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Based on document review, Arizona Administrative Code (A.A.C.), and interview, it was determined that the administrator failed to ensure that an annual assessment of the facility's risk of exposure to infectious tuberculosis (TB) which has the potential risk that the facility will not identify the appropriate level of precautions to implement as part of the facility TB control plan.

Findings include:

Arizona Administrative Code "R9-10-113 Tuberculosis Screening" requires: "...A. If a health care institution is subject to the requirements of this Section, as specified in an Article in this Chapter, the health care institution's chief administrative officer shall ensure that the health care institution establishes, documents, and implements tuberculosis infection control activities that: ...2. Include: ...d. Annually assessing the health care institution's risk of exposure to infectious tuberculosis...."

A current TB control plan was requested but not provided.

Employee #3 provided a draft copy of a TB Control plan that has not yet been completed and adopted by the governing authority.

A copy of the annual assessment of the facility's risk of exposure to infectious tuberculosis was requested. None was provided.

Employee #13 confirmed on 10/22/2024 that the facility did not conduct an annual assessment of their risk of exposure to infectious tuberculosis.

Based on manufacturer's recommendations, policy and procedures, observation, and interview, it was determined that the facility failed to ensure available supplies in:

1. the ED trauma room #5 and;

2. Copper Mountain Clinic were not expired which poses a risk of ineffective and/or inaccurate results from the use of expired items.

Findings include:

1.

BD blood culture 30 ml bottles - (2) bottles expired 08/01/2024 and (2) bottles expired 07/02/2024
BD PST gel/lithium heparin tubes (dark green) - (1) tube expired 01/31/2024, (2) tubes expired 06/30/2024, (7) tubes expired 07/31/2024
Vacuette Tube 6 ml (pink top) tubes - (7) tubes expired 01/01/2024
BD EDTA Vacutainer (lavender top) tubes - (2) tubes expired 11/30/2023, (2) tubes expired 05/31/2024, (1) tube expired 08/31/2024
BD PST gel lithium heparin tubes (light green) - (1) tube expired 07/31/2024 and (4) tubes expired 08/31/2024
BD Citrate tubes (light blue) - (1) tube expired 01/31/2022, (5) tubes expired 01/31/2023, (2) tubes expired 04/30/2024, (5) tubes expired 06/30/2024, (4) tubes expired 09/30/2024
BD SST Vacutainer (gold top) tubes - (1) expired tube 09/30/2023, (1) expired tube 10/31/2023, (2) expired tubes 03/31/2024, (1) expired tube 04/30/2024, (2) expired tubes 07/31/2024
(1) 16 fl ox (473 ml) bottle Betadine Solution 10% Povidone Iodine Antiseptic Solution expired 01/2023
Povidont-Iodine Swabstick (3's) - (2) packages expired 03/2024 and (1) package expired 04/2024

Employees #3 and 40 confirmed on 10/22/2024 that the aforementioned supplies in the ED trauma room were not discarded when expired according to the manufacturers listed expiration date.

2.

Policy titled, "Medications", revealed: "...Medication will be stored according to the requirements listed on the medication package or in accordance with the United States Pharmacopoeia current recommendations. Factors to consider are generally temperature, humidity, light, and security...Expired medication will be removed from stock at the end of the month. Medications that will expire before the next month end will be removed and disposed of...."

Aplisol Manufacturer's Instructions revealed: "...Aplisol vials should be inspected visually for both particulate matter and discoloration prior to administration and discarded if either is seen. Vials in use for more than 30 days should be discarded...."

Observation on 10/21/2024 revealed (3) antigen vials for injection prescribed to Patient #28 with an expiration date of 09/21/2024. Further observation revealed (1) open vial of Tuberculin, Purified Protein Derivative, Diluted Aplisol with no open date and/or discard date marked on vial.

Employee #41 confirmed on 10/21/2024 the antigen vials and Tuberculin were expired and not removed from stock.

Based on observation and interview, it was determined that the facility failed to ensure the behavioral health restraint/seclusion room in the ED was ligature free which has the potential risk of patient harm if tie off points are available to a patient who may self harm.

Findings include:

Observation on 10/22/2024 revealed that the ED had a behavioral health restraint/seclusion room. The room was equipped with a platform patient bed and an anti-ligature light fixture. The anti-ligature light fixture was not installed flush with the ceiling and wall above the patient bed and had a 1/8 to 1/4 inch gap along the top and sides of the fixture that could be used as a tie off point/ligature.

Employee #3 confirmed on 10/22/2024 that the behavioral health restraint/seclusion room was not ligature free and had a tie-off point due to the anti-ligature fixture not being installed flush against the wall and ceiling.

Based on facility policy and procedure, observations, and staff interviews, it was determined the facility failed to ensure:

1. medical equipment had annual preventative maintenance performed;

2. facility blood draw chairs, patient exam beds, and a procedure chair's upholstery did not contain upholstery tears. This deficient practice poses a health and safety risk to the patient if the facility's medical equipment is not functioning properly and or in good working order.

Finding Include:

1.

Policy titled, "Preventative Maintenance", revealed: " ...Preventative Maintenance on all medical equipment will be performed annually or per manufacturer's recommendations ...."

Observation on 10/22/2024 revealed the DexaScan machine had a preventative maintenance last performed in 01/2023.

Observation on 10/22/2024 revealed the DexaScan Lunar Prodigy Advanced machine had a preventative maintenance last performed in.

Employee #7 confirmed on 10/22/2024 the machine did not have preventative maintenance performed per policy and procedures.

2.

Policy titled, "Cleaning of Patient Room/Equipment and Medical Devices", revealed: "...Mt. Graham Clinics are dedicated to providing a safe environment for patient, staff and visitors and has established the following guideline to ensure the cleanliness and disinfection of all non- critical items. Mt. Graham Clinics have established the following procedures for ensuring that shared patient care equipment is clean before use and that all used, contaminated equipment is appropriately cleaned before use...6. Patient exam tables need to be cleaned and disinfected after each patient is discharged to prevent cross contamination...."


Observation on 10/21/2024 and 10/22/2024 revealed the following tears in upholstery:
(2) blood draw chairs in laboratory revealed;
(1) exam bed in the Orthopedic clinic;
(1) exam bed in Outpatient Radiology; and
(1) stereotactic chair (arm rests) in Outpatient Radiology

Employee #7 confirmed on 10/21/2024 and 10/22/2024 the above-mentioned equipment contained tears/rips in the upholstery.

Based on document review, observation, and interview, it was determined that the facility failed to ensure:

1. (3) of (6) medication refrigerators were locked or otherwise secured to prevent unauthorized access;

2. that oral and injectable medication was secured to prevent unauthorized access;

3. single use vials in the rehabilitaiton clinic were secured to prevent unauthorized access; and

4. (2) medicaiton storage cabinets in the orthopedic clinic was secured to prevent unauthorized access which has the potential risk for removal, tampering, or other compromise to medications for patient care;

Findings include:

1. and 2. The facility policy titled "Medication Storage" requires: "...Medication Storage Areas...Medication stock and storage areas are secured by automated dispensing machine (ADM), locked door, locked cabinet, staff only restricted areas. Medication storage location type and security level is dependent on the type of medication that is stored...Medication will be stored and distributed in a secure manner...Medication that is not designated as a controlled substance will be available from the main pharmacy, in ADMs, and other secure areas. Access is by physical key or electronic, and is authorized by the DOP according to policy...Storage areas outside of the pharmacy are: ADMs locked by doors and drawers...Cabinets locked by a door...Drawers locked by a door...Rooms locked by a door...Areas where only authorized personnel are permitted...."

1. Observation on tour on 10/22/2024 revealed (3) medication refrigerators in the ED, PACU, and ICU that were not locked and secured, nor were the refrigerators behind a locked or otherwise secured door. All three refrigerators were keyed for a physical lock but were found unlocked and had multiple patient medications inside. The refrigerators were not behind a locked door, and were accessible to any staff, other personnel members, or individual in the facility that would not necessarily have authorized access to medications such as technicians, cleaning/environmental services staff, or other non-nurse personnel doing work in the facility.

Employee #3 and the Director of Pharmacy confirmed on 10/22/2024 that the three unlocked medication refrigerators contained medication that would be accessible to non-authorized individuals.

2. Observation on tour on 10/22/2024 through the ED revealed the following unsecured medications.

(1) Lidocaine HCL 1% 20 mL multiple dose vial for injection
(1) Xylocaine HCL with epinephrine 20 mL multiple dose vial for injection
(1) Bupivacaine HCL 0.5% 30 mL Single dose vial (open, not discarded)
(1) Nitroglycerin sublingual tablets, 25 count bottle

The unsecured medications were on a countertop and shelf above the countertop in a hallway pass-through in the ED. The area was accessible to non-nurse and other non-authorized individuals.

Employee #3 and 40 confirmed on 10/22/2024 that the above listed medications were not secured to prevent unauthorized access.

3. and 4. Policy titled, "Medications", revealed: "...Medication will be stored according to the requirements listed on the medication package or in accordance with the United States Pharmacopoeia current recommendations. Factors to consider are generally temperature, humidity, light, and security...Security: Medications will be stored in non-patient areas and out of the open...."

Observation of Mt. Graham Rehabilitation Clinic on 10/21/2024 revealed the clinic utilizes multiple "Husky" brand tool chests with locking mechanisms for medication and supply storage. Further observation revealed a total of (5) single dose vials of Dexamethasone stored in 3 separate unlocked tool chests.

Employee #7 confirmed on 10/21/2024 the single does vials of Dexamethasone were not stored in a secure manner.

4. Observation of Mt. Graham Orthopedic Clinic on 10/21/2024 revealed (2) medication storage cabinets were unlocked.

Employee #43 confirmed on 10/21/2024 the medication cabinets were unlocked and not secure.

Based on document review, observation, and interview, it was determined that the facility failed to ensure medication vials were appropriately labeled and discarded upon expiration. Failure to appropriately label and discard medications when expired has the potential risk that an ineffective and/or contaminated medication will be administered to a patient.

Findings include:

The facility policy titled "Patient Care Area Medication Stock" requires: "...Beyond-Use Dating of Sterile Containers...Sterile medications that are single use or multiple use should be handled following specific procedures for access, access dating, storage, and disposal...Multiple Dose Vials (with preservative): Discard after 28 days after initial access unless compromised. Must be labeled with date, and initials of person opening...Multiple Dose INSULIN Vials: Discard after 28 days after initial access...."

Observation on 10/22/2024 revealed an open, expired vial of Humalog in the medication refrigerator in the ICU. The Humalog 10 mL vial was labeled with an open date of 09/19/2024.

Employee #3 confirmed on 10/22/2024 that the Humalog insulin was not disposed of within 28 days after opening as required.

Observation on 10/22/2024 revealed on open, used single dose vial of Bupivacaine HCL on a shelf in the medication preparation area in the ED.

Employee #40 confirmed on 10/22/2024 that the single dose vial of medication had not been discarded after use as required.

Observation on 10/22/2024 revealed an open, in use multiple dose vial of Lidocaine HCL on a shelf in the medication preparation area in the ED that was not labeled with an open date or discard date.

Employee #3 confirmed on 10/22/2024 that the medication vial was not labeled with a date to determine the discard date as required.

Based on document review and interview, it was determined that the facility failed to ensure an H&P was either documented or reviewed and acknowledged prior to a surgical procedure under anesthesia for Patients #18, 19, and 21 which has a potential risk of not identifying whether there is anything in a patient's overall condition that would affect the planned course of treatment for the patient.

Findings include:

The facility document titled "24 Hour Surgical Attending Attestation" revealed: "...The patient has been seen and the proposed surgical procedure has been discussed with the patient. Their questions were answered, and the result of testing and examination have been discussed. The patient is prepared and willing to proceed with the proposed procedure...."

The policy titled "Exceptions to Comprehensive Medical History and Physical Examination" requires: "...Per the Mt. Graham Regional Medical Center Rules and Regulations set forth by the Medical Staff, a comprehensive H&P dated within 30 days, and attestation of changes or no changes in condition within 24-hours of the procedure are required for patients prior to surgery or a procedure requiring anesthesia services...."

Patient #18's medical record dated 10/21/2024 did not contain evidence that the H&P conducted within the last 30 days was reviewed and contained an attestation if any changes or no changes in the patient's condition were noted. The patient's record contained a "24-hour attestation" signed by the physician; however, the physician did not document if any changes or no changes were found in patient condition. The "attestation" read like a surgical consent with no mention of the patient's condition or that an H&P had been conducted within the last 30 days was reviewed or that there were or were not changes in the patient's condition.

Employee #8 and 9 confirmed on 10/21/2024 that Patient #18's medical record did not contain evidence that the physician reviewed the H&P conducted within 30 days of admission or noted if there were any changes or attestation of no changes in patient condition prior to surgery.

Patient #19's medical record dated 10/17/2024 did not contain evidence that an H&P conducted within the last 30 days was reviewed and any changes nor no changes in patient condition.

Employee #8 and 9 confirmed on 10/21/2024 that patient #19's medical record did not contain evidence that an H&P conducted within the last 30 days or that the physician made any note of the patient's condition or changes in patient condition.

Patient #21's medical record dated 10/21/2024 did not contain evidence that the H&P conducted within the last 30 days was reviewed and contained an attestation if any changes or no changes in the patient's condition were noted. The patient's record contained a "24-hour attestation" signed by the physician; however, the physician did not document if any changes or no changes were found in patient condition. The "attestation" read like a surgical consent with no mention of the patient's condition or that an H&P had been conducted within the last 30 days was reviewed or that there were or were not changes in the patient's condition.

Employees #8 and 9 confirmed on 10/21/2024 that patient #21's medical record did not contain evidence that and H&P conducted within the last 30 days had been reviewed and if any changes in patient condition were noted.

Based on policy and procedure, manufacturer's recommendations, Centers for Disease Control and Prevention (CDC) observation, and staff interview, it was determined the facility failed to ensure vaginal probes were disinfected using high level disinfection. This deficient practice poses the risk to patient health and safety if vaginal probes are not disinfected to prevent transmitting pathogens among patients.

Findings include:

Policy titled, "Ultrasound Trophon Policy", revealed: "...All transvaginal ultrasound probes are to be high level disinfected using the Trophon cleaning system in accordance to the manufacturer's instructions for use...."

Policy titled, "Cleaning of Patient Room/Equipment and Medical Devices", revealed: "...This policy applies to all Healthcare Workers, Providers and Students at Mt. Graham Clinics...Critical Items: Items which come into contact with mucous membranes and/or are used in invasive procedures such as colonoscopies, thermometers and surgical equipment...Mt. Graham Clinics are dedicated to providing a safe environment for patient, staff and visitors and has established the following guideline to ensure the cleanliness and disinfection of all non- critical items. Mt. Graham Clinics have established the following procedures for ensuring that shared patient care equipment is clean before use and that all used, contaminated equipment is appropriately cleaned before use. Mt. Graham Clinics do not reprocess single use/disposable devices..."

Policy titled, "Infection Control", revealed: "...Mt. Graham Clinics ate in accordance with Mt. Graham Regional Medical Center Infection Control Policies and Procedures...Regular cleaning of all patient rooms/equipment and medical devices will be done by CMC staff with hospital-approved disinfectant...Regular assessment of infection control practices will be done to seek opportunities for improvement. Any concerns for infection control will be directed to Mt Graham Regional Medical Center's Infection Preventionist for remediation...."

"Center for Disease Control and Prevention: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Update: June 2024", revealed: "...A vaginal probe and all endocavitary probes without a probe cover are semi critical devices because they have direct contact with mucous membranes (e.g., vagina, rectum, pharynx). While use of the probe cover could be considered as changing the category, this guideline proposes use of a new condom/probe cover for the probe for each patient, and because condoms/probe covers can fail 195, 197-199, the probe also should be high-level disinfected...Condoms have been found superior to commercially available probe covers for covering the ultrasound probe (1.7% for condoms versus 8.3% leakage for probe covers)201. These studies underscore the need for routine probe disinfection between examinations ...."

"Canon guidelines for cleaning, disinfection, and sterilization of transducers", revealed: "...Scopes are considered Low/Middle-Level disinfection. List of acceptable chemicals for this section describes the methods for cleaning, disinfection, and sterilization. Cleaning and disinfection between patients must be performed to prevent transmission of disease. All transducers must be thoroughly cleaned prior to disinfection. The level of disinfection required is based on patient contact. In accordance with the tables and figures in section 3, immerse the transducer in a cleaning solution or wipe the transducer using wipes to dissolve or remove all remaining organic materials. Use a single-use sponge if necessary. If dried organic materials are present on the transducer, immerse it in the cleaning solution for a prolonged period. Before disinfection, the transducer must be cleaned. Note that local regulations may require that the transducer be disinfected before sterilization. Disinfect the transducer using the chemicals listed in section 3 List of Chemicals. Ensure that the entire immersible range of the transducer is completely in contact with the disinfectant. To maintain the effectiveness of the disinfectant, ensure that the concentration, temperature, and other conditions specified in the documentation provided by the manufacturer are met. To confirm the effectiveness of the disinfectant, use the criteria (such as effective period, number of times of use, discoloration, and results of using the effectiveness test kit) described in the documentation provided by the manufacturer. List of Chemical for cleaning: Cidezme, 3M Rapid Multi-Enzyme, Aniosyme, Neodisher. List of low/middle-Level Disinfections...Sani-cloth...."

Employee #42 confirmed on 10/22/2024 the facility does not use a Trophon system for high level disinfection. Employee #42 confirmed probe covers are utilized during every transvaginal exam. After the exam, the probe cover is removed then probe is wiped down with Sani-Cloth wipes.

Based on review of policies and procedures, observation, and staff interview, it was determined the facility failed to ensure staff:

1. stored patient protected health information (PHI) in a secure manner; and

2. locked the computer screen displaying PHI on diagnostic imaging. This deficient practice poses the risk to patient health and safety if PHI is not protected from unauthorized use.

Findings include:

1. and 2. Policy titled, "Required and Permitted Disclosures of Protected Health Information (PHI)" revealed: "...To outline permitted use and disclosures of protected health information...Privacy Rule: The Standards for Privacy of Individually Identifiable Health Information, found in the Code of Federal Regulations at 45 CFR §164.500-534.
Protected Health Information (PHI): Individually identifiable health information transmitted or maintained in any form or medium. Examples include but are not limited to name, date of birth, Social Security numbers, diagnosis, and so forth...Policy/Procedure MGRMC may disclose certain items of protected health information as outlined in the Standards for Privacy of Individually Identifiable Health Information as listed in the guidelines below. Patients acknowledge receipt of the Mt. Graham Notice of Privacy Practices when signing the Clinic Consent to Treatment or the Conditions of Treatment and Admission documents at the time of service. Printed copies of the Notice of Privacy Practices are available at patient registration stations and on the hospital's website at https://www.mtgraham.org. PHI that does not meet the guidelines outlined below may not be disclosed without the authorization of the patient or patient's personal representative. Such disclosures must be documented using the "Authorization to Use, Disclose, or Release Protected Health Information" form per policy HIM-034 Release of Medical Information...."

Tour of the clinic on 10/21/2024 revealed a small room with a door in the clinic hallway containing (2) sets of computers/monitors adjacent to one another displaying diagnostic imaging. Located on the images was the patient's name, date of birth, and date of service-(PHI).

Employee #43 confirmed on 10/21/2024 the room is used for Providers to review diagnostic imaging of patients. Employee #43 confirmed the door of the room was open and not closed to prevent unauthorized viewing of PHI.

2.

Tour of the clinic on 10/21/2024 revealed an unsecured room in the back of the clinic near Provider offices with approximately 3-4 shelves of patient diagnostic films.

Employee #43 confirmed on 10/21/2024 the room with the diagnostic films were old patient records and stored in an unsecured manner.