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Based on observation and staff interview the Critical Access Hospital (CAH) failed to ensure the approved diet manual remained readily available to Medical and Nursing staff as required by state law. The administrative staff identified a census of 15 patients. The Director of Foodservice reported the foodservice staff provided approximately 37 patients meals daily.

Failure to ensure the approved diet manual is readily available to Medical and Nursing staff could potentially result in inappropriate diet orders and/or inaccurate diet information provided to patients.

Iowa Administrative Code - Food and Nutrition Services General Requirements
481 - 51.20(2)d. A current diet manual approved by the dietitian and the medical staff shall be used as the basis for diet orders and for planning therapeutic diets. The diet manual shall be reviewed, revised and updated at least every five years. Copies of the diet manual shall be readily available to all medical, nursing, and food service personnel.

Findings include:

1. Review of a CAH policy titled "Diet Manual Selection and Approval", reviewed 2/2016, revealed in part " ... Copies or summaries of the manual are in the ... Medical Surgical Area ..."

2. Observation on 2/23/16 at 9:40 AM, during a tour of the nursing units revealed 2 of 4 medical/surgical nursing cubicles and the Obstetrics unit lacked a copy of the document "Therapeutic Diets from Simplified Diet Manual".

3. During an interview on 2/23/16, at 9:40 AM, and a follow-up interview at 2:15 PM, Staff J, Clinical Dietitian, acknowledged the CAH's current approved diet manual did not remain readily available to the medical and nursing staff. Staff J reported manuals had previously been available at the the medical/surgical, obstetrics and intensive care unit nursing stations but discovered they had been mistakenly discarded and no longer located in any of these areas. She confirmed she realized the manuals were no longer stored in the nursing units when she attempted to write the medical staff approval date in them back in 11/2014. Staff J reported a laminated diet definition summary sheet, titled "Therapeutic Diets from Simplified Diet Manual", are located in the nursing units but confirmed the units lacked access to the approved manual.

Based on observation, review of manufacture's guidelines, policies/procedures, and staff interview the Critical Access Hospital (CAH) failed to ensure the Posey chair sensor pads were used for 6 months in accordance with the manufacture's guidelines 2 of 2 chair alarm sensor pads in use. The CAH identified a census of 15 patients at the start of the survey.

Failure to ensure the staff followed the manufacturer's guidelines for use of Posey chair sensor pads could potentially result in the chair alarm sensor pads to malfunction and cause the alarm not to sound and place patients at risk for injury and harm.

Findings include:

1. Observation on 2/22/16 at 11:30 AM, during the initial tour of the acute care nursing unit, with Staff B, Chief Operating Officer/Chief Nursing Officer (COO/CNO), revealed 5 Posey chair sensor pads stored and ready for use in a cupboard on the nursing unit. Further inspection of the Posey chair sensor pads revealed 5 of 5 lacked an expiration date.
An additional observation on 2/22/16 at 4:30 PM, revealed Patient #4 and #7 using chair alarm sensor pads, both pads in use lacked expiration dates.

Review of the Posey chair sensor pad guidelines, undated, posted on the outside of the sensor pad reads in part...Warranty This product is warranted for a period of 6 months.

Review of the Policy/Procedure titled "Fall Prevention", updated on 4/15 reads in part...IV. B. Bed alert/chair alarm may be used at the discretion of the nurse, and is recommended for confused patients. The policy/procedure lacked information related to the specific use of the Posey chair sensor pads and the warranty.

An interview on 2/22/16 at 11:30 AM, during the initial tour of the acute care nursing unit, Staff B verified the Posey chair sensor pads stored for use in the cupboard, lacked an expiration date or a date the item was put into use.

An interview on 2/22/16 at 4:15 PM, Staff R, Director Inpatient Services, lacked the knowledge the Posey chair sensor pads expired 6 months after initial patient use. Staff R verified the Posey chair sensor pads lacked a date of when the pad was put into use.

Based on observation, policy review, and staff interviews, the Critical Access Hospital (CAH) failed to secure 7 of 7 hazardous waste containers with discarded medications that were stored in a biohazard storage room.

Failure to secure discarded medications in hazardous waste containers in the biohazard storage room could potentially result in unauthorized access to medications which could lead to the diversion of medications.

Findings include:

1. Review of CAH policies titled "Pharmacy Security", reviewed 4/2015, and "Medication Distribution", reviewed 2/2015, revealed the policies addressed the security of medications in the pharmacy and nursing areas but failed to address the security of the wasted medications stored in the biohazard storage room.

Review of the CAH policy titled "Hazardous drugs Policy", updated 12/2015, revealed in part " ... Any partially used medications, including IV bags and tubing with medications added, shall be disposed of in the black hazardous waste containers ... When container is full, pharmacy personnel will transport the box to the Biohazard room ..." The policy failed to address the security of the wasted medications from unauthorized access.

2. Observation on 2/23/16 at 11:15 AM, in the biohazard storage room showed 3 large and 4 small black hazardous waste containers with unsecured lids, filled with discarded medications.

3. During an interview on 2/23/16 at 11:15 AM, Staff K, Director of Plant Operations/Environmental services (EVS) confirmed the medications in the unsecured black hazardous waste containers are accessible to all staff that have key access to the room, including 5 plant operations and 16 EVS staff.

During an interview on 2/23/16, at 4:35 PM, Staff L, Director of Pharmacy, reported the 7 unsecured black hazardous waste containers with discarded medications are stored in the biohazard storage room until they are picked up by a contracted company for proper disposal. Staff L reported the unsecured black hazardous waste containers did not contain narcotics. However, the unsecured black hazardous waste containers contained multiple types of medications. Staff L agreed the maintenance and EVS staff could potentially access the discarded medications in the unsecured black hazardous waste containers.

I. Based on observation, policy, document review and staff interviews, the Critical Access Hospital (CAH) failed ensure the Foodservice Department staff had a system in place to evaluate and monitor patient food temperatures in order to meet the Food and Drug Administrations Food Code requirements to prevent foodborne illness. The administrative staff identified a census of 15 patients. The Dietary Manager reported dietary staff provided an average of 37 patient meals daily.

Failure to ensure the Foodservice Department staff had a system in place to evaluate, monitor, and maintain proper food holding temperatures during meal service could potentially result in foodborne illness, severe illness, and patient harm.

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 cold food held at a minimum of 41 degrees F or below and hot food held at a minimum of 135 degrees Fahrenheit (F.) or above.

2. Review of a Foodservice policy titled "Infection Control" undated, included in part "... Hot foods are heated to 170 degrees F. and served as close as possible to 170 degrees. Cooks are responsible for checking food temperatures. Temperatures are randomly checked and documented two to three times per month ... Refrigerated foods are kept at 40 degrees F. or below ..."

3. Review of documented temperature records from August 2015 through January 2016 showed staff recorded food temperatures on 2 days for each of the 5 months. Review of February 2016 showed staff recorded food temperatures on 1 of 22 days.

4. During an interview on 2/22/16, at 11:00 AM, Staff V, Foodservice Worker, reported she measured hot food temperatures before the patient meal service but did not document them.

During an interview on 2/22/16 at 11:30 AM, Staff W, Foodservice Worker, reported she measured hot food temperatures before patient meal service but did not document them.

During an interview on 2/22/16, at 1:45 PM, Staff I, Foodservice Director, reported food temperatures are measured and recorded monthly by one of the supervisors.

During a follow-up interview on 2/24/16, at 9:00 AM, Staff I Foodservice Director reported the dietary staff should measure food temperatures prior to patient meal service to ensure they are at the required temperatures but confirmed the staff only documented the temperatures monthly. Staff I acknowledged the lack of documented food temperatures for all meals did not provide ongoing monitoring and evaluation of compliance.


II. Based on policy, document review, and staff interview the Critical Access Hospital (CAH) hospital failed to follow their system to identify and prevent transmission of infections and communicable diseases for contracted employees. Problems were identified for 3 of 3 contracted employees (Staff S, T and U) selected for review. The CAH identified 9 sleep study staff and 9 therapy staff contracted to provide services to 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 CAH policy titled "Employee Health Exams", updated 6/2015, revealed in part " ... each employee has a general physical exam by a CCHS (Cass County Memorial Hospital) nurse every 4 years ... "

2. Review of personnel files for Staff S, Contracted Sleep Study, Staff T, Contracted Speech Therapist, and Staff U, Contracted Physical Therapist, revealed it lacked of a documented health exam within the past 4 years.

3. During an interview on 2/25/16, at 1:15 PM and 1:25 PM, Staff M, Director of Human Resources, confirmed the CAH lacked documented evidence of a current health exam for contracted Staff S, Staff T and Staff U. Staff M reported the CAH did not have a policy for contracted staff and volunteers health requirements. Staff M reported the employee health policy would cover the contracted staff and volunteers.

Based on observation, policy review and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to secure and protect patient information from unauthorized users. The problem was identified for 1 of 1 Obstetrics units and 1 of 1 Health Information Management (HIM) department.

Failure to secure the patient information could potentially cause a misuse of patient information and/or stolen identity for the individual patients.

Findings include:

1. Review of CAH policy titled "Physical Access and Security", dated 11/27 15, revealed in part ". . . Physical safeguards will be implemented to protect Cass County Health System's CCHS) facilities, information, equipment and other assets from unauthorized physical access ... Physical access to areas within CCHS facilities which contain ... storage devices containing PHI [Personal Health Information] or confidential information will be restricted to those who have a need to have such access ... "

Review of CAH policy titled "HIPAA [Health Insurance Portability and Accountability Act] Compliance Policy" undated, revealed in part "... CCHM [Cass County Memorial Hospital] shall implement a HIPPA Compliance Plan containing reasonable and appropriate administrative, technical and physical safeguards to protect against any reasonably anticipated threats or hazards to the security or integrity of such information; and unauthorized uses or disclosures of such information ..."

2. During tour of the obstetrics unit on 2/22/16 from 11:30 AM to 12:15 PM, observations revealed 3 log books (Delivery Room Log book, Scheduled Outpatient Log book, and Nonscheduled Outpatient Log book) that contained patient names and protected health information in an unlocked drawer.

3. Review of the log books revealed the following:

a. Delivery room log book contained patient information for 90 deliveries from June 2015 to present.

b. Outpatient scheduled log book contained patient information for an average of 8 outpatients per month from December 9, 2005 to present.

c. Nonscheduled log book contained patient information for an average of 10 outpatients per month from October 21, 2010 to present.

4. During an interview on 2/22/16 at 11:30 AM, Staff H, Registered Nurse (RN), verified housekeeping staff have access to the obstetrics unit when obstetrics staff were not present and could potentially have access to patient information contained in the log books. Staff H acknowledged the housekeeping staff did not need access to this type of information to perform their job duties.

5. Observation on 2/23/16 at 4:00 PM, revealed the Health Information Management (HIM)Department occupied a large open room with several cubicle workstations, a medical record scanning room and shared space with the adjacent Rural Health Clinic.

6. During an interview on 2/23/16 at 4:00 PM, Staff EE, HIM/Chart Analyst, reported the HIM department is unlocked during staffed hours and housekeeping staff clean during these hours. She reported the area had badge access for authorized individuals after hours, but did not know for sure which individuals would be included.

During an interview on 2/25/16, at 11:00 AM, Staff K, Director of Plant Operations/Environmental Services (EVS) provided a report of individuals with badge access to the HIM department. Staff K acknowledged the badge access allowed individuals to access the HIM department during unsupervised hours and identified the individuals on the report included staff from EVS, Plant Operations, Information Systems, Rural Health Clinic, Fire, Police Department, and Emergency staff. Staff K acknowledged the report showed vendors with inactive badge access and reported these were made inactive on 2/24/16 (during the survey). Staff K confirmed 5 Plant Operations staff, 16 EVS staff, 4 Information Systems staff and the Rural Health Clinic had a master key to the HIM department, for unsupervised access during unstaffed hours.

During an interview on 2/29/16 at 10:30 AM, Staff BB, Health Information Manager/Privacy Officer, reported the HIM department is accessible by key and badge access allowing the individuals access during unstaffed hours. Staff BB explained the majority of medical records are locked when the department is closed but confirmed the scanning room door does not lock and the patient information contained in that room is not secured after hours. She confirmed the personal health information would be accessible to unauthorized users entering during unstaffed hours. Staff BB verified in the past 3 months, employees from EVS, Plant Operations, Marketing and Information Systems accessed the HIM area and would be considered unauthorized users of personal health information. She confirmed the badge access allowed for the potential of access of patient personal information during unstaffed hours.

On 2/29/16 at 4:20 PM, Staff BB verified the HIM department scanning room contained approximately 328 folders of patient information.

Based on review of policies/procedures, Medical Staff Bylaws/Rules and Regulations, medical records, and staff interviews, the Critical Access Hospital (CAH) failed to have a system in place to ensure the pre-anesthesia assessment occurred prior to surgery for 10 of 13 patients. (Patients #10, 11, 22, 23, 26, 27, 28, 33, 35, and 37) The CAH reported an average of 140 procedures requiring anesthesia per month.

Evaluating patients for anesthesia risk before surgery is essential in determining if the patient may have severe adverse reactions to the anesthesia. Failure to ensure staff performed the pre-anesthesia risk evaluation immediately prior to surgery could result in the failure to identify a anesthesia risk resulting in poor patient outcomes.

Findings include:

1. Review of policy/procedure titled "Anesthesia Responsibilities", dated 11/2015, revealed in part, ". . . All patients will be evaluated by anesthesia preoperatively and postoperatively. . . Pre-anesthesia evaluation must be performed prior to inpatient or outpatient surgery. . . ."

Review of Medical Staff Bylaws/Rules and Regulations, dated February 2010, revealed in part, ". . . All entries in the medical record must be dated, timed and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided. . . ."

2. Review of medical records on 2/29/16 for Patients #10, 11, 22, 23, 26, 27, 28, 33, 35, and 37 revealed the lack of time of a pre-anesthesia evaluation to ensure the pre-anesthesia evaluation occurred prior to surgery.

3. During an interview on 2/29/16 at 3:00 PM, Staff CC, Director Surgery, acknowledged the the lack of time of a pre-anesthesia evaluation to ensure the pre-anesthesia evaluation occurred prior to surgery for Patients #10, 11, 22, 23, 26, 27, and 28.

During an interview on 2/29/16 at 3:20 PM, Staff FF, Registered Nurse - System Analyst, acknowledged the the lack of time of a pre-anesthesia evaluation to ensure the pre-anesthesia evaluation occurred prior to surgery for Patients #33, 35, and 37 during closed medical record review.

During an interview on 2/29/16 at 3:35 PM, Staff B, Chief Operating Officer/Chief Nursing Officer (COO/CNO), verified all medical record entries including pre-anesthesia evaluations needed to be timed.

Based on review of policies/procedures, documentation, and staff interviews, the Critical Access Hospital (CAH) failed to ensure the periodic evaluation of its total CAH program included a representative sample of both active and closed clinical records for 14 of 14 patient care services provided. (Laboratory, Rehabilitation Services, Diagnostic Imaging, Pharmacy, Emergency Department, Surgery/Anesthesia, Nursing, Obstetrics, Cardiac Rehabilitation, Diabetes Education, Wound Care, Respiratory Therapy, Behavioral Health Services, and Food Services) The CAH staff identified a current census of 15 inpatients at the start of the survey.

Failure to include a representative sample of both active and closed clinical records in the annual Total Program Evaluation could potentially result in failure to identify potential changes needed in services provided.

Findings include:

1. Review of policies/procedures revealed the lack of a policy/procedure that addressed the Annual Program Evaluation including a representative sample of both active and closed clinical records for all patient care services provided.

2. Review of the "Critical Access Hospital Annual Report July 1, 2014 to June 30,2015" lacked documentation review of a representative sample of both active and closed clinical records for Laboratory, Rehabilitation Services, Diagnostic Imaging, Pharmacy, Emergency Department, Surgery/Anesthesia, Nursing, Obstetrics, Cardiac Rehabilitation, Diabetes Education, Wound Care, Respiratory Therapy, Behavioral Health Services, and Food Services.

3. During an interview on 2/29/16 at 11:35 AM, Staff Y, Administrative Assistant, acknowledged the lack of a policy/procedure that addressed the Annual Program Evaluation including a representative sample of both active and closed clinical records for all patient care services provided.

During an interview on 2/29/16 at 11:00 AM, Staff C, Chief Executive Officer (CEO), and Staff B, Chief Operating Officer/Chief Nursing Officer (COO/CNO), verified the annual evaluation of the CAH total program lacked documentation of a review of a representative sample of both active and closed clinical records for Laboratory, Rehabilitation Services, Diagnostic Imaging, Pharmacy, Emergency Department, Surgery/Anesthesia, Nursing, Obstetrics, Cardiac Rehabilitation, Diabetes Education, Wound Care, Respiratory Therapy, Behavioral Health Services, and Food Services.

Based on review of documentation and staff interview, the Critical Access Hospital (CAH) quality improvement staff failed to evaluate all patient care services for 2 of 14 patient care services (Respiratory Therapy, Bone Density) and 5 of 8 contracted patient care services (Anesthesia, PET, Sleep Study, Telepsychiatry, and Stereotactic Breast Biopsy).

Respiratory Therapy - 14107 events past 12 months
Bone Density - average 10 per month
Anesthesia - 1727 procedures past 12 months
PET - 25 scans from October 2015 to present
Sleep Study - 143 procedures past 12 months
Telepsychiatry - 120 encounters past 12 months
Stereotactic Breast Biopsy - 4 past 12 months

Failure to monitor and evaluate all patient care services for quality of care could potentially expose patients to inappropriate and/or substantial care.

Findings include:

1. Review of CAH "Performance Improvement Quality Plan for Fiscal Year 2016", revealed in part ". . . The program is designed to collect data and will include measures of both processes and outcomes. All individuals, all departments and services are included in this assessment and improvement program. . . ."

2. Review of the Quality Council Meeting minutes dated January 27, 2015 to December 22, 2015 and quality reports for Anesthesia revealed the quality reports included data collection only and lacked any corrective actions taken and follow up and monitoring to determine the effectiveness of actions taken. The quality reports for Respiratory Therapy included timeliness of EKGs completed and lacked reports for respiratory therapy. The quality reports lacked reports from Bone Density, Sleep Study, PET, Stereotactic Breast Biopsy, and Telepsychiatry.

3. During an interview on 2/25/16 at 1:00 PM, Staff Z, Performance Improvement Director, confirmed quality reports for:
a. Anesthesia revealed the quality reports included data collection only and lacked any corrective actions taken and follow up and monitoring to determine the effectiveness of actions taken
b. Respiratory Therapy included timeliness of EKGs completed and lacked reports for respiratory therapy
c. Bone Density, Sleep Study, PET, Stereotactic Breast Biopsy, and Telepsychiatry lacked reports.

Based on medical record review and staff interviews the CAH failed to ensure the completion of a nutrition assessment on patients admitted for a skilled care stay for 2 of 3 patients selected for review. The administrative staff identified a census of 15 patients, including 2 skilled patients.

Failure to complete a nutrition assessment could potentially lead to unidentified nutrition problems, additional complications and an increased length of stay.

Findings include:

1. During an interview on 2/22/16, 3:35 PM, Staff J, Clinical Dietitian, reported the nursing staff complete a basic nutrition screen upon admission, which may trigger a nutrition referral based on predetermined criteria and she would complete a nutrition assessment. Staff J reported if nutrition-related concerns became apparent after a patient admission she would complete a nutrition assessment as needed. Staff J confirmed the process remained the same for acute and skilled admissions.

During an interview on 2/24/16 at 8:15 AM, Staff B, Chief Operating and Nursing Officer, reported the CAH did not have separate policies for skilled care patients, so staff would follow the basic nursing policies. She reported the CAH plans for a short-term (less than 14 days) skilled stay and attempt to place elsewhere, but occasionally have a longer stay.

2. Medical record review on 2/29/16 identified the following concerns:

a. Patient # 51 had a skilled care stay from 8/29/15 to 10/7/15 and the record lacked a nutrition assessment.

b. Patient #52 had a skilled care stay from 11/25/15 to 12/26/15 and the record lacked a nutrition assessment completed by the clinical dietitian during their skilled stay.

3. During an interview on 2/29/16 at 3:15 PM, Staff AA, Nurse Educator and Staff J confirmed the medical records did not contain a nutrition assessment. Staff J confirmed she did not have a policy to differentiate between the nutrition screening and assessment process for an acute versus skilled patient and followed the same process for both. Staff J confirmed she did not complete nutrition assessments on skilled care patients unless a provider ordered a referral, the admission nutrition screen generated a referral or she became aware of a nutrition-related concern through her own chart review.

Based on medical record review and staff interviews the Critical Access Hospital (CAH) failed to ensure the completion of a nutrition assessment within 14 days of a patient admission for skilled care stay in 1 of 3 closed patient records selected for review. The administrative staff identified a census of 15 patients, which included 2 skilled patients. The administrative staff identified 5 patients admitted in the past 6 months with skilled stays of 14 days or longer.

Failure to complete a nutrition assessment could potentially lead to unidentified nutrition problems, additional complications and an increased length of stay.

Findings include:

1. During an interview on 2/22/16, 3:35 PM, Staff J, Clinical Dietitian, reported the nursing staff complete a basic nutrition screen upon admission, which may trigger a nutrition referral based on predetermined criteria and she would complete a nutrition assessment. Staff J reported if nutrition-related concerns became apparent after a patient admission, she would complete a nutrition assessment as needed. Staff J confirmed the process remained the same for acute and skilled admissions.

During an interview on 2/24/16 at 8:15 AM, Staff B, Chief Operating and Nursing Officer, reported the CAH did not have separate policies for skilled care patients so staff would follow the basic nursing policies. She reported the CAH plans for a short-term (less than 14 days) skilled stay and attempt to place elsewhere but occasionally have a longer stay.

2. Closed medical record review of skilled patient admissions, on 2/29/16, revealed Patient
#55 had a nutrition assessment but the completion failed to occur within 14 days of admission.

3. During an interview at 3:15 PM, Staff AA, Nurse Educator and Staff J confirmed Patient
#55's closed medical record contained a nutrition assessment but the completion occurred on day 17 of the skilled care admission . Staff J confirmed she did not have a policy to differentiate between the nutrition screening and assessment process for an acute versus skilled patient and followed the same process for both. Staff J confirmed she did not complete nutrition assessments on skilled care patients, regardless of length of stay, unless a provider ordered a referral, the admission nutrition screen generated a referral or she became aware of a nutrition-related concern through her own chart review.