Or. Admin. Code § 333-535-0090 - Laboratory Suite

(1) Inpatient hospital laboratory facilities shall be provided for hematology, clinical chemistry and urinalysis, and may include cytology, pathology, immunohematology, microbiology, serology, and immunology to meet requirements for services as stated in General Rules (OAR 333-535-0010). These may be provided within the hospital or through an effective contract arrangement with a nearby laboratory service. Hospital laboratories located in freestanding clinics shall conform to rules under section (2) of this rule. The following shall be provided:

(a) Laboratory work counter(s) with space for microscopes, appropriate chemical analyzer(s), incubator(s), and centrifuge(s). Work areas shall include sinks with water and access to electrical services as needed;

(b) Refrigerated blood storage facilities for transfusions shall be provided. Blood storage refrigerator shall be equipped with temperature-monitoring and alarm signals located for 24-hour response. Blood banks must be provided emergency power for continued cooling during an interruption of the normal power supply;

(c) Dedicated hand-washing stations shall be located within 20 feet of each workstation and within each room with a workstation;

(d) Appropriate storage facilities, including refrigeration shall be provided for reagents, patient specimens, controls, and supplies;

(e) Urine and feces collection rooms shall be equipped with a toilet and hand-washing station. This may be outside the laboratory suite;

(f) Blood collection facilities shall include a work counter, conveniently located hand-washing station, space for patient seating and sharps container(s);

(g) Chemical safety provisions, which may include emergency shower, eye flushing devices, and appropriate storage for flammable liquids shall be provided in accordance with Oregon State Public Health Laboratory Licensing rules, OAR 333-024-0005 through 333-024-0055, and Oregon OSHA Administrative Rules;

(h) Facilities and equipment for sterilization of contaminated specimens before transport to incineration facilities in accordance with Oregon State Public Health Laboratory Licensure Rules and Oregon OSHA Administrative Rules;

(i) If radioactive materials are used or stored, facilities shall be available for their safe storage and disposal;

(j) Administrative areas including offices as well as space for clerical work, filing, and record maintenance shall be provided apart from testing or storage areas;

(k) Lounge, locker, and toilet facilities shall be conveniently located for laboratory staff. These may be outside the laboratory area and shared with other departments; and

(l) The Functional Program shall describe the type and location(s) for all special laboratory equipment that is to be wired, plumbed, or plugged in, and the building utility systems required to operate each.

(2) Laboratory services serving hospital outpatient clinics may be onsite or through an effective contractual arrangement with a laboratory service or through the primary hospital laboratory. Services may include hematology, clinical chemistry, urinalysis, cytology, pathology, microbiology, serology, immunology, and immunohematology. When these services are not effectively provided elsewhere, the following shall be available within the clinic:

(a) Laboratory work counter(s), with sink;

(b) Designated sink equipped for hand-washing station in addition to process sink(s);

(c) Storage cabinet(s) or closet(s);

(d) Specimen collection room with a toilet, hand-washing station, and an area for handling and storing specimens;

(e) Blood collection facilities including secure seating, a work counter, and access to a hand-washing station. Collection facilities may be within the laboratory or in satellite location(s); and

(f) Refrigeration for storage of reagents, controls and patient specimens as necessary. Separate refrigeration must be provided for injectibles and food or drink that is to be consumed by patients or staff.

(3) Laboratory units shall conform to OAR 333-024-0000 and the rules there under regarding laboratory requirements. Standards contained in NFPA 99 regarding laboratories and health related institutions are also required.

Notes

Or. Admin. Code § 333-535-0090

HB 183, f. & ef. 5-26-66; HB 209, f. 12-18-68; HD 7-1979, f. & ef. 7-17-79; HD 11-1980, f. & ef. 9-10-80; Renumbered from 333-023-0200(9); HD 29-1988, f. 12-29-88, cert. ef. 1-1-89, Renumbered from 333-074-0245; HD 21-1993, f. & cert. ef. 10-28-93; HD 2-2000, f. & cert. ef. 2-15-00; PH 14-2005, f. 8-10-05, cert. ef. 8-15-05; PH 10-2009, f. & cert. ef. 10-1-09; PH 18-2019, repeal filed 10/01/2019, effective 1/1/2020

Publications: Publications referenced are available from the agency.

Statutory/Other Authority: ORS 441.060

Statutes/Other Implemented: ORS 441.060