HospitalInspections.org

Based on observation, policy review and staff interview, the hospital's administrative staff failed to ensure the surgery staff kept patient medical information secure from unauthorized access to patient information found in a folder on the counter of 1 of 1 Pathology room within the surgery suite. Failure to keep patient medical information confidential could potentially result in unauthorized access of a patient's personal/medical information and potentially result in unauthorized release of personal information. The Hospital's Administrative staff identified the Pathology lab performs an average of 1 - 2 pathological tests per month.

Findings include:

1. Review of policy, "Protection of Information Guidelines," effective 3/2020, revealed in part, "Unattended printing is discouraged unless physical access restriction are used to prevent unauthorized persons from viewing the material being printed."

2. Observation on 3/8/2022 at 9:00 AM, during a tour of the Surgery Suite with the Surgical Nurse Manager and the Regional Director of Surgery, revealed a binder with approximately 8 stickers with patient information used to identify patients that may be pregnant, through a rapid test for qualitative detection of the human chorionic gonadotropin (HCG) found in plasma, serum, and urine. The binder was not secured allowing housekeeping access, and potentially allowing unauthorized personnel access to confidential patient information.

3. During the tour of the Surgery Suite the Surgical Nurse Manager acknowledged housekeeping cleans this room daily after hours when medical staff is not present.

Based on observations, policy review, and staff interviews, the Hospital's administrative staff failed to ensure pharmacy oversight of sample medications in 2 of 4 provider-based outpatient service clinics (urology and cardiology). Failure of pharmacy oversight in the dispensing of sample medications could result in outdated, recalled, or otherwise unusable medications being available for physicians and mid-level providers to give to patients, as well as, the potential for theft of medications by unauthorized persons. The Hospital Administrative staff identified a total of 3,842 patient visits in the year 2021.

Findings include:

1. Review of the policy, "Samples of Medications," effective 12/2020, revealed in part, "Medication samples located in out-patient practitioner clinics ... tracking log must be maintained as procurement and dispensing of such samples to allow for recall tracking."

2. Observation during tour of the MultiSpecialty Clinic on 3/7/22 at 3:40 PM with Clinic Supervisor, revealed 2 clinics (urology and cardiology) stored and utilized sample medications.

3. During an interview, at the time of the observation, the Clinic Supervisor reported when the samples are received by the nursing staff and the staff place the medication in a central cabinet that is locked. The staff used to keep a log of the medication outdates but that practice stopped on 5/2021. The Clinic Supervisor revealed she did not know of a reason why they stopped logging the expired medications. She further indicated that when the medication is dispensed to the patient, it is logged in the Hospital's electronic medical recorded under the patient's name with the sample medications lot number and is trackable, should there be a drug recall. The Clinic Supervisor reported the Hospital's pharmacist did not play a role in oversight of the sample medications in the clinic, although the pharmacist was aware they stored sample medications in the clinics. The Clinic Supervisor confirmed the expired medication that was disposed of could not be tracked due lack of documentation.

4. During an interview on 3/8/22 at 1:43 PM with the Director of Pharmacy, revealed the pharmacy logs all medication coming into the Hospital and the dispersion of the medication is tracked in the electronic medical record. The Director of Pharmacy verified the clinic should be logging all expired medication that would be returned to the Pharmaceutical Representative. The Pharmacy Director did acknowledge pharmacy had no oversight of the sample medication used in the clinics.

Based on document review and staff interview, the Hospital administrative staff failed to ensure timely physician notification for the occurrence of a medication error for 9 of 17 medication errors reviewed. (Patient #1, Patient #2, Patient #3, Patient #4, Patient #5, Patient #6, Patient #7, Patient #8, and Patient #9). 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 Hospital administrative staff reported a census of 9 patients on entrance.

Findings include:

1. Review of the policy, "Variance Reporting and Follow-Up," last reviewed 9/2001, revealed in part: "When a variance occurs for medication ... in regards to patient, the physician will be notified." " ... all pertinent medical and nursing information should be documented on the chart."

2. Review of medication errors from 3/1/2021 to 3/1/2022 revealed:

a. The nursing staff made a medication error (medication administered-wrong time) on 4/28/2021 at 9:00 AM which involved Patient #1. Patient #1's medication error paperwork lacked documentation in the electronic medical record (EMR) 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 (medication administered-wrong time) on 6/3/2021 at 6:00 AM which involved Patient #2. Patient #2's medication error paperwork lacked documentation in the EMR 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-without lab requirement) on 7/1/2021 at 2:47 PM which involved Patient #3. Patient #3's medication error paperwork lacked documentation in the EMR 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 administered-duplication) on 7/15/20201at 1:20 PM 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.

e. The nursing staff made a medication error (wrong dose- and missed dose) on 8/1/2021 at 7:48 PM which involved Patient #5. Patient #5's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #5's medical care of the medication error.

f. The nursing staff made a medication error (medication ordered-not administered) on 11/10/2021 at 6:30 PM which involved Patient #6. Patient #6's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #6's medical care of the medication error.

g. The nursing staff made a medication error (wrong time) on 12/14/2021 at 5:00 PM which involved Patient #7. Patient #7's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #7's medical care of the medication error.

h. The nursing staff made a medication error (wrong time) on 12/22/2021 at 12:00 PM which involved Patient #8. Patient #8's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #8's medical care of the medication error.

i. The nursing staff made a medication error (wrong medication) on 1/23/2022 at 3:00 PM which involved Patient #9. Patient #9's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #9's medical care of the medication error.

3. During an interview on 3/10/2022 at 10:18 AM, the Regional Director of Risk Management acknowledged the medication error paperwork for Patient #1, Patient #2, Patient #3, Patient #4, Patient #5, Patient #6, Patient #7, Patient #8, and Patient #9 lacked documentation that the nursing staff notified the patient's provider of the medication error.

Based on observation, document review, and interviews, the Hospital's administrative staff failed to ensure the Specialty Clinic staff change the 500 milliliter (mL) 0.9% Sodium Chloride irrigation bottle after uroflowmetry (a procedure that measures the flow of urine) for each patient, in accordance with the manufacturer's directions in 1 of 1 minor procedure room. Failure to change the Sodium Chloride irrigation bottle after each patient could potentially result in cross contamination of the Sodium Chloride fluid with bacteria or other microorganisms, potentially causing an infection in the next patient. The Hospital's Administrative staff identified the MultiSpecialty Clinic staff performed an average of 2 voiding trials per month from 1/1/2021 to 1/1/2022.

Findings include:

1. Observations during a tour of the multispecialty clinic on 3/7/2022 at approximately 3:40 PM in a minor procedure room (used for uroflowmetry testing procedures) revealed 2 of 2 Baxter 0.9% Sodium Chloride Irrigation, USP 500 ml bottles, opened and sitting in a supply closet. Review of the manufacturer's instructions indicated in part, "Cautions: ... Discard unused portion." The Sodium Chloride for irrigation did not contain any chemicals to prevent bacteria from growing in the solution water once the hospital staff opened the bottles for irrigation.

2. During an interview at the time of the tour on 3/7/2022 in the MultiSpecialty Clinic, the Clinic Supervisor indicated the MultiSpecialty Clinic staff opened the bottles of Sodium Chloride for irrigation of the uroflowmetry testing procedures that are scheduled. The Sodium Chloride is poured into the reservoir chamber of the uroflowmetry machine. The MultiSpecialty staff only discarded the bottle of Sodium Chloride for irrigation once solution had been open for 60 days from the date of opening the Sodium Chloride bottle or if the bottle was emptied prior to the 60 day mark.

3. During an interview on 3/7/2020 at approximately 4:00 PM, the MultiSpecialty Clinic Supervisor verified the Sodium Chloride should have been used as a single dose and not as a multidose solution. The Regional Pharmacy Director acknowledged Baxter 0.9% Sodium Chloride Irrigation, USP 500 ml bottles manufactures directions indicate the product is for single patient use only.

Based on document review, policy review and staff interviews the Hospital administrative staff failed to ensure employee health exams included the minimum required information as part of their system to identify and prevent employee illness and transmission of infections and communicable diseases. The problem was identified for 8 of 13 employees (Patient Care Technician A, Phlebotomist B, Registered Nurse C, Ultrasound Technician D, Housekeeper E, Foodservice Associate F, Registered Nurse H, and Surgical Technician I) and 1 of 2 contracted employees (Registered Nurse N) selected for review.

Failure to identify infections and communicable diseases among employees could potentially result in the transmission of a communicable disease to patients.

Findings include:

1. Review of the Iowa Administrative Code 481-51.24(3)c revealed the requirement ... "The health assessment shall include, at a minimum, vital signs and an assessment for infectious or communicable diseases ..."

2. Review of a Hospital policy titled "Program for Prevention and Control of Infections in the Organization", effective 12/2019, revealed in part "... Team members in all departments play a central role in the prevention and control of infections. To attain the maximum contribution from them, the following must be considered ... An employee health program which will assist in early detection of disease, other conditions, or infections resulting in less time loss from work because of illness...".

3. Review of a document titled "Physical Assessment", reviewed 1/2022, revealed the document identified areas to review immunizations, past and present medical history but failed to include an area to document vital signs.

4. Review of the health information for Patient Care Technician A revealed the most recent health exam, documented on 8/13/2021, failed to include vital signs as part of the health assessment.

5. Review of the health information for Phlebotomist B revealed the most recent health exam, documented on 8/13/2021, failed to include vital signs as part of the health assessment.

6. Review of the health information for Registered Nurse (RN) C revealed the most recent health exam, documented on 7/27/2021, failed to include vital signs as part of the health assessment.

7. Review of the health information for Ultrasound Technician D revealed the most recent health exam, documented on 10/15/2021, failed to include vital signs as part of the health assessment.

8. Review of the health information for Housekeeper E revealed the most recent health exam, documented on 4/20/2021, failed to include vital signs as part of the health assessment.

9. Review of the health information for Food Service Associate F revealed the most recent health exam, documented on 5/13/2019, failed to include vital signs as part of the health assessment.

10. Review of the health information for RN H revealed the most recent health exam, documented on 10/24/2019, failed to include vital signs as part of the health assessment.

11. Review of the health information for Surgical Technician I revealed the most recent health exam, documented on 8/27/2019, failed to include vital signs as part of the health assessment.

12. Review of the health information for Registered Nurse N revealed the most recent health exam, documented on 1/28/2022, failed to include vital signs as part of the health assessment.
.
13. During an interview on 3/9/2020, at 9:40 AM, the Employee Health Nurse reported their previous physical health assessment form used to include vital signs but had been removed several years ago.

14. During an interview on 3/9/2022, at 10:10 AM, the Infection Prevention Coordinator confirmed the identified health exams failed to include vital signs as part of the initial and routine employee health exams.

Based on observation, document review, policy review and staff interviews, the Hospital's administrative staff failed to ensure 1 of 1 Dental Assistant (Dental Assistant O), who performed the role of first assistant during surgical procedures performed by Dentist P, did not hold any approved privileges to assist in performing surgical procedures, nor was she initially appointment through the Medical Staff. Failure to ensure Dental Assistant O had privileges to assist in performing surgical procedures could potentially result in the Hospital staff allowing Dental Assistant O assisting in procedures in which she lacked competence and skill to safely assist in the performance and result in providing care beyond their capabilities and compromise safety of the Hospital patients. The Hospital administrative staff identified Dental Assistant O, was never appointed through the Hospital's Medical Staff and she was only provided information through the Human Resource Department.

Findings include:

1. During a tour of the Surgical Suite on 3/8/2022 at 9:00 AM, the Surgery Nurse Manager revealed Dentist P performs dental procedures on children with assist of scrub personnel. During an interview at the time, the Surgery Nurse Manager reported Dentist P, brings in a dental assistant that he utilizes as first assist in surgery, indicated the dental assistant had been credentialed.

2. Review of the Hospitals Credentialing and Privileging Policy, finalized 11/6/2020, revealed in part "... application will contain a request for specific clinical privileges and will require detailed information concerning the applicant's professional qualifications. The applicant will sign the application and certify that he or she is able to perform the privileges requested and responsibilities of appointment."

3. During an interview on 3/9/2022, at 4:16 PM, with the HR Business Partner, acknowledged the files for Dental Assistant O failed to show qualifications to perform as first surgical assistant. Dental Assistant O did not follow the credentialing process and did not have any privileges recorded in the Operating Room log for staff to verify.