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Based on document review, policy review, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure 1 of 1 applicable teleradiologist selected for review (Tele-Radiologist E), received outside entity peer review by the appropriate entity, to evaluate the appropriateness of diagnosis and treatment furnished to patients at the Critical Access Hospital, prior to reappointment to the medical staff. Failure to ensure all medical staff members received outside entity peer review affects the CAH's ability to assure physicians provide quality care to the CAH patients. The CAH administrative staff identified Tele-Radiologist E provided care to 273 patients from 1/1/20 to 9/30/20.

Findings include:

1. Review of the CAH's undated network agreement, revealed in part " ... The parties agree that should the governing body of the CAH request assistance, [Network Hospital] through participating members of its medical staff and other personnel designated by the [Network Hospital], shall assist CAH in reviewing the quality and appropriateness of the diagnosis and treatment furnished by the CAH's doctors of medicine or osteopathy for purposes of assisting the CAH to carry out the requirements of its quality assurance plan ..."

2. Review of the CAH's peer review services agreement with their Network Hospital, dated 10/1/04, revealed in part "... Quarterly charts from [the CAH] will be reviewed by a [Network Hospital] designated physician. The purpose of these reviews is to identify opportunities for improvement in medical care and/or in the process of the delivery of care at [the CAH] ..."

3. Review of a CAH agreement titled "Agreement for the purchase of Diagnostic Teleradiology Services", dated 3/1/07, revealed an agreement for professional teleradiology services with Tele-radiology Entity B. The agreement contained an addendum, dated 2/18/09, which identified a fee schedule for peer review services, however the body of the entire agreement lacked any reference to peer review services.

4. Review of a CAH policy, "Periodic Evaluation and Quality Assurance Review," revised 9/2020, revealed in part "... Contract for Medical Staff peer review with [Network Hospital] provides quarterly review of 10% of closed inpatient records ... Findings are shared with the Medical Staff ... Contract for Medical Staff peer review with [Network Hospital] provides quarterly review of emergency department closed records ... Findings are shared with the Medical Staff ... Contract for radiology/tele-radiology Medical Staff Peer Review with [Teleradiology Entity B ] provides review of closed records ... Findings are shared with the Medical Staff ..."

5. Review of external peer review for the selected physicians revealed the medical staff approved Tele-Radiologist E for reappointment to the Medical Staff on 11/27/18. The Board of Trustees approved Tele-Radiologist E for reappointment to the Medical Staff on 12/11/18. Tele-Radiologist E's file lacked the results of any external peer review conducted by the Network Hospital, prior to Tele-Radiologist E's reappointment to the Medical Staff. Tele-Radiologist E worked for Teleradiology Entity A.

6. During an interview on 10/21/20, at 10:00 AM, Executive Assistant B, reported external peer review is conducted on all members of the medical staff providing services to CAH patients, and a summary of the results becomes part of the appointment/reappointment packet. She reported their Network Hospital conducts external peer review on the medical staff treating inpatients and emergency room patients, except for the teleradiologists contracted through Teleradiology Entity A. The external peer review for these members of the medical staff is conducted by Teleradiology Entity B.

7. During an interview on 10/21/20, at 3:20 PM, the Director of Patient Care, confirmed Teleradiology Entity B conducted external peer review for Teleradiology Entity A.

8. During an interview on 10/22/20, at 9:05 AM, Executive Assistant B confirmed Teleradiology Entity B does not belong to the Network Hospital system.

Based on observation, document review, and staff interviews, the Critical Access Hospital (CAH) staff failed to remove outdated supplies from supplies available for patient use in 1 of 1 Outpatient Clinic and 1 of 1 Emergency Department. Failure to remove outdated supplies could potentially result in staff using the expired items for patient care beyond the manufacturers' expiration dates, after which the manufacturer will no longer guarantee the safety and quality of the supplies. The CAH administrative staff identified a census of 11 patients at the beginning of the survey and approximately 3,387 Clinic visits per month, for fiscal year ending 06/30/2020.

Findings include:

1. Observations during a tour of the Outpatient Clinic on 10/20/2020 at approximately 09:40 AM, with the Outpatient Clinic Manager and the Director of Patient Care, revealed the following expired supplies:

Outpatient Exam Room #23
a. 2 of 2 mini cath packs (kits for accessing vein), expired 09/2015

Outpatient Exam Room #30
a. 1 of 1 vacutainer (used for collecting blood samples), expired 08/31/2019.
b. 1 of 3 25 gauge 1" needle (used for accessing vein), expired 01/2020.

Outpatient Exam Room # 20
a. 1 of 3 red top laboratory tubes for blood collection, expired 01/15/2020.
b. 1 of 1 orange top laboratory tubes for blood collection, expired 08/31/2019.

Outpatient Exam Room #32
a. 2 of 4 blue top laboratory tubes for blood collection, expired 09/30/2020.

2. Review of the policy, "Outdated Meds/Supplies Inventory", approved 10/2020, revealed in part, "... Ensure that all outdated supplies and medications are removed and/or taken out of service in a timely manner ... On a monthly basis at the beginning of the month ... designate someone to complete outdated meds/supplies ... Designee will complete quality assurance checklist ... Any outdated meds/supplies will be removed at the time of inventory ..."

3. During an interview on 10/20/2020 at approximately 10:15 AM, the Clinic Manager revealed the Clinical nursing staff failed to follow the expectations for restocking practices and failed to maintain a log of staff responsible for removing outdated supplies.

5. During an interview on 10/21/2020 at approximately 01:00 PM, the Director of Patient Care revealed that a quality assurance checklist was not available.

6. Observations on 10/19/2020 at 3:30 PM, during a tour of the Emergency Department, revealed the following expired supplies:

ER Exam Room 2:
a. 4 of 4 Ready to Use Enemas, saline expired 3/2020
b. 2 of 2 Betadine Solution bottles expired 8/2020

Trauma Bay 1, Emergency Crash Cart :
a. 2 of 2 3.5 Endotracheal (ET) tubes expired 08/2020
b. 3 of 4 4.5 ET tubes expired 07/2020
c. 2 of 2 of 5 Nelcor adult CO2 Detectors expired 4/21/2020
d. 2 of 2 E-Z Stabilizer for IO expired 8/16/2020
e. 1 of 1 Illinois Bone Marrow Aspirator/Intraosseous Infusion Needle expired 7/19/2020
f. 2 of 2 #3 Single Use Laryngeal Masks expired 03/2020
g. 1 of 4 Insyte Autoguard 18G IV needle expired 06/2020

7. During an interview on 10/19/2020 at the time of the tour, the Nursing Supervisor/Trauma Coordinator confirmed the outdated supplies in the emergency department. The Nursing Supervisor/Trauma Coordinator reported it was the responsibility of the nursing staff to monitor and remove from use outdated patient care supplies from the emergency department.

8. Review of document "Crash cart checklist" revealed the emergency department crash cart was last checked for emergency supplies on 10/19/2020.

9. Review of policy "Crash Cart Supply & Defibrillator Check," last approved 09/2019, revealed in part, "... RN assigned to review the crash cart will check to make sure the items listed on the checklist ... are present in adequate amounts ... if items are missing, resupply ..." The Crash cart checklist does not include the above listed expired items and the policy failed to direct the nursing staff to check for and remove outdated supplies from possible patient use.

Based on observation, document review and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure all drugs are properly secured when it maintained drugs, including controlled medications (medications that can cause physical and mental dependence) in 2 of 2 medication cabinets containing medications (Outpatient Clinic and Physical Therapy) in unsecured departments which allow access by unauthorized personnel. Failure to appropriately secure drugs, including controlled medication, could result in unauthorized access to the medication and potential drug diversion for personal use.

Findings include:

1. Observations during a tour of the Outpatient Clinic on 10/20/2020 at approximately 09:30 AM, revealed 1 cabinet located in the Triage Area in the Outpatient Clinic which is locked after Outpatient Clinic hours, however, the key for the cabinet is openly hanging on a hook on the wall and provided easy access for unauthorized personnel. This area is used as a thru-way for the Urgent Care clinical area after the Outpatient Clinic is closed. The medication cabinet contained:

a. Solu Medrol 125mg/mL, approximately 15 vials (a corticosteroid used for allergic conditions, rheumatic disorders, and other conditions).

b. Dexamethasone 10mg/mL, approximately 115 vials (a corticosteroid used for anti-inflammatory and immunosuppressant effects).

c. Dexamethasone 4mg/mL, approximately 25 vials (a corticosteroid used for anti-inflammatory and immunosuppressant effects).

d. Bupivacaine 25mg/10mL, approximately 11 vials (a numbing medicine).

e. Depo-Medrol 400mg/5mL, 1 vial (an anti-inflammatory glucocorticoid).

f. Depo-Medrol 80mg/mL, approximately 30 vials (anti-inflammatory glucocorticoid).

g. Xylocaine 200mg/20mL, approximately 14 vials (anumbing medicine).

h. Bupivacaine 25mg/10mL, approximately 25 vials (a numbing medicine).

i. Diphenhydramine 50mg/mL, approximately 25 vials (an antihistamine for relief of allergies, hay fever, nausea, dizziness)

j. Epinephrine 1mg/mL, approximately 18 vials (treats life-threatening allergic reactions).

k. Ceftriaxone 250mg, approximately 30 vials (an antibiotic for bacterial infections).

l. Ceftriaxone 500mg, approximately 50 vials, (an antibiotic for bacterial infections).

m. Ceftriaxone 1g, 6 vials (an antibiotic for bacterial infections).

n. Cyanocobalamine 1000mcg/mL, approximately 70 vials (Vitamin B-12 used for anemia).

o. Medroxyprogesterone 150mg/mL, approximately 35 vials (a form of progesterone which regulates the female hormone related to ovulation).

p. Kenalog 40mg/mL, approximately 35 vials (a corticosteroid (anti-inflammatory) used for joint pain).


2. During an interview on 10/20/2020, at the time of the tour (approximately 10:00 AM), the Clinic Manager and the Director of Patient Care acknowledged the cabinet in the Triage Area of the Outpatient Clinic, which contained drugs, including controlled substances, were not secured. The Triage Area had 2 entry doors which are not locked when the department is not staffed. The Clinic Manager and Director of Patient Care acknolwdged it would be possible for an unauthorized person to access the cabinets.

3. Observation during a tour of the Physical Therapy Department on 10/20/2020, at approximately 01:30 PM, revealed 1 cabinet located in an open area that is locked after hours, however, the key is unsecured and easily accessible after hours to unauthorized personnel. The medication cabinet contained Dexamethasone 10mg/mL, approximately 5 vials (a corticosteroid used for anti-inflammatory and immunosuppressant effects).

4. During an interview on 10/20/2020 at approximately 01:30 PM, the Physical Therapy Manager, Occupational Therapy Manager, and Director of Therapy, acknowledged the cabinet in the Physical Therapy Department is locked, however, the key is unsecured and is potentially available to unauthorized personnel after hours.

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure timely physician notification for the occurrence of a medication error for 4 of 13 medication errors reviewed (Patient #1, Patient #2, Patient #3, and Patient #4). Failure to notify the physician of medication errors could potentially result in the provider not knowing about the medication error and either failing to take steps to address the consequences of the medication error, or the provider making a medical decision without the knowledge of the medication error, either way potentially resulting in inappropriate treatment or even a fatal reaction. The CAH administrative staff reported a census of 11 patients on entrance, and an average daily census of 6 patients per day.

Findings include:

1. Review of "Reporting of Notification Reports Involving Unanticipated Patient and Non-Employees Events," last reviewed 07/2020, revealed in part: "... reporting unanticipated patient and non-patient events such as ... medication errors ... unanticipated events include ... medication event ... objective ... is to communicate information to appropriate members ... regarding unanticipated events ... events will be immediately reported ..."

2. Review of medication errors from October 21, 2019 to October 10, 2020 revealed:

a. The nursing staff made a medication error (incorrect medication administered) on 10/07/2020 at 8:40 PM which involved Patient #1. Patient #1's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #1's medical care of the medication error.

b. The nursing staff made a medication error (wrong dose-wrong patient) on 11/08/2019 at 10:30 PM which involved Patient #2. Patient #2's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #2's medical care of the medication error.

c. The nursing staff made a medication error (medication administered too close to last dose) on 11/22/2019 at approximately 8:00 PM which involved Patient #3. Patient #3's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #3's medical care of the medication error.

d. The nursing staff made a medication error (medication ordered not given) on 12/13/2019 at approximately 8:00 AM which involved Patient #4. Patient #4's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #4's medical care of the medication error.

3. During an interview on 10/20/2020 at 1:30 PM, the Director of Patient Care acknowledged the medication error paperwork for Patient #1, Patient #2, Patient #3, and Patient #4, lacked documentation that the nursing staff notified the patient's provider of the medication error.

4. During an interview on 10/21/2020 at approximately 9:00 AM, the Risk Manager acknowledged and confirmed the medication error paperwork for Patient #1, Patient #2, Patient #3, and Patient #4, lacked documentation that the nursing staff notified the patient's provider of the medication error.

5. During an interview on 10/21/2020 at approximately 3:30 PM, the Director of Patient Care acknowledged that no policy existed spectifically for the reporting of medication errors and/or adverse events to the provider.

Based on review of records, policy, and staff interviews the Critical Access Hospital's (CAH) Administrative staff failed to ensure each patient that received surgical services had properly executed informed consents for 3 of 8 closed patient medical records (Patients #5, Patient #7, and Patient #8) Failure to inform all patients who received surgery of the options and consequences needed in order to make an informed consent to a procedure or treatment could potentially result in the patient having an unwanted procedure. The CAH administrative staff identified approximately 643 surgical procedures in the past fiscal year.

Findings include:

1. Review of Patient #5's medical record, surgery date 7/02/2020, revealed the consent form, "Consent to Surgery or Special Diagnostic or Therapeutic Procedures" lacked the date and time the patient signed the consent and lacked a witness signature, date, and time.

Review of Patient #7's medical record, surgery date 8/13/2020, revealed the consent form, "Consent to Surgery or Special Diagnostic or Therapeutic Procedure" lacked a witness signature, date, and time.

Review of Patient # 8's medical record, surgery date 9/27/2020, revealed the consent form, "Consent to Surgery or Special Diagnostic or Therapeutic Procedure" lacked a witness signature, date, and time.


2. Review of the "Informed Consent Policy," last reviewed 05/2020, revealed in part, "... all written consents are to be witnessed, dated, and timed.... consent form must be properly witnessed ... role of staff in consent process prior to the procedure is to verify the patient's understanding of the content of the consent ... [for the] procedure ... to which ... is consenting."

3. During and interview on 10/22/2020 at approximately 10:00 AM, the Surgery Nurse Manager acknowledged the surgery consent forms for Patient #5, Patient #7, and Patient #8's surgical procedures lacked a signature of a witness, including date and time, and were not properly executed informed consents.

Based on observation, document review, and staff interview, the Critical Access Hospital's (CAH) administrative staff failed to ensure the CAH staff kept patient medical information secure from unauthorized access in 1 of 1 x-ray film storage room, 1 of 1 Surgery Department, 1 of 1 Health Information Management (HIM) Department, and 1 of 1 Senior Life Solution Department. The Radiology Manager identified approximately 200 x-ray films plus an undetermined number of loose x-rays stored in 1 of 1 maintenance storage room. The Surgery Manager identified approximately 55 surgeries per month. The Health Information staff identified 350 paper records and 16,200 patient microfilm records. The Senior Life Program Director identified 10 outpatients currently enrolled in the program. Failure to keep patient medical information confidential could potentially result in theft of a patient's information and potentially result in identify theft.

Findings include:

1. Review of the policy "Storage of Records," revealed in part, "... Floyd Valley Healthcare must safeguard the information in the record against loss, defacement, tampering, use by unauthorized persons, and damage by fire or water...."

2. Observation on 10/20/2020 at approximately 3:20 PM, during a tour of the maintenance storage room with the Radiology Manager and the Director of Finance revealed 1 of 1 x-ray film storage area in 1 of 1 maintenance storage room. The Radiology Manager identified approximately 200 x-ray films stored on 1 open shelf and 3 - 55 gallon barrels that contained an undetermined number of loose x-rays in the x-ray film storage room.

During an interview at the time of the tour, the Radiology Manager acknowledged the x-ray films contained patient information.

During an interview at the time of the tour the Director of Finance acknowledged the housekeeping staff have a key that would allow them to access the x-ray film storage room when Radiology staff were not present.

Observation on 10/21/2020 at 11:55 AM, Housekeeping Staff D used their master key to unlock the maintenance storage room that contained unsecured x-ray films which included patient information.


3. Observation on 10/20/2020 at approximately 10:30 AM, during tour of the surgery department with the Surgery Manager, revealed 1 of 1 patient medical record for the procedure scheduled the following day, was unsecured on top of a work counter.

During an interview at the time of the tour, the Surgery Manager acknowledged the housekeeping staff have a key that would allow them to access the surgery department when surgery staff were not present to clean the surgery area. The Surgery Manager acknowledged the patient medical records for the next day surgeries were not secure and accessible to unauthorized staff.


4. Observation of the HIM Department on 10/20/20 at 8:00 AM revealed the department staff stored paper copies of patient medical information on a large open shelving unit. Next to the shelving unit, an unlocked cabinet stored 2 large microfilm log books, used to identify patient names, service dates and the microfilm roll location. During an interview at the time of the tour, the HIM manager reported the department is locked after hours and the only CAH staff with key access included the department staff, maintenance staff, senior management and the purchasing manager.

During an interview on 10/21/20 at 12:05 PM, Housekeeping Staff D reported housekeeping staff do not enter the HIM department to clean until HIM staff arrive, but demonstrated her key was able to unlock the door to the HIM department.

During an interview on 10/21/20 at 2:30 PM, HIM Staff C confirmed the microfilm cabinet and paper records remained unsecured during department hours when HIM staff were not present.

During additional interviews on 10/21/20 at 3:30 PM and 10/22/20 at 8:05 AM, HIM Staff C estimated approximately 300-350 paper patient records stored on the open shelving unit in the department and approximately 16,200 patient names, with dates of service, contained in the microfilm logs.


5. Observation on 10/21/2020 at 10:25 AM during tour of the Senior Life Solutions department with the Senior Life Solutions Program Director revealed 10 open patient medical records stored in 1 of 1 locked store room in the Senior Life Solutions department. The Senior Life Solutions Program Director acknowledged housekeeping staff have a key to the department as the housekeeping staff clean the area on the weekends when Senior Life Solutions staff were not present.

Observation on 10/21/2020 at approximately 10:35 AM, the Director of Finance used his master key to unlock the locked storage room that contained open patient medical records in the Senior Life Solutions department.

Observation on 10/21/2020 at 11:55 AM, Housekeeping Staff D used their master key to unlock the Senior Life Solutions Department door and proceeded to unlock the locked storage room that contained open patient medical records in the Senior Life Solutions department.

During an interview on 10/21/2020 at 11:55 AM, Housekeeping Staff D confirmed the housekeeping staff clean the Senior Life Solutions on the weekend when Senior Life Solutions staff were not present. Housekeeping Staff D verified the housekeeping staff enter the locked storage room that contained open patient medical records when they cleaned the department as that is were the Senior Life Solutions staff store their recyclables and trash.


6. During an interview on 10/21/2020 at 10:40 AM, the Facility Operations Manager acknowledged the master keys allow staff to gain access to all areas of the hospital except pharmacy. The Facility Operations Manager acknowledged the housekeeping staff have a master key that allowed them to gain entrance into the Senior Life Solutions Department and allowed the housekeeping staff to open the locked storage room that contained open patient medical records in the Senior Life Solutions Department.


7. During an interview and review of documentation provided on 10/21/2020 at 1:40 PM, the Patient Relations Manager provided a list of CAH staff that had a key to the maintenance store room and master keys. Review of the documentation revealed that 30 staff members had keys to the maintance store room, and 23 staff members had master keys.

Based on review of records, policy, and staff interviews the Critical Access Hospital's (CAH) Administrative staff failed to ensure safe medication practices to avoid sources and transmission of infection when medication from 2 of 2 multi-dose medication vials (ketamine and labetalol) were prepared for patient administration in a patient care area and used for multiple patients. Failure to prepare medication in a dedicated clean medication area, away from immediate patient treatment areas, could result in inadvertent contamination of the medication and vial leading to possible infectious organisms and illness passed to other patients who received medication from the same contaminated medication vial. The CAH administrative staff identified approximately 643 surgical procedures were performed in the past fiscal year.

Findings include:

1. Review of CDC guidelines (www.cdc.gov), revealed in part, "Multi-dose vials should be dedicated to a single patient ... if must be used for more than one patient, they should only be kept and accessed in a dedicated clean medication preparation area, away from immediate patient treatment areas ... to prevent inadvertent contamination ... If a multi-dose vial enters an immediate patient treatment area it should be dedicated for single-patient use only ... 'immediate patient treatment area' ... includes operating and procedure rooms, anesthesia and procedure carts ..."

Review of the Nursing - Anesthesia policy "Proper Drug Handling", last approved 09/2019, revealed the policy lacked guidance on the preparation and use of multi-dose vials when the medication is intended for use on multiple patients.

Review of the pharmacy policy "Multiple/Single Use Vials", last approved 9/2020, revealed the policy lacked guidance on preparation and use of multi-dose vials when the medication is intended for use on multiple patients.

2. Observations on 10/20/2020 at approximately 8:00 AM, CRNA Student I prepared and administered Ketamine (a medication used for anesthesia) 50 mg from a multi-dose ketamine vial, dated opened 10-7, that was taken from a drawer in the anesthesia cart in the OR, with the patient present on the OR table. The medication, Ketamine, was prepared on top of the anesthesia cart and the multi-dose vial of ketamine was returned to the anesthesia cart medication drawer following the surgical procedure.

Observation of the anesthesia cart, following the surgical procedure, revealed a second opened multidose vial, Labetalol 100 mg/20 ml, dated opened 10/15.

3. During an interview on 10/20/2020 at the time of the observation, CRNA J, supervising CRNA for CRNA Student I, reported he was not aware of the CDC guidelines that medication from a multi-dose could not be prepared in the immediate patient care area. CRNA J reported limited use of multi-dose vials but occasionally used other medications in multi-dose vials, such as labetalol for treatment of high blood pressure.

During an interview on 10/22/2020 at 8:30 AM, Staff Pharmacist H reported multi-dose vials must be dated when opened and were good for 28 days once the vial was opened and accessed. Staff Pharmacist H revealed she was not aware of the CDC multi-dose guidelines that dictate if a multi-dose vials is intended for use on multiple patients the medication must be prepared in a dedicated clean medication area, away from immediate patient treatment areas.