Pathological and clinical services shall be provided or made available when appropriate to meet the needs of the patients and adequately support the ambulatory surgical center's (ASC's) clinical capabilities.     
       (1) Pathology and clinical laboratory services shall include, but are not limited to:                (A) conducting laboratory procedures that are appropriate to the needs of the patients;                 (B) performing tests in a timely manner;                 (C) distributing test results within 24 hours after completion of a test and maintaining a copy of the results in the laboratory; and                 (D) performing and documenting appropriate quality assurance procedures, including, but not limited to, calibrating equipment periodically and validating test results through use of standardized control specimens or laboratories.        
       (2) Preoperative laboratory procedures may be required as follows.                (A) It shall be at the discretion of the governing body upon the recommendation of the medical staff to require preoperative laboratory orders.                 (B) If specific preoperative laboratory work is required, the medical staff shall approve them in accordance with the medical staff bylaws. Other laboratory work shall be performed only on the order of a physician, podiatrist, dentist, or advanced practice registered nurse and written on the patient's chart.                 (C) These services shall be provided either directly within or through an effective contract arrangement with a Medicare-approved reference laboratory.                 (D) The contractual agreement with the Medicare-approved reference laboratory shall provide for routine and stat work to include pathology, clinical, and blood bank services, if blood is authorized by the ASC, and shall be available for review.        
       (3) The patient may be instructed to go directly to the Medicare-approved reference laboratory, or the specimen may be collected on the ambulatory surgical center's premises and then referred to the Medicare-approved reference laboratory.      
       (4) If the specimens are collected on the premises only, the following shall be maintained:                (A) procedures and policies governing the Medicare-approved reference laboratory specimen requirements; identification, collection, labeling, storage, and transportation of the specimen, and preventive maintenance of equipment used in processing and storage of specimen;                 (B) a log book which shall include patient name and identification number, doctor's name, date the specimen was drawn and sent to the Medicare-approved reference laboratory, laboratory tests ordered, date the final report came back from the reference laboratory, and condition of the specimen. The final report shall be on the patient's chart, with copies kept in the ASC's laboratory.        
       (5) If laboratory tests are performed on the premises, the following shall be maintained:                (A) procedures governing identification, collection, labeling, and storage of specimens;                 (B) a log book, which shall include patient name and identification number, practitioner's name, date the specimen was drawn, test ordered, and results;                 (C) procedures for each test procedure performed by the laboratory, including source of reagents, standards, and calibration procedures, and information concerning the basis for the tested normal ranges;                 (D) procedures and documentation of performed maintenance on equipment used to process laboratory work;                 (E) dated reports of all examinations performed and made a part of the patient's medical record; and                 (F) proficiency testing.        
       (6) Quality control of the laboratory shall be monitored through the quality assurance committee.      
       (7) If the ASC designates its laboratory to perform as an independent laboratory, it shall be surveyed according to 42 Code of Federal Regulations, §§493.1 - 493.1780.      
       (8) The ASC can allow laboratory work to be performed and brought in from other Medicare-approved reference laboratories or practitioners' offices, and the reports shall be on the patient's charts before surgery.                (A) Written criteria describing the length of time tests can be done prior to surgery shall be developed by the medical staff and approved by the governing body.                 (B) Laboratory work shall be performed in a Medicare-approved reference laboratory or in the patient's healthcare practitioner's office. This shall be written in a policy accepted by the medical staff and governing body.        
       (9) If it is the ASC's policy to administer blood, policies shall be developed on administration of blood transfusions to include autologous blood units in accordance with the ASC's operative procedures. If the operative procedure(s) performed in the ASC requires or may require the necessity for transfusions, policies and procedures shall include provisions for stat and routine transfusions. These policies and procedures shall include, but are not limited to, collection, labeling, and transportation of specimen in accordance with the ASC or contract service policies. All patient results shall appear in the patient's chart.      
       (10) If the ASC performs surgery which incorporates the removal of a tissue specimen or the freezing of a tissue specimen, the specimen shall be submitted to a Medicare-approved reference laboratory. The following shall be maintained:                (A) procedures governing the Medicare-approved reference laboratory specimen requirements, identification, collection, labeling, storage, and transportation of the specimen;                 (B) documentation to include patient name and identification number, practitioner's name, date the tissue specimen was collected and referred to the Medicare-approved reference laboratory, and date the final report came back from the Medicare-approved reference laboratory. Final copies shall be placed in the patient's chart, with copies kept in the ASC; and                 (C) the medical staff bylaws may exempt tissue specimens from pathology examination, and the list of exemptions shall be available for review.        
       (11) The medical staff bylaws shall define those specimens for macroscopic pathology examination only and both macroscopic and microscopic pathology examinations.      
       (12) The original pathology report shall be included in the patient's chart.      
       (13) Pathology tissue reports and positive cytology reports shall have the authorized signature of the pathologist interpreting the report.      
     Source Note:        The provisions of this §135.13 adopted to be effective June 18, 2009, 34 TexReg 3948