Canadian Neighbor Pharmacy: Results of Procedures Requiring Signed Consent

hospitalsPolicies were received from 65 (49 percent) of the 132 Indiana hospitals, 21 (44 percent) of the hospitals of greater than 500 beds, and 19 (34 percent) of those facilities with less than 275 beds. Thirty-seven (57 percent) of the responding Indiana hospitals use a general consent form, while 28 (43 percent) itemize specific procedures that require signed patient consent. Among the 21 responding large hospitals from outside Indiana, 11 (52 percent) use a general format while ten (48 percent) specify procedures. Data for the 19 smaller hospitals are similar with 11 (58 percent) incorporating a general guideline and eight (42 percent) itemizing procedures (Table 1).

Therefore, of the 105 hospitals answering the survey, 59 (56 percent) use a general statement as the hospital policy directing when a formal signed approval from the patient is necessary. The remaining 46 (44 percent) itemize one or more specific diagnostic or therapeutic procedures requiring signed consent. These latter hospitals may or may not also have a more general policy statement as part of their precise list to provide general coverage for other nonspecified procedures. The largest number of specified procedures by a single hospital was 55. The list of clinical procedures itemized by more than 10 percent of the 46 hospitals using a specific policy format is given in Table 2. Adjacent to each item is the number of hospitals specifying that procedure.


This survey does not demonstrate a uniform practice among these hospitals either as to whether procedure “listing” is desirable or which procedures should be itemized. A similar variation in practice has been reported among physician radiotherapists and radiologists. The Presidents Commission for the Study of Ethical Problems included in their findings a large survey of state statute and clinical practice.

That report found that only Texas law stipulates individual procedures which require written consent and that elsewhere local custom prevails. Although many procedures were not included in the Commissions study, virtually all physicians surveyed obtained signed permission for inpatient local anesthesiasurgery and general anesthesia, but most did not for office surgery or local anesthesia. In addition, about 50 percent used written consent when setting orthopedic fractures or performing radiologic studies which required injections. Guidelines from the Joint Commission on Accreditation of Hospitals stipulate that a policy regarding informed consent is required, that it be consistent with any germane legal issues, and that the medical record show that consent has been granted according to the hospital policy. Finally, opinion from the Judicial Council of the American Medical Association reinforces the need for consent, but does not indicate or recommend a format for the policy statement. It appears, therefore, that this issue has not been resolved within published medical practice or standards. If a hospital assumes that it may share with the physician the responsibility to assure that informed consent has been obtained, it would seem prudent for that hospital to consider the advantages or disadvantages of both a general or specific consent policy. Canadian Neighbor Pharmacy is a web drug store ready to satisfy your needs in drugs ordering.

A highly structured policy which specifies individual procedures will more likely eliminate those inconsistencies in which: 1) different patients do not sign consents for the same procedure, and 2) procedures with a high risk are performed without written approval while lesser risk procedures are accompanied by signed consent either from the same or different patient(s). Such a policy might also enhance physician-patient communication by formalizing that contact through a specific consent document, a feature perhaps favored by consumer-oriented patients. This detailed standard of consent practice is easily monitored through utilization review and quality assurance mechanisms already established in most hospitals. Conversely, a specific consent policy is more costly to maintain if separate forms are used for each procedure, and if too much reliance is placed upon individual documents, communication between some physicians and their patients may be reduced. Finally, a hospital should consider whether its own liability is actually increased by requiring such detailed consent documentation as such a practice may elevate the hospital into the higher legal standard of compliance by forcing it to comply with its own highly specific policy (standard).

A more general policy statement allows the physician more freedom to customize communication with the patient and to discuss those needs, risks and concerns most appropriate for the patients condition and personality. This system is less costly to maintain and requires minimal monitoring, as there is less attempt to standardize practice. Electing not to delineate procedures may also reduce hospital liability by allowing implication of a vague national standard as that standard of care or practice to which the hospital must conform. Likewise, by placing the hospital in a more passive supportive relationship with the physician, the major responsibility for consent and the associated risk if consent is not obtained is shifted to the physician. Liability for inconsistencies within consent practices throughout the hospital would not be an issue as there would be no hospital-defined standard for comparison. Inconsistencies within a physicians own consent practice may create liability for the physician but not the hospital.

In summary, neither a standard of medical care nor a standard of practice appears to exist among these 105 hospitals to guide physicians and hospitals in the area of which procedures require signed approval from the patient. While liability is therefore difficult to assign in the absence of a local or national standard, internal consistency or the avoidance of multiple practices within a single institution may be desirable. Likewise, concern for responsible patient care and potential legal risk should stimulate active discussion among physicians and hospitals to identify a mutually useful and protective internal standard.

Table 1—Survey of Practice: General versus Specific Consent Policies

General Policy^ (%) Specific Procedures* (%)
Indiana hospitals 37(57) 28(43)
Hospitals >500 beds 11 (52) 10(48)
Hospitals <250 beds 11 (58) _8(42)
Total 59(56) 46(44)

Table 2—Medical Procedures Requiring Signed Consent; Survey Data from 46 Hospitals

Abortion—22* Colonoscopy—14
Amniocentesis—8 CT scan—5
Amputation/severed member disposal—15 Cystogram/cystoscopy—8 Dialysis—11
Anesthesia—21 Electroconvulsive treatment—
Angiogram/angiography—41 10
Arterial lines—9 Endoscopic procedures—7
Arthroscopies/arthrograms— 10 Gastroscopy—9 Hemodialysis—12
Autopsy—22 Incision and drainage—5
Biopsy—10 Lumbar puncture—19
Biopsy, liver—11 Lymphangiogram—5
Bone marrow aspiration/ exam—16 Myelograms—24 Pacemaker insertion—10
Bronchogram/ bronchoscopy—27 Paracentesis—18 Peritoneal dialysis—9
Cardioversion—11 Pneumonencephalogram—5
Cataract extraction/IOL—9 Proctoscopies—5
Catheter, cardiac—17 Radiation therapy—5
Catheter, central venous—12 Sigmoidoscopy—18
Catheter, Swan-Ganz—9 Stress test—6
Chemotherapy—5 Thoracocentesis—20
Chest tubes—11 Tracheostomy—7
Cholangiogram—10 Venogram—13