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Based on document review and staff interview, the Critical Access Hospital (CAH) failed to ensure the Network Hospital met with the CAH's Quality Assurance (QA) representatives no less than on a semi-annual basis, in accordance with the Network Agreement for Quality Assurance.

Failure to ensure the Network Hospital met with the CAH's Quality Assurance representatives no less than on a semi-annual basis, in accordance with the Network Agreement for Quality Assurance, could result in the CAH's quality staff's failure to identify and act on patient care related issues which could potentially result in adverse patient outcomes.

Findings include:

1. Review of the Network Agreement, dated December 1, 2013, included in part, "...(Network Hospital) through participating members of its medical staff or other personnel designated by (Network Hospital), shall meet with Hospital's [CAH's] QA representatives no less than on a semi-annual basis to provide objective oversight and assistance to...review findings under Hospital's QA Plan, to facilitate development and implementation of quality plans, and to propose corrective steps as needed..."

2. Review of documentation revealed the lack of evidence showing the Network Hospital semi-annually reviewed the CAH's quality assurance plan and its implementation of the plan per the Network Agreement. Documentation revealed the Network Hospital met with the CAH's QA staff July 14, 2014.

3. During an interview on 5/27/15 at 2:40 PM, Staff D, Chief Nurse Executive (CNE), acknowledged the lack of documented evidence showing the Network Hospital semi-annually reviewed the CAH's quality assurance plan and the implementation of the plan per the Network Agreement. The CNE acknowledged the Network Hospital only met with the CAH staff one time on July 14, 2014 and not semi-annually per the Network Agreement.

Based on observation, document review, and staff interview, the Critical Access Hospital (CAH) failed to ensure boxes of Intravenous (IV) solutions were properly stored and never stored on the floor in 1 of 1 pharmacy overstock room. The CAH staff reported a current census of 14 patients.

Failure to ensure staff stored boxes of IV solution off the floor in the pharmacy overstock room could potentially result in contamination or damage of boxes and the IV bags of solutions used for patient care.

Findings include:

1. Observation during tour of the pharmacy overstock room on 5/26/15 at 1:50 AM with Staff C, Pharmacy Director, revealed the following boxes of IV solutions were stored on the floor.

- 1 box of 12 bags of 1000 ml D5LR (Dextrose 5 Lactated Ringers)
- 1 box of 12 bags of 1000 ml D5NS (Dextrose 5 Normal Saline)
- 2 boxes of 24 bags of 500 ml D51/2NS
- 2 boxes of 12 bags of 1000 ml LR
- 2 boxes of 24 bags of 500 ml D51/4NS
- 1 box of 12 bags of 1000 ml Dextrose 5%
- 2 boxes of 12 bags of 1000 ml 0.45% Sodium Chloride
- 5 boxes of 12 bags of 1000 ml 0.9% Sodium Chloride
- 3 boxes of 24 bags of 500 ml 3% Sodium Chloride
- 2 boxes of 24 bags of 250 ml Sodium Chloride

2. Review of the CAH's policies revealed the CAH lacked evidence of a policy regarding the proper storage IV solution boxes in the pharmacy overstock room.

3. During an interview on 5/26/15 at 1:50 PM, Staff C, Pharmacy Director, acknowledged the boxes of IV solutions were stored on the floor in the pharmacy overstock room.

Based on review of policies, meeting minutes, and staff interview, the Critical Access Hospital (CAH) staff failed to ensure the required group of professionals, including a mid-level provider and a physician annually reviewed all patient care policies and procedures for all patient care departments.(Anesthesia, Behavioral Health, Cardiac Rehab, Diabetes Education, Diagnostic Imaging, Dietary, Emergency Department, Environmental Services, General Nursing, Infection Control, Laboratory, Maintenance, Medical Records, Nursing Administration, OB/Nursery, Outpatient Department, Peri-operative, Pharmacy, and Rehab Services)

Failure to ensure the required group of professionals including a mid-level provider and a physician reviewed all patient care policies annually could result in the failure to identify changes in patient care needs not reflected in the current CAH policies and procedures and limit the opportunities for updating to reflect current practice.

Findings include:

1. Review of CAH policy titled "Annual Review of Clinical Policy & Procedure Manuals", dated 8/05, revealed in part, "All clinical policy and procedure manuals of Myrtue Medical Center will be reviewed on an annual basis. The revisions, additions, and deletions will be submitted to the Critical Access Hospital Committee, Medical Staff and Board of Trustees for their review and approval."

2. Review of Critical Access Hospital Meeting Minutes for June 5, 2014 documented the absence of a mid-level provider and a physician and the committee approved the policies for Anesthesia, Behavioral Health, Cardiac Rehab, Diabetes Education, Diagnostic Imaging, Emergency Department, General Nursing, Infection Control, Medical Records, Nursing Administration, OB/Nursery, Outpatient Department, Peri-operative, Pharmacy, and Rehab Services.

A form titled Critical Access Committee Policy and Procedure Review, dated June 5, 2014, revealed a physician and mid-level provider signed a statement "As a member of Myrtue Medical Center's Critical Access Committee, I have reviewed the below named policy and procedure manuals. Anesthesia, Behavioral Health, Cardiac Rehab, Diabetes Education, Diagnostic Imaging, Emergency Department, General Nursing, Infection Control, Medical Records, Nursing Administration, OB/Nursery, Outpatient Department, Peri-operative, Pharmacy, and Rehab Services."

a. Review of Critical Access Hospital Meeting Minutes for October 3, 2014 documented the absence of a mid-level provider and a physician and the committee approved the policies for Anesthesia, Cardiac Rehab, Critical Access, Diagnostic Imaging, Emergency Department, General Nursing, Infection Control, Laboratory, Nursing Administration, OB/Nursery, Outpatient Department, and Peri-operative.

A form titled Critical Access Committee Policy and Procedure Review, dated October 3, 2014, revealed a physician and mid-level provider signed a statement "As a member of Myrtue Medical Center's Critical Access Committee, I have reviewed the below named policy and procedure manuals. Anesthesia, Cardiac Rehab, Critical Access, Diagnostic Imaging, Emergency Department, General Nursing, Infection Control, Laboratory, Nursing Administration, OB/Nursery, Outpatient Department, and Peri-operative."

b. Review of Critical Access Hospital Meeting Minutes for November 26, 2014 documented the absence of a mid-level provider and a physician and the committee approved the policies for Anesthesia, Cardiac Rehab, Diagnostic Imaging, General Nursing, Infection Control, Laboratory, Medical Records, OB/Nursery, Outpatient Department, Peri-operative, and Respiratory Therapy.

A form titled Critical Access Committee Policy and Procedure Review, dated November 26, 2014, revealed a physician and mid-level provider signed a statement "As a member of Myrtue Medical Center's Critical Access Committee, I have reviewed the below named policy and procedure manuals. Anesthesia, Cardiac Rehab, Diagnostic Imaging, General Nursing, Infection Control, Laboratory, Medical Records, OB/Nursery, Outpatient Department, Peri-operative, and Respiratory Therapy."

c. Review of Critical Access Hospital Meeting Minutes for February 25, 2015 documented the absence of a mid-level provider and a physician and the committee approved the policies for Cardiac Rehab, Diabetes Education, Diagnostic Imaging, Emergency Department, General Nursing, Infection Control, Laboratory, Nursing Administration, OB/Nursery, Outpatient Department, and Peri-operative.

A form titled Critical Access Committee Policy and Procedure Review, dated February 25, 2015, revealed a physician and mid-level provider signed a statement "As a member of Myrtue Medical Center's Critical Access Committee, I have reviewed the below named policy and procedure manuals. Cardiac Rehab, Diabetes Education, Diagnostic Imaging, Emergency Department, General Nursing, Infection Control, Laboratory, Nursing Administration, OB/Nursery, Outpatient Department, and Peri-operative."

3. During an interview on 5/27/15 at 2:00 PM, Staff D, Chief Nurse Executive (CNE), acknowledged a mid-level and physician were not present at the Critical Access Hospital Meetings for June 5, 2014, October 3, 2014, November 26, 2014, and February 25, 2015. The CNE reported the revised policies were presented to the Medical Staff Meetings however, the entire policy/procedure manuals are not reviewed. The CNE went on to report only the changes to policies and procedures are reviewed and if there are no changes, the policies and procedures are not reviewed by the required group of professionals.

Based on policy review and staff interviews the Critical Access Hospital (CAH) Administrative staff failed to ensure the pharmacy staff had a system in place to provide oversight of proper storage, inventory, and to ensure only qualified staff, within their scope of practice, distributed the prescription diabetic medication samples to the patients in 1 of 3 outpatient clinics. The pharmacy staff failed to ensure qualified staff tracked and documented the receipt and distribution of all prescription diabetic medication samples provided by pharmaceutical companies.

The Diabetes Education Coordinator reported the program had 57 active patients and reported 22 samples were dispensed to 15 patients since January 1, 2015.

Failure of pharmacy staff to have a system in place to provide oversight, to ensure only qualified staff dispensed all prescription diabetic medication samples to patients, tracked, and documented the receipt and distribution of all prescription diabetic medication samples provided by pharmaceutical companies could potentially result in a patient receiving the wrong medications, incorrect doses of medications, outdated and/or recalled medication. Failure to document the receipt and distribution of all prescription diabetic medication samples could potentially result in diversion of medications by unauthorized persons.

Findings include:

1. Review of a CAH policy titled "Drug Samples", approved in 8/2014, revealed in part "...A record of all samples dispensed in outpatient clinics will be kept and will contain Name, strength and amount of each drug Control (lot) # and expiration date Patient name
Physician name/outpatient clinic Nurse... "

2. 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, pediatric physician, or veterinarian...shall not dispense prescription drugs or controlled substances..."

3. During an interview on 5/26/15 at 2:35 PM, Staff B, Diabetes Education Coordinator, Registered Nurse (RN) reported the following information. Pharmaceutical companies provide a variety of prescription diabetic medication samples that are stored in a small refrigerator in her office. Staff B dispensed the prescription diabetic medication samples to new insulin start patients and patients with financial needs regarding insurance coverage. Staff B did not keep a log or documentation confirming receipt, inventory, or distribution of the prescription diabetic medication samples she distributed to the patients. However, Staff B reported she documented what medication sample the patient received in the patient's medical records. In the event of a medication recall by the manufacturer she would have to look back at patient records and attempt to determine if any patients had received a specific medication. Staff B reported the lot number of the distributed prescription diabetic medication samples was not documented in patient's medical record. Staff B reported the pharmacy staff were aware she had the diabetic prescription medication samples. However, they did not have any involvement in the receipt, storage or dispensing of them.

4. Observation on 5/26/15 at 3:20 PM in Staff's B's office showed 1 refrigerator that held the following diabetic prescription medication samples:

- 10 milliliters (ml) insulin vials (100 units/ml):
- 5 each Levemir insulin
- 4 each Novolog insulin
- 7 each Humalog 75/25 mix insulin
- 16 each Humalog insulin
- 3 each Humulin N insulin

Prefilled pens with 3 ml of insulin (100 units/ml):
- 5 each Levemir Flex Touch pens
- 2 each Novolog 70/30 flex pen
- 9 each Novolog flex pens
- 7 each Humalog Mix 75/25 pens
- 7 each Humalog Kwik Pens
- 4 each Lantus Solostar pens
- 4 Apidra Solostar pens

- 4 each Toujeo pens prefilled with 1.5 ml of insulin (300 units/ml)

Prefilled pens with non-insulin injectable medications used to treat diabetes:
- 9 each 2 milligram (mg) Bydureon pens
- 4 each 3 ml Victoza pens
- 2 each 1.2 ml Byetta pens
- 3 each Trulicity kits, each with 2 - 0.75 mg pens
- 8 each Trulicity kits, each with 2- 1.5 mg pens

- 2 each Afreeza kits with 30 - 4 unit doses of insulin inhalation powder

5. During an interview on 5/26/15 at 4:05 PM Staff C, Pharmacy Director, reported she was aware the prescription diabetic medication samples were stored and dispensed from Staff B's office. Staff C reported she had been involved in the diabetes education program setting and the process of prescription medication samples utilized in 2 of 3 hospital clinic settings. Staff C, Pharmacy Director agreed she should also be involved in this hospital's diabetes education program setting. Staff C, Pharmacy Director added the report or a log of prescription diabetic medication sample's should show the date of receipt, manufacturer, strength, lot number, expiration date, quantity received, and the patient information for each sample dispensed. Staff C expressed concern regarding the lack of pharmacy oversight over the process, to ensure patients received the right medication, right dose, appropriate patient education. Staff C reported she had concerns over the proper storage, security of the medications and adequate tracking of the samples, in the event of a medication recall. Staff C reported she was unaware and would have to check if an RN should dispense medications.

During a follow-up interview on 5/27/15 at 10:40 AM, Staff B, reported her supervisor provided a log to document pertinent information identified by the Director of Pharmacy and when the samples were given to patients. Staff B, Diabetes Education Coordinator reported the critical access hospital did not have a policy regarding handling and distributing prescription diabetic medication samples within the diabetes education program. Staff B reported she did not lock the refrigerator that held the prescription diabetic medication samples and housekeeping had the ability to access her office after hours. Staff B agreed the unsecured prescription diabetic medication samples would provide the opportunity for diversion of medications by unauthorized personnel.

During an interview on 5/29/15 at 7:50 AM, Staff D, Chief Nursing Executive (CNE), reported Staff B, Diabetes Education Program Coordinator failed to recognize provision of medications samples as dispensed medications and thought an RN could distribute the prescription diabetic medication samples to patients with a physician order.

I. Based on observation, document review, and staff interviews, the facility failed to have a system in place that assured Medical Imaging staff in the Computed Tomography room (CT- computer-processed X-rays that produces tomographic images or 'slices' of specific areas of the body) used intravenous (IV) solution bags (A solution of sodium chloride and water used for IV infusion.) labeled "single dose container" for only 1 patient. The Radiology Department had an average of 58 CT procedures, using the IV solution and tubing set, per month.

Failure to ensure staff used a new single dose bag of IV solution for each patient increases the risk of transmission of infectious diseases between patients or between a used IV solution bag and healthcare personnel during the preparation and administration of IV solutions.

Findings include:

1. Review of the manufacturer's label titled, "0.9% Sodium Chloride (NS) Injection" 250 ML (milliliters) included in part, "...single dose Container..."

2. Observation and interview on 5/27/15 at 8:10 AM during the tour of the Radiology Department area showed, a"single use only" tubing connected to an empty IV NS bag dated 5/26/15. The single use tubing used to transfer NS solution from the IV NS bag to the contrast infusion set to inject contrast media into a patient's veins. Staff A, Radiology Manager, agreed staff used the 250 ml "single dose" bag of IV NS and tubing on the IV pole for more than one patient.

3. The hospital did not have a policy regarding the use of "single dose" IV solution container for "single use only" one patient in accordance with the manufacturer's label on

4. During an interview on 5/27/15 at 8:20 AM, Staff A reported after she reviewed the single dose container of normal saline 250 ml Staff A, Radiology Manager agreed it should be used on only 1 patient and discarded.


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II. Based on observation, policy review and staff interviews, the Critical Access Hospital (CAH) Nutrition Services staff failed to follow sanitary practices for food storage, preparation and patient meal service. The administrative staff identified a census of 14 patients and the Dietary Director reported dietary staff provided approximately 36 to 45 patient meals daily.

Failure to maintain sanitary practices during meal service and food handling could result in food contamination of the patient's food, including the risk of causing a foodborne illness when cross contamination occurs.

Findings include:

1. The Food Code, published by the Food and Drug Administration and considered a standard of practice for the food service industry, in both the 2005 and 2013 editions, requires employees wear hair restraints such as hats, hair coverings or nets, worn to effectively keep their hair from contacting exposed food; clean equipment, utensils, linens, unwrapped single-service and single-use articles.

2. Review of an infection control/dietary department policy titled, "Traffic Control", approved in 9/14, revealed in part, "... the policy allowed personnel in the kitchen without hair restraints and failed to ensure the policy met food code requirements and prevent the potential for hair contacting clean equipment, utensils, linens and other items..."

3. Observation on 5/26/15 at 10:30 AM showed during the initial kitchen environment tour, Staff F, Dietary Department Director without donning a hair restraint entered the kitchen, walked through food preparation areas to Staff E's, Foodservice Supervisor, office (located on the opposite side of the kitchen). Again, without donning a hair restraint, Staff D walked back through the food preparation area in the kitchen and exited through a door located on the opposite side of the kitchen. Observation showed Staff E, Foodservice Supervisor without donning a hair restraint, entered the kitchen, from her office, walked throughout the food preparation and storage areas in the kitchen during the environment tour

4. Additional observations of the lack of hair restraints or effective hair restraints included:

a. On 5/26/15, at 11:10 AM, Staff F, Dietary Department Director entered the kitchen and walked through food preparation areas to the desk, utilized to organize menus and diet orders, located adjacent to the steam table and hot food area. Staff F remained in the area approximately 10 minutes and failed to don a hair restraint at any point.

b. On 5/26/15, at 11:40, AM, Staff I, Cook/Salads Foodservice Worker, entered the kitchen and failed to don a hair restraint. She walked through food preparation areas to a reach in refrigerator. Staff I obtained a can of Pepsi from the refrigerator and walked back through the kitchen to exit.

c. On 5/26/15, at 11:50 AM, Staff F, Dietary Department Director entered the kitchen and failed to don a hair restraint. She walked through food preparation areas to Staff E's office, and walked back through the kitchen to exit, approximately 5 minutes later.

d. On 5/27/15, at 11:15 AM, Staff E, Foodservice Supervisor, entered the kitchen and failed to don a hair restraint. She walked through food preparation areas to her office. Upon leaving her office, approximately 5 minutes later, she spoke with 2 dietary staff members, in the bakery area, then exited the kitchen, walking through the bakery area.

e. On 5/27/15, at 11:26 AM, Staff H, Cook/Salad Foodservice Worker, donned a hair restraint but failed to cover the front hairline, leaving approximately 2 inches of front hairline exposed. Staff H proceeded to work on food preparation.

f. On 5/27/15, at 11:50 AM, Staff F Dietary Department Director entered the kitchen and failed to don a hair restraint. She walked through food preparation areas to Staff E's office, and walked back through the kitchen to exit, approximately 5 minutes later.

g. On 5/27/15, at 11:52 AM, Staff J, Marketing Specialist/Community Wellness Coordinator, entered the kitchen through the back entrance and failed to don a hair restraint. She traveled through food preparation areas to the dish room area, and left a large drink cooler in the soiled dish area. She walked back through the kitchen, exited the back entrance and returned with a second large drink cooler and, once again, failed to don a hair restraint. She walked through food preparation areas to the dish room and walked back through to exit.

h. On 5/27/15, at 1:30 PM, Staff H Cook/Salad Foodservice Worker and Staff I Cook/Salads Foodservice Worker observed to have hair restraints on, while working with soiled and clean dishes in the dish room. Staff H's hair restraint failed to cover her bangs and the hair along the side, down past the ears. Staff I's hair restraint failed to cover her front hairline, with approximately 2 inches of hair exposed.

i. On 5/28/15, at 8:35 AM, Staff I Cook/Salads Foodservice Worker observed in the kitchen with a hair restraint, which failed to cover her bangs and the hair along the side, down past the ears.

5. Review of an Infection Control/Dietary Department policy titled "Food Storage - Refrigerator", approved in 9/2014, revealed in part ". . . All foods in the refrigerator must be covered . . . "

6. On 5/26/15 at approximately 10:30 AM during the initial kitchen environment tour, observation showed 2 trays in a Trails refrigerator with uncovered dished food items. The uncovered dish food items were 6 dishes of jello, 6 dishes of macaroni salad, 6 pieces of frosted cake and 13 dishes of pudding. During an interview at the time of the observation, Staff F, Dietary Department Director reported the food items were prepared for patient use and should be covered.

7. During an interview on 5/28/15, at 9:40 AM again, Staff F Dietary Department Director confirmed stored food items should be covered.

8. Review of the food handling policies failed to identify when glove use would be necessary and handwashing requirements related to glove use with ready to eat foods.

Review of the Food Code, published by the Food and Drug Administration and considered a standard of practice for the food service industry, in both the 2005 and 2013 editions, requires gloves to be used for only one task, such as working with ready-to-eat food and for no other purpose, and discarded when damaged or soiled, or when interruptions occur in the operation. Food employees must clean their hands after handling soiled equipment and utensils, during food preparation, as often as necessary to remove soil and prevent cross contamination when changing tasks and before donning gloves for working with food.

9. Observation on 5/26/15 from 11:20 AM to 12:05 PM, during noon patient meal service revealed, during ready to eat food handling Staff G, Cook failed to wash her hands between each glove before she handled 8 of 8 sandwich buns for patient meals. Observation showed Staff G, Cook touched multiple surfaces between the glove changes such as pot holders, oven doors, garbage can lid, microwave door and cans of soup and then handled the buns with a contaminated glove.

10. During an interview on 5/28/15, at 8:35 AM, Staff F, Dietary Department Director reported dietary employees are trained to use gloves with ready to eat food. Staff F, Dietary Department Director failed to identify all dietary staff should perform handwashing prior to donning clean gloves. Staff F, Dietary Department Director reported the staff should wash hands prior to donning gloves if they had handled something soiled like the phone or garbage.

Based on observation and staff interview the Critical Access Hospital (CAH) failed to ensure 2 of 2 radiation exposure cords were secured in the general x-ray and fluoroscopy x-ray rooms to prevent staff from entering into the x-ray room during patients x-ray procedure. The CAH staff reported completing an average of 680 x-ray procedures a month.

Failure to secure radiation exposure cords could potentially result in staff exposed to unnecessary radiation upon entrance into the x-ray room during a patient's procedure.

Findings include:

1. Observation on 5/27/15 at 8:10 AM during the tour of the radiology department with Staff A, Radiology Manager showed staff failed to secure 2 of 2 radiation exposure cords in the general x-ray and fluoroscopy x-ray room. The 2 radiation exposure cords reached approximately 6 to 8 feet into the x-ray rooms which could potentially allow staff access to the x-ray rooms during the patient's x-ray procedures.

2. During an interview on 5/27/15 at 8:30 AM, Staff A agreed the radiation cords were not secured and could allow staff access to the x-ray rooms during patient x-ray procedures. Staff A reported the cords should be secured at a short length to avoid staff access to the x-ray room during procedures. Staff A acknowledged the CAH did not have a policy regarding the length of the radiation exposure cords.

Based on review of policy, documents and staff interviews the Critical Access Hospital (CAH) failed to ensure the hospital's patient rights policy included verbiage to inform all patients they can receive visitors who he or she desires, including but not limited to, a spouse, a domestic partner, including a same-sex domestic partner. The CAH administrative staff identified a census of 14 inpatients at the time of the survey, with 13,008 out patient visits for 2014 and 11,797 inpatient admissions for 2014.

Failure to provide the current visitation rights to inpatients and outpatients could result in patients not fully understanding their rights to receive visitors as they choose.

Findings include:

Review of the document titled, "A Guide for Patients and Family brochure" revised on 11/12, stated in part, "...Communication: Patients have the right of access to people outside the hospital/clinic by means of a personal visit, oral, and/or written communication, unless their physician determines that this will hinder treatment..." The document failed to contain the information required to: Inform each patient or support person they had the right to receive visitors whom he or she designates, including, but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend, and his or her right to withdraw or deny such consent at any time.

During an interview on 5/26/15 at 10:30 AM Staff D, Chief Nursing Executive, reported the patient rights were revised in 2012, and agreed that they lacked all of the required verbiage for patient visitation rights.