Form #3 Foreign body left during procedure abstraction tool

Abstraction Instrument for Validation of Selected AHRQ

Quality Indicators

PSI 5: Foreign Body Left during Procedure (February 1, 2008; version 2.6)

Form Approved

OMB No. 0935-0124

Exp. Date XX/XX/20XX

Public reporting burden for this collection of information is estimated to average 60 minutes per response, the estimated time required to complete the survey. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Form Approved: OMB Number 0935-0124  Exp. Date xx/xx/20xx. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: AHRQ Reports Clearance Officer Attention: PRA, Paperwork Reduction Project (0935-0124) AHRQ, 540 Gather Road, Room #5036, Rockville, MD 20850.

Section 1: Abstractor details

1.1 Date abstraction completed

_ _ /_ _ /_ _ _ _ MM/DD/YYYY

2. Abstractor identification number

_ _ _ _ _ _ _ _

Section 2: Record identification/validation

2.1 AHRQ Study identification number

_ _ _ _ _ - _ _ _ _

2.2 Medical record number/Patient control number

_ _ _ - _ _ - _ _ _ _

2.3 Date of birth

_ _ /_ _ /_ _ _ _ MM/DD/YYYY

2.4 Gender

• Male

• Female

2.5 Date of admission

_ _ /_ _ /_ _ _ _ MM/DD/YYYY

6. Date of discharge

_ _ /_ _ /_ _ _ _ MM/DD/YYYY

Section 3: Ascertainment of event

1. Did the patient have a foreign body that was unintentionally left in during a procedure or operation during THIS hospitalization or a reaction to a foreign substance that was placed during THIS hospitalization?

• Yes

• No  If NO, describe the circumstances on why you believe this chart was flagged for review in the TEXT BOX provided.

_____________________________________________________________________________________________________________________________________________________________________________________________

3.2 Was this admission related to an unintentional foreign body that was left in during a procedure prior to this hospitalization or from a reaction to a foreign substance from a previous surgery or procedure (prior to this hospitalization)?

• Yes  If YES, describe the circumstances on why you believe this chart was flagged for review in the TEXT BOX provided.

• No

_____________________________________________________________________________________________________________________________________________________________________________________________

If NO to Q 3.1 or YES to 3.2, END the abstraction here.

3.3 How many unintentional foreign bodies did the patient have? _ _

Foreign body 1:

3.4.1 For each unintentional foreign body, was the foreign body related to an operative procedure performed in the operating room?

• Yes If YES, answer supplemental questions S1-17

• No  If NO, answer supplemental questions P1-10.

Foreign body 2:

3.4.2 For each unintentional foreign body, was the foreign body related to an operative procedure performed in the operating room?

• Yes If YES, answer supplemental questions S1-17

• No  If NO, answer supplemental questions P1-10.

Foreign body 3:

3.4.3 For each unintentional foreign body, was the foreign body related to an operative procedure performed in the operating room?

• Yes If YES, answer supplemental questions S1-17

• No  If NO, answer supplemental questions P1-10.

NOTE: Make a copy of pages 4-7 for each foreign body or substance NOT related to an operative procedure performed in the operating room:

Make a copy of pages 8-11 for each foreign body or substance left-in during an operative room procedure.

Duplicate Page: This page corresponds to foreign body/ substance number _ _ .

For each unintentional foreign body or substance associated with a test or procedure NOT performed in the operating room, answer the following set of questions:

P.1 Date that the acute reaction to a foreign substance or the unintentional foreign body was discovered:

_ _ | _ _ | _ _ _ _ [MM/DD/YYYY]

P.2 Date of the procedure associated with the reaction to foreign substance or unintentional foreign body

_ _ | _ _ | _ _ _ _ [MM/DD/YYYY]

P.3 How was the acute reaction to a foreign body or the unintentional foreign body discovered?

• At the time of procedure

• Physical examination without presenting signs/symptoms

• Routine post-procedure screen or test (non-symptom-directed x-ray)

• Symptomatic detection

  • Mass

  • Infection

  • Reported signs/symptoms such as cramping and/or pain

  • Obstruction

  • Other ____________

• Discovered incidentally at time of another operation or procedure

• During subsequent surgery related to signs/symptoms/complications

• Other IF other, explain in the TEXT BOX

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

P.4 Select the category which best describes the procedure associated with unintentional acute reaction to a foreign body or the unintentional foreign body.

• Abdominal paracentesis

• Arterial line placement

• Aspiration of fluid or tissue, puncture, and/or catheterization

• Aspiration needle biopsy

• Cardiac catheterization

Duplicate Page: This page corresponds to foreign body/ substance number _ _ .

• Central line placement

• Coiling or other endovascular surgical procedure

• Endoscopic examination

• Epidural or spinal procedure

• Infusion or transfusion

• Injection or vaccination

• Kidney dialysis or other perfusion

• Pacemaker placement

• Tunneled catheter placement

• Thoracentesis

• Unable to determine/Critical documentation missing

• Other procedure  List in the TEXT BOX.
  
  

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

P.5 What was the ICD-9-CM code(s) associated with the selected procedure from Q P.4?

ICD-9-CM code -	Look-up box for procedure names
1.	1.
2.	2.
3.	3.

P.6 What best describes the foreign body or substance?

• A medical device

• Cement, bonding or bone wax

• Central line catheter or catheter tip

• Coil

• Cotton

• Drain (e.g., VP shunt, peritoneal shunt, etc)

• Drainage tube

• Glass (medical related)

• Guidewire or guidewire fragment

• Instrument-non-needle (e.g., clip, )

• Metal needle or needle tip

• Peripheral line catheter or catheter tip

• Stent

• Staple

• Sponge (ray-tec)

• Sponge (lap) or gauze

• Sponge- type of unknown

• Substance (e.g., cement, bonding material, or bone wax)

• Other medical type device or substance (e.g., basket from broken device)

State in the TEXT BOX

______________________________________________________________________________________________________

• Non-medical device  State in the TEXT BOX

_____________________________________________________________________________________________________

• Critical documentation missing

• Other State in the TEXT BOX

______________________________________________________________________________________________________

P.7 What was the rank of the person performing the procedure associated with the foreign body or substance (i.e., the person who was inserting or manipulating the needle or device)?

• Attending physician

• Physician, unknown rank

• Physician-in-training (fellow, resident, intern)

  • [IF P7= physician-in-training] Was this trainee working under the direct supervision of an attending physician?

• Yes

• No

• Medical student

[IF S.7=medical student] Was this student working under the direct supervision of an attending physician?

• Yes

• No

[IF S.7=medical student NOT working under the direct supervision of an attending physician] Was this student working under the direct supervision of a physician-in-training?

• Yes

• No

• Physician extender IF YES,

• PA

Duplicate Page: This page corresponds to foreign body/ substance number _ _ .

• NP

• Other licensed health care professional IF YES,

• RN

• LVN

• Respiratory therapist

• Other

• Other non-licensed health care worker

• Patient or caregiver

• Other ________[TEXT BOX]

• Unable to determine

If Q P.7 = physician (any type), go to Q P.8, if not skip to Q P.9.

P.8 If Q P.7 = physician, what is his/her area of specialty?

• Pulmonology/Critical Care (Intensivist)/Cardiology

• Surgeon or surgical subspecialist

• Hospitalist/Internal medicine/Family practice

• Emergency Medicine

• Radiologist/Interventional radiologist

• Anesthesia

• Other __________ [TEXT BOX]

P.9 What were the circumstances surrounding the event:

• Procedural error or complication due to provider (e.g., inappropriate manipulation of guide wire during central line placement, cutting of cutdown catheter during dressing change, etc)

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

• Device failure/malfunction

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

• Patient behavior

Duplicate Page: This page corresponds to foreign body/ substance number _ _ .

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

• Lack of adequate pain control or anesthesia

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

• Other ------

P.10 Please provide a brief synopsis of circumstances surrounding this event using excerpts from the medical record (TEXT BOX).

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Duplicate Page for Additional procedures

Duplicate Page: This page corresponds to foreign body/ substance number _ _ .

ANSWER THE FOLLOWING QUESTIONS FOR EACH foreign bodies or substances left unintentionally left during surgery.

S.1 Date of discovery of the foreign body or diagnosis of the acute reaction to a foreign substance accidentally left during an operative procedure:

_ _ | _ _ | _ _ _ _ [MM/DD/YYYY]

S.2 List the start date of the procedure of the causative operative event most likely associated with retained foreign body or substance.

_ _ | _ _ | _ _ _ _ [MM/DD/YYYY]

S.3 List the start time of the procedure of the causative operative event most likely associated with retained foreign body or substance.

_ _ : _ _ [HH:MM]

S.4 List the end date of the procedure of the causative operative event most likely associated with retained foreign body or substance.

_ _ | _ _ | _ _ _ _ [MM/DD/YYYY]

S.5 List the end time of the procedure of the causative operative event most likely associated with retained foreign body or substance.

_ _ : _ _ [HH:MM]

S.6 List ICD-9-CM procedures codes associated with the operative event most likely associated with retained foreign body or substance. Limit the response to the top five procedures.

ICD-9-CM code -	Look-up box for procedure names
1.	1.
2.	2.
3.	3.
4.	4.
5.	5.

• Critical documentation missing

S.7 Was there an unplanned change in the procedure performed (e.g., a change in the planned procedure)?

Duplicate Page: This page corresponds to foreign body/ substance number _ _ .

• Yes If YES, explain in the text box provided

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

• No

• Critical documentation missing

S.8 Urgency of the surgical procedure

• Emergent or unscheduled

• Scheduled either prior to admission or during this admission (non-emergent)

• Critical documentation missing

S.9 Number of surgical teams involved in the surgical event (e.g., neurosurgical team working on the head and orthopedics working on a fracture) _ _

S.10 Did the surgical team include residents or interns?

• Yes

• No

S.11.Sponge count(s) performed:

• Yes

• Pre

• Post

• No, ND or N/A to procedure

IF pre-post sponge count performed, did they agree?

• Yes

• No

S.12 Instrument count(s) performed:

• Yes

• Pre

• Post

• No, ND or N/A to procedure

IF pre-post instrument count performed, did they agree?

• Yes

• No

Duplicate Page: This page corresponds to foreign body/ substance number _ _ .

S.13 Needle count(s) performed:

• Yes

• Pre

• Post

• No, ND or N/A to procedure

IF pre-post instrument count performed, did they agree?

• Yes

• No

S.14 Was an intraoperative radiographic study performed to look for a potentially retained foreign body?

• Yes If YES, was the screening performed based on:

• Routine protocol

• Surgeon concern or request

• Inaccurate instrument or sponge count

• Suspected contamination of surgical field

• Not documented

• No

S.15 Was the operative site reopened to look for a foreign body or to remove foreign material?

• Yes If YES, when was exploration performed

• Prior to leaving the operating room AND before the skin was closed.

• Prior to leaving the operating room AND after the skin was initially closed

• Unable to determine from documentation if the skin was closed, but prior to leaving the operating room

• After leaving the operating room of the initial surgery. IF YES, specify the start date and time of surgery to retrieve the retained foreign body or substance.

_ _ | _ _ | _ _ _ _ [MM/DD/YYYY]

_ _ : _ _ [HH:MM]

• Critical documentation missing

• No

Duplicate Page: This page corresponds to foreign body/ substance number _ _ .

S.16 Intraoperative blood loss (use surgeon documentation as primary source)

_ _ _ _ cc

S.17 How was the foreign body or reaction to a foreign substance reaction discovered?

• Intra-operative screening or tests

• Routine postoperative examination and/or test

• Symptomatic detection

  • Mass

  • Infection

  • Reported signs/symptoms such as cramping and/or pain

  • Obstruction

  • Other ____________

• Discovered incidentally at time of another operation

• During subsequent surgery related to signs/symptoms/complications

• Other  IF other, explain in the TEXT BOX

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

S.18 What best describes the foreign body or foreign substance?

• A medical device/substance. Select the type of the list below.

• Cement, bonding or bone wax

• Central line catheter or catheter tip

• Coil

• Cotton

• Drain (e.g., VP shunt, peritoneal shunt, etc)

• Drainage tube

• Glass (medical related)

• Guidewire or guidewire fragment

• Instrument-non-needle (e.g., clip, )

• Metal needle or needle tip

• Peripheral line catheter or catheter tip

• Stent

• Staple

• Sponge (ray-tec)

• Sponge (lap) or gauze

• Sponge- type of unknown

• Substance (e.g., cement, bonding material, or bone wax)

• Other medical type device or substance (e.g., basket from broken device)

State in the TEXT BOX

______________________________________________________________________________________________________

• Non-medical device  State in the TEXT BOX

_____________________________________________________________________________________________________

• Critical documentation missing

• Other State in the TEXT BOX

______________________________________________________________________________________________________

COMPLETE THE FOLLOWING QUESTIONS FOR ALL RETAINED FOREIGN BODIES AND/OR SUBSTANCES

Section 4: Patient risk factor(s)

4.1 Height

_ _ _._]( cm) or _ _ ft, __inches

4.2 Weight

_ _ _ ._ (kg) or _ _ _ . _ pounds (lbs)

4.3 BMI

[ _ _._ ]

Section 5: Evaluation and treatment

5.1 Which of the following complications occurred due to the unintentionally retained foreign body or substance? Select all that apply.

• Sepsis or infection, inflammatory process or other acute reaction (e.g., pericarditis, peritonitis, etc.) If YES, select the best descriptor from the following:

• Sepsis

• Blood stream infection

• Localized infection

• Generalized peritonitis

• Pericarditis

• Meningitis

• Emphyema

• Other

• Emboli/thrombi

• Ischemia due to disruption of arterial blood flow

• Adhesions

• Obstruction

• Perforation

• Fistulae or erosion

• Nerve compression

• Death

• None

• Other (explain in TEXT Box)

__________________________________________________________________________________________________________________________________________________________________

5.2 Which of the following interventions did the patient undergo because of the unintentionally foreign body or substance? Select all that apply.

• Antibiotic therapy

• Removal by bedside procedure

• Post-operative blood transfusion

• Removal during incidental surgery

• Surgery to specifically remove foreign object

• Corrective or reparative surgery related to foreign body or substance

• Death

• None

• Other State in the text box.

__________________________________________________________________________________________________________________________________________________________________

Section: 6 Outcomes

1. Does the chart suggest that the patient suffered any adverse effects or consequences from this event? Check all that apply.

• Additional pain or discomfort

• Extended length of hospital stay

• Residual disability or impairment of normal function

• Death

• None or negligible

• Unable to determine/unsure

6.2 If the patient expired, was the death related to the unintentionally retained foreign body or substance?

• Yes

• No

• Critical documentation missing

6.3 Was the patient readmitted to your facility within 30 days of discharge?

• Yes

• No

• Critical documentation missing

6.4 If yes to Q6.3, was the reason for re-admission related to foreign body or substance?

• Yes

• No

• Critical documentation missing

6.5 If there are special circumstances or comments related to this case that you feel are important that were not captured in the survey, please state in the TEXT BOX provided [limit 200 characters]:

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