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Title: Section 405.6 - Quality assurance program

Effective Date


405.6 Quality assurance program. The governing body shall establish and maintain a coordinated quality assurance program which integrates the review activities of all hospital services to enhance the quality of patient care and identify and prevent medical, dental and podiatric malpractice.

(a) The governing body shall establish a quality assurance committee, at least one member to be a member of the governing body of the hospital and who is not otherwise affiliated with the hospital in an employment or contractual capacity. The quality assurance committee shall report its activities, findings and recommendations to the governing body as often as necessary, but no less often than four times a year. The quality assurance committee shall:

(1) develop a written plan which details:

(i) the establishment and implementation of a medical, dental and podiatric malpractice prevention program;

(ii) the manner in which the committee will relate to the medical staff executive committee, if any, the hospital governing body and the chief executive officer;

(iii) the manner in which the medical, dental and podiatric malpractice program will relate to other hospital administrative mechanisms and procedures;

(iv) the role and responsibility of each service or department in the quality assurance process; and

(v) the authority of the committee regarding recommendation or implementation of corrective action;

(2) administer the hospital quality assurance program to assure:

(i) the identification of actual or potential problems concerning patient care and clinical performance;

(ii) the assessment of the cause and scope of problems identified;

(iii) the development and recommendation of proposed courses of action to address problems identified;

(iv) the use, in the revision of hospital policies and procedures, of information gathered regarding problems identified;

(v) the implementation, through established mechanisms, of actions necessary to correct the identified problems;

(vi) the monitoring and evaluation of actions taken and the implementation of remedial action to ensure effectiveness; and

(vii) the documentation of all measures taken pursuant to this section in the quality assurance program.

(b) The activities of the quality assurance committee shall involve all patient care services and shall include, as a minimum:

(1) review of the care provided by the medical and nursing staff and by other health care practitioners employed by or associated with the hospital. Such review shall include a determination that the hospital is admitting only those patients for whom it has appropriate staff, resources and equipment and transferring those patients for whom the hospital does not have the capability to provide care, except under conditions of disasters and/or emergency surge that may require admissions to provide care to those patients;

(2) review of mortalities;

(3) review of morbidity in circumstances other than those related to the natural course of disease or illness;

(4) review of infections, complications, errors in diagnosis, transfusions and results of treatments;

(5) review of medical records, medical care evaluation studies, complaints, incidents and staff suggestions regarding patient care and safety, utilization review findings, profile analysis and other pertinent data sources;

(6) the maintenance and continuous collection of information concerning the hospital's experience with negative health care outcomes and incidents injurious to patients, patient grievances, professional liability premiums, settlements, awards, costs incurred by the hospital for patient injury prevention and safety improvement activities; and

(7) the committee shall oversee and coordinate the following:

(i) the establishment of a medical, dental and podiatric staff privileges review procedure through which credentials, physical and mental capacity, and competence in delivering health care services are reviewed at least biennially as part of an evaluation of staff privileges and in accordance with section 405.4 of this Part. These procedures shall include the collection of the following information from a physician, dentist or podiatrist prior to granting or renewing professional privileges or association in any capacity with the hospital:

(a) the name of any hospital or facility with which the physician, dentist or podiatrist has had any association, employment, privileges or practice and, if such association, employment, privileges or practice have been suspended, restricted, terminated, curtailed or not renewed, the reasons for such action;

(b) the substance of any pending malpractice actions or professional misconduct proceedings in this or any other state and any report made pursuant to section 405.3(e) of this Part;

(c) any judgment or settlement of any professional malpractice action and any finding of professional misconduct in this or any other state; and

(d) any information relative to findings pertinent to violations of patients' rights as set forth in section 405.7 of this Part;

(ii) upon initial application for or renewal of hospital staff privileges, the receipt of a waiver by the physician, dentist or podiatrist of any confidentiality provisions concerning the information set forth in subparagraph (i) of this paragraph and a sworn statement by the physician, dentist or podiatrist that the information is complete, true and accurate;

(iii) prior to granting or renewing privileges or association to any physician, dentist, or podiatrist, or hiring a physician, dentist or podiatrist, the hospital shall request from:

(a) any hospital with or at which such physician, dentist or podiatrist, has or had privileges, was associated or was employed during at least the preceding 5 years the following information concerning the physician, dentist or podiatrist:

(1) any pending professional misconduct proceedings or any professional malpractice actions in New York or another state;

(2) any judgment or settlement of a malpractice action and any finding of professional misconduct in New York or another state; and

(3) any information required to be reported by hospitals pursuant to section 405.3(e) of this Part; and

(b) the National Practitioner Data Bank or any successor database, any information available concerning:

(1) payments for the benefit of the physician, dentist or podiatrist in settlement of, or in satisfaction of, in whole or in part, a claim or a judgment against such physician, dentist or podiatrist for medical malpractice;

(2) licensure actions by any medical or professional board relating to the physician, dentist, or podiatrist;

(3) adverse actions affecting clinical privileges of the physician, dentist or podiatrist; and

(4) other actions or information relevant to the professional competence and conduct of the physician, dentist or podiatrist.

(iv) The provision by the hospital, within 45 days, in response to requests from any other hospital or facility performing credentials review for medical staff appointment or reappointment, of information related to the physician's, dentist's or podiatrist's professional practice within the facility for at least 5 years;

(v) the maintenance of a file on each physician, dentist and podiatrist granted privileges or otherwise associated with the hospital which shall contain the information collected pursuant to subparagraphs (i) through (iii) of this paragraph, to be updated at least on a biennial basis, and all other relevant information gathered in accordance with the hospital's quality assurance program and as required by this section;

(vi) a biennial review of credentials, physical and mental capacity and competence in delivering health care services of all clinical staff who are employed or associated with the hospital which for physicians, dentists and podiatrists shall include a comprehensive review of the information maintained in accordance with subparagraph (v);

(vii) a procedure for the prompt resolution of grievances by patients or their representatives related to accidents, injuries, treatment and other events that may result in claims of medical, dental or podiatric malpractice;

(viii) education programs dealing with patient safety, patients' rights, injury prevention, staff responsibility to report professional misconduct, legal aspects of patient care, improved communication with patients and causes of malpractice claims for staff personnel engaged in patient care activities; and

(ix) continuing education programs for medical, dental and podiatric staff in their areas of speciality.


VOLUME C (Title 10)