HospitalInspections.org

Based on document review and staff interview, the Hospital's administrative staff failed to develop, evaluate, and implement an effective Quality Improvement Program to evaluate and improve the quality and appropriateness of patient care and to improve quality on a continuous basis including all services, offered at the hospital for 9 of 34 (Surgery, Speech Therapy, Occupational Therapy, ECHO, DEXA Scan (Bone density), Ultrasound, MRI, Lactation Services, and Wound Clinic) departments. The Hospital's administrative staff identified a census of 9 patients at the beginning of the survey. Failure to create and implement an effective quality improvement program that included involvement of all of the Hospital's departments to improve quality on a continuous basis could potentially result in the Hospital staff's failure to identify, monitor, address, and improve patient care problems in each patient care area through the efforts of all involved departments.

Findings include:

1. Review of the policy, "Quality Assessment and Performance Improvement (QAPI) Process," approved on 1/2021, revealed in part, "Each department and service, including those services furnished under contract, will have a systematic, ongoing process for assessing the improving the performance of the care or service provided. The primary focus of this process is the monitoring of data-driven indicators related to improved health outcomes and the prevention/reduction of medical errors." " ...The Board of Trustees is ultimately responsible for assuring the quality of care and services provided by MercyOne Newton Medical Center by reviewing quality and effectiveness of patient care services provided by its Medical Staff member and professional staff ...holding Medical Staff, Hospital Administration, and Quality Council accountable for implementing and evaluating quality assessment and performance improvement efforts. Review periodic reports of findings, actions and results from quality improvement activities in order to assess the program's effectiveness. Reviewing the department specific quality indicators to be conducted annually."

2. Review of the Quality/Performance Committee Meeting minutes, dated 5/12/21, 8/11/21, 11/10/21, and 2/9/22, revealed the meeting minutes lacked evidence of department reports for Surgery, Speech Therapy, Occupational Therapy, ECHO, DEXA Scan, Ultrasound, MRI, Lactation Services, and Wound Clinic.

3. Review of the Board of Governors Meeting minutes, dated 3/23/21, 5/25/21, 7/27/21, 9/28/21, 11/16/21, and 1/26/22, revealed the meeting minutes lacked evidence of department reports for Surgery, Speech Therapy, Occupational Therapy, ECHO, DEXA Scan, Ultrasound, MRI, Lactation Services, and Wound Clinic.

4. During an interview on 3/21/22 at 3:36 PM with the Director of Operations, acknowledged the quality department reports lacked evidence of department reports for Surgery, Speech Therapy, Occupational Therapy, ECHO, DEXA Scan, Ultrasound, MRI, Lactation Services, and Wound Clinic.

Based on observation, policy review and staff interview, the Hospital Administrative staff failed to ensure the surgery staff and therapy staff kept patient medical information secure from unauthorized access to patient information. 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 Administration reported an average of 267 surgical procedures per month during the previous fiscal year from June 2020 to July 2021. The Hospital's Administration reported an average of 1,240 patient visits for all therapies (occupational therapy, physical therapy, speech therapy, and cardiac rehab) during the previous fiscal year (July 2020 to July 2021).

Findings include:

1. Review of the policy, "Confidentiality in the Operating Room," last effective date 12/2021 revealed in part, "Patient charts, records, documents, orders and health information will be covered at all times ..... Paper documents will be placed in locked cupboard at end day."

2. Observation on 3/15/2022, during a tour of the Surgery Department with the Surgical Nurse Manager and the Inpatient Manager, revealed 2 blue bins sitting in the floor filled with a multitude of paper records.

3. Observation on 3/15/2022, during a tour of the Surgery Department with the Surgical Nurse Manager and the Inpatient Manager, revealed a binder in the pre-operative area with approximately 53 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 urine. The binder was not secured, allowing housekeeping access, and potentially allowing unauthorized personnel access to confidential patient information.

4. Observation on 3/15/2022, during a tour of the Surgery Department with the Surgical Nurse Manager and the Inpatient Manager, revealed a fax machine in the unsecured surgical registration desk area.

5. Observation on 3/15/2022, during a tour of the Surgery Department with the Surgical Nurse Manager and the Inpatient Manager, revealed a blue bin in the surgical department storage room filled with multiple paper patient records.

6. During the tour of the Surgery Suite, Surgery Department Clerk I, revealed the fax machine in the surgical registration desk area is the only fax machine for the surgical department and receives incoming faxes containing patient information after hours.

7. During the tour of the Surgery Suite, Surgical Nurse Manager E, acknowledged housekeeping has access to the surgical storage room, pre-operative area and registration desk area. Surgical Nurse Manager E also acknowledged that housekeeping cleans the unsecured pre-operative area and the surgical registration desk areas, and has access to after hours when medical staff is not present.

8. Observation on 3/15/2022, during a tour of the Therapy Department with the Therapy Manager and the Inpatient Manager, revealed several patient medical records in the unsecured therapist's office.

9. During the tour of the Therapy Department, Therapy Manager H, acknowledged there incoming faxes containing patient information is received after hours, there are no locked cabinets or drawers in the therapist's office, housekeeping cleans the therapist office, and housekeeping has access to after hours when medical staff is not present.

10. Review of policy, "Security of Medical Records," revealed "...patient is entitled to the protection rights of information".

Based on observations and staff interviews, the Acute Hospital administrative staff failed to ensure pharmacy oversight and appropriate tracking of sample medications in 1 of 1 diabetes education outpatient service. Failure of pharmacy oversight and appropriate tracking of the receipt and dispensing of sample medications could result in inadequate records of the receipt and dispensing of sample medications, outdated, recalled, or otherwise unusable medications being available for the Diabetes Education Coordinator to give to patients, as well as, the potential for theft of medications due to inadequate tracking of sample medications. The Diabetes Education Coordinator reported 743 patient visits in 2021 and 19 injectable sample medications stored in the clinic.

Findings include:

1. Observation of the sample injectable diabetes medications stored in the Diabetes Education Coordinators office, on 3/14/2022, at 4:30 PM, revealed a locked refrigerator stored 9 Triseba sample kits, 13 Ozempic sample kits and 1 Trulicity sample kit.

2. During an interview, at the time of the observation, the Diabetes Education Coordinator reported the samples are delivered and accepted by the hospital's affiliated clinic and she brings them to her office for storage. The Diabetes Education Coordinator acknowledged she does not maintain documentation of the receipt and dispensing of the samples and is not sure if the hospital pharmacy is aware she has them, but confirmed the hospital pharmacy is not involved in any oversight of the process. She reported when she provides a sample medication to a hospital patient, she documents a progress note in the electronic diabetes education record, which is printed and scanned into the patient's hospital medical record and the Diabetic Education Coordinator confirmed, in the event of a medication recall, it would be difficult to determine what patients received the medication. The Diabetes Education Coordinator acknowledged she did not know if the hospital had a policy to address sample medications in an outpatient setting.

3. During an interview on 3/15/2022, at 1:45 PM, Pharmacist A reported she had become inadvertently aware of the use of sample diabetes injectable medication during conversations that occurred while completing her tasks on inpatient units. Pharmacist A acknowledged she did not believe the pharmacy department was involved in any pharmacy oversight of the medications stored in the Diabetes Education Coordinator's office. Pharmacist A acknowledged the importance of documentation to show the receipt, storage and dispensing of medications, and should include include documentation of the date, type/dose of medication, quantity, lot number and expiration date of each medication received. She reported documentation of the dispensing of each medication should include the date given, quantity and to whom it was given. Pharmacist A confirmed in the event of a medication recall, or any concerns regarding a particular medication, the lack of adequate documentation of the receipt, storage and dispensing of medication would make it difficult to determine the hospital patients who may have received the medication.

4. During an interview on 3/14/2022, at 3:45 PM, the Compliance Officer confirmed the hospital did not have a policy to address pharmacy oversight and the process to ensure appropriate documentation of the receipt, storage and dispensing of sample medications.

I. Based on observation, document review, and interviews, the Hospital's administrative staff failed to ensure the Surgery staff change the 500 milliliter (mL) 0.9% Sodium Chloride irrigation bottle after endoscopy (a procedure used to examine a person's digestive tract) for each patient, in accordance with the manufacturer's directions in 1 of 2 minor procedure rooms (Procedure Room 1). 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 Surgery staff performed an average of 92.25 scopes per month during fiscal year 2021 (July 2020 - June 2021).

Findings include:

1. Observations during a tour of the surgery department on 3/15/2022 at approximately 12:45 PM in minor procedure room #1 (used for scopes) revealed Baxter 0.9% Sodium Chloride Irrigation, USP 500 ml bottle, connected to the scope. Review of the manufacturer's instructions indicated in part, "Precautions .....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 prior to an endoscopic provedure in procedure room #1 on 3/15/2022 at approximately 12:45 PM, Registered Nurse (RN) D indicated the Surgery staff use the same bottle of Sodium Chloride for multiple endoscopy testing procedures that are scheduled. The Sodium Chloride is connected to the scope and the Surgery staff only discarded the bottle of Sodium Chloride for irrigation once solution had been open for 24 hours from the date of opening the Sodium Chloride bottle or if the bottle was emptied prior to the 24 hour mark.

3. During an interview on 3/7/2020 at approximately 2:00 PM, the Surgery Manager verified the Sodium Chloride should have been used as a single dose and not as a multidose solution. The Surgery manager acknowledged Baxter 0.9% Sodium Chloride Irrigation, USP 500 ml bottles manufacture's directions indicate the product is for single patient use only.






II. Based on observation, document review, and staff interview, the Acute Hospital administrative staff failed to ensure the staff removed outdated supplies from the Medical Surgical, Emergency, Special Care Unit, and the Obstetrics (OB) departments. Failure to remove outdated supplies from the Acute Hospital's supplies, available for patient use, could potentially result in the staff using expired medications for patient use after the manufacturer's expiration date, potentially resulting in the staff using supplies on a patient after the date which the manufacturer guaranteed the sterility and efficacy of the medication. The census based on arrival was 9 patients in the medical-surgical department and 2 in the Special Care Unit. The hospital administration revealed the average daily census is 9.24.

Findings include:

1. Observations on 3/14/22, during a tour of the Medical-Surgical unit, revealed outdated supplies:
a. 3M Coban, single patient use roll. Sporadic throughout the unit.
b. Ecolab Foam Hand Sanitizer, expiration 9/2021. Mounted on the wall in the Med-surg physical therapy room.
c. 3M Microfoam surgical tape, 1 box of 6, expiration 8/2021.


2. During an interview on 3/14/2022, with Environmental Services (EVS) Staff B, acknowledged EVS staff are responsible for replacing wall-mounted hand sanitizer.

3. Review of the manufacturer's instructions for the 3M coban-self-adherent wrap, revealed "..... Supplied in boxes of individually packaged rolls."

4. During an interview on 3/14/2022, the Inpatient Manager acknowledged the medical-surgical staff failed to remove the outdated supplies from multiple areas on the unit. The Inpatient Manager acknowledged it was their responsibility to monitor for outdated medications and supplies.

5. Review of the "Outdated Supplies for Medical Surgical" policy, last reviewed 08/2022, revealed "...supplies will be checked monthly for outdates."

6. Observations on 3/14/2022, during a tour of the Emergency Department, revealed outdated supplies:
a. Pediatric ambu-bag (a hand-held device commonly used to provide positive pressure ventilation to patients who are not breathing or not breathing adequately), expiration 12/2021. Pediatric crash cart.
b. 1 BD Vacutainer, Sodium Citrate lab tube, expiration 2/28/2022. Pediatric crash cart.
c. 2 nasopharyngeal airways with adjustable flange 18 French, expiration 8/2020.
d. One white oral airway, removed from original package, no manufacturer or expiration date.

7. Review of the manufacturer's instructions for the 3M coban-self-adherent wrap, revealed "..... Supplied in boxes of individually packaged rolls."

8. During an interview on 3/14/22, the Interim Emergency Room Nurse Manager revealed staff check for outdated supplies and medications monthly. The interview further revealed that nasopharyngeal and oral airways are not stored in their original packaging in exam rooms.

9. Observations on 3/14/22, during a tour of the Special Care Unit, revealed outdated supplies:
a. 2 tubes of BBL culture swab, expiration date 2/28/2022. Storage cupboard.
b. 10 BD Vacutainer, Sodium Citrate lab tubes, expiration 2/28/2022. Lab draw tray.

10. During an interview on 3/14/2022, the Inpatient Manager acknowledged the Special Care Unit staff failed to remove the outdated supplies from multiple inpatient rooms. The Inpatient Manager acknowledged it was their responsibility to monitor for outdated medications and supplies.

12. Observation on 3/14/2022, during a tour of the Obstetrics unit, revealed outdated supplies:
a. 3M Coban, single patient use roll. Sporadic throughout the unit.

13. Review of the "Outdated Supplies for Obstetrics" policy, last reviewed 8/2022, revealed "... supplies will be checked monthly for outdates."

14. Review of the manufacturer's instructions for the 3M coban-self-adherent wrap, revealed "..... Supplied in boxes of individually packaged rolls."

15. During an interview on 3/14/2022, the Inpatient Manager acknowledged the obstetrics staff failed to remove the outdated supplies from multiple inpatient rooms. The Inpatient Manager acknowledged it was their responsibility to monitor for outdated medications and supplies.

I. Based on observation, document review, and staff interviews, the Acute Hospital administrative staff failed to ensure the surgical EVS staff properly clean the operating room suite during 1 of 1 observed terminal clean procedures, (Suite #2). Failure to ensure surgical staff followed the approved Surgical Services Department Infection Control Protocol Policy could potentially result in the surgical EVS staff failing to remove bacteria and could potentially transmit bacteria to another patient, potentially causing a life-threatening infection. The hospital's administrative staff identified the surgical services staff performed an average of 267 surgical procedures per month during the fiscal year from June 2020 to July 2021.


Findings include:

1. Review of the "Surgical Services Department Infection Control Protocol Policy", reviewed on 3/14/22, revealed in part, "Floors and walls of the OR suites should be cleaned and disinfected .... Entire floor surface will be disinfected, including areas under the OR table and mobile equipment .... Wheels and casters of OR furniture/equipment should be disinfected."


2. Observation of a terminal clean by EVS Staff G on 3/14/2022 in Operating Room suite #2, revealed the following:

-- EVS Staff G did not clean OR suite #2 walls.

-- EVS staff G, did not move or clean the floor underneath the anesthesia cart.

-- EVS Staff G immediately wiped the floor after spraying cleaner on the floor, instead of waiting the manufacturer recommended time after spraying the cleaner on the floor.

-- EVS Staff G walked several times across the floor, after mopping, without shoe covers and wearing soiled, tattered pants that drag on the floor.

-- EVS Staff G used the same rag to wipe the outside of a biohazard bin and lid, then a stainless steel tray beside the operating table that is used for instruments or supplies during the procedure.

-- EVS Staff G did not clean the bottom side of both arm extension boards on the clean operating table.

-- EVS Staff G did not clean the arm extension board straps.

-- EVS Staff G did not clean any cords on the operating table.

-- EVS Staff G used the same rag to wipe down a stainless tray positioned next to the operating table after cleaning a trash can holder.

-- EVS Staff G did not wipe down any wheels or casters on any mobile equipment.

- EVS Staff G failed to perform hand hygeine or change their gloves after cleaning the equipment.

-- EVS Staff G held clean linen up next to their chest, then placed the linen on the operating table.

-- EVS Staff G did not wash hands after completing terminal clean.


3. Review of the label on the bottle of disinfectant that EVS Staff G sprayed on the floor of Operating Suite #2 revealed the manufacturer required the hospital staff to allow the disinfectant to stay wet for 10 minutes, in order for the disinfectant to function as the manufacturer intended.

4. During an interview at the time of the observations, EVS Staff G indicated they would not perform any further cleaning until after the surgical staff performed their next surgical procedure.




II. Based on observation, document review, and staff interviews, the hospital's administrative staff failed to ensure 1 out of 1 observed surgical environmental services (EVS) (EVS Staff G) wore appropriate surgical attire while performing 1 of 1 observed terminal cleaning of a surgical suite (Surgical Suite #2). Failure to ensure staff wore head coverings that fully cover all hair could potentially result in bacteria, fungi, or viruses on the surgical staff members' hair entering the environment and potentially resulting in the patient developing a life-threatening surgical site infection. The hospital's administrative staff identified the surgical services staff performed an average of 267 surgical procedures per month during the fiscal year from June 2020 to July 2021.

Findings include:

1. Observations on 3/15/22, revealed surgical EVS Staff G entered surgical suite #2 with hair that hung approximately 2 inches outside the surgical bonnet behind both ears and entire back of head.

2. Observations on 3/15/22, revealed surgical EVS Staff G wore pants that were tattered and soiled, dragging on the surgical floor. As EVS Staff G cleaned the floor, her tattered, soiled pants drug along the clean floor.

3. Review of the policy, "Surgical Attire", approved on 12/2019, revealed in part ... "Personnel entering the surgical suites or restricted areas will wear ... Head covering that cover all head and facial hair, sideburns and neckline ..."

4. During an interview on 3/14/2022, the Inpatient Manager and Surgical Services Manager acknowledged surgical EVS Staff G did not fully cover their hair or wear clean surgical attire while performing a terminal clean in surgical suite #2. The Supervisor of Outpatient Nursing Services reported the hospital followed the AORN (Association of Peri-Operative Registered Nurses, a nationally recognized guideline agency) guidelines statement for surgical attire.

5. Review of the AORN Guideline for Surgical Attire, copyright 2021, revealed in part, "Cover the scalp and hair when entering the semi-restricted and restricted area. [Recommendation]." " ... hair and skin can harbor bacteria that may dispersed into the perioperative environment."