C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER G—STANDARDS AND CERTIFICATION › PART 482—CONDITIONS OF PARTICIPATION FOR HOSPITALS › Subpart D—Optional Hospital Services

42 C.F.R. § 482.51

Condition of participation: Surgical services

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If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered.

(a) Standard: Organization and staffing. The organization of the surgical services must be appropriate to the scope of the services offered.

(1) The operating rooms must be supervised by an experienced registered nurse or a doctor of medicine or osteopathy.

(2) Licensed practical nurses (LPNs) and surgical technologists (operating room technicians) may serve as “scrub nurses” under the supervision of a registered nurse.

(3) Qualified registered nurses may perform circulating duties in the operating room. In accordance with applicable State laws and approved medical staff policies and procedures, LPNs and surgical technologists may assist in circulatory duties under the surpervision of a qualified registered nurse who is immediately available to respond to emergencies.

(4) Surgical privileges must be delineated for all practitioners performing surgery in accordance with the competencies of each practitioner. The surgical service must maintain a roster of practitioners specifying the surgical privileges of each practitioner.

(b) Standard: Delivery of service. Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care.

(1) Prior to surgery or a procedure requiring anesthesia services and except in the case of emergencies:

(i) A medical history and physical examination must be completed and documented no more than 30 days before or 24 hours after admission or registration, and except as provided under paragraph (b)(1)(iii) of this section.

(ii) An updated examination of the patient, including any changes in the patient's condition, must be completed and documented within 24 hours after admission or registration when the medical history and physical examination are completed within 30 days before admission or registration, and except as provided under paragraph (b)(1)(iii) of this section.

(iii) An assessment of the patient must be completed and documented after registration (in lieu of the requirements of paragraphs (b)(1)(i) and (ii) of this section) when the patient is receiving specific outpatient surgical or procedural services and when the medical staff has chosen to develop and maintain a policy that identifies, in accordance with the requirements at § 482.22(c)(5)(v), specific patients as not requiring a comprehensive medical history and physical examination, or any update to it, prior to specific outpatient surgical or procedural services.

(2) A properly executed informed consent form for the operation must be in the patient's chart before surgery, except in emergencies.

(3) The following equipment must be available to the operating room suites: call-in-system, cardiac monitor, resuscitator, defibrillator, aspirator, and tracheotomy set.

(4) There must be adequate provisions for immediate post-operative care.

(5) The operating room register must be complete and up-to-date.

(6) An operative report describing techniques, findings, and tissues removed or altered must be written or dictated immediately following surgery and signed by the surgeon.

[51 FR 22042, June 17, 1986, as amended at 72 FR 66933, Nov. 27, 2007; 84 FR 51821, Sept. 30, 2019]
Notes of Decisions
Cited in 7 cases (2 in the last 5 years), 2010–2022 · leading case: Waldmann v. Fulp, 259 F. Supp. 3d 579 (S.D. Tex. 2016).
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Waldmann v. Fulp, 259 F. Supp. 3d 579 (S.D. Tex. 2016). “” 42 C.F.R. § 482.51 . Medicare’s interpretive guidelines state that: [i]f the hospital utilizes RN First Assistants, surgical PA, or other non-MD/DO surgical assistants, the hospital must establish criteria, qualifications and a credentialing process to grant specific…”
Studnicka v. Pinheiro, 618 F.3d 799 (8th Cir. 2010). “3(a); 42 C.F.R. § 482.51 (b)(2). According to Studnicka, this statute established a “standard of conduct” that the defendants violated.”
Chaudhry v. Smith (E.D. Cal. 2021). “16 42 C.F.R. § 482.51 . 17 28 This regulation simply introduces the statutory basis for this group of regulations: “This part is based on the 18 indicated provisions of the following sections of the Act.”
Wollman v. Massachusetts Gen. Hosp. Inc. (D. Mass. 2018). “13 (b)(1) (Condition of Participation includes patient’s right “to participate in the development and implementation of his or her plan of care” and “right to make informed decisions regarding his or her care’); 42 C.F.R. § 482.51 (Condition of Participation includes “a properly…”
Wollman v. Massachusetts Gen. Hosp. Inc. (D. Mass. 2019). “13 (b)(1)–(2) (stating that condition of participation includes patient’s right “to participate in the development and implementation of his or her plan of care” and “right to make informed decisions regarding his or her care”); 42 C.F.R. § 482.51 (b)(2) (stating that condition…”
United States of Am. v. Univ. of Pittsburgh Med. Ctr. (W.D. Pa. 2022). “32 ; 42 C.F.R. §§ 482.51 (b)(2), 482.24(c)(4)(v); 21 C.”
Goodwin v. Pagano CA2/3 (Cal. Ct. App. 2015). “13(b)(2),” “violation of 42 CFR 482.51(b)(2),” and negligence against the Hospital and doctors Pagano, Hakak, Khalife, and Oh; battery, against Khalife only; and “violation of Los Angeles Superior Court Rule 3.”
— 42 C.F.R. § 482.51(b)(2) — 1 case
Goodwin v. Pagano CA2/3 (Cal. Ct. App. 2015). “13(b)(2),” “violation of 42 CFR 482.51(b)(2),” and negligence against the Hospital and doctors Pagano, Hakak, Khalife, and Oh; battery, against Khalife only; and “violation of Los Angeles Superior Court Rule 3.”
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