(a) A center shall have access to laboratory services to meet each patient's needs, including the ability to

1. (1) conduct a breath analysis for immediate determination of blood alcohol level;
2. (2) conduct a dipstick urine drug screen; and
3. (3) obtain rapid laboratory results.

(b) A center shall

1. (1) maintain a Centers for Medicare and Medicaid Services Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver under 42 C.F.R. 493.35 - 493.37 or a registration certificate under 42 C.F.R. 493.43 - 493.45 for the provision of on-site laboratory services or on-site point of care testing; or
2. (2) provide for laboratory services through a contracted laboratory that has a Centers for Medicare and Medicaid Services Clinical Laboratory Improvement Amendments (CLIA) certification.

(e) A center shall develop, implement, and comply with written policies and procedures in accordance with applicable federal, state, and local laws and ordinances that govern

1. (1) safe administration and handling of prescription and non-prescription medication;
2. (2) medication storage, recording, and control;
3. (3) disposal of discontinued or expired medication and containers with worn, illegible, or missing labels;

4. (4) prescription medication use, including

   1. (A) medical monitoring when medication is administered to identify specific target symptoms;
   2. (B) a procedure to provide information on each medication's anticipated results, potential benefits and side effects, and potential adverse reactions that may result from not taking the medication as prescribed, to center staff and the patient, patient's legal guardian, chosen representative, or parent of a minor patient, if applicable;
   3. (C) involving a patient, and if applicable, patient's legal guardian, chosen representative, or parent of a minor patient in decisions concerning medication; and
   4. (D) training staff to recognize a medication's potential side effects;
5. (5) abbreviations and symbols approved for use in the center;

6. (6) recording and reporting medication errors and adverse drug reactions to

   1. (A) the patient's physician or prescriber; and
   2. (B) the clinical director;
7. (7) reporting and resolving inventory discrepancies or the misuse or abuse of controlled substances, in accordance with federal and state law;
8. (8) emergency pharmaceutical services; and
9. (9) the emergent or urgent procurement, including the acceptable time frame for procurement, of medication when the required medication is not available on site.

(f) A center shall

1. (1) allow medication to be administered only by a licensed health care professional whose scope of practice includes the administration of medication;
2. (2) allow medication to be administered only according to a licensed prescriber's order;

3. (3) keep medication in a locked, illuminated, and clean cabinet, closet, or room that is

   1. (A) maintained at a controlled temperature according to the manufacturer's recommendation; and
   2. (B) accessible only to a licensed health care professional authorized to administer medications;
4. (4) store medication that requires refrigeration in a refrigerator or refrigeration unit separate from refrigerators or refrigeration units that store food, beverages, or laboratory specimens;
5. (5) administer medication only upon the written or verbal order of a licensed prescriber;
6. (6) require the licensed prescriber to sign a verbal order not more than 24 hours after making the verbal order;

7. (7) immediately report, and document the patient's medical record, medication errors, adverse drug reactions, or interactions with other medication, food, or beverages taken by the patient to

   1. (A) the patient's physician or licensed prescriber;
   2. (B) the supervising pharmacist; and
   3. (C) the clinical director;
8. (8) keep controlled substances in a locked cabinet or compartment separate from other medications;
9. (9) maintain current and accurate records on the receipt and disposition of controlled substances;

10. (10) reconcile controlled substances at least twice a day; reconciliation shall be completed by

    1. (A) a licensed health care professional authorized to administer controlled substances; or
    2. (B) an automated system that provides reconciliation;
11. (11) report discrepancies in controlled substance inventories to the center's administrator, clinical director, and supervising pharmacist in accordance with federal and state laws;
12. (12) develop and utilize a process to obtain medication within a time frame that meets each patient's needs; and
13. (13) develop and utilize a process to provide pharmaceutical services 24 hours a day.