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Based on observation, interview, and policy review, the hospital failed to provide a secure environment that prevented patients' medical records from being accessed by unauthorized individuals.

This deficient practice failed to provide safe storage and retention of the Protect Health Information (PHI) in the medical records for all patients, current and past, the hospital has served. The hospital census was 41 inpatients.

Findings included:

1. Observation on 06/13/2024 at 8:59 AM, showed:
· The medical records department was located in the basement of the facility that requires staff access.
· The medical records department was a four-person cubicle housed in an area with information technologies, revenue cycle, accounting, and the pharmacy manager's desk.
· There was not restricted access to the medical records cubicle from unauthorized staff.
· There was one medical record employee present in the cubicle and three open workstations.


2. During an interview on 06/13/2024, 8:59 AM, Staff M, stated the medical records department was only accessible to staff but not restricted to medical record staff only.

3. Review of the hospital policy titled, "Medical Record Retention and Destruction", reviewed 10/2023, showed:
· Hospital shall retain, store, and destroy medical records in compliance with applicable legal and regulatory requirements.
· Other acquired documentation from outside resources used for clinical decision making and treatment planning will be scanned and stored in the patient's electronic medical record (EMR) and will be available in electronic image format.
· Paper copies from outside facilities can be destroyed once scanned and verified in the patient's EMR.
· Storage areas for inactive records can include either an area inside the hospital that has been approved for record storage use, or an off-site, private, professional record storage facility with which the hospital has ab active contract for storage and retrieval.
· Storage areas approved for records storage must be physically secure and environmentally controlled to protect records from unauthorized access and damage or loss due to temperature fluctuations, fire, water damage, pests and other hazards.

Based on observation, interview, and policy review, the hospital failed to promptly secure paper medical records from outside providers in 18 of 18, outside paper medical records.
This deficient practice failed to provide safe storage and retention of the Protect Health Information (PHI) in the medical records for all patients, current and past, the hospital has served. The hospital census was 41 inpatients.

Findings Included:

1. Observation on 06/13/2024 at 8:59 AM, showed:
· There was one medical record employee present in the cubicle and three open workstations.
· There were outside paper medical records for 18 different patients on a table in the center of the cubicle that were not secured from employees without medical record authorization.

2. During an interview on 06/13/2024, 8:59 AM, Staff M, stated the 18 outside paper medical records had been on the table for close to a month or more after an employee for the department is no longer with them. They stated the expectation when a patient arrives with outside paper medical records is that the records should be scanned and shredded. They stated that apparently didn't happen here.


3. Review of the hospital policy titled, "Medical Record Retention and Destruction", reviewed 10/2023, showed:
· Policy: Hospital shall retain, store, and destroy medical records in compliance with applicable legal and regulatory requirements.
· Other acquired documentation from outside resources used for clinical decision making and treatment planning will be scanned and stored in the patient's electronic medical record (EMR) and will be available in electronic image format.
· Paper copies from outside facilities can be destroyed once scanned and verified in the patient's EMR.
· Storage areas for inactive records can include either an area inside the hospital that has been approved for record storage use, or an off-site, private, professional record storage facility with which the hospital has ab active contract for storage and retrieval.
· Storage areas approved for records storage must be physically secure and environmentally controlled to protect records from unauthorized access and damage or loss due to temperature fluctuations, fire, water damage, pests and other hazards.

Based on observation, interview and policy review, the facility failed to ensure controlled substance medications were secured under double-lock in a pharmacy refrigerator. These failures had the potential to allow unauthorized access of medications. The hospital census was 41 inpatients.

Findings included:

1. Observation on 6/11/24 at 3:30 PM, in the pharmacy, in an unlocked unsecure refrigerator, showed 10 drawn-up syringes (2 mg/ml) labeled Lorazepem (a controlled substance that can cause paranoia, suicidal ideation, impaired memory and judgement) one (30 ml) oral dose of Lorazepam and 16 vials (2mg/ml) of Lorazepam.

2. During an interview on 6/12/24 at 1:47 PM, Staff I, Director of Pharmacy, stated they were aware of the controlled substances needing to be double-locked and did not think about it since it was inside the pharmacy.

3. Review of the facility's policy titled, "Pharmacy Accountability Process For Controlled Substances," last reviewed on 09/2023, showed the direction for staff to ensure Controlled Substances were stored under a double-lock system.

Based on observation, interview, nationally-recognized standards review and policy review, the hospital failed to have systemic practices in place to ensure:
- The containment and separation of the Sterile Processing Clean room (room used to sterilize instruments) from the exposure of contaminants.
- Staff measured the amount of water used to mix the enzyme cleaner per manufacture recomendations, used to clean instruments in the Sterile Processing Decontamination room.
- The Sterile Processing Decontamination room and Sterile Processing Clean room were terminally cleaned each day the areas were used.
- The containment and separation of the soiled laundry and clean laundry for patients.
- The cleaning and maintenance of equipment in the kitchen.
- Eyewash solution was not expired for the emergency eyewash station in the kitchen.
- Staff performed hand hygiene (washing hands with soap and water or use of appropriate hand sanitizer) when indicated when staff prepared medications for patients.
- Staff maintained equipment used for patients.

The severity and cumulative effects of these systemic practices resulted in the hospital's non-compliance with 42 CFR 482.42 Condition of Participation: Infection Prevention and Control and Antibiotic Stewardship Programs and resulted in the hospital's failure to ensure quality health care and safety.

Please refer to A-750 for details.

Based on observation, interview, nationally-recognized standards review and policy review, the hospital failed to have systemic practices in place to ensure:
- The containment and separation of the Sterile Processing Clean room (room used to sterilize instruments) from the exposure of contaminants.
- Staff measured the amount of water used to mix the enzyme cleaner per manufacture recomendations, used to clean instruments in the Sterile Processing Decontamination room.
- The Sterile Processing Decontamination room and Sterile Processing Clean room were terminally cleaned each day the areas were used.
- The containment and separation of the soiled laundry and clean laundry for patients.
- The cleaning and maintenance of equipment in the kitchen.
- Eyewash solution was not expired for the emergency eyewash station in the kitchen.
- Staff performed hand hygiene (washing hands with soap and water or use of appropriate hand sanitizer) when indicated when staff prepared medications for patients.
- Staff maintained equipment used for patients.
These failed practices had the potential to expose patients, visitors and staff to cross-contamination and increased the potential to spread infection. The hospital census was 41 inpatients.

Findings included:

Sterile Processing Rooms
1.Observation on 6/12/24 at 2:10 PM, in the Central Sterile Clean room, showed the room was not contained and was a high-traffic area with two laundry carts, storage carts and two closets for pediatric patient toys with cloth curtains that staff frequently access. These items in the room, prevented terminally cleaning.

2.Although requested, the facility failed to produce a terminal cleaning log of the Central Sterile Rooms on the days the areas were used.

3.During an interview with Staff C, Respiratory Therapy Director, stated they were unaware the area needed to be contained, terminally cleaned and they follow AAMI National Guidelines.

4.AAMI National Guidelines Recommendations showed staff were to terminally clean sterile processing areas each day the areas are used. Sterile processing personnel conduct critical processes, such as decontaminating, assembling, and sterilizing surgical instrumentation, in support of operating and invasive procedure rooms. As such, the recommendations for terminal cleaning apply in sterile processing areas as in areas where surgical and other invasive procedures are performed. Furthermore, sterile processing areas where decontamination occurs have some of the highest risks for environmental contamination of all perioperative areas. Environmental cleaning in sterile processing areas is critical for reducing the risk of disease transmission from reservoirs of bloodborne pathogens and microorganisms in the decontamination environment.

5.Observation with concurrent interview on 6/12/24 at 2:15 PM, in the Central Sterile Decontamination room, showed the enzymatic cleaner used to clean the instruments with manufacturer recommendations. Staff C stated they were not measuring the amount of water to mix the enzymatic cleaner per the manufacturer recommendations.

6.During an interview on 6/12/24 at 2:20 PM, Staff C, Respiratory Therapy Director, stated they follow AAMI National Guidelines.

7.During an interview on 6/13/24 at 12:22 PM, Staff Y, Infection Prevention and Quality Specialist, stated they expected staff to accurately measure the cleaners per manufacturer guidelines and they were unaware of the high traffic in the Central Sterile Clean room.

8.Review of the American National Standards Institute (ANSI) and Associate for the Advancement of Medical Instrumentation (AAMI) document titled, "ANSI/AAMI ST79:2017, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities Amendment 2: Inspection of Insulated Instruments," dated 2020, showed each time a medical device is processed, it should be visually inspected for cleanliness and integrity. When recommended in the instrument manufacturer ' s written IFU, enhanced inspection should be used and the enhanced visualization tool manufacturer ' s written IFU should be followed. Health care facilities should have a method of ensuring the cleanliness and integrity of every instrument and medical device used in every procedure.

Laundry
9. Observation on 6/12/24 at 4:20 PM, in the laundry room, showed the washers and dryers across from each other and the soiled laundry brought into the clean room exposing contaminants to the clean laundry.

10.During an interview on 6/12/24 at 4:30 PM, Staff K, Director of Facilities, stated they did not realize the soiled clothes were exposed in the clean laundry room.

11.During an interview on 6/13/24 at 12:22 PM, Staff Y, Infection Preventionist and Quality Specialist, stated they were unaware of the exposure in the laundry room and they did not perform environmental rounds in the laundry.

12.Review of the facility ' s policy titled, "Laundry Service and Linen Handling," last reviewed on 05/2022, showed laundry was to be handled and processed in such a manner to prevent the transmission of infectious organisms from one patient to another or from patient to staff.

Kitchen
13.Observation on 6/10/24 at 3:15 PM, in the kitchen, showed:
- An unclean hotbox/holding box.
- A large amount of residue on the range oven.
- A large amount of residue and dirt on the top of the dishwasher.
- Residue on the wall behind the dishwasher.
- Eyewash solution with an expiration date of 08/2023 in the emergency eyewash station.

14.During an interview on 6/11/24 at 10:30 AM, Staff A, Dietary Manager, stated they expected staff to clean the hotbox, range oven, dishwasher and wall behind the dishwasher. They also stated they expected staff to check the eyewash solution for current dates.

15.During an interview on 6/13/24 at 12:22 PM, Staff Y, Infection Preventionist and Quality Specialist, stated they performed kitchen environmental rounds quarterly, they expected staff to maintain any need of cleaning and repairs and they expected the staff to check for expiration dates.

16.Review of the facility ' s policy titled, "Dietary Manual," last reviewed 07/2023, showed food contact surfaces were to be cleaned once per day and non-food contact surfaces of equipment shall be cleaned as often as necessary to keep the equipment free of accumulation of dust, dirt, food particles and other debris.

17.Review of the facility ' s policy titled, "Infection Control Plan," last reviewed on 03/2024, showed the Infection Prevention staff were to complete hospital-wide rounds on an ongoing, routine basis, including but not limited to: central line, kitchen, isolation precaution, high touch surface cleaning, and environment of care rounds.

MEDICATION ADMINISTRATION
18. Observation on 06/12/24 at 9:00 AM, showed Staff Z, Registered Nurse (RN), on the West Unit prepared and administered medications to Patient #5:
- Staff Z failed to perform hand hygiene upon entry into the treatment room to administer two subcutaneous (Sub Q - under the skin) injections.
- With un-gloved hands, Staff Z removed the bar code scanner from the computer workstation on wheels and scanned the patient's identification (ID) band and each bar code on the medications.
- After scanning the bar codes on the medications, Staff Z put on gloves, however, Staff Z failed to perform hand hygiene before gloving.
- Patient #5 dropped an object onto the floor and Staff Z picked the item off the floor, removed gloves and re-gloved, however, Staff Z failed to perform hand hygiene after removal of gloves or before re-gloving.
- After Staff Z administered the Sub Q medications, Staff Z removed gloves but failed to perform hand hygiene after glove removal.

19. Observation on 06/12/24 at approximately 9:30 AM, showed Staff U, RN, on the East Unit prepared and administered medications to Patient #18.
- Staff U failed to perform hand hygiene before Staff U retrieved medications from the automated medication dispensing system to administer medication to Patient #18 per the patient's gastrostomy tube (G-Tube - a soft flexible tube inserted through the skin of the abdomen and into the stomach, used to administer medications, fluids, and tube feedings).
- Staff U performed hand hygiene upon entry into the patient's room and put on gloves, removed the bar code scanner from the computer workstation on wheels and scanned the patient's ID band and each medication bar code.
- After Staff U used the bar code scanner, Staff U removed gloved and re-gloved, however, Staff U failed to perform hand hygiene after removal of gloves or before re-gloving.
- Staff U attached the patient's G-Tube to the patient and administered each medication and at the completion of administering the medications, Staff U flushed the patient's G-Tube with water.
- Wearing the same gloves worn to administer the medications and flush the patient's G-Tube, Staff U applied topical medication to the patient per orders.

20.Staffs' failure to perform hand hygiene and remove/change gloves when indicated increased the risk of cross-contamination towards patients, staff, supplies and anything touched with contaminated hands and/or gloves.

21. During an interview on 06/12/24 at 9:11 AM, Staff Z, RN, stated:
- Staff received education/training related to hand hygiene and gloving during orientation, on an on-going basis, and yearly per electronic education.
- Staff was expected to perform hand hygiene:
- Upon entry & exit of patients' rooms;
- Before and after staff touched a patient;
- Before gloving, after removal of gloves, and before re-gloving; and
- Anytime staff touched medical equipment.
- Staff was expected to wear/change gloves:
- Anytime staff touched a patient;
- Anytime gloves are indicated.

22. During an interview on 06/13/24 at 11:54 AM, Staff D, East Unit Nursing Manager, stated staff was expected to perform hand hygiene and wear/changes gloves:
- Upon entry and exit of patients' rooms.
- When retrieving and handling medications.
- Anytime staff touch anything in the patient's environment.
- Before gloving, after removal of gloves and before re-gloving.
- Remove gloves after providing care for a patient and perform hand hygiene before retrieving supplies from the supply drawer.
- Follow the facility's policy and procedure related to hand hygiene.

23. During an interview on 06/13/24 at 11:54 AM, Staff F, West Unit Nursing Manager, stated staff was expected to perform hand hygiene and wear/change gloves:
- With aseptic techniques.
- The 5 Moments of Hand Hygiene.
- Before medication preparation and administration.

24. During an interview on 06/13/24 at 12:53 PM, Staff L, Infection Control Prevtionist, stated staff was expected to:
-Follow the 5 Moments of Hand Hygiene.
- To removal gloves after using the bar code scanner on patients' ID bands and bar codes on medications, before removing medications from the medication packages, and before administering medication to the patient.
- Perform hand hygiene before gloving, after removal of gloves, and before re-gloving.
- Follow the facility's hand hygiene policy and procedure.

25. Observation on 6/11/24 at 2:07 PM, in Patient #12 ' s room, during a J tube (Jejunostomy feeding tube, a soft, plastic tube placed through the skin of the abdomen into the midsection of the small intestine used to administer food and medication) medication administration, showed:
- Staff H, Registered Nurse (RN), washed hands and put gloves on;
- Scanned the medication and the patient ' s wrist band;
- Touched the computer;
- Touched the patient;
- Opened the medication and placed in the crusher;
- Mixed medication with 10 ml of water;
- Administered medication;
- Administered 5 ml of flush;
- Recapped the patient ' s J tube and signed off the computer; and
- Showed Staff H used the same contaminated gloves throughout the medication administration.

26. During an interview on 6/11/24 at 2: 10 PM, Staff H, RN, stated they did not realize how much they touched the computer with the same gloves.

27. During an interview on 6/13/24 at 12:22 PM, Staff Y, Infection Preventionist and Quality Specialist, stated they expected staff to follow WHO and the five moments of hand hygiene.

28. Review of the facility's policy titled, "Hand Hygiene," dated 03/2024, showed staff directives:
- The 5 Moments for Hand Hygiene, defined by the WHO (World Health Organization)
- Before touching a patient
- Before clean/aseptic procedures
- After body fluid exposure/risk (and after removing gloves)
- After touching a patient
- After touching patient surroundings
- Other indication for handwashing and hand antiseptic
- Decontaminate hands after contact with body fluids or excretions, mucous membranes, non-intact skin, and wound dressings if hands are not visibly soiled.
- Decontaminate hands if moving from a contaminated-body site to a clean-body site during patient care.
- Staff education: All staff will be educated regarding proper hand hygiene practice upon hire and on an ongoing basis.

EQUIPMENT
29. Observation on 06/12/24 and 06/13/24, on the East Unit showed a large medical wedge cushion on a stretcher located by Room 15. The top and sides of the wedge cushion had several strips of wide gray colored adhesive tape on the top and each side.

30. During an interview on 06/13/24 at 8:57 AM, Staff DD, QAPI, acknowledged the large medical wedge cushion on the stretcher located by Room 15 had wide gray colored strips of adhesive tape on the top and sides. Staff DD stated the wedge cushion belonged to the facility and was not a patient's.

31.The wide gray colored strips of adhesive tape on the large medical wedge cushion made the surface non-cleanable and increased the risk to harbor bacteria and germs.


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