to be?
As much that is known about the "implant" at the time of the consent should be written. If the company name is known by the physician at the time of the consent, then it should be written on the consent.Is a witness to the consent required?
Yes. The New York State Surgical and Invasive Procedure Protocol (NYSSIPP) includes a witness signing the consent.When a procedure is performed outside of the operating/procedure room, do the radiological images need to be viewed in the patient's location?
Images should be viewed closest to the place that the procedure/surgery is being performed.Does the protocol require the pre-operative process to be done on all bedside procedures?
Yes. The pre-operative process should be done on all bedside procedures considered invasive, as defined in the New York State Surgical and Invasive Procedure Protocol (NYSSIPP).Who is responsible for displaying the correct images prior to the procedure?
The facility is to make the determination as to who is responsible for displaying the correct images, and the surgeon/proceduralist is responsible to make sure they are the correct images.On survey, what proof would DOH require that compliance to the protocol is being assessed?
Each facility has to determine what Quality Assurance (QA) monitoring and documentation are done both in and out of the operating room.Who should confirm the patient's first and last name, date of the study, and "Left-Right" orientation of the images for viewing?
A physician assistant, attending physician, nurse practitioner, resident, or registered nurse can verify the patient's first and last name and second identifier, date of the study, and "Left-Right" orientation. The purpose of the second person in the radiological review is to VERIFY that the first and last name of the patient and their date of birth, or second identifier, is correct, the date of the study, and that the x-ray or image is displayed in the correct orientation, using markers on the image that indicate Left (L) or Right (R). No diagnostic evaluation is required for this verification.With regard to the pre-operative verification process, where it calls for radiology and surgical review pre-operatively in high risk cases, who decides what is a high risk case and what is the protocol for outside films?
The surgeon defines what they consider "high risk" and then consults with the radiology service prior to the procedure. With the New York State Surgical and Invasive Procedure Protocol (NYSSIPP) as a base, the executive committee of the medical staff may decide to make the determination that certain procedures are "high risk" and enforce those procedures for all surgeons doing them. Outside images are retrieved and reviewed by the surgeon and radiologist at the facility in which the operation/procedure is to be performed.Do the surgical and radiological review of these high-risk studies need to be face-to-face?
With Picture Archiving and Communication System (PACS), the review does not need to be face-to-face but the review does need to be synchronous or simultaneous. The surgeon and radiologist both need to be looking at the images at the same time so it is "reviewed together."Our facility identified craniotomy/burr holes as high-risk procedures. If it is two in the morning and there is no radiologist in the building, what do we do? The patient may be bleeding, so can we write a note stating it is life or death and waive the radiologist reviewing the film?
If it is a true emergency and no radiologist is available, then it is proper treatment to proceed without the simultaneous surgeon/radiologist review. A radiology resident, if present, can be part of the review. The "time out" will verify the correct patient, correct site and side, the procedure to be performed, proper patient position, availability of correct implants, special equipment, and radiological review, etc. Lack of availability for simultaneous surgeon/radiologist review should be included in the "time-out" documentation.In high-risk procedures, is it acceptable for the surgeon and radiologist to review images over the telephone while both are reviewing the same images on Picture Archiving and Communication System (PACS), or is a face-to-face review required?
In high risk procedures, the surgeon and radiologist may review images over the phone as long as they are viewing the same image simultaneously.The New York State Surgical and Invasive Procedure Protocol (NYSSIPP) indicates the physician/dentist/podiatrist doing the procedure must do the marking using their own initials. Can someone other than the attending physician performing the procedure, such as a resident/fellow/physician assistant (PA)/nurse practitioner (NP) who would be an involved active participant in the surgery/procedure, do the site marking?
If someone other than an attending physician, dentist, or podiatrist is performing a surgery/procedure, such as a physician assistant (PA)/nurse practitioner (NP)/resident/fellow, and they are an active participant in the surgery/procedure and they are present at the start of the surgery/procedure, then they can mark the site using their own initials.
For example, there are procedures that may be performed by physician assistants (PAs) and nurse practitioners (NPs) where a physician is not involved, e.g., chest tube placement, and they can mark the site. In marking, they are acknowledging performing a significant part of the procedure and they will be there at the start of the procedure. A physician assistant (PA) may be taking the vein grafts for a coronary artery bypass graft (CABG) and they can mark the appropriate leg. A senior resident may be performing a significant part of a procedure, such as a craniotomy, and as long as they are present at the start, they can mark their own initials.At what point should the site marking occur?
Site marking can be performed as early as the day before a surgery or procedure as long as all the requirements are met.Can the patient receive sedation for the regional block prior to the surgeon initialing the patient's surgical site?
As per the New York State Surgical and Invasive Procedure Protocol (NYSSIPP), marking the operative/procedural site section should take place with the patient/family involved, awake and aware, if possible.In the case of multiple radiation treatments, does the site have to be marked at each visit?
Radiation therapy is considered invasive and the New York State Surgical and Invasive Procedure Protocol (NYSSIPP) does apply. You would do a "time out" each time assuring the correct patient, correct site and side, correct procedure, etc. are in place. Because the tattoo "site marking" is in place for the exact site for radiation, the technician or radiologist does not need to mark the site. Remember each time the radiological studies are reviewed, the second person confirms that the image belongs to the patient using first and last names, the patient's date of birth or second identifier, and that the image is displayed in the correct orientation, using (left/right) markers on the image that indicate Left (L) or Right (R).Do labia and/or ovarian sites need to be marked?
The labia would fall under problematic sites to mark requiring use of a special purpose wristband. Whether an ovarian site(s) is unilateral or bilateral should be marked with initials of the physician at or near the incision site of the operative or procedural side.How do you mark internal organs/sites if you do a procedure laproscopically? Example: the left ovary.
Mark the skin of the operative or procedural side at or near the incision site for the planned surgery or use a special purpose wristband.For multiple surgical procedures, is it permissible for the surgeon doing the second procedure to mark the site after completion of the first procedure, prior to the re-draping?
No. All surgical sites should be marked prior to the first surgery and the surgeon marking the site(s) should participate in the "time out" performed for each procedure they mark.Do all surgeons who are performing one of multiple surgical interventions scheduled in one day, have to mark their own sites prior to the first procedure?
Yes. All surgeons who are performing one of multiple surgical interventions scheduled in one day have to mark their own sites prior to the first procedure unless another practitioner agrees to mark the site and will be present for that procedure's "time out."Since the intended level for injection is not always possible for intrathecal analgesia and epidural analgesia during labor, must skin marking be done with the intended level?
When the anesthetic is necessary for a midline spinal procedure, e.g., epidural of the lower half of the body, the level of the block does not make a clinical difference and marking is not necessary. However, if the procedure involves laterality, as in pain block, then it should be marked.If a surgical procedure is bilateral, for example, bilateral myringotomy with insertion of tubes or bilateral inguinal hernia repair, does the surgeon need to initial both the right and left side, or does the bilateral nature of the procedure eliminate the question of laterality?
Both sites in a bilateral procedure should be marked by the surgeon. According to New York State Surgical and Invasive Procedure Protocol (NYSSIPP), all sites involving laterality, (e.g., brain) and/or paired organs, multiple structures (e.g., fingers, toes, hernias, lesions), or multiple levels must be marked.In what circumstance would it be acceptable to sedate and prepare a patient for the operating room prior to the surgeon marking the site?
It is expected that almost all patients be fully awake and participate in the marking of their surgical site. However, there are patients coming to the operating room from the intensive care unit (ICU) or patients who may not have capacity to understand their circumstances or suffer from severe anxiety. When it is in the best interest of the patient and the outcome of the patient, it is permissible to provide sedation to a patient prior to the marking of the site. It is imperative, however, that the circumstances and the indication for such treatment be documented in the patient's chart.When there is a remote incision that is not the final surgical site, e.g., a groin incision for an endoscopic carotid endarterectomy, which area should be marked?
When the access point for surgery bears no relation to the actual surgical site AND there is no clinical reason to access a particular site/vessel, a mark is not necessary at the access site. In such cases it does put greater emphasis on the need to STOP, perform a FULL "TIME OUT," and confirm and document AGREEMENT OF ALL PARTICIPANTS ON THE SITE(S) immediately prior to the surgery.If a patient is undergoing a left colon resection or a right hemicolectomy, are the physicians required to mark pre-operatively, reaffirm at the "time out," or both?
Physicians are required to both mark at or near the incision site pre-operatively and reaffirm at the "time out" so that it will be visible when the patient is draped. A right or left hemicolectomy is a good example of a surgery that does require marking. "Time out" and the corresponding documentation apply to all surgical and invasive procedures.Fluoroscopic procedures are particularly challenging to reduce wrong side intervention. Does the state have any recommendations for these challenging cases?
Though not part of the New York State Surgical and Invasive Procedure Protocol (NYSSIPP), the use of Right or Left radio-opaque markers placed on the skin adjacent to the exact surgical or procedural site is a good process change.Has any facility shared information about a pen that does not disappear after prepping or that is visible on dark skin?
The New York State Department of Health does not provide recommendations for pens for site marking and does not have any connection to any manufacturer.What is the intent for marking the nerve root? The anesthesiologist does the block at the time they see the patient. The process for doing nerve root blocks is that they are done by the anesthesiologist at the time the patient is seen by the anesthesiologist. They are not marked and then done later. For example, the anesthesiologist would see the patient, mark their initials, then insert the needle.
Nerve blocks are done for different reasons and in different settings. When a unilateral block is planned, it should be marked/initialed in discussion with the patient. Distractions occur frequently in the health care setting, with much activity outside of the operating room. Marking of all unilateral procedures is necessary to reduce the risk of a quick, simple needle/injection being done on the wrong side. Please note that continuous attendance is no longer an exemption.Can a regional block be performed as in epidural, interscalene, axillary, popliteal or fossa block before the patient has talked to the surgeon?
Yes. A block can be performed before the patient talks to the surgeon and marked with the initials of the practitioner. The surgeon will then initial their own initials prior to the "time out."For carotid angiogram, when an intended site is determined, do you have any solutions or recommendations on how to mark the site/side since access can be obtained from the right or left groin and the carotid area is also draped?
Marking isn't the issue here. It is the "time out" where they confirm the patient and procedure. The access site doesn't impact the vessel that will be injected and studied.When is a special purpose alternative wristband appropriate for the patient?
A special purpose wristband is an alternative to marking in those special cases when site identification is necessary, but either the patient refuses site marking, the patient is a neonate (marking may cause a permanet tatoo), or when the anatomical location makes marking either difficult or not readily visible during surgical preparation or during the "time out."When is marking not required?
A full list of exceptions to site marking is included in the New York State Surgical and Invasive Procedure Protocol (NYSSIPP), Section E "Exceptions to Site Marking."What are hospitals using for the Special Purpose wristband? Is there any information available on purchasing?
Facilities should be able to obtain the special purpose wristbands from the same source they receive their regular wristbands.For procedures done outside of the operating room, is it mandated that the "time out" be done with another person?
No. However, when a procedure is being done without assistance it is strongly advised that the person enlist an observer or assistant to participate in the "time out."If the patient is having an upper endoscopy and colonoscopy done by the same physician, what is the criterion for the "time out"?
The "time out" for both can be done at the same time since the endoscopist is the same for both procedures.Is a "time out" required for Computerized Tomagraphy (CT) procedures with contrast?
Yes. The New York State Surgical and Invasive Procedure Protocol (NYSSIPP) applies to all Computerized Tomagraphy (CT) procedures with contrast including the "time out." A full "time out" should be performed identifying the correct patient using two patient identifiers (such as patient first and last name plus a second identifier), correct side and site of the procedure that is to be scanned, and the correct contrast agent, route, and dose.A patient having a surgical procedure is brought into the operating room with an anesthesiologist, two RNs, and a technician present. The Anesthesiologist performs a spinal anesthetic. The surgeon then comes into the room to perform the surgical procedure. Are two "time out" procedures required, one before the spinal (with the anesthesiologist and staff in the room at that time) and one before the surgery with the entire team?
Yes. Each procedure should have its own "time out." The spinal anesthetic would be one procedure and the surgery the other.Does the state consider a Papanicolaou (Pap) test to fall under New York State Surgical and Invasive Procedure Protocol (NYSSIPP)? [Revised December 12, 2008]
As of 12/12/08, the NYSSIPP does not apply in all its detail to Pap smears. It would be appropriate, however, to include a step in your process for this procedure that verifies labeling of specimens.Does the surgeon need to be present during the needle localization for a biopsy?
No. The surgeon does not need to be present during the needle localization for a biopsy as long as the radiologist and any other required staff are present as necessary.
