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Based on policy and procedure review, review of professional literature, review of the North Dakota Century Code, and review of facility's Plan of Correction (POC) and mail revisit documentation/information, the Critical Access Hospital (CAH) failed to limit access to the hospital pharmacy by designated nursing staff to times of emergent circumstances, and ensure nursing staff obtained only the amount of medication to treat the immediate needs of the patient; and failed to ensure drugs were dispensed in accordance with professional principles for 15 weeks (June 23-October 7, 2010) reviewed. Failure to limit access to the pharmacy, retrieve drugs according to regulations and facility policy and procedure, and properly dispense drugs limited the pharmacy's ability to maintain control of the drugs, and allowed an opportunity for inaccurate and unsafe drug administration.

Findings include:

The Centers for Medicare and Medicaid Services (CMS) outlined the standards of practice for the administration of pharmaceutical services. A fundamental purpose of pharmaceutical services is to ensure the safe and appropriate use of medications. The pharmacy director is responsible for developing, implementing, and periodically reviewing and revising policies and procedures for the provision of pharmaceutical services that ensure patient safety through the appropriate control and distribution of medications. The pharmacist is to maintain control over all medications in the CAH. When the pharmacist is unavailable, only a designated individual may remove drugs from the pharmacy and in amounts sufficient for immediate therapeutic needs. The pharmacist or pharmacy supervised personnel are to be the persons to compound, label, and dispense drugs or biologicals in accordance with State and Federal laws and regulations and accepted national principles. The pharmacist must ensure the proper dispensation of medication and appropriate supervision to provide safe and appropriate use of medications.

The North Dakota Century Code, Chapter 61-07-01 "Hospital Pharmacy" stated, ". . . 61-07-01-0. Drug distribution and control. . . . 2. Responsibility. The director is responsible for the safe and efficient distribution of, control of, and accountability for drugs. . . . Accordingly, the director is responsible for, at a minimum, the following: . . . f. Filling and labeling all containers from which drugs are to be administered. . . . m. Meeting all compliance and other requirements of the . . . rules and laws and this chapter. . . . 5. Physician's orders. . . . e. Pharmacist review. The pharmacist shall review the prescriber's order, or a direct copy thereof, before the initial dose of medication is dispensed . . . In cases when the medication order is written when the pharmacy is 'closed' or the pharmacist is otherwise unavailable, the medication order should be reviewed by the pharmacist as soon thereafter as possible, preferably within twenty-four hours. . . . 61-07-01-05. Absence of pharmacist. . . . During such times as a hospital pharmacy may be unattended by a pharmacist, arrangements must be made in advance by the director for the provision of drugs . . . by use of the night cabinets or floor stock, or both, and in emergency circumstances, by access to the pharmacy . . . 3. Access to pharmacy. Whenever any drug is not available from floor supplies or night cabinets, and such drug is required to treat the immediate needs of a patient whose health would otherwise be jeopardized, such drug may be obtained from the pharmacy in accordance with the requirements of this section. . . ."

Review of facility policy "Pharmacy Access" occurred 10/07/10. This policy, revised June 2010, stated, "To define who may access the pharmacy in the absence of the pharmacist. The pharmacy shall be kept locked at all times. A pharmacist is available on an on-call basis outside of regular scheduled hours. Only those persons listed below shall have access to the pharmacy. a. Registered Pharmacist. b. Designated Supervisory RN [registered nurse]. c. Pharmacy Technician. One supervisory RN in any given assigned shift is responsible after regular pharmacy hours for removing drugs from the pharmacy stock. . . . Only one dose of the required medication may be removed at a time until the pharmacist or pharmacy technicians are available. The sign out log will be monitored by the pharmacist weekly. . . . The medication cart with the patient and stock drawers will be filled as needed by the pharmacist and/or pharmacy technicians with unit dosed medications. . . ."

Review of facility policy "Dispensing/Returns" occurred 10/07/10. This policy, revised January 2009, stated, "1. Physician's write orders on the Dr.'s [doctor's] order sheet for new admissions and changes of medications for present patients. The pharmacist or the tech [pharmacy technician] will pick up new orders and changes at the nurses station. 2. Pharmacist or tech will receive any of the following when he reports to the hospital to fill the days orders. a. MD [Medical Doctor] orders for new patients or for present patients with order changes. b. Patient's medication bottle returned for refill. c. Patient's medication returned because of discharge. 3. All orders are filled for a three (3) day supply with the exception of holding patient medications an [sic] medications requiring a one day stop order which are refilled daily. . . ."

Review of the facility's POC occurred 10/07/10. Review of pages 2-4, stated, "On 6/7/10, the Pharmacy Access policy was revised to reflect the changes to restrict access to pharmacy. The after hours log was also revised . . . and will be randomly reviewed by the Pharmacist . . . On 06/08/10 a memo was sent to the nursing and pharmacy staff . . . notifying them of the changes. A meeting was held with the pharmacist, pharamacy [sic] technicians and the Director of Patient Care. The pharmacist and the technicians were informed that it is their duty to fill the patient med drawers and the stock drawers. They are to check the stock drawers on Mondays and Fridays and as needed in times of high census. Nursing staff will notify them of any new admits. . . . All medications will be unit dosed when received in pharmacy and checked by the pharmacist. This will be discussed in depth with the nursing staff at the June nurses meeting. . . . Only one dose of the required medication may be removed at a time until the pharmacist or a pharmacy technician is available. . . . A log, 'The Pharmacy Sign-Off Sheet' . . . was designed for the techs [technicians]. They will initial duties when completed. This log, as well as the 'After Hours Log' will be reviewed and initialed weekly by the pharmacist . . . These logs will be used by the pharmacist to audit RN access to the pharmacy and to ensure that the techs are completing their duties. . . . The nursing staff was retrained on 6/23/10 of their responsibility regarding pharmacy access. . . ."

Review of the Memo sent to the nursing and pharmacy staff from the Director of Patient Care occurred 10/07/10. The Memo, dated 06/08/10, stated, "Please note the following, effective immediately: One supervisory RN, in any given assigned shift, is responsible (after regular pharmacy hours) to remove drugs from the pharmacy stock. The responsible nurse, in times of an emergency, may delegate this to another RN. Removal of any drug from the pharmacy by an authorized RN must be recorded on the After Hours Pharmacy Log showing patient name, room number, name of drug, strength, amount taken, date, time and RN signature. This Log will be reviewed by the Pharmacist."

Review of documentation provided by the Director of Patient Care occurred 10/07/10. This documentation, dated 06/23/10, stated, "A meeting was held with . . . pharmacist . . . the pharm [pharmacy] techs regarding nursing service and pharmacy access. . . . The pharmacy after hours log has been revised and will be monitored by the pharmacist for compliance. . . . Nursing is not to fill the med cart. This is pharmacy responsibility. This is to be done by the pharmacist or the pharm techs. . . . The med carts are to be filled twice a week and as needed in times of high census. The techs are to check for new admits every morning and the nursing staff will page them for new admits throughout the day [sic] Drugs are to be unit dosed on arrival and checked by the pharmacist. . . ."

Review of the June Nurses Meeting agenda occurred 10/07/10. The meeting agenda, dated 06/23/10, stated, ". . . 1. Pharmacy-Access to the pharmacy has to be restricted. Only one RN per shift is to have access. . . . The after hours log has been revised and will be monitored by the pharmacist and myself. . . . (See revised pharmacy access policy.) 2. Nursing is not to fill the med cart. This is to be done by the pharmacist or the techs. . . . 3. The techs will fill the med cart twice a week . . . and more frequently if needed during high census. 4. The techs will check for new admits every am [morning] and fill new orders. The nursing staff re [sic] to page them during working hours when new admits come in. After hours pill [sic] just enough medications until the tech can fill them. 5. Drugs will be unit dosed when received in pharmacy and these will be checked by the pharmacist."

Review of the Pharmacy After Hours Logs, dated June 23-October 7, 2010, occurred 10/07/10. The June log showed nursing staff accessed the pharmacy every day and obtained medications for patients. The access occurred mainly in the late evening to early morning hours (7:30 p.m. to 2:35 a.m.), and included weekdays. The log showed medications removed for two to three different patients at a time, and sometimes two to five different medications removed for the same patient. Review of the log also showed nursing staff removed more than a single dose of medication for a patient at a time (Hydroxyzine 25 milligrams (mg)-1 bottle, Slow Magnesium 64 mg-1 bottle, Levothyroxine 112 micrograms (mcg)-1 bottle, Metoprolol 25 mg-1 bottle, etc.).

Review of documentation signed by a pharmacy technician on 07/01/10, occurred 10/07/10, and stated, "Please sign out 1 dose at a time thank you."

Review of the pharmacist's audit occurred 10/07/10. Review showed the pharmacist initialed the Pharmacist Audit Form or the Pharmacy After Hours Logs, and the Pharmacy Sign Off Sheet every week (June 26-September 26, 2010) to reflect monitoring of RN access and pharm tech duties. A note written on the pharmacist audit form by the pharmacist, dated 08/17/10, stated, "1. Note posted-only one dose at a time. Noted: may take more than 1 tab [tablet]/cap [capsule] to equal prescribed dose. 2. Improvement noted in all areas-some still taking more than one dose-please address at nurses meeting. . . . Techs have been noted to be diligent in their areas. . . . 5. Threshold met? Not quite. Ideal is 100%. I feel we are at about 90%. Will follow up and audit again. . . ."

Review of the July and August Pharmacy After Hours Logs showed nursing staff continued to access the pharmacy nearly every day and obtained medications for patients. The access occurred mainly in the evening to early morning hours (5:45 p.m. to 7:30 a.m.), and included weekdays. The log showed medications removed for two to three different patients at a time, and sometimes three to seven different medications removed for the same patient. Review of the log also showed nursing staff removed more than a single dose of medication for a patient at a time (Augmentin 875 mg-1 bottle, Crestor 10 mg-1 bottle, Triamterene-HCTZ 37.5/25 mg-1 bottle, Isosorbide 30 mg-1 bottle, Diltiazem 240 mg-1 bottle, Glipizide 5 mg-1 bottle, etc.).

Review of the September Nurses Meeting agenda occurred 10/07/10. The meeting agenda, dated 09/09/10, stated, "1. Evan-Med Carts . . . The pharmacist and/or techs will fill them. Nursing staff is to enter pharmacy only in an emergency when the techs or pharmacist are not available. Only one dose can be taken at a time. . . ."

Review of the September, and October Pharmacy After Hours Logs showed nursing staff continued to access the pharmacy nearly every day and obtained medications for patients. The access occurred mainly in the late evening to early morning hours (6:50 p.m. to 7:30 a.m.), and included weekdays. The log showed medications removed for two to three different patients at a time, and sometimes two to five different medications removed for the same patient. Review of the log also showed nursing staff removed more than a single dose of medication for a patient at a time (Hytrin 5 mg-1 bottle, Augmentin 875 mg-1 bottle, Altace 10 mg-1 bottle, Levothyroxine 88 mcg-1 bottle, Keflex 500 mg-1 bottle, Neurontin 300 mg-1 bottle, Tramadol 50 mg-1 bottle, Labetalol 100 mg-1 bottle, etc.).

During a phone interview on 10/06/10 at 9:30 a.m., an administrative nurse (#1) confirmed the CAH continued to have an issue with the frequency of nursing staff accessing the pharmacy to obtain medications for patients. The administrative nurse (#1) stated the CAH provided additional education to the nursing staff about the issue of removing more than a single dose of medication from the pharmacy, and stated an increase in compliance after the education. She stated the pharm techs dispensed medications to the two new medication carts the CAH purchased each day for the nursing staff, and filled medications per new physician orders and patient admissions. The nurse (#1) stated the pharmacist checked or verified the pharm techs dispensing.

Review of the mail revisit documentation lacked evidence the CAH corrected this issue as nursing staff continued to frequently enter the hospital pharmacy and remove multiple doses of medications in non-emergency situations, due to the pharmacy staff's failure to dispense all medications. The CAH provided no further documentation or information to support staff recognized this noncompliance and implemented corrective action.

Failure to correct this issue permitted nursing staff to perform duties outside their scope of practice, and limited the pharmacist's ability to ensure safe medication practices and maintain responsibility for the overall administration of the pharmacy service. The failure limited the CAH's ability to provide pharmaceutical services in a safe and appropriate manner.