SARASOTA MEMORIAL HOSPITAL POLICY

Transcription

1 PS1013 SARASOTA MEMORIAL HOSPITAL POLICY TITLE: PREVENTION OF RETAINED SURGICAL ITEMS: SOFT GOODS, SHARPS AND INSTRUMENTS EFFECTIVE DATE: REVIEW/REVISED DATE: POLICY TYPE: Job Title of Responsible Owner: Director of Perioperative Services 11/01/99 6/23/17 Clinical 1 of 12 Non-Clinical PURPOSE: POLICY STATEMENT: To establish standards for the accounting for soft goods, sharps, and instruments used during operative or other invasive procedures when the depth and location of the wound is such that the item could be lost or retained in the patient. It is the policy of Sarasota Memorial Health Care System (SMHCS) to account for all soft goods, sharps, and instruments used during operative or other invasive procedures and ensure that there are no unplanned retained surgical items. Soft goods and sharps will be counted on ALL procedures. Instruments will be counted on procedures in which a major body cavity is entered, and when the possibility exists that an instrument could be retained in the wound. Unnecessary activity and distractions should be curtailed during the counting process to allow the scrub person and RN circulator and/or Registered Cardiac Invasive Specialist circulator in cath lab to focus on counting tasks. EXCEPTIONS: 1. Counts may be waived by the RN and/ or MD in Emergent Situations and in cases where there is doubt about the ability to get an accurate final count due to the complexity, length of procedure, or large number of items counted. An x-ray shall be taken for all waived counts at the end of the procedure to verify that no surgical items were retained in the patient and it will be documented on the procedure record. In addition, an Occurrence Report will be completed and sent to Risk Management. 2. Instrument counts are not required on the following: a. Thoraco-abdominal spine surgery (Use waived count protocol, taking an X-ray at the end of the procedure). b. Vaginal deliveries c. Pacemakers/ICD s 3. The Cath lab may use RN circulator or Registered Cardiac Invasive Specialist circulator for counting. 4. Initial instrument count will be done on ALL Laparoscopy (including extended incision cases), robotic, and hernia cases.

2 2 of Instruments should be accounted for on all procedures in which the likelihood exists that an instrument could be retained. Additionally, all procedures with a high likelihood of converting to open should have an initial count. DEFINITIONS: Radiopaque Surgical Soft goods: Sponges, (e.g., Raytec 4x4s, lap tapes, kitners ( peanuts ), intestinal sponges, tonsil sponges, neuro patties/sponges), towels, and textiles. All types of sponges should contain a radiopaque indicator that is viewable when x-rayed, including vaginal packing and throat packs. Sharps: suture needles, sternal wires, scalpel blades, hypodermic needles, blunt needles, cautery/bovie tips, safety pins and similar small sharp accessories. Miscellaneous items: to be included in the soft good and sharps count, such as hemoclip cartridges, vessel loops, suture boots, umbilical tapes, vaginal packing, vascular inserts, cautery scratch pads, trocar sealing caps, micro bulldogs, acorn tips, navigational system reflective spheres, rubber bands, stapler reloads, Raney clips, surgical spear sponges, flexible iris retractor, scleral plugs, and other small items that have the likelihood of being retained in the wound. Defogger will be counted as bottle + sponge (disposal of cap into trash will be verified by the RN circulator). PROCEDURE: 1. SOFT GOODS AND SHARPS : Sharps, soft goods, miscellaneous items should be accounted for during all procedures for which the items are used. The potential risk for retention cannot always be predicted; therefore, all items opened or used in a procedure must be accounted for at the end of the procedure. a. Initial counts of radiopaque soft goods should be performed and recorded for all surgical procedures. b. Sponges and sharps will be completely separated, counted audibly and concurrently viewed by two staff members, one of which must be an RN circulator and/or Registered Cardiac Invasive Specialist circulator in cath lab. Surgical technology students may count under the supervision of the scrub person. 1) Keep all sponges banded and on the back table prior to counting. 2) Sponges and all soft goods should be left in their original configuration and should not be cut or altered in any way. 3) All types of sponges should be marked with a radiopaque indicator, which is viewable when x-rayed. X-ray detectable towels are available and their use is encouraged. Note: If an item is used that does not

3 3 of 12 have the radiopaque indicator, it will be tagged with an instrument and counted (example: OR towels that do not have an x-ray detectable marker, Gauze strips). 4) Non-radiopaque sponges used for preps that have a similar appearance to counted radiopaque sponges should be isolated before beginning the procedure to avoid possible confusion with the counted radiopaque sponges. 5) Any Raytec sponges and lap tapes NOT kept on the field, must be counted, contained, and recorded on the count sheet. 6) Packages containing an incorrect number of radiopaque sponges or a manufacturing defect should be removed from the field, bagged, labeled, isolated from the rest of the radiopaque sponges in the OR, and excluded from the count. Packages containing an incorrect number of radiopaque sponges may be removed from the room before the patient s entry. Save package information, notify CC/CM and complete on-line occurrence report. 7) If the surgical sponge package is banded, the band should be broken and discarded at the time of the count. 8) Radiopaque sponges should not be used as postoperative wound dressings. 9) Dressing sponges included in custom packs should remain sealed and isolated on the field until the final count is resolved. 10) All soft goods used in the surgical wound should be radiopaque. Non-radiopaque soft goods will NOT be used in the surgical wound. (e.g. towels, linen, nonradiopaque sponges.) c. A count worksheet will be used to track counted items before, during, and after the procedure. In the OR, it is not a permanent part of the medical record, but will remain with the OR copy of the medical record. In the Invasive Cardiology area, it is documented in the permanent electronic medical record. d. Soft goods and Sharps Counts will be done: 1) Before the procedure begins to establish a baseline. 2) Before closure of a cavity within a cavity (uterus, bladder, aorta, atrium, dura, open procedures with implantation of mesh). 3) At the beginning of wound closure. 4) At skin closure or end of procedure when counted items are no longer in use (i.e., final count).

4 4 of 12 5) At the time of permanent relief of the scrub person and/or circulating nurse, although direct visualization of all items may not be possible. The surgeon should be informed at the time of permanent relief that the policy requires a shift change count. If the surgeon waives this relief count, the waived count protocol applies; this includes post-op x-ray, regardless of whether relief staff count at the end of the case and get a correct count. The scrub and circulator will verbally acknowledge which step of the closure count is being performed (closure of cavity within a cavity, beginning of wound closure, and skin closure). 6) The final Raney clip count will be completed once the bone flap is closed, skull flaps are approximated and just prior to removal of the clips from the skull flaps. They do not need to be counted again. This is the final count for the Raney clips ONLY. 7) The final count should not be considered complete until all soft goods and sharps used in closing the wound are removed from the wound and returned to the scrub person. e. If a patient is admitted to the O.R. with a pre-existing open wound, and there exists the likelihood that a foreign object might be retained, an x-ray will be taken at the end of the case. The protocol for count discrepancy / waived count will be implemented before the patient leaves the O.R. 1) Packages containing suture needles will be counted as the number indicated on the package. The scrub person will verify this count when the package is opened with the circulating nurse. Used needles will be kept on a disposable needle mat to insure their containment on the field. Needles that fall off the field should either be placed in a specimen cup or sharps needle box with patient ID until final counts are performed. f. When additional items are added to the sterile field, they will be counted and documented on the count worksheet. If there are multiple circulators, or if there is relief of the circulator anytime during the case, additional added items will also be initialed on the count worksheet. g. Counted items must remain within the room during the procedure. 1) Linen and trash containers will not be removed from the room until counts are completed and reconciled. 2) X-ray detectable sponges should not be used as dressings. 3) Counted sponges should not be sent with a specimen to pathology or the lab.

5 5 of 12 h. Loose sponges, tapes, or towels packed in the patient during the procedure will be documented on the count worksheet upon insertion and accounted for when removed and initialed by the circulating RN. The scrub person is responsible for communicating to the circulator the location and number(s) of packed sponges / tapes/towels. This is to ensure that all packed item(s) are noted on the count sheet and accounted for before closure. i. During the case, scrubbed personnel will open, separate, and discard used sponges in kick buckets lined with impervious plastic liners. j. Sponges passed off the field are to be separated and visually counted by the circulator and scrub person (do not leave used sponges on your back table). k. Used sponges will be placed in sponge holders starting at the top left pocket. Use a separate hanging bag for each type of sponge (i.e., raytec 4X4s and laps) Raytec 4x4s and laps should be placed in each individual pocket with the radiopaque tape visible (10 raytec 4x4s and 10 laps per count bag). l. Closing counts should be performed in the same sequence: the surgical site and sterile field, the Mayo stand, the back table, and then off the field. m. The circulating nurse will inform the surgeon of status of all counts (correct, incorrect, reconciled or waived). n. Contaminated sponges and sharps will be handled and disposed of according to SMHCS Policy 00.IFC.12, Handling and Disposal of Biomedical Waste and Sharps. o. When soft goods are intentionally used as therapeutic packing, the soft good should be radiopaque whenever possible (e.g., intra-cavity, oral, superficial): 1) When the patient leaves the OR with this packing in place, the number and types of items placed should be documented in the medical record: a) as reconciled and confirmed by the surgeon when this information is known with certainty, or b) as incorrect if the number and type of sponges used for therapeutic packing is not known with certainty. 2) The number and types of soft goods used for therapeutic packing should be included and communicated as part of the transfer of patient care information. 3) If therapeutic packing is removed or added during a procedure performed in ICU or on a nursing unit, the RN caring for the patient during the procedure should document in the patient s medical record the number and type of items removed or added.

6 6 of 12 4) When the patient is returned to the OR for a subsequent procedure: a) The number and type of radiopaque soft goods removed should be documented in the medical record. b) The radiopaque sponges removed should be isolated and not included in the counts for the removal procedure. c) The surgeon and the surgical team should perform a methodical wound examination and consider taking an intraoperative radiograph if all sponges are not accounted for. d) The count on the removal procedure should be noted as reconciled if all radiopaque soft goods have been accounted for. e) An x-ray will be taken at the end of the case, even if the soft good count was correct. 2. INSTRUMENT : a. Instruments will be counted on procedures in which a major body cavity is entered (e.g., thorax, peritoneum, retroperitoneum), etc. and when the likelihood exists that an instrument could be retained. b. Preprinted count sheets should be used to record the counted instruments. c. Smaller trays and surgeon s special trays may be counted as total number of pieces. d. Instrument counts will be done: 1) Before the procedure begins to establish a baseline. 2) At the beginning of wound closure when the counted items are no longer in use. 3) At the time of permanent relief of the scrub and/or circulating nurse. The surgeon should be informed at the time of permanent relief that the policy requires a shift change count. If the surgeon waives this relief count, the waived count protocol applies; this includes post-op x-ray, regardless of whether relief staff count at the end of the case and get a correct count. 4) The final instrument count should not be considered complete until those instruments used in closing the wound are removed from the wound and returned to the scrub person. e. When additional instruments are added to the sterile field, they will be counted and documented on the count worksheet. If there are multiple circulators or if there is relief of the circulator anytime during the case, additional instruments added will also be initialed on the count worksheet.

7 7 of 12 f. All instruments will be counted, except on those procedures addressed in the exception section. g. Instruments will be counted audibly and concurrently viewed by two staff members, one of which is an RN circulator and/or Registered Cardiac Invasive Specialist circulator in cath lab. Surgical technology students may count under the supervision of the scrub person. h. Count multi-part retractors as follows: blades and hardware are counted separately: rings, table attachments and bars are not counted. i. Individual pieces of assembled instruments (e.g., suction tips, wing nuts, sheaths) should be accounted for separately and documented on the count sheet. j. Instruments dropped or passed off the sterile field will remain in clear view for counting later. k. Counts must be performed in the same sequence each time. The count must begin at the surgical site and the immediate surrounding area, proceed to the mayo stand, instrument back table and lastly the items already removed from the field. The circulating nurse will inform the surgeon of status of all counts (correct, incorrect or waived). l. All counted instruments must remain within the room during the procedure until counts are completed and reconciled. All parts of broken or disassembled instruments will be accounted for. m. Contaminated instruments will be handled according to established policies and procedures for processing instruments in compliance with SMHCS Corporate Policy 00.IFC.16, Standard Practices for Decontamination, Distribution and Sterilization of Patient Care Items. 3. PROTOCOL FOR COUNT DISCREPANCY/WAIVED COUNT: a. An x-ray will be taken for all count discrepancies and waived counts to ensure that a foreign body is not retained in the patient, unless the item is non-radiopaque. If there is any question of whether the item is radiopaque or not, an x-ray will be performed and a final x-ray must be taken after the count discrepancy is reconciled. b. For count discrepancies involving non-radiopaque items the surgical team will complete a thorough exam of the field and surrounding area. The RN circulator will submit occurrence report stating the surgical site was cleared by surgeon/pa exam.

8 8 of 12 c. Prior to requesting x-ray for a missing item: 1) Circulator will inform surgeon and CC/CM/CRN about the discrepancy. 2) Surgeon/Physician and/or PA, ARNP, RNFA will examine the wound. 3) Scrub person will search sterile areas and the circulator will search unsterile areas including trash and linen containers. 4) If a sharp (e.g., blade, needle, hypo...) is found on the floor, or any area other than the sterile field, an x-ray will be taken as an additional confirmation for correct sharps count before the patient is removed from the OR table. 5) If a sponge is found under the OR table or there is reasonable doubt about the location of the recovered sponge off the sterile field, an x-ray will be taken as an additional confirmation for correct sponge count before the patient is removed from the OR table. 6) Note: A C-Arm may be used to facilitate the search for the missing item but shall NOT be used to make the permanent film. d. The radiology technologist will: 1) Notify the radiologist that a film needs to be read for count discrepancy or waived count. 2) Assess the need to take multiple x-rays if one x-ray will not include the entire operative field (e.g., CABG patients will need the chest and legs, a large patient may need more than 1 film to observe their entire abdomen or chest). Frequently an anterior/posterior and lateral film are necessary to ensure structures are not blinding visibility. 3) Once the image has been acquired by the technologist, the technologist will then upload the image into the systems PACS (picture archive communication system) and the image will be available for the OR physician to view as well as the Radiologist. 4) Document on the requisition X-ray for count verification, and indicate what the missing item is or if x-ray is for waived count. e. A STAT wet-read of all count films will be done by a radiologist on duty within the facility. The radiologist is to promptly call the report directly to the circulating RN or surgeon/proceduralist in the operating or procedure room. Where the possibility of a retained item is identified on the wet-read, the radiologist must speak directly to surgeon or

9 9 of 12 proceduralist. In cases where the radiologist has a negative count film, that result can be given to the circulator in the room. 1) The patient will remain in the room and on the OR table until x-ray for count verification has been taken, read and cleared by the radiologist unless contraindicated by the patient s condition (as determined by the anesthesiologist and/or surgeon). 2) When the circulating RN receives the report, he or she shall convey the radiologist s report to the surgeon as soon as it is received, and document the report results in the Electronic Medical Record and/or occurrence report. 3) If the radiologist and/or surgeon requests additional x- rays for count verification, or is there is any question by any member of the surgical team that a justification film should be done, the patient must remain in the OR on the OR table until the x-ray is read and cleared by the radiologist. f. The radiologist s STAT wet-read and permanent interpretations of the count verification film will be completed post-op and maintained as a permanent part of the patient s medical record. g. The circulating RN will submit an Occurrence Report providing all relevant information to Risk Management for the count discrepancy or waived count. h. If an x-ray is not performed in the O.R. due to critical status of the patient as determined by surgeon and/or anesthesiologist, the circulator will report to the R.N. accepting the patient the need for an x-ray to be taken ASAP (when the patient s condition permits). The circulator in the O.R. will complete an Occurrence Report stating x-ray unable to be taken in O.R. due to critical status as determined by surgeon / anesthesiologist, and the name of the R.N. who was given report. The R.N. on the floor will notify the surgeon ASAP once the x-ray has been performed and the radiologist has read the x-ray. The R.N. on the floor will document on an Occurrence Report the radiologist verifying the x-ray, the results of the x- ray and the surgeon who was notified and the time. 4. PROTOCOL FOR REMOVING IMPLANTED DEVICES: a. Any time an implant is removed (especially if there are multiple pieces) the explant should be inspected to ensure that all the pieces that were to be explanted are accounted for. b. A verification x-ray may be completed at the discretion of the surgeon and/or staff if there is question that all the pieces of the explant are not accounted for.

10 10 of 12 c. Documentation should include who inspected the explant and any other actions taken. Refer to policy # : Implant/Explant Handling and Documentation 5. DOCUMENTATION: a. Soft good, sharp, and instrument counts shall be documented in Electronic Medical Record (on the department specific intraoperative / procedure record form if computer is not available) including but not limited to: 1) Types of counts (i.e., soft goods, sharps, instruments) and number of counts 2) Names and titles of personnel performing the counts 3) Results of counts 4) Notification of surgeon 5) Instruments remaining with the patient or sponges intentionally retained as packing 6) Actions taken if count discrepancy occurred 7) Waived counts and reason 8) X-ray taken for count verification, site, results and name of radiologist who read the film 9) If a major body cavity wound is not closed (example: chest, abdomen), and patient is discharged from the O.R. with x-ray detectable sponges packing the wound, the type and number of sponges retained in the wound must be documented on the O.R. / procedural record and this information must also be given to the accepting R.N. during report. 10) If a wound is not closed, and patient is discharged from the O.R. with packing, the type of packing, exact location, and the number/amount of the item packed in the wound must be documented on the O.R. / procedural record and this information must also be given to the accepting R.N. during report b. An Occurrence Report will be completed for all count discrepancies, incorrect counts and waived counts according to SMHCS Corporate Policy 00.RSK.12, Sentinel/Adverse Event/ Incident/Occurrence/ Medication Variance: Reporting And Management. 6. PROTOCOL FOR DEATH IN THE O.R. AND ORGAN PROCUREMENT: a. If a patient expires during the operative procedure, only one soft good, needle, and instrument count will be performed at the end of closure. This will be documented on the Intraoperative Record.

11 11 of 12 b. During an Organ Procurement Case only one soft good, needle, and instrument count will be done at the end of the procedure. This will be documented on the Intraoperative Record. RESPONSIBILITY: REFERENCES: AUTHOR (S) It is the responsibility of the department/unit directors to ensure that this policy is followed. Perioperative Standards and Recommended Practices, Standards of Nursing, AORN, Inc., Current Edition. Comprehensive Accreditation Manual for Hospitals (2015), The Joint Commission, Oakbrook Terrace, Illinois Deb Bohanon, Director of Radiology Perioperative Leadership Team Renee Maietta, APN, Women s Services Jana Putnal, Manager, Invasive Cardiology Travis Brantley, Lead OR Radiologic Technologist

12 12 of 12 APPROVALS: Signatures indicate approval of the new or reviewed/revised policy. Committees/Sections/Departments: Date Surgical Governance Council 6/5/17 Op and Others Committee 5/9/17 Director/Responsible Owner: Vice President/Executive Director: Chief of Medical Operations (if clinical policy or appropriate) Chief of Staff: (if clinical policy or appropriate) Medical Executive Committee: (if clinical and review requested by CMO and COS) Chief Executive Officer: David Patterson, ACNO, Cardiovascular and Surgical Services 6/8/17 Connie Andersen, C.N.O. 6/9/17 Dr. R. Stephen Taylor, C.M.O. 6/13/17 Dr. Scott Stevens, COS 6/13/17 N/A David Verinder, CEO 6/14/17