N.J. Admin. Code § 8:8-5.1

Current through Register Vol. 56, No. 21, November 4, 2024

Section 8:8-5.1 - Records

(a) Suitable legible records prepared with indelible material shall be maintained for a period of not less than five years. Records needed to trace a unit of blood or blood component from its source to final disposition shall be kept for at least 10 years after transfusion or five years after the latest expiration date for the individual product, but in no case for less than 10 years.

1. The blood bank shall have a policy addressing the confidentiality of donor and recipient records.

(b) All corrections to errors made in the records shall:

1. Not conceal the original entry;

2. Document the reason for the correction; and

3. Include the date the change was made and the initials of the person making the change.

(c) Worklists or loadlists that list the sequence of specimens tested shall be prepared prior to testing.

(d) Workrecords of tests shall be maintained and these records shall indicate final results together with all corresponding instrument readings and calculations. Where instrumentation produces tracings or printouts of results, these tracings or printouts shall be retained in a readily traceable manner and may serve as the workrecord.

(e) If records are maintained on computer systems, the following apply:

1. Prior to use or when modifications are made to the program, validation of all computer programs, including, but not limited to, those dealing with processing, labeling, and distribution of blood and blood components, shall be required as follows:

i. To determine if software consistently performs as required and within pre-established limits; and

ii. To include review of confidentiality of donor information, security of data and system documentation.

2. Adequate provisions shall be made to safeguard against the eventuality of unexpected electronic loss of data from the computer storage medium.

3. A system shall be in existence which maintains duplicate records on electronic storage media, updates these duplicates continuously and/or transfers electronically stored data periodically to hard copy such as prints or microfiche.

4. Written procedures shall be available for describing each of the blood bank's methods for performing requirements in (e)1 through 3 above.

5. The computer shall automatically note, at the time of correction, when corrections are made to verified results.

6. The computer record shall maintain the original verified entry, including the date, time and the identity of the person performing the test. When corrections to verified results are made, both the original and corrected entries shall show the date, time and identity of the person performing the original and corrected records.

7. Records maintained on computer shall comply with all requirements of this chapter.

8. The computer shall list donor collection records by the sequential donor numeric or alphanumeric identifier.

(f) The records shall:

1. Include all data secured and developed by blood banks concerning donor and/or recipient testing, donor identification, medical qualifications, registration as well as the processing, storage and distribution and final disposition of blood and blood components;

2. Make it possible to trace a unit of any blood or blood component by a sequential numeric or alphanumeric identifier from source (donor collection facility) to final disposition (for example transfused, shipped, autoclaved);

3. Be readily available for review;

4. Be made available on forms provided by the Department for the purpose of preparing the State's Statistical Summary of Blood Use report annually by January 31, of each year;

5. Include the actual result of each test observed recorded immediately, and the final interpretation recorded upon completion of testing;

6. Include all the significant steps of the process and who performed them; and

7. Include written documentation of any verbal instructions including the identity of all involved individuals.

(g) Before blood is issued for transfusion, test results for each recipient sample shall be compared with the following:

1. Past records of previous ABO and Rh typing results for the past 12 months; and

2. Past records of all patients known to have significant unexpected antibodies; severe adverse reactions to transfusion, and/or difficulty in blood typing.

(h) If computers are used, an alternate method shall be available and used which allows access to the information required in (g) above in the case of computer failure.

(i) Records shall include at least the following:

1. Donor records:

i. An annual record of each unit of blood and blood component, listed by sequential numeric or alphanumeric identifier, as to its source bank and final disposition;

ii. Donor history, examination, consent, deferral, reactions and also the results of required laboratory tests performed on all blood donors;

iii. An annual alphabetical file of donor registration cards or a cross index system;

iv. Blood and component labelling, including initials of person responsible for such labelling;

v. Storage temperatures of components, including dated and initialled temperature recording charts;

vi. Results of visual inspection of blood;

vii. Results of blood processing, including results and interpretation of all tests and retests;

viii. Component preparation, including all relevant dates and times;

ix. Documentation of separation and pooling of recovered plasma;

x. Documentation of units included in pooled products;

xi. Reissue records, including records of proper temperature maintenance; and

xii. A system that relates a donor with each previous donation.

2. Recipient records shall include:

i. An alphabetical file of the recipient and all units administered;

ii. Each recipient's ABO and Rh type available for immediate reference for at least the past 12 months;

iii. Patients known to have significant unexpected antibodies, adverse reactions to transfusion and/or difficulty in blood grouping and typing available for immediate reference for at least the past five years;

iv. Transfusion request records;

v. Test results, interpretations and release or issue date for compatibility testing;

vi. Emergency release of blood including written or validated electronic signature of the requesting physician and the type of blood and/or blood component.

3. List of therapeutic bleedings, including signed request by physician, donor's disease and disposition of units;

4. Detailed procedure manual including all policies and procedures developed for use in the blood bank and required by this chapter;

5. Evidence of annual review of the procedure manual by the blood bank director;

6. A data sheet for each cytapheresis procedure and the following information recorded: volume of blood processed; anticoagulants given; duration of procedure; volume of product; drugs given; identity of the donor; any reactions that occurred and how they were treated and any other information necessary to ensure the proper preparation of the component and the safety of the donor.

7. Quality control and quality assurance records, including, but not limited to: periodic evaluation of personnel, blood and blood components, reagents, equipment, including dates of performance; tests performed; observed results; interpretations; identification of personnel performing the tests; any appropriate corrective action taken; and review by the supervisor and/or director.

8. Antibody identification records;

9. Reports of adverse reactions and laboratory investigations of suspected transfusion reactions.

10. Lot numbers of supplies and reagents.

11. A method to identify persons performing each significant step in collecting, processing, compatibility testing and distributing blood or blood components; and

12. Shipping records from the blood distributor with written documentation that indicates that, at the time of blood and blood component receipt, components listed on the shipping record were verified as received.

N.J. Admin. Code § 8:8-5.1

Recodified from 8:8-4.1 and amended by R.1989 d.246, effective 5/15/1989.
See: 21 N.J.R. 407(a), 21 N.J.R. 1412(a).
Rule on donor identification previously at N.J.A.C. 8:8-5.1 recodified to N.J.A.C. 8:8-6.1.
Requirements added concerning record maintenance, corrections, work records, computer systems, written procedures, reporting requirements, quality control and identification of staff involved in blood processing.
Amended by R.1994 d.350, effective 8/1/1994.
See: 26 N.J.R. 1057(a), 26 N.J.R. 3171(a).
Amended by R.2005 d.283, effective 10/3/2005.
See: 36 N.J.R. 4261(a), 37 N.J.R. 3815(a).
In (a), added 1; in (f), deleted "and" at the end of 4, replaced ";" for "." at the end of 5, and added 6 and 7; in (i), substituted "all blood" for "plasmapheresis and cytapheresis" in 1ii, substituted "pooled product" for "pooling of source plasma" in 1x, rewrote 2vi, substituted "corrective" for "correction" and added "the" preceding "supervisor" in 7, and substituted "investigations" for "investigation" and "suspected" for "suspect" in 9.