HospitalInspections.org

Based on review of policy, personnel records, and staff interviews the Critical Access Hospital (CAH) failed to have a system in place to ensure 1 of 3 contracted staff Staff G, Sleep Study Technician completed Mandatory Reporting Child and Dependent Adult training in accordance with the CAH policy and Iowa Administrative Code 235B.

Failure to have a system in place to ensure all contracted staff completed the required Mandatory Reporting Child and Dependent Adult training in accordance with the CAH policy and Iowa Administrative Code 235B, could potentially result in the lack of staff identifying and reporting suspected child and dependent adult abuse at the CAH.

Findings include:

1. Review of the policy titled, " Mandatory Reporting - Child and Dependent Adult Training " Revised 1/2013 stated in part, " ...New employees that are required to be certified in Mandatory Reporting and cannot provide evidence of current certification or who have not been certified, must become certified within approximately 30 days of his/her hire date ... "

2. Review of a document titled, "Iowa Administrative Code 235B" included in part, " ... Information education and training requirements...A person required to report cases of dependent adult abuse pursuant to sections of 235B and 235E ...shall complete two hours of training relating to the identification and reporting of dependent adult abuse within 6 months of initial employment ...The person shall complete at least two hours of additional dependent abuse identification and reporting training every five years ..."

3. Review of contracted staff, Staff G, Sleep Study Technician's personnel record lacked documented evidence of Mandatory Reporting Child and Dependent Adult training.

4. During interviews on 8/19/15 and 8/20/15 at 11:00 AM, the Executive Director of Human Resources reported she did not maintain personnel records for contracted staff at the CAH. The Executive Director of Human Resources reported he was unaware of an orientation process for contracted staff and who would be responsible to ensure the contracted staff meet all the requirements to provide services to the patients at the CAH.

During an interview on 8/20/15 at 10:00 AM, the Quality/Employee Health/Infection Control Director reported the contracted sleep study company did not obtain verification Staff G completed the Mandatory Reporting - Child and Dependent Adult Training. The Quality/Employee Health/Infection Control Director reported there is no way to ensure the contracted staff meet all the requirements because she is not always informed when contracted staff are coming into the CAH to provide services to patients. The surveyor did not receive documented evidence to show Staff G completed the Mandatory Reporting - Child and Dependent Adult Training prior to the end of the survey.

Based on observations, review of policies, procedures, documents, and staff interviews the Critical Access Hospital (CAH) Emergency Department (ED) staff failed to perform daily Lifepak 20 defibrillator monitor (An eltectronic device that delivers electric shock to restore the rhythm of a bibrillating heart.) checks to ensure the monitor worked. The ED Nurse Manager identified an average daily patient census of 18 in the emergency department.

Failure to ensure staff performed the daily Lifepak 20 defibrillator monitor checks could potentially result in equipment failure when needed for an emergency life threatening event resulting in a patient's death.

Findings include:

1. Review of a policy titled, "Crash Cart Check/Restocking " revised 6/15 stated in part, "...to ensure properly functioning equipment...are readily available in a life-threatening situation ...an RN will perform the...daily...checks... They will document their initials in the appropriate space on the crash cart/emergency supply check record ...defibrillators - these are checked on a daily basis to assure that the defibrillator will work appropriately on battery ... "

2. Observation on 8/17/15 at 2:55 PM during initial tour of the ED showed a Lifepak 20 defibrillator on a cart in Trauma room #1.

Review of the document titled, "Crash Cart/Emergency Supply Check Record " revealed the following:

a. Lack of documentation to show staff checked the Lifepak 20 defibrillator monitor to ensure thhe monitor functioned properly appropriately for 2 of 31 days in March 2015 (3/12/15 and 3/26/15).

b. Lack of documentation to show staff checked the Lifepak 20 defibrillator monitor to ensure the monitor functioned properly for 1 of 30 days in April 2015 (4/25/15).

c. Lack of documentation to show staff checked the Lifepak 20 defibrillator monitor to ensure the monitor functioned properly for 2 of 31 days in May 2015 (5/4/15 and 5/6/15).

d. Lack of documentation to show staff checked the Lifepak 20 defibrillator monitor to ensure the monitor functioned properly for 6 of 31 days in July 2015 (7/2/15, 7/7/15, 7/9/15, 7/12/15, 7/22/15, and 7/28/15).

e. Lack of documentation to show staff checked the Lifepak 20 defibrillator monitor to ensure the monitor functioned properly for 3 of 17 days in August 2015 (8/8/15, 8/9/15 and 8/14/15).

3. During an interview at the time of observation, the ED Nurse Manager acknowledged the nursing staff failed to perform the Lifepak 20 defibrillator monitor checks on the days identified in accordance with the CAH policy.

Based on review of policy, documents, and staff interviews the Critical Access Hospital (CAH) administrative staff failed to ensure the CAH's emergency fuel and water agreements specified the amount of emergency fuel and water needed and the specific delivery timeframe of the water and fuel to the CAH during an interruption in those services. Administrative staff reported a patient census of 10 at the time of the survey, an average daily census of 7.

Failure to ensure the administrative staff established emergency fuel and water agreements that included the specific amount of fuel and water needed and the delivery timeframe to the CAH during an interruption of fuel and water services could potentially result in the lack of fuel and water at the CAH to provide emergency care and treatment for the inpatients and those patients who arrived in the emergency department seeking emergency care and treatment.

Findings include:

1. Review of a Plant Operations policy titled, "Disruption of Services Department Functions " Revised 5/1999, stated in part, "...If electrical failure should occur ...Emergency water supply can be obtained through Emergency Arrangements by Engineering. Arrangements for delivery of bottled water will be made by Engineering Department ... " The policy failed to ensure the staff identified the readily available supplies at the CAH, the specific amount of fuel and water needed, and the delivery timeframe to the CAH in the event of an interruption of fuel and water services.

2. During a tour of the CAH on 8/18/15 at 9:00 AM, the Plant Operations Manager provided the CAH fuel and water agreement documents. The Plant Operations Manager agreed the CAH fuel and water agreements did not show the specific amount of fuel and water or the delivery timeframe to the CAH in the event of interruption of fuel and water services at the CAH.

3. Review of the document dated 1/19/09 revealed an agreement for emergency fuel. However, the emergency fuel agreement lacked the quantity of fuel needed and the delivery timeframe to the CAH in the event of an interruption of fuel services at the CAH.

Review of the document dated 4/4/12 revealed an agreement for emergency water. However, the emergency water agreement failed to show the agreement was a specific emergency water agreement between the provider and the CAH. The water agreement document lacked the quantity of water needed and the delivery timeframe to the CAH in the event of an interruption of water services at the CAH.

4. During an interview on 8/19/15 at 3:15 PM, the Emergency Department Manager reported she played the lead role in the development of the CAH's emergency disaster plans. The Emergency Department Manager reported the CAH's emergency disaster situations did not include emergency fuel and water needs in the event of an interruption of fuel and water services at the CAH.

5. The Administrative Assistant, Staff S provided two emergency water agreements found in Administration. Review of one of the documents dated 12/23/04 revealed an agreement for emergency water. However, the emergency water agreement failed to show the agreement was a specific emergency water agreement between the provider and the CAH. The water agreement document lacked the quantity of water needed and the delivery timeframe to the CAH in the event of an interruption of water services at the CAH. Review of the second document dated 4/15/09 revealed an agreement for emergency water. However, the emergency water agreement failed to show the agreement was a specific emergency water agreement between the provider and the CAH. The water agreement document lacked the quantity of water needed and the delivery timeframe to the CAH in the event of an interruption of water services at the CAH.

6. During an interview on 8/20/15 at 9:45 AM, the Plant Operations Manager reported the company on the agreement dated 12/23/04 is no longer in business. The Plant Operations Manager reported the emergency water agreement dated 4/15/09 is the agreement that was renewed on 5/1/15 and is the emergency water agreement for the CAH. When asked for the new emergency water agreement, the Plant Operations Manager reported the CAH did not receive a renewed 5/1/15 written emergency water agreement. The administrative staff did not provide emergency fuel and water agreements that showed the quantity of fuel and water needed and the delivery timeframe to the CAH in the event of an interruption of water services at the CAH.

Based on review of Board of Directors By-laws, Medical Staff By-laws, Board of Directors meeting minutes, Medical Staff meeting minutes, documents, and interview with staff, the Board of Directors (governing body) failed to ensure the Medical Staff as well as the Board of Directors themselves administered policies to determine and maintain quality health care at the Critical Access Hospital, (CAH). The CAH administrative staff identified a current census of 10 patients at the time of the survey and an outpatient case volume of 109,492 patients yearly.

1. The Board of Directors failed to assure all policies and procedures were reviewed annually by the required group of professionals and during the Annual Program Evaluation. (Refer to C-272, and C-334)

2. The Board of Directors failed to ensure the quality improvement program included a system to identify new problem identification and data analysis of all patient care services that included 9 contracted services and the emergency department services. (Refer to C-337)

The Board of Directors failed to ensure all physicians received outside entity peer review prior to reappointment to the Medical Staff. (Refer to C-340)

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

Based on review of Critical Access Committee meeting minutes, policies, and staff interview, the Critical Access Hospital (CAH) failed to ensure the required group of professionals reviewed all patient care policies for 21 of 21 patient care departments. The departments included Laboratory; Pharmacy; Health Information; Acute Care; Plant Operations; Ambulance Services; Emergency Services; Cardiac and Pulmonary Rehabilitation; Sleep Lab; Digital Mammography; Nutrition Consultation; Obstetrics; Occupational Therapy; Physical Therapy Services; Radiology Services; Cardiopulmonary Services; Admissions; Environmental Services; Infection Control; Contractual Services Nuclear Medicine; Stereotactic Biopsy and Magnetic Resonance Imaging. The CAH administrative staff identified a current census of 10 patients at the time of the survey and an outpatient case volume of 109,492 patients yearly.

Failure to ensure the required group of professionals reviewed all patient care policies for 21 of 21 departments could potentially result in failure to develop and implement new policies and procedures if needed regarding patients needs and/or opportunities to update policies and procedures if needed.

Findings include:

1. Review of policy titled, "Critical Access Hospital Committee" revised 7/15 stated in part, ..."The Critical Access Hospital Committee serves as an oversight committee for the CAH coordination. Policies and procedures are developed with the advice and approval of this group of professionals...the CAH committee shall...approval annual policy and procedure revisions for all patient services departments..."

2. Review of CAH Annual Program Evaluation meeting minutes from July 1, 2013 through June 30, 2015 lacked documented evidence of a policy and procedure review by the CAH Advisory Council.

3. During an interview on 8/18/15 at 10:45 AM, Staff I, Quality Assurance Director, said she was responsible for submitting information to the CAH committee regarding changes, revisions and formulation of new policies and procedures. She acknowledged the CAH Annual Program Evaluation meeting minutes lacked documented evidence of policy and procedure review by the CAH Advisory Council for the past 2 years. Staff I said they were currently developing forms to improve the process because she was aware that this was a problem. She acknowledged their policy clearly directed the CAH committee will meet annually and review all policies.

Based on observations, review of policies, documents, and staff interviews the Critical Access Hospital (CAH) administrative staff failed to ensure dietary staff used good infection control/sanitary practices during food handling and patient meal service. Staff reported a census of 10 patients at the time of the survey. The Director of Nutrition Services reported the dietary staff served an average of 22 patient meals daily.

Failure to ensure staff used good infection control/sanitary practices during food handling and meal service could potentially result in contamination of food served to patients, staff and visitors.

Findings include:

1. Review of a policy titled, " Infection Control " Revised 8/2014 stated in part, " ...Plastic disposable gloves will be worn by food service employees ...If the glove is contaminated it will be replaced with a fresh glove before handling food or working in the preparations or service area ... "

2. Review of the documents presented to the dietary staff during an in service showed the following:

a. A document titled, " Food Safety Staff In Service " dated 4/9/15 stated in part, " ...showed staff should change gloves with a change in tasks ... "

b. A document titled, " 2013 Food Code " dated 2/21/14 stated in part, " ...Showed the need to sanitize hands before donning gloves ...to wash hands and change gloves if tasks change ... "

c. The Food Code, published by the Food and Drug Administration edition 2005 and 2013 included in part, " ...Required gloves to be used for only one task and discard when damaged or soiled ...or when interruptions occur in the operation ...hands must be washed before donning gloves when working with food ... "

3. Observation on 8/18/15 at 11:25 AM during food preparation showed the following:

a. Staff N, Cook donned gloves, measured food temperatures, touched countertops, saran wrap box, utility cart, the microwave pot holders, bucket that held sanitizer and a cloth. Staff N with the same potentially contaminated gloves touched a grilled cheese sandwich, a baked potato, and a bread stick as Staff N placed each food item on the patient's plate.

b. Staff O, Baker/Dishwasher touched the refrigerator handles, microwave, utility cart, and without sanitizing hands, donned gloves. Staff O working in the patient meal tray line, wearing the potentially contaminated gloves removed dinner rolls from a bag for the patient's meal.

4. During an interview on 8/20/15 at 9:00 AM, the Director of Nutrition Services reported dietary staff are trained to wear gloves when handling food and to change gloves when they become soiled or in contact with contaminated surfaces. The Director of Nutrition Services reported all dietary staff should wash their hands prior to donning gloves.

II. Based on review of policies, documents, and staff interview the Critical Access Hospital (CAH) administrative staff failed to ensure the CAH had a system in place to monitor the contract employee's personnel records to ensure contract staff heath examinations were completed.

Failure to ensure the CAH had a system in place that included monitoring of the contracted staff personnel health examinations could potentially result in causing harm to patients in the event of an unknown staff 's exposure and transmission of communicable diseases to the patients. The CAH failed to ensure 1 of 3 contracted staff reviewed had documented evidence of a health examination. (Staff F, Sleep Study Technician)

Findings Include:

1. Review of policy titled, " Employee Health " dated 6/2014 stated in part, " ...In order to prevent the spread of infection and communicable disease ...required to conduct a health examination prior to employment ...every ...contract employee ...must undergo an examination before the first day scheduled ... "

2. Review of Staff F, Sleep Study Technician personnel record lacked documented evidence of a health examination.

3. During interviews on 8/19/15 at 1:20 PM and 8/20/15 at 11:00 AM, the Executive Director of Human Resources reported he did not maintain personnel records for contracted staff at the CAH. The Executive Director of Human Resources reported he was unaware of an orientation process for contracted staff and who would be responsible to ensure the contracted staff meet all the requirements to provide services to the patients at the CAH.

During an interview on 8/20/15 at 10:00 AM, the Quality/Employee Health/Infection Control Director reported the contracted sleep study company did not obtain verification Staff F had a current health exam. The Quality/Employee Health/Infection Control Director reported there is no way to ensure the contracted staff meet all the requirements because she is not always informed when contracted staff are coming into the CAH to provide services to patients. The surveyor did not receive documented evidence to show Staff F had a current health examination prior to the end of the survey.



22898

III. Based on observation, review of documents, and interview with staff, the Critical Access Hospital (CAH) failed to date the glucometer control solution at the time the bottle was initially opened. The control solutions were used by staff to test the accuracy of the glucometers in the acute care and obstetrics units prior to patient testing.

Failure to date the control solutions used could result in unreliable results when testing the glucometers in the acute care and obstetrics units and allow inaccurate results when checking the blood glucose of patients. Inaccurate test results could potentially cause inappropriate treatment and result in severe adverse outcomes.

Findings include:

1. Observation on 8/17/15 at 10:10 AM, with Staff D, RN Director of Nursing, revealed the high and low control bottles for the glucometer on the acute care unit lacked the date the bottles were initially opened.

2. Observation on 8/17/15 at 1:30 PM, with Staff D, revealed the bottles for the high and low control solutions for checking the glucometer lacked the date the bottles were initially opened.

3. Review of the product insert for Accu-Chek Inform II Control solutions used to test the glucometers included the following guidance. " Testing control solutions with known glucose levels establish that the operator and the system are performing acceptably. Control results must be within the defined acceptable range before valid patient testing is allowed. Note: Write the date the bottle was opened on the bottle label. The control solution is stable for 3 months from that date or until the "Use by" date on the bottle label, whichever comes first."

4. Review of the CAH policy titled Accu-Chek Blood Inform II Glucose Monitor Testing, dated February 2014, lacked guidance to staff related to the use of the high and low control solutions prior to testing patients or to dating of control solutions when initially opened.

5. During an interview on 8/17/15 at 1:30 PM, Staff D acknowledged a lack of the dates the solutions were initially opened on the labels of the control solutions.

Based on review of Medical Staff By-laws, medical records, and staff interview, the Critical Access (CAH) administrative staff failed to ensure emergency department providers dated and/or timed all medical record entries for 3 of 3 active medical records (Patient # 9, #10, and #11) and 5 of 5 closed medical records (Patient's #12, #13, #14, #15, and #16). The Emergency Department (ED) Services Director identified a census of 3 ED patients at the time of the survey and an average daily ED census of approximately 18 patients.

Failure to ensure ED physicians documented the time and date each physician entry could potentially impact continuity of care and services that are based on time intervals or time lines.

Findings include:

1. Review of Medical Staff Bylaws amended 12/15/08 stated in part, "...The attending physician shall be responsible for the preparation of a complete...medical record for each patient...all clinical entries in the patient's medical record shall be accurately dated, timed..."

2. Review of 3 of 3 active ED medical records revealed ED physician's failed to date and/or time all physician assessments prior to the patients discharge and discharge instructions (Patients # 9, #10, and #11).

3. Review of 5 of 5 closed ED medical records revealed ED physician's failed to date and/or time all physician assessments prior to the patients discharge and discharge instructions (Patients #12, #13, #14, #15, and #16).

4. During an interview on 8/18/15 at 7:30 AM, Staff I, Quality Director acknowledged ED physicians failed to date and time the medical record entries for the patients identified in active and closed medical record review and said the Medical Staff Bylaws directed physicians to date and time all medical record entries.

5. During an interview on 8/18/15 at 11:05 AM, Staff M, ED Nurse Manager acknowledged ED physicians failed to date and time the physician assessments prior to the patients discharge and discharged instructions for the patients identified in active and closed medical record review.

Based on observation, review of documents, and interviews with staff, the Critical Access Hospital (CAH) failed to secure documents containing patient information from unauthorized users. The CAH identified an inpatient census of 10 at the time of the survey.

Failure to secure patient information from unauthorized users could potentially result in persons accessing patients private medical and identity information when they have no need to know that information.

Findings include:

1. Observation on 8/17/15 at 1:30 PM, with Staff P, RN (registered nurse) and Staff D, RN Director of Nursing Officer revealed a cardboard box on the floor under the nursing station desk in the obstetrics unit. The box contained patient information and documents waiting to be shredded.

During an interview at the time of the observation, Staff P, acknowledged the box contained materials to be shredded and reported the box was emptied daily. Review of the box's contents revealed patient information dated 8/11/15. Additional information revealed the obstetrics department was closed on 8/16/15 and reopened 8/17/15, leaving the unsecured cardboard box accessible to anyone who entered the department. Interview at 1:30 PM, with Staff D, Director of Nursing, revealed she was unaware of the unsecured patient information in the OB department.

Review of the undated Access List for the obstetrics unit showed the list of the staff from other areas in the CAH had badge access to enter the obstetrics unit. The list included staff from the following units: Laboratory; Radiology; Cardiopulmonary; Nursing Administration; Acute Care; Surgery; Emergency Department; Specialty Clinic; Ultrasound; Pharmacy; Anesthesia; BioMed; Housekeeping; and the Physicians.

2. Observation on 8/18/15 at 10:30 AM, with Staff T, Surgery Manager, and Staff D revealed a storeroom in the surgery department containing 7 log books from anesthesia, surgery, post anesthesia care unit, and outpatient services. All the log books, dated 2005-2013, contained private patient information and were unsecured in the storeroom. Surgery is a secured unit but housekeeping has access using their badges. During an interview with Staff T and Staff D, they acknowledged the log books were unsecured and contained private patient identity and medical information.

3. Review of the policy titled, "Collection of Confidential Patient Information for Shredding", dated 10/11, showed it included the following statement. All confidential patient information in paper form must be placed in a locked shred bin to be destroyed after its use..."

Based on medical record review, policy and procedure review, and staff interview, the critical access hospital (CAH) failed to follow the CAH's policies to ensure that all same day surgical patients had a responsible adult to drive the patient home at the time of discharge for 8 of 15 sampled surgical patients receiving same day surgical procedures (Patient #17, #18, #19, #20, #21, #22, #23, and #24). Findings include:

1. The CAH nursing staff failed to follow its policies and allowed Patient #23 to drive himself/herself home following discharge from the CAH without the operating surgeon's prior authorization. (Refer to C-325) The CAH nursing staff failed to document information regarding the presence of a responsible adult with the same day surgical patient at the time the patient was discharged from the CAH for Patients #17, #18, #19, #20, #21, #22, and #24. (Refer to C325)
The cumulative effect of the CAH and its nursing staff's failure to ensure each day surgery patient had a responsible adult to drive each day surgery patient home at the time of their discharge resulted in the CAH's inability to ensure each of these patients arrived at home or an alternate destination safely without potentially endangering the day surgery patients and the public.

Based on medical record review, policy review, and staff interview, the CAH (Critical Access Hospital) failed to follow the CAH's policy to ensure all patients receiving anesthesia during outpatient surgical procedures were discharged in the company of a responsible adult to drive the patient home after discharge. The medical records for 8 of 15 sampled closed surgical patients lacked documentation showing there was an accompanying adult with them at discharge to drive them home from the same day surgery unit (Patient #17, #18, #19, #20, #21, #22, #23, and #24). One patient, Patient #23, was allowed to drive home on the day of surgery without a responsible adult. The CAH reported approximately 608 surgeries were conducted at the CAH in the past year.

A post-operative patient is not safe to drive after receiving anesthesia and pain medications during and after the procedure. Failure of the CAH to ensure each post- surgical patient has a responsible adult to drive the patient home when discharged on the day of the surgical procedure could potentially result in harm to the patient and others in the community if the patient was allowed to leave without a responsible adult to drive them home.

Findings include:

1. General anesthesia is used to place the surgical patient in a deep state of sleep with high potency medications. The patient may be given narcotic medications for pain relief after surgery. The CAH had policies in place to ensure same day surgery patients were not allowed to drive themselves home on the day of the surgical procedure.

a. The CAH's policy titled, "Dismissal and Transportation from Post Anesthesia Care Unit", last revised 3/13, included the following requirement related to discharge of a surgical patient. The patient must be accompanied by a responsible adult.

b. The CAH's policy titled, "Outpatient 2 (Same Day) - Ambulatory Surgery Procedure, last revised 3/13, the section titled "Dismissal of Patient" included in part, "...Patient must be accompanied by someone who can drive them home. Patients "WILL NOT" be allowed to drive themselves home. A cab is called for patients who do not have a driver and it has been approved by the surgeon prior to the procedure..."

c. The CAH's Outpatient (Ambulatory Surgery Procedure), last revised 3/13, included the following item in the list of directions for discharge. The patient will be accompanied by a significant other.

d. The CAH's Same Day Surgery Discharge Instructions for People Who Have Had General Anesthesia or Sedation, dated 11/97, included the following information for same day surgical patients. The medicine which was used to put him/her to sleep will be acting in his/her body for the 24 next hours, so he/she might feel a little sleepy. This feeling will slowly wear off. Because the medicine is still in his/her system for the next 24 hours, the adult person should not:

Drive a car or operate machinery or power tools. Following additional items that the patient should not do for the next 24 hours, an added caution was printed in bold print. It stated...We strongly suggest that a responsible adult be with this person for the rest of the day and night for his/her protection and safety.

2. Patient #23 was allowed to drive himself/herself home after day surgery on 8/1/15.

Patient #23 presented to the CAH's ED (Emergency Department) on 7/31/15 for right upper quadrant abdominal pain. The patient had a CT (computerized tomography) scan and was diagnosed with gall bladder disease. The patient was treated and released. On 8/1/5, the patient presented to the ED again with worsening right upper quadrant abdominal pain and was admitted to observation as an outpatient for acute gallbladder disease and surgery.

Patient #23 was admitted to the CAH as an outpatient on 8/1/15 for a laparoscopic cholecystectomy, a procedure in which the gallbladder is removed by laparoscopic techniques through small incisions. Patient's #23's Pre-Surgical orders, dated 8/1/15, were initiated at 9:25 AM. The Anesthesia Record dated 8/1/15 recorded the patient had general anesthesia the anesthesia start time was 9:37 AM and the anesthesia stop time was 10:48 AM. The procedure ended at 10:50 AM.

Patient #23's Progress notes dated 8/1/15 revealed Patient #23 returned to the nursing unit following surgery and post-op recovery at 11:40 AM. At 12:42 PM, the patient complained of severe abdominal pain. Staff R, registered nurse (RN), administered two Hydrocodone/APAP 5/325 tablets, an oral narcotic pain medication at 12:54 PM. The medical record for the patient revealed two additional tablets of the Hydrocodone/APAP 5/325 tablets pills were administered by Staff R at 4:47 PM.

Patient #23's progress notes revealed, 2 milligrams (MG) of Morphine, a narcotic pain medication was administered by Staff R at 12:20 PM through the patient's intravenous (IV) line. The progress notes revealed Staff R administered Toradol 15 MG through the patient's IV line at 6:55 PM prior to discontinuing the Patient's IV access. Toradol is a nonsteroidal anti-inflammatory drug for pain and its side effects include dizziness and drowsiness.

Patient#23's progress notes in the medical record included an entry by Staff R, at 6:35 PM. " Patient states, "I'm driving myself home. It's ok, I'll be fine." Staff R called Practitioner E, a family practice physician at the CAH. Practitioner E was not the practitioner who performed the surgical procedure for Patient #23. Staff R asked the physician about the patient driving home alone. Practitioner E said this is ok as long as he/she lives within the city limits. Staff R verified with the patient that the patient lived in Denison. Patient #23's medical record lacked a physician order for discharge at the time of the survey.

At 6:59 PM, Staff R reviewed the discharge instructions with the patient and the patient expressed understanding of the instructions. At 7:12 PM, Patient #23 was discharged from the CAH. Staff R assisted the patient by wheelchair to his/her private car. Patient #23's medical record lacked acknowledgement of post op follow-up by CAH staff, or calls regarding the patient's safe arrival at home after discharge. The patient's Post-Operative Home Instructions - Lap Cholecystectomy dated 8/1/15 lacked documentation on how Patient #23 left the CAH after discharge on 8/1/15.

Patient #23's Discharge Summary, dated 8/1/15, by Practitioner E included the following information ...Hospital Course: Patient was admitted in the early morning of August 1 secondary to abdominal pain. The patient had cholecystitis (inflammation of the gallbladder) and cholelithiasis (gallstones). A surgeon was consulted and then performed laparoscopy and removed the patient's gallbladder. Today patient continued to improve. By evening she was ready to be discharged. Patient had no concerns.

The patient's Post-Operative Home Instructions - Lap Cholecystectomy dated 8/1/15 lacked information on how Patient #23 left the CAH after discharge on 8/1/15.

3. The following staff interviews were conducted as part of the survey. The interviews were related to the care and discharge of Patient #23 on 8/1/15

a. During an interview on 8/20/15 at 9:00 AM, Staff D, the RN Director of Nursing, acknowledged Patient #23's medical record showed he/she drove himself/herself home after same day surgery with general anesthesia. Practitioner E, a locum physician at the CAH with a start date of 7/17/15 at the CAH, did give the order to discharge but the patient's medical record lacked a written order to discharge the patient. A locum physician is a physician who works in the place of the regular physician when that physician is absent, or when a hospital/practice is short-staffed.

b. During an interview on 8/20/15 at 10:20 AM, Staff R, RN, the nurse that discharged Patient #23, reported the patient lacked a phone and the nurse had offered the patient her own personal phone. Patient #23 stated she was going to drive home alone, the patient 's significant other was home with the patient's three children and had no drivers license. The patient was new in town and had no friends to call for a ride. Staff R called Practitioner E, who had rounded on Patient #23 several times during the day. The physician asked the nurse if Patient #23 lived in town. Staff R verified that Patient #23 lived in town, was not dizzy or groggy, and did not want to stay at the hospital any longer. Staff R questioned the discharge order and contacted Staff Q (RN, House Supervisor) who agreed with the discharge.

c. During an interview on 8/20/15 at 11:20 AM, Staff Q reported the patient had no one to call for a ride home. Staff Q added the fact that, typically patients do not drive themselves home after surgery but the patient was very alert. Staff Q said she thought the patient would be OK to go home and added she felt sorry for the patient. Staff Q commented that patients may have driven themselves home after surgery in the past. It doesn't happen a lot but there may have been an instance in the past with a discharge of surgical patient on the day of surgery. Staff Q was unable to provide any additional information. Staff Q added that Practitioner E had rounded on Patient #23 several times during that day.

d. During an interview on 8/20/15 at 2:40 PM, with Practitioner E, the discharging physician reported Patient #23 was an early AM admit, had surgery for removal of her gallbladder and had few changes during the day. The patient was cognitive, awake, looked good, and did not want to stay another day at the hospital. I saw no reason why the patient could not be discharged and drive home. I talked with him/her, saw him/her that evening, she looked stable to me. The patient's eyes were not drooping and there was no slurring of speech. When asked about the pain medication the patient received during the day, Practitioner E was unaware of how Toradol would affect the patient's driving but agreed the Hydrocodone could impair his/her driving.

e. During an interview on 8/20/15 at 3:00 PM, Staff F, CRNA (Certified Registered Nurse Anesthetist) revealed he was the CRNA assigned to the surgery and he remembered the case. It was a normal surgical case for gallbladder removal. The patient was given Versed, lidocaine, Propofol, Fentanyl, and Zemuron (drugs are used by anesthesia professionals to produce a deep sleep required for surgical procedures). These drugs are metabolized in less than hour with the exception being Zemuron. Neostigmine is used to reverse the Zemuron. He reported surgical patients are advised not to drive after anesthesia and the same advice is given to all patients.

4. The additional patients identified in the sample lacked documentation verifying the patients were discharged with a responsible person to drive them home.

a. Patient #17 was admitted on 7/2/15 for left knee arthroscopy. The surgeon inserts a narrow tube attached to a fiber-optic video camera through a small incision of about a 1/4th inch. The view inside the joint is transmitted to a high-definition video monitor allowing the surgeon to inspect, diagnose, and treat orthopedic problems in the patient's knee joint. The patient had general anesthesia for the procedure. The patient's Surgical Dismissal Instructions, dated 7/2/15, lacked documentation of the identity of the responsible adult that accompanied Patient #17 home. Discharge instructions for the patient included no driving for 3-5 days.

b. Patient #18 was admitted on 7/9/15 for a laparoscopic cholecystectomy. The patient had general anesthesia for the surgical procedure. The patient's Surgical Dismissal Instruction Sheet dated 7/9/15, lacked documentation of the person accompanying Patient #18 home. The instructions included a section for the patient to avoid driving or operating machinery section that was not marked.

c. Patient # 19 was admitted on 7/17/15 for ORIF (Open Reduction and Internal Fixation) of the left great toe. The patient received general anesthesia for the procedure. The patient's Discharge Instructions, dated 7/17/15, lacked documentation showing how the patient left the CAH or the identity of the responsible adult taking the patient home and the information for the patient to avoid driving or operating machinery.

d. Patient #20 was admitted on 7/22/15 for laparoscopic cholecystectomy with general anesthesia. Documentation of the Patient's discharge found in the Patient Progress notes, dated 7/22/15, revealed the patient was discharged home. The patient's medical record lacked discharge instructions. The dismissal sheet was signed and indicated a follow-up appointment was made for patient. The patient's medical record lacked information on the condition of the patient, how Patient #20 left the CAH, and the identity of a responsible adult taking the patient home.

e. Patient #21 was admitted on 7/15/15 for a hernia repair. A hernia occurs when an organ or fatty tissue squeezes through a weak spot in a surrounding muscle or connective tissue called fascia. The patient had general aanesthesia for the procedure. The patient's Surgical Dismissal Instruction Sheet, dated 7/15/15 included a section for avoid driving or operating machinery section but the section was not completed. The patient's medical records lacked information on how the patient left the CAH and the responsible person accompanying the patient home.

f. Patient #22 was admitted on 8/4/15 for Carpal Tunnel Release on both wrists with general anesthesia and local anesthesia. Carpal tunnel syndrome is caused by a pinched nerve in the wrist. The patient's Surgical Dismissal Instruction, dated 8/4/15, included a section for the patient to avoid driving or operating machinery but the section was not completed. The document lacked the information on how the patient left the CAH and the adult accompanying the patient home.

g. Patient #24 was admitted on 7/2/15 for removal of Left foot fibroma (a fibrous growth containing nerves) with general anesthesia. The Post-Operative Instructions dated 7/2/15 lacked information related to driving or operating machinery and how the patient left the CAH and the accompanying the patient home.

Based on review of the Quality Improvement Plan, Quality Improvement activities, Board of Trustee Bylaws and meeting minutes, Credential files, and staff interviews, the Critical Access Hospital (CAH) quality improvement staff failed to ensure the quality program included a system to identify new problem identification and data analysis for all patient care areas to the Board of Directors, Medical Staff, and the CAH committee. The CAH administrative staff identified a current census of 10 patients at the time of the survey and an outpatient case volume of 109,492 patients yearly, an average daily census of 7 and an out patient case volume of 93 patients monthly.

The CAH identified 8 active physicians, 9 affiliate physicians, 26 courtesy physicians and 36 consulting physicians credentialed to provide services to CAH patients.

1. The Quality Improvement staff failed to assure all policies and procedures were reviewed annually by the required group of professionals annually and at the Annual Program Evaluation. (Refer to C-334)

2. The Quality Improvement staff failed to ensure the quality improvement program included a system to identify new problem identification and data analysis of all patient care services that included 9 contracted services and the emergency department services. (Refer to C-337)

3. The Quality Improvement staff failed to ensure all physicians received outside entity peer review prior to reappointment to the Medical Staff. (Refer to C-340)

The cumulative effect of these systemic failures and deficient practices resulted in the CAH's inability to ensure the evaluation of the services provided to the inpatients and outpatients of the CAH and would suggest a system breakdown resulting in this condition level deficiency.

Based on review of policies, procedures and staff interview, the Critical Access Hospital
(CAH) failed to review policies and procedures at the Annual Program Evaluation to determine established policies were followed and any changes were made as needed. The CAH administrative staff identified a current census of 10 patients at the time of the survey and an outpatient case volume of 109,492 patients yearly.

Failure to develop and implement a total program evaluation that evaluated current, newly developed, and/or revisions to CAH policies and procedures could potentially result in failing to determine whether the utilization of patient care services was appropriate, the established policies were followed, and any changes to policies are revised directly impacting the CAH's ability to meet the needs of all patients.

Findings include:

1. Review of policy titled "Annual Program Evaluation" revised 10/12, revealed the following in part, ..."The Critical Access Hospital carries out or arranges for a periodic evaluation of its total program to determine...the established policies and procedures were followed, and if any changes are needed...The annual program evaluation will be performed by the CAH committee...the CAH committee will meet during the first quarter of each fiscal year. Information reviewed will include: ...review of policies and procedures."

2. Review of CAH total program meeting minutes lacked documented evidence of review of CAH policies and procedures since October, 2012.

3. During an interview on 8/18/15 at 11:15 AM, Staff I, Quality Assurance Director acknowledged the CAH failed to review policies and procedures for all services at the annual program evaluation. Staff I reported if the departments had reported any changes or revisions to policies there would be nothing "formally" documented.

Based on review of Quality Improvement Plan (QIP), Board of Trustee Bylaws, Quality Committee Board meeting minutes and administrative staff interview the Critical Access Hospital (CAH) failed to develop, evaluate and implement an effective Quality Assurance Program to identify new and ongoing quality and appropriateness of patient care on a continuous basis including all services offered. The CAH identified 9 of 21 departments reported quality measures.

Failure to have an effective quality assurance program that included new problem areas for identification, monitoring, implementing corrective actions and data collection to improve quality of care and services on a continuous basis could potentially expose patients to inappropriate and/or substandard care.

Findings include:

1. Review of document titled, "Quality Improvement Plan" undated, stated in part, "...The Quality Committee of the Board will...review, discuss and trend or identify additional opportunities for improvement from various Quality Monitoring activities...identify and ensure that performance improvement reports/information are provided to the medical staff via their departments as appropriate..."

2. Review of the document titled, "Board of Trustee Bylaws" dated 6/2012 stated in part, "...The Quality of Service Committee shall meet....and be responsible for...review of the quality of service provided to consumers...make recommendations to the Medical Staff, Board of Trustees and Administration relative to improvement of the quality of services provided by all service areas...provide an annual report to the Board of Trustees related to accomplishments and shortfalls with respect to Quality of Services..."

3. Review of the document titled, "Medical Staff Bylaws" dated 12/08 stated in part, "...Conduct quality assurance activities in accordance with the Hospital's Quality Assurance Plan. The Quality Assurance Plan shall be implemented to carry out a systematic process for evaluating the quality of treatment of patients...evaluation shall include...routine collection of information about important aspects of patient care...periodic assessment of this information to identify opportunities to improve care and to identify problems in patient care...development of objective criteria for monitoring and evaluation, that reflect current knowledge and clinical experience..."

4. Review of the documents titled, "Quality Council Meeting Minutes" from July 2013 to July 2015 lacked documented evidence the Nuclear Medicine, Stereotactic Biopsy, Magnetic resonance imaging (MRI), Cardiac and Pulmonary Rehabilitation, Mammography, Respiratory Therapy, Sleep Study and emergency department services monitored and evaluated new problems/activities regarding patient care services and/or that the departments changed quality monitors.

5. Review of the documents titled, "Quality Committee of the Board of Trustees meeting minutes" from July 2014 to July 2015 revealed the Quality Director reviewed the quality measures however, the statistics reported were based on the same quality monitors for 8 of 21 departments including Nuclear Medicine, Stereotactic Biopsy, Magnetic resonance imaging (MRI), Cardiac and Pulmonary Rehabilitation, Mammography, Respiratory Therapy, Sleep Study). Concerns were also identified for Emergency room services. The meeting minutes lacked documented evidence that all departments within the CAH changed quality monitors.

6. During an interview on 8/20/15 at 9:00 AM, Staff I, Quality Assurance Director acknowledged the Quality Improvement Committee failed to conduct quality studies that are continuous and changing. She said there would be no evidence of the "true" picture of their quality improvement program presented to the Quality Council Committee and Board because the quality monitors did not change in over 2 years. Staff I acknowledged although the 11 of 21 departments identified were conducting quality improvement activities they were not changing the quality measures to identify and address new and/or ongoing problems in each area to ensure all patient care services were reviewed for appropriateness of treatments. She acknowledged the Quality reports to the Medical Staff lacked documented evidence of the "true" picture of their quality improvement program as well.

7. During an interview on 8/20/15 at 9:40 AM, the Chief Nursing Officer (CNO) acknowledged the Quality Improvement Committee failed to ensure systems were in place to identify new or ongoing problems for 9 of 21 departments. She said these departments were not conducting quality activities according to the QIP plan and CAH policy/procedures. The CNO said they had been discussing the concerns for the past 2 months and intended on taking actions to remedy the situation.

Based on review of the Quality Improvement Plan, policies/procedures, Quality Manager job descriptions, Quality Improvement activities, and staff interviews, the Critical Access Hospital (CAH) quality improvement staff failed to ensure the quality program included a system to identify new problem identification and data analysis of all patient care services provided for 10 of 21 patient care services that included 8 contracted services (Nuclear Medicine, Stereotactic Biopsy, Magnetic resonance imaging (MRI), Cardiac and Pulmonary Rehabilitation, Mammography, Respiratory Therapy, Sleep Study). Concerns were also identified for Emergency room services.

The Quality Director and Chief Nursing Officer (CNO) reported the following monthly census for the departments identified:
Nuclear Medicine: 182 patients yearly
Stereotactic Biopsy: 3 patients yearly
MRI: 829 patients yearly
Cardiac Rehab: 1, 702 patients yearly
Pulmonary rehab (including Sleep study, EKG and EEG [electrocardiogram] services): 109 patients yearly
Mammography: 1,420 patients yearly
Respiratory therapy: 3,062 procedures yearly
Emergency Services: Approximately 6,570 patients yearly.

Failure to identify new problem identification and data analysis of all patient care services could potentially expose patients to inappropriate and/or substandard care.

Findings include:

1. Review of CAH policy titled "Quality Improvement Plan" (QIP), undated, revealed the following in part, ..."the optimal approach to quality care involves multiple department...to establish and effectively implement the processes and mechanisms that comprise the QIP plan...potential processes are identified by the hospital's leadership team for...designs, redesign, or improvement...to minimize risk for patients...the Quality Committee will...review, discuss and trend or identify additional opportunities for improvement from various Quality Monitoring activities."

2. Review of CAH policy titled "Quality Assessment Performance and Improvement Program" (QAPI), reviewed 1/15, revealed the following in part, "...The purpose of the program is to improve health outcomes and provide for patient safety...Professional staff are responsible for monitoring and evaluation of the quality of patient care and services. Analysis of this data allows the department to identify trends, process variations and assess performance patterns. The data is used in performance improvement to make changes in processes or programs."

3. Review of document titled "Quality Manager Job Description' dated 3/13, revealed the following in part, "...Provides planning, leadership, and management of health plan quality assessment and performance improvement (QAPI) activities...review and evaluate effectiveness of QI efforts and initiatives to improve the health and safety of Crawford County Memorial Hospital (CCMH) patients...coordinate the hospital wide QAPI program."

3. Review of Quality Committee Meeting minutes from July 2013 to July 2015 lacked evidence that Nuclear Medicine, Stereotactic Biopsy, Magnetic resonance imaging (MRI), Cardiac and Pulmonary Rehabilitation, Mammography, Respiratory Therapy, Sleep Study and emergency room services monitored and evaluated new problems/activities regarding patient care services.

4. During an interview on 8/17/15 at 1:45 PM, Staff M, Emergency Services Director said the quality indicators they were monitoring in their department had not changed nor had there been revisions in goals for "some time". She said although they were following the core measures from Centers for Medicare Services (CMS) they were not identifying new quality measures within their department that were patient specific.

5. During an interview on 8/19/15 at 3:00 PM, Staff I, Quality Assurance Director, acknowledged the QAPI committee failed to ensure the quality activities for Nuclear Medicine, Stereotactic Biopsy, Magnetic resonance imaging (MRI), Cardiac and Pulmonary Rehabilitation, Mammography, Respiratory Therapy, Sleep Study and emergency room services included new problem identification and data analysis of all patient care services provided by their departments. She said department heads in each area identified had been monitoring the same quality indicators for 2 years and she was aware they were struggling to include new areas for identifying Quality Improvement activities. Staff I acknowledged the current system for QAPI failed to ensure new problems that assessed all areas of patient care activities. She said problems and activities should have changed, the committee is responsible to collaborate with all departments for identifying new problems and they failed to change them to ensure they were patient specific and ongoing data analysis for all departments.

6. During an interview on 8/20/15 at 9:35 AM, the CNO acknowledged the QAPI committee failed to ensure the quality activities for the departments identified were not identifying, conducting, and making process changes or programs to identify new projects for quality improvement that affect clinical outcomes, patient safety and quality of care. She said moving forward they intended to "close the loop" and educate all staff on the hospital Quality Improvement program to ensure it included a system to identify new and/or ongoing problems.

Based on review of policy, document, and staff interviews, the Critical Access Hospital (CAH) failed to ensure 2 of 6 active physicians, 3 of 3 consulting physicians and 1 of 1 affiliated physician received an outside entity peer review prior to reappointment to the Medical Staff and to ensure 1 of 6 active physicians received an outside entity peer review performed by an equivalent peer to evaluate the appropriateness of diagnosis and treatment furnished to patients at the CAH. (Physicians C, D, G, H, I, J and K) The CAH identified 8 active physicians, 9 affiliated physicians, 26 courtesy physicians and 36 consulting physicians credentialed to provide services to CAH patients.

Failure to ensure all medical staff members received an outside entity peer review, with the outside entity peer review performed by a physician reviewer with enough knowledge of the respective areas of practice, affects the CAH's ability to assure physicians provide quality care to their patients.

Findings include:

1. Review of the CAH's Medical Staff Bylaws, amended 12/15/08, stated in part, "...The Quality Assurance Plan shall be implemented to carry out a systematic process for evaluation the quality of the treatment of patients service by the Hospital and the clinical performance of all individuals with privileges. Evaluation shall include at least the following...Periodic assessment of this information to identify opportunities to improve care and to identify important problems in patient care..."

2. Review of the CAH's Board of Trustee Bylaws, restated on 6/25/12, stated in part "...The Quality of Service [Committee] shall meet at least quarterly...It shall be responsible for...review the quality of service provided to consumers...Review and recommend Board action for provider credentialing; Receipt of reports from the President (or designee) of the Medical Staff..."

During an interview on 8/20/15 at 11:30 AM Staff C, Chief Executive Officer clarified the receipt of reports from the Medical Staff, as referred to in the Board of Trustee Bylaws would include the peer review reports.

3. Review of CAH documentation on 8/20/15 revealed the facility failed to ensure the CAH completed outside entity peer review for the services provided to patients at the CAH for Physicians D, G, H, I, J and K. Further review of documentation revealed the outside entity peer review performed for Physicians C lacked evidence the peer review had been conducted by an equivalent peer.

4. Review of the credential file for Physician C, Obstetrics, revealed an outside entity peer review had been completed prior to reappointment to the medical staff, but failed to identify the qualifications of the reviewer. Staff D, Director of Nursing, identified Physician C saw 685 patients during the last fiscal year.

5. During an interview on 5/20/15 at 8:00 AM, Staff I, Director of Quality reported the outside entity peer review for Physicians C occurred however, the documentation failed to identify the qualifications of the reviewer.

Review of the credential files for Physician D and K failed to show an outside entity peer review completed prior to reappointment to the medical staff. During an interview on 8/20/15 at 8:00 AM, Staff I confirmed the cases she had sent out for peer review were completed after the physicians reappointment to the medical staff. Staff D, Director of Nursing, identified Physician D saw 1456 patients and Physician K saw 773 patients during the last fiscal year.

Review of the credential file for Physician G failed to show an entity peer review completed prior to reappointment to the medical staff, During an interview on 8/20/15 at 8:00 AM, Staff I confirmed the peer review contained in the file, occurred before the current credentialing period. Staff D identified Physician G saw 1609 patients during the last fiscal year.

Review of the credential file for Physician H and Physician I, Radiologists, failed to show an outside entity peer review. During an interview on 8/20/15 at 10:05 AM Staff D, Director of Nursing, reported she checked with the Radiology Manager who reported the main contracted radiology group completed their own peer review, which they could receive copies of upon request. This company subcontracts for night and weekend coverage and the Radiology Manager did not know if the contracted company completed peer review on the subcontracted radiologists. Staff D confirmed no peer review had been provided to the medical staff and governing board prior to Physician H and I's reappointment to the medical staff. Staff D identified Physician H read 2018 radiology reports and Physician I read 1988 radiology reports during the last fiscal year.

Review of the credential file for Physician J, Ophthalmologist, failed to show an outside entity peer review prior to reappointment to the medical staff. During an interview on 8/20/15, beginning at 8:00 AM, Staff I confirmed a lack of outside entity peer review and reported the reappointment of Staff J occurred prior to her duties involving quality. Staff D, Director of Nursing, identified Physician J saw 205 patients during the last fiscal year.

Review of a Quality Improvement policy titled "Medical Staff Peer Review", dated 9/2011, stated in part "...Active Medical Staff members will have a sample of medical records submitted for Peer Review for each medical specialty...Peer Review may be done by any member of the Medical Staff or by a Peer Review service provider..." The policy failed to define the CAH's process for outside entity peer review prior to reappointment.