Md. Code Regs. 10.51.05.11

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.51.05.11 - Equipment Maintenance

A. General. The laboratory shall develop, establish, maintain, implement, and follow an equipment calibration and maintenance procedure and policy.

B. A licensee shall ensure that equipment, before being placed into use, is calibrated or checked to establish that the equipment meets either the laboratory's or manufacturer's specifications, or both, as determined by the director.

C. A licensee shall ensure that records are maintained on all items of equipment including at a minimum:

(1) Identity of the item of equipment and the equipment's ancillary parts;

(2) Manufacturer's name and serial number or other unique identifier;

(3) Performance checks ensuring the equipment complies with the manufacturer's specifications;

(4) Current location, if applicable;

(5) Manufacturer's instructions or operating manual;

(6) Dates and results of calibrations, adjustments, and service and date of next calibration;

(7) Documentation of all maintenance performed, including date and signature of the individual performing the maintenance; and

(8) Documentation of any damage, malfunction, modification, or repair to the equipment.

D. A licensee shall ensure that any equipment that gives questionable results or is not functioning properly is immediately taken out of use and the equipment:

(1) Is clearly labeled as out of service;

(2) Is examined and repaired or retired;

(3) Is calibrated or shown to perform correctly before being put back into service; and

(4) Has forensic analysis results on previously examined evidence evaluated for accuracy back to the previous calibration.

E. A licensee shall ensure that the equipment, including both hardware and software, is safeguarded from adjustments that invalidate or alter calibrations or test examinations and analyses.

F. A licensee shall ensure that operator's manuals for all equipment and instruments are available to all examiners and analysts who use the equipment or instruments.

Md. Code Regs. 10.51.05.11