Header:
WISCONSIN ADMINISTRATIVE CODE
DEPARTMENT OF HEALTH SERVICES
CHAPTER DHS 124 HOSPITALS
SUBCHAPTER IV -- SERVICES
Date:
08/31/2009
Document:
DHS 124.17 Laboratory services.
(1) LABORATORIES. (a) Requirement. The hospital shall have a well-organized and adequately supervised clinical laboratory with the necessary space, facilities and equipment to perform the laboratory services needed by the hospital's patients.
(b) Services and facilities. 1. The extent and complexity of laboratory services shall be commensurate with the size, scope, and nature of the hospital and the needs of the medical staff, except that basic laboratory services necessary for routine examinations shall be available regardless of the size, scope and nature of the hospital.
2. All equipment shall be in good working order, routinely checked and precisely calibrated.
3. Provision shall be made to carry out adequate clinical laboratory examinations, including blood chemistry, microbiology, hematology, serology, clinical microscopy and anatomical pathology, and to provide blood bank services. Any of these services may be provided under arrangements with a laboratory approved under 42 CFR 493 (CLIA) to provide these services. In the case of work performed by an outside laboratory, the original report or a legally reproduced copy of the report from that laboratory shall be contained in the medical record.
(c) Availability. 1. Laboratory services shall be available at all times.
2. Adequate provision shall be made for ensuring the availability of emergency laboratory services, either in the hospital or under arrangements with another laboratory under 42 CFR 493 (CLIA). These services shall be available 24 hours a day, 7 days a week, including holidays.
3. A hospital that has contracted for laboratory services is in compliance with this paragraph if the contracted services meet all applicable rules of this section.
(d) Personnel. 1. A laboratory shall have a sufficient number of personnel to supervise the provision of laboratory services and to promptly and proficiently perform laboratory examinations.
2. Services shall be under the direction of a pathologist or an otherwise qualified physician, or a laboratory specialist qualified by a doctoral degree from an accredited institution with a chemical, physical or biological science as the major area of study and with experience in clinical laboratory services.
3. The laboratory may not perform procedures and tests that are outside the scope of training of laboratory personnel.
(e) Routine examinations. The medical staff shall determine the routine laboratory examinations required on all admissions.
(f) Records. 1. Authenticated laboratory reports shall be filed in the patient's medical record. Duplicate records shall be maintained by the laboratory for at least 2 years.
2. The laboratory director shall be responsible for laboratory reports.
3. A mechanism by which the clinical laboratory report shall be authenticated by the technologist shall be delineated in the laboratory services policies and procedures.
4. The laboratory shall have a procedure for ensuring that all requests for tests are ordered in writing by a physician, dentist or other individual authorized by the medical staff.
(2) ANATOMICAL PATHOLOGY. (a) Pathologist. 1. Anatomical pathology services shall be under the direct supervision of a pathologist on a full-time, part-time or consultative basis. If it is on a consultative basis, the hospital shall provide for, at minimum, monthly consultative visits by the pathologist.
2. The pathologist shall participate in staff, departmental and clinicopathologic conferences.
3. The pathologist shall be responsible for the qualifications of staff.
4. An autopsy may be performed only by a pathologist or an otherwise qualified physician.
(b) Tissue examination. 1. The medical staff and a pathologist shall determine which tissue specimens require macroscopic examination and which require both macroscopic and microscopic examinations.
2. The hospital shall maintain an ongoing file of tissue slides and blocks. Nothing in this section shall be interpreted as prohibiting the use of outside laboratory facilities for storage and maintenance of records, slides and blocks.
3. If the hospital does not have a pathologist or otherwise qualified physician, there shall be an established plan for sending all tissues requiring examination to a pathologist outside the hospital.
4. A log of all tissues sent outside the hospital for examination shall be maintained. Arrangements for tissue examinations done outside the hospital shall be made with a laboratory approved under approved under 42 CFR 493 (CLIA).
(c) Records. 1. All reports of macroscopic and microscopic tissue examinations shall be authenticated by the pathologist or otherwise qualified physician.
2. Provisions shall be made for the prompt filing of examination results in the patient's medical record and for notification of the physician or dentist who requested the examination.
3. The autopsy report shall be distributed to the attending physician and shall be made a part of the patient's record.
4. Duplicate records of the examination reports shall be kept in the laboratory and maintained in a manner which permits ready identification and accessibility.
(3) BLOOD BANK SERVICES. (a) Access. Facilities for procurement, safekeeping and transfusion of blood and blood products shall be provided or made readily available, as follows:
1. The hospital shall maintain proper blood and blood product storage facilities under adequate control and supervision of the pathologist or other authorized physician;
2. For emergency situations the hospital shall maintain at least a minimum blood supply in the hospital at all times and have a written plan for acquiring blood quickly, as needed, from an outside source;
3. Where the hospital depends on an outside blood bank, there shall be an agreement between the hospital and the outside blood bank to govern the procurement, transfer and availability of blood and blood products. That agreement shall be reviewed and approved by the medical staff, chief executive officer and governing body; and
4. There shall be provision for prompt blood typing and cross-matching, either by the hospital or by arrangement with others on a continuing basis, and under the supervision of a physician.
(b) Safety precautions. 1. Blood storage facilities in the hospital shall have an adequate refrigeration alarm system, which shall be regularly inspected.
2. Blood and blood products not used by their expiration dates shall be disposed of promptly.
(c) Records. A record shall be kept on file in the laboratory and in the patient's medical record to indicate the receipt and disposition of all blood and blood products provided to the patient in the hospital.
(d) Review committee. 1. A committee of the medical staff shall review all transfusions of blood or blood derivatives and make recommendations to the medical staff concerning policies to govern practice.
2. The review committee shall investigate all transfusion reactions occurring in the hospital and shall make recommendations to the medical staff for improvements in transfusion procedures.
(4) PROFICIENCY TESTING. The hospital laboratory shall participate in proficiency testing programs that are offered or approved in those specialties for which the laboratory offers services, as specified in 42 CFR 493 (CLIA).
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