HospitalInspections.org

Based on policy reviews, patient record reviews, document reviews, and interviews, the critical access hospital (CAH) failed to meet the Condition of Participation of Provision of Services.

The hospital failed to ensure the emergency department (ED) RNs were providing care in accordance with the patient's needs and the specialized qualifications and competency of the nurse related to administration of paralytic/anesthetic medications for conscious sedation. Review of four (Patient (P) 11, P19, P20, P25) of four patient records who received conscious sedation from a sample of 29 patients showed no documented evidence that each patient had continuous monitoring of oxygen saturation, cardiac rate and rhythm, blood pressure, respiratory rate, and level of consciousness throughout the administration of conscious sedation. This failure had the potential for serious harm, impairment, or death for any patient that would present to the ED who required the administration of paralytic/anesthetic medications for conscious sedation.

The hospital was notified of an immediate jeopardy related to Provision of Services on 04/27/21 at 8:10 PM. The hospital submitted a credible plan of removal with validation of the plan, and the IJ was removed on 04/29/21 at 1:25 PM. The plan of removal included the following:

1. The "Moderate Sedation" policy was revised 04/28/21 to include the guidelines for patient monitoring and drug administration and protocols for dealing with potential complications or emergency situations that were developed in accordance with nationally accepted standards of practice; the expectation that the RN managing the care of the patient receiving moderate/procedural sedation shall have no other responsibilities that would leave the patient unattended or compromise continuous monitoring; and training and demonstrated competency of the ED RNs regarding administration and monitoring of moderate/procedural sedation.

2. The competency and skills required of the ED RNs will include effects of the medication, potential side effects of the medication, contraindications for the administration of the medication, and the dose of the medication to be administered; the ability to competently and safely administer the medication by the specified route; anticipate and recognize the potential complications of the medication; recognize emergency situations; institute emergency procedures; and competently and safely administer reversal medications.
A training education and competency process will be implemented immediately to ensure that all RNs are properly trained and competent for moderate/procedural services. The first training will occur on 04/28/21 and will be completed for all nurses by 04/29/21. Any nurse that does not complete the training and meet competency in moderate/procedural sedation will not be allowed to participate in the moderate/procedural sedation services until competency is proven. Records of training and competency will be maintained in the RN's personnel file. Training and Competency will be performed on an annual basis or as needed. The Chief Nursing Officer (CNO) and the Director of Human Resources will monitor compliance of training by including it on an annual training calendar for all RNs.

3. To ensure the RN is able to commit to a one-to-one patient relationship during a moderate/procedural sedation service, the facility will continue to utilize the second RN on shift, on-site assistance from the 24/7 Paramedic EMS (emergency medical services) Crew, on-call RN, on-call Respiratory Therapist and if needed the CNO. The needed assistance will be in place before the service is rendered.

4. The CNO and delegated assistant will monitor compliance to the policy through chart reviews on 100% of moderate/procedural sedation services for at least one year and 50% thereafter if compliance is maintained. Results of monitoring will be reported to the monthly QAPI (quality assessment and performance improvement) Committee with any new adjustments that are needed.

Findings include:

1. The facility failed to implement its policy for storage, handling, dispensation, and administration of drugs and biological's, specifically, 1) failed to ensure one of one drug storage area was administered in accordance with acceptable professional principles; 2) failed to ensure outdated, mislabeled, or otherwise unusable drugs are not available for patient use. Observation showed unsecured anesthetic and paralytic medications were located on shelves in the medication storage room that were not separated from all other medications, and opened, unlabeled, and expired medications were available for use in the medication storage room and in the physical therapy wound care treatment room. These failures have the potential to affect all patients receiving medications and treatments in the facility by subjecting them to potential adverse medication outcomes and increased risk of infections. (see findings in tag C1016).

2. The hospital failed to ensure the RN supervised and evaluated the nursing care for each patient. the hospital failed to ensure the emergency department (ED) RNs were providing care in accordance with the patient's needs and the specialized qualifications and competency of the nurse related to administration of paralytic/anesthetic medications for conscious sedation. (See findings in tag C1046).

3. The RN failed to ensure critical lab values were reported to the physician for one (Patient (P) 13) of five (P7, P13, P27, P28, P29) patient records reviewed for reporting critical lab values from a sample of 29 patients. This failure had the potential to affect any patient receiving services in the hospital who had lab work ordered by the physician.

The RN failed to ensure wounds were assessed and wound care was provided as ordered by the physician and wound care orders were clarified as needed for two (P3, P6) of five patient (P3, P6, P10, P21, P22) records reviewed for wound assessments and wound care from a sample of 29 patients. This failure had the potential to affect any patient admitted to the hospital with wounds. (see findings in tag C1048).

4. The hospital failed to ensure RNs administered medications in accordance with written and signed physician orders for three (Patient (P) 3, P10, P13) of five patient records reviewed for failure had the potential to affect any patient admitted to the hospital who had physician orders for medications. (see findings in tag C1049).

5. The hospital failed to ensure RNs implemented the policy for reporting adverse drug reactions and errors in the administration of drugs to the physician for three (Patient (P) 3, P10, P13) of five patient records reviewed for medication administration from a sample of 29 patients. This failure had the potential to affect any patient admitted to the hospital who had physician orders for medications. (see findings in tag C1018).

Based on observations, interviews, document review, and review of facility policies, it was determined the facility failed to implement the policy for storage, handling, dispensation, and administration of drugs and biologicals. Specifically, 1. failed to ensure one of one drug storage areas was administered in accordance with acceptable professional principles, 2. failed to ensure outdated, mislabeled, or otherwise unusable drugs are not available for patient use, including, but not limited to, the pharmacy room had unsecured anesthetic and paralytic medications located in the medication storage room, opened, unlabeled, and expired medications available for use in the medication storage room and in the physical therapy wound care treatment room. These failures
have the potential to affect all patients receiving medications and treatments in the facility for potential adverse medication outcomes and increased risk of infections.

Findings include:

Review of the facility's policy titled "Stock Inspection/Drug Disposal" dated 05/20/20, revealed "The pharmacist will review all pharmacy stock on a monthly basis and check for the manufacturer's expiration dates. The following procedure will be followed for disposing of drugs and documenting the disposal of discontinued, recalled, defective and outdated drugs ...outdated drugs discovered during the monthly inspections are removed from the active inventory and placed in the designated storage area ...destruction of non-controlled drugs shall be conducted by the pharmacy technician or pharmacist under the direct supervision of the pharmacist and in accordance with state and federal laws."

Review of the facility's policy titled, "Proper Storage of Drugs" dated 05/20/20, revealed "The department supervisor is responsible for proper drug storage, which is not limited to temperature."

1. During the tour of the medication storage room on 04/26/21 at 10:10 AM, accompanied by the Chief Nursing Officer (CNO), seven bottles propofol (anesthetic agent) 200 milligrams (mg)/20 milliliters(ml), 24 vials of etomidate (anesthesia agent) 20 mg/10 ml, and nine vials of vecuronium (paralytic) 10 mg were observed on the third shelf, located next to the stock of antibiotic vials.

During an interview with the CNO on 04/26/21 at 10:15 AM, the CNO confirmed it was not a safe practice for these particular medications to be left on the shelf with other medications. These medications were removed by the CNO.

During an interview conducted on 04/26/21 at 1:22 PM, with the facility's Pharmacist, the Pharmacist was questioned who has access to the medication storage room? He/she responded," the long-term care nursing staff, acute inpatient and swing bed nursing staff, and emergency room nursing staff. The Pharmacist was asked who monitors the anesthetics and paralytics? The Pharmacist responded, "the paralytics and anesthetics were not classified as controlled substance, they don't need to be monitored. When questioned if leaving these out on the shelve was a safe practice? The Pharmacist stated, "well, there is a camera on in the medication room." The Pharmacist was further questioned how often does he/she conduct inspections? The Pharmacist stated, "I am in the facility every Monday, Tuesday, and Wednesday and I conduct monthly inspections for outdated medications." When asked to provide documentation of the monthly inspections the Pharmacist was unable to provide documented evidence these were performed. When the Pharmacist was questioned if he counts the propofol, etomidate, and vecuronium? The Pharmacist stated, "No, I do not count or monitor those medications."

On 04/27/2021 at 3:17 PM the Pharmacist provided additional documentation to the surveyors that included the following:

"Treating Propofol as a Controlled Substance: Although propofol is not currently regulated by the DEA (Drug Enforcement Administration). It was recommended to be added as a schedule IV drug in 2010. To minimize the risks associated with the drug, organizations should be considered treating it as a controlled substance at their facility. Sept 17, 2018.
Storage: According to the 2020 to 2021 ISMP( Institute for Safe Medication Practices) Medication Safety Best Practices for Hospitals, neuromuscular blockers should be segregated, sequestered, and differentiated from all other medications wherever they stored."
Referenced from https://www.ismp.org.

2. During the tour of the medication storage room on 04/26/21 at 10:10 AM, accompanied by the Chief Nursing Officer (CNO), the following medications were observed to be expired and/or opened:

Two bottles of Paroxetine (anti-depressant) tablets 10 mg were observed, the first bottle was open and with an expiration date of 03/21, and the second bottle was closed but also expired 03/21.

Seventeen multi-dose vials of Heparin lock Flush Solution 100 units (ut)/ml, five ml vials, expired 02/21.

Thirteen medication peel pack cards with individual patient names with no documentation if patient is still in facility and whether the medication cards were expired.

Seven bottles of medications in plastic tray for Long-Term Care (LTC) patient that is deceased.

Ten 20 ml vials of meropenem (antibiotic) expired 03/21

Located on the bottom shelf observed multiple LTC patient medication cards that the CNO stated, "those need to be discarded."

The CNO confirmed the above findings of medications expired and/or opened, located in the facility's medication storage room during the tour.

3. During the tour of the Physical Therapy (PT), wound care room, conducted on 04/26/21 at 12:30 PM, with the CNO and Physical Therapy Manager, revealed the following expired, opened, and undated medications:

One tube of Vitamin A and D ointment (moisturizer for skin irritation) four ounces (oz) opened, not labeled when opened and expired 08/20. One jar of Vitamin A and D ointment, opened, and not labeled when opened.

One tube of Aquaphor healing ointment (used for minor skin irritations) 1.75 oz opened, not labeled and expired 02/21

One tube Silver Sulfadiazine cream (treat infection) one percent (%), 85 grams(gm), opened, not labeled. One tube Silver Sulfadiazine cream 1 %, 85 gm, opened, not labeled, expired 01/21. One tube patient specific Silver Sulfadiazine cream 1%, opened, not labeled, expired 11/21/18, another tube of Silver Sulfadiazine cream 1%, opened, not labeled, not expired.

One tube Clobetasol Propionate (corticosteroid)0.05% with patient specific label with a discard after date of 07/16 and expiration date of 01/16.

Bacitracin antibiotic ointment opened, unlabeled and expired 07/20, tube Bacitracin with Zinc ointment, opened, unlabeled and expired 07/13

Mupirocin 2% tube of ointment expired 06/20, second tube of Mupirocin 2% ointment expired 07/20, third tube of Mupirocin 2% ointment expired 02/19, fourth tube of patient specific Mupirocin 2% ointment opened not labeled and expired 01/08/20.

Santyl Collagenase 30 gm tube, opened, unlabeled, expired 12/13, tube Santyl Collagenase 30 gm, opened, unlabeled expired 08/14, tube Santyl Collagenase 30 gm, opened, unlabeled expired 12/16, and tube Santyl Collagenase 30 gm, opened, unlabeled, expired 10/19.

Silver Stat antibacterial wound dressing tube gel, 0.5 oz, opened, unlabeled, expired 06/20.

Two tubes of Medi-honey (Antimicrobial Wound Gel) wound and burn dressing gel, 0.5%, opened and not labeled, not expired.

One tube of Triamcinolone Acetonide(Antimicrobial Wound gel) cream 0.1%, opened, not labeled, not expired.

One tube Therhoney wound gel, opened, not labeled, expired 02/06/19.

One tube of Granulex ointment (used for debridement), opened, not labeled, expired 08/14.

One tube Clotrimazole (athletes foot ointment) , opened, not labeled, expired 02/20.

One tube of Stomahesive (skin barrier), opened, not labeled, expired 09/20
and a tube Stomahesive skin barrier, opened, not labeled, expired 09/16.

One tube of Resta Crème (moisturizer), opened, not labeled, not expired.

One tube of Accuzyme ointment opened, not labeled, expired 12/09.

One tube of Hypergel 20% NaCl (debridement gel), opened, not labeled, expired 09/16.

Three tubes of Phytoplex silicone cream(skin treatment), expired 04/18 and three tubes of Phytoplex silicone cream, expired 03/18.

All items were confirmed during the tour on 04/26/21 at 12:30 PM by the CNO and Physical Therapy Manager, as being opened, unlabeled and expired.

Based on policy review, record reviews, and interviews, the hospital failed to ensure registered nurses (RNs) implemented the policy for reporting adverse drug reactions and errors in the administration of drugs to the physician for three (Patient (P) 3, P10, P13) of five patient records reviewed for medication administration from a sample of 29 patients. This failure had the potential to affect any patient admitted to the hospital who had physician orders for medications.

Findings include:

Review of the policy titled "Medication Errors," effective 05/03/07, showed ". . . Definitions: 1. Medication error: Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient or consumer. Such event may be related to professional practice health care products, procedures, and system, including prescribing; order communications; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use. . . c. A medication was given at the wrong time, either greater than one hour before or greater than one hour after ordered time. . . f. A medication was omitted from being given . . . k. Failure to notify the physician of a medication error . . . 2. A medication omission: Any patient not receiving a medication at the appropriate time or as scheduled per the physician's order. . . Procedure: 1. If any of the problems defined in this procedure, occur, the RN/LPN [licensed practical nurse] shall initiate the following: a. Notify the attending physician of the error in a timely manner. B. Document the time, route and medication given on the medication sheet and fill out a Physician Notification Form. . . g. Complete a "Quality Review Report" by the end of the shift and route to the Quality Services Director. . ."

Review of the policy titled "Oral Medications (Not Antibiotics), effective 05/08/06, showed that TID (medications administered three times a day) times were "0800 [8:00 AM] 1400 [2:00 PM] 2000 [8:00 PM]. "If the physician does not specify "stat" or that a certain number of doses be given the first day or any other special instructions, please follow the following rules: 1. If the first day medication comes to the floor so that it would be given to the patient later than 1 hour after the regularly scheduled dose, it should not be given until the next regularly scheduled dose. 2. If the first day medication comes to the floor so that it can be given at the regularly scheduled time or up to 1 hour after that time, it should be given and then continued on schedule. If at any time the medication nurse feels the above rules would cause any problem, she should communicate with either the physician or the pharmacy for clarification. 3. All medication will be given within a one hour interval of schedule. 1 hour before or 1 hour after time specified. . ."

Review of an untitled policy, effective 05/03/07 and reviewed 04/28/21 (during the survey), showed "It is the policy of battle Mountain General Hospital that stat medications orders are administered immediately and only once. . . Definitions: Stat: A medication (stocked on the patient care area) with an immediate onset of action that is needed in a potentially life threatening, emergency situation or when there is severe discomfort. . ."

1. Review of P3's electronic medical record (EMR), under the "Admission H&P" (history and physical) tab under the inpatient tab, showed P3 was admitted on 10/31/20 at 4:20 PM with a primary diagnosis of "pressure ulcer, urinary incontinence, acute urinary tract infection." Further review showed P3 was discharged on 11/01/20.

Review of P3's physician orders, located under the "Orders" tab, showed a physician's order on 10/31/20 at 7:10 PM by Physician (MD) 4 for "Vancomycin [glycopeptide antibiotic] IV [intravenous] 500 mg [milligrams] every 12 hours scheduled Starting 10-31-20 at 20:00 [8:00 PM] 500 mg in 250 ml [milliliters] 0.9 % [per cent] sodium chloride (2 mg/ml) 125 ml/hr [milliliters per hour] for 2 hours." Review of P3's "Medication Administration Record (MAR)," located under the "Nurses' Notes" tab, showed "Vancomycin IV 500 mg every 12 hours 10-31-20 None due." There was no documented evidence Vancomycin was administered as ordered by MD 4. Further review showed a physician's order on 10/31/20 at 7:10 PM by MD 4 for "Tramadol [used to help relieve moderate to moderately severe pain] l Oral 100 mg 3 times per day scheduled Starting 10-31-20 at 20:00 [8:00 PM]." Review of P3's MAR showed Tramadol oral 100 mg was administered by RN 6 at 7:15 PM, prior to the time ordered by MD 4 to start the medication. Further review of the MAR showed RN 6 administered Tramadol 100 mg at 1:50 AM with notation of "Scheduled for 08:00 (Wrong time reason: LE [late entry])." There was no documented evidence of a physician's order to administer Tramadol at 1:50 AM on 11/01/20. Further review showed a physician's order by MD 4 on 11/01/20 at 12:10 AM for "Haloperidol [synthetic antidepressant drug used chiefly in the treatment of psychotic conditions] oral 5 mg once now." Review of P3's MAR showed Haloperidol oral 5 mg was administered by RN 6 at 8:30 on 10/31/20 with notation of "Scheduled for 11-01-2020 01:10 (post DST [daylight savings time]) (Wrong time reason: LE [late entry]"

There was no documented evidence the above medication errors were reported to P3's physician.

There was no documented evidence presented by the hospital of a completed "Quality Review Report" for the three above medication errors for P3.

In an interview on 04/28/21 at 11:56 AM, Business Officer Manager (BOM), who assisted the surveyor with navigating the EMR, stated she was the medical record director also. She confirmed there was no documentation in the EMR that RN 6 notified the physician of the medication errors.

2. Review of P10's EMR showed a written "Physician's Order," located under the "Orders" tab, by MD 3. Review of the order showed P10 was admitted on 02/01/21 with a diagnosis of "L [left] anterior upper leg cellulitis s/p [status/post] mole incision [with] suture closure." Further review showed a physician's order by MD 3 on 02/02/21 at 12:55 AM for pantoprazole [used to treat certain stomach and esophagus problems such as acid reflux] IV 40 mg once now 40 mg in 100 ml 0.9% sodium chloride (0.4 mg/ml) 400 ml/hr for 15 minutes." Review of P10's MAR showed RN 5 administered pantoprazole IV 40 mg on 02/01/21 at 8:05 PM prior to MD 3's order. There was no documented evidence P10 received pantoprazole IV 40 mg once on 02/02/21 at 12:55 AM as ordered.

There was no documented evidence the above medication error was reported to P10's physician.

There was no documented evidence presented by the hospital of a completed "Quality Review Report" for the above medication error for P10.

In an interview on 04/28/21 at 12:00 PM, BOM, who assisted the surveyor in navigating the EMR, stated there was no documentation in P 10's EMR that RN 5 notified the physician of the medication error.

3. Review of P13's "Admission H&P," located under the "Admission H&P" tab under the inpatient tab, showed P13 was admitted on 03/03/21 with diagnoses of "hypernatremia, CHF [congestive heart failure], pleural effusion, hyponatremia." Review of P13's EMR showed the following physician orders, located under the "Orders" tab:
03/03/21 at 5:01 PM by MD 2 - "Furosemide [Lasix] [used to reduce extra fluid in the body (edema) caused by conditions such as heart failure, liver disease, and kidney disease] IV push 20 mg once STAT:"
03/04/21 at 10:12 AM by MD 2 - "Furosemide IV push 20 mg once now;"
03/05/21 at 3:25 PM by MD 3 - Ceftriaxone [used to treat a wide variety of bacterial infections] IV 1 g [gram] every 24 hours now 1 g in 100 ml 0.9% sodium chloride (0.01 g/ml) 100 ml/hr for 1 hour"

Review of P13's MAR showed Furosemide ordered on 03/03/21 at 5:01 PM was administered by RN 1 two hours 34 minutes after the medication was ordered to be given stat, with the notation "Wrong time reason: busy in ER [emergency room]." Further review showed Furosemide ordered on 03/04/21 at 10:12 AM was administered by RN 1 at 6:54 PM, six hours 42 minutes after it was ordered to be given "now" at 10:12 AM, with a notation "(Wrong time reason: no IV access earlier)." Further review showed RN 6 on 03/05/21 at 6:45 PM, administered Ceftriaxone three hours 20 minutes after it was ordered to be given now at 3:25 PM, with no documented evidence of the reason the administered late.

There was no documented evidence the above medication errors were reported to P13's physician.

There was no documented evidence presented by the hospital of a completed "Quality Review Report" for the above medication errors for P13.

In an interview on 04/28/21 at 11:30 AM, BOM, who assisted the surveyor in navigating the EMR, stated there was no documentation in the EMR that RN 1 and RN 6 had notified the physician of the medication errors.

In an interview on 04/29/21 at 10:20 AM, Chief Nursing Officer (CNO) stated "I expect stat medications to be given as soon as possible like now." CNO stated "usually when a medication error is reported, I review it. . . we have not been doing good chart reviews since COVID started." CNO stated "a late medication administration and giving the medication before an order is documented should result in an incident report."

In an interview on 04/29/21 at 10:45 AM, Risk Manager (RM) stated she is responsible for QAPI [quality assessment and performance improvement]. RM stated the hospital had a zero medication error rate, and she has had "no medication errors reported since October 2019."

Based on policy review, review of the "Nevada State Board of Nursing Practice Decision: The Role of the RN [registered nurse] in Moderate/Procedural Sedation," medical record reviews, and interviews, the hospital failed to ensure the emergency department (ED) RNs were providing care in accordance with the patient's needs and the specialized qualifications and competency of the nurse related to administration of paralytic/anesthetic medications for conscious sedation. Review of four (Patient (P) 11, P19, P20, P25) of four patient records who received conscious sedation from a sample of 29 patients showed no documented evidence that each patient had continuous monitoring of oxygen saturation, cardiac rate and rhythm, blood pressure, respiratory rate, and level of consciousness throughout the administration of conscious sedation. This failure had the potential for serious harm, impairment, or death for any patient that would present to the ED who required the administration of paralytic/anesthetic medications for conscious sedation. The hospital was notified of an immediate jeopardy related to this failure on 04/27/21 at 8:10 PM (see findings in tag C1004).

Findings include:

Review of the "Nevada State Board of Nursing Practice Decision: The Role of the RN in Moderate/Procedural Sedation," last edited 03/26/18, showed "It is within the scope of practice of the RN to administer medications for the purpose of induction of moderate/procedural sedation for sort term, diagnostic or surgical procedures provided the following criteria are met: 1. A qualified legally authorized practitioner credentialed practitioner credentialed in emergency airway management and cardiovascular support selects and orders the medications to achieve moderate/procedural sedation. 2. The qualified practitioner is present at the bedside but is unable to personally administer the medication because the practitioner is performing other critical tasks for the patient. 3. Guidelines for patient monitoring, drug administration and protocols for dealing with potential complications or emergency situations are available and have been developed in accordance with nationally accepted standards of practice. 4. The RN managing the care of the patient receiving moderate/procedural sedation shall have no other responsibilities that would leave the patient unattended or compromise continuous monitoring. 5. The RN has completed ACLS [advanced cardiac life support] and PALS [pediatric advanced life support] (for the pediatric patient) and-NRP [neonatal resuscitation program] (for the neonatal patient). 6. The RN has demonstrated current competencies regarding the administration and monitoring of moderate/procedural sedation. 7. The RN may administer IV [intravenous] anesthetic agents for the purpose of moderate/procedural sedation in an appropriate setting to the practice determined by the facility that employs the RN. The facility should have written policies regarding the location of where sedation may occur, the training and qualifications of personnel, monitoring equipment, pharmacological guidelines, patient recovery, quality assurance and documentation. . . Competencies The registered nurse must be competent to perform the function, and the function must be performed in a manner consistent with the standard of practice. . . This knowledge base includes but is not limited to: effects of the medication, potential side effects of the medication, contraindications for the administration of the medication, and the dose of the medication to be administered. The requisite skills include the ability to: competently and safely administer the medication by the specified route, anticipate and recognize the potential complications of the medication, recognize emergency situations, and institute emergency procedures and competently and safely administer reversal medications. . .The institution shall have in place a process for evaluating and documenting the RN's demonstration of the knowledge, skills and abilities for the management of patients receiving agents to render procedural sedation. Evaluation and documentation of competency shall occur on an annual basis. Safety Considerations . . . The RN shall ensure the immediate, on-site availability of back-up personnel for airway management, resuscitative and emergency intubation and of emergency equipment which contains resuscitative and antagonistic medications, reversal agents, airway and ventilatory adjunct equipment, defibrillator, suction and a source for administration of 100% [per cent] oxygen. The RN administering agents to render moderate/procedural sedation shall conduct a nursing assessment to determine that administration of the drug is in the patient's best interest. . . Definitions of Sedation. . . Moderate sedation: a drug-induced depression of consciousness during which patients respond to purposefully to verbal commands either alone or accompanied by tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Protective airway reflexes and cardiovascular function are usually maintained. . . Procedural sedation: a technique of administering sedatives or dissociative agents with or without analgesics to induce a state that allows the patient to tolerate unpleasant procedures while maintaining cardio respiratory functions. . . Anesthetic Agents: Medications may include those classified as anesthetic agents, but are not to be administered to provide anesthesia. . ."

Review of the hospital policy titled "Moderate Sedation (Conscious Sedation)," effective May 2009, showed ". . . Procedure: 1. Verify the doctor's order for the prescribed medication. 2. Review the patient's medical record and verify documentation of the following information: preexisting medical conditions; history of tobacco, alcohol, or substance use or abuse; previous anesthesia and sedation experiences; current medications; allergies; the last time the patient ate or had oral fluids; a recent height and weight measurement; and physical examination findings, including the evaluation of the airway and cardiac and respiratory assessments. . . 16. Confirm the patient's nothing-by-mouth status before the procedure, minimum fasting recommendations include 2 hours for clear liquids, 4 hours for breast milk, 6 hours for infant formula, 6 or more hours for a light meal or nonhuman milk, and 8 hours or more for fried or fatty foods or meat. If the need for the procedure is an emergency, collaborate with the doctor to compare the risks and benefits of the procedure, considering the amount and type of liquids or solids ingested. . . 22. Record the patient's vital signs, level of consciousness (LOC), skin color, and respiratory status to use as baselines. . . 27. After the patient is prepped and draped for the procedure, conduct a time-out with the procedural team to perform a final assessment that the correct patient, site, positioning, and procedure are identified and as applicable, all relevant information and necessary equipment are available. . . Documentation: Document according to your facility's documentation system and include those parameters deemed necessary by your facility. Those items should include but aren't limited to pre-procedure assessment findings, procedure and site verification, and time-out; the name, dose, route, time, and effects of all medications administered; the patient's LOC, ventilation, and oxygenation status; and the procedure start and end times. Documentation should also include vital signs at intervals determined by the type and quantity of medication administered and the patient's condition. . ."The hospital policy did not address that the RN managing the care of the patient receiving moderate/procedural sedation shall have no other responsibilities that would leave the patient unattended or compromise continuous monitoring. The policy did not address all the requirements in the "Nevada State Board of Nursing Practice Decision: The Role of the RN in Moderate/Procedural Sedation" including the qualifications and competency of the RN performing conscious sedation to include assessing the effects of the medication, potential side effects of the medication, contraindications for the administration of the medication, and the ability to administer reversal medications competently and safely.

1. Review of P11's EMR, printed for review by Business Officer Manager (BOM) with no tabs separating sections of the EMR, showed P11 was admitted on 02/02/21 at 8:06 PM with a diagnosis of pneumonia. Further review showed P11 was transferred to a short-term hospital on 02/03/21 at 10:36 AM in critical condition with diagnoses of pneumonia and respiratory failure (as documented on the "summary of the hospital visit").

Review of P11's physician orders showed the following orders:
02/03/21 at 9:02 AM by Physician (MD) 2 - "Rocuronium IV [intravenous] push 100 mg [milligram] once STAT"
02/03/21 at 9:03 AM by MD 2 - "Etomidate [short-acting intravenous anesthetic agent used for the induction of general anesthesia and sedation for short procedures such as reduction of dislocated joints, tracheal intubation, cardioversion and electroconvulsive therapy] IV push 20 mg once STAT"
02/03/21 at 9:29 AM by MD 2 - "Ketamine [dissociative injectable anesthetic that can provide pain relief and short-term memory loss (for example, amnesia of a medical procedure)] IV push 100 mg once STAT"
02/03/21 at 9:47 AM by MD 2 - "Ketamine IV push 100 mg once STAT"
02/03/21 at 9:58 AM by MD 2 - "Ketamine IV push 100 mg once STAT"
02/03/21 at 10:05 AM by MD 2 - "Propofol [used as an "induction agent," the drug that causes loss of consciousness for general anesthesia in major surgery; in lower doses it is also used for "conscious sedation" of patients getting procedures on an outpatient basis] IV push 100 mg once STAT"

Review of P11's "Medication Administration Record (MAR)"showed RN 5 administered the following medications on the following day and time:
Etomidate IV push 20 mg on 02/03/21 at 8:36 AM;
Ketamine IV push 100 mg on 02/03/21 at 9:23 AM, 9:43AM, 9:54 AM;
Propofol IV push 100 mg on 02/03/21 at 10:01 AM;
Rocuronium IV push 100 mg on 02/03/21 at 8:35 AM.

Review of the "Procedure Documentation Endotracheal Intubation" documented by MD 2 on 02/03/21 at 8:45 AM showed time-out was completed, etomidate was the induction agent, rocuronium was the paralytic agent.

Review of P11's EMR showed no documented evidence of continuous cardiac monitoring, confirmation of P11's nothing-by-mouth status before the procedure, and documentation of vital signs, LOC, skin color, and respiratory status prior to the procedure, throughout the procedure, and after completion of the procedure. (See interview documented with RN 2 below).

2. Review of P19's EMR, assisted by BOM to navigate the EMR, showed P19 presented to the ED on 09/22/20 at 2:47 PM, as reviewed in the "First Contact with Patient" documented by MD 2 on 09/22/21 at 4:31 PM located under the "ED Provider assessment tab, with the chief complaint of "not acting himself." Further review showed "10 year old male is brought over from clinic because of concern about altered mental status. He was seen in the emergency department yesterday after his mother was holding him and fell down several steps, presumably striking his head. He had a brief ocular seizure at the time but had recovered his baseline mental status for the most part yesterday. We have elected not to do a CT [computerized tomography] scan but to have him seen the next day if he wasn't improving. He continues to complain of a mild headache and vomited twice overnight. He has also been somewhat "out of it." His mental status is difficult to assess because of history of semi-lobar holoprosencephaly [disorder caused by the failure of the prosencephalon (the embryonic forebrain) to sufficiently divide into the double lobes of the cerebral hemispheres. The result is a single-lobed brain structure and severe skull and facial defects]."

Review of P19's physician orders, located under the "Orders" tab, showed an order by MD 2 on 09/22/21 at 3:25 PM for "Ketamine IV push 15 mg once now."

Review of P19's MAR showed Ketamine IV push 15 mg was administered on 09/22/20 at 3:25 PM by RN 2.

Review of P19's EMR "Flowsheet Measurements," located under the "Flowsheets" tab, showed heart rate, blood pressure, respiratory rate, and oxygen saturation were assessed on 09/22/20 at 3:00 PM by RN 3, on 09/22/20 at 3:40 PM by RN 2, on 09/22/20 at 3:55 PM by RN 2, and on 09/22/20 at 4:33 PM by RN 3. There was no documented evidence P19's vital signs were assessed with continuous cardiac monitoring from 3:00 PM to 3:40 PM while P19 was administered Ketamine at 3:25 PM.

Review of P19's "Nursing Notes," located under the "Nursing Notes" tab, showed RN 3 documented on 09/22/20 at 3:35 PM that P19 was "taken to CT via gurney by this RN and RN 2 [10 minutes after Ketamine was administered] 1550 [3:50 PM] - pt [patient] brought back into ED room 1 VS [vital signs] taken. Mother is at side." There was no documented evidence that P19's cardiac status and vital signs were continuously monitored by RN 2 and RN 3 while Patient 19 was transported to CT, during the CT procedure, and during transport from CT back to the ED.

In an interview on 04/27/21 at 2:30 PM, RN 3 stated she thinks she's "only done it once or twice, and other times was a helper to another nurse [regarding administering and monitoring conscious sedation]." RN 3 stated "I try to collaborate with EMS [emergency medical service] on my own, because we don't see a lot, it's spread out and we don't get them every day." RN 3 stated "it's frightening when I get a call for a possible intubation." Regarding monitoring for conscious sedation, RN 3 stated "I can't recall asking or looking for a policy and procedure." RN 3 stated she "checks vitals and keeps checking them every 15 minutes. . . I like to place the monitor at every 15 minutes. I know there are parameters but don't know if there are parameters for blood pressure and such." RN 3 stated "I try to write that down" when asked if she documents her monitoring every 15 minutes. When asked what some of the side effects are for paralytic agents, RN 3 stated "any patient can be allergic, but I can't name any side effects." When asked if they keep reversal agents at the bedside, RN stated the crash cart has Narcan, and the crash cart is kept in ER 2. When asked if she would have to leave the patient to get the crash cart or to go to the pharmacy for Narcan, RN 3 stated they "usually try to admit the patient to ER 2 if they know the patient will need conscious sedation. If not in ER 2, we would have to go to get it." When asked about care provided to P19, RN 3 stated when she is the 10 AM to 10 PM nurse, one of the RNs will be in charge of the patient even though they're working with the patient together. RN 3 stated "usually with RN 2 having more experience, RN 2 usually would say she'll take the patient." RN 3 stated she "assumed RN 2 was charting for P19." RN 3 stated they "were most likely in the CT room and waited behind the window with the CT tech and then accompanied the patient back to the ED." RN 3 stated I don't think so" when asked if P19 was connected to a cardiac monitor during transport to and from the CT room."

In an interview on 04/27/21 at 3:08 PM, RN 2 stated the doctor administers Propofol and Ketamine. When told by the surveyor that documentation showed she had administered both, RN 2 reviewed P19's medical record and stated "they only did this once and MD 2 administered his own medication." She stated "she thought it was only once, but the second time she prepared and administered it with MD 2 present. When asked what type of monitoring the surveyor should see in P19's record, RN 2 stated "respiratory rate, oxygen saturation, heart rate, blood pressure, and a cardiac strip." RN 2 stated they "print monitor strips and have them scanned into the chart." RN 2 stated she "usually does a blood pressure check every 15 minutes throughout the procedure. RN 2 stated "probably for Propofol I would do every 5 minutes or so." RN 2 stated "most of the time if I'm taking a lot of vitals, I print the strip out and I don't know if the strips weren't copied and downloaded for some reason," when told that cardiac strips were not documented in P19's medical record. After reviewing P19's medical record, RN 2 stated P19 "wasn't monitored as frequently as he should have." Regarding P19's monitoring after receiving Ketamine while being transported to CT, RN 2 stated "I don't recall him being on a monitor when taken to CT, and by the time he was finished with CT, he was waking up." RN 2 stated she and RN 3 were standing behind the window in CT. RN 2 stated she "could see his [P19's] respirations easily from that window." When asked about training related to conscious sedation and paralytic agents, RN 2 stated training was done "only by the preceptors who have done it before . . . and we had a flight nurse come in and give us some training." RN 2 stated "it's pretty informal so I don't believe it's documented in the personnel record."

3. Review of P20's "ED Provider Assessment," located under the "ED Provider Assessment" tab, showed P20 presented on 08/12/20 at 11:13 AM after "injuring his right wrist tis morning at work. . ." Further review showed "obvious deformity at the distal radius near the right wrist. . ." Further review showed P20's fracture was reduced after procedural sedation, and a reverse sugar tong splint was applied to the reduced fracture.

Review of P20's physician orders, located under the "Orders" tab, showed an order by MD 2 on 08/12/20 at 12:05 PM for "Ketamine IV push 40 mg once now" and "Propofol IV push 40 mg once now."

Review of P20's MAR, located under the "Medication Administration" tab, showed RN 2 administered Ketamine IV push 40 mg at 10:46 AM and propofol IV push 40 mg at 10:47 AM, both prior to the physician's order documented at 12:05 PM.

Review of P20's EMR showed a scanned cardiac monitor strip, located under the "Admin Documents" tab, dated 08/12/20 at 11:00 AM with a hand-written notation of "1100 awake."

Review of P20's EMR "Flowsheet Measurements," located under the "Flowsheets" tab, showed heart rate, blood pressure, respiratory rate, and oxygen saturation were assessed by RN 2 on 08/12/20 at 9:25 AM, 10:00 AM, 10:15 AM, 10:45 AM, 11:00 AM, and 12:15 PM. There was no documented evidence P20's cardiac rhythm was monitored continuously and his vital signs were assessed for 14 minutes after the administration of Ketamine, 13 minutes after the administration of propofol, and for one hour 15 minutes after the first vital assessment at 11:00 AM.

See interview with RN 2 documented above.

4. Review of P25's "ED Nursing Initial Assessment Notes" documented by RN 4 on 04/10/21 at 9:12 PM, printed for review by BOM with no tabs separating sections of the EMR, showed P25 was "carried into ED by parent after wrestling on a trampoline. Pt [patient] has gross deformity to the rt [right] elbow pt moved finges [sic] . . ."

Review of P25's radiologic elbow exam performed on 04/10/21 showed "Impression: Elbow dislocation with associated joint effusion, soft tissue swelling without convincing evidence of acute fracture. . ."

Review of P25's physician orders showed an order by MD 1 on 04/10/21 at 11:19 PM for "Ketamine IV push 35 mg once now."

Review of P25's MAR showed RN 4 administered Ketamine IV push 35 mg on 04/0/21 at 10:53 PM, prior to the physician order being documented.

Review of P25's "Flowsheet Measurements" showed heart rate, blood pressure, respiratory rate, and oxygen saturation were documented on 04/10/21 by RN 4 at 8:54 PM, 9:42 PM, 10:45 PM, 10:55 PM, 11:16 PM, and 11:36 PM and at 12:20 AM on 04/11/21. There was no documentation of continuous cardiac monitoring during and after the administration of ketamine and an assessment of LOC.

In an interview on 04/29/21 at 10:03 AM, RN 4 stated he "does connect the patient to the cardiac monitor and oxygen" when he administers and monitors conscious sedation. RN 4 stated he "usually runs strips for the record and can't say why he didn't do it that time [for P25]."

Review of the personnel files of RN2, RN 3, RN 4, and RN 5 showed no documented evidence of training and evaluation of competency in administering conscious sedation and monitoring patients during and post administration of conscious sedation.

In an interview on 04/27/21 at 4:17 PM, Chief Nursing Officer (CNO) stated that the RNs have not had the required training in accordance with the "Nevada State Board of Nursing Practice Decision: The Role of the RN in Moderate/Procedural Sedation." CNO stated she has no training documentation or competency evaluations to present for the RNs working in the ED. CNO stated she never held formal training on moderate/procedural sedation.

Based on policy reviews, record reviews, and interviews, the hospital failed to ensure the registered nurse (RN) supervised and evaluated the nursing care for each patient:

1. The RN failed to ensure critical lab values were reported to the physician for one (Patient (P) 13) of five patient records reviewed for reporting critical lab values from a sample of 29 patients. This failure had the potential to affect any patient receiving services in the hospital who had lab work ordered by the physician.

2. The RN failed to ensure wounds were assessed and wound care was provided as ordered by the physician and wound care orders were clarified as needed for two (P3, P6) of five patient records reviewed for wound assessments and wound care from a sample of 29 patients. This failure had the potential to affect any patient admitted to the hospital who may require wound care.

Findings include:

1. Review of the policy titled "Critical Results Reporting," effective 12/01/20, showed the process of communicating critical lab results include staff from the diagnostic testing departments, nursing and the medical staff. . . The objective is to provide the responsible licensed caregiver critical test results with in [sic] an established time frame so that the patient can be treated rapidly as possible. . ." There was no documented evidence that the policy addressed the specific time frame in which critical test results had to be reported to the physician.

Review of P13's "Admission H&P," located under the "Admission H&P" tab under the inpatient tab, showed P13 was admitted on 03/03/21 with diagnoses of "hypernatremia, CHF [congestive heart failure], pleural effusion, hyponatremia." Further review of lab results, located under the "Labs" tab, showed on 03/06/21 the ECO2 [a measurement of the enzymatic carbonate in the blood] result was 39.0 [reference range 21.0 - 32.0] with notation of "critical result called to RN 5 by Lab Manager (LM) on 3/6/2021 at 2:05 PM." Review of the record showed no documented evidence RN 5 notified Medical Director, the attending physician, of the abnormal lab result.

Review of the lab result of 03/07/21 showed ECO2 result was 42.5 (reference range 21.0 - 32.0) with note of "value confirmed by repeat analysis Critical result called to RN 3 by LM on 3/7/2021 at 9:16 AM." Review of the record showed no documented evidence RN 3 notified Medical Director of the abnormal lab result.

In an interview on 04/28/21 at 11:30 AM, Business Office Manager (BOM), who assisted the surveyor with navigating the EMR (electronic medical record), stated she was also the medical records director. BOM confirmed the EMR had no documented evidence that the above critical lab results had been reported to Medical Director by RN 3.

In an interview on 04/29/21 at 10:20 AM, Chief Nursing Officer (CNO) stated "if the physician is present, the nurse sometimes tells the physician the critical lab value, but it should be documented" in the EMR.

2. Review of the policy titled "Wound Management Protocols," effective 05/03/16 and reviewed 04/29/21 (day of survey), showed ". . . Battle Mountain Generals [sic] Hospital Physical Therapy's policy is to: Provide nursing personnel with simple guidance regarding appropriate dressing selection in the absence of wound specialist expertise. Identify appropriate interventions related to specific wound etiology and evidence based practice . . ." There was no documented evidence that physician orders were obtained based on the physical therapy department's wound management protocols.

Review of the hospital policy titled "Assignment of Patients," effective 03/19/10, showed ". . . Patients will have a systems reassessment done at the beginning of each shift. The daily shift assessment in the electronic health record will be utilized every 12 hours. . ."

a. Review of P3's electronic medical record (EMR), under the "Admission H&P" (history and physical) tab under the inpatient tab, showed P3 was admitted on 10/31/20 at 4:20 PM with a primary diagnosis of "pressure ulcer, urinary incontinence, acute urinary tract infection." Further review showed P3 was discharged on 11/01/20.

Review of documentation by Physician (MD) 4 on 10/31/20 at 10:50 AM showed "Patient states he had a right below the knee amputation on October 3. . . Both the ER [emergency room] note and the follow-up with the primary care doctor state that the incision looked as though it dehisced but was not infected at the time. He has continued redness worsening around the wound that he is complaining of today and serosanguineous drainage from the wound staining his dressings daily since. He is also ran out of his material for redressing. . ."

Review of the physician orders, located under the "Orders" tab, showed no documented evidence of a physician's order for wound care and no clarification order by the RN for wound care orders.

Review of the "Flowsheet Measurements," located under the "Flowsheets" tab, showed no documented evidence of an assessment by the RN of the wound to P3's right below the knee incision site and no documented evidence of wound care performed throughout P3's hospital stay.

In an interview on 04/28/21 at 11:56 AM, BOM stated, after reviewing P3's EMR, she could find no documented evidence of wound care orders for P3's wound, an assessment by a RN of P3's wound, or wound care provided by the RN.

b. Review of P6's EMR's "Admission Order," located under the "Orders" tab, showed P6 was admitted on 11/24/20 with a diagnosis of muscle weakness by MD 5. Review of an order, located under the "Orders" tab, on 11/24/20 at 5:54 PM by MD 5 showed "Order wound care every day." There was no documented evidence of specific wound care orders, the site that the order referred to, and a clarification order by a RN to obtain the specific orders for wound care.

Review of "Nurses' Notes," located under the "Nurses' Notes" tab, showed the following documentation for P6:
11/24/20 at 7:45 PM by RN 5 - Integumentary "impaired (Left foot has dressing covering. Patient has had an amputation in the past and infection of foot is still a problem. Patient is on antibiotics long term for s/s [signs/symptoms] of infection."
11/25/20 at 8:25 AM by RN 1 - Integumentary "impaired (wound noted to medial left foot)"
11/26/20 at 9:05 AM by RN 1 - Integumentary "impaired (diabetic wound to medial left foot, dressing dry and intact.)"
11/27/20 at 8:24 AM by RN 1 - Integumentary "impaired (DM [diabetes mellitus] wound to L [left] medical foot)
11/27/20 at 8:15 PM by RN 6 - Integumentary "impaired (wound in her left foot and RBKA [right below the knee amputation])"
11/28/20 at 8:30 PM by RN 6 - Integumentary "impaired (wound left foot.)"
11/29/20 at 8:01 PM by RN 5 - Integumentary "impaired (Patient requires wound care to left foot r/t [related to] infection with amputation.)"
11/30/20 at 8:00 AM by RN 2 - Integumentary "Pt. [patient] is being tx [treated] for L [left] knee infection, continues on antibiotics"
12/01/20 at 8:00 AM by RN 2 - Integumentary "dressing changes daily Pt. tolerates well, wound healing"
12/01/20 at 7:05 PM by RN 5 - Integumentary "impaired (left foot requires wound care)"
12/02/20 at 7:40 AM by RN 2 - Integumentary "wound to L foot dressing change"
12/02/20 at 8:45 PM by RN 3 - Integumentary "impaired (left foot wound.) dressing/ mepiplex [foam heel dressing that conforms to any shaped heel that will not stick to the wound and absorbs exudate and prevents maceration] changes daily"
12/03/20 at 8:11 AM by RN 1 - Integumentary "impaired (breakdown noted under abdominal folds. DM wound noted to medial left foot"
12/03/20 at 8:20 PM by RN 6 - Integumentary "impaired (left foot wound [with] dressing"
12/04/20 at 8:00 AM by RN 1 - Integumentary "impaired (excoriation under abdominal folds, open wound to distal medial nub on LLE [left lower extremity])"
12/04/20 at 8:35 PM by RN 6 - Integumentary "impaired (wound left foot.)"
12/05/20 at 8:48 AM by RN 1 - Integumentary "impaired (excoriation under abdominal folds. DM wound to bottom, medial left foot)"
12/05/20 at 8:30 PM by RN 6 - Integumentary "impaired (wound left foot.)"
12/06/20 at 7:30 AM by RN 2 - Integumentary " wound to L foot, dressing clean, dry intact"
12/06/20 at 9:45 PM by RN 5 - Integumentary "impaired (Left lower toes have been amputated and patient is getting over an infection in foot.)"
12/07/20 at 7:30 AM by RN 2 - Integumentary "wound to LLE dressing change dressing clean dry intact"
12/08/20 at 9:15 PM by RN 5 - Integumentary "impaired (Patient has wound to left foot where toes were amputated. Meplix border dressing covering wound. Dressing changed after shower.)"
12/09/20 at 7:48 AM by RN 1 - Integumentary "impaired (redness to abdominal folds. DM wound to bottom of LLE)"
12/09/20 at 7:40 PM by RN 3 - Integumentary "LLE partial left foot amputated and recent debridement at prior hospitalization reno. Pt has a dressing in place. Dressing changes and wound care provided. Monitored for s/s of infection."
12/10/20 at 7:57 AM by RN 1 - Integumentary "impaired (redness to abdominal folds. DM wound to bottom of LLE)"

There was no documented evidence of an assessment, including measurement, amount of or lack of drainage, appearance of the surrounding tissue, and presence or absence of odor, by a RN of P6's wound to the left foot and abdominal folds and documentation of wound care provided.

In an interview on 04/28/21 at 12:15 PM, BOM stated review of the entire EMR showed no documentation by the RN of an assessment of P6's wounds to the left foot and abdominal folds and no documentation of the specific wound care provided during P6's entire hospital stay.

In an interview on 04/29/21 at 10:20 AM, Chief Nursing officer (CNO) stated physical therapists usually gives wound care, but there should be an assessment by the RN and the wound care documented when wound care is performed by the RN. CNO stated "we have not been doing good chart reviews since COVID started."

Based on policy review, record reviews, and interviews, the hospital failed to ensure registered nurses (RNs) administered medications in accordance with written and signed physician orders for three (Patient (P) 3, P10, P13) of five patient records reviewed for medication administration according to physician orders from a sample of 29 patients. This failure had the potential to affect any patient admitted to the hospital who had physician orders to receive medications.

Findings include:

Review of the policy titled "Oral Medications (Not Antibiotics), effective 05/08/06, showed that 1. TID (medications administered three times a day) times were "0800 [8:00 AM] 1400 [2:00 PM] 2000 [8:00 PM]. "If the physician does not specify "stat" or that a certain number of doses be given the first day or any other special instructions, please follow the following rules: 1. If the first day medication comes to the floor so that it would be given to the patient later than 1 hour after the regularly scheduled dose, it should not be given until the next regularly scheduled dose. 2. If the first day medication comes to the floor so that it can be given at the regularly scheduled time or up to 1 hour after that time, it should be given and then continued on schedule. If at any time the medication nurse feels the above rules would cause any problem, she should communicate with either the physician or the pharmacy for clarification. 3. All medication will be given within a one hour interval of schedule. 1 hour before or 1 hour after time specified. . ."

Review of an untitled policy, effective 05/03/07 and reviewed 04/28/21 (during the survey), showed "It is the policy of Battle Mountain General Hospital that stat medications orders are administered immediately and only once. . . Definitions: Stat: A medication (stocked on the patient care area) with an immediate onset of action that is needed in a potentially life threatening, emergency situation or when there is severe discomfort. . ."

1. Review of P3's electronic medical record (EMR), under the "Admission H&P" (history and physical) tab under the inpatient tab, showed P3 was admitted on 10/31/20 at 4:20 PM with a primary diagnosis of "pressure ulcer, urinary incontinence, acute urinary tract infection." Further review showed P3 was discharged on 11/01/20.

a. Review of P3's physician orders, located under the "Orders" tab, showed a physician's order on 10/31/20 at 7:10 PM by Physician (MD) 4 for "Vancomycin [glycopeptide antibiotic] IV [intravenous] 500 mg [milligrams] every 12 hours scheduled Starting 10-31-20 at 20:00 [8:00 PM] 500 mg in 250 ml [milliliters] 0.9 % [per cent] sodium chloride (2 mg/ml) 125 ml/hr. [milliliters per hour] for 2 hours."

Review of P3's "Medication Administration Record (MAR)," located under the "Nurses' Notes" tab, showed "Vancomycin IV 500 mg every 12 hours 10-31-20 None due." There was no documented evidence Vancomycin was administered as ordered by MD 4.

b. Further review showed a physician's order on 10/31/20 at 7:10 PM by MD 4 for "Tramadol [used to help relieve moderate to moderately severe pain] l Oral 100 mg 3 times per day scheduled Starting 10-31-20 at 20:00 [8:00 PM]."
Review of P3's MAR showed Tramadol oral 100 mg was administered by RN 6 at 7:15 PM, prior to the time ordered by MD 4 to start the medication.

c. Continued review of the MAR showed RN 6 administered Tramadol 100 mg at 1:50 AM with notation of "Scheduled for 08:00 (Wrong time reason: LE [late entry])." There was no documented evidence of a physician's order to administer Tramadol at 1:50 AM on 11/01/20.

d. Further review showed a physician's order by MD 4 on 11/01/20 at 12:10 AM for "Haloperidol [synthetic antidepressant drug used chiefly in the treatment of psychotic conditions] oral 5 mg once now."

Review of P3's MAR showed haloperidol oral 5 mg was administered by RN 6 at 8:30 PM on 10/31/20 with notation of "Scheduled for 11-01-2020 01:10 (post DST [daylight savings time]) (Wrong time reason: LE [late entry]" Prior to the order given for administration.

In an interview on 04/28/21 at 11:56 AM, Business Officer Manager (BOM), who assisted the surveyor with navigating the EMR, stated she was the medical record director also. She confirmed documentation in P3's EMR showed medications were not administered as ordered by MD 4.

2. Review of P10's EMR showed a written "Physician's Order," located under the "Orders" tab, by MD 3. Review of the order showed P10 was admitted on 02/01/21 with a diagnosis of "L [left] anterior upper leg cellulitis s/p [status/post] mole incision [with] suture closure."

Further review showed a physician's order by MD 3 on 02/02/21 at 12:55 AM for pantoprazole [used to treat certain stomach and esophagus problems such as acid reflux] IV 40 mg once now 40 mg in 100 ml 0.9% sodium chloride (0.4 mg/ml) 400 ml/hr. for 15 minutes."

Review of P10's MAR showed RN 5 administered pantoprazole IV 40 mg on 02/01/21 at 8:05 PM prior to MD 3's order. There was no documented evidence P10 received pantoprazole IV 40 mg once on 02/02/21 at 12:55 AM as ordered.

In an interview on 04/28/21 at 12:00 PM, BOM, who assisted the surveyor in navigating the EMR, stated there was no documentation in P 10's EMR that RN 5 administered pantoprazole as ordered by MD 3.

3. Review of P13's "Admission H&P," located under the "Admission H&P" tab under the inpatient tab, showed P13 was admitted on 03/03/21 with diagnoses of "hypernatremia, CHF [congestive heart failure], pleural effusion, hyponatremia."

a. Review of P13's EMR showed the following physician orders, located under the "Orders" tab:
03/03/21 at 5:01 PM by MD 2 - "Furosemide [Lasix] [used to reduce extra fluid in the body (edema) caused by conditions such as heart failure, liver disease, and kidney disease] IV push 20 mg once STAT:"

Review of P13's MAR showed Furosemide ordered on 03/03/21 at 5:01 PM was administered by RN 1 two hours 34 minutes after the medication was ordered to be given stat, with the notation "Wrong time reason: busy in ER [emergency room]."

b. On 03/04/21 at 10:12 AM an order by MD 2 - "Furosemide IV push 20 mg once now;"

Further review showed Furosemide ordered on 03/04/21 at 10:12 AM was administered by RN 1 at 6:54 PM, six hours 42 minutes after it was ordered to be given now at 10:12 AM, with a notation "(Wrong time reason: no IV access earlier)."

c. On 03/05/21 at 3:25 PM an order by MD 3 - Ceftriaxone [used to treat a wide variety of bacterial infections] IV 1 g [gram] every 24 hours now 1 g in 100 ml 0.9% sodium chloride (0.01 g/ml) 100 ml/hr. for 1 hour"

Further review showed RN 6 administered Ceftriaxone on 03/05/21 at 6:45 PM, three hours 20 minutes after it was ordered to be given now at 3:25 PM, with no documented evidence of the reason the administered late.

In an interview on 04/28/21 at 11:30 AM, BOM, who assisted the surveyor in navigating the EMR, stated there was no documentation in P13's EMR that RN 1 and RN 6 administered medications as ordered by MD 2 and MD 3.

In an interview on 04/29/21 at 10:20 AM, Chief Nursing Officer (CNO) stated "I expect stat medications to be given as soon as possible like now." CNO stated "usually when a medication error is reported, I review it. . . we have not been doing good chart reviews since COVID started." CNO stated "a late medication administration and giving the medication before an order is documented should result in an incident report [Quality review Report]."

Based on observations, policy reviews, document reviews, and interviews, the critical access hospital (CAH) failed to meet the Condition of Participation: Infection Prevention and Antibiotic Stewardship Program.

The hospital failed to ensure the emergency department (ED) respiratory equipment was maintained in a clean and sanitary environment and that the facility's autoclave sterilizing equipment was operating appropriately and sterilized equipment was maintained to ensure their integrity.

1) During the observations conducted of three of four (ER 1, ER 3, and ER 4) ED patient care rooms several respiratory care products were observed hanging on the walls. The items were opened or had puncture holes to hang on the walls and were covered in dust. This practice resulted in the products losing their integrity and becoming contaminated.

2) During the observations of one of one physical therapy wound care room, multiple sterile processed equipment was observed to have yellowed stains on the inside of the package indicating this equipment was contaminated. During interviews with the central supply staff, it was confirmed the autoclave has been malfunctioning since February 2021 and the manufacturer and administration had not been made aware of the malfunction.

These failures had the potential for serious harm, impairment, or death for any patient presenting to the facility who required the administration of oxygen therapy in the ED and who required the use of sterilized equipment for treatment throughout the facility by exposing and infecting patients with environmental contaminants from contaminated equipment and biological matter from non-sterilized instrumentation. (See tag C 1208 for detailed information).

Based on observations, interviews, documents, and facility policies it was determined the facility failed to protect the facility's patients from environmental and biological contaminants. Specifically, 1. The facility failed to ensure respiratory equipment in the emergency department (ED) is maintained and stored in a clean and sterile environment, and 2. The facility failed to ensure the facility's autoclave (reprocessing/sterilizing equipment) used to sterilize instruments in the hospital was maintained and monitored for the integrity of the sterilized instrumentation.
These failures have the potential to increase the risks for healthcare acquired infections(HAI) for all the patients that present for treatment at the facility.

Findings include:

1. During the tour of the facility acute care wing conducted on 04/26/21 at 10:01 AM accompanied by the Chief Nursing Officer (CNO), observations conducted of the infusion room revealed five 20 milliliter (ml) Luer lock syringes, two 60 ml Luer Lock syringes that appeared to have a yellowish tint to them, and one 60 ml Luer-Lock syringe that was out of the package and laying on a tray in a cart. These were confirmed and given to the CNO.

2. During the tour of the emergency room (ER) conducted on 04/26/21 at 10:45 AM the following observations were made:

a. 10:48 AM ER room four, there were 32 gauze sponge packages in a cupboard with the sterile packages that were wrinkled and not flat with water damage that had gotten wet and dried out. Five adult oxygen cannulas and four adult oxygen masks, three oxygen extender tubing, and one adult non-rebreather mask observed hanging on the wall to have all the protective covers punctured compromising the cleanliness and the integrity of the equipment.

b. 10:50 AM ER room two, there was an ambu-bag with oxygen tubing and mask attached that was not protected in packaging for cleanliness, a suction canister mounted to wall with tubing and yankaur tip attached and not contained for cleanliness. The CNO confirmed the yankaur tip should not have been opened and that the ambu-bag was being used for training and should be labeled and bagged as such.

Further observation in room two revealed supplies hanging on the wall with holes punched in the protective covering of the following items included: two 12 Fr. Stylettes, two infant six Fr stylettes, five oxygen nasal cannulas, two adult venti-masks, three hand-held nebulizers, three pediatric oxygen nasal cannulas, five pediatric oxygen masks, two non-rebreather masks, four pediatric aerosol masks, two pediatric non-rebreather masks, four suction catheter kits, six Salem sump tubes, six urinary catheters, three lavage tubes, four stomach tubes, and seven feeding tubes. Holes punched in each of the packages plastic protective coverings allowed all medical equipment the potential for contamination.

c. 11:04 AM ER room one there were one Probe Cover kit, use by date of 02/2017, one Iodoform packing strip 1 inch by 5 yards, opened and not dated, one opened 4 inch by 8 inch adhesive surgical dressing, one opened/undated bottle of Dyna Hex 4 (antimicrobial cleanser), 10 French (Fr) Delee suction catheter with a dusty and unreadable package covering, one 10 Fr Whistle tip suction catheter that had a yellowish color, one dust covered adult manual resuscitator mask with oxygen reservoir opened with use by date of 10/17/19, three venti-mask with covers that had holes in the protective cover hanging on wall that were dusty, two pediatric soft touch nasal cannula with a hole in the protective cover hanging on the wall, one adult oxygen nasal cannula with a hole in the protective cover hanging on the wall, two pediatric oxygen concentrator mask with holes in the protective covering hanging on the wall, four adult non-rebreather masks with holes in the protective covers hanging on the wall, seven disposable nebulizers with holes in the protective covers hanging on the wall, and three pediatric bag valve mask systems covered in dust hanging on the wall.

All the above observed contaminated items with punctures in the packaging were confirmed by the CNO during an interview on 04/26/21 at 11:29 AM. The CNO was questioned who was responsible for ensuring the ER equipment was kept cleaned? The CNO stated, " housekeeping does the general cleaning but for the equipment obviously no one is."

Review of the facility's policy titled "Routine Cleaning, Restocking, and Checking Outdates" with an effective date of 04/98 and revision date of 04/29/21 revealed " ...monthly assessment sheets will be maintained in the ER , listing assignments, dates to be completed, and an area to for [sic] for routine cleaning, restocking, and checking out of dates ..."


2. During the tour conducted on 04/26/21 at 12:05 PM of the physical therapy wound care room observations were made of seven bandage scissors and one forceps sterilized instruments in a bin sitting on top of the counter. The sterilized instruments protective covers has stains within the sterile wrapper.

During an interview conducted on 04/26/21 at 12:05 PM the physical therapy manager confirmed the findings and stated, " most of the things come from central supply, they don't have a system for checking for compromised integrity and expiration dates for equipment."

3. During the tour conducted on 04/26/21 at 12:25 PM of the central supply/decontamination areas, the Central Supply Manager (CSM) was asked who was responsible for the processing the instruments for the facility? The CSM stated, "it is the Purchasing Specialist (PS)." The PS was asked if he/she was aware of the stains on the packaging of the sterile instruments? He/she stated, " yes, I noticed water spots on the packaging in the last couple cycles." The PS was asked specifically when he/she first noticed it? The PS stated, "I run one load a month so it would have been in February" The PS was asked if he/she reported it to their supervisor? The PS stated, "Yes, I reported it to my supervisor (CSM), but since the biofilm indicators or spore tests are the most accepted means of monitoring sterilization because they assess the sterilization process directly by killing known highly resistant microorganisms is run with the loads came back from the laboratory as negative, I wasn't concerned."

During an interview with the Infection control preventionist (ICP) on 04/26/21 at 3:54 PM, the ICP was questioned if the facility has had any HAIs (Healthcare acquired infections)? The ICP stated, "No, the facility does not have any HAIs." The ICP was made aware of the findings in the ER, physical therapy, and that the auto clave has been malfunctioning. The ICP was asked if he/she was aware of any of these situations? The ICP stated, "no, I was not aware, I do make rounds every day, but I don't track the infections in the physical therapy wound care, and the central supply staff don't communicate with me much. They should have made me aware."

Review of the facility's policy titled, " Shelf Life of Hospital Sterilized Packs, Trays and Sets" dated 02/01/21, revealed "all items sterilized by Central Service share be considered sterile unless the package/pack/tray/container is damaged or wet. Damage includes: any type of moisture."

Review of the facility's policy titled " Steam Sterilization- Guidelines" dated 02/01/21, revealed " ...visually check outside wrapper for dryness. A wrapped tray of instruments is considered unacceptable and must be re-sterilized. If there are water droplets or visible moisture on the exterior of the package or on the tape used to secure it ...report any suspected malfunctions to the supervisor immediately ...cleaning and monitoring of the sterilizer is the responsibility of Central Service Technician."

Review of the facility's policy titled "Infection Control" dated 12/9/04, revealed "the objective of the Infection Control Policies and Procedures are to: 1. Prevent the spread of communicable/contagious diseases, 2. Prevent the spread of nosocomial infections. 3. Maintain a sanitary environment for employees, clients, visitors, and the general public ...Sterile products such as catheters, disposable needles, and syringes, should remain sterile until the package is opened or damaged.