Two ACHC Renal Dialysis Accreditation Standards address laboratory services provided by renal dialysis facilities:

• Standard RD2-C: The facility makes available laboratory services (other than the specialty of tissue pathology and histocompatibility testing), to meet the needs of the facility patient. (494.130) V675-676
• Standard RD4-L.01: Written policies and procedures are established and implemented that identifies which waived tests can be conducted and ensures appropriate training for individuals conducting tests.

Tips for Compliance

• Renal dialysis facilities that perform laboratory tests must have the appropriate CLIA certificate for the level of testing conducted.
• Facilities that provide their own laboratory services — such as waived tests (e.g., dipstick urinalysis, fecal occult blood tests, spun microhematocrit tests, and finger-stick blood glucoses obtained by glucose monitoring devices) — are required to have a CLIA certificate of waiver.
• Facilities that perform Panel Reactive Antibody (PRA) testing for patients on the transplant wait-list must have a “regular” CLIA certificate of compliance or certificate of accreditation, which allow the laboratory to perform moderate or high-complexity testing.
• Facilities must be able to demonstrate, either by written policies and procedures or a list of waived tests, which tests can be performed at the facility.
• The facility must identify which personnel may perform waived tests and must conduct appropriate training for these individuals (i.e., upon hire, ongoing as needed, and annually). Training must include quality control measures for the use of equipment according to the manufacture’s guidelines for waived testing, including but not limited to:
  • Instructions for using the equipment.
  • Frequency of equipment calibration, cleaning, testing, and maintenance.
  • Quality control procedures.
• If a facility has a contract or agreement with a certified provider(s) to perform or refer specimens for laboratory testing to an outside laboratory, the referral laboratory must be CLIA certified. The facility must have a copy of the referral laboratory’s CLIA certificate. The contract or agreement must address the types of lab tests to be performed, collection and handling of specimens, how results will be reported, and the time frame in which results are reported. In addition, there must be an approved list of alerts/panic value results and a policy on how those will be reported.
• Laboratory reports include but are not limited to:
  • Name and address of the laboratory performing the test.
  • Name of the ordering physician.
  • Identifying patient information:
    • Name.
    • Medical record number.
    • Date of birth.
  • Date of the specimen collection.
  • Date and time of the results.
• All renal dialysis facilities must ensure there is documentation in patient medical records that all laboratory tests prescribed were provided as ordered.