HospitalInspections.org

Based on staff interview the Critical Access Hospital (CAH) failed to ensure Administrative staff established a written gas and fuel agreement with local companies and/or other sources to provide emergency gas and fuel supply to the CAH in the event of a disruption of gas and fuel supply. The administrative staff identified a census of 12 patients and an average census of 15 patients.

Failure to ensure Administrative staff established a gas and fuel agreement with local utility companies and/or other sources to ensure emergency gas and fuel is supplied as needed in the event of a disruptions of fuel and gas could potentially result in the lack of fuel and water at the CAH to providee emergency care and treatment for the inpatients and those patients who arrived in the emergency department seeking emergency care and treatment.


Findings include:


1. During an interview on 9/28/15 at 8:00 AM Staff R, Director of Support Services reported the CAH had a written emergency fuel and water agreements but he was not able to locate the agreements.

During an interview on 9/30/15 at 9:45 AM Staff R, Director of Support Services reported the written emergency fuel and water agreements were not found.

Based on review of Board of Trustees meeting minutes and staff interviews, the Board of Trustees (governing body) failed to ensure the Board of Trustees administered policies to determine and maintain quality health care at the Critical Access Hospital.

1. The Board of Trustees failed to evaluate all contracted services and failed to ensure quality improvement information was reviewed. Refer to C-241.

2. The Board of Trustees failed to ensure all policies and procedures were reviewed annually by the required group of professionals, a physician and a midlevel provider, and they were always present at the meetings. Refer to C-272.

The cumulative effect of these systemic failures and deficient practices resulted in the facility's inability to ensure the quality health care provided to patients.

I. Based on review of the CAH's Performance Improvement Plan and Critical Access Hospital (CAH) Board of Trustees meeting minutes and staff interview, the CAH failed to document an evaluation of all contracted services. The administrative staff identified a current census of 12 patients at the time of the survey and an outpatient case volume of 163,191 yearly.

Failure to evaluate all contracted services provided to patients could allow contracted staff to provide the services without current qualifications and might result in patients receiving substandard care.

Findings include:

1. Review of CAH "Boone County Hospital Integrated Performance Improvement Plan", dated December 2014, revealed in part, "...The Board of Trustees has the ultimate responsibility for overseeing the performance improvement activities of the hospital and assuring that one level of care is provided for all patients..."

2. Review of the Board of Trustees committee meeting minutes from 9/25/14 to 8/27/15 revealed a lack of documentation regarding the evaluation of the contracted services and if they were meeting the needs of the CAH.

3. During an interview on 9/29/15 at 10:00 AM, Staff Z, Assistant Administrator Quality, confirmed the Board of Trustees meeting minutes lacked documentation regarding the evaluation of the contracted services.


II. Based on review of document, Board of Trustees meeting minutes, and staff interview, the CAH staff failed to present or document information regarding the Quality Improvement meeting minutes at the Board of Trustees meetings for board members' consideration and evaluation.

Failure of the CAH Board of Trustees to review and evaluate Quality Improvement meeting minute information could result in a decline in the CAH Quality Improvement program and delay in needed actions.

Findings include:

1. Review of a document titled, "Boone County Hospital Integrated Performance Improvement Plan", dated December 2014, revealed in part, ". . . The Board of Trustees has the ultimate responsibility for overseeing the performance improvement activities of the hospital and assuring that one level of care is provided for all patients. . . ."

2. Review of the Board of Trustees committee meeting minutes from 9/25/14 to 8/27/15 revealed a lack of documentation showing review and evaluation of the Quality Council meeting minutes by the board members.

3. During an interview on 9/30/15 at 10:00 AM, Staff Z, Assistant Administrator Quality, stated the Board of Trustees does not receive quality improvement information for all services provided by the CAH. Staff Z confirmed the Board of Trustees meeting minutes failed to address quality improvement information for all services provided by the CAH.

Based on review of policies, procedures, documentation, and staff interviews, the Critical Access Hospital (CAH) failed to ensure the physician periodically reviewed 1 of 1 mid-level practitioner's patient medical records, in conjunction with the mid-level practitioner. (Staff Y)

The CAH staff reported the volume of services by the mid-level practitioner for FY 2015 of 2034 patient visits in the wound clinic.

Failure to ensure a physician periodically reviewed 1 of 1 mid-level practitioner's patient medical records in conjunction with the mid-level practitioners could potentially result in misdiagnosing patients and/or providing inappropriate or substandard patient care.

Findings include:

1. Review of CAH policies, procedures, Medical Staff By-Laws and Rules and Regulations revealed the lack of a requirement to ensure the physician periodically reviewed the mid-level practitioner's patient medical records, in conjunction with the mid-level practitioner.

2. Review of documentation revealed no documentation of physician review of the mid-level practitioner's patient medical records, in conjunction with the mid-level practitioner.

3. During an interview on 9/30/15 at 8:20 AM, Staff Y, Advanced Registered Nurse Practitioner, stated she talked to the physician weekly about patients but do not sit down and review records and the treatment provided. Staff Y acknowledged the lack of documentation of any review of patients in the wound clinic.

During an interview on 9/30/15 at 12:25 PM, Staff Z, Assistant Administrator Quality/IT, acknowledged the lack of a policy to ensure the physician periodically reviewed the mid-level practitioner's patient medical records, in conjuntion with the mid-level practitioner. Staff Z acknowledged Staff Y provided care to patients at the CAH in the wound clinic and the lack of documentation to show the physician reviewed the mid-level practitioner's patient medical records, in conjunction with the mid-level practitioner.

Based on review of policies, procedures, documentation, and staff interviews, the Critical Access Hospital (CAH) failed to ensure the mid-level practitioner participated with a physician in the periodic review of 1 of 1 mid-level practitioner's patient medical records. (Staff Y)

The CAH staff reported the volume of services by the mid-level practitioner for FY 2015 of 2034 patient visits in the wound clinic.

Failure to ensure the mid-level practitioner participated with a physician in the periodic review of the mid-level practitioners' patient medical records could potentially result in mid-level practitioners misdiagnosing patients and/or providing inappropriate or substandard patient care.

Findings include:

1. Review of CAH policies/procedures, Medical Staff By-Laws and Rules and Regulations revealed the lack of a requirement to ensure the physician periodically reviewed the mid-level practitioner's patient medical records, in conjunction with the mid-level practitioner.

2. Review of documentation revealed no documentation of physician review of the mid-level practitioner's patient medical records, in conjunction with the mid-level practitioner.

3. During an interview on 9/30/15 at 8:20 AM, Staff Y, Advanced Registered Nurse Practitioner, stated she talked to the physician weekly about patients but do not sit down and review records and the treatment provided. Staff Y acknowledged the lack of documentation of any review of patients in the wound clinic.

During an interview on 9/30/15 at 12:25 PM, Staff Z, Assistant Administrator Quality/IT, acknowledged the lack of a policy to ensure the physician periodically reviewed the mid-level practitioner's patient medical records, in conjunction with the mid-level practitioner. Staff Z acknowledged Staff Y provided care to patients at the CAH in the wound clinic and the lack of documentation to show the physician reviewed the mid-level practitioner's patient medical records, in conjunction with the mid-level practitioner.

Based on review of policies, meeting minutes, staff interview, the Critical Access Hospital (CAH) failed to ensure the required group of professionals, including a physician and a mid-level provider reviewed all patient care policies for 20 of 20 patient care departments. (Laboratory, Infection Control, Surgical Services, Cardiopulmonary Rehabilitation, Clinic, Emergency Room, Nutritional Services, Radiology, Physical Therapy, Occupational Therapy, Speech Therapy, Health Information Management, Pharmacy, Inpatient Services, Diabetes Education, Wound Care, Ambulance, Swing Bed, Tech Services, Engineering, and Materials Management)

Failure to ensure the required group of professionals reviewed all patient care policies annually could potentially result in failure to address and develop policies for changing patient care needs not addressed in the CAH policies and/or opportunities to update the policies as needed.

Findings include:

1. Review of the CAH policy titled "Governing Critical Access", dated 10/14, revealed in part, ". . . All Department Directors and Assistant Administrators are responsible for the annual review of all policies and procedures that indicate their ownership. Policies for review and approval will be submitted to the Critical Access Advisory Committee which consists of the follow members: CEO, Medical Staff Members, Assistant Administrator for Nursing, Assistant Administrator for Quality and Patient Safety, Physician Assistant/ARNP, Network Nurse Affiliate. . . ."

2. Review of the Critical Access Hospital Advisory Committee meeting minutes for the past 12 months revealed the following information on attendance at the meetings:
a. the midlevel provider was not present at the November 25, 2014, February 23, 2015, April 28, 2015, and July 28, 2015 meetings;
b. the physician was not present at the July 28, 2015 meeting;
c. the Mercy Network representative was not present at the November 25, 2014, February 23, 2015, April 28, 2015, and July 28, 2015 meetings.

Review of November 25, 2014 meeting minutes included in part, "...Departments presenting their policies and procedures for review have presented a Table of Contents for each manual, as well as a detailed description of revisions, corrections, updates and deletion..." The following department policies and manuals were approved: Laboratory, Infection Control, Surgical Services, and Cardiopulmonary Rehabilitation.

Review of February 23, 2015 meeting minutes included in part, "...Departments presenting their policies and procedures for review have presented a Table of Contents for each manual, as well as a detailed description of revisions, corrections, updates and deletion..." The following department policies and manuals were approved: Clinic, Emergency Room, Nutritional Services, Radiology, and Engineering.

Review of April 28, 2015 meeting minutes included in part, "...Departments presenting their policies and procedures for review have presented a Table of Contents for each manual, as well as a detailed description of revisions, corrections, updates and deletion..." The following department policies and manuals were approved: Physical Therapy, Occupational Therapy, Speech Therapy, Health Information Management, Pharmacy, Inpatient Services, and Materials Management.

Review of July 28, 2015 meeting minutes included in part, "...Departments presenting their policies and procedures for review have presented a Table of Contents for each manual, as well as a detailed description of revisions, corrections, updates and deletion..." The following department policies and manuals were approved: Diabetes Education, Wound Care, Ambulance, Swing Bed, and Tech Services.

3. During an interview on 9/30/15 at 8:15 AM, Staff B, Assistant Administrator for Nursing, stated when the physician was not present at the annual policy and procedure review meeting, the policies were sent to the physician for approval. Staff B acknowledged a mid-level provider was not present at the annual policy and procedure review committee meetings for the past 12 months and an ARNP was on staff since 10/2014. Staff B also acknowledged a Mercy Network representative was not present at the annual policy and procedure review committee meetings for the past 12 months as stated in the policy. Staff B stated only the table of contents and new policies were available at the annual policy and procedure committee meetings and not the entire policy and procedure manuals.

I. Based on observation, policy review and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure a licensed pharmacist provided oversight, tracked storage and dispensing of sample medications to patients in 1 of 1 CAH offsite clinics, (Boone County Family Practice). The Clinic Director reported an average census of 100 patient visits a month, 4 patients a week received sample medications in the clinic.

Failure to ensure a licensed pharmacist provided oversight, tracked the storage and dispensing of sample medications to patients in the offsite clinic could potentially result in outdated or recalled medications being available for physicians and mid-level providers to dispense to patients, inappropriate medications or doses of medications, or otherwise unusable medications being available for use to patients, as well as, the potential for diversion of medications by unauthorized persons.

Findings include:

1. Review of the policy titled, "Medication Management: Dispensing and Preparing" effective 4/2010 included in part, "...Responsibility: A licensed pharmacist must monitor all medication preparation and dispensing by non-pharmacist personnel..."

2. Observation on 9/30/15 at 10:15 AM during the tour of the Boone County Family Medicine with Staff E, Clinic Director revealed 7 locked cabinets on the west wing contained sampled medications dispensed for the following medical diagnoses:

Lipids (cholesterol)- 171 tablet/capsules
Antihypertensives (blood pressure)- 294 tablet/capsules
Pain- 381 tablet/capsules
Acid reflux- 123 tablet/capsules
Anticoagulants- 338 tablet/capsules
Erectile dysfunction- 90 tablet/capsules
smoking cessation- 262 tablets
antidepressants- 377 tablet/capsules
Psuedobulbar effect- 52 tablets
Fibromyalgia- 42 tablets
Alzheimers/ADHD- 331 tablets
Antipsychotic- 40 tablets
Diabetic- 727 tablets

The 7 locked cabinets on the east wing of the clinic contained sample medications dispensed for the following medical diagnoses:

Respiratory- 77 tablets and 60 inhalers
Estrogen- 42 tablets
Bladder retention- 140 tablets
Diabetic- 14 tablets, 12 insulin vials, 41 insulin pens and 8 insulin cartridges

During an interview on 9/30/15 at 10:15 AM, with Staff E, Clinic Director, when asked if the pharmacist provided oversight of the sample medications, Staff E stated the CAH pharmacist had no oversight of the sample medications and did not come to the clinic to review the sample medications.Staff E stated the clinic had not utilized a system to track and account for sample medications for 2 years. Staff E said she knew the system should be in place, but the clinic was very busy and this did not get implemented.

3. During an interview on 9/30/15 at 11:50 AM, Staff F, Pharmacist stated she did not have oversight of the sample medications in the offsite clinic and had not been to the clinic to review the sampled medications for the past one and half years. Staff F, stated Staff E, Clinic Director had sent her a monitoring log to utilize for tracking sample medications about one and half years ago. Staff F said she thought the clinic implemented the tracking log system, but had no oversight of the sample medications to clarify if the clinic staff implemented the system.




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II. Based on observation, review of policy, document and staff interview the CAH (Critical Access Hospital) failed to ensure clinc staff removed all expired medication from 1 of 1 crash cart in the Boone County Family Medicine Clinic

Failure to ensure staff removed expired medications from the crash cart could potentially put the patient at risk for unsafe and ineffective treatment in the event of an emergency.

Findings include:

1. Review of policy titled, "Expired Medical Products" dated 8/11 included in part "...Purpose: The purpose of this policy is to prevent any staff member from using a product that is not within the expiration date or usability date set by the manufacturer. Practice: Medical and other supplies should be checked once a month for expiration and manufacturing date. If the expiration date is less than 30 days the item is to be removed from use..."

2. Observation on 9/30/15 at 10:25 AM, with Staff E, Clinic Director during the initial tour of the clinic showed 1crash cart located in the procedure room. The crash cart contained 2-1mg syringes of Atropine (medication used to increase heartbeats) with an expiration date of 8/15; no other Atropine was available in the crash cart.

3. Review of the document, Boone Family Medicine -Nurse Station check list for expired supplies, dated 2015 lacked documented evidence the clinic staff checked expired supplies in August 2015.

4. During an interview on 9/30/15 at 10:25 AM, Staff E, Clinic Director reported the Registered Nurse's are responsible to check all outdated supplies.

During an interview on 9/30/15 at 12:00 PM, Staff F, Pharmacist reported the clinic staff checked supplies in crash cart for expiration dates, and called if they have a drug to dispose of and restock.

Based on review of policies, procedures, medication error documentation, and staff interview, the Critical Access Hospital (CAH) nursing staff failed to notify the physician when medication errors occurred for 7 of 12 patients. (Patients #18, 19, 20, 21, 22, 23, and 24) The administrative staff identified a census of 12 patients and an average census of 15 patients.

Failure to report medication errors to the physician could potentially cause harm to patients if the patient received the wrong dosage of medication or medication at the wrong time.

Findings include:

1. Review of CAH policy titled "Medication Errors & Reporting", dated 8/10, revealed in part "...Medication errors shall be reported in a timely manner to the practitioner who ordered the medication, or if unavailable, to the physician on call..."

2. Review of patient medication error reports revealed the physician was not notified of the following medication errors:

The Medication Error report for Patient #18 revealed the patient missed a dose of medication.

The Medication Error report for Patient #19 revealed the patient received a medication by the wrong route.

The Medication Error report for Patient #20 revealed the patient received an extra dose of medication.

The Medication Error report for Patient #21 revealed the patient missed a dose of medication.

The Medication Error report for Patient #22 revealed the patient missed a dose of medication.

The Medication Error report for Patient #23 revealed the patient received an incorrect dose of medication.

The Medication Error report for Patient #24 revealed the patient missed a dose of medication.

3. During an interview on 9/30/15 at 12:40 PM, Staff B, Assistant Administrator Nursing, acknowledged the CAH policy included a requirement for reporting the medication errors to the physician. Staff B also acknowledged documentation revealed nursing staff failed to notify the physician about the medication errors for Patients # 18, 19, 20, 21, 22, 23, and 24.

I. Based on observation, Manufacturer's Guidelines review, policy review and staff interview, the Critical Access Hospital (CAH) failed to ensure the radiology staff performed the Cidex Solution test and documented the results of the Cidex Solution test strips before each use of the Cidex OPA solution 1 of 2 Ultrasound rooms to ensure staff used the proper concentration to disinfect the "dirty" pelvic ultrasound probes. The Radiology Director reported an average of approximately 66 pelvic ultrasound procedures per month.

Failure to ensure radiology staff performed the Cidex Solution test and documented the results of the Cidex Solution test strips before each use of the Cidex OPA solution could potentially result in the use of inefficient Cidex OPA solution to disinfect "dirty" pelvic ultrasound probes. The use of inefficient Cidex OPA solution could potentially result in microorganisms remaining on the pelvic ultrasound probes and result in cross contamination between patients causing severe illness or death.

Findings include:

1. Review of the radiology department policy titled Use of Cidex OPA Solution, effective 8/2014 revealed in part... "VI. B. Log test strip results daily."

2. Review of the manufacturer's instructions for Cidex OPA Solution, copyright 2006 to 2015, revealed in part... "1. Monitoring of Germicide: During reuse, it is recommended the Cidex OPA Solution be tested with Cidex OPA Solution Test Strips prior to each use. This is to ensure the Minimum Effective Concentration [MEC] of ortho-phthalaldehyde is present."

3. Observations, during a tour of the Radiology Department, with Staff D, Radiology Director on 9/28/15 at 3:20 PM revealed 1 of 2 ultrasound rooms contained Cidex OPA Solution in a plastic containter on the counter.

4. Review of documents titled, "Cidex OPA Solution Test Logs" dated 7/1/2015 to 9/28/2015 revealed radiology staff failed to test Cidex OPA Solution prior to each use.

5. During an interview on 9/28/15 at 3:30 PM, Staff C, Ultrasound Technician stated she tested the Cidex OPA Solution one time a day. Staff C stated she did not test the Cidex OPA solution prior to each time she used the Cidex OPA Solution to disinfect the pelvic ultrasound probes.

During an interview on 9/29/15 at 10:55 AM, Staff D, Radiology Director stated the Cidex OPA manufacturer's guidelines stated it was recommended to test the Cidex OPA solution prior to each use, but he did not consider this was a requirement. Staff D stated, the ultrasound staff tested the solution one time a day because of this interpretation of the manufacturer's guidelines.


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II. Based on observation, review of policies, manufacturer's information, AORN (Association Operating Room Nurses) Guidelines, and staff interview the CAH (Critical Access Hospital) failed to follow manufacturer's instructions for the use of disinfection solution used to clean the endoscopes. The CAH administrative staff identified 50 endoscopes procedures a month.

Failure to ensure staff marked the date opened on Rapicide PA disinfectant jugs in accordance with the manufacturer's instructions could potentially result in the use of expired disinfection solution to clean the endoscopes could potentially result in microorganisms remaining on the endoscopes and result in cross contamination between patients causing severe illness or death.

Findings include:

1. Review of the policy titled, "Endoscopy Cleaning Procedure" dated 11/10, lacked information for the disinfectant solution used at the hospital, "Rapicide PA disinfectant."

2. Review of the manufacturer's information titled, "Rapicide PA high level disinfectant" included in part "...Storage: The product may be used for twenty-one (21) days after the containers are opened. DO NOT use after that time has expired..."

3. Review of the "AORN 2015 Edition included in part, "...Failure to follow the manufacturer's written instructions could result in ineffective cleaning that interferes with high-level disinfection or sterilization..."

4. Observation on 9/29/15 at 7:30 AM, with Staff U, Scrub Technician, during the tour of surgical department, revealed Rapicide PA high level disinfectant used to disinfect the endoscopes, in the Advantage machine. Two Rapicide PA bottles, in the Advantage machine, lacked a date the bottles were opened and an expiration date.

During an interview on 9/22/15 at 9:30 AM, Staff U acknowledged the Rapicide PA disinfectant lacked an open date on each of 2 opened jugs. Staff U reported he failed to date the jugs. Staff U was unaware the Rapicide PA high level disinfectant expired 21 days after the jugs were opened in accordance with the manufacturer's information.

During an interview on 9/29/15 at 12:30 PM, Staff T, Operating Room Director, reported the OR followed AORN guidelines.


III. Based on observation, policies, manufacturer's instructions, AORN (Association Operating Room Nurses) Guidelines, and staff interviews the operating room (OR) staff failed to follow manufacturer's intructions to perform the leak test procedure prior to immersing fluids into "dirty' endoscopes. The Administrative staff identified the OR staff performed 50 endoscopes procedures at the CAH each month.

Failure to ensure staff followed the manufacturer's instructions with the use of the hand held leak test machine to perform a leak test prior to immersing fluids into the "dirty" endoscope could potentially result in the failure to idenify the loss of the integrity of the watertight construction of the endoscope equipment.

Findings include:

1. Review of policy and procedure titled, "Endoscopy Cleaning Procedure" dated 11/10 included in part, "...Purpose: To ensure that endoscopic equipment is properly reprocessed and properly functioning after each use. Immediate after Procedure: Attach leakage testing device..."

2. Review of the document titled, "Pentax Instructions for use", dated 3/12, included in part, "...Before reprocessing and/or immersion in any fluids, PENTEX endoscopes should be tested for loss of integrity in their watertight construction by using PENTEX brand leak test..."

3. Review of manufacturer's information titled, "Pentax Operation Manual" dated 10/2011, included in part, "...6) Leak Test the scope PRIOR to immersing in any fluid..."

4. Review of the "AORN 2015 Edition Guidelines" dated 2015 included in part, "...1c. New, repaired, or refurbished flexible endoscopes and accessories should be leak tested, cleaned, and high-level disinfected or sterilized before use in a health care organization. Leak tests determine if perforations in either the outer covering or the lining of the internal channels may have occurred during manufacturing, shipping, repairing, or refurbishing..."

5. Observation and interview on 9/29/15 at 7:30 AM showed Staff U prepared to clean and disinfect the "dirty' endoscope. Staff U stated, the hand leak test machine used to perform the lesk test on the endoscope was broken. When asked when Staff U stopped using the hand held leak test machine, Staff U reported he was unable to give an exact time frame however, Staff U estimated it had been approximately 1 to 2 weeks since he last used the hand held leak test machine. When asked if Staff U notified management regarding the non-functional hand held leak test machine, Staff U reported he thought it would be alright to bypass that step. Staff U reported endoscopes are processed in the Advantage Plus endoscope reporcessor (Machine used to disinfect the endoscopes.) and the leak test would be done during that process.

6. During an interview Staff T, Operating Room Director reported Staff U verified the hand leak test machine was out of service on 9/23/15.

7. Review of documents titled, "Operating Room Log" dated 9/23/15 through 9/29/15 (The dates the hand held leak test machine was non-functioning.) showed Staff U failed to follow the manufacturer's instructions during the following:

a. On 9/23/15, 3 of 3 endoscope cleaning and disinfection procedures.
b. On 9/24/15, 3 of 3 endoscope cleaning and disinfection procedures.
c. On 9/25/15, 2 of 2 endoscope cleaning and disinfection procedures.
d. On 9/28/15, 2 of 2 endoscope cleaning and disinfection procedures.
e. On 9/29/15, 1 of 1 endoscope cleaning and disinfection procedure.

8. During an interview on 9/30/15 at 2:30 PM, Staff X, Infection Preventionist RN, revealed the CAH failed to track endoscopy procedures for infectious outbreaks..

During an interview on 9/29/15 at 9:30 AM with Staff S, Interim Central Sterile Coordinator/Lead Scrub Technician, Staff T reported Staff U, Scrub Technician failed to notify OR management that the hand leak test machine malfunctioned. Staff T reported the OR had a second hand leak test machine available for the Pentax endoscopes.

9. Review of documents in Staff U personal file revealed since 12/14 (date of hire) lacked documented evidence of cleaning and disinfection of endoscope training.

During an interview on 9/29/15 at 12:30 PM, with Staff T, Operating Room Director, revealed the OR followed AORN guidelines.


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IV. Based on observations, policy review and staff interviews, the Critical Access Hospital (CAH) Dietary Department failed to use sanitary practices during food handling and patient meal service. The administrative staff identified a census of 12 patients and an average census of 15 patients. The Director of Dietary Services identified dietary staff provided an average of 46 patient meals daily.

Failure to maintain sanitary practices during meal service and food handling could potentially result in contamination of the patient's food leading to foodborne illness.

Findings include:

1. Observation during food preparation and meal service on 9/28/15 from 9:50 AM to 10:30 AM and 11:05 AM to 11:25 AM, and again on 9/29/15, from 10:55 AM to 11:25 AM, revealed Staff Q, Cook, donned a hair net, but failed to effectively restrain approximately 2 inches of her bangs.

2. Observation during food preparation and meal service on 9/28/15 from 11:05 AM to 11:25 AM, revealed Staff P, Cook, assigned to dish patient food from the steamtable for lunch. Staff P without sanitizing hands, donned gloves. She touched multiple surfaces, including but not limited to, a container of onion slices, counters, steamtable pans/lids, patient menus (handled and completed by patients and other staff), package of hamburger buns, plate base warmer. Continuted observation showed Staff P, with the same potentially contaminated gloves when plating food, handled the hamburger buns.

During an interview on 9/29/15, at 1:00 PM, Staff O, Director of Dietary Services, reported staff received training on hand hygiene and proper glove use upon hire and on an ongoing basis. She reported staff are expected to wash their hands prior to donning gloves and should change them if they switch tasks or they becomes soiled. She acknowledged the identified observations of concern with Staff P resulted in cross contamination with glove use.

Review of a Nutritional Services policy titled, "Infection Control: Nutritional Services", reviewed in February 2015, revealed in part "...Food service personnel shall be clean and wear clothing, including a cap or a hair net sufficient to contain and restrain the shedding of hair...Gloved hands are considered a food contact surface that can get contaminated or soiled. Failure to change gloves between tasks can contribute to cross-contamination... "

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 food employees wear hair restraints that are designed and worn to effectively keep their hair from contacting exposed food, clean equipment and utensils. The Food Code also 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 and hands must be washed before donning gloves when working with food.


V. Based on document review, policy review and staff interviews the Critical Access Hospital (CAH) hospital failed to follow their system to identify and prevent transmission of infections and communicable diseases for employees and volunteers. Problems were identified for 1 of 3 volunteers (Staff H), 1 of 8 contracted employees (Staff M) and 5 of 17 employees selected for review (Staff I, J, K, L and N).

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 Policy", effective 8/2015 inclcluded in part "...a health assessment, utilizing the Employee/Volunteer Health Assessment Questionnaire will be required ...conducted by the Employee Health Nurse/designee. The Employee Health Nurse (EHN) will review the health assessment questionnaire...A CBC Hemogram ...will be obtained on all current employees/volunteers at the time of assessment ...Results will be sent to Employee Health upon completion and be reviewed by the EHN...If an employee is identified by the EHN as having a potentially infectious and/or communicable disease, they will be referred to a physician for further evaluation and follow up..."

2. Review of the health information files for Staff H and Staff N revealed an incomplete form titled, "Employee/Volunteer Health Assessment Questionnaire", which failed to document the evaluation to identify the individual was free of acute/chronic infections and/or contagious disease and findings were within acceptable parameters as identified in the CAH employee health policy. The forms lacked a signature and date of an employee health nurse evaluation.

3. During an interview on 9/30/15, at 8:15 AM, Staff G, Registered Nurse (RN) Employee Health, reported health assessments are completed on all employees (including contracted) and volunteers, are completed every 3 years. She reported blood work is completed at the time the health assessment is due, and once that is back, and all the information is reviewed and the determination is made the individual is likely free of communicable disease and deemed appropriate to work with the CAH patients. Staff G acknowledged the identified volunteer/employees did not have a dated health assessment form,completed with the required labs and the designation the individual is free of acute/chronic infectious and/or contagious disease. She reported the forms probably got filed before the lab results came back.

Based on policy review and staff interviews the Critical Access Hospital (CAH) failed to integrate all outpatient Diabetes Education and Nutrition Therapy patient medical records into the hospital medical record system.

The Diabetes Education Program Coordinator/Registered Dietitian (RD) reported education had been provided to a total of 145 patients in 2015 and estimated approximately 175 patient records were stored in her patient record file cabinets.

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:

1. Review of CAH policies titled "Diabetes Center Plan of Care", reviewed on 7/9/15, and "Patient Education: Nutrition Education in the Outpatient Setting", effective 7/14/15, confirmed patient medical records for the diabetes and nutrition education visits are stored separate from the HIM departments medical record system and not integrated in the hospital's medical record system.

2. During an interview on 9/30/15, beginning at 1:00 PM, Staff W, Registered Dietitian (RD)/Diabetes Education Coordinator, reported she dictated all her documentation for diabetes and nutrition therapy education into a stand-alone electronic system called DiaMed, which did not integrate into the electronic system, Meditech, utilized for inpatient and other outpatient services. Staff W reported following each patient visit she printed the dictated note from DiaMed, which became part of the patients record stored in her area. She reported she sent a copy to the referring provider but did not send the information to the Health Information Management (HIM) department. Staff W reported the only information she entered into Meditech were patient charges associated with the visit. She reported she stored her patient medical records for diabetes and nutrition education in file cabinets in the storage room, next to her office and she was the only one who had access to these records. Staff W acknowledged this resulted in the lack of integration of the medical record and limited access to this portion of the patients record. She did not think anyone else had the ability to access the DiaMed program because when the HIM department contacted her when a copy of a patient's record was requested.

During an interview on 9/30/15, at 2:00 PM, Staff V, Director of HIM, acknowledged Staff W did not send documentation of her outpatient visits to the HIM department to scan into their electronic health record system (Meditech). She reported the only information available in Meditech, associated with the patient visit, would be the provider referral, which would be scanned into Meditech upon receipt. Staff V reported other outpatient departments sent paper documentation to the HIM department, which would be scanned into the Meditech system, which would allow access to all the information associated with the visit. Staff V confirmed the information Staff W's patient information would not be accessible to others within the hospital, as no one else had access to the DiaMed system. She reported if a copy of the patient record was requested, Staff W would copy the file and send it to HIM.

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 the shred bins/cabinets located throughout the hospital and a Health Information Management (HIM) medical record storage area in the basement.

The Director of Support Services estimated the CAH had approximately 12 large grey shred bins and 12 small shred cabinets designed to protect personal information until destruction. He estimated greater than 1000 patient medical records stored in the HIM department storage area in the basement.

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 a CAH policy titled "Minimum Necessary Use or Disclosure of Protected Health Information", effective 3/2015, revealed in part "Boone County Hospital . . . will take reasonable steps to limit the use or disclosure of . . . health information to the minimum necessary to accomplish the intended purpose . . . Each Organization will make "reasonable efforts" to limit the use, disclosure, access to or requests for protected health information (PHI) to the minimum necessary . . . The Privacy Officer is responsible for overseeing and making reasonable efforts to ensure workforce members' and others' access and use is limited to PHI that is required to carry out their duties . . ."

2. During the CAH environment tour on 9/29/15, beginning at 8:00 AM, observed a basement area which contained separated locked areas utilized by various departments to store information and materials. During an interview at the time, Staff R, Director of Support Services, reported one of the areas belonged to the Health Information Management (HIM) department for storage of old patient medical records. Staff R reported his Engineering Services staff had a key to the HIM storage area, in addition to the HIM department director.

The basement also contained an area to store large grey shred bins. During an interview at the time, Staff R reported the Engineering Services staff would empty the smaller cabinets into the large grey bins, upon department request. He reported keys to the shred bins were located in an unlocked cabinet in the maintenance shop, accessible to all of the Engineering Services staff. Staff R acknowledged his staff did not have the need to access patient information to perform their duties and the potential for concern with unrestricted access to the shred bin keys and the information found in them.

3. During a follow-up interview on 9/30/15, at 9:45 AM, Staff R confirmed 5 Engineering Services Staff had unrestricted access to patient information contained in the shred bins and the HIM department medical record basement storage area.

During an interview on 9/29/15, at 2:30 PM, Staff V, Director of Health Information Management reported she knew the Engineering Services staff had the keys to the shred bins. Staff V reported she had not thought about the potential concern related to Engineering Services staff access to patient information and acknowledged they did not need access to this type of information to perform their job duties.

Based on review of documents and administrative staff interviews, the Critical Access Hospital (CAH) failed to develop and implement an annual Periodic Evaluation. The CAH lacked an annual Total Program Evaluation that included: 1) the number of patients served and the volume of services provided; 2) a sampling of open and closed records to determine the appropriateness of services offered; 3) review of all health care policies and procedures including updates, new policies and existing policies requiring no changes; and 4) results of the review and how they were used to implement changes. Refer to C-331, C-332, C-333, C-334, and C-335.

The CAH failed to develop and implement an effective quality assurance program.

The CAH's Quality Assurance/Improvement program lacked problem prevention, identification, identification of corrective actions, implementation of corrective actions, evaluation of corrective actions, and measures to improve quality on a continuous basis.

The CAH failed to evaluate all patient services including contracted services.

The accumulative effect of these deficiencies would suggest a system breakdown resulting in these condition level deficiencies. Refer to C-336 and C-337.

Based on review of documents and administrative staff interviews, the Critical Access Hospital (CAH) failed to develop and implement a periodic, annual evaluation of its total program. The administrative staff identified a current census of 12 patients at the time of the survey and an outpatient case volume of 163,191 yearly.

Failure to develop and implement an annual total program review could potentially result in the CAH failing to meet the needs of their inpatients, outpatients, and staff.

Findings include:

1. Review of the CAH policy titled "Governing Critical Access", dated 10/14, revealed in part, ". . . Annual Review of Critical Access Program. The hospital will conduct an annual review of operations. . . ."

2. Review of the CAH's administrative documents lacked an annual Total Program Evaluation. The last available Total Program Evaluation was titled "Critical Access Hospital Program 2014 Annual Evaluation" for 7/1/13 to 6/30/14 was completed August 26, 2014.

3. During an interview on 9/29/15 at 4:15 PM, Staff Z, Assistant Administrator Quality, stated the CAH was late in getting the annual Total Program Evaluation completed.

During an interview on 9/30/15 at 8:10 AM, Staff B, Assistant Administrator Nursing, acknowledged the lack of an annual Total Program Evaluation. Staff B also acknowledged the last Total Program Evaluation was completed August 26, 2014 for 7/1/13 to 6/30/14. Staff B stated the CAH has not completed the annual Total Program Evaluation for 7/1/14 to 6/30/15.

Based on review of documents and administrative staff interviews, the Critical Access Hospital (CAH) failed to complete an annual Total Program Evaluation that identified the number of patients served and the volume of services provided at the CAH. The administrative staff identified a current census of 12 patients at the time of the survey and an outpatient case volume of 163,191 yearly.

Failure to complete an annual Total Program Evaluation that included the number of patients served and the volume of services could potentially result in the CAH failing to meet the needs of their patients.

Findings include:

1. Review of the CAH policy titled "Governing Critical Access", dated 10/14, revealed in part, ". . . Annual Review of Critical Access Program. The hospital will conduct an annual review of operations. . . Utilization of services, including at least the number of patients served and the volume of services. . . ."

2. Review of the CAH's administrative documents lacked an annual Total Program Evaluation. The last available Total Program Evaluation was titled "Critical Access Hospital Program 2014 Annual Evaluation" for 7/1/13 to 6/30/14 was completed August 26, 2014.

3. During an interview on 9/29/15 at 4:15 PM, Staff Z, Assistant Administrator Quality, stated the CAH was late in getting the annual Total Program Evaluation completed.

During an interview on 9/30/15 at 8:10 AM, Staff B, Assistant Administrator Nursing, acknowledged the lack of an annual Total Program Evaluation that included the number of patients served and the volume of services provided annually. Staff B also acknowledged the last Total Program Evaluation was completed August 26, 2014 for 7/1/13 to 6/30/14. Staff B stated the CAH has not completed the annual Total Program Evaluation for 7/1/14 to 6/30/15.

Based on review of documents and administrative staff interviews, the Critical Access Hospital (CAH) failed to complete an annual Total Program Evaluation that included a representative sample of both active and closed clinical records and the last completed Total Program Evaluation failed to include a representative sample of both active and closed clinical records. The administrative staff identified a current census of 12 patients at the time of the survey and an outpatient case volume of 163,191 yearly.

Failure to complete an annual Total Program Evaluation that included a representative sample of both active and closed clinical records could potentially result in the CAH failing to meet the needs of their inpatients and outpatients.

Findings include:

1. Review of the CAH policy titled "Governing Critical Access", dated 10/14, revealed in part, ". . . Annual Review of Critical Access Program. The hospital will conduct an annual review of operations. . . A representative sample (10%) of both active and closed records. . . ."

2. Review of the CAH's administrative documents lacked an annual Total Program Evaluation. The last available Total Program Evaluation was titled "Critical Access Hospital Program 2014 Annual Evaluation" for 7/1/13 to 6/30/14 was completed August 26, 2014 and failed to include a representative sample of both active and closed clinical records of services furnished.

3. During an interview on 9/29/15 at 4:15 PM, Staff Z, Assistant Administrator Quality, stated the CAH was late in getting the annual Total Program Evaluation completed.

During an interview on 9/30/15 at 8:10 AM, Staff B, Assistant Administrator Nursing, acknowledged the lack of an annual Total Program Evaluation that included the number of patients served and the volume of services provided annually. Staff B also acknowledged the last Total Program Evaluation was completed August 26, 2014 for 7/1/13 to 6/30/14 and failed to include a representative sample of both active and closed clinical records of services furnished. Staff B stated the CAH has not completed the annual Total Program Evaluation for 7/1/14 to 6/30/15.

Based on review of documents and administrative staff interviews, the Critical Access Hospital (CAH) failed to complete an annual Total Program Evaluation and failed to annually evaluate, review, and revise the CAH's health care policies as needed. The administrative staff identified a current census of 12 patients at the time of the survey and an outpatient case volume of 163,191 yearly.

Failure to complete an annual Total Program Evaluation and annually evaluate, review, and revise the CAH's health care policies could potentially result in the CAH failing to meet the needs of their inpatients and outpatients.

Findings include:

1. Review of the CAH policy titled "Governing Critical Access", dated 10/14, revealed in part, ". . . Annual Review of Critical Access Program. The hospital will conduct an annual review of operations. . . All policies and procedures that did not change in applicability from existing hospital conditions of participation (COP) have been reviewed and approved by the Critical Access Hospital Advisory Committee and submitted to the Board of Trustees for approval. Those policies and procedures that are department or program specific are current and will continue to be reviewed and updated annually and then submitted to the Critical Access Hospital Advisory Committee for approval. . . ."

2. Review of the CAH's administrative documents lacked an annual Total Program Evaluation. The last available Total Program Evaluation was titled "Critical Access Hospital Program 2014 Annual Evaluation" for 7/1/13 to 6/30/14 was completed August 26, 2014.

3. During an interview on 9/29/15 at 4:15 PM, Staff Z, Assistant Administrator Quality, stated the CAH was late in getting the annual Total Program Evaluation completed.

During an interview on 9/30/15 at 8:10 AM, Staff B, Assistant Administrator Nursing, acknowledged the lack of an annual Total Program Evaluation that included annual review of CAH's policies and procedures. Staff B stated only the table of contents and new policies were available at the annual policy and procedure committee meetings and not the entire policy and procedure manuals. Staff B stated the CAH has not completed the annual Total Program Evaluation for 7/1/14 to 6/30/15.

Based on review of documents and administrative staff interviews, the Critical Access Hospital (CAH) failed to conduct an Total Program Evaluation to develop and implement a periodic, annual evaluation of its total program; and to determine whether the utilization of services was appropriate, established policies were followed, and any changes were made as needed. The administrative staff identified a current census of 12 patients at the time of the survey and an outpatient case volume of 163,191 yearly.

Failure to conduct an annual Total Program Evaluation review could potentially result in the CAH failing to meet the needs of their patients and making policy changes as appropriate.

Findings include:

1. Review of the CAH policy titled "Governing Critical Access", dated 10/14, revealed in part, ". . . Annual Review of Critical Access Program. The hospital will conduct an annual review of operations. . . ."

2. Review of the CAH's administrative documents lacked an annual Total Program Evaluation. The last available Total Program Evaluation was titled "Critical Access Hospital Program 2014 Annual Evaluation" for 7/1/13 to 6/30/14 was completed August 26, 2014 and failed to address the purpose of the evaluation was to determine whether the utilization of services was appropriate, the established policies were followed, and any changes were needed.

3. During an interview on 9/29/15 at 4:15 PM, Staff Z, Assistant Administrator Quality, stated the CAH was late in getting the annual Total Program Evaluation completed.

During an interview on 9/30/15 at 8:10 AM, Staff B, Assistant Administrator Nursing, acknowledged the lack of an annual Total Program Evaluation to determine whether the utilization of services was appropriate, the established policies were followed, and any changes were needed. Staff B stated the last available Total Program Evaluation was titled "Critical Access Hospital Program 2014 Annual Evaluation" for 7/1/13 to 6/30/14 was completed August 26, 2014 and failed to address the purpose of the evaluation was to determine whether the utilization of services was appropriate, the established policies were followed, and any changes were needed. Staff B stated the CAH has not completed the annual Total Program Evaluation for 7/1/14 to 6/30/15.

Based on review of documentation and staff interview, the Critical Access Hospital (CAH) failed to develop, evaluate, and implement an effective Quality Improvement Program to evaluate and improve the quality and appropriateness of patient care and to improve quality on a continuous basis including all the services, including contracted services, offered at the CAH. Concerns with 12 of 23 departments to report to quality measures (Surgery, Physical Therapy, Occupational Therapy, Speech Therapy, Infusion Therapy, Nuclear Medicine, Telemedicine - Cardiology, Sleep Study, Anesthesia, Boone Clinic, Diabetes Education, and Environmental Services)

Failure to have an effective quality improvement program that included involvement of all of the CAH's departments to improve quality on a continuous basis could result in failure to ensure patient care problems were identified, monitored, addressed and improved in each patient care area through the efforts of all involved departments.

Findings include:

1. Review of CAH "Boone County Hospital Integrated Performance Improvement Plan", dated December 2014, revealed in part, ". . . The Boone County Critical Access Hospital freestanding QA/Quality Improvement program, should be facility wide, including all departments and all services provided under contract. . . The goal of performance improvement in the organization is to ensure that the organization designs processes well and systematically monitors, analyzes, and improves its performance to improve patient outcomes. . . ."

2. Review of the CAH's Quality Council meeting minutes dated May 27, 2014 to April 28, 2015 revealed the following information:

a. The CAH lacked reports concerning problem prevention and identification, corrective action taken, and outcome of effective action from the following departments: Physical Therapy, Diabetes Education, Boone Clinic, and Environmental Services.

b. The CAH lacked reports on issues involving patient care from the following departments: Surgery, Occupational Therapy, Speech Therapy, Infusion Therapy, Nuclear Medicine, Telemedicine - Cardiology, Sleep Study, and Anesthesia.

3. During an interview on 9/30/15 at 10:00 AM, Staff Z, Assistant Administrator Quality, confirmed not all departments report to quality problem prevention and identification, corrective actions taken and outcome of effective actions. Staff A also confirmed not all departments reported on issues involving patient care.

Based on review of documentation and staff interview, the Critical Access Hospital (CAH) quality improvement staff failed to evaluate all patient care services provided for 12 of 23 patient care services that included Surgery, Infusion Therapy, Boone Clinic, Diabetes Education, and Environmental Services and contracted services that included Physical Therapy, Occupational Therapy, Speech Therapy, Nuclear Medicine, Telemedicine - Cardiology, Sleep Study, and Anesthesia.

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 "Boone County Hospital Integrated Performance Improvement Plan", dated December 2014, revealed in part, ". . . The Boone County Critical Access Hospital freestanding QA/Quality Improvement program, should be facility wide, including all departments and all services provided under contract. . . The goal of performance improvement in the organization is to ensure that the organization designs processes well and systematically monitors, analyzes, and improves its performance to improve patient outcomes. . . ."

2. Review of the CAH's Quality Council meeting minutes dated May 27, 2014 to April 28, 2015 revealed the following information:

a. The CAH lacked reports concerning problem prevention and identification, corrective action taken, and outcome of effective action from the following departments: Physical Therapy, Diabetes Education, Boone Clinic, and Environmental Services.

b. The CAH lacked reports on issues involving patient care from the following departments: Surgery, Occupational Therapy, Speech Therapy, Infusion Therapy, Nuclear Medicine, Telemedicine - Cardiology, Sleep Study, and Anesthesia.

3. During an interview on 9/30/15 at 10:00 AM, Staff Z, Assistant Administrator Quality, confirmed not all departments report to quality problem prevention and identification, corrective actions taken and outcome of effective actions. Staff A also confirmed not all departments reported on issues involving patient care.

Based on Patient Rights document review, medical record review and staff interviews, the Critical Access Hospital (CAH) failed to ensure patients, inpatients and outpatients were informed of their visitation rights including the ability to receive designated visitors, but not limited to a spouse, a domestic partner (including same-sex domestic partner) and another family member or friend for 4 of 4 current swing bed patients (Patients #1, 2, 3, and 4), 5 of 5 closed swing bed patients (Patients #5, 6, 7, 8, and 9), 8 of 8 current acute inpatients (Patients #10, 11, 12, 13, 14, 15, 16 and 17) and all outpatients. The CAH administrative staff reported a census of approximately 145,000 outpatients visits a year receiving services.
Failure to provide all inpatients, skilled patients and outpatients, with patient rights information could potentially result in limiting/restricting access of visitors to patients that infringed on their right to have a support person present when they are provided any type of care services or treatment modalities.

Findings include:

1. Review of the policy titled "Visitation Policy" effective 4/2015 revealed in part... "Definitions: Members of family include spouses, domestic partners, and both different-sex and same-sex significant others."

2. Review of documents "Swing Bed Program Admission Agreement and Patient's Bill of Rights" revised 3/2006, provided to swing bed patients on admit to the CAH, revealed a lack of documentation regarding his or her consent 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 friend.

Review of documents "Patient Rights and Responsibilities" located in the Patient Handbook, dated 2/2010, provided to acute care patients and outpatients on admit to the CAH, revealed a lack of documentation regarding his or her consent 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 friend

3. Review of documentation in Patient #1, 2, 3, and 4, current swing bed patient's medical records, and closed records for Patient #5, 6, 7, 8 and 9's discharged medical records, revealed documentation staff provided them a copy of the Swing Bed Program Admission Agreement and Patient's Bill of Rights lacking the above information.

4. During an interview on 9/28/15 at 2:35 PM, Staff A, Registered Nurse/ Informatics Technician acknowledged the Swing Bed Patient Rights provided to swing bed patients lacked information for same sex domestic partner.

During an interview on 9/30/15 at 9:45 AM, Staff B, Assistant Administrator, Nursing acknowledged the Patient Rights provided to swing bed patients, acute care patients and outpatients lacked information for same sex domestic partner.