New York State Surgical and Invasive Procedure Protocol (NYSSIPP) - FAQ

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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, 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. Example: 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.

What are the accountability expectations of the DOH with respect to the protocol?

It is to be considered a standard of care, which can involve alternative processes that meet or exceed the standards in the protocol. Article 28 facilities will be held accountable to the protocol when investigations into future wrong procedural events are done.

What are the expectations of the protocol for smaller hospitals?

These standards of care are to be followed by all Article 28 facilities regardless of size.

Is an Extra Corporial Shockwave Lithotripsy (ESWL) procedure considered invasive?

Yes, as noted under 'Scope' section of the New York State Surgical and Invasive Procedure Protocol (NYSSIPP).

Does the New York State Surgical and Invasive Procedure Protocol (NYSSIPP) mandate compliance monitoring?

Yes. Facilities should make routine compliance monitoring of areas that perform applicable procedures an integral part of their quality improvement activities including addressing non-compliance.

Scheduling

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Is the surgeon responsible for making sure the correct procedure is scheduled? If not, who is?

This is determined by the hospital. The intent is not to micromanage these processes. One suggestion was that the individuals who make these arrangements should utilize a verification system to ensure the correct procedure is scheduled and follow up phone conversations with written fax or letter.

During the scheduling process, what information regarding an implant to be placed or device to be removed should be included?

As much that is known about the implant or device to be removed should be included at the time of scheduling such as name of device, brand name, size, etc.

Does the information for scheduling need to be verified by the operating room (OR)?

Yes. The person in the operating room or department responsible for accepting scheduling requests, must verify the information provided by the surgeon/physician. Both parties must mutually agree upon the method of verification.

Should information on surgical approach be included for scheduling?

Yes. The entire procedure including the exact site, level, etc. must be written out. Example: If the approach for a laproscopic 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? The use of acronyms on the schedule is not specifically addressed. Procedures such as electroconvulsive therapy (ECT), eosphagogastroduodenoscopy (EGD), or coronary artery bypass graph (CABG) are commonly referred to by the acronym in verbal and written communication.

Acronyms and/or abbreviations must not be used on the 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.

If it is not known at the time of booking, it can be added later with confirmation from the physician's office and scheduler in the operating room.

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 what we call the Scheduling & the Consent Document. The "name and description of the procedure" are to be 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 has to 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 operating room schedule can have technical terminology but the consent MUST have both, the technical procedure/surgical name and the laymen's terms.

Consent

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What should be done if there is a minor change that needs to be made to the consent?

The consent form must be redone, even for a minor change.

How should the name and description of surgery or procedure be handled on the consent form?

The medical terminology should be listed first – then the laymen's term for the procedure. For example, left femoral herniorraphy – repair a weakness of the wall of the left groin. At least one NYS Hospital and Medical Staff has identified that they will have the patient or guardian complete the informed consent including procedure before signing. This will both increase patient involvement in the process and demonstrate understanding of the procedure.

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 than it should state "saphenous vein graft (SVG) from left, right or both legs." If the 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 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. If the company name is known by the physician at the time of the consent then yes it should be written on the consent.

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. On the same line should be the actual layman's terms that the patient can understand. This may be a struggle in some cases. Examples: 1) herniorraphy – repair of a weakness in the wall of the groin. 2) laminectomy – removal of a piece of bone in the spine. 3) abdomino-perineal resection – removal of the large intestine, rectum and anus with an opening placed in the abdominal wall.

Is a witness to the consent required?

The New York State Surgical and Invasive Procedure Protocol (NYSSIPP) does not address having a witness sign the consent. There is no regulatory or statutory requirement for a witness. It is however, common practice. The surgeon's and the patient's signature prior to the surgery are both requirements.

Pre-Operative/Pre Procedural Verification Process

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When a procedure is performed outside of the operating room do the films need to be viewed in the patient's room?

No, not if there is not a view box or monitor in the room. The film must be viewed where it is best viewed closest to the place that the procedure/surgery is being performed.

Does the new protocol require the pre-operative process to be done on all bedside procedures?

Yes, if they are considered invasive, as defined in the New York State Surgical and Invasive Procedure Protocol (NYSSIPP).

Who is responsible for putting up the correct x-rays in the operating room (OR)?

The facility is to make this determination, and the surgeon is responsible to make sure they are the correct films.

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 is done both in and out of the operating room (OR). One suggestion was that 'real-time' and 'retrospective' monitoring be done and include all expectations for documentation as outlined in the protocol.

Who should confirm the patient's name, date of the study and "Left- Right" orientation of the films for viewing in the operating room?

A physician assistant, attending physician, nurse practitioner, resident, registered professional or nurse can verify the portions of the image that are in writing. 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 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 he/she considers "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 films are either retaken and reviewed by the surgeon and radiologist or reviewed by the surgeon and radiologist at the facility in which the operation is to be performed.

Does the surgical and radiological review of these high risk studies need to be face-to-face?

In this day of Picture Archive and Communication System (PACS), it does not need to be face-to-face but it does need to be synchronous or simultaneous. They 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 in the facility then it is proper treatment to proceed without the 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 and special equipment radiological review, etc. Documentation should follow both for the "time out" as well as the inability to do the radiologist/surgeon review.

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 are on Picture Archive and Communication System (PACS), or is a face to face review required?

Over the phone is acceptable, as long as they are viewing the same picture simultaneously.

Site Marking

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The New York State Surgical and Invasive Procedure Protocol (NYSSIPP) indicates the physician/dentist/podiatrist doing the procedure must do the marking using his/her own initials. During your state educational sessions you indicated that someone other than attending physician performing the procedure, such as a resident/fellow who would be an involved active participant in the surgery/procedure, could do the site marking. Would you clarify this and comment on the situation where some of our hospitals that do not have residents, but have PA's that act as first assistants. Are these PA's allowed to mark the surgical site?

We indicated that someone other than the primary surgeon may be "doing the operation". For example, NOT a student who is holding a retractor or the scrub tech that cuts the sutures but someone who is significantly involved. There are procedures that may be done by physician assistant's (PA's) and nurse practitioners (NP's) where a physician is not involved, as in the example of a chest tube, and they can mark the site. In so marking, they are being acknowledged as 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 graph (CABG) and he/she can mark the appropriate leg. A physician assistant (PA), however, is not doing the craniotomy, but a senior resident may be doing a significant part of the procedure and as long as he/she is there at the start they can mark their own initials.

At what point should the site marking occur?

Marking can be done as early as the day before 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?

Yes. Utilizing the New York State Surgical and Invasive Procedure Protocol (NYSSIPP) applies to blocks, as they are an invasive procedure. The anesthesia team will initial the site of the block after the pre-procedural verification and the "time out", then give the block when the patient is properly sedated.

In the case of multiple radiation treatments, does the site have to be marked at each visit?

Radiation therapy is considered invasive so 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 when the radiological studies are reviewed every five days, the second person confirms that the image belongs to the patient first and last names and second identifier and that the image is displayed in the correct orientation, using (left/right) markers on the image.

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. Ovarian site(s) if it is unilateral or bilateral need to be marked with initials of the physician.

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 must be marked prior to the first surgery and the surgeon marking the site(s) must participate in the "time out" performed for each procedure he/she marks.

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, example: 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 does require marking.

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?

No. Both sites in a bilateral procedure must be marked by the surgeon. According to New York State Surgical and Invasive Procedure Protocol (NYSSIPP), all sites involving laterality, for example: brain and/or paired organs, multiple structures as 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 can be fully awake and participate in the marking of their surgical site. However, there are patients coming to the OR from the 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 patients chart.

When there is a remote incision that is not the final surgical site, which area should be marked? One example would be a groin incision for an endoscopic carotid endarterectomy. If the intended surgical site is marked, that may not be visible when the patient is draped.

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, for example: gortex graft or known aneurysm, a mark is not necessary at the access site. In such cases it does put greater emphasis on the need to STOP, FULL "TIME OUT" and 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?

Both. Make the mark at or near the incision site so that it/they 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 being placed on the skin adjacent to the exact surgical or procedural site is a good process change. We agree with your concept of marking the correct side and site of the "main therapeutic event".

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, unless another practitioner agrees to mark the site, and will be present for that procedure's "time out".

One scenario mentioned was that a team does an unofficial "time out" most often in the pre-op area with the patient alert and awake and discuss the right procedure and site with the patient. The surgeon may or may not be present. Then after the patient has been anesthetized, the official "time out" takes place with the surgeon and marking is done.

The protocol calls for the patient being alert and awake at the time of the official "time out" whenever possible, with all team members absolutely present. In this scenario, the patient would not be aware of marking. Only the practitioner doing the procedure is permitted to do the marking- unless we have a multiple procedure issue on an individual, and another surgeon/part of the same day's operation(s) marks and then participates in the "time out" for that surgeon's procedure.

Has any facility shared information about a pen that does not disappear after prepping or that is visible on dark skin?

While the New York State Department of Health does not have any connection to any manufacturer, the Department of Health is aware that marking darker skin can be challenging.

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 his 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 while rushing to move on to the next procedure. Rushing has been identified as the #1 situation resulting in wrong site/side procedures. 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 his or her 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. Access site doesn't impact the vessel that will be injected and studied.

How do you mark internal organs/sites if you do a procedure laproscopically? Example: the left ovary.

You could mark the skin of the side that would be treated or use a special purpose wristband. For spinal procedures, an internal marker, with second "time out", is the expectation.

Wrist Band

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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 reuses site marking, 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?

Marking is not required when:
a) There is a single lesion to be repaired in an openly visible position. Example: open fracture humerus of tibia to be repaired; single open laceration to be repaired.
b) Entry is via a midline orifice and the structure to undergo a procedure is also midline and/or directly in view of the physician performing the procedure.

What are hospitals using for the Special Purpose wristband? Any information available on purchasing?

Facilities ought to be able to get the special purpose wristbands from whoever currently provides their regular wristbands. They should pick one that meets their needs.

Time Out

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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". You want to make sure that a full "time out" is done, that you have the correct patient first and last names, the second ID, correct side and site of the procedure that is to be scanned, correct contrast agent, route and dose.

A patient having a surgical procedure is brought into the operating room with an anesthesiologist, two RNs, and tech 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?

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 has its own "time out". What does "each procedure" mean is the next question? In this case it is easy. The spinal would be one procedure and the surgery the other. Suppose the patient also has a tubal ligation? That would be done by the same surgeon and part of the original "time out". The "time out" needs to be done by the surgeon doing the procedure so if he/she is present at the beginning it can be done then. If he/she is not present at the beginning and the procedure is not included in the "time out", then it needs to be done prior to the procedure.

Does the state consider a pap test to fall under New York State Surgical and Invasive Procedure Protocol (NYSSIPP)? [Revised December 12, 2008]

The answer to this questions has changed 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 verify's labeling of specimens.

Does the surgeon need to be present during the needle localization for a biopsy?

No, as long as the radiologist and any other staff deemed appropriate are present.

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