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Based on policy review, document review and staff interviews the Critical Access Hospital (CAH) administrative staff failed to ensure pharmacy oversight of manufacturer's injectable diabetic prescription medication samples and ensure dispensing of samples to patients was conducted by employees within their scope of practice.

The Diabetes Education Center Registered Nurse (RN) reported the program served 80 patients in 2013 and the program currently had 71 active patients. The sample drug log revealed 35 samples were dispensed to 12 patients from 9/2013 through 12/2013.

Failure of pharmacy staff to provide oversight of sample prescription medications could result in inappropriate medications or doses of medications, outdated, recalled, or otherwise unusable medications available to provide to patients, as well as, the potential for diversion of medications by unauthorized persons.

Findings include:

1. Review of a pharmacy policy titled "Storage of Pharmaceuticals", revised in 4/2014, revealed in part ". . . Medication storage and preparation areas within the pharmacy and throughout the hospital shall be under the supervision of the Pharmacist . . . "

Review of a Diabetes Center policy titled "Storage of Insulin and Non-Insulin Injectables", reviewed in 7/2014, revealed in part ". . . Medication storage with the Diabetes Center shall be under the supervision of the CDE (Certified Diabetes Educator) from the Diabetes Center and the Pharmacist . . ."

2. During an interview on 12/15/14 at 3:15 PM, Staff A, Employee Health/Diabetes Education Center RN, reported she maintained a supply of manufacturer prescription samples of prefilled injectable diabetic medication pens (a simple device to set a medication dose and inject) to teach outpatient diabetes education patients how to manage their diabetes and dispensed samples to patients for use at home.

Staff A reported she maintained a log of the manufacturer injectable diabetic medication samples. She relayed the pharmacist was aware the Diabetes Education Center stored and dispensed the samples, but was not involved in the process, aside from receiving any samples that had become outdated.

3. Observation of Staff A's sample supply, on 12/15/14, at 3:20 PM, revealed the following samples were stored in a locked refrigerator, located in Staff A's office:

3 each 2 milligram (mg) Bydureon vials
4 each 1 milliliter (ml) Lantus Solostar pen
6 each 3 ml. prefilled Humalog Kwik pen
2 each 3 ml. prefilled Levemir Flex pen
1 3 ml. prefilled Novolog Flex pen

4. Review of a document titled "Insulin Log" revealed information on samples received and dispensed and identified 35 samples dispensed to 12 patients since September 2013.

5. During a follow-up interview on 12/17/14 at 11:20 AM, Staff A reported the Diabetes Education Center has used manufacturer samples for approximately 10 years, without pharmacy oversight. Staff A acknowledged she has wondered if she should be giving prescription medication samples to patients.

6. During an interview on 12/17/14 at 12:00 PM, Staff D, Pharmacy Manager, confirmed she was aware the Diabetes Education Center had manufacturer prescription samples and did not have any oversight over the medications. Staff D could not verify any of the processes used regarding storage, and dispensing of the samples but "assumed" Staff A monitored refrigerator temperatures and maintained some type of log. Staff D acknowledged only pharmacists and physicians could dispense medications but then questioned if Staff A's specialized training, as a diabetic educator, qualified her to dispense the prescription samples.

7. During an interview on 12/17/14 at 1:30 PM, Staff C, Chief Nursing Officer, confirmed an RN should not be dispensing prescription medication and thought the Diabetes Education Center samples included pharmacy oversight.

8. Review of the Iowa Administrative Code, Hospital Pharmacy Practice, last updated 2/5/14, revealed in part ". . . 657-7.8(8) Samples. The use of drug samples within the institution shall be eliminated to the extent possible . . . If the use of drug samples is permitted for hospital outpatients, that use of samples shall be controlled and the samples shall be distributed through the pharmacy or through a process developed in cooperation with the pharmacy and the institution's appropriate patient care committee, subject to oversight by the pharmacy . . ."

Review of the Iowa Code 2014, Chapter 147 titled "General Provisions, Health-Related Professions" revealed in part ". . . 147.107 Drug dispensing, supplying, and prescribing - limitations. 1. A person, other than a pharmacist, physician, dentist, podiatric physician, or veterinarian . . . shall not dispense prescription drugs or controlled substances . . ."

Based on review of medication error reports, patient medical records, policies and procedures, and staff interviews, the Critical Access Hospital (CAH) nursing staff failed to notify the physician when medication errors occurred for 12 of 20 patients (Patients # 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12). The CAH staff reported a census of 8 inpatients at the start of the survey.

Failure to report medication errors when they occur to the physician could potentially cause harm to patients if receiving the wrong medication, receiving medication at the wrong time, or by the wrong route. If the physician is unaware of the error, additional orders for medications by the physician are completed without consideration of the error.

Findings include:

1. Review of the CAH policy titled "Medication Administration", revised 4/14, revealed in part. . . "Errors in administration of medication will be reported to the attending practitioner, and a medication occurrence report will be sent to the department manager. . . ."

2. Review of patient medication event reports revealed:

a. Review of the Medication Error Reports for Patients #1, 2, 3, 4, 5, 6, 7, and 8 and review of the patient's medical records lacked documentation the physician was notified the medication errors occurred.

b. Review of the Medication Error Report for Patient #9 dated 8/6/14 revealed the physician was not notified of the medication error until 6 days after the error occurred.

c. Review of the Medication Error Report for Patient #10 dated 7/5/14 revealed the physician was not notified of the medication error until 9 days after the error occurred.

d. Review of the Medication Error Report for Patient #11 dated 7/2/14 revealed the physician was not notified of the medication error until 8 days after the error occurred.

e. Review of the Medication Error Report for Patient #12 dated 5/13/14 revealed the physician was not notified of the medication error until 28 days after the error occurred.

3. During an interview on 12/16/14 at 8:45 AM, Staff N, Quality Improvement Coordinator stated nurses were to notify the physician of all medication errors that occurred. Staff N verified the lack of documentation the physicians were notified when medication errors occurred for Patients # 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12.

During an interview on 12/15/14 at 2:45 PM, Staff O, Registered Nurse (RN), stated the nursing staff were to notify the physician when medication errors occurred.

Based on review of policies/procedures, meeting minutes, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure the required group of professionals, including a physician, reviewed all patient care policies annually for 5 of 16 patient care departments (Laboratory, Cardiac/Pulmonary Rehabilitation, Diabetic Education, Quality Improvement, and Pharmacy). The CAH staff reported a census of 8 inpatients at the start of the survey.

Failure to ensure the required group of professionals reviewed all patient care policies annually could potentially result in failure to address any changes or updates needed in the CAH policies and procedures.

Findings include:

1. Review of CAH policy titled "Critical Access Hospital Advisory Committee and Annual Review Program", dated 2010, revealed in part, ". . . Jackson County Regional Health Center will maintain a committee of professionals to assist in the development and/or review of all patient care policies and procedures. . . Composition of the Committee will include, at a minimum, one or more doctors of medicine or osteopathy, one or more physician's assistants, nurse practitioners or clinical nurse specialists and at least one member not on staff at Jackson County Regional Health Center. . . ."

2. Review of CAH Advisory Committee Meeting Minutes for May 28, 2014 revealed the absence of the physician at the meeting and the committee approved policies for Laboratory, Cardiac/Pulmonary Rehabilitation, Diabetic Education, and Quality Improvement.

Review of CAH Advisory Committee Meeting Minutes for September 16, 2014 revealed the absence of the physician at the meeting and the committee approved policies for Pharmacy.

3. During an interview on 12/17/14 at 3:25 PM, Staff C, Chief Nursing Officer (CNO), acknowledged the physician was not present at the CAH Advisory Committee meetings on May 28, 2014 or September 16, 2014 for annual review of the above stated policies and procedures and lacked documentation the physician review those policies.

Based on record review and staff interview the Critical Access Hospital (CAH) failed to integrate the outpatient Diabetes Education Center patient medical records into the hospital medical record system.
The Diabetes Education Center Registered Nurse (RN) reported the program currently served an average of 8 to 10 patients weekly and served a total of 80 patients during the 2013 program year.
Failure to integrate the outpatient Diabetes Education Center patient medical records into the hospital medical record system could potentially result in a loss of communication in the care of the patient.
Findings include:
During an interview on 12/15/14 at 3:15 PM Staff A, Employee Health/Diabetic Education RN, reported the center's patient medical records were permanently stored in the education center and none of the record was sent to the medical records department, even after discharge. During a follow-up interview, Staff A confirmed the center's medical record storage cabinets contained approximately 370 closed medical records accumulated over the past 15 years.
A review of the CAH's policy and procedure manuals revealed the CAH administrative staff failed to identify a method of communication between outpatient services allowing for the integration of all patient information.
During an interview on 12/16/14 at 10:15 AM, Staff B, Business Office/Medical Records Manager, reported the only pieces of information from Diabetes Education Center patients contained in the hospital medical record system included a face sheet and the condition of admission. Staff B acknowledged other outpatient department's medical information flowed to the medical record department and became integrated into the hospital medical record system but confirmed the Diabetes Education Center medical records were not, which would limit access to the patient information. During a follow-up interview on 12/17/14 at 12:30 PM, Staff B confirmed the CAH did not have a policy to address how outpatient medical records are integrated into the hospital medical record system

Based on review of physician's surgery privileges, Medical Staff Bylaws, operating room log, and staff interviews, the Critical Access Hospital (CAH) failed to ensure the delineation of privileges for procedures performed at the CAH for 4 of 8 physicians performing surgery reviewed (Physicians A, B, C, and D). The CAH administrative staff identified 270 surgical procedures performed during the past 12 months.

Failure to delineate specific privileges for all physicians performing surgery could put the patient at risk for surgical complications and could result in patients receiving surgical interventions from unqualified professionals.

Findings include:

1. Review of surgical privileges for Physicians as follows.

a. Physician A's privileges, maintained in the Surgical Services area, revealed no privileges for hernia repairs with or without mesh, or laparoscopic cholecystectomy.

b. Physician B's privileges, maintained in the Surgical Services area, revealed no privileges for lens implants during cataract surgical procedures.

c. Physician C's privileges, maintained in the Surgical Services area, revealed no privileges for lens implants during cataract surgical procedures.

d. Physician D's privileges, maintained in the Surgical Services area, revealed no privileges for hernia repairs with without mesh, laparoscopic cholecystectomy or laparoscopic hernia repairs.

2. During an interview on 12/17/14 at 2:30 PM, Staff P, Surgical Services Coordinator, verified the following physicians lacked privileges for the following procedures documented in the operating room log performed at the CAH.

a. Physician A performed 9 hernia repairs (4 were with mesh) and 9 laparoscopic cholecystectomy procedures in the past 12 months.

b. Physician B performed 112 cataract surgeries with lens implant procedures in the past 12 months.

c. Physician C performed 57 cataract surgeries with lens implant procedures in the past 12 months.

d. Physician D performed 7 hernia repairs, including 1 with mesh, 5 laparoscopic hernia repairs, and 9 laparoscopic cholecystectomy procedures in the past 12 months.

3. Review of the Medical Staff Bylaws, dated July 15, 2014, revealed the following, in part, ". . . Every member of the Medical Staff, an AHP or a First Assistant at Surgery providing clinical services at the Hospital by virtue of Medical Staff membership or otherwise, shall be entitled to exercise only those clinical privileges specifically granted to him by the Governing Board. . . ."

Based on document, policy and procedure review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the periodic evaluation of its total program included a review of a representative sample of both active and closed clinical records for all services provided. (Nursing, Emergency Services, Radiology, Laboratory, Cardiac and Pulmonary Rehabilitation, Diabetic Education, Nutritional Services, CardioPulmonary, Speech Therapy, Occupational Therapy, Physical Therapy, General Surgery Clinic, Surgery, and Sleep Study) The CAH staff reported a census of 8 inpatients at the start of the survey.

Failure to include review of a representative sample of both active and closed clinical records in the periodic evaluation could result in failure to identify potential changes needed in services provided.

Findings include:

1. Review of CAH policy titled "Critical Access Hospital Advisory Committee and Annual Review Program", dated 2010, revealed in part, ". . . Jackson County Regional Health Center carries out an annual review of its total CAH program: . . . Representative samples of both active and closed clinical records. . . ."

2. Review of the "Critical Access Hospital Annual Program Review", dated Fiscal Year 2014, lacked documentation of a review of a representative sample of both active and closed clinical records for Nursing, Emergency Services, Radiology, Laboratory, Cardiac and Pulmonary Rehabilitation, Diabetic Education, Nutritional Services, CardioPulmonary, Speech Therapy, Occupational Therapy, Physical Therapy, General Surgery Clinic, Surgery, and Sleep Study.

3. During an interview on 12/17/14 at 2:10 PM, Staff N, Quality Improvement Coordinator, verified the annual evaluation of its total CAH program lacked documentation of a review of a representative sample of both active and closed clinical records for Nursing, Emergency Services, Radiology, Laboratory, Cardiac and Pulmonary Rehabilitation, Diabetic Education, Nutritional Services, CardioPulmonary, Speech Therapy, Occupational Therapy, Physical Therapy, General Surgery Clinic, Surgery, and Sleep Study.

Based on document review, staff and patient interviews, the critical access hospital (CAH) failed to ensure outpatients and visitors were informed of their visitation rights, including the ability to receive designated visitors, but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend, for patients receiving outpatient services. The Chief Nursing Officer identified an average annual census for the following outpatient areas.

Cardiac Rehab: 861 outpatient visits,
Emergency room: 4,775 outpatient visits,
Lab: 25,187 outpatient procedures,
Cardio Pulmonary testing: 956 outpatient visits,
Diabetic Education: 231 outpatient visits,
General Surgery Clinic: 539 outpatient visits, 243 outpatient procedures,
Physical Therapy, Speech Therapy and Occupational Therapy: 7,259 outpatient visits,
Pulmonary rehab: 307 outpatient visits,
Radiological services: 8,897 outpatient visits, and
Outpatient surgery: 524 outpatient visits.

Failure to inform patients of their visitation rights could potentially result in the staff failing to extend visitation rights to all patient populations and their visitors causing increased stress for the patients.

Findings include:

1. Review of the "Visitation Regulations" policies and procedures on 7/14 revealed the policies were in compliance with the requirements of Patient Rights at 42 CFR 485.635 (f).

2. During an interview on 12/17/14 at 3:30 PM, the Chief Nursing Officer (CNO) acknowledged the patient rights information provided to outpatients by the admissions clerk staff did not include the patient's rights to receive designated visitors, but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend. The CNO said they were in the process of correcting this error and would be educating admissions clerk staff to include visitation rights information at the time patient registered for outpatient services at their hospital.