Both referring and testing laboratories must keep a record of each written request for laboratory services, each specimen, and each test result for at least six years from the date on which the results were reported to the authorized prescriber. If the testing laboratory is a subsidiary-related entity of the referring laboratory, such records may be maintained at one location, but must be made available to the MassHealth agency and the Attorney General’s Medicaid Fraud Division upon request, in accordance with 130 CMR 450.205. If an independent clinical laboratory cannot produce the record to substantiate a MassHealth claim, the MassHealth agency may deny or recover payment for that claim. The laboratory record must contain the following information:

1. (A) the written request for laboratory services with all information required by 401.416;
2. (B) the identification number of the specimen;
3. (C) the name or any other means of identifying the person from whom the specimen was taken;
4. (D) the name of the authorized prescriber and, if applicable, the referring laboratory that submitted the specimen;
5. (E) the date on which the specimen was collected by the authorized prescriber or laboratory, the location of the collection, and the name of the collector;
6. (F) the date on which the specimen was received in the laboratory;
7. (G) the condition of unsatisfactory specimens when received (for example, broken, leaked, hemolyzed, or turbid);
8. (H) the specific tests performed;
9. (I) the date or dates on which each test was performed;
10. (J) the results of each test, the name and address of all persons to whom each test result is reported, and the date of reporting; and
11. (K) the name and address of the laboratory to which the specimen was referred, if applicable.

Commonwealth of Massachusetts Subchapter Number and Title Page

MassHealth 4. Program Regulations

4-7

Provider Manual Series (130 CMR 401.000)

Transmittal Letter Date

Independent Clinical Laboratory Manual

LAB-35 04/01/10