[Code of Federal Regulations] [Title 42, Volume 4] [Revised as of October 1, 2007] From the U.S. Government Printing Office via GPO Access [CITE: 42CFR482.27] [Page 521-522] 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, 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. [[Page 522]] (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] Effective Date Note: At 72 FR 48573, Aug. 24, 2007, Sec. 482.27 was amended by removing the designation of paragraph (a), redesignating paragraphs (b) and (c) as paragraphs (a) and (b), revising redesignated paragraph (b), and adding paragraph (c), effective Feb. 20, 2008. For the convenience of the user, the added and revised text is set forth as follows: [Page 522-524] 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. * * * * * (b) Standard: Potentially infectious blood and blood components--(1) Potentially human immunodeficiency virus (HIV) infectious blood and blood components. Potentially HIV infectious blood and blood components are prior collections from a donor-- (i) Who tested negative at the time of donation but tests reactive for evidence of HIV infection on a later donation; (ii) Who tests positive on the supplemental (additional, more specific) test or other follow-up testing required by FDA; and (iii) For whom the timing of seroconversion cannot be precisely estimated. (2) Potentially hepatitis C virus (HCV) infectious blood and blood components. Potentially HCV infectious blood and blood components are the blood and blood components identified in 21 CFR 610.47. (3) Services furnished by an outside blood collecting establishment. If a hospital regularly uses the services of an outside blood collecting establishment, it must have an agreement with the blood collecting establishment that governs the procurement, transfer, and availability of blood and blood components. The agreement must require that the blood collecting establishment notify the hospital-- (i) Within 3 calendar days if the blood collecting establishment supplied blood and blood components collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection; (ii) Within 45 days of the test, of the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by FDA; and [[Page 523]] (iii) Within 3 calendar days after the blood collecting establishment supplied blood and blood components collected from an infectious donor, whenever records are available, as set forth at 21 CFR 610.48(b)(3). (4) Quarantine and disposition of blood and blood components pending completion of testing. If the blood collecting establishment (either internal or under an agreement) notifies the hospital of the reactive HIV or HCV screening test results, the hospital must determine the disposition of the blood or blood product and quarantine all blood and blood components from previous donations in inventory. (i) If the blood collecting establishment notifies the hospital that the result of the supplemental (additional, more specific) test or other follow-up testing required by FDA is negative, absent other informative test results, the hospital may release the blood and blood components from quarantine. (ii) If the blood collecting establishment notifies the hospital that the result of the supplemental, (additional, more specific) test or other follow-up testing required by FDA is positive, the hospital must-- (A) Dispose of the blood and blood components; and (B) Notify the transfusion recipients as set forth in paragraph (b)(6) of this section. (iii) If the blood collecting establishment notifies the hospital that the result of the supplemental, (additional, more specific) test or other follow-up testing required by FDA is indeterminate, the hospital must destroy or label prior collections of blood or blood components held in quarantine as set forth at 21 CFR 610.46(b)(2), 610.47(b)(2), and 610.48(c)(2). (5) Recordkeeping by the hospital. The hospital must maintain-- (i) Records of the source and disposition of all units of blood and blood components for at least 10 years from the date of disposition in a manner that permits prompt retrieval; and (ii) A fully funded plan to transfer these records to another hospital or other entity if such hospital ceases operation for any reason. (6) Patient notification. If the hospital has administered potentially HIV or HCV infectious blood or blood components (either directly through its own blood collecting establishment or under an agreement) or released such blood or blood components to another entity or individual, the hospital must take the following actions: (i) Make reasonable attempts to notify the patient, or to notify the attending physician or the physician who ordered the blood or blood component and ask the physician to notify the patient, or other individual as permitted under paragraph (b)(10) of this section, that potentially HIV or HCV infectious blood or blood components were transfused to the patient and that there may be a need for HIV or HCV testing and counseling. (ii) If the physician is unavailable or declines to make the notification, make reasonable attempts to give this notification to the patient, legal guardian, or relative. (iii) Document in the patient's medical record the notification or attempts to give the required notification. (7) Timeframe for notification--(i) For donors tested on or after February 20, 2008. For notifications resulting from donors tested on or after February 20, 2008 as set forth at 21 CFR 610.46 and 21 CFR 610.47 the notification effort begins when the blood collecting establishment notifies the hospital that it received potentially HIV or HCV infectious blood and blood components. The hospital must make reasonable attempts to give notification over a period of 12 weeks unless-- (A) The patient is located and notified; or (B) 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 12 weeks. (ii) For donors tested before February 20, 2008. For notifications resulting from donors tested before February 20, 2008 as set forth at 21 CFR 610.48(b) and (c), the notification effort begins when the blood collecting establishment notifies the hospital that it received potentially HCV infectious blood and blood components. The hospital must make reasonable attempts to give notification and must complete the actions within 1 year of the date on which the hospital received notification from the outside blood collecting establishment. (8) Content of notification. The notification must include the following information: (i) A basic explanation of the need for HIV or HCV testing and counseling; (ii) Enough oral or written information so that an informed decision can be made about whether to obtain HIV or HCV testing and counseling; and (iii) A list of programs or places where the person can obtain HIV or HCV testing and counseling, including any requirements or restrictions the program may impose. (9) 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 the confidentiality of medical records and other patient information. (10) 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 [[Page 524]] the patient or his or her legal representative or relative. For possible HIV infectious transfusion recipients that are deceased, the physician or hospital must inform the deceased patient's legal representative or relative. If the patient is a minor, the parents or legal guardian must be notified. (11) Applicability. HCV notification requirements resulting from donors tested before February 20, 2008 as set forth at 21 CFR 610.48 will expire on August 24, 2015. (c) General blood safety issues. For lookback activities only related to new blood safety issues that are identified after August 24, 2007, hospitals must comply with FDA regulations as they pertain to blood safety issues in the following areas: (1) Appropriate testing and quarantining of infectious blood and blood components. (2) Notification and counseling of recipients that may have received infectious blood and blood components.