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Based on policy review and staff interview the Critical Access Hospital (CAH) failed to schedule patient meals in accordance with applicable state regulations. The Administrative Staff identified a census of 3 patients and the Dietary Manager reported an average of 15 to 18 patients meals served daily.

Failure to avoid extensive lapses between meals could potentially result in failure to provide patients with adequate nutrition.

Findings include:

1. Review of the Iowa Administrative Code for the Department of Inspections and Appeals, Chapter 51 titled, "Hospitals", last updated 12/10/14, revealed in part, "... 51.20(2)b.(2) Not more than 14 hours shall elapse between the evening meal and breakfast of the following day..."

Review of a Dietary Department policy titled, "Meal Service and Preparation", effective on 3/15/15, revealed in part, "...Three meals are served daily with no more than 14 hours between the evening meal and breakfast...Breakfast...will be delivered at 7:50 to 8:00...supper...will be delivered at 16:50..."


2. During an interview on 6/15/15, at 11:00 AM, Staff O, Dietary Manager, reported the scheduled patient meal times as 7:50 AM (breakfast), 11:50 AM (lunch) and 4:50 PM (supper).

During an interview on 6/16/15, at 8:10 AM, Staff O reported the meal service schedule had remained the same since her employment at the CAH. She reported she knew there was a 14 hour time span rule but did not realize the current scheduled meal times extended the time between supper and breakfast to 15 hours.

Based on observation, review of documents, and staff interviews the Critical Access Hospital (CAH) failed to date the Truetest glucose control solution bottles when opened and removed outdated Truetest control solution bottles from 2 of the 4 patient care areas where staff used Glucometers to test patient blood glucose levels.

Failure to date the Truetest glucose control solution bottles when staff opened the bottles and/or removed outdated Truetest glucose control solution bottles from all patient care areas where staff used Glucometers to test patient blood glucose levels could potentially result inaccurate patient blood glucose test results.

Findings include:

1. Review of the package insert for the True Test Glucose Control Instructions for Use stated in part, "... Discard bottle after Expiration Date printed on the bottle label or 3 months after date written on bottle..."

2. Review of policy titled, "Disposable Supplies, Multi-use Vials/Bottles, Ointments, and Topical Creams", dated May 2011, stated in part "...All disposable supplies, multi-use bottles, or multi-use tubes are labeled with date and time of initial use..."

3. Observation and interview on 6/15/15 at 12:05 PM, with Staff D, RN Patient Care Manager verified, the 2 of 2 Truetest glucose control solution bottles failed to display the date when staffed opened the bottles. date. Staff D reported the CAH had a high volume of diabetic patients that used the Glucometer frequently.

Observation and interview on 6/16/15 at 1:45 PM, with Staff F, RN Patient Care Manager of the Clinics, verified 2 of 2 Truetest glucose control solution bottles were outdated. Staff F reported the clinic rarely used the Glucometer.

I. Based on observations, policy/procedure review, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure pharmacy oversight of manufacturer's medication samples in 1 of 2 outpatient clinic locations. (Visiting Physician Clinic) The clinic staff reported a census of approximately 2 to 3 patients a month seen at the clinic that could receive the sample medications.

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

Findings include:

During an observation on 6/16/15 at 2:05 PM with Staff G, Clinic Registered Nurse, Visiting Clinic Manager revealed 1 locked cabinet at the nurse's in the Visiting Physician Clinic containing sample medications available for patient usage. The following medications were located in the locked cabinet:

a. Pradaxa 75 mg (milligram)- 8 boxes with 12 tablets in each box.
b. Pradaxa 150 mg- 27 boxes with 12 tablets in each box.
c. Eliquis 5 mg- 6 boxes with 14 tablets in each box.
d. Eliquis 2.5 mg- 10 boxes with 14 tablets in each box.
e. Xarelto 15 mg- 6 bottles with 5 tablets in each bottle.
f. Crestor 10 mg- 4 boxes with 42 tablets in each box.
g. Crestor 5 mg- 2 boxes with 42 tablets in each box.
h. Vascepa 1 gram- 6 boxes with 8 capsules per bottle.
i. Ranexa 1000 mg- 8 packs with 14 tablets per pack.

Review of CAH policy titled "Drug Procurement/Inventory Control", revised 2/2010, revealed, in part... "Inspection: All drug storage areas within Ringgold County Hospital will be inspected monthly by the Pharmacy Department."

During an interview on 6/16/15 at 2:40 PM, Staff H, Director of Pharmacy, stated he was not aware of any sample medications kept in the Visiting Clinic Clinic, therefore had no oversight of those medication samples brought in by the Iowa Heart physicians.

II. Based on observation, staff interview, and record review, the Critical Access Hospital (CAH) pharmacy staff failed to develop and maintain a system where sample drugs are controlled and distributed through the pharmacy or through a process developed in cooperation with the pharmacy, for pharmacy oversight in 1 of 2 outpatient clinics, (Visiting Physician Clinic). The clinic manager reported an average monthly census of 2 to 3 patients receiving sample medications.

Failure to provide oversight could potentially result in expired medications available to patients, the potential for theft of medications by unauthorized persons and patients receiving medications recalled by the manufacturer.

During an observation on 6/16/15 at 2:05 PM with Staff G, Clinic Registered Nurse, Visiting Clinic Manager revealed 1 locked cabinet at the nurse's in the Visiting Physician Clinic containing sample medications available for patient usage. The cabinet did not contain a perpetual inventory log identifying the medication in the cabinet or medications provided to patients during clinic visits. The following medications were located in the locked cabinet:

a. Pradaxa 75 mg (milligram)- 8 boxes with 12 tablets in each box.
b. Pradaxa 150 mg- 27 boxes with 12 tablets in each box.
c. Eliquis 5 mg- 6 boxes with 14 tablets in each box.
d. Eliquis 2.5 mg- 10 boxes with 14 tablets in each box.
e. Xarelto 15 mg- 6 bottles with 5 tablets in each bottle.
f. Crestor 10 mg- 4 boxes with 42 tablets in each box.
g. Crestor 5 mg- 2 boxes with 42 tablets in each box.
h. Vascepa 1 gram- 6 boxes with 8 capsules per bottle.
i. Ranexa 1000 mg- 8 packs with 14 tablets per pack.

Review of CAH policy titled "Drug Samples", effective 11/2006, revealed, in part... "3. All samples will be signed out with the patient's name, medication name, strength, date lot number, expiration date and quantity."

During an interview on 6/16/15 at 2:05 PM, Staff G confirmed the clinic lacked a perpetual inventory log documenting the required information as stated in the CAH Drug Sample policy. The visiting physicians supply the medications in the clinic, but staff did not log the medications when received or document when patients received the medications.

During an interview on 6/16/15 at 2:40 PM, Staff H stated the clinic should have a perpetual inventory log of the sample medications kept in the Visiting Clinic Clinic.

Based on personnel record review, policy review and staff interview the Critical Access Hospital (CAH) administrative staff failed to follow a consistent system to identify and prevent transmission of infections and communicable diseases among personnel, who provided services to patients. Problems were identified for 2 of 17 CAH employees (Staff T and U) and 3 of 4 contracted employees selected for review (Staff Q, R and S). The Administrative staff identified a census of 3 patients.

Failure to identify infections and communicable diseases could potentially result in causing harm to patients through exposure and transmission of communicable diseases.

Findings include:

1. Review of a personnel policy titled "Employee Physical Examinations", reviewed and revised in 12/2014, revealed in part ". . . All new employees of Ringgold County Hospital must successfully complete a complete physical exam prior to starting work . . . and Mantoux (a skin test for tuberculosis) 3. Every four (4) years, employees must undergo a complete physical assessment . . . 4. Complete employee assessments will be completed every four (4) years by the Employee Health Nurse . . . 5. Results of these tests are on file in the Chief Nursing Officer Assistant's Office . . ." The policy failed to address the procedure to obtain and document health information for contracted employees, who provided services to patients.

2. Review of the personnel records showed the following:

a. Staff T, Emergency Medical Technician (EMT), revealed it lacked documented evidence of a Tuberculosis (TB) test or health exam.

b. Staff U, Lab Technician, revealed a document titled "Every 4 Years Physical Examination", dated 1/20/09, and identified as the most recent health exam contained in the record.

c. Staff Q, Contracted Occupational Therapist (OT), revealed it lacked documented evidence of a health exam.

d. Staff R, Contracted Speech Therapist (ST), revealed it lacked documented evidence of a health exam.

e. Staff S, Contracted Registered Dietitian (RD), revealed it lacked documented evidence of a health exam.

3. During an interview on 6/16/15 at 4:00 PM, Staff B, Administrative Assistant, and Staff P, Human Resources/Administrative Assistant, confirmed they had no health information on Staff Q, R, S and T and acknowledged the physical exam on file for Staff U failed to fall within the past 4 years. Staff B and P reported they would attempt to contact the employees and request current health information.

4. During an interview on 6/17/15, at 9:00 AM, Staff B, reported new employees are required to have a physical exam and TB test prior to starting and the physical exam is required every 4 years after that. She reported the department managers are responsible to ensure contracted staff, within their departments, have the required physical exams and the information is kept within their department.

During a follow-up interview on 6/17/15 at 10:35 AM and 11:30 AM, Staff B and P reported they remained unable to provide documented evidence of a TB test on Staff T or current health exams on Staff T and U and contracted Staff Q, R and S.

Based on observations, policy review, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to protect all confidential patient information from unauthorized access in 1 of 1 Health Information Management department. The Business Office Manager identified approximately 1,100 CAH patient records, 400 Mount Ayr Medical Clinic patient records and 3,000 radiology films stored in the Health Information Management department.

Failure to secure medical records against unauthorized access could result in identity theft and/or unauthorized disclosure of personal medical information.

Findings include:

1. Review of a Health Information management policy titled, "Security and Access of Medical Records", approved 1/12/14, stated in part, "...It is the hospital's responsibility to safeguard both the record and its information content against loss, defacement and tampering and from use by unauthorized individuals...5. Providers/Staff will have access to hard copy records on a "need to know" basis. 6. All paper records not scanned into the EHR [Electronic Health Record] will be maintained in patient files in the HIM [Health Information Management] Department behind locked doors when the department is not attended..."

2. Observations on 6/16/15 at 10:10 AM during the tour of the Health Information Management (HIM) department, with Staff K, HIM Specialist and Staff L, Business Office Manager revealed the opened shelves held multiple radiology film jackets and CAH patient medical records. In addition, the tables and counter in the HIM area held multiple clinic patient records.

3. During an interview and observation of the HIM area Staff K and Staff L reported an unlocked door that entered into the physician's lounge remained unlocked at all times. Inside the physician lounge had an additional door with a keyless digital door lock, that exited into a hall. Staff K and Staff L agreed the housekeeping staff would have access to the HIM department, and the unsecured records, during unsupervised hours when they entered through the physician's lounge door to collect the trash from the HIM department.
Staff K and Staff L reported physicians/providers and nursing staff, in addition to housekeeping, had the code to the keyless lock but were unaware if additional staff had the code.

During an interview on 6/16/15 at 10:30 AM Staff C, Chief Nursing Officer, reported Registered Nurses (RN), physicians/providers and housekeeping had the keyless lock code to enter into the physicians lounge, but did not know the door between the physician lounge and the HIM department remained unlocked at all times.

During an interview on 6/16/15 at 10:55 AM Staff N, Housekeeper, reported she had the keyless lock code to enter the physician's lounge. Staff N demonstrated she had the ability to enter the area. She reported during the night shift the housekeeping staff entered through the physician's lounge door or used the badge reader key for the door to clean the HIM department. Staff N demonstrated the key unlocked the hall door that entered into the HIM department. She reported all housekeeping staff used the key at the hall door entrance or entered through the physician lounge to the HIM department.

During an interview on 6/16/15 at 11:35 AM Staff M, Lead Housekeeper, confirmed housekeeping was scheduled to clean the HIM department at night and they had key access to the area.

During an interview on 6/16/15 at 11:45 AM Staff O, Dietary Manager, reported she and Staff S, Registered Dietitian, had the code to the keyless lock on the physician's lounge and confirmed this allowed access into the HIM department.

During a follow-up interview on 6/16/15 at 4:30 PM Staff C reported she did not know housekeeping had key access to the HIM department and were scheduled to clean the HIM department at night. She acknowledged housekeeping staff should not have unsupervised access to patient medical records.

Staff V, Director of Facilities/Housekeeping/Laundry verified, 4 laundry/housekeeping staff and 2 maintenance staff had a key to access the HIM department.

Based on review of documents and Medical Staff Rules and Regulations, and staff interview, the Critical Access Hospital (CAH) failed to delineate privileges for 1 of 1 Orthopedic Technician, Staff A, who was not an employee of the hospital, to assist with orthopedic surgical procedures.

The Chief Nursing Officer (CNO) identified Staff A assisted with 6 orthopedic surgical procedures a month provided by an associated practitioner, Practitioner A.

Failure to privilege all assistants that accompany providers could result in patients receiving surgical intervention from unqualified professionals.

Findings include:

1. Review of Operating Room (OR) Log on 6/16/15 at 8:00 AM with Staff I, Registered Nurse (RN)/Operating Room Manager revealed Staff A provided surgical assistance for Practitioner A during orthopedic surgical interventions for patients. Staff A assisted with 6 surgical procedures a month completed by Practitioner A. During an interview at the time of the OR log review, Staff I acknowledged Staff A lacked delineation of privileges to assist Practitioner A with orthopedic surgical procedures.

Review of "Amended and Restated Rules and Regulations of the Medical Staff" dated 6/16/08 revealed the following in part, ..."the Governing Board has delegated responsibility and authority to the Medical Staff to assure the quality of medical professional services provided by individuals with approved clinical and practice privileges and the Medical Staff accepts accountability for those services...purpose: to assure...professional performance of all Allied Health Professionals (AHPs) authorized to practice in the Hospital, through the appropriate delineation of the clinical and practice privileges that each may exercise in the hospital...The Governing Board, in consultation with the Executive Committee, shall determine the services provided in the hospital and the categories of AHPs eligible to provide services...Medical and Surgical Assistants are persons who are not employees of the hospital, and who are not members of the Medical staff...but who work from time to time in the hospital...all...surgical assistants who request privileges to provide services in the hospital under the direction and supervision of a Medical Staff member shall do so on an appropriate form approved by the Governing Board. Applicants shall submit information pertaining to their educational background and their experience in the specialty in which the privileges are requested, providing dates, places and descriptions of duties performed and by whom supervised."

Review of Administrative and Operating Room policies and procedures failed to show a CAH policy for delineation of privileges for surgical technicians who assist Practitioners during surgical procedures.

2. During an interview on 6/16/15 at 11:20 AM, Staff B, Administrative Assistant/Credentialing Specialist acknowledged Staff A lacked privileges to assist Practitioner A with orthopedic surgical procedures at their hospital in accordance with the Medical Staff Rules and Regulations. Staff B stated she did not know Staff A required privileges by the hospital to assist with surgical procedures at the CAH. Review of credential files at the time of the interview revealed Staff A lacked delineation of privileges to assist with orthopedic surgical procedures since 2008.

During an interview on 6/16/15 at 1:00 PM, the CNO acknowledged they failed to delineate surgical privileges to Staff A to provide assistance to Practitioner A during surgical procedures performed in their OR. The CNO stated she did not know Staff A required privileges by the hospital to assist with surgical procedures and she was unaware the hospitals Medical Staff Bylaws/Rules and Regulations directed credentialing staff to delineate privileges to surgical technicians at the CAH.

Based on review of documents, the Continuous Quality Improvement Plan (CQI) and Board of Trustee meeting minutes, and staff interviews, the Critical Access Hospital (CAH) quality improvement staff failed to evaluate all patient care services provided for 3 of 19 patient care services. (Surgery, anesthesia and infusion).

The Chief Nursing Officer identified an average daily census of patients for surgery, anesthesia and infusion as follows:

Surgery: In-patient - year to date 11 patients monthly
Out-patient - year to date 261 patients monthly

Anesthesia: The same number of patients as surgery

Infusion: In-patient - year to date 1,591 patients monthly
Out-patient - year to date 145 patients monthly
Failure to monitor and evaluate all patient care services for quality of care could potentially expose patients to inappropriate and/or substandard care and services.

Findings include:

1. Review of CAH "Continuous Quality Improvement Plan", dated 8/28/14, revealed in part, ..."CQI is a dynamic process through which standards are set and actions are taken to ensure achievement of these standards...The purpose of the CQI program is to enhance patient care...through a continuing objective assessment of important aspects or patient care and the correction of identified problems...The Board has the final authority and ultimate responsibility for the overall CQI program...requiring and reviewing summary reports of all quality measurement and improvement activities as specified in the plan...the CQI committee is a coordinating advisory body for all plans and programs that relate to monitoring and evaluating the quality and appropriateness of patient care...the quality and appropriateness of patient care in the following services are monitored with improvements made as necessary. Reports are required from the following departments/services on a scheduled basis: anesthesia...medical/surgical nursing services (infusion)...surgery...each department reports to the CQI committee quarterly based on an established schedule...each department manager will evaluate the department's specific plan annually or more often if needed to determine its effectiveness, appropriateness and completeness in meeting its stated objectives. The revised indicators must focus on patient care problems areas. They are then presented to the CQI committee for approval."

Review of "CAH Quality Assurance and Performance Improvement Program Fiscal Year (FY) 14", dated 6/30/14 revealed the following in part, ..."All patient care services and other services affecting patient health and safety are evaluated and included the following components with clear evidence...defines who is responsible to evaluate the patient care services, how patient care services are evaluated...that a structure for and follow up of the Quality Assurance Performance Improvement (QAPI) data is provided to Medical staff and that a structure for and follow up of the QAPI data is being provided to the Governing Body."

Review of CQI committee meeting minutes from October 2014 to May 2015 lacked Quality Improvement (QI) reports and/or quality monitors from surgery, anesthesia and infusion services.

Review of Board of Trustee meeting minutes from 10/20/14 to May 18, 2015 lacked QI reports and/or quality monitors from surgery, anesthesia and infusion services.

2. During an interview on 6/16/15 at 8:00 AM, Staff I, Nurse Manager for surgery, anesthesia and infusion services said she failed to provide an QI activities since she started the position six months ago.

During an interview on 6/16/15 at 4:00 PM, the Chief Nursing Officer (CNO) said she was aware surgery, anesthesia, and infusion services failed to submit QI monitoring activities to the QI committee. The CNO acknowledged the committee failed to ensure Staff I followed the QI plan and they were in the process of correcting this problem. She stated she knew this would be a concern from a regulatory standpoint.

Based on review of document and staff interview, the Critical Access Hospital (CAH) failed to ensure 2 of 2 tele-radiologists, 1 of 1 Ears/Nose/Throat (ENT) specialist, 1 of 1 Orthopedic surgeon, 1 of 1 Oncologist, and 1 of 1 Emergency room (ER) physicians selected for review, received outside entity peer reviews performed by the Network Hospital to evaluate the appropriateness and diagnosis and treatment furnished by physicians at the CAH. (Physician's A, B, C, D, E, and F).

The Chief Nursing Officer (CNO) identified patient census from 12/16/14 to 6/16/15 as follows:

Physician A, Orthopedic surgeon, provided care to 38 patients
Physician B, ENT physician, provided care to 15 patients
Physician C, Oncology physician, provided care to 72 patients
Physician D, ER physician provided, care to 239 patients
Physician E read 54 radiology exams for the CAH patients
Physician F read 84 radiology exams for the CAH patients

Failure to ensure all medical staff members received outside entity peer reviews could potentially effect the CAH's ability to ensure all physicians provided quality of care to the patients at the CAH.

Findings include:

1. Review of CAH administrative and Health Information Management (HIM) policies and procedures failed to show the CAH had policies for external peer review.

2. Review of the "Peer Review Services Agreement" dated 2/20/15, from the CAH's Network Hospital, revealed in part, ...[Network Hospital] shall assist the CAH...in evaluating the quality and appropriateness of diagnosis and treatments furnished by physicians at the CAH...evaluated periodically by an outside entity."

Review of "CAH Quality Assurance and Performance Improvement Program Fiscal Year (FY) 14", dated 6/30/14, revealed the following in part, ..."The Quality and Appropriateness of the diagnosis and treatment furnished by the doctors of medicine or osteopathy at the CAH are evaluated (External Peer Review) by one hospital that is a member of the network...this applies to any distant side physicians and practitioners providing tele-medicine services."

Review of "Bylaws of the Board of Trustees", dated June 21, 2010, revealed the following in part, ..."The Board shall require the conduct of specific review and evaluation activities to assess, preserve and improve the overall quality, efficiency and safety of patient care...the Medical staff, health care professional staff, and administration shall conduct and be accountable to the Board for conducting review and evaluation activities...these activities shall include: a review and evaluation of the quality of patient care through a valid and reliable patient care audit procedure."

3. Review of CAH documentation on 6/16/15 at 1:25 PM, revealed the facility failed to ensure the CAH received completed peer reviewed by the Network Hospital specific for the services provided to patients at the CAH for Physicians A, B, C, D, E, and F.

4. During an interview on 6/17/15 at 8:05 AM, the CNO acknowledged the CAH had not received completed external peer review by the Network hospital specific for the services provided to patients at the CAH for Physicians A, B, C, D, E, and F for the medical staff to use the provider-specific results during the physician's credentialing and privileging process. The CNO said from an quality assurance standpoint process she knew they were not in regulatory compliance.

Based on review of policies, procedures and staff interviews the administrative staff failed to ensure the Activity Coordinator completed a State approved training course and/or was supervised by a qualified activities professional. The CAH administrative staff reported a current census of 0 skilled patients and a daily average of 1 skilled patients.

Failure to ensure the Activity Coordinator completed a State approved training course could potentially result in staff failure to employ activities meeting each patients individual interests, physical, and mental needs in order to improve their psychosocial well-being and enhance recovery.

Findings include:

1. Review of the CAH Activity Coordinator job description, stated in part, ..." Completion of the approved State Activities Director Certification course is required."

2. Review of the CAH policy, "Swing Bed, Activities Program" revised 3/2011 stated in part..."II. The activities program is directed by a qualified professional who: 1. Is a qualified therapeutic recreation specialist, 2. Is an activities professional who is licensed or registered in the state of Iowa, 3. Is eligible for certification as a therapeutic recreation specialist or an activities professional by a recognized accrediting body on or after October 1, 1990, 4. Has 2 years experience in social or recreational program within the last 5 years, 5. Is a qualified occupational therapist or occupational therapy assistant, or 6. Has completed a training course approved by the state of Iowa."

3. During an interview on 6/15/15 at 11:25 AM, Staff D, Acute Care Patient Manager stated the CAH did not have a qualified Activity Coordinator at this time. Staff D said she was aware a qualified professional did need to oversee the activities program for Swing Bed patients.

4. During an interview on 6/15/15 at 11:45 AM, Staff C, Chief Nursing Officer (CNO) confirmed the current Activity Coordinator had no formal training required for the position of Activity Coordinator. The CNO stated since the former Activity Coordinator left employment on 1/11/14, the CAH has not had a qualified Activity Coordinator. Staff C stated Staff E was in the process of completing an approved Activity Coordinator course, but had not completed the course yet.

5. During an interview on 6/15/15 at 12:00 PM, Staff E, Certified Nursing Assistant stated she was in the process of completing the Activity Coordinator course, but still needed to complete her practicum. Staff E said she did not have a certificate of completion to be qualified as the Activity Coordinator.