Carilion Medical Center

“FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE CFR(s): 482.41(c)(2) Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. This Standard is not met as evidenced by: 46466 Based on observation, interviews and facility document review, the facility failed to maintain/repair malfunctioning ED equipment to ensure a level of safety and quality. The findings include: On April 28, 2025 at 12:30 PM, a tour of the facility’s Emergency Department (ED) was conducted with Staff Members #4, #17 and #18. During the tour, the surveyor observed a malfunctioning overhead light in ED patient room G04. Patient #3 included in the survey sample reported that during their ED visit on April 11, 2025 the overhead light was not functioning and the provider elected to use the flashlight on their phone during a pelvic exam. Staff Member #17 indicated during the tour that if an overhead light in one of the patient rooms was not functioning, staff had to place a work order and maintenance would repair the issue. Staff Member #17 stated that their maintenance department did not do routine maintenance checks on the equipment in the ED patient rooms and they rely on staff to place a work order if something is non-operational or malfunctioning. Staff Member #17 explained that the ED has portable lights that can be brought into a patient room if an overhead light is not functioning or sufficient and speculums used for pelvic exams also contained a build-in light source. On April 28, 2025 at 2:00 PM, three (3) ED complaints/grievances received by the facility between February 1, 2025 and present and related to the cleanliness of the ED were reviewed. One (1) of the logged complaints was from Patient #3, included identical allegation as investigated during this survey and was received by the facility on April 18, 2025. On April 28, 2025 at 4:45 PM, Staff Member #2 stated that facility staff were not aware of the malfunctioning overhead light in ED room G04 until today and that upon discovery a work order was placed for a repair. Staff Member #17 explained “a non-employee” provider did not notify an ED staff member of the issue nor placed a work order for repairs. Staff Member #3 stated that the patient complaint about the malfunctioning overhead light was probably not addressed sooner because the Grievance Department only received the complaint on April 18, 2025 and the Grievance Department has 30 days to resolve that complaint from the date of receipt. On April 28, 2025 the surveyor requested to interview Staff Member #24, who performed a pelvic exam on a Patient #3 in ED room G04 on April 11, 2025. At the time of the exit conference on April 29, 2025, neither the survey team nor the facility received a call-back from the contracted staff. On April 29, 2025 at 11:10 AM, a review of Staff Member #24’s personnel file was conducted with Staff Member #25. The personnel record revealed that Staff Member #24 was granted privileges to provide services within the facility. The personnel record also revealed that Staff Member #24 signed an “Information Release/Acknowledgment” letter documenting that they agreed to abide by the facility’s policies and procedures. Staff Member #25 stated that prior to being granted privileges, providers are sent copies of the facility’s By-Laws and Policies and Procedure to review.”

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 46466 Based on observation, interviews and facility document review, the facility failed to ensure adequate cleaning and disinfection of the Emergency Department patient rooms. The findings include: On April 28, 2025 at 12:30 PM, a tour of the facility’s Emergency Department (ED) was conducted with Staff Members #4, #17 and #18. During the tour, Staff Member #17 indicated that the ED had their own, dedicated Environmental Services (EVS) staff and uses a system called teletracking. When a patient is discharged from a patient room, a notification is sent to the EVS staff to alert them that the room needs to be cleaned. Once the EVS staff completes the cleaning, EVS staff changes the room status to “clean” and the system notifies clinical staff that the room is ready for a new patient. Staff Member #17 explained that when cleaning patient rooms staff are expected to wipe down all surfaces with disinfectant, clean floors, remove trash and dirty linen and replace with clean linens. On April 28, 2025 at 3:10 PM, a review of Patient #3’s medical record was reviewed with Staff Member #17. Patient #3’s medical record documented that Patient #3 was placed in room G04 on April 11, 2025 at 7:49:13 PM. On April 29, 2025, the surveyor reviewed the facility’s EVS teletracking log and found that on April 11, 2025 at 7:39:05 PM, room G04 was “dirty”. An EVS staff member documented that room G04 was “in progress” for cleaning at 7:41:00 PM. The same EVS staff member documented at 7:42:26 PM that room G04 was “clean”. The documentation revealed that the EVS staff member “cleaned” room G04 in one (1) minute and 26 seconds. The log didn’t contain documentation that additional staff assisted in cleaning of the room G04 during that time. The log also documented that room G04 was “occupied” at 7:49:25 PM. On April 29, 2025 at 12:10 PM, during an interview Staff Member #23 stated that the approximate average time to clean/disinfect a patient room by one staff is about 14 minutes. Staff Member #17 commented that the logged timeframe of one (1) minute, 26 seconds by the EVS worker for cleaning of room G04 on April 11, 2025 at 7:42 PM was not an appropriate amount of time for the one (1) EVS staff member to properly clean the room. However, Staff Member #23 explained that it was possible that there was another staff member cleaning the room at the same time, but the documentation in the teletracking log did not capture that. Staff Member #23 indicated that if EVS staff got a notification that a room needed to be cleaned “STAT”, more than one person would help with the cleaning if there were enough staff available. Staff Member #23 further indicated that EVS staff did not handle any biohazard waste products, such as a urine, blood, bodily fluids. The clinical staff were responsible to dispose of the biohazard waste products. SM23 did not provide a policy/procedure regarding the facility’s process for EVS staff members logging into the EVS teletracker, nor for providing support to clinical staff with removal biohazard waste. On April 29, 2025, a review of the facility’s policy “9.10 - Emergency Room Cleaning and Disinfection”, issued 10/1/2024, indicated in part: “...Procedure...Remove trash from patient suites, High dust and disinfect vertical surfaces, including doors, walls, doorknobs, light switches, and IV poles, Disinfect horizontal surfaces such as bedside tables, ledges, sink surfaces, and dispensers, clean or remove Privacy Curtains based on patient condition (isolation status). If using disposable curtains, dispose of them according to facility guidelines where applicable, refill hand soap and towels if needed, dry mop floor and place a caution/wet floor sign, inspect work to ensure all areas are cleaned to standard, damp mop floor surfaces with disinfectant using either traditional or microfiber methods...”. On April 29, 2025, a review of the facility’s policy “7.10 - Clinical Exam Room Cleaning Procedure”, issued 10/1/2024, indicated in part: “...Procedure...Place caution/wet floor sign at room entrance prior to beginning assignment, remove exam room trash from the cans, damp wipe the can and replace the liner...Place clean liners into the waste cans...Bring caddy containing chemicals and plastic pail into the room, along with high dusting tool, high dust, beginning at the entranceway and working around the room in a circle. High dust horizontal surfaces above shoulder height starting opposite the restroom...Using germicidal/disinfectant cleaner and a microfiber clean cloth, disinfect/sanitize all patient contact surfaces, including exam table, phone, chairs, low ledges and counter, light switches and doorknobs...spot wipe/disinfect stains and spots from walls and other vertical surfaces...Generally heavy body fluids including but not limited to blood, feces, etc. are handled by the clinical staff with support from EVS....Remove caddy and high dusting from the room and place on the cart, Dust mop the room beginning with corners and edges, moving from the far side of the room toward the door...Dust under the bed, furniture and behind the door. Leave the dust mop at the door. Bring the dustpan and counter brush/squeegee to the doorway...damp mop hard surface floors beginning with corners and edges, moving from the far side of the room toward the door...”. On April 29, 2025 at 12:35 PM and during the exit conference, Staff Member #3 presented video surveillance footage that captures room G04 being cleaned on April 11, 2025 at 7:40 PM by two (2) EVS staff members. The video camera was installed near the ceiling in an ED hallway, room G04 was visible on the opposite end of the hallway as the camera and the video footage was not angled to capture a view of events occurring inside the room. The footage revealed two (2) EVS workers approach the doorway of room G04 with the cleaning caddy, one (1) staff member was seen entering the room, while the other EVS staff member stood in the hallway for approximately 15-20 seconds, looking down at something in their hand. Afterwards, that EVS staff was seen entering room G04 with the first EVS staff. Neither EVS staff pulled the cleaning caddy into the room. The EVS staff were in the room for approximately two (2) minutes and 45 seconds. Both exited room G04 at approximately 7:42 PM and pushed the cleaning caddy around the corner. Neither staff appeared to carry out a trash bag or a dust mop.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 21229 Based on clinical record review, staff interview and review of facility documents and documentation, the facility failed to ensure patient rights of three (3) of three (3) patients (Patient #11, 12, and #13) who presented to the facility for treatment were protected as evidenced by: failure to adhere to facility policy for determining patient capacity for treatment (A-0131), failure to monitor patients after being administered a chemical restraint (A-0160), failure to use least restrictive interventions to protect patients and others (A-0164) and failure to obtain orders for chemical and physical restraints (A-0168). The cumulative effect of these findings led to violation of patient rights. Cross references: §482.13(b)(2) Patient Rights: Informed Consent §482.13(e)(1)(i)(B) Patient Rights: Chemical Restraint §482.13(e)(2) Patient Rights: Use of Restraint or Seclusion §482.13(e)(5) Patient Rights: Restraint or Seclusion Order 42929”

“PATIENT RIGHTS: EXERCISE OF RIGHTS CFR(s): 482.13(b) Patient Rights: Exercise of Rights This Standard is not met as evidenced by: 21229 Based on clinical record review staff interview, and facility document review, the facility staff failed to ensure each patient was permitted to exercise their rights. Patient #11 was: 1. “Held” in the Emergency Department without being informed of their status/ability to leave. and 2. Was administered medications (Intramuscular injection- IM) over refusal/objection. The findings included: 1. Patient #11 presented to the Emergency Department (ED) on 12/13/23, according to the “ED Provider Note” with complaints of increased depression...some auditory hallucinations...no s/h (suicidal/homicidal) ideations...would like to have thyroid level drawn...Medical Decision Making: medically stable for psychiatric evaluation...” A “ED Triage” note dated 12/13/23 at 2:00 p.m. evidenced: “...sad, withdrawn and cooperative...Is the patient an ECO (Emergency Custody Order)? No...” At 3:40 p.m. it was documented in the RN (Registered Nurse) note: “Is the patient an ECO? No”. On 12/13/23 at 5:07 p.m., the documentation in the clinical record evidenced: “During AES (Adult Emergency Services) assessment pt (patient) became agitated, through (sic) ipad, attempted to leave department...Per AES TDO (Temporary Detaining Order) is recommended...Patient prevented from leaving ED by Carilion PD (Police Department)...” At 15:40 p.m. on 12/13/23 there was documentation under the “Behavioral Health Assessment - Is the Patient an ECO? No.” On 12/13 at 5:23 p.m., the Mental Health Therapist had entered a note: “recommended TDO...City Magistrate has agreed to issue TDO, however pt cannot be served or transported on a TDO without bed placement...” On 12/14/23 it was documented at 7:00 a.m. in the “Behavioral Health Assessment : Is the patient an ECO? No...” The only documentation about the issuance of an ECO was in the Physician Assistant note 12/14/23 at 1:17 p.m. “...ECO issued this a.m....” The clinical record evidenced on 12/14/23 at 17:16 (5:16 p.m.) “Carilion PD exit annex due to ECO ending at 1700 (5:00 p.m.).” Patient #11 remained in the ED until 11:56 p.m. (12/14/23) when it was documented that “PD arrived to transfer patient to psych facility...Pt left in PD custody.” There was no documentation of when the ECO nor TDO were formally served to the patient, only that the patient had been “prevented” from leaving the department. In an interview with SM #5 on 2/5/24 at 3:10 p.m., the SM stated: “The ECO was started at 0900 (9:00 a.m. 12/14/23) and lasts for eight (8) hours...the TDO was recommended but when we call the magistrate they will not issue the TDO until we have a bed confirmed, but they tell us that they will issue it. It takes time to find a bed...” The surveyor inquired about the legality of holding the patient without the ECO or the TDO, the rights of the patient and whether the patient was informed they were able to leave. SM #5 stated “Legally they can leave but we are not willing to let them leave due to the risk to the patient and the community...” The surveyor asked, in this case with Patient #11, why the ECO was allowed to elapse and the patient still held. SM #5 stated, “We could have had the Magistrate list the bed of last resort on the papers but we do not like to dump on the state hospital...” The surveyor asked if the patient was informed of their right to leave. SM #5 stated the patient was not told they could leave because they were on a recommended TDO. The facility policy and procedure “Patient rights and Responsibilities” effective 11-2021 evidenced, in part: “...IV. Procedure: A. Patient Rights- held when the individuals treating physician, clinical psychologist or clinical social worker has made a part of the individuals record a written statement that , in the exercise of their professional judgement the furnishing to ...would be reasonably likely to endanger the life or physical safety of the individual or another person...reasons must be clearly documented...c. Information may not be withheld from a patient in the belief that providing the information will cause the patient to forgo the treatment...4. The right to obtain complete, current information concerning diagnosis...treatment...7. The right to reasonable informed participation in decisions involving his/her care, treatment and services...13. Receive care in a safe setting free from all forms of harassment or abuse. This includes freedom from restraint or seclusion that is not indicated for safety or medical indications...15. The right to refuse treatment to the extent permitted by law...” The Facility policy “ECO, TDO, and Judicial Authorization - Obtaining and Care of Patient effective 9-2023” evidenced, in part: “...III. Policy Statement: A. An ECO is issued by a magistrate when upon sworn petition of any responsible person, treating physician or upon his/her won motion to facilitate a face-to-face meeting with the person and a designee of the Community Services Board to determine if the patient needs further hospitalization or treatment...B. A paperless ECO may be obtained in certain situations...C. The purpose of a psychiatric TDO is to require short term detention of a patient who is believed to be suffering from a mental illness, at risk of harm, and is unwilling or incapable of consenting to treatment...Procedure: Emergency Custody Order:...3. Process: a. The magistrate issues the ECO. The ECO is served through law enforcement...b. The patient will be taken into custody for a period not to exceed 8 (eight) hours. An ECO cannot be extended...4. Paperless ECO : A Carilion Police Officer, based on their own observations or the reliable reports of others...may take a person into custody...The period of custody shall not exceed 8 (eight) hours. b. If a patient is voluntary needing mental health treatment and requests to leave the hospital, staff will notify the practitioner/ACP(Advanced Care Practitioner) or nurse and Carilion Police for further evaluation. A decision will be made by the practitioner/ACP in collaboration with Carilion Police to determine if criteria is met for ECO. c. All reasonable attempts should be made to enlist the patients cooperation in remaining in the ED or hospital. Carilion Police will apply the least restrictive means of physical restraint may only be used as a last resort...B. Temporary Detention Order...c. The TDO will not be formally issued until bed placement has been arranged...” The surveyor discussed the concerns with facility administration on multiple occasions throughout the survey 2/4 through 2/6/24 (SM # 5, 25, 28, 29, 31 and 32.) 2. Review of the clinical record for Patient #11 revealed the patient was administered “Haldol (an antipsychotic) 5mg (milligrams), Ativan 2mg, and Benadryl 50mg IM (intramuscular injection) on 12/13/23 at 7:58 p.m. for (7:52 p.m.) “verbally aggressive, hateful and disrespectful to staff, continued to push the code button over and over”. It was also documented the “Police Department was at the bedside.” The surveyor was unable to locate in the clinical record evidence detailing the medication administration to the patient who was displaying agitation and whether or not the patient accepted the medication, however in an interview with Staff Member (SM) #22 on 2/6/24 at 2:50 p.m. the SM stated: “We tried to talk to (patient) and calm (them)...I let (patient) know I was giving the med and (patient) put up a fuss so the officers stood on each side of (patient) and each officer placed their one hand on the upper arm and one on forearm below on both of the (patient’s) arms and (patient) didn’t struggle. (Patient) voiced some derogatory words but (patient) didn’t jerk or struggle. (Patient) did say ‘you are not going to do that to me’, but (patient) didn’t struggle when the police officers placed their hands on (patent’s arms).” It was again documented Patient #11 received the same “cocktail” of medications IM on 12/14/23 at 9:28 a.m. for “severe agitation”. The note documented in the clinical record at 12/14/23 0930 (9:30 a.m.) evidenced, “Pt in hallway speaking to Carilion security...requesting to know when (patient) will be leaving...9:00 a.m. Pt currently on phone agitated..Carilion PD called and are at bedside. Pt currently calling 911 and Carilion PD at bedside. 9:03 a.m. This tech distress badge activated.” There was no further documentation as to what the distress situation was or interventions from the facility other than the documentation of medication administration. On 2/6/24 at 12:50 p.m. the surveyor interviewed SM #21 who stated, “I administered the IM...(patient) was agitated and violent at that time and assaulted a police officer. (Patient) did need to be physically restrained by PD who responded to the assault; I will say subdued (patient) would be more accurate. I tried to talk (patient) down...I can’t really remember but I think (patient) might have agreed to submit, but I don’t really know...” The facility presented a document from the Carilion Police dated 12/13/23 and timed at 7:33 p.m. start - 8:00 p.m. ended: “...dispatched to annex to stand by while medical gave medication to a disorderly patient...when medication was ready (name of officer) and I tried to talk to (Patient #11) to get (patient) to roll up (their) sleeve and take the medication. After a few minutes (Patient) did not comply and with a nod from (name of officer) I took control of (Patient #11’s) left arm...(Patient) did not resist, pull away or tense up. I rolled up (patient) sleeve and medical administered the medication. After that (patient) started crying...” An interview with SM #29 (Carilion Chief of Police) on 2/5/24 at 2:45 p.m., evidenced: “We are both police and security for the facility...in 2015 the General Assembly made a path to privatize eight police departments, Carilion being one of them...we are Carilion Employees and we go through the main orientation and follow the policies that all employees receive. We also have our own specialized departmental orientation...patients have the right to refuse...we do not hold any patients unless we have an order to do so...” The facility policy “Patient rights and Responsibilities effective 11-2021” documented: “...15. The right to refuse treatment to the extent permitted by law...” The Facility policy “Patient Decision Making: Informed Consent to Treatment effective 11-2021” evidenced, in part: “...Refusal of treatment to which a normally prudent patient would normally agree does not by itself indicate lack of capacity sufficient to demonstrate that a patient is incapable of making an informed decision...” The surveyor discussed the concerns with facility administration on multiple occasions throughout the survey 2/4 through 2/6/24 (SM # 5, 25, 28, 29, 31 and 32.)”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 21229 Based on clinical record review, staff interview and facility document review, the facility failed to follow facility procedure for determining capacity of Patient #11. The findings include: Failure to follow facility determination of capacity procedure. Review of facility policy titled “Patient Decision Making: Informed Consent to Treatment” dated August 2021 revealed in pertinent part: “Refusal of treatment to which a reasonable prudent patient would normally agree does not by itself indicate lack of capacity sufficient to demonstrate that a patient is incapable of making an informed decision.” The policy further revealed, “Determination that a patient is incapable of making an informed decision regarding health care must be documented in the patient’s chart by the patient’s attending physician and also documented in the chart by a second physician or licensed clinical psychologist. The second physician or licensed clinical psychologist should not otherwise be involved in the treatment of the patient being assessed unless an independent reviewer is not reasonably available.” The scope of the policy revealed it “ ... includes all Carilion facilities where approval has been granted;” no departmental exclusions were identified. Review of Patient #11’s medical record titled “ED (Emergency Department) Provider Note” dated December 13, 2023, timed 1356 (1:56 PM) indicated the patient presented voluntarily for increased depression with auditory hallucinations; the patient denied suicidal or homicidal ideation and was deemed medically stable for psychiatric evaluation. The ED Psychiatric Provider documented in Patient #11’s medical record on 12/13/2023 at 2:32 p.m. ,”(patient) requires psychiatric admission and (patient) is impulsive, aggressive and does not have capacity at this time ...” There was no documentation by the ED provider related to Patient #11’s decision making capacity. On 12/13/23 at 8:38 p.m., an “Emergency Psychiatric Consultation” was documented and evidenced: “...While (patient) denies any SI (suicidal ideations) or HI (homicidal ideations), (patient) requires inpatient admission as (patient) is impulsive, aggressive and does not have capacity at this time...” The surveyor interviewed Staff Member #25 on February 6, 2024 at 10:46 AM. Staff Member #25 stated: “...in the spirit and context of doing capacity assessments, in the ED, the volume of patients we see in a twenty-four hour period is, by nature, a good volume...we have held to the interpretation that the capacity is a component of the mental health evaluation...as far as a capacity consult, we don’t have that in ED...we have the attending and the mental health evaluation...the determination of capacity is done differently on the units...” Staff Member #25 confirmed that the above noted facility policy “Patient Decision Making: Informed Consent to Treatment” applies to all facility departments and the ED department didn’t have at the time of survey and/or Patient #11’s visit a different written policy for this process. 42929”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(1)(i)(B) [A restraint is-] (B) A drug or medication when it is used as a restriction to manage the patient’s behavior or restrict the patient’s freedom of movement and is not a standard treatment or dosage for the patient’s condition. This Standard is not met as evidenced by: 21229 Based on clinical record review, staff interview and facility document review, the facility staff failed to follow the policy and procedure for the ordering and monitoring of a chemical restraint for three (3) of three (3) patients, Patient #11, #12, and #13. All three (3) patients were administered a combination of medications Haldol 5mg, Ativan 2mg and Benadryl 50mg aka “B52” intramuscularly in order to control their behavior which was not a standard treatment or dosage for the patient’s condition(s). The findings include: Review of the facility policy: “Restraints/Seclusion, Use of” revealed in part: “...Violent/Self Destructive (Behavioral) Manual hold or Chemical: Assessment- 1. A comprehensive Assessment...2. Less restrictive alternatives..C. Restraint Orders - Determine order type of restraint per clinical indication and justification for patient safety...Documentation: Includes the physician, NP (Nurse Practitioner), PA (Physician Assistant) patient evaluation and findings to support the use of restraint or seclusion....Monitor the physical and psychological well being of the patient every 15 (fifteen) minutes including respiratory,and circulatory status, skin integrity. Vital signs will be assessed as often as needed taking into consideration the patient’s condition. cognitive status and intervention risk. Additional monitoring q2 (every two) hours while awake and PRN (as needed)...Required: A description of the patient’s behavior and the intervention used. Any alternatives or other less restrictive interventions attempted. The patient’s condition or symptom(s) that warranted the use of the restraint. The patients response to the intervention used...the intervals for monitoring, revisions to the plan of care and education to the patient and family...Chemical Restraint: A drug or medication when it is used as a restriction to manage the patients behavior or restrict the patients freedom of movement and is not a standard treatment or dosage for the patient’s condition [CMS 482.13 (a)]...a face to face evaluation must be performed in person...” Patient #11 Review of the clinical record for Patient #11 revealed the patient was administered Haldol (an antipsychotic) 5mg (milligrams), Ativan 2mg (sedative), and Benadryl 50mg (antihistamine) IM (Intramuscular injection) aka “B52” on December 13, 2023 at 7:58 PM due to being “verbally aggressive, hateful and disrespectful to staff, continued to push the code button over and over”. This medication combination wasn’t a part of Patient #11’s maintenance medication regiment of their psychiatric condition. Following the administration of B52, the medical record evidenced patient was asleep until 11:38 PM when they briefly awoke for 6 minutes, made a phone call and slept until 6:39 AM on December 14, 2023. Review of Patient #11 medical record evidenced that patient received “B52” IM (Intramuscular Injection) again on December 14, 2023 at 9:28 AM for “severe agitation”. The medical record didn’t contain further documentation as to what the distress situation was or what interventions staff performed before administering this medication combination to patient. Patient #11’s medical record contained orders documented on December 13, 2023 at 1639 (4:35 PM) for Haldol 5mg, Benadryl 50 mg, Ativan 2mg once PRN (as needed) for agitation, psychosis and a second order for the same medication combination on December 13, 2023 at 1643 (4:43 PM) Q8H PRN (every 8 hours as needed) for agitation. The medical record didn’t contain documentation the medication combination was used as a chemical restraint. Review of Patient #11’s medical record didn’t reveal documentation of patient’s condition and or monitoring after “B52” IM administration, except a tech note on December 14, 2023 at 10:35 AM, “Due to aggressive behavior, group is deferred at this time. Will continue to follow patient.” and a nurse’s note on December 14, 2023 at 10:45 AM, “appears asleep” and at 1:00 PM when patient refused to take oral medications. Patient #12 Patient #12 presented to the ED on December 16, 2023 with “suicidal ideations and a plan to jump off a bridge”. On December 16, 2023 at 4:38 PM it was documented the patient was “hitting self in face and screaming”, being verbally abusive to staff and police officers and security were present in the annex. The patient was administered at 4:31 PM Haldol 5mg, Ativan 2mg, and Benadryl 50 mg via intramuscular injection without a manual hold. There was no order for the use of a chemical restraint nor any documentation of interventions prior to the medication administration or monitoring after administration of “B52”. The medical record documented patient #12 was sleeping until they were transferred to another unit at 8:37 PM. Patient #13 Patient #13, according to the clinical record, presented to the ED via EMS (Emergency Medical Services) on December 19. 2023 for a Mental Health evaluation from (another community setting) where they had been therapeutically managed for “alcohol abuse”. On December 20, 2023, at 4:50 a.m. it was documented, “Patient keeps coming up to the nurses station getting agitated and saying inappropriate words. Patient given B52 (Haldol, Ativan and Benadryl) at this time...” There was no order for a chemical restraint and no documentation of any interventions prior to the medication administration or monitoring, nor further description of the patient’s behavior warranting the use of the medication combination per facility policy. The medical record documented patient #13 was sleeping until 5:00 PM. On February 6, 2024, at approximately 2:00 PM the surveyor interviewed Staff Member # 26 about the use of the “B52”, a medication combination in this Emergency Department. SM #26 indicated, “We use different medications in the ED for agitation...this combination of medication is used to treat the underlying condition because the patient is hostile and aggressive or violent...I do not like the term chemical restraint because it infers that I am harming a patient...I am treating the underlying condition so they can interact better and help them regain control...” The surveyor interviewed Staff Member # 23 (Senior Director of Pharmacy) regarding the use of the medications combination aka “B52” on February 6, 2024, at 1:15 PM. SM #23 stated they were not familiar with this combination of medications, its therapeutic effects, frequency of use in the ED and that the medication was not “commonplace”. The surveyor requested any literature from the facility regarding the national standards of practice and/or clinical studies related to the use of this medication combination in treating acute agitation. The facility didn’t provide such information by the end of the survey.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(2) Restraint or seclusion may only be used when less restrictive interventions have been determined to be ineffective to protect the patient, a staff member, or others from harm. This Standard is not met as evidenced by: 21229 Based on clinical record review, staff interview and review of facility documents, the facility staff failed to ensure evidence that least restrictive interventions were attempted or ineffective at protecting the patient or others from harm prior to administering an intramuscular (IM) medication for one (1) patient, Patient #13 and prior to placing one (1) patient, Patient #11 in a manual hold. The findings include: Review of the facility’s policy titled “Restraints/Seclusion, Use of” effective 05-2022 revealed in part: “... B. Manual Hold 1. A manual hold is initiated when a patient is exhibiting behavior that imminently threatens the safety of the patient or others and it is determined that other least restrictive alternatives are not viable and/or effective. A manual hold is against the patient’s will. The hold utilized will be consistent with the requirements outlined by the department of Behavioral Health and Developmental Services. ... Documentation: Required: A description of the patient’s behavior and the intervention used. Any alternatives or other less restrictive interventions attempted....” Patient #13, according to the clinical record, presented to the ED via EMS (Emergency Medical Services) on December 19. 2023 for a Mental Health evaluation from (another community setting) where they had been therapeutically managed for “alcohol abuse”. Review of Patient #13’s medical record revealed documentation on December 20, 2023 at 4:50 AM, “Patient keeps coming up to the nurses station getting agitated and saying inappropriate words. Patient given B52 (Haldol, Ativan and Benadryl) at this time...” The medical record didn’t contain documentation of less restrictive intervention attempts prior to the medication administration or monitoring, nor further description of the patient’s behavior warranting the use of the medication combination per facility policy. Review of Patient #11’s medical record titled “ED (Emergency Department) Provider Note” dated December 13, 2023, timed 1356 (1:56 PM) indicated the patient presented to ED voluntarily for increased depression with auditory hallucinations. Clinical Associates note on December 13, 2023, at 7:52 PM contained evidence that Patient #11 was verbally aggressive to staff, hateful, and disrespectful. The patient continued to push the code button “over and over” and the “PD” [the facility’s policy department) were at the bedside. Despite Patient #11 having PRN oral medication orders and identified coping skills, neither appeared to be offered and used. Patient #11’s medical record didn’t contain evidence of less restrictive interventions being used, other than verbal redirecting, prior to Patient #11 being placed in a hold by law enforcement to administer forced intramuscular medications, Haldol 5 mg, Ativan 2 mg IM, and Benadryl 50 mg at 7:58 PM. During an interview on January 18, 2024 at 9:30 AM, Staff Member #22 stated that they gave Patient #11 a “cocktail” of medication to include intramuscular Haldol. Staff Member #22 stated that they did not often work in the behavioral health portion of the ED and did not often administer Haldol. Staff Member #22 reported Patient #11 was paranoid, cursing at staff, and was threatening staff members and patients. Staff Member #22 reported attempting to verbally de-escalate the patient multiple times, but these interventions “seemed to make things worse.” Staff Member #22 stated that the patient did not want the Haldol injection and that two (2) police officers restrained the patient in order for the injection to be administered. Staff Member #22 recalled that after the injection the patient went to sleep. During an interview January 18, 2024 at 10:30 AM, Staff Member #28 indicated that if law enforcement holds the patient, it is not considered a restraint, but if hospital staff members perform the hold it would be considered a restraint. Staff Member #28 further explained that the emergency room has a standard from their medical director stating if a patient is aggressive to the point of potentially causing physical harm, medication can be administered, and law enforcement can hold the patient down. Staff Member #28 stated this is never considered a chemical restraint. The goal of the medication is therapeutic to relax the patient and not sedate them. 42929”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 21229 Based on clinical record review, staff interview and review of facility documents, the facility staff failed to obtain orders for a manual hold to administer medications for one (1) patient, (Patient #11). The findings include: Review of facility policy titled “Restraints/Seclusion, Use of” effective date 05-2022 revealed in part: “... III. Policy Statement(s) A. In accordance with the mission of [the facility], restraint or seclusion must only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time. B. Manual Hold 1. A manual hold is initiated when a patient is exhibiting behavior that imminently threatens the safety of the patient or others and it is determined that other least restrictive alternatives are not viable and/or effective. A manual hold is against the patient’s will. The hold utilized will be consistent with the requirements outlined by the department of Behavioral Health and Developmental Services. ... 3. Orders must be in place prior to application except in emergent initiation of restraint. ... Violent/Self Destructive (Behavioral, Manual Hold or Chemical. Use in a situation of imminent risk to protect patient from injury to self or others when the behavior is dangerous, violent, or aggressive. (Applicable regardless of patient setting). ... Manual Hold: In an emergent situation, a manual hold is initiated with a verbal order from a provider obtained as soon as possible. ... A required progress note will include behavior of patient prior to manual hold, the number of staff required to hold patient, medication administered, and assessment for signs of injury ...” Review of the facility’s policy titled “Patient Rights and Responsibilities” effective 11-2021 evidenced in part: “... A. Patient Rights: Each patient and/or his or her legally authorized representative, if the patient is not capable to understand, presenting for care has the following rights: ... 13. Receive care in a safe setting free from all forms of harassment or abuse. This includes freedom from restraint or seclusion that is not indicated for safety or medical indications ...” Review of Patient #11’s medical record titled “Clinical Associates note” documented on December 13, 2023, at 7:52 PM contained evidence that Patient #11 was verbally aggressive to staff, hateful, and disrespectful. The patient continued to push the code button “over and over” and the “PD” [the facility’s police department) were at the bedside. Patient #11’s medical record didn’t contain evidence of less restrictive interventions being used, other than verbal redirecting, prior to Patient #11 being placed in a hold by law enforcement (facility staff) to administer forced intramuscular medications, Haldol 5 mg, Ativan 2 mg IM, and Benadryl 50 mg aka “B52” at 7:58 PM. The surveyor was unable to locate in Patient #11’s clinical record an order for a restraint or manual hold. In an interview on February 6, 2024, at 2:50 PM Staff Member #22 recalled, “We tried to talk to (patient) and calm (them)...I let (patient) know I was giving the med and (patient) put up a fuss, so the officers stood on each side of (patient) and each officer placed their one hand on the upper arm and one on forearm below on both of the (patient’s) arms and (patient) didn’t struggle. (Patient) voiced some derogatory words but (patient) didn’t jerk or struggle. (Patient) did say ‘you are not going to do that to me’, but (patient) didn’t struggle when the police officers placed their hands on (patient’s arms).” Patient #11 medical record evidenced that patient received the same “B52” medication combination IM again on December, 14, 2023 at 9:28 AM for “severe agitation”. At this time, patient was under ECO. Review of Patient #11’s medical record found a “Nursing Note” documented on December 14, 2023, at 0930 (9:30 AM) which evidenced in part, “Pt in hallway speaking to Carilion security...requesting to know when (patient) will be leaving...9:00 a.m. Pt currently on phone agitated..Carilion PD called and are at bedside. Pt currently calling 911 and Carilion PD at bedside. 9:03 a.m. This tech distress badge activated.” There was no further documentation in Patient #11’s medical record as to what the distress situation was or what interventions facility staff performed other than administering the “B52” medication with assistance from Carilion security officers who restrained the patient. Review of Patient #11’s medical record failed to reveal an order for manual hold while administering medication and assessment of patient after these interventions. An interview on 2/5/24 at 2:45 PM, Staff Member #29, Carilion Chief of Police explained: “We are both police and security for the facility...in 2015 the General Assembly made a path to privatize eight police departments, Carilion being one of them...we are Carilion Employees and we go through the main orientation and follow the policies that all employees receive. We also have our own specialized departmental orientation...patients have the right to refuse...we do not hold any patients unless we have an order to do so...” In an interview on January 18, 2024, at 9:30 AM and on February 6, 2024, at 12:50 PM Staff Member #21 recalled the events surrounding medication administration on December 14, 2023, “I administered the IM...(patient) was agitated and violent at that time and assaulted a police officer. (Patient) did need to be physically restrained by PD who responded to the assault; I will say subdued (patient) would be more accurate. I tried to talk (patient) down...I can’t really remember but I think (patient) might have agreed to submit, but I don’t really know...” Staff Member #21 recalled attempting to verbally de-escalate the patient multiple times, but these interventions “seemed to make things worse.” Staff Member #21 stated after the injection the patient went to sleep. During an interview on January 18, 2023, Staff Member #33, a physician in the ED, stated that physical holds are not used in the ED. The surveyor informed the physician that according to documentation in medical record a patient in the survey sample was held by police to administer medication. The physician stated that holds are only used in extreme circumstances and acknowledged law enforcement at times holds patients to facilitate administration of medication. The facility presented a document from the Carilion Police dated December 13, 2023, and timed as 7:33 PM start - 8:00 PM end that read in part “...dispatched to annex to stand by while medical gave medication to a disorderly patient...when medication was ready (name of officer) and I tried to talk to (Patient #11) to get (patient) to roll up (their) sleeve and take the medication. After a few minutes (Patient) did not comply and with a nod from (name of officer) I took control of (Patient #11’s) left arm...(Patient) did not resist, pull away or tense up. I rolled up (patient) sleeve and medical administered the medication. After that (patient) started crying...” During an interview January 18, 2024, at 10:30 AM, Staff Member #28, physician stated that law enforcement will physically hold patients to administer medications if the patient is a danger to themselves or others. Staff Member #28 stated that if law enforcement holds the patient, it is not considered a restraint, but if hospital staff members perform the hold it would be considered a restraint. Staff Member #28 explained that the emergency room has a standard from their medical director stating if a patient is aggressive to the point of potentially causing physical harm, medication can be administered, and law enforcement can hold the patient down. Staff Member #28 stated this is never considered a chemical restraint. The goal of the medication is therapeutic to relax the patient and not sedate them. 42929”

“POSTING OF SIGNS CFR(s): 489.20(q) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to post conspicuously in any emergency department or in a place or places likely to be noticed by all individuals entering the emergency department, as well as those individuals waiting for examination and treatment in areas other than traditional emergency departments (that is, entrance, admitting area, waiting room, treatment area) a sign (in a form specified by the Secretary) specifying the rights of individuals under section 1867 of the Act with respect to examination and treatment for emergency medical conditions and women in labor; and to post conspicuously (in a form specified by the Secretary) information indicating whether or not the hospital or rural primary care hospital (e.g., critical access hospital) participates in the Medicaid program under a State plan approved under Title XIX. This Standard is not met as evidenced by: 36946 42929 Based on observations, interviews, and document review, the facility failed to post conspicuously a sign specifying the rights of individuals with respect to the examination and treatment of emergency medical conditions and women in labor act at the emergency medical services (EMS) entrance and the entrance to the emergency department waiting room from the hospital. Findings: During a tour of the emergency department on 01/16/2024 at 4:07 p.m. with Staff Member (SM) 6 and SM 2, the surveyor was brought into the facility’s emergency department through a door connected to the hospital. SM 2 stated that patients could present to the emergency department through this door. The surveyor observed there was no Emergency Medical Treatment and Labor Act (EMTALA) signage visible at this location. The surveyor observed EMTALA signage on the wall inside the doors of the main emergency department entrance that is accessed from the street. There was no other EMTALA signage observed within the waiting room. The surveyor observed that there was no EMTALA signage visible at the EMS entrance to the emergency department. SM 2 stated that the facility is constructing another building that will allow them to expand their emergency department, and that construction is occurring outside of the EMS entrance, but that entrance is still being used. When the surveyor asked SM 2 about the signage, SM 2 confirmed that it wasn’t visible and that it must have been moved or covered up due to the construction. The provided facility’s policy titled “Transfer: EMTALA” effective date 05-2021 did not address EMTALA signage. The above concerns were reviewed with the staff at the exit conference on 01/18/2023.”

“EMERGENCY ROOM LOG CFR(s): 489.20(r)(3) [The provider agrees,] in the case of a hospital as defined in §489.24(b) (including both the transferring and receiving hospitals), to maintain a central log on each individual who comes to the emergency department, as defined in §489.24(b), seeking assistance and whether he or she refused treatment, was refused treatment, or whether he or she was transferred, admitted and treated, stabilized and transferred, or discharged. §489.24 The provisions of this regulation apply to all hospitals that participate in Medicare and provide emergency services. This Standard is not met as evidenced by: 36946 Based on staff interview and document review it was determined hospital staff failed to maintain an accurate central log on each individual who came to the emergency department and whether he or she refused treatment, was refused treatment, was transferred, admitted and treated, stabilized and transferred, or discharged. Specifically, the hospital’s log contained inaccurate information regarding transfers and did not specify whether or not the patient was transferred or stabilized and transferred in 89 out of 7,344 patients entered into the December 2023 log and failed to ensure documentation of any discharge disposition in 66 out of 7,344 patients in December 2023’s central log. Findings: Twenty (20) medical records were reviewed between 01/16/24 and 01/18/24. Patient #11 was listed on the hospital’s central log as “transferred” on 12/29/23. Upon review of the patient’s record, the patient was not transferred, but admitted to the hospital’s rehabilitation unit. During record review, the surveyor asked staff member #5 why the patient was listed as transferred on the central log, but had not been transferred. Staff member #5 stated that the patient was “transferred” to the hospital’s rehabilitation unit. Staff member #5 confirmed the rehabilitation unit was within the same certified hospital and the patient was not transferred to another facility. The surveyor asked staff member #5 how one can determine from the central log whether a patient was transferred to another facility or transferred to another unit within the hospital. Staff member #5 stated there was no way to determine which patients were transferred to another facility from the emergency department’s central log. The hospital’s policy related to maintaining a central log of emergency department patients was requested. Staff member #11 confirmed the hospital had no policy related to a central log. The central log was reviewed with staff member #11 on 01/18/24 who confirmed they were unable to determine from the central log which patients were transferred to another hospital. Staff member #11 also acknowledged the log did not contain documentation of whether or not patients were stabilized or transferred and that 66 patients on December’s log contained no disposition. The above noted findings were reviewed with the staff at the exit conference on 01/18/2023.”

“APPROPRIATE TRANSFER CFR(s): 489.24(e)(1)-(2) (1) General If an individual at a hospital has an emergency medical condition that has not been stabilized (as defined in paragraph (b) of this section), the hospital may not transfer the individual unless - (i) The transfer is an appropriate transfer (within the meaning of paragraph (e)(2) of this section); and (ii)(A) The individual (or a legally responsible person acting on the individual’s behalf) requests the transfer, after being informed of the hospital’s obligations under this section and of the risk of transfer. The request must be in writing and indicate the reasons for the request as well as indicate that he or she is aware of the risks and benefits of the transfer. (B) A physician (within the meaning of section 1861(r)(1) of the Act) has signed a certification that, based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual or, in the case of a woman in labor, to the woman or the unborn child, from being transferred. The certification must contain a summary of the risks and benefits upon which it is based; or (C) If a physician is not physically present in the emergency department at the time an individual is transferred, a qualified medical person (as determined by the hospital in its bylaws or rules and regulations) has signed a certification described in paragraph (e)(1)(ii)(B) of this section after a physician (as defined in section 1861(r)(1) of the Act) in consultation with the qualified medical person, agrees with the certification and subsequently countersigns the certification. The certification must contain a summary of the risks and benefits upon which it is based. (2) A transfer to another medical facility will be appropriate only in those cases in which - (i) The transferring hospital provides medical treatment within its capacity that minimizes the risks to the individual’s health and, in the case of a woman in labor, the health of the unborn child; (ii) The receiving facility (A) Has available space and qualified personnel for the treatment of the individual; and (B) Has agreed to accept transfer of the individual and to provide appropriate medical treatment. (iii) The transferring hospital sends to the receiving facility all medical records (or copies thereof) related to the emergency condition which the individual has presented that are available at the time of the transfer, including available history, records related to the individual’s emergency medical condition, observations of signs or symptoms, preliminary diagnosis, results of diagnostic studies or telephone reports of the studies, treatment provided, results of any tests and the informed written consent or certification (or copy thereof) required under paragraph (e)(1)(ii) of this section, and the name and address of any on-call physician (described in paragraph (g) of this section) who has refused or failed to appear within a reasonable time to provide necessary stabilizing treatment. Other records (e.g., test results not yet available or historical records not readily available from the hospital’s files) must be sent as soon as practicable after transfer; and (iv) The transfer is effected through qualified personnel and transportation equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer. This Standard is not met as evidenced by: 36946 Based on staff interview and document review, it was determined the hospital failed to ensure transfers were carried out appropriately in two (2) of five (5) applicable medical records reviewed. Medical record #’s 3 and 13. Specifically, the patient’s medical records failed to contain documentation of a physician certification that the benefits outweighed the risks of transfer, failed to document the name of the physician who accepted the transfer at the receiving hospital, failed to ensure all medical records were sent to the receiving hospital, and failed to ensure the transfer was performed through qualified personnel and transportation equipment. Findings: The medical record for patient #13 contained documentation that the patient presented to the Emergency Department (ED) on 12/02/23 with recent bladder removal surgery on 11/19/23. The patient noted bleeding, pain, and swelling to the incision cite and came to the ED. The physician note from the ED reads in part: “On arrival here (they) was hemodynamically stable but tachycardic pale appearing with tenderness along (their) incision site and concern for potential abscess versus hematoma/intraabdominal bleeding. Patient was anemic more than (their) baseline with initial CBC of 7.5 and a Chem-8 of 6.5. Type and screen ordered and two units of RBCs (red blood cells) were ordered. Patient had leukocytosis and persistent tachycardia with clinical examination consistent with concern of infection. Patient was treated empirically with broad-spectrum antibiotics metronidazole and ceftriaxone. CT imaging of the abdomen demonstrated development of intra-abdominal abscesses along the abdominal wall as well as fluid collections along the incision and potential infectious etiologies in the lung bases. [Name of hospital] was contacted as this patient was a recent postoperative case...and they would like the patient transferred for definitive management.” The medical record failed to contain evidence of a signed physician certification including the risk and benefits of the transfer, failed to contain evidence of the name of the physician accepting the patient at the receiving facility, failed to contain evidence that the transferring hospital confirmed the receiving hospital had space and qualified personnel prior to transferring the patient, failed to contain evidence any records were sent to the receiving hospital prior to transfer and failed to contain evidence of documentation of the type of transportation that was required or utilize to effectuate the transfer. The last documentation in the medical record was at 9:54 AM on 12/02/23 of a pain assessment completed by the nurse. The documentation contained no information about when the patient left the facility or what type of transportation the patient took to the receiving hospital. The record contained no documentation that the patient consented to the transfer or that the risks and benefits of the transfer were explained to them. Staff member #5 confirmed during record review that this information should have been documented on the transfer form and that the medical record failed to contain such form. The medical record for patient #3 contained documentation that the patient was transferred to an inpatient psychiatric hospital on 12/14/23. The record contained a document, “Transfer/EMTALA Form.” The Transfer/EMTALA form contained a field for the physician to indicate who initiated the transfer. This field was left blank. The form contained a field to indicate if the patient was stable or unstable at the time of transfer. This field was also left blank. The form contained an area to document what documents were sent to the receiving facility. This field was also left blank. The medical record contained no documentation of whether or not the patient was stable at the time of discharge or what documents if any were sent to the receiving hospital. On 01/16/2024 at 9:22 AM, the surveyor reviewed patient #3’s ED “Transfer/EMTALA Form” with staff member #5. Staff member #5 stated that nurses complete the top section of the form to include the “RN Signature” and “Report given to at the receiving facility.” Staff member #5 stated that the next section of the form on page one (1) to include if the patient is “stable” or “unstable” should be completed by the provider. Staff member #5 stated that the facility is currently working on educating staff on ensuring the “Checklist of Documents” section at the bottom is being completed. Staff member #5 confirmed the medical record for patient #3 did not contain documentation of whether or not the patient was stable at time of discharge and what documents if any were sent to the receiving hospital. The facility’s policy titled, Transfer: EMTALA was reviewed and reads in part: “C. Psychiatric Patients: Patients who may be a danger to themselves or others due to mental or emotional illness or disturbance shall be noted as unstable on the Certificate of Transfer. These patients shall only be transported by ambulance, or law enforcement, with appropriate measures taken for the patient’s security, so that no deterioration in condition is likely to result from the transfer, including harm to the patient or others”... “Patient Transfers to Other Hospitals: C. Documentation: The condition of each patient transferred shall be documented in the medical record by the physician responsible for providing the medical examination and stabilizing treatment. 1. The Transfer/EMTALA form will be completed, including a summary of the risks and benefits of the proposed transfer. 2. The patient’s consent or refusal must be documented in the medical record and on the Certificate of Transfer. “... “E. Medical Records: When a patient is transferred, the Emergency Department or other department transferring the patient will send with the patient appropriate medical records regarding its treatment of the individual including, but not limited to, observation of signs or symptoms, preliminary diagnosis, treatment provided, results of any tests, informed written consent and certificate of transfer, and the name and address of any on-call physician who has refused or failed to appear within a reasonable period of time to provide stabilizing treatment. Records not available at the time of transfer will be sent to the receiving facility as soon as possible. F. Report: A report should be called to the receiving facility by the primary nurse for the patient including patient history, condition, and treatments provided at the sending facility to assist the receiving facility in preparing for the patient’s arrival. G. Method of Transportation: Appropriate level of transportation will be determined by the Emergency Department, transfer center, or attending physician and appropriate medical transport and qualified personnel will be contacted and obtained by the Emergency Department staff for patients in the Emergency Department and Transfer Center staff for all other patients.””

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 21229 Based on the findings during a complaint investigation and the associated finding of Immediate Jeopardy and document review, the Governing Body failed to ensure oversight was provided to ensure the services provided by the facility were safe and compliant with the regulations. This included identification of concerns in the following Conditions of Participation and Standards: 482.21 Condition of Participation - QAPI - A0263 482.21(a),(c)(2),(e)(3) Standard- Quality Patient Safety A0286 482.42 Condition of Participation- Infection Control - A0747 482.42(a)(3) Standard- Infection Control Surveillance and Prevention -A0750 Observations, interviews, document reviews and the concerns identified from an anonymous complaint evidenced an ongoing concern of the proper decontamination and sterilization of surgical instruments since September 2023. Please refer to: QAPI - A0263 and A0286 Infection Control - A0747 and A0750 for further information.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 21229 Based on interviews, observations, document review and a complaint investigation resulting in a finding of Immediate Jeopardy for the Condition of Participation 482.42 Infection Control, the facility failed to monitor effectivity of corrective actions related to proper decontamination and sterilization of surgical instruments as outlined in an acceptable IJ removal plan effective 9/25/2023 and implement measures preventing surgical instrument contamination. On 11/20 and 11/21/23 the survey team observed nine (9) of nine (9) surgical instrument trays which were identified as sterile and ready for use to be contaminated. These observations were witnessed and confirmed by the facility staff who accompanied the survey team on the tour. The facility’s Joint Quality Meeting Minutes didn’t contain any evidence of discussion/plan related to the ongoing surgical instrument concerns, patient diversions due to cardiac instruments shortage and contamination issues or any other information addressing the ongoing surgical instrumentation issues. Please refer to: A0286 - Patient Safety and Governing Body - A0043 and A0063 Infection Control - A0747 and A0750 for further information.”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-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 collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 21229 Based on observation, staff interview, facility document review and during the course of a complaint investigation, the facility staff failed to ensure the prevention and potential spread of infectious diseases by monitoring and ensuring the proper decontamination and sterilization of surgical instruments. Observations of nine (9) randomly sampled surgical trays on on 11/20/23 (four (4) trays inspected ) and 11/21/23 (five (5) trays inspected) that were identified as sterile and ready for use found all nine (9) trays to contain instruments contaminated with unknown brownish red substance, spots easily removable with a gloved finger, pitting/etching and dark and light areas of staining. Trays included in the survey sample included trays processed by the facility as well as by a third party vendor. These observations were witnessed and confirmed by the facility staff who accompanied the survey team on the tour. After consultation with the State Agency and CMS and based on the above noted observations, the survey team identified and notified the facility staff on 11/21/23 at 3:23 p.m. of the finding of Immediate Jeopardy (IJ). The serious concerns regarding observed contamination of surgical instruments presenting potential for serious harm and potential for exposure to infections, delay, and/or prolongation of surgical interventions were discussed with the facility leadership. An immediate plan of removal was requested. On 11/22/23 at 4:53 p.m., the facility presented an acceptable plan of removal. In Summary the plan of removal included implementation of the following immediate corrective actions: All instruments processed on-site, at sister facilities and by 3rd party vendor will be routinely inspected in the OR prior to use by OR nursing staff. If staff has concerns related to contamination an “in room expert”/instrument specialist (dedicated staff knowledgeable in infection control and prevention who has certification and training in infection control and/or documented experience with surgical instrument decontamination and sterilization practices. ) is called and determines if tray is safe to use. If the instrument specialist deems at least one instrument to have potential for contamination, the entire tray is rejected, photo documentation will be created and report entered in Safewatch. All surgical trays are inspected also at point of use cleaning and visibly defective instruments are removed from trays. In central sterilization all trays are inspected for defects, defective instruments removed, assembled, audited 100% with photo verification. In addition, facility will perform random sampling audits post autoclave daily, conduct real time audits, and administration audits using AORN Guidelines for Perioperative Practice; Sterile Technique Guidelines and ANSI/AAMI standards. The plan of removal detailed the process for “In room Process” (Operating Room tray procedure, observation and inspection). Effective 11/22/23, staff is not permitted to start their shift until they are educated on the new process and signed attestation of understanding. The facility also agreed to closely collaborate with the state epidemiology survey team specializing in Hospital Acquired Infections and agreed to an infection prevention and control assessment site visit on 12/01/2023 and committed to provide SA with regular updates on corrective actions implementation and monitoring of effectiveness. The surveyor, on 11/24/23 at 12:00 p.m., after making observations, conducting interviews, reviewing documentation and consulting with the State Agency and CMS, notified the facility of removal of the Immediate Jeopardy however, condition level noncompliance remained. Please refer to A0750 for further information.”

“MEDICAL STAFF - ACCOUNTABILITY CFR(s): 482.12(a)(5) [The governing body must] ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. This Standard is not met as evidenced by: 21229 Based on observation, staff interview, facility document review and during the course of a complaint investigation, the Governing Body failed to provide oversight to ensure patient safety and infection control concerns were fully addressed and mitigated. The findings included: The survey team made observations of sterile and “ready for use” surgical trays of 11/20 and 11/21/23 which evidenced a continuing problem of potential contamination of instruments and use of damaged instruments. The survey team requested to review the Governing Body Meeting minutes from 9/29/23 through 11/20/23. The documents didn’t contain any concerns or actions related to the ongoing problem with surgical instrument issues. The only reference was made at the 10/24/23 meeting which stated, “The Board also received an update on our Central Sterile Processes and a recent Virginia Department of Health visit.” There was no documentation of what was discussed or any actions or suggestions from the Board. Numerous interviews conducted during the survey on 11/20/23 and 11/21/23, evidenced staff’s concerns related to continuing problems with surgical instrument contamination. The survey team reviewed 544 Safewatch reports (event reports) from 9/29/23 through 11/20/23 entered by staff, all related to surgical instrument issues. Each report documented a single event involving multiple trays related to concerns for potential contamination of instruments and trays. The facility presented evidence of “diversion” of cardiac patients to other facilities due to not having the instruments available to perform scheduled cardiac surgical procedures. It was discussed with the facility during the exit conference on 11/24/23 at 12:15 p.m., they would have to respond with a plan of correction for the Conditions of Participation identified.”

“CARE OF PATIENTS CFR(s): 482.12(c) In accordance with hospital policy, the governing body must ensure that the following requirements are met: This Standard is not met as evidenced by: 21229 Based on observation, staff interview, facility document review and during the course of a complaint investigation, the Governing Body failed to provide oversight to ensure patient safety and infection control concerns were fully addressed and mitigated. The findings included: The survey team made observations of sterile and “ready for use” surgical trays of 11/20 and 11/21/23 which evidenced a continuing problem of potential contamination of instruments and use of damaged instruments. The survey team requested to review the Governing Body Meeting minutes from 9/29/23 through 11/20/23. The documents didn’t contain any concerns or actions related to the ongoing problem with surgical instrument issues. The only reference was made at the 10/24/23 meeting which stated, “The Board also received an update on our Central Sterile Processes and a recent Virginia Department of Health visit.” There was no documentation of what was discussed or any actions or suggestions from the Board. Numerous interviews conducted during the survey on 11/20/23 and 11/21/23, evidenced staff’s concerns related to continuing problems with surgical instrument contamination. The survey team reviewed 544 Safewatch reports (event reports) from 9/29/23 through 11/20/23 entered by staff, all related to surgical instrument issues. Each report documented a single event involving multiple trays. The facility presented evidence of “diversion” of cardiac patients to other facilities due to not having the instruments available to perform scheduled cardiac surgical procedures. It was discussed with the facility during the exit conference on 11/24/23 at 12:15 p.m., they would have to respond with a plan of correction for the Conditions of Participation identified.”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 21229 Based on interviews, observations and document review and the findings from an anonymous complaint, it was determined the facility’s Quality Assurance and Performance Improvement Program failed to adequately address and correct known issues related to inadequate cleaning and sterilization of surgical instruments. The findings included: The surveyors requested on 11/20/23 at 3:00 p.m., and received a total of 4 (four) trays to examine which had been processed at this facility and identified as sterile and ready for use. Of the four (4) trays, all had instruments that were visibly contaminated with spots that were easily removable with a gloved finger, dark and light areas of staining, numerous instruments with pitted surfaces, and an instrument with a reddish discoloration. The observations were witnessed by facility staff/leadership. On 11/21/23 at 12:00 p.m. the survey team requested and received five (5) surgical instrument trays that were identified as sterile and ready for use. Three (3) trays were processed within the facility, one (1) by the outside vendor and one (1) tray was processed in a sister facility. Five (5) of five (5) trays contained instruments with visible pitting, staining, spotting that could be removed with the gloved finger. The observations were witnessed by facility staff/leadership. The survey team reviewed each of the 544 Safewatch reports (event reports) entered by staff from 9/29/23 through 11/20/23, all related to surgical instrument issues. These reports were single events and involved multiple trays regarding concerns related to contamination of the instruments. In addition, the facility presented evidence of cardiac patients “diversion” to other facilities due to sterile and contamination-free cardiac instrument shortage. On 11/21/23 at 8:20 a.m., SM #7 stated the facility was in communication with the outside vendor daily and “we send them a list of what we find and what was wrong with the trays. They are supposed to be pulling the instruments that are damaged and giving us a list so that we can replace them...there are five day a week audits of the trays with the team leads and infection control as well as leadership and trays are removed if concerns are found...” SM #7 stated that they observed “a black sooty type of substance” on the bottom of trays, believed to be caused by baskets rubbing on baskets or new pans. SM #7 further stated “we remove any instruments that are of a concern, or trays that do not pass the inspection and determine if the instrument needs replaced or if education needs to be done...we are still having meetings about the water and we are testing...there has been diversion for cardiac surgery because multiple trays were used and no clean trays were available; I don’t know how many times.” On 11/21/23 at 9:50 a.m. SM #9 and 10 stated, “ Education was done with staff and we talked about the water problems ...instruments are being replaced and some are going off-site for processing...” The SM stated the education provided to staff was regarding visual inspection of instruments and trays, reporting of variances/concerns and pre-cleaning of instruments after procedures prior to decontamination and sterilization. A staff member #8 (SM #8) stated on 11/21/23 that there are continuing issues and the staff are doing their best to work through them. SM #8 stated that administration/leadership believed that steaming takes care of everything and have developed a policy that puts the OR staff and surgeons at odds regarding the rejection of the trays. “They heard our concerns, but we still have a policy”. SM #8 further explained that there have been patients sent to other facilities or rescheduled due to not having instruments available. “The surgeons see what the staff sees...this is a continuing problem...” The facility policy “Cleaning, Care, Transport of Reusable Instruments/Medical Devices was reviewed and was identified by facility SM #12 as the most recent update. (Last updated 7/21) The facility policy “Sterile Field, Guidelines for Preparing, Maintaining and Monitoring” was reviewed (effective 11-2023) and was identified by SM #12 as the policy most recently updated and that things were being “reviewed by Quality”. This policy evidenced, in summary, that after OR staff visually inspected the trays, if there were concerns about the use, the surgeon “has the ability to over-ride” and the tray could be used. This was the concern expressed that would “put staff at odds”. The survey team reviewed additional policies and procedures, facility event reports (Safewatch), OR logs, Quality, Governing Body and Infection Control Meeting minutes (September through November 2023), selected personnel files for credentialing, orientation, competencies, and education/training, conducted multiple interviews, made pertinent observations of sterile processing as well as observations of surgical instrument trays. The Joint Quality Meeting Minutes of meeting on 10/19/23 contained no evidence of surgical instrument issues, Safewatch reports, or diversion of patients due to lack of instruments were discussed, addressed or tracked. The concerns related to the Conditions of Participation and standards identified were discussed with the facility during the exit conference on 11/24/23 at 12:15 p.m.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 21229 Based on observation, staff interview, facility document review and during the course of a complaint investigation, the facility staff failed to ensure the prevention and potential spread of infectious diseases by monitoring and ensuring the proper decontamination and sterilization of surgical instruments. The survey team inspected nine (9) surgical trays that were identified as sterile and ready for use. Nine (9) of nine (9) trays observed contained visibly contaminated instruments. The findings included: On 11/20/23 between 2:15 p.m. and 3:00 p.m., the survey team, accompanied by facility Administration Staff Members (SM) #4, 5, 6, 7, 9, and #10 inspected four (4) randomly selected surgical instrument trays that were sterilized and identified as ready for use. Two (2) of the trays were processed by an outside vendor and two (2) of the trays were identified as being processed in-house. Four (4) of four (4) trays had visibly contaminated instruments with spots that were easily removed with a gloved finger, dark and light areas of staining, numerous instruments with pitted surfaces, and an instruments with a reddish discoloration. The survey team requested a resi-test** of the discolored instrument.(**Resi-test- a cleaning indicator used after manual or automated cleaning to determine if a medical device is free from protein. Used to detect residual levels of protein on the surface of a surgical instrument, that is not otherwise identifiable by visual inspection. Testing for proteins focuses on certain types of protein commonly present in blood and is an essential part of a hospital sterile services regulatory compliance. (www.steris.com)). The test was performed by facility staff who identified the test result was “positive”. The observations were witnessed by facility staff/leadership. On 11/21/23 at 12:00 p.m. the survey team requested and received five (5) surgical instrument trays that were identified as sterile and ready for use. Three (3) trays were processed on-site, one (1) was processed by third party vendor and one (1) tray was processed at a sister facility. Five (5) of five (5) trays contained instruments with visible pitting, staining, spotting that could be removed with the gloved finger. The trays were processed within the facility and by the outside vendor. The observations were witnessed my facility staff/leadership. The survey team reviewed each, of a total of 544 “Safewatch” reports, submitted from 9/30/23 through 11/20/23 which identified multiple trays of instruments that were rejected for use by the Operating Room scrub team due to potential contamination. The instruments had been brought into the OR suite and opened for visual inspection prior to surgical cases and contained visible contamination and were rejected for use by the OR staff. On 11/21/23 at 8:20 a.m., SM #7 stated the facility was in communication with the outside vendor daily and “we send them a list of what we find and what was wrong with the trays. They are supposed to be pulling the instruments that are damaged and giving us a list so that we can replace them...there are five day a week audits with the team leads and infection control as well as leadership. We are ordering new instruments...if a case is deemed contaminated (contaminated wound class per AORN : open, fresh accidental wounds, major breaks in sterility during surgery, spillage from the GI tract, incisions with nonpurulent inflammation), this must be disclosed to the patient (discussion with the patient/RP that instruments used during their surgical procedure were sterilized, but still contained potential areas of concern for contamination. This would be documented in the patient record.) The surgeon would have to put the wound class as contaminated...they (staff) have the opportunity to do the resi-test...a lot of things they call upstairs (OR) does not need to be called...yes we have had issues with galvanic residue and a black sooty type of substance, but we think it may be baskets rubbing on baskets or new pans. The black soot is on the bottom so it is easy to identify...we are till having meetings about the water and we are testing...there has been diversion for cardiac surgery because multiple trays were used and no clean trays were available; I don’t know how many times.” On 11/21/23 at 9:50 a.m. SM #9 and 10 stated, “ Education was done with staff and we talked about the water problems...instruments are being replaced and some are going off-site for processing...there was a huge influx of Safewatch reports after the training...there are five to seven hundred trays a day (500-700)...I think there has been an improvement since the last time...” The SM stated the education provided to staff was regarding visual inspection of instruments and trays, reporting of variances/concerns and pre-cleaning of instruments after procedures prior to decontamination and sterilization. The survey team reviewed multiple policies and procedures related to the cleaning and sterilization of surgical instruments and maintaining a sterile field. Also reviewed were employee files for job competencies, as well as facility audits of instruments. Infection Control reports were reviewed as well as meeting minutes. The survey team observed decontamination process “at the point of use” as well as the process of cleaning and sterilization of instruments in the central sterilization which followed the facility policies and procedures. The facility processes a large volume (500 -700 trays/day) containing surgical instruments for numerous specialties, many with a specific manufacturer instruction for use (IFUs). The facility utilizes CensiTrac electronic tracking system for instruments/trays which generates instrument specific IFUs for staff to follow. The surveyors were not provided with audit logs performed as outlined in the removal plan accepted by SA on 9/25/23 and/or any documentation related to additional steps the facility took to remedy the persistent issues with surgical instrument contamination. On 11/21/23 at 12:00 p.m. the survey team requested and received five (5) surgical instrument trays that were identified as sterile and ready for use. Three trays- General Major, Total Knee and GYN trays were processed on site, Cardiac heart pan II was processed by third party vendor and Coronary tray was processed at a sister facility. Five (5) of five (5) trays contained instruments with visible pitting, staining, spotting that could be removed with the gloved finger. The trays were processed within the facility and by the outside vendor. The observations were witnessed my facility staff/leadership. It was discussed with the facility during the exit conference on 11/24/23 at 12:15 p.m., they would have to respond with a plan of correction for the Conditions of Participation identified with an acceptable plan of correction which would demonstrate sustainable and long term corrections and monitoring for the deficiencies identified.”