[Code of Federal Regulations]

[Title 42, Volume 3]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR482.27]



[Page 492-493]

 

                         TITLE 42--PUBLIC HEALTH

 

  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 

                  HEALTH AND HUMAN SERVICES (CONTINUED)

 

PART 482_CONDITIONS OF PARTICIPATION FOR HOSPITALS--Table of Contents

 

                   Subpart C_Basic Hospital Functions

 

Sec. 482.27  Condition of participation: Laboratory services.



    (a) The hospital must maintain, or have available, adequate 

laboratory services to meet the needs of its patients. The hospital must 

ensure that all laboratory services provided to its patients are 

performed in a facility certified in accordance with part 493 of this 

chapter.

    (b) Standard: Adequacy of laboratory services. The hospital must 

have laboratory services available, either directly or through a 

contractual agreement with a certified laboratory that meets 

requirements of part 493 of this chapter.

    (1) Emergency laboratory services must be available 24 hours a day.

    (2) A written description of services provided must be available to 

the medical staff.

    (3) The laboratory must make provision for proper receipt and 

reporting of tissue specimens.

    (4) The medical staff and a pathologist must determine which tissue 

specimens require a macroscopic (gross) examination and which require 

both macroscopic and microscopic examinations.

    (c) Standard: Potentially infectious blood and blood products--(1) 

Potentially HIV infectious blood and blood products are prior 

collections from a donor who tested negative at the time of donation but 

tests repeatedly reactive for the antibody to the human immunodeficiency 

virus (HIV) on a later donation, and the FDA-licensed, more specific 

test or other followup testing recommended or required by FDA is 

positive and the timing of seroconversion cannot be precisely estimated.

    (2) Services furnished by an outside blood bank. If a hospital 

regularly uses the services of an outside blood bank, it must have an 

agreement with the blood bank that governs the procurement, transfer, 

and availability of blood and blood products. The agreement must require 

that the blood bank promptly notify the hospital of the following:

    (i) If it supplied blood and blood products collected from a donor 

who tested negative at the time of donation but tests repeatedly 

reactive for the antibody to HIV on a later donation; and

    (ii) The results of the FDA-licensed, more specific test or other 

followup testing recommended or required by FDA completed within 30 

calendar days after the donor's repeatedly reactive screening test. (FDA 

regulations concerning HIV testing and lookback procedures are set forth 

at 21 CFR 610.45-et seq.)

    (3) Quarantine of blood and blood products pending completion of 

testing. If the blood bank notifies the hospital of the repeatedly 

reactive HIV screening test results as required by paragraph (c)(2)(i) 

of this section, the hospital must determine the disposition of the 

blood or blood product and quarantine all blood and blood products from 

previous donations in inventory.

    (i) If the blood bank notifies the hospital that the result of the 

FDA-licensed, more specific test or other followup testing recommended 

or required by FDA is negative, absent other informative test results, 

the hospital may release the blood and blood products from quarantine.

    (ii) If the blood bank notifies the hospital that the result of the 

FDA-licensed, more specific test or other followup testing recommended 

or required by FDA is positive, the hospital must dispose of the blood 

and blood products in accordance with 21 CFR 606.40 and notify patients 

in accordance with paragraph (c)(4) of this section.

    (4) Patient notification. If the hospital has administered 

potentially HIV infectious blood or blood products (either directly 

through its own blood bank or under an agreement described in paragraph 

(c)(2) of this section) or released such blood or blood products to 

another entity or appropriate individual,



[[Page 493]]



the hospital must take the following actions:

    (i) Promptly make at least three attempts to notify the patient's 

attending physician (that is, the physician of record) or the physician 

who ordered the blood or blood product that potentially HIV infectious 

blood or blood products were transfused to the patient.

    (ii) Ask the physician to immediately notify the patient, or other 

individual as permitted under paragraph (c)(8) of this section, of the 

need for HIV testing and counseling.

    (iii) If the physician is unavailable, declines to make the 

notification, or later informs the hospital that he or she was unable to 

notify the patient, promptly make at least three attempts to notify the 

patient, or other individual as permitted under paragraph (c)(8) of this 

section, of the need for HIV testing and counseling.

    (iv) Document in the patient's medical record the notification or 

attempts to give the required notification.

    (5) Timeframe for notification. The notification effort begins when 

the blood bank notifies the hospital that it received potentially HIV 

infectious blood and blood products and continues for 8 weeks unless--

    (i) The patient is located and notified; or

    (ii) The hospital is unable to locate the patient and documents in 

the patient's medical record the extenuating circumstances beyond the 

hospital's control that caused the notification timeframe to exceed 8 

weeks.

    (6) Content of notification. The notification given under paragraphs 

(c)(4) (ii) and (iii) of this section must include the following 

information:

    (i) A basic explanation of the need for HIV testing and counseling.

    (ii) Enough oral or written information so that the transfused 

patient can make an informed decision about whether to obtain HIV 

testing and counseling.

    (iii) A list of programs or places where the patient can obtain HIV 

testing and counseling, including any requirements or restrictions the 

program may impose.

    (7) Policies and procedures. The hospital must establish policies 

and procedures for notification and documentation that conform to 

Federal, State, and local laws, including requirements for 

confidentiality and medical records.

    (8) Notification to legal representative or relative. If the patient 

has been adjudged incompetent by a State court, the physician or 

hospital must notify a legal representative designated in accordance 

with State law. If the patient is competent, but State law permits a 

legal representative or relative to receive the information on the 

patient's behalf, the physician or hospital must notify the patient or 

his or her legal representative or relative. If the patient is deceased, 

the physician or hospital must continue the notification process and 

inform the deceased patient's legal representative or relative.



[57 FR 7136, Feb. 28, 1992, as amended at 61 FR 47433, Sept. 9, 1996]