Medical Legal Aspects of Regional Anesthesia: Physician Perspective

 1. Patient identity confirmed

 2. Time out complete

 3. Informed consent complete

 4. Allergies noted

 5. Patient medications, history and physical examination reviewed

 6. Pertinent laboratory data reviewed (e.g., coagulation studies and platelet count)

 7. A functioning I.V. has been established before the procedure

 8. Resuscitation drugs and equipment on hand

 9. Sterile technique protocol observed

10. Hand wash, mask, gloves used

11. All questions answered before the procedure begins

12. Other pertinent information depending on type of block used, for example, fetal heart rate before and after performing an epidural for a laboring patient

13. Signature, date, and time the checklist is completed

Avoiding Wrong-Site Blocks

Both the American Society of Anesthesiologists and American Society of Regional Anesthesia and Pain Medicine recognize that wrong-site blocks continue to be a cause for concern. Both professional organizations acknowledge efforts by entities such as the Joint Commission with its “Universal Protocol™ ” and the World Health Organization and its pre-surgical checklist that serve as guides to promote safer medical practice. Anesthesia professionals offer valuable input to regulatory agencies to make future checklists more effective and relevant.

The incidence of wrong-site blocks is not known. The use of protocols and checklists has not eliminated the problem. With respect to chronic pain management, Cohen et al., reported an incidence of 0.027 % in analyzing quality assurance data from ten institutions over 2 years [39]. This study included 48,941 collective procedures. The authors noted that the lack of observing a “universal protocol” was common to most of the cases of wrong-site block. Lack of communication, not marking the operative site, too few and variable ancillary personnel, a large number of cases and rapid turnover, multiple providers involved with the case, and bilateral pathology seemed to increase the risk of wrong-site intervention. Interestingly, many times the patients realized that the intervention was being performed at the wrong site but said nothing! Table 34.2 lists the authors’ suggestions for practitioners of chronic pain management. Concerning the performance of blocks in general, Mulroy et al., published a regional block pre-procedural checklist (Table 34.3) [40]. To these suggestions, this author suggests that the practitioner take into account Operator Fatigue. Devising and using a well-conceived checklist hopefully will insure the administration of proper-site regional anesthesia.

Table 34.2
Steps to consider for preventing wrong-site errors [39]

 1. Full implementation of [the] “Universal Protocol™”

 2. Implementation of [the] “Teams STEPPS™” approach or similar system emphasizing teamwork and communication (Agency for Healthcare Research and Quality; www.​ahrq.​gov)

 3. Make reporting mandatory

 4. Minimize personnel turnover during cases

 5. Designate clear-cut responsibilities rather than overlapping duties

 6. Avoid bilateral preparation and drape for unilateral procedures

 7. Perform time out in the procedure room and confirm with awake patient before sedation is administered

 8. Whenever possible, have relevant imaging studies available in the room

 9. Standardize “left-right” fluoroscopy orientation and always confirm spinal level by counting from above and below

10. Take “extra” precautions in patients with unusual anatomy, bilateral pathology, and when patients with the same name or procedure are scheduled together

Table 34.3
Regional block pre-procedural checklist

1. Patient is identified, two criteria

2. Allergies and anticoagulation status are reviewed

3. Surgical procedure/consent is confirmed

4. Block plan is confirmed, site is marked

5. Necessary equipment is present, drugs/solutions are labeled

6. Resuscitation equipment is immediately available: airway devices, suction, vasoactive drugs, lipid emulsion

7. Appropriate ASA monitors are applied: intravenous access, sedation, and supplemental oxygen are provided, if indicated

8. Aseptic technique is used: hand cleansing is performed; mask and sterile gloves are used

9. “Time out” is performed before needle insertion for each new block site if the position is changed or separated in time or performed by another team

Mulroy et al.: [From Erratum Statement] [41]

The Time Out

The Joint Commission (JC) requires documentation that a time out has been performed before a procedure is undertaken on a patient. This includes a time out for regional anesthesia interventions. The time out is only part of the Joint Commission’s Universal Protocol™. All sections of the Protocol should be observed. The specific requirements of the Universal Protocol™ can be accessed (www.​jointcommission.​org). The professional staff at the facility where the procedure is performed determines the amount and type of time out documentation that is recorded in the medical record. The criteria required in the time out process are found in Table 34.4. The information collected in the time out includes, but is not limited to the items listed in Table 34.5.

Table 34.4
Criteria required in the time out process

1. That the process is standardized

2. That all members of the procedure team are present at the time the process is initiated and none leaves during conduction of the time out

3. That a designated member of the team starts and records the time out

4. That the time out is conducted immediately before starting the invasive procedure (block)

5. That all members of the procedure team actively communicate during the time out

6. If a patient has more than one procedure and the person performing subsequent procedures is different another time out must be performed

7. Documentation of the time out is entered in the medical record

Table 34.5
Information confirmed by the time out process

1. Correct patient identity

2. Correct site verified

3. Is patient marked correctly? (See “Mark the Procedure site” on the Universal Protocol™)

4. Can the mark be seen during performance of the procedure?

5. Procedure to be performed

6. Identify members of the procedure team who were present during the time out. All members participate in the time out

7. Date, time, and sign the time out document and enter it into the medical record

Special care must be taken to verify the procedure site if the block is unilateral or if the patient is moved after initial examination. Perform the time out immediately before the procedure begins, and the patient is in position for the block.

Pre-procedure Verification Process

The Universal Protocol™ specifies steps to be followed to conduct acceptable pre-procedure verification of the patient’s identity and the procedure. The critical step in this process is to identify the patient and to place an identification bracelet on his wrist or leg if the patient is a baby. Two [2] licensed health care providers should verify that this step has been conducted properly.

Prevention of Falls and Other Block-Related Adverse Events

Many patients are discharged home after receiving a nerve block as part of their postoperative pain management regimen. Common blocks are those of the brachial plexus, femoral nerve, popliteal fossa, and other peripheral nerves. Placement of a catheter and utilization of a pump will extend the duration of the block. Most of these patients have a motor component to their blocks. As long as the block is present, the patient is at risk of falling especially if the block is of the lower extremity. The sensory component of the block may prevent the patient from feeling pressure, pain, or malpositioning that can cause tissue or nerve damage. In addition, the block may prevent the patient from feeling the pain associated with cast pressure or too tight a dressing. Finally, the patient might experience catheter-related problems.

To help prevent injury to patients who are discharged with an active block, the patient and his caretaker must be educated as to any special care required. Both the patient and his caretaker must be willing to take on added responsibilities to assure that the block does not contribute to postoperative complications. After the patient and his caretaker understand their responsibilities, they should sign an agreement stating that they understand the instructions, that they have no questions, and that they accept the added responsibility associated with the block.

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Oct 25, 2017 | Posted by in Uncategorized | Comments Off on Medical Legal Aspects of Regional Anesthesia: Physician Perspective
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