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mixing of chemical agents, improper labeling, and other similar sources of pharmacy error. Nursing station medication containers, solutions stored in central sterile supply, and all biologicals stored in refrigerators should be checked at frequent intervals by the staff pharmacist in order to locate and remove outdated, deteriorated, improperly labeled, obsolete or excess items.189 Blood and blood derivatives must always be stored and transported in accordance with the professional standards established for their use. The Government can also be held liable for harm resulting to patients from hospital staph infection.190 Accordingly, special efforts must be made to guard against the transmission of such disease organisms, including the periodic examination of personnel assigned to contagious wards.

Proper maintenance of premises is another area of concern in the operation of PHS hospitals and clinics, not only to protect patients from injuries, but to protect the public and members of the staff as well. Particular attention should be given to stairways, hallways, ramps, elevators, and all other critical points where injuries are likely to occur.

(6) Malpractice review program—Knowledge of the basic principles of malpractice prevention is undoubtedly the prime requisite in any malpractice prevention program, but something more is necessary to assure the effective implementation of such a program. In 1959, the AMA-AHA Medicolegal Education Committee recommended 191 that all hospitals undertake a continuing review of those phases of their operations which relate to patient care, with the objective of reducing or eliminating the causes of accidental injury or harm to patients. To achieve this purpose, it was recommended that each hospital establish an in-house committee composed of appropriate members of the hospital's administrative and professional

188 Liability will accrue for failure to provide proper pharmacy facilities. Evans v. Lawrence & Memorial Associated Hospitals, 133 Conn. 311, 50 A. 2d 443 (1946). 189 See generally Archambault, G. F.: “Pharmacy Accidents Can Be Prevented," Hospitals, 31: 68 (Apr. 1, 1957).

190

Kapuschinsky v. United States, 248 F. Supp. 732 (D.S.C. 1966).

191 See Groeschel, A. E.: "Hospital-Physician Liability: Inhospital Medicolegal Education Committee Can Pinpoint Problem Areas," Hospitals 33: 41 (July 16, 1959).

staff, whose purpose would be to (1) view patient care from the specific standpoint of patient safety, (2) improve patient care, (3) prevent, accidental injury to patients, and (4) reduce grievances, claims, and suits arising out of patient care activities.

These recommendations have great merit and might well serve as guidelines for malpractice review programs at all PHS hospitals, clinics and health centers. A malpractice review, undertaken by the medical officer in charge, and such other members of his staff as he may designate, should include (1) continuing review and analysis of practices and procedures involved in all aspects of patient care so that situations that might give rise to accidental injury or harm to a patient will be recognized; (2) continuing search and recommendations for methods of eliminating such situations; and (3) continuing review and analysis of individual cases in which there has been, or is, a possibility of accidental injury or harm to patients to the end that causative factors may be ascertained and preventive measures instituted.

Consideration should be given to such matters as the qualifications of personnel, nursing policies and procedures, pharmacy practice, the clinical laboratory, and other areas of professional competence. Wherever possible, specific problems brought to light during the malpractice review should be promptly corrected. Needless to say, corrective measures taken at this point are of far greater value than the best defensive efforts of even the most capable of lawyers, once a malpractice suit is started. With respect to those problems not capable of resolution at the local level, a complete report of the problem should be forwarded to the appropriate area office, supervising station, or division headquarters, with a recommendation concerning the solution of the problem.

Part D

SEC. 1

PHS Malpractice Litigation [Policies and Procedures]

GENERAL

During the years since the enactment of the FTCA, PHS malpractice suits have involved nearly every aspect of patient care. By and large, however, the Service has generally fared well in these suits, the majority of which have been concluded in its favor.192 Nevertheless, every new suit presents its own problems, many of which concern procedural matters quite unfamiliar to the PHS medical and administrative personnel involved.

The material in this part is intended to provide guidelines to the more common procedural problems encountered in PHS malpractice litigation, and to discuss the pertinent Departmental and PHS policies and procedures relating thereto.

(a) Commencement of Suit

A malpractice suit under the FTCA is commenced when the plaintiff files a complaint with the appropriate Federal District Court, serves a copy of the summons and complaint upon the U.S. Attorney in that district, and serves another copy on the Attorney General in Washington, D.C., by registered mail.193

Once the suit is commenced against the United States, responsibility for the conduct of the litigation normally rests with the local U.S. Attorney in whose district the suit was commenced. Since

192 In fiscal 1965, a total of $30,000 was paid to the complaining parties in 5 cases. In 10 other cases, suit was either dismissed or judgment was rendered in favor of the Government. The detailed statistics are contained in the annual reports filed by the PHS Board of Claims with the Executive Officer, PHS.

193 Rule 3 and rule 4(d) (4) of the Federal Rules of Civil Procedure. The FTCA was recently amended to provide that before suit may be instituted against the United States, the claimant must first present his claim to the appropriate Federal agency and the claim must have been denied by the agency. See 28 U.S.C. 2675, as amended by P.L. 89-506, 80 Stat. 306. This new provision applies to claims accruing on and after January 19, 1967.

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malpractice litigation is a specialized field of law, most malpractice suits handled by U.S. Attorneys are supervised by malpractice specialists in the Torts Section of the Civil Division, Department of Justice. Within the Department of Health, Education, and Welfare, the Office of the General Counsel is responsible for the preparation of investigation reports on all PHS malpractice cases, and for maintaining liaison with the Department of Justice and the U.S. Attorneys to whom cases are assigned. DHEW Regional Attorneys perform similar functions with respect to malpractice cases arising within their regions.

(b) Agency Investigation Report

Established Justice Department procedures call for a complete. agency investigation report of the circumstances of each malpractice suit, with one copy of the report being forwarded to the Department of Justice in Washington, and another to the U.S. Attorney to whom the case is assigned in the field. The agency investigation report provides the essential information necessary to answer the allegations of the complaint and to raise affirmative defenses thereto. The report is prepared by the Office of the General Counsel, DHEW, based upon information secured from PHS field facilities in the manner described below.

(c) Role of PHS Board of Claims

The PHS Board of Claims is an administrative unit established by the Surgeon General under the direction of the Executive Officer of the Public Health Service.194 The Board is responsible for the administration of the Service's function with respect to all claims against the Service, including those related to patient care and hospital management. The Board consists of four members appointed by the Executive Officer, PHS, each of whom represents one of the constituent units of the Service.

When the Office of the General Counsel forwards a copy of the complaint in a malpractice suit to the Chairman of the PHS Board of Claims, the latter, in accordance with established procedures,

191 DHEW General Administration Manual, Ch. PHS:4-00-15.

195

See Division of Hospital Operations Manual, Part D-1.10.4.

195

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