Rio Grande Hospital

“PROVISION OF SERVICES CFR(s): §485.635 Condition of Participation: Provision of Services This Condition is not met as evidenced by: 52287 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.635 Provision of Services was out of compliance. C-1044- The person principally responsible for the operation of the CAH under §485.627(b)(2) of this chapter is also responsible for the following: (i) Services furnished in the CAH whether or not they are furnished under arrangements or agreements. (ii) Ensuring that a contractor of services (including one for shared services and joint ventures) furnishes services that enable the CAH to comply with all applicable conditions of participation and standards for the contracted services. Based on observations, interviews, and document reviews, the facility failed to ensure contracted services enabled the facility to provide care in a safe and effective manner. (Cross-reference C-2523)”

“PATIENTS RIGHTS CFR(s): A CAH must protect and promote each patient’s rights. This Condition is not met as evidenced by: 52287 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.614 Patient Rights was out of compliance. C-2523- The patient has the right to receive care in a safe setting. Based on interviews and document reviews, the facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure physical holds were not used as a physical restraint according to facility policy. This failure was identified in one of one medical records reviewed of a patient in which a physical hold was implemented by security staff. (Patient #21) (Cross-reference C-1044)”

“AGREEMENTS AND ARRANGEMENTS CFR(s): §485.635(c)(4) The person principally responsible for the operation of the CAH under §485.627(b)(2) of this chapter is also responsible for the following: (i) Services furnished in the CAH whether or not they are furnished under arrangements or agreements. (ii) Ensuring that a contractor of services (including one for shared services and joint ventures) furnishes services that enable the CAH to comply with all applicable conditions of participation and standards for the contracted services. This Standard is not met as evidenced by: 52287 Based on observations, interviews, and document reviews, the facility failed to ensure contracted services enabled the facility to provide care in a safe and effective manner. (Cross-reference C-2523) Findings include: Reference: The Governing Board Bylaws read, the chief executive officer (CEO) shall be responsible for the employment of any additional staff in a manner consistent with the Board of Directors Governing Policies. 1. The facility failed to ensure the contracted security company had policies, procedures, job descriptions, training, competencies, and standards in place to ensure care was provided in a safe and effective manner. A. Observations i. On 5/28/25 at 9:35 a.m., an observation conducted in the Emergency Department (ED) revealed security guard (Guard) #6 was by themself in the ED. During the observation, Guard #6 stated they had not finished their new hire orientation and it was their third day of employment. Guard #6 also stated they would be alone until their preceptor arrived at 12:00 p.m. Guard #6 further stated they had not worked as a security guard prior to working at the facility, and had no formal training on how to interact with behavioral health patients who presented to the facility. B. Document Review i. Review of email correspondence sent to chief nursing officer (CNO) #4 from the human resources manager on 5/28/25 at 4:18 p.m. included required information for employees at the facility. The required information included background information, Colorado Adult Protective Services (CAPS) checks, reference checks, employment verification, job descriptions, statements of confidentiality, company policies signed by employees, policy manual acknowledgement, skills, and competencies. After multiple requests, the facility was unable to provide personnel files, policies, procedures, job descriptions, training, competencies, and standards in place to ensure care was provided in a safe and effective manner by security personnel. ii. Review of the security provider contract read they provided security services for crowd management and control, door and perimeter security, and roving (mobile) security coverage. The contract further stated security personnel were trained to handle issues at the facility and assisted local law enforcement interactions when needed. Lastly, security personnel were trained to meet the facility’s security needs. However, the security contract did not state what qualifications personnel were required to have to provide safe and effective care to patients. The contract also lacked provisions for personnel training for restraint use, restraint competencies, use-of-force practices, and personnel scope of practice. C. Interviews i. On 6/3/25 at 8:05 a.m., an interview was conducted with CNO #4. CNO #4 stated the security provider trained security personnel and performed new hire orientations. Additionally, CNO #4 stated they did not know what security personnel duties were and what policies were in place to guide them. ii. On 6/3/25 at 8:45 a.m., an interview was conducted with the CEO #5. CEO #5 stated the facility did not require the security provider to provide education, training, or personnel records to the facility. CEO #5 further stated they had not provided facility oversight for the contracted security services. Additionally, CEO #5 stated they were not aware of the facility’s responsibility to provide oversight, or the need to establish policies, procedures, and job descriptions for the contracted security personnel who worked at the facility.”

“PRIVACY AND SAFETY CFR(s): The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 52287 Based on interviews and document reviews, the facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure physical holds were not used as a physical restraint according to facility policy. This failure was identified in one of one medical records reviewed of a patient in which a physical hold was implemented by security staff. (Patient #21) (Cross-reference C-1044) Findings include: Facility policy: The Restraints policy read, physical holds were not authorized by the hospital. The Definitions section of the policy defined restraint as any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his/her arms, legs, body, or head freely. Holding a patient in a manner that restricts the patient’s movement against his/her will, including a therapeutic hold, is a restraint. 1. The facility failed to ensure security personnel did not utilize bodily force (physical holds or physical take-downs) to restrain patients. A. Document Review i. Medical record review revealed, on 3/14/25 at 6:27 p.m., Patient #21 presented to the Emergency Department (ED) by ambulance for homicidal ideations. At 6:30 p.m., registered nurse (RN) #9 conducted a safety sweep and removed all hazardous items from the room, and Patient #21 was placed in the room. Patient #21 changed into paper scrubs and a sitter was placed with the patient for one to one monitoring. Review of the nursing progress note entered by RN #9 revealed at 7:33 p.m., Patient #21 stood up beside the bed, ran toward the door in an attempt to leave the room, and yelled threats of physical harm at Physician #2. Security guard (Guard) #7 intervened, and both the patient and Guard #7 ended up on the ground. Patient #21 continued to yell, punch, and kick while restrained on the ground. ii. Review of the Security Daily Activity Sheet revealed Guard #7 documented a physical altercation involving Patient #21 on 3/14/25. According to the altercation report completed by Guard #7, at 7:27 p.m. Patient #21 charged toward the door of their ED room while shouting threats of physical harm toward Physician #2. Guard #7 was the sitter assigned to the patient. When the patient charged the door, Guard #7 physically grabbed the patient causing them both to fall to the ground. Once on the ground, Guard #7 forcibly secured Patient #21’s upper body by holding the patient’s arms around their torso. Guard #7 then wrapped their legs around Patient #21’s waist to physically control and restrain the patient on the ground. While restrained, RN #9 administered 10 mg of Haldol (a medication used to calm a patient) intramuscularly into Patient #21’s right thigh. The medical record review and Guard #7’s altercation report contrasted with the Restraints policy which read, any physical hold that restricts a patient’s movement against their will, including therapeutic holds, was a restraint. Additionally, the policy read physical holds were not approved for use within the facility. iii. Upon request, the facility was unable to provide evidence it had established a use-of-force policy or scope of practice, training and education for security to use physical holds as a restraint. This lack of training and policy guidance contributed to the physical holding of Patient #21. B. Interviews i. On 5/28/25 at 12:45 p.m., an interview was conducted with Guard #1. Guard #1 stated they were a former police officer and the current owner of the contracted security company used at the facility. Guard #1 stated as a former police officer they had been trained how to use physical holds as a restraint. Guard #1 stated they trained all security staff on how to implement and use physical holds in the hospital. Guard #1 stated physical holds were used as a restraint by the security staff at the hospital. Guard #1 stated since they were the owner of the security company they determined what training and education the security staff received. Guard #1’s interview contrasted with the Restraints policy which read, the use of physical holds was not authorized in the hospital. ii. On 5/29/25 at 11:09 a.m., an interview was conducted with chief nursing officer (CNO) #4. CNO #4 stated security guards did not perform physical holds on patients. CNO #4 stated they had not been informed Guard #7 had physically restrained Patient #21 on 3/14/25. iii. On 5/29/25 at 11:10 a.m., an interview was conducted with the Chief Executive Officer (CEO) #5. CEO #5 stated they were unaware of the event in which Guard #7 had physically restrained Patient #21. CEO #5 stated the physical holding of Patient #21 was considered a patient safety event. CEO #5 also stated the facility had not established policies, procedures, or workflows for security staff, and did not require the security company to notify the hospital when a safety event occurred. CEO #5 stated they had not developed or implemented a formal oversight process for security personnel and believed facility oversight was not needed.”

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 52664 Based on observation, interviews, and document reviews, the facility failed to comply with the Medicare provider agreement as defined in §489.20 and §489.24 related to Emergency Medical Treatment and Labor Act (EMTALA) requirements. FINDINGS 1. The facility failed to meet the following requirements under the EMTALA regulations: C-2406: Applicability of Provisions of this Section (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must-(i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. Based on observations, interviews, and document reviews, the facility failed to ensure a patient who presented to the dedicated emergency department (ED) received a medical screening examination (MSE) to determine the presence of an emergent medical condition in one of one patients reviewed who presented to the ED escorted by law enforcement. (Patient #7)”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) and 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 52664 Based on observations, interviews, and document reviews, the facility failed to ensure a patient who presented to the dedicated emergency department (ED) received a medical screening examination (MSE) to determine the presence of an emergent medical condition in one of one patients reviewed who presented to the ED escorted by law enforcement. (Patient #7) Findings include: Facility policy: According to the Emergency Treatment and Labor Act (EMTALA) policy, this policy applies to all individuals seeking or needing an examination or treatment for emergency medical services who come to the hospital’s dedicated emergency department or on hospital property, even if they present at a location other than the dedicated emergency department. Hospital property includes parking lots, sidewalks, and any additional buildings owned by the hospital within 250 yards. The hospital will provide an appropriate MSE within the capability of the hospital’s dedicated emergency department, including ancillary services routinely available to the dedicated emergency department, to determine whether an emergency medical condition exists. The examination will be conducted by an individual(s) determined qualified by hospital bylaws or rules and regulations. Reference: According to the Medical Staff Rules and Regulations for appropriate screening examinations, all persons presenting in the emergency room must receive an appropriate medical screening by qualified medical personnel to determine whether an emergency medical condition exists. “Qualified Medical Personnel” consists of such categories of personnel as have been designated by the Board from time to time and may include a physician, or Allied Health Professional (AHP) member of the Medical Staff or an Allied Health Professional (AHP) with appropriate privileges or a registered nurse. No person will be denied access to treatment or accommodations that are available and medically indicated. 1. The facility failed to ensure a patient who presented for treatment in the ED received a MSE to determine the presence of an emergent medical condition. A. Document Review i. Review of the Emergency Room Register revealed Patient #7 presented with the police department (PD) to the ED on 4/4/25 at 3:45 p.m. ii. On 5/27/25 at 5:14 p.m., upon request, the facility was unable to provide a medical record for Patient #7’s visit to the ED on 4/4/25 at 3:45 p.m. iii. Review of email correspondence sent on 4/5/25 at 9:11 a.m. to the chief nursing officer (CNO) from a separately certified facility revealed there had been a potential EMTALA violation. iv. Review of the facility’s EMTALA 2025 Action Plan revealed Patient #7 had been at the facility for 30 minutes and had not been brought in to the ED for an immediate MSE. Patient #7 and PD officers had been asked to wait outside. Additionally, Guard #1 did not understand that a provider was required to see Patient #7 immediately, even if a mental health evaluation could not be completed right away. Further review of the EMTALA 2025 Action Plan revealed security staff were to receive education on current EMTALA rules. v. On 5/27/25 at 5:14 p.m., upon request, the facility was unable to provide evidence of EMTALA education which had been provided to security staff. B. Observation i. On 6/2/25 at 5:15 p.m., observation of video surveillance footage from 4/4/25 was conducted. At 3:48 p.m., Patient #7 presented to the ED entrance handcuffed with two PD officers. At 3:54 p.m., security guard (Guard) #1 met Patient #7 and the two PD officers in the ED entrance. At 4:11 p.m., Patient #7 and one of the PD officers walked outside. At 4:14 p.m., Provider #2 arrived at the ED entrance, spoke with one of the PD officers in the ED entrance, and then re-entered the ED. At 4:16 p.m., Patient #7 and the two PD officers walked away from the ED. Video surveillance revealed Patient #7 did not re-enter the ED, and Provider #2 did not see or speak to Patient #7 before they left the ED. This was in contrast to the EMTALA policy which read, the hospital would provide an appropriate MSE within the capability of the hospital’s dedicated emergency department, including ancillary services routinely available to the dedicated emergency department, to determine whether an emergency medical condition existed. The examination would be conducted by an individual(s) determined qualified by hospital bylaws or rules and regulations. Additionally, video surveillance revealed Patient #7 appeared calm, non-aggressive, and stood with their hands cuffed behind their back throughout their duration of time in the ED entrance. C. Interviews i. On 5/28/25 at 8:47 a.m., an interview was conducted with certified nursing assistant (CNA) and ED check-in clerk (Clerk) #3. Clerk #3 stated two PD officers and Patient #7 had entered the ED entrance. Clerk #3 also stated other patients in the waiting area were upset because Patient #7 was loud and used foul language. Clerk #3 stated they had asked Guard #1 to speak with the PD officers. Additionally, Clerk #3 stated Patient #7 was not seen in the ED by the nurses or Provider #2. ii. On 5/28/25 at 12:45 p.m., an interview was conducted with Guard #1. Guard #1 stated PD officers brought Patient #7 to the facility for an evaluation. Guard #1 stated Patient #7’s behavior was inappropriate and they informed PD officers to wait with Patient #7 outside while the room was cleaned and prepared. This was in contrast to video surveillance review which revealed Patient #7 appeared calm, non-aggressive, and stood with their hands cuffed behind their back throughout their duration of time in the ED entrance. Guard #1 also stated they informed PD officers they were required to stay with Patient #7 for 12 hours. Additionally, Guard #1 stated they were not aware of EMTALA requirements and had not yet performed the EMTALA training with other security officers. iii. On 6/2/25 at 4:44 p.m., an interview was conducted with Provider #2. Provider #2 stated Patient #7 did not receive a MSE. Provider #2 stated Guard #1 was not qualified to provide an MSE and was also not qualified to assess for behavioral health emergencies. Additionally, Provider #2 stated patients were at risk if security guards sent them away without a MSE. iv. On 5/28/25 at 2:19 p.m., an interview was conducted with CNO #4. CNO #4 stated all action items listed in the EMTALA 2025 Action Plan had been completed. This was in contrast to the interview with Guard #1 who stated they and other security guards had not completed EMTALA training. This was also in contrast to the EMTALA 2025 Action Plan which revealed security staff should have received education on current EMTALA rules.”

“This survey was conducted in accordance with the Federal Register at Section 42 CFR Part 482.41(b). The initial comments (ID Prefix Tag #K000) are informational only, and are a representation of the facility’s general characteristics. The facility, a type II (111) single story structure built August 2004, and a portion of the building was updated in 2019 and is equipped with a complete automatic fire suppression system. The inaccessible, non-combustible, attic space had a one-hour fire-rated separation from the occupied spaces, is not used for storage, and does not contain combustible insulation. Sprinkler protection for this space is not required. The main hospital building is separated by a two hour fire rated wall from the clinic. Also inspected as a part of this survey was OCLs in Creede and South Fork This survey, conducted on February 23, 2024, included an inspection for compliance with the fire safety requirements of the 2012 edition of NFPA-101, Life Safety Code, (Chapter 19 Existing Health Care Occupancies). The facility is required to maintain and not diminish the Life Safety Code features required at the time of licensure or certification, for new construction. This survey concluded with a discussion of the deficiencies with the Administrator, the Director of Nursing, and a member of the maintenance staff.”

“Cooking Facilities CFR(s): NFPA 101 Cooking Facilities Cooking equipment is protected in accordance with NFPA 96, Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations, unless: * residential cooking equipment (i.e., small appliances such as microwaves, hot plates, toasters) are used for food warming or limited cooking in accordance with 18.3.2.5.2, 19.3.2.5.2 * cooking facilities open to the corridor in smoke compartments with 30 or fewer patients comply with the conditions under 18.3.2.5.3, 19.3.2.5.3, or * cooking facilities in smoke compartments with 30 or fewer patients comply with conditions under 18.3.2.5.4, 19.3.2.5.4. Cooking facilities protected according to NFPA 96 per 9.2.3 are not required to be enclosed as hazardous areas, but shall not be open to the corridor. 18.3.2.5.1 through 18.3.2.5.4, 19.3.2.5.1 through 19.3.2.5.5, 9.2.3, TIA 12-2 This Standard is not met as evidenced by: 47557 Based on observation it was determined that the facility failed to maintain the kitchen hood suppression system as required by NFPA 96, (Chapter 12, Section 12.1.2.3.1) and cooking appliance restraint as required by NFPA 54, 9.6.1.2. Commercial cooking equipment under suppression system does not have wheel blocks installed NFPA 96, 12.1.2.3 The fire-extinguishing system shall not require reevaluation where the cooking appliances are moved for the purposes of maintenance and cleaning, provided the appliances are returned to approved design location prior to cooking operations. NFPA 54 -2012 Fuel and Gas Code 9.6.1.2 Restraints. Movement of appliances with casters shall be limited by a restraining device installed in accordance with the connector and appliance manufacturer installation instructions. This deficiency has the potential to affect occupants, who might include residents, staff, and visitors within the entire facility. Deficient items were discussed with the Administrator at the exit conference.”

“Fire Alarm System - Testing and Maintenance CFR(s): NFPA 101 Fire Alarm System - Testing and Maintenance A fire alarm system is tested and maintained in accordance with an approved program complying with the requirements of NFPA 70, National Electric Code, and NFPA 72, National Fire Alarm and Signaling Code. Records of system acceptance, maintenance and testing are readily available. 9.6.1.3, 9.6.1.5, NFPA 70, NFPA 72 This Standard is not met as evidenced by: 47557 Based on a record review it was determined that the facility failed to maintain the fire alarm system components and devices in accordance with the Life Safety Code Section 9.6 and NFPA 72. 1.No Semi-Annual report available for review 2.No 2 year smoke detector sensitivity report available for review NFPA 101, Section 9.6.1.5* To ensure operational integrity, the fire alarm system shall have an approved maintenance and testing program complying with the applicable requirements of NFPA 70, National Electrical Code, and NFPA 72, National Fire Alarm and Signaling Code. NFPA 72- 14.4.2.2* Systems and associated equipment shall be tested according to Table 14.4.2.2. (15). Alarm notification appliances (a) Audible: Test shall be performed in accordance with the manufacturer ’ s published instructions. Appliance locations shall be verified to be per approved layout, and it shall be confirmed that no floor plan changes affect the approved layout. It shall be verified that the candela rating marking agrees with the approved drawing. It shall be confirmed that each appliance flashes. Failure to maintain the fire alarm system has the potential to harm all occupants, staff, and visitors within the building should a delay occur in locating a fire throughout the facility. These deficiencies have the potential to affect occupants, who might include residents, staff, and visitors within the entire facility. Deficient items were discussed with the Administrator and Maintenance director at the exit conference.”

“Corridor - Doors CFR(s): NFPA 101 Corridor - Doors Doors protecting corridor openings in other than required enclosures of vertical openings, exits, or hazardous areas resist the passage of smoke and are made of 1 3/4 inch solid-bonded core wood or other material capable of resisting fire for at least 20 minutes. Doors in fully sprinklered smoke compartments are only required to resist the passage of smoke. Corridor doors and doors to rooms containing flammable or combustible materials have positive latching hardware. Roller latches are prohibited by CMS regulation. These requirements do not apply to auxiliary spaces that do not contain flammable or combustible material. Clearance between bottom of door and floor covering is not exceeding 1 inch. Powered doors complying with 7.2.1.9 are permissible if provided with a device capable of keeping the door closed when a force of 5 lbf is applied. There is no impediment to the closing of the doors. Hold open devices that release when the door is pushed or pulled are permitted. Nonrated protective plates of unlimited height are permitted. Dutch doors meeting 19.3.6.3.6 are permitted. Door frames shall be labeled and made of steel or other materials in compliance with 8.3, unless the smoke compartment is sprinklered. Fixed fire window assemblies are allowed per 8.3. In sprinklered compartments there are no restrictions in area or fire resistance of glass or frames in window assemblies. 19.3.6.3, 42 CFR Parts 403, 418, 460, 482, 483, and 485 Show in REMARKS details of doors such as fire protection ratings, automatics closing devices, etc. This Standard is not met as evidenced by: 47557 Based on observation it was determined the facility failed to maintain corridor doors in accordance with NFPA 101. 1.Roll down fire door need to be inspected | Cafe Fire door x 2, Medical records 2. Pair of fire doors by laundry did not close fully NFPA 80 5.2.1* Fire door assemblies shall be inspected and tested not less than annually, and a written record of the inspection shall be signed and kept for inspection by the AHJ. NFPA 101, 19.3.6.3.1* Doors protecting corridor openings in other than required enclosures of vertical openings, exits, or hazardous areas shall be doors constructed to resist the passage of smoke and shall be constructed of materials such as the following: (1) 13/4 in. (44 mm) thick, solid-bonded core wood (2) Material that resists fire for a minimum of 20 minutes NFPA 101, 19.3.6.3.5* Doors shall be provided with a means for keeping the door closed that is acceptable to the authority having jurisdiction, and the following requirements also shall apply: (1) The device used shall be capable of keeping the door fully closed if a force of 5 lbf (22 N) is applied at the latch edge of the door. (2)Roller latches shall be prohibited on corridor doors in buildings not fully protected by an approved automatic sprinkler system in accordance with 19.3.5.7. This deficiency has the potential to affect occupants, who might include residents, staff, and visitors within the entire facility. Deficient items were discussed with the administrator and maintenance director at the exit conference.”

“HVAC CFR(s): NFPA 101 HVAC Heating, ventilation, and air conditioning shall comply with 9.2 and shall be installed in accordance with the manufacturer’s specifications. 18.5.2.1, 19.5.2.1, 9.2 This Standard is not met as evidenced by: 47557 Based on observation and staff interview, it was determined that the facility failed to maintain smoke dampers in accordance with Life Safety Code Section NFPA 105 Fire Dampers was overdue for facility (6 year) NFPA 105, 6.5.1 Smoke dampers for dedicated and non-dedicated smoke control systems shall be inspected and tested in accordance with NFPA 92A, Standard for Smoke-Control Systems Utilizing Barriers and Pressure Differences. 6.5.2* Each damper shall be tested and inspected one year after installation. The test and inspection frequency shall then be every 4 years, except in hospitals, where the frequency shall be every 6 years. 6.5.3 Care shall be exercised that all tests are completed in a safe manner wearing the appropriate personal protective equipment. 6.5.4 Full unobstructed access to the damper shall be verified and corrected as required. LSC 19.5.2.1 requires air conditioning, heating, ventilating ductwork and related equipment to be installed in accordance with NFPA 90A, Standard for the Installation of Air Conditioning and Ventilating Systems. NFPA 90A, 2012 Edition, Section 4.3.12.1.1 states egress corridors shall not be used as a portion of a supply, return, or exhaust air system serving adjoining areas unless otherwise permitted by 4.3.12.1.3.1 through 4.3.12.1.3.4 This deficiency has the potential to affect occupants, who might include residents, staff, and visitors within the entire facility. Deficient items were discussed with the administrator and maintenance director at the exit conference.”

“Fire Drills CFR(s): NFPA 101 Fire Drills Fire drills include the transmission of a fire alarm signal and simulation of emergency fire conditions. Fire drills are held at expected and unexpected times under varying conditions, at least quarterly on each shift. The staff is familiar with procedures and is aware that drills are part of established routine. Where drills are conducted between 9:00 PM and 6:00 AM, a coded announcement may be used instead of audible alarms. 19.7.1.4 through 19.7.1.7 This Standard is not met as evidenced by: 47557 Based on record review, it was determined that the facility failed to conduct fire drills in accordance with the Life Safety Code, Section 19.7.1.6 1.Fire Drills | Missed 2nd shift 3 qrt of 2023 NFPA 101, 19.7.1.6 Drills shall be conducted quarterly on each shift to familiarize facility personnel (nurses, interns, maintenance engineers, and administrative staff) with the signals and emergency action required under varied conditions. This deficiency has the potential to affect occupants, who might include residents, staff, and visitors within the entire facility. Deficient items were discussed with the administrator and maintenance director at the exit conference.”

“COMPLIANCE WITH FED, ST, AND LOCAL LAWS CFR(s): The CAH and its staff are in compliance with applicable Federal, State and local laws and regulations. This Condition is not met as evidenced by: 42693 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.608 Compliance with Federal, State, and Local Laws, was out of compliance. C-0814 - All patient care services are furnished in accordance with applicable State and local laws and regulations. Based on record review and interviews, the facility failed to ensure compliance with State regulations. Specifically, the facility failed to ensure regulatory compliance with the use of restraints in one of one medical records reviewed (Patient #14).”

“EMERGENCY SERVICES CFR(s): The CAH provides emergency care necessary to meet the needs of its inpatients and outpatients. This Condition is not met as evidenced by: 49541 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.618 Compliance with Federal, State, and Local Laws, was out of compliance. C-0886 - Drugs and biologicals commonly used in life-saving procedures, including analgesics, local anesthetics, antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids, antiarrhythmics, cardiac glycosides, antihypertensives, diuretics, and electrolytes and replacement solutions. Based on observations, interviews, and document review, the facility failed to ensure expired medications were not readily available for patient use. Specifically, the facility failed to ensure medications used to treat cardiac conditions were accessible to staff for use on patients in two of two crash carts (a cart stocked with supplies to be used in a medical emergency) observed.”

“PROVISION OF SERVICES CFR(s): §485.635 Condition of Participation: Provision of Services This Condition is not met as evidenced by: 42693 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.635 Provision of Services was out of compliance. C-1016 - Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use. Based on observations, interviews, and document review, the facility failed to ensure oversight of pharmacy services regarding the implementation of mechanisms to prevent and detect the diversion of providers’ prescription pads in one of one clinics observed. C-1030 - Radiology services. Radiology services furnished by the CAH are provided by personnel qualified under State law, and do not expose CAH patients or personnel to radiation hazards. Based on observations, interviews and document review, the facility failed to ensure lead aprons used to prevent radiation exposure at the off-campus clinic were maintained according to the manufacturer’s instructions for use in one of one observations of the clinic. C-1038 - Laboratory Services The CAH provides basic laboratory services essential to the immediate diagnosis and treatment of the patient that meet the standards imposed under section 353 of the Public Health Service Act (42 U.S.C. 236a). (See the laboratory requirements specified in part 493 of this chapter.) The services provided include the following: (i) Chemical examination of urine by stick or tablet method or both (including urine ketones). (ii) Hemoglobin or hematocrit. (iii) Blood glucose. (iv) Examination of stool specimens for occult blood. (v) Pregnancy tests. (vi) Primary culturing for transmittal to a certified laboratory. Based on observations, interviews and document review, the facility failed to ensure lab equipment was maintained to provide the immediate diagnosis and treatment of patients in one of one observations of the off-campus clinic location. C-1046 - Standard: Nursing Services Nursing services must meet the needs of patients. (1) A registered nurse must provide (or assign to other personnel) the nursing care of each patient, including patients at a SNF level of care in a swing-bed CAH. The care must be provided in accordance with the patient’s needs and the specialized qualifications and competence of the staff available. Based on medical record review and interviews, the facility failed to ensure patients received assistance or were offered assistance with activities of daily living (ADLs) in 21 of 26 inpatient, swing bed or observation status patient medical records reviewed.(Patients #1, #2, #3, #4, #5, #7, #8, #9, #10, #11, #13, #14, #15, #16, #17, #18, #20, #22, #24, #25, and #26). C-1049 - All drugs, biologicals, and intravenous medications must be administered by or under the supervision of a registered nurse, a doctor of medicine or osteopathy, or, where permitted by State law, a physician assistant, in accordance with written and signed orders, accepted standards of practice, and Federal and State laws. Based on medical record review and interviews, the facility failed to ensure medications were administered to patients at the time scheduled by the provider in 13 of 26 inpatient, swing bed or observation status patient medical records reviewed. (Patient #3, #4, #5, #6, #8, #12, #13, #17, #18, #19, #20, #24, and #25).”

“INFECTION PREVENT & CONTROL & ABT STEWAR PROG CFR(s): The CAH must have active facility-wide programs, for the surveillance, prevention, and control of HAIs and other infectious diseases and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic-resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in coordination with the facility-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 42693 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.640 Infection Prevention and Control and Antibiotic Stewardship Programs was out of compliance. C-1206 - The infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the CAH and between the CAH and other healthcare settings. Based on observations, interviews, and document review, the facility failed to ensure staff performed hand hygiene and glove use according to national standards and facility policy based on one of one patient care observations. C-1208 - The infection prevention and control includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and that the program also addresses any infection control issues identified by public health authorities. Based on observations, interviews, and document review, the facility failed to follow the instructions for use (IFUs) for the reprocessing of surgical and procedural equipment. Specifically, the facility failed to ensure the endoscope pre-cleaning process was followed in one of one observation. Additionally, the facility failed to ensure equipment used during the instrument pre-cleaning process was maintained according to the IFUs.”

“COMPLIANCE STATE AND LOCAL LAWS AND REGS CFR(s): All patient care services are furnished in accordance with applicable State and local laws and regulations. This Standard is not met as evidenced by: 42693 Based on record review and interviews, the facility failed to ensure compliance with State regulations. Specifically, the facility failed to ensure regulatory compliance with the use of restraints in one of one medical records reviewed (Patient #14). Findings include: Facility policies: The Restraint policy read, An order for restraint or seclusion is obtained from the attending physician responsible for patient’s care. The order Must NEVER be written as a standing or PRN order. In an emergency, restraints may be utilized prior to obtaining an order if either during the emergency or immediately following the emergency, a restraint order is obtained from the ordering physician. Monitoring and assessing during the restraint: The condition of the patient will be monitored by a registered nurse (RN) or trained staff. Assessing the patient will be conducted by an RN. Information obtained from trained staff during the monitoring of the patient during restraint is incorporated into the RN assessment and formulation of the patient care and readiness for discontinuation. For non-violent restraints, staff is to monitor the patient every two hours unless more frequent monitoring of the patient is determined to be necessary. Based on clinical judgment, the frequency of assessment and monitoring may be individualized based on the patient’s condition, cognitive state, medications, and type of restraints used. Observe and monitor the patient at least every two hours or more often if necessary based on the patient’s medical needs, for physical and emotional well-being, patient safety (body positioning, adequacy of circulation/respirations, condition of skin and point of contact with the restraint device), and correct application of restraints, whether less restrictive methods are possible, and continued need for restraints. Release the restraints every two hours for five minutes except when the patient is sleeping or restraint removal is deemed unsafe. Provide/offer interventions at least every two hours in the following areas: Toileting, ROM/repositioning/ambulation, skincare, food/fluid intake. Monitor closely the patient whose medical condition places them at high risk for potential complications from being restrained. The Verbal or Telephone Orders policy read, the verbal order must be written in the Physician Orders section of the chart upon receiving the order by the nurse taking the order. The verbal order must include the following: the date, the time, the order, the name of the patient, the age and weight of the patient, when applicable for medication orders, indication when applicable, specific instructions for use when applicable, the name of the ordering prescriber and the electronic signature of the receiving nurse. The entire verbal/telephone order must be read back to the prescriber and documented as read back. The prescriber/ on-call prescriber must sign a verbal order as soon as possible. The order should be signed the next time the prescriber sees the patient or within 24 hours of giving the verbal order in the paper or in the electronic chart. Verbal orders should be used infrequently. They should only be used in emergent situations or when it is not feasible for the prescriber to write a written order or place the order within the electronic health record. References: According to the Standards for Hospitals and Health Facilities Chapter 2 - General Licensure Standards 6 CCR 1011-1 Chapter 2, Part 8.4.1 A facility or agency that uses restraint shall ensure that: (A) At least every fifteen (15) minutes, staff shall monitor any client held in mechanical restraints to assure that the client is properly positioned, that the client’s blood circulation is not restricted, that the client’s airway is not obstructed, and that the client’s other physical needs are met; (B) No physical or mechanical restraint of a client shall place excess pressure on the chest or back of that client or inhibit or impede the client’s ability to breathe; (C) During physical restraint of a client, an agent or employee of the facility or agency shall check to ensure that the breathing of the client in such physical restraint is not compromised. 1. The facility failed to ensure orders for restraints were signed and active when used on a patient. A. Medical Record Review i. On 12/8/23 Patient #14 was admitted to the facility for disorientation after being found laying on their floor for two days. A nurse note on 12/10/23 at 2:06 p.m. read, the patient was pulling at medical equipment. The provider was notified and provided a verbal/telephone order for the patient to be placed in bilateral wrist restraints. A review of provider orders on 1/24/24 revealed an order for restraints was entered on 12/10/23 at 2:18 p.m. by registered nurse (RN) #2. The status of the order read as pending. There was no indication the provider order had been signed by the provider. This was in contrast to the verbal or telephone order policy which read the prescriber must sign a verbal order as soon as possible. The order should be signed the next time the prescriber sees the patient or within 24 hours of giving the verbal order. B. Interviews i. On 1/25/24 at 11:50 a.m., an interview was conducted with the inpatient nurse manager (Manager) #3. Manager #3 stated a verbal order could be taken by a registered nurse, however should only be used in an emergency. Manager #3 explained they were unsure of the timeframe for which a provider needed to sign the order. Manager #3 stated it was important for an order to be signed by the provider to verify the provider had determined the course of treatment for the patient. They stated there was a risk to the patient being improperly restrained if the order was not verified and signed by a provider. 2. The facility failed to ensure a patients placed in restraints were monitored according to state regulations. A. A review of the facility’s restraint policy revealed staff were to monitor a patient in restraints every two hours unless more frequent monitoring was determined to be necessary. The policy was in contrast to the Standards for Hospitals and Health Facilities Chapter 2 - General Licensure Standards 6 CCR 1011-1 Chapter 2, Part 8.4.1(A) which read, at least every fifteen (15) minutes, staff shall monitor any client held in mechanical restraints to assure that the client was properly positioned, that the client’s blood circulation is not restricted, that the client’s airway was not obstructed, and that the client’s other physical needs were met. B. A review of Patient #14’s medical record revealed gaps in monitoring while the patient was in restraints. i. On 12/8/23 Patient #14 was admitted for treatment of sepsis (a severe infection) and dementia. A review of Patient #14’s provider orders revealed an order for restraints was entered on 12/10/23 at 2:18 p.m. by RN #2. A comment entered with the order read, place bilateral wrist restraints to maintain critical lines and for patient safety. Check circulation every 15 minutes. a. A review of the nurse notes revealed a note was written every hour from 12/10/23 at 1:00 p.m. until 12/11/23 at 7:52 a.m. The notes revealed the patient’s circulation was checked. There was no evidence the patient’s circulation was checked every 15 minutes as ordered by the provider. This was in contrast to the Standards for Hospitals and Health Facilities Chapter 2 - General Licensure Standards 6 CCR 1011-1 Chapter 2, Part 8.4.1(A) which read, at least every fifteen (15) minutes, staff shall monitor any client held in mechanical restraints to assure that the client is properly positioned, that the client’s blood circulation is not restricted, that the client’s airway is not obstructed, and that the client’s other physical needs are met. b. On 1/25/24 at 11:50 a.m., an interview was conducted with Manager #3. Manager #3 stated they would have to review the restraint policy if they had a patient in restraints. Manager #3 stated they assumed the policy met the state guidelines for the use of restraints. The interview was in contrast to the review of the facility policy and state regulations which revealed conflicting timeframes for patient restraint monitoring.”

“DRUG AND BIOLOGICALS CFR(s): Drugs and biologicals commonly used in life-saving procedures, including analgesics, local anesthetics, antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids, antiarrythmics, cardiac glycosides, antihypertensives, diuretics, and electrolytes and replacement solutions. This Standard is not met as evidenced by: 49541 Based on observations, interviews, and document review, the facility failed to ensure expired medications were not readily available for patient use. Specifically, the facility failed to ensure medications used to treat cardiac conditions were accessible to staff for use on patients in two of two crash carts (a cart stocked with supplies to be used in a medical emergency) observed. Findings include: Facility policy: The Emergency Medications policy read, it is the policy of the hospital to have emergency medications available on notice of an emergent situation or a Code Blue. The Director of Pharmacy is responsible to keep the emergency kits and the crash carts with up-to-date medications that may be useful in an emergency situation. 1. The facility failed to ensure emergency medications were removed from use after the supplies had expired. A. Observations revealed expired medications and supplies in two of two crash carts observed. i. On 1/22/24 at 1:05 p.m., observations were conducted in the inpatient care unit. Observations of the crash cart revealed two IV bags of dobutamine (a cardiac medication used in emergencies) with an expiration date of 1/1/24. Emergency Department and Inpatient Nurse Manager (Manager) #3 removed the expired medication from the crash cart during the observation. ii. On 1/22/24 at 1:24 p.m., observations were conducted in the emergency department. Observations revealed two IV bags of dobutamine with an expiration date of 1/1/24. Manager #3 removed the expired medication from the crash cart during the observation. B. Interviews i. On 1/25/24 at 12:35 p.m., an interview was conducted with registered nurse (RN) #4. RN #4 stated the pharmacy technician was responsible for checking the expiration dates of the medications in the crash carts. RN #4 stated the charge nurse would check the crash carts daily for expired supplies and required equipment that was present; however, they would not check the medication expiration dates. RN #4 stated it was important to check for expiration dates for patient safety. RN #4 stated medications given after the expiration date may not work and could have caused the patient to have a reaction. ii. On 1/25/24 at 11:49 a.m., an interview was conducted with Manager #3. Manager #3 stated the pharmacist was responsible for checking the expiration dates of the medications in the crash carts on a monthly basis. Manager #3 stated the charge nurse would check the crash carts daily for expired supplies, validate the oxygen tank was full, and check the automated external defibrillator (AED). Manager #3 stated medications given after the expiration date may not work and could have caused harm to the patient. iii. On 1/25/24 at 11:51 a.m., an interview was conducted with chief nursing officer (CNO) #9. CNO #9 stated the pharmacy technician, pharmacist, and ultimately, the CNO was responsible for checking the crash carts for expired medications. CNO #9 stated medications administered after the expiration date may not have the intended effect and may not work. CNO #9 stated that expired cardiac medications could lose their potency, not correct a lethal cardiac rhythm, and could result in death. The interview with CNO #9 was in contrast to the Emergency Medications policy, which stated the director of pharmacy was responsible for maintaining the emergency kits and the crash carts with up-to-date medications that may be useful in an emergency. Furthermore, the facility was unable to provide evidence the crash carts were maintained with unexpired medications for the purpose of responding to a Code Blue (a code to alert staff of respiratory or cardiac arrest)”

“PATIENT CARE POLICIES CFR(s): [The policies include the following:] (iv) Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use. This Standard is not met as evidenced by: 49541 Based on observations, interviews, and document review, the facility failed to ensure oversight of pharmacy services regarding the implementation of mechanisms to prevent and detect the diversion of providers’ prescription pads in one of one clinics observed. Findings include: Facility policy: The facility’s Drugs and Biologicals policy read, all drugs and biologicals will be kept under a single lock, and all controlled drugs will be stored under a double lock. Extra prescription pads will be kept under lock in the Pharmacy Room. Providers will keep prescription pads on their person and not in patients’ rooms or offices at any time. No one other than providers shall have access to prescription pads. 1. The facility failed to ensure staff and patients’ access to providers’ prescription pads (tamper-resistant prescription paper used to order medications) was limited to prevent and detect diversion. A. Observations i. On 1/24/24 at 11:05 a.m., observations in the rural health clinic office revealed admission supervisor (Supervisor) #6 opened the top drawer of the provider’s desk. Supervisor #6 stated they were looking for extra paper to take notes. Further observations revealed a prescription pad and multiple detached blank prescriptions. When questioned, Supervisor #6 stated the prescription pad was not supposed to be unlocked and closed the desk drawer. Further observations revealed the prescription pad remained unsecured throughout the observation. B. Interviews i. On 1/24/24 at 12:05 p.m., an interview was conducted with Supervisor #6. Supervisor #6 stated the providers’ prescription pads should have been stored and securely locked in the pharmacy room. Supervisor #6 stated the providers were responsible to safeguard their prescription pads. Supervisor #6 stated it was important to keep the prescription pads secured to prevent access to patients and staff members. Supervisor #6 stated unsecured prescription pads could have been taken by staff or patients and used to forge prescriptions, leading to potential overdose and even death. ii. On 1/24/24 at 4:28 p.m., an interview was conducted with clinic manager (Manager) #12. Manager #12 stated prescription pads should have been kept on the provider’s person or locked in the pharmacy room. Manager #12 stated the providers were responsible for securing their prescription pads. Manager #12 stated it was possible for an individual to unlawfully obtain and create fraudulent prescriptions, which could have resulted in harm to patients. iii. On 1/24/24 at 4:28 p.m., an interview was conducted with chief executive officer (CEO) #13. CEO #13 stated the facility had an incident of diversion with prescription pads in the past. CEO #13 stated the facility’s policy was for the provider to lock their prescription pads in the pharmacy room, and the providers were solely responsible for securing their prescription pads. CEO #13 stated only the providers should have access to the prescription pads. CEO #13 stated providers not securing their prescription pads puts the facility at risk for drug diversion.”

“LABORATORY SERVICES CFR(s): The CAH provides basic laboratory services essential to the immediate diagnosis and treatment of the patient that meet the standards imposed under section 353 of the Public Health Service Act (42 U.S.C. 236a). (See the laboratory requirements specified in part 493 of this chapter.) The services provided include the following: (i) Chemical examination of urine by stick or tablet method or both (including urine ketones). (ii) Hemoglobin or hematocrit. (iii) Blood glucose. (iv) Examination of stool specimens for occult blood. (v) Pregnancy tests. (vi) Primary culturing for transmittal to a certified laboratory. This Standard is not met as evidenced by: 42693 Based on observations, interviews, and document review, the facility failed to ensure lab equipment was maintained to provide the immediate diagnosis and treatment of patients in one of one observation of the off-campus clinic location. Findings include: Facility policy: The iSTAT Chem8+ policy read, for quality control, run an external quality control (QC) simulator each day of patient testing. Quality controls were to be completed. Run an external QC simulator each day of patient testing. An external liquid QC is to be performed once per month of patient testing. References: Bayer Contour Meter System read, use only Bayer’s Contour control solutions to practice on the system or to run a check to make sure the meter and the test strips are working properly. Remove a strip from the bottle. Tightly close the lid immediately after you have removed the test strip. Note: Check the expiration and discarded dates. Make sure the test strip does not appear torn or damaged. Bayer’s Contour Control IFUs read, Contour controls are aqueous glucose solutions intended for self-testing by people with diabetes and healthcare professionals as a quality control check. It is important not to use the control if the expiry date printed on the bottle label and the carton has passed or it has been six months since you first opened the bottle. It will help to write the six-month discard date on the label in the area provided when you first open. 1. The facility failed to ensure quality checks (QC) were done on lab equipment to ensure accurate patient results. A. Observations i. On 1/24/24 at 9:00 a.m., observation of an off-campus clinic location was conducted. The observation revealed a glucometer (a machine used to measure a patient’s blood sugar level) and the solutions to test the quality controls of the glucometer. The glucometer’s QC solution vials were noted to have been opened, however, the date of when they were opened was not noted on the vial. This was in contrast to the Contour control IFUs which read, it was important not to use the control if the expiry date printed on the bottle label and the carton has passed or it has been six months since the bottle was first opened. It would help to write the six-month discard date on the label in the area provided when first opened. The facility was unable to provide evidence of when the QC controls were opened. Additionally, the facility failed to provide evidence of when the QC checks were completed on the glucometer. ii. On 1/24/24, observation of the off-campus clinic was continued. Observations of the lab area revealed the iSTAT machine ( a machine used to obtain chemistries, electrolytes, hematocrit, and hemoglobin levels in a patient’s blood) was missing the monthly liquid QC checks. This was in contrast to the iSTAT Chem8+ policy which read, an external liquid QC was to be performed once per month of patient testing. B. Interviews i. On 1/24/24 at 9:36 a.m., x-ray and lab technician (Tech) #1 was interviewed. Tech #1 stated she was unaware of when the glucometer QC solution was opened and was unaware whether the solutions needed to be labeled when opened. Tech #1 stated it was important for the QC checks to be performed to ensure the machine was working properly and to ensure the correct lab results were provided. During the interview, the iStat machine was discussed with Tech #1. Tech #1 stated they were unaware if a monthly QC check needed to be performed on the machine. Tech #1 stated if the QC checks were not completed on the lab equipment, there was a risk for inaccurate results. The facility was unable to provide a log indicating the iStat machine had received the monthly QC checks. ii. On 1/24/24 at 12:33 p.m., an interview was conducted with registered nurse (RN) #5. RN #5 stated it was important to ensure the QC checks outlined in the equipment IFUs were important to follow to ensure the machine was working and the results were valid. RN #5 stated if invalid results resulted, there was a risk a patient could receive improper care. iii. On 1/24/24 at 12:05 p.m., an interview was conducted with clinic admission supervisor (Supervisor) #6. Supervisor #6 stated it was the lab tech’s responsibility to perform QC checks on the lab equipment. Supervisor #6 stated it was important to perform the QC checks to ensure the equipment was working properly. Supervisor #6 stated if lab results were inaccurate, there was a risk of patients being treated improperly.”

“RADIOLOGY SERVICES CFR(s): §485.635(b)(3) Radiology services. Radiology services furnished by the CAH are provided by personnel qualified under State law, and do not expose CAH patients or personnel to radiation hazards. This Standard is not met as evidenced by: 42693 Based on observations, interviews and document review, the facility failed to ensure lead aprons used to prevent radiation exposure at the off-campus clinic were maintained according to the manufacturer’s instructions for use in one of one observations of the clinic. Findings include: Facility policy: The Lead Apron and Glove and Other Radiation Protective Equipment Check for Damage, Cracks or Tear Causing Transmittent Radiation Exposure read, the purpose is to perform checks of all protective lead aprons and gloves and other radiation protective shielding annually to prevent undue radiation exposure to hospital personnel. All aprons, gloves and other radiation protective shielding preventing undue radiation exposure to hospital personnel will be x-rayed. The equipment will be x-rayed individually and is to be performed by the radiologic technologist. Document the results of all protective equipment yearly. Reference: The Infab X-ray Protection Apron IFUs read, the infab’s lead and bi-layer garments will give safe x-radiation protection for several years if properly used and maintained. Recommendations and use limitations are provided below. The following file pertains to the labeling, use, fit, maintenance, protection, ergonomics, manufacturing, and design of Infab’s lightweight apparel. Care, Maintenance, and Inspection: The warranty of the garments is 2 years from the date of manufacture. Infab core material is guaranteed for 2 years against cracking, stiffening, or pinholes; with careful use and proper storage, the useful life should be several years. When not in use, garments should be placed on a hanger. Regular inspections of the garment, at least annually, are recommended, using radiographic or fluoro operating at 70-90kV. Lines may indicate cracks. 1. The facility failed to ensure the lead apron at the off-campus location clinic was maintained according to the IFUs. A. Observations i. On 1/24/24 at 9:46 a.m., an observation of the clinic was conducted. The observation revealed two burgundy lead aprons hanging from the rack on the wall of the radiology room. The aprons appeared to have no visible cracks or holes upon observation. B. Interviews i. On 1/24/24 at 9:36 a.m., an interview was conducted with x-ray and lab technician (Tech) #1. Tech #1 stated the facility did not have a preventative maintenance (PM) log for the lead aprons. They stated the lead aprons had been purchased in 2008, however the facility had never x-rayed the lead aprons to ensure its integrity. Tech #1 was unable to state the frequency for how often the lead aprons were to be checked for integrity according to the IFUs. Tech #1 stated if the lead aprons had holes or damage, there was a potential of overexposure of radiation to patients or staff which could lead to serious adverse effects such as an increased risk for developing cancer. The interview was in contrast to the lead apron IFUs and facility policy which read, lead aprons were to be checked for integrity every year. ii. On 1/24/24 at 12:33 p.m., an interview was conducted with registered nurse (RN) #5. RN #5 stated they would assist the radiology department with positioning patients and holding the x-ray plate (a device used to obtain an x-ray image). RN #5 stated they wore the lead apron to prevent over-exposure to radiation. They further explained, over-exposure to radiation had the potential to put the staff member at risk of developing cancer. iii. On 1/24/24 at 12:05 p.m., an interview was conducted with the clinic admission supervisor (Supervisor) #6. Supervisor #5 stated staff members at the clinic were to wear lead aprons before performing x-rays. Supervisor #5 stated they were unaware of the frequency of when the lead aprons should be checked for integrity. They further stated that it was important to ensure the integrity of the lead apron in order to prevent overexposure of radiation to the patients and staff. iv. On 1/25/24 at 10:57 a.m., an interview was conducted with radiology manager (Manager) #10. Manager #10 stated the radiology technicians were responsible for performing preventative maintenance checks on the lead aprons to ensure integrity and that a log should be maintained to document the checks. Manager #10 stated the aprons were to be checked for integrity every year or two years. Manager #10 explained if there was damage to a lead apron there was a risk of increased radiation exposure which could lead to damaged tissue. Manager #10 stated they believed the personnel at the clinic were responsible for checking the lead aprons for integrity.”

“NURSING SERVICES CFR(s): Nursing services must meet the needs of patients. (1) A registered nurse must provide (or assign to other personnel) the nursing care of each patient, including patients at a SNF level of care in a swing-bed CAH. The care must be provided in accordance with the patient’s needs and the specialized qualifications and competence of the staff available. This Standard is not met as evidenced by: 42693 Based on medical record review and interviews, the facility failed to ensure patients received assistance or were offered assistance with activities of daily living (ADLs) in 21 of 26 inpatient, swing bed or observation status patient medical records reviewed.(Patients #1, #2, #3, #4, #5, #7, #8, #9, #10, #11, #13, #14, #15, #16, #17, #18, #20, #22, #24, #25, and #26). Findings include: Facility policies: The Oral Hygiene policy read, patients shall be offered oral hygiene and assisted as necessary to perform oral hygiene routinely as a part of an hour of sleep care and morning care to promote oral cleanliness and comfort. Document the procedure on the nurse’s notes. The Range of Motion (ROM) and ADL’s policy read, all patients will be offered assistance with activities of daily living at regular intervals throughout the day. Document all ADL’s on the certified nurse assistant (CNA) flow sheet. 1. The facility failed to ensure assistance with ADLs were offered or provided to patients. A. Medical Record Review i. On 4/13/23 until 5/4/23, Patient #6 received care at the facility for atrial fibrillation with a rapid ventricular rate (when the rapid contractions of the atria make the ventricles of the heart beat too quickly). a. A review of Patient #6’s flowsheets revealed the patient was offered a shower or bath or refused a shower or bath 8 out of the 21 days they were at the facility. There was no evidence in the medical record Patient #6 was offered or provided oral care throughout their entire stay. ii. On 12/14/23 Patient #12 was admitted for treatment of septic arthritis (an infection in the joint fluid and joint tissues). Patient #12 was a current patient at the time of the survey. a. A review of Patient #12’s flowsheets at the time of the survey revealed the patient was offered a bath or shower or refused a bath or shower 9 out of 41 days they were at the facility. There was no evidence in the medical record Patient #12 was offered or provided oral care throughout their stay. iii. On 12/1/23 Patient #19 was admitted to the facility for treatment of cellulitis (an infection of the skin). Patient #19 was discharged from the facility on 12/5/23. a. A review of Patient #19’s flowsheets at the time of the survey revealed the patient was not offered a bath or shower or refused a bath or shower during their stay. Additionally, there was no evidence in the medical record Patient #19 was offered or provided oral care throughout their stay. iv. Similar findings of the lack of daily oral care and daily ADL assistance offered to patients were noted in Patients #1, #2, #3, #4, #5, #7, #8, #9, #10, #11, #13, #14, #15, #16, #17, #18, #20, #22, #24, #25, and #26. This was in contrast to the ADL policy which read, all patients would be offered assistance with activities of daily living at regular intervals throughout the day. This was also in contrast to the Oral Hygiene policy which read, Patients shall be offered oral hygiene and assisted as necessary to perform oral hygiene routinely to promote oral cleanliness and comfort. B. Interviews i. On 1/25/24 at 12:35 p.m., an interview was conducted with registered nurse (RN) #4. RN #4 stated oral care and other ADLs were offered to patients depending on their condition. She stated when completed, ADLs were documented in the patient’s medical record. RN #4 stated bathing and oral care were important to provide to patients in order to prevent infection and skin breakdown. ii. On 1/25/24 at 11:49 a.m., an interview was conducted with the inpatient nurse manager (Manager) #3. Manager #3 stated, ADLs were completed by both RNs and CNAs. Manager #3 stated it was expected for staff to offer assistance with oral care three times a day to patients and to offer a bath or shower to patients once a day. They further explained if a patient refused oral care or a shower or bath, the staff member was to document the refusal in the patient’s chart. Manager #3 explained it was important to offer or assist with bathing and oral care in order to preserve and respect patients dignity. Manager #3 stated if patients were not bathed often, there was a risk for patient harm to their skin. Additionally, they explained if oral care was not offered or provided to patients, there was a risk of the patient developing cavities or infections of the mouth.”

“NURSING SERVICES CFR(s): §485.635(d)(3) All drugs, biologicals, and intravenous medications must be administered by or under the supervision of a registered nurse, a doctor of medicine or osteopathy, or, where permitted by State law, a physician assistant, in accordance with written and signed orders, accepted standards of practice, and Federal and State laws. This Standard is not met as evidenced by: 42693 Based on medical record review and interviews, the facility failed to ensure medications were administered to patients at the time scheduled by the provider in 13 of 26 inpatient, swing bed or observation status patient medical records reviewed. (Patient #3, #4, #5, #6, #8, #12, #13, #17, #18, #19, #20, #24, and #25). Findings include: Facility policies: The Medication Administration policy read, routine scheduled medications will be administered in a timely fashion within 60 minutes before or after the scheduled time. Administration times: Medications are administered via physician orders in concert with the definition and time frame established by nursing and Pharmacy in collaboration with the medical staff members. While STAT drugs are given immediately (within 15 minutes of the order), As Soon As Possible (ASAP) drugs (within 45 minutes of the order), and routine drug times are determined in such a way as to promote optimum blood levels but interfere as little as possible with patient rest and change of shift routines. The Standardized Times policy read, the use of standard times shall be used only for the delivery of drugs that are deemed safe to do so by the Medical Staff. 1. The facility failed to ensure medications were administered when scheduled and/or 60 minutes after the scheduled time according to facility policy. A. Medical Record Review i. On 2/8/23 Patient #3 was admitted to the facility for treatment of a diabetic foot ulcer. A review of Patient #3’s medication administration record (MAR) revealed medications were administered beyond the scheduled time. a. On 2/10/23 at 8:00 p.m., Insulin Lispro (a fast-acting medication to lower a patient’s blood glucose level) was scheduled to be administered. The MAR revealed the medication was not administered until 2/11/23 at 2:26 a.m., 6 hours and 26 minutes after the scheduled time. There was no evidence why the medication was administered beyond the scheduled time. ii. On 4/13/23 until 5/4/23, Patient #6 received care at the facility for atrial fibrillation with a rapid ventricular rate (when the rapid contractions of the atria make the ventricles of the heart beat too quickly). A review of Patient #3’s MAR revealed medications were administered beyond the scheduled time. a. On 4/16/23 at 9:00 a.m., Insulin Lispro was scheduled to be administered. The MAR revealed the medication was not administered until 12:38 p.m., three hours and 38 minutes after the scheduled time. b. On 4/21/23 at 11:00 a.m., Insulin Lispro was scheduled to be administered. The MAR revealed the medication was not administered until 1:37 p.m., two hours and 37 minutes after the scheduled time. c. On 4/27/23 at 8:00 p.m., Insulin Lispro was scheduled to be administered. The MAR revealed the medication was not administered until 4/28/23 at 12:15 a.m., four hours and 15 minutes after the scheduled time. d. On 5/1/23 at 4:30 p.m., Insulin Lispro was scheduled to be administered. The MAR revealed the medication was not administered until 9:19 p.m., four hours and 49 minutes after the scheduled time. There was no evidence why the medication was administered beyond the scheduled time. iii. On 12/14/23 Patient #12 was admitted for treatment of septic arthritis (an infection in the joint fluid and joint tissues). A review of Patient #12’s MAR revealed medications were administered beyond the scheduled time. a. On 1/4/24 at 8:00 p.m., Cefazolin (a medication used to treat bacterial infections) was scheduled to be administered. The MAR revealed the medication was not administered until 10:07 p.m., two hours and seven minutes beyond the scheduled time. b. On 1/16/24 at 1:00 p.m., Cefazolin was scheduled to be administered. The MAR revealed the medication was not administered until 4:06 p.m., three hours and six minutes beyond the scheduled time. There was no evidence why the medication was administered beyond the scheduled time. iv. On 1/9/24 Patient #13 was admitted to the facility for altered mental status (AMS). A review of Patient #13’s MAR revealed medications were administered beyond the scheduled time. a. On 1/10/24 at 6:30 a.m., Insulin Lispro was scheduled to be administered. The MAR revealed the medication was not administered until 10:08 a.m., three hours and 38 minutes beyond the scheduled time. There was no evidence why the medication was administered beyond the scheduled time. v. A review of Patient #4, #5, #8, #17, #18, #19, #20, #24 and #25’s medical records revealed similar findings of medications being administered beyond the scheduled time. B. Interviews revealed medications were to be administered at the time prescribed by the provider. i. On 1/25/24 at 12:36 p.m., an interview was conducted with registered nurse (RN) #4. RN #4 explained the nurse was to adhere to the five patient rights of medication administration when medications were administered to patients to include, administration at the right time. RN #4 explained this was important to ensure a patient did not receive too much of a dose of medication. ii. On 1/25/2024 11:50 a.m., an interview was conducted with the inpatient nurse manager (Manager) #3. Manager #3 stated if medications were not administered at the scheduled time, there was a risk for patient safety and concerns for the patient to receive too much of one medication.”

“RECORDS SYSTEM CFR(s): For each patient receiving health care services, the CAH maintains a record that includes, as applicable-- (i) Identification and social data, evidence of properly executed informed consent forms, pertinent medical history, assessment of the health status and health care needs of the patient, and a brief summary of the episode, disposition, and instructions to the patient; This Standard is not met as evidenced by: 42693 Based on medical record review and interviews, the facility failed to ensure consent for treatment was provided to patients in six of 25 inpatient and swing bed status patient medical records reviewed. (Patient #1, #7, #11, #16, #17, and #22). Findings include: References: The facility’s patient rights read, the facility respects your rights as a patient and recognizes that you are an individual with unique healthcare needs. You have the right to: Be informed of your patient rights in advance of receiving or discontinuing care when possible. Give informed consent for all treatments/procedures and receive an explanation in layman’s terms of recommended treatment or procedure; risks and benefits of the treatment or procedure; the likelihood of success, serious side effects, and risks including death; and alternatives and consequences if treatment is declined. The facility’s consent for treatment form read, Consent for health care services: I, suffering from a condition requiring inpatient or outpatient hospital medical care, hereby voluntarily consent to the rendering of care, which may include routine hospital services, diagnostic procedures, medical treatment, or other hospital care and services as the attending physician or others holding clinical privileges at the hospital consider necessary, and performed by the employees and staff of the hospital. For Inpatient Only: a copy of patient rights/responsibility was given - yes or no. I acknowledge that I have read this form and understand its contents and have received a copy hereof. I further acknowledge that I am the patient, or person duly authorized either by the patient or otherwise, to sign this agreement, consent to and accept its terms. 1. The facility failed to ensure all patients admitted for treatment were advised of their rights to treatment and failed to provide evidence of signed consent forms in the medical record. A. Medical Record Review i. On 1/4/23, Patient #1 was admitted to the facility for a pulmonary embolism (a blockage of the blood vessels that send blood to your lungs) and a deep vein thrombosis (a blood clot that develops within a deep vein in the body). A review of Patient #1’s record revealed a lack of evidence Patient #1 was provided and signed a consent for treatment. ii. On 5/9/23, Patient #7 was admitted for cellulitis (a bacterial skin infection). A review of Patient #7’s medical record revealed a lack of evidence Patient #7 was provided and signed a consent for treatment. iii. On 8/8/23, Patient #11 was admitted for bacterial pneumonia (an infection of the lungs caused by bacteria). Patient #11’s medical record revealed a lack of evidence Patient #11 was provided and signed a consent for treatment. iv. A review of Patient #16, #17, and #22’s medical records review similar findings. The medical record reviews were in contrast to the facility’s patient rights which read, a patient had the right to be given informed consent for all treatments and procedures. B. Interviews i. On 1/25/24 at 12:35 p.m., an interview was conducted with registered nurse (RN) #4. RN #4 stated when patients presented to the emergency department, they were provided a consent for treatment. They further explained, if the patient was experiencing an emergency or was unable to sign a consent for treatment, staff would potentially accept verbal consent. RN #4 stated it was important for the consent form to be completed and signed to ensure the patient had been provided their consent for treatment. ii. On 1/25/24 at 11:50 a.m., an interview was conducted with the inpatient nurse manager (Manager) #3. Manager #3 stated it was important for patients to provide their consent for treatment so the patient had a say in the treatment they were provided. They further explained, if a consent for treatment was not obtained, there was a potential to provide care to a patient against their will.”

“INFECTION PREVENT & CONTROL POLICIES CFR(s): The infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the CAH and between the CAH and other healthcare settings; This Standard is not met as evidenced by: 49541 Based on observations, interviews, and document review, the facility failed to ensure staff performed hand hygiene and glove use according to national standards and facility policy based on one of one patient care observations. Findings include: Facility policies: The Hand Hygiene policy read, this policy applies to all healthcare personnel (HCP) and visitors. The purpose is to outline the process for appropriate hand hygiene. Hand Hygiene is the single most important process for interrupting the transmission of organisms from person-to-person, and preventing healthcare-acquired infections. The following is the World Health Organization’s outline for when you should sanitize your hands: before touching a patient; before clean or aseptic procedures; after body fluid exposure risk; after touching a patient; and after touching patient surroundings. Additional situations in which your hands should be washed or sanitized include before putting on gloves and after removing your gloves; when moving hands from a contaminated body site to a clean body site during patient care; and before handling clean equipment such as patient charts, computer monitors, keyboards and mouse, and IV pumps. 1. The facility failed to ensure staff performed hand hygiene and glove use according to policy and national standards to reduce the risk of infection. A. Observations i. On 1/24/24 at 9:36 a.m., observations were conducted in the rural health clinic lab. Observations revealed technician (Tech) #1 performed a blood draw. Tech #1 did not remove their gloves or wash their hands after the procedure. Tech #1 walked the patient down the hall to the restroom for a urine sample with gloved hands. Tech #1 removed their gloves but did not perform hand hygiene and returned to the lab. Tech #1 with ungloved hands, labeled lab vials and used CaviWipes to wipe down hard surfaces. Tech #1 did not perform hand hygiene throughout the observation. B. Interviews i. On 1/24/24 at 9:36 a.m., an interview was conducted with Tech #1. Tech #1 stated they forgot to remove their gloves and wash their hands after the lab draw. Tech #1 stated gloves should not have been worn in the hallway since there was potential for cross-contamination to multiple surfaces. Tech #1 stated that gloves should be worn when labeling blood samples. Tech #1 stated to prevent the spread of infection; it was important to wash their hands and wear personal protective equipment (PPE). Tech #1 stated patients and staff were put at risk of contracting infections if the staff members did not wash their hands or wear PPE properly. ii. On 1/24/24 at 12:33 p.m., an interview was conducted with registered nurse (RN) #5. RN #5 stated gloves worn while drawing labs should be removed directly after the procedure was performed. RN #5 further stated used gloves should not be worn in the hallway and patient care areas. RN #5 stated hand hygiene should be performed before and after patient care, after hands became soiled, and before and after gloves were applied and removed. RN #5 stated it was important to perform hand hygiene for infection control purposes. RN #5 stated improper hand hygiene could lead to cross-contamination and increase the risk of infection for the patients and staff. iii. On 1/24/24 at 12:05 p.m., an interview was conducted with the clinic admission supervisor (Supervisor) #6. Supervisor #6 stated proper hand hygiene should be performed before and after patient care to prevent cross-contamination and prevent the spread of infections. Supervisor #6 stated patients and staff were at a higher risk of infection when staff did not perform hand hygiene correctly. iv. On 1/24/24 at 12:04 p.m., an interview was conducted with infection control and chief quality officer (Officer) #8. Officer #8 stated health clinics associated with the hospital would follow the same policies and procedures. Officer #8 stated they used a web-based application to complete hand hygiene audits. Officer #8 stated the facility’s hand hygiene compliance was at 42%. Officer #8 stated staff were educated on infection control and how and when to perform hand hygiene during new hire orientation and annual competencies training. Officer #8 stated hand hygiene was important to prevent the spread of infection. v. On 1/25/24 at 11:52 a.m., an interview was conducted with chief nursing officer (CNO) #9. CNO #9 stated hand hygiene should be performed before and after entering a patient’s room, anytime a staff member touched a patient, and when the hands became visibly soiled. CNO #9 stated Officer #8 performed the hand hygiene audits at the facility. CNO #9 stated the hand hygiene audits were discussed in the infection control meetings. CNO #9 stated the reported hand hygiene audit numbers were not up to their standards. However, CNO #9 was unable to provide evidence related to hand hygiene audits and current rates. CNO #9 stated proper hand hygiene was important to prevent the spread of infection. CNO #9 stated improper hand hygiene put the patients at risk of infection, especially patients who were already immunocompromised (weak immune system).”

“INFECTION PREVENT SURVEIL & CONTROL OF HAIs CFR(s): The infection prevention and control includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and that the program also addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 42693 Based on observations, interviews, and document review, the facility failed to follow the instructions for use (IFUs) for the reprocessing of surgical and procedural equipment. Specifically, the facility failed to ensure the endoscope pre-cleaning process was followed in one of one observation. Additionally, the facility failed to ensure equipment used during the instrument pre-cleaning process was maintained according to the IFUs. Findings include: Facility policy: The Endoscopy Processing policy read, the policy was to provide a safe patient environment when performing procedures utilizing endoscopes by reducing the risk of potential contamination equipment being used for procedures and to provide a safe environment for personnel when processing soiled endoscopes. The following steps should be utilized when preparing the endoscope for processing. Immediately following the procedure, clean/wipe all debris from the insertion tube using an enzymatic cleaner and run brushes through channels. Aspirate detergent several times through the biopsy/suction channel. Remove all removable caps. Visually inspect the insertion tube as well as the outside of the entire scope for any possible signs of damage. Perform the leak test as follows: For the dry test: secure the leakage tester connector to the air vent on the scope light guide. Be sure the PVE soaking cap is securely in place over the electrical contacts. The leakage tester connector and air vent on the scope light guide must be dry before connecting. To obtain proper connection, align the air vent pin and then clockwise rotation of the leakage tester connector. Turn the gauge faceplate to zero the pressure indicator. Pressurize the scope by pumping the hand bulb until the indicator on the gauge is in the green zone. Do not pressurize in the red zone as it may cause serious damage to the scope. During this leakage test flex the insertion tube in various directions as well as angulate the distal tip of the insertion tube to confirm the absence of a leak. For the wet test: after it has been determined there are no major leaks from the dry test, the scope may be immersed to test for loss of integrity in the watertight construction of the scope. Before immersing, remove the red ETO gas sterilization venting cap and make certain the PVE soaking cap is securely on covering the electrical contacts. With the leakage tester securely attached to the scope and the scope pressurized into the green zone, the PVE soaking cap securely attached over the electrical contacts, all valves and inlet seals removed, the entire scope may be immersed in clean water. Do not immerse the leakage tester, only the connector and a small portion of the tubing may be immersed. Observe the scope closely. Flex the scope as above in the dry test as well as angulate the distal end of the insertion tip. A few bubbles may be noted at first. This is normal. If a continuous stream of bubbles is noted from the same spot, this indicates a leak. Immediately removed from the water. Do not use the scope. The Surgical Instrument Decontamination policy read, the policy’s purpose is to minimize the potential risk for surgical site infections by providing instruments, supplies, and other items free of contamination at the point of use. A handle brush should be used with friction in cleaning all surfaces of each instrument and device. The cleaning brushes will also be cleaned after use according to the IFU for each different brush. References: The Fujifilm Reprocessing Summary and Guide for Flexible GI Endoscopes read, flexible endoscopes are reusable medical devices which require special handling after each clinical use to render them safer for subsequent patient procedures. Leak testing: the endoscope should first be leak tested per the manufacturer’s recommendations. Instruments should be fully immersed in a basin containing clean water during the wet leak test. Ensure that all removable scope components are detached from the endoscope prior to leak testing. Attach a dry waterproof/soaking cap to the endoscope prior to immersion in any fluid. Inspect the leak tester before use and connect it to the scope out of water. Dry leak test the scope before immersion. Ensure the leak tester has no fluid/moisture inside the tubing, connector or bulb. Perform a dry leak test by pressurizing the scope, letting it stand for 30 seconds and checking if the indicator needle on the Fujifilm tester gauge drops 10 gradations. Perform a wet leak test in clean water while manipulating the bending section and remote/video switches; confirm that no leak exists by looking for a continuous stream of air bubbles. The Batrik Medical Manufacturing Reusable Brushes IFUs read, the reusable brushes are intended to assist in the cleaning of medical devices in conjunction with a suitable cleaning solution. All components used in the manufacturing of our reusable brushes are made of commonly used materials and do not require special sterilization handling outside your facility’s standard sterilization protocol. Between usages, inspect for wear, fraying or damaged bristles. If observed, the brush should be discarded in compliance with your facility disposal instructions. Cleaning and sterilization: These products have been manufactured using materials that withstand repeated steam sterilization cycles achieving 273?. Although the product is designed for considerable re-use, variables such as frequency of sterilization, cleaning application and handling can impact the product’s useful life. 1. The facility failed to ensure endoscopes were reprocessed according to the manufacturer’s IFUs. a. On 1/24/24 at 7:50 a.m., an observation of certified surgical technician (Tech) #11 reprocessing an endoscope was conducted. During the observation, Tech #11 did not retroflex the tip of the endoscope during both the dry leak test and the wet leak test. The observation was in contrast to the manufacturer IFUs which read, leak testing should be conducted per the manufacturer’s recommendations. Perform a wet leak test in clean water while manipulating the bending section and remote/video switches; confirm that no leak exists by looking for a continuous stream of air bubbles. The observation was also in contrast to the endoscope reprocessing policy which read, during the leakage test, flex the insertion tube in various directions as well as angulate the distal tip of the insertion tube to confirm the absence of a leak. During the wet leak test, flex the scope as above in the dry test as well as angulate the distal end of the insertion tip. b. On 1/24/24 at 10:35 a.m., an interview was conducted with Tech #11. Tech #11 stated when he performed the leak test on the endoscopes, they did not move the tip around. Tech #11 further stated if they had a question about how to reprocess an endoscope, they would refer to the manufacturer’s IFUs. This interview was in contrast to the manufacturer IFUs and the endoscope reprocessing policy which read, flex the insertion tip to check for leaks. c. On 1/25/24 at 11:52 a.m., an interview was conducted with chief nursing officer (CNO) #9. CNO #9 stated it was important for manufacturer IFUs to be followed to ensure equipment was cleaned appropriately to prevent the spread of infection. 2. The facility failed to ensure IFUs for equipment used to clean surgical instruments were followed. a. On 1/23/24, an observation was conducted of the sterile processing area. During the observation, Tech #11 was observed reprocessing instruments from an orthopedic total knee casket. Tech #11 was observed cleaning the surgical instruments with a scrub brush. In addition to the brush utilized by Tech #11, numerous other brushes were identified stored in a plastic bin on the sink. The brushes in the plastic bin appeared to be worn and had been used. b. On 1/23/24 at 8:20 a.m., an interview was conducted with Tech #11. Tech #11 stated the scrub brushes used on the instruments were reused and did not need to be sterilized in between use. They stated the brush typically could be used for four months or until the bristles of the brush began to fall out. The interview was in contrast to the manufacturer IFUs which read, the products have been manufactured using materials that withstand repeated steam sterilization cycles achieving 273?. Although the product is designed for considerable re-use, variables such as frequency of sterilization, cleaning application, and handling can impact the product’s useful life. c. On 1/25/24 at 11:52 a.m., an interview was conducted with CNO #9. CNO #9 stated it was important for staff to follow the manufacturer IFUs to ensure surgical instruments were cleaned in order to prevent the spread of infection between patients.”