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Tag No.: A0144
Based on observation, record review and interview, the rehabilitation hospital failed to ensure the patient's right to received care in a safe setting. This deficient practice was evidenced by:
1) Failure to ensure EvenCare Blood Glucose Test Strips had a documented open date on the test strip vial; and
2) Failure to ensure Room "a" sharps container was removed from the patient care area prior to the container exceeding its maximum limit.
Findings:
1) Failure to ensure EvenCare Blood Glucose Test Strips had a documented open date on the test strip vial
A review of the User's Guide for the Medline EvenCare G3 Blood Glucose Monitoring System, revealed in part: "Important: For vial test strips, record the date on the bottle when you open a new bottle of test strips. Discard any unused test strips six months after opening."
Observations during a hospital walk-though on 06/05/2025 from 10:40 AM to 1:10 PM revealed EvenCare Blood Glucose Test Strips being located on medication cart #1 and medication cart #2 without a documented "Date Opened" on the bottle.
In an interview on 06/05/2025 and present while the medication carts were being observed, S5LPN confirmed the above mentioned findings on medication cart #1 and S6LPN confirmed the above mentioned findings on medication cart #2.
2) Failure to ensure Room "a" sharps container was removed from the patient care area prior to the container exceeding its maximum limit
A review of hospital policy, "Disposal of Infectious Waste," PolicyStat ID 16297283, last revised on 09/2017 and had been approved and effective as of 08/2024, revealed in part: "Policy: To ensure the handling and disposal of infectious waste is done safely as to not cause injury or exposure to patients, visitors, and employees. To outline the employee responsibility for the disposal of infectious wastes. To ensure safety from exposure to biomedical wastes. Procedure: Objects that are contaminated with potentially infectious materials shall be placed in an impervious bag. If outside contamination of the bag is likely to occur, a second bag shall be added. Needles and sharps should be disposed of in puncture-resistant containers. All Biological waste shall be identified with a "Biohazard" label."
A review of hospital policy, "Cleaning Occupied Rooms," PolicyStat ID 13675828, last revised on 09/2017 and had been approved and effective as of 05/2023, revealed in part: "Policy: All patient rooms will be cleaned on a daily basis. Procedure: B. Close and discard sharps containers when they are ¾ full. Sharps containers are considered biohazardous waste and will be disposed of as such."
Observations during a hospital walk-though on 06/05/2025 from 10:40 AM to 1:10 PM revealed Room "a" sharps container overflowing with syringes and lancets.
In an interview on 06/09/2025 and present during the hospital walk-through, S1ADM confirmed the above mentioned findings and further agreed the sharps container should have been changed for the safety of staff, patients and/or any visitors that may come in contact with a contaminated item not being properly disposed.
Tag No.: A0405
Based on observation, record review and interview, the rehabilitation hospital failed to ensure drugs and biologicals were administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This deficient practice was evidenced by a multiple-dose, 10 ml vial of Novolin R U-100 being open and available for patient use without a documented beyond-use date on or attached to the vial.
Findings:
A review of hospital policy, "Expiration and Beyond-Use Dates," PolicyStat ID 13676256, last revised on 09/2017 and had been approved and effective as of 05/2023, revealed in part: "Policy: Beyond-use dates for medication shall be assigned according to this policy. Beyond-Use Dated for Prepackaged Products: Beyond-use dates shall be assigned to all prepackaged products. Beyond-use dates shall be assigned in accordance with the Federal and State Laws and Regulations. In no case shall the assigned date exceed the Manufacturer's expiration date."
A review of hospital policy, "Multiple-Dose Vials," PolicyStat ID 16298091, last revised on 04/2021 and had been approved and effective as of 03/2025, revealed in part: "Policy: It is the policy of this facility to ensure proper and safe use of multi-dose vials of medication. Policy Explanation and Compliance Guidelines: 1. Multiple-dose Medications are clearly marked by the Manufacturer with an explanation date. b. if a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that open vial. 6. Unit manager will perform random checks of opened multi-dose vials for appropriate dating."
Observations of medication cart #1 during a hospital walk-though on 06/05/2025 from 10:40 AM to 1:10 PM revealed a multiple-dose, 10 ml vial of Novolin R U-100 being open and available for patient use without a documented beyond-use date on or attached to the vial.
In an interview on 06/05/2025 at 12:10 PM, S5LPN confirmed the above mentioned findings and further confirmed an open, multiple-dose vial of medication should be labeled with a beyond-use date.
Tag No.: A0438
Based observation and interview, the rehabilitation hospital failed to provide a system of record maintenance that ensures the integrity of the authentication and protects the security of all record entries. This deficient practice was evidenced by the storage of paper medical records in a storage closet and on the floor of Room "d" without protection from damage which could include fire, water damage and/or other threats.
Findings:
A review of hospital policy, "Safeguarding PHI," PolicyStat ID 16298083, last revised on 03/2021 and had been approved and effective as of 03/2025, revealed in part: "Policy: To reasonable safeguard Protected Health Information from any intentional or unintentional use or disclosure that is in violation of the Health Insurance Portability and Accountability Act (HIPPA) Standards for Privacy of Individually Identifiable Health Information (Privacy Standards), 45 CFR Parts 160 and 164, and any and all other Federal Regulations and interpretive guidelines promulgated hereunder regarding safeguarding of Protected Health Information. Procedure: B. Safeguards for Written PHI: All Documents containing PHI should be stored appropriately to reduce the potential for incidental use or disclosure. Documents should not be easily accessible to any unauthorized staff or visitors. Active Records on Nursing Unit: 1. Active Medical Records shall be stored in an area that allows staff providing care to patients to access the records quickly and easily as needed. 3. Active Medical Records shall not be left unattended on the Nurses' Station desk or other areas where patients, visitors, and unauthorized individuals could easily view the records. 6. Medical Records shall be protected from loss, damage, and destruction. Thinned Records, Inactive Medical Records: 1. Thinned and inactive Medical Records will be filed in a systemic manner in a location that ensures the privacy and security of the information. The Health Information Manager or a designee shall monitor the storage and security of such Medical Records. When records are left unattended, records will be in a locked room, file cabinet, or drawer."
Observations during a hospital walk-though on 06/05/2025 from 10:40 AM to 1:10 PM revealed a storage closet which contained boxed medical records being stored on open, metal shelving units. The boxes were identified with medical records from the years 2019 to 2024. The metal, shelving units were open, with no protection from damage such as fire or water. Other observations during the tour revealed a storage box being stored on the flooring, under a counter in Room "d" . This box was identified with medical records from 2025.
In an interview on 06/05/2025 and present on the hospital walk-through, S2ADM confirmed the above mentioned findings and further confirmed the medical records need to be protected from potential destruction.
Tag No.: A0458
Based on record review and interview, the rehabilitation hospital failed to ensure a medical history and physical examination was completed and documented for each patient no more than 24 hours after admission or registration. This deficient practiced was evidenced by the failure to document a completed medical history and physical examination within 24 hours of admission on 1 (#1) of 3 (#1-#3) patient's medical records reviewed.
Findings:
A review of hospital policy, "History and Physicals," PolicyStat ID 13676094, last revised on 09/2017 and had been approved and effective as of 05/2023, revealed in part: "Policy: An H&P must be completed and documented for each patient no more than 30 days prior to or 24 hours after hospital admission, but prior to surgery or a procedure requiring anesthesia services. The H&P documentation must be placed in the medical record within 24 hours admission, but in all cases prior to surgery or a procedure requiring anesthesia services."
A review of Patient #1's electronic medical record (EMR) revealed an admission date of 05/16/2025 at 3:52 PM. A review of the document, "Form: Provider History and Physical (IRF)" revealed the History and Physical date of service as 05/17/2025, with the document being signed by S7NP on 05/17/2025 at 7:31 PM.
In an interview on 06/09/2025 at 9:30 AM and present for the EMR review, S2DON confirmed the above mentioned findings and further confirmed the H&P would not be available for staff to view in the EMR until the provider electronically signed the document.
Tag No.: A0502
Based on observation and interview, the rehabilitation hospital failed to ensure all drugs and biologicals were kept in a secure area and locked when appropriate. This deficient practice was evidenced by 2 medications carts being stored and unattended at the main entry of the hospital.
Findings:
A review of hospital policy, "Safeguarding PHI," PolicyStat ID 16298222, last revised on 04/2022 and had been approved and effective as of 12/2024, revealed in part: "Policy: It is the policy of this facility to ensure all medications housed on our premises will be stored in the pharmacy and/or medication rooms according to the manufacturer's recommendations and sufficient to ensure proper sanitation, temperature, light, ventilation, moisture control, segregation, and security."
Observations during a hospital walk-though on 06/05/2025 from 10:40 AM to 1:10 PM revealed 2 medications carts being stored and unattended within 10 - 15 feet of the main entry of the hospital. The hospital entry door was not under controlled or secured access during this time frame. Any individual could exit the building with a rolling medication cart uninhibited. Observations of these 2 medication carts revealed their contents as being floor stock medications and the prescribed medications for Patients #3 and #R1 - R10.
In an interview on 06/05/2025 and present on the hospital walk-through, S2ADM confirmed the above mentioned findings and further confirmed the carts were unattended at the time of our arrival to this area.
Tag No.: A0701
Based on observation and interview the rehabilitation hospital failed to ensure the condition of the physical plant and the overall hospital environment was maintained in such a manner that the safety and well-being of patients are assured. This deficient practice was evidenced by the clean linen storage room not being maintained in a climate controlled and sanitary environment.
Findings:
Observations during a hospital walk-though on 06/05/2025 from 10:40 AM to 1:10 PM revealed the clean linen storage room having a large opening in one side wall, approximately 5 feet in width by 6 feet in height. This opening appeared to be the same size as the commercial clothing/linen dryer next to it. This opening in the wall allow access to a room which would have been enclosed and behind this opening and the existing dryer and appeared to be the location of the dryer exhaust ventilation. This dryer exhaust, ventilation room consisted of unfinished dry wall and the exterior wall had 2 vents approximately 2 feet by 2 feet which opened to the outside. These 2 vents had a wire mesh covering on the interior sides with the mesh openings being approximately 1cm by 1cm. This mesh would not hinder all pest or insects from entering this room. Further, these 2 openings prevented this room from being climate controlled. With these findings, the appropriate storage of the clean linen within this area, could impede the cleanliness and sanitary storage of the clean linen.
In an interview on 06/05/2025 and present on the hospital walk through, S1ADM confirmed the above mentioned findings and the opening in the wall was the space where a prior clothing/linen dryer was located, which had been removed. Further, S1ADM confirmed the opening between the 2 rooms should not be there.
Tag No.: A0724
Based on observation and interview, the rehabilitation hospital failed to ensure facilities, supplies and equipment were maintained to an acceptable level of safety and quality. This deficient practice was evidenced by:
1) Failure to ensure expired supplies were removed from the patient care area; and
2) Failure to ensure Room "a" sharps container was removed from the patient care area prior to the container exceeding its maximum limit.
Findings:
1) Failure to ensure expired supplies were removed from the patient care area
A review of hospital policy, "Expiration and Beyond-Use Dates," PolicyStat ID 13676256, last revised on 09/2017 and had been approved and effective as of 05/2023, revealed in part: "Policy: Beyond-use dates for medication shall be assigned according to this policy. Beyond-Use Dated for Prepackaged Products: Beyond-use dates shall be assigned to all prepackaged products. Beyond-use dates shall be assigned in accordance with the Federal and State Laws and Regulations. In no case shall the assigned date exceed the Manufacturer's expiration date. Expiration Date Monitoring: The expiration dates of all medications and devices shall be checked during the routine medication area inspections and all medications and devices scheduled to expire during the next month shall be removed from stock."
Observations of Room "b" during hospital walk-though on 06/05/2025 from 10:40 AM to 1:10 PM revealed a bottle of Gentian Violet Topical Antiseptic with an expiration of 10/2024 located in the room's cabinet.
In an interview on 06/05/2025 at 11:32 AM S3RN confirmed the above mentioned findings.
2) Failure to ensure Room "a" sharps container was removed from the patient care area prior to the container exceeding its maximum limit
A review of hospital policy, "Disposal of Infectious Waste," PolicyStat ID 16297283, last revised on 09/2017 and had been approved and effective as of 08/2024, revealed in part: "Policy: To ensure the handling and disposal of infectious waste is done safely as to not cause injury or exposure to patients, visitors, and employees. To outline the employee responsibility for the disposal of infectious wastes. To ensure safety from exposure to biomedical wastes. Procedure: Objects that are contaminated with potentially infectious materials shall be placed in an impervious bag. If outside contamination of the bag is likely to occur, a second bag shall be added. Needles and sharps should be disposed of in puncture-resistant containers. All Biological waste shall be identified with a "Biohazard" label."
A review of hospital policy, "Cleaning Occupied Rooms," PolicyStat ID 13675828, last revised on 09/2017 and had been approved and effective as of 05/2023, revealed in part: "Policy: All patient rooms will be cleaned on a daily basis. Procedure: B. Close and discard sharps containers when they are ¾ full. Sharps containers are considered biohazardous waste and will be disposed of as such."
Observations during a hospital walk-though on 06/05/2025 from 10:40 AM to 1:10 PM revealed Room "a" sharps container overflowing with syringes and lancets.
In an interview on 06/09/2025 and present during the hospital walk-through, S1ADM confirmed the above mentioned findings and further agreed the sharps container should have been changed for the safety of staff, patients and/or any visitors that may come in contact with a contaminated item not being properly disposed.
Tag No.: A0750
Based on observation, record review and interview, the rehabilitation hospital failed to ensure infection prevention and control program included maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities. This deficient practice was evidenced by:
1) Failure to ensure single patient use supplies were assigned and appropriately labeled to a single patient;
2) Failure to ensure food was not stored in lab specimen refrigerator; and
3) Failure to ensure cardboard shipping boxes were not used as storage containers on the shelving of the clean supply storage.
Findings:
1) Failure to ensure single patient use supplies were assigned and appropriately labeled to a single patient
Observations during a hospital walk-though on 06/05/2025 from 10:40 AM to 1:10 PM revealed the following single patient use items open and available for patient use in the patient care area and not assigned to a patient:
Room "d" patient preparation counter: 1 container of DeRoyal Algidex Ag Packing Strip Antimicrobial Packing Gauze; 2 containers of Curad Iodoform Packing Strip; and 2 containers of Curad Plain Packing Strip; and
Rooms "b" and "c": an opened 16 ounce bottle of Medline Skintegrity Wound Cleanser in each room.
In an interview on 06/05/2025 at 11:32 AM, S3RN confirmed the above mentioned findings.
2) Failure to ensure food was not stored in lab specimen refrigerator
A review of hospital policy, "General Refrigerator Cleaning," PolicyStat ID 13676063, last revised on 09/2017 and had been approved and effective as of 05/2023, revealed in part: "Policy: To provide for the proper and safe storage of medications, patient nourishment and employee food. Procedure" Objective: Medications, food and nutrition products, and laboratory specimens will be stored under proper conditions of sanitation, temperature, light, moisture, ventilation, and security to maintain product stability."
Observations during a hospital walk-though on 06/05/2025 from 10:40 AM to 1:10 PM revealed the lab specimen refrigerator in Room "d" had a black plastic bag containing unknown contents which appeared to be the size of a food storage container.
In an interview on 06/05/2025 at 11:30 AM, S3RN confirmed the presence of the black plastic bag in the refrigerator and the bag contained an employee's lunch.
3) Failure to ensure cardboard shipping boxes were not used as storage containers on the shelving
Observations during a hospital walk-though on 06/05/2025 from 10:40 AM to 1:10 PM revealed the clean supply storage in the Room "d" had brown cardboard boxes being used as storage bins on the shelving units. Corrugated cardboards cannot be properly sanitized and potentially harbor contaminants which are unsuitable where infection control measures are necessary.
In an interview on 06/05/2025 at 11:30 AM, S3RN confirmed the above mentioned findings.