HospitalInspections.org

Condition of Participation for Emergency Services
Mary Hurley Hospital
Coalgate, OK

Based on observation and interview, the facility failed to meet the Conditions of Participation for Emergency Services by failing to ensure appropriate medications used for life-saving measures were immediately available putting all patients at risk who require emergency services (Refer to C-203 regarding medication availability in the Emergency Department).

Findings include:

An Immediate Jeopardy (IJ) was identified and notification to the facility was made on 08/05/19 at 1:46 PM regarding the presence of Succinylcholine Chloride (a rapid acting muscle relaxant medication used for emergency intubations) in the Emergency Department (ED). It was further determined the facility failed to have the medication Dantrolene used to treat Malignant Hyperthermia (MH), (an often fatal condition that can potentially occur from the use of Succinylcholine) and a MH kit available in the facility for emergency response.

The Malignant Hyperthermia Association of the United States (MHAUS) states the nationally accepted standard is for 720 total milligrams (mg) of Dantrolene to be stocked in a facility that uses Succinylcholine Chloride for emergency purposes.

IJ was formally determined to exist on 08/05/19 at 1:45 PM under 42 CFR 485.618 Emergency Services at C-0200. The Chief Executive Officer (CEO) was notified of the identified IJ on 08/05/19 at 1:50 PM, and of the need for a Plan of Removal to be put in place immediately to remove the IJ.

A final Plan of Removal was submitted to the Center for Medicare & Medicaid Services (CMS) State Survey Agency (SSA) and Regional Office (RO) on 08/06/19 at 12:07 PM.

The following is the facilities official plan of removal for the Immediate Jeopardy identified at Mary Hurley Hospital due to the presence of Succinylcholine in the facility and the absence of Dantrolene:

1. The Pharmacy and Therapeutics (P&T) committee of the hospital approved the immediate removal of Succinylcholine Chloride from the formulary and shelves on 08/05/19 2:15 PM.

2. Immediate reeducation and notification of nursing staff and providers began on 08/05/19 to inform the staff of the medication removal and alternative medications available for use in the event of the need to intubate a patient.

3. Written notice of the removal of the medication was posted in the emergency department.

4. The current stock of Succinylcholine Chloride was packaged and sealed for return to the pharmaceutical supplier on 08/05/2019 at 2:24 PM and the medication was picked up for removal from the facility on 08/06/19 at 12:02 PM.

5. The facility determined if Rapid Sequence Intubation (RSI) be necessary, the facility would provide Ketamine, Ativan, Zemuron (Rocuronium) or Norcuron (Vecuronicum) to maintain sedation and/or paralysis.

The facility's "Plan of Removal" was validated by on site surveyors through an additional inspection and review of documentation to ensure the removal plan was implemented. The validation of the facility's "Plan of Removal" was implemented was provided to CMS, SSA, and the RO on 08/06/19 at 2:40 PM, at which time the CEO was notified that the IJ was considered removed.

Based on observation, interview, document review, and review of facility policy, the Critical Access Hospital (CAH) failed to maintain a sufficient supply of a medication used to reverse a potentially life-threatening adverse drug reaction to another medication, which is used in emergency situations to rapidly intubate patients.

The failure of the CAH to recognize the potential occurrence of life-threatening reactions to the administration of succinylcholine during the rapid intubation of patients, and the failure to maintain a sufficient supply of dantrolene onsite to counteract the adverse reaction, had the potential to affect all patients presenting to the CAH for emergency treatment and represented an immediate jeopardy situation. (Cross reference C-0200 for further information.)

Findings include:

Review of the drug manufacturer's package insert (drug information sheet) for succinylcholine chloride injection, USP, revised 05/2019, revealed, "Succinylcholine is a depolarizing skeletal muscle relaxant . . . indicated . . . to facilitate tracheal intubation [insertion of an artificial breathing tube] . . . [and] has been associated with acute onset of malignant hyperthermia, a potentially fatal hypermetabolic state of skeletal muscle. . . . Malignant hyperthermia frequently presents as intractable spasm of the jaw muscles . . . which may progress to generalized rigidity, increased oxygen demand, tachycardia [rapid heart rate], tachypnea [rapid breathing] and profound hyperpyrexia [fever]. . . . Intravenous dantrolene sodium is recommended as an adjunct to supportive measures in the management of this problem."

Review of the drug manufacturer's package insert for dantrolene sodium, revised 01/2019, revealed, "Dantrolene Sodium for Injection is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. Dantrolene Sodium for Injection should be administered by continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized."

During observation and interview on 08/05/19 at 10:00 AM, the Assistant Chief Nursing Officer (ACNO), stated, "We have succinylcholine onsite, but we don't have any dantrolene. I didn't know it [dantrolene] was needed." Subsequent observation of the CAH's medication refrigerator revealed one sealed vial tray that held 25 multiple-dose 10 milliliter (mL) vials of succinylcholine chloride injection with a dose concentration of 20 milligrams (mg)/ml. The labeling on the outside of the vial tray read: "WARNING: Paralyzing Agent. Causes Respiratory Arrest. Facilities must be immediately available for artificial respiration." Upon further observation of the contents of the medication refrigerator, no dantrolene sodium was found. The ACNO stated the medication refrigerator was the only one for the CAH including the emergency department (ED).

Observation of the "Pharmacy" room on 08/05/19 at 10:07 AM, accompanied by the ACNO, revealed no supply of dantrolene sodium. During an interview at this same time, the ACNO stated the "Pharmacy" room supplied the entire CAH including the ED.

During an interview on 08/05/19 at 12:55 PM, the consultant pharmacist stated that he checks the medication refrigerator and the "Pharmacy" room weekly for expired medications and multidose vials that are open past 28 days, and provides the Director of Nursing with a report of his findings. The consultant pharmacist stated he was aware the CAH had a supply of succinylcholine in the medication refrigerator and no supply of dantrolene, and that it would take, "about 20 minutes to get it."

During an interview on 08/05/19 at 1:35 PM, the medical director for the CAH stated he understood that the CAH had succinylcholine onsite, but no dantrolene. The medical director stated, "I never use it for intubation. I'm uncomfortable with it." When asked why the CAH had a supply of succinylcholine onsite, the medical director stated, "When the helicopters come in they may use it." The medical director stated that he is part of the P&T (Pharmacy and Therapeutics) Committee for the CAH, and is involved in determining which medications should be on the premises.

The facility did not have a policy or procedure in place for the use of the succinylcholine.

Based on observation, interview, record review, and review of facility policy, the Critical Access Hospital (CAH) failed to ensure the staff utilized appropriate infection control and prevention measures for hand hygiene and for the administration of intravenous medication for one of 25 sampled patients, (Patient (P)2). Additionally, the CAH failed to ensure the dietary staff used viable test strips when testing the sanitation level of the water used for cleaning dishes, and failed to ensure the facility's "Food Service Equipment Sanitation" policy included procedures for testing the sanitation level of the water used to clean dishes to ensure the required sanitation levels are met.

Findings include:

1. Observation on 08/06/19 beginning at 9:55 AM revealed Registered Nurse (RN)1 prepared to administer an intravenous (IV- in the vein) infusion of ranitidine hydrochloride (HCl) (a medication used to suppress stomach acid) to P2. After checking the patient's orders, and gathering a vial of ranitidine HCl, a 100 milliliter (ml) bag of 0.9% sodium chloride (normal saline or NS), and required IV supplies, RN2 placed the items on the countertop in the medication preparation room, and then retrieved and donned a pair of gloves. The RN then removed the plastic lid from the top of the vial of ranitidine, and without first wiping the rubber septum on top of the vial with an alcohol pad, punctured the septum with the needle of the syringe, and drew up the ranitidine. RN2 then injected the medication into the port of the 100 ml bag of NS without first wiping the port of the IV bag with an alcohol pad. After disposing of the needle/syringe and empty medication vial, RN2 removed and discarded his/her gloves in the trashcan and left the medication room without performing hand hygiene. RN2 entered P2's room, and ensured the identity of the patient. Without first performing hand hygiene, the RN donned a clean pair of gloves, hung the bag of IV medication, and completed the hookup and initiation of the IV infusion. RN2 then removed his/her gloves, labeled the IV bag, and disposed of used supplies. The RN then washed and dried his/her hands in patient's bathroom, and exited the room.

During an interview on 08/06/19 at 10:10 AM, RN2 stated, "I thought I washed my hands after I took off my gloves, but I was nervous." The RN was unaware of the need to use an alcohol pad to wipe the septum on vials of medication after removing the plastic cap, and to wipe the injection port on bags IV fluids. The RN could not be certain of the last infection control or hand hygiene inservice he/she attended, but estimated it was a "couple of months ago."

A review of RN2's training records revealed the nurse participated in his/her annual competency evaluations on 11/16/18, which included successful completion of using IV infusion pumps, preparing IV additive medications, management of IV "piggy back" (intermittent infusion) medication administration, standard precautions, and a "Hand Hygiene Quiz."

A review of the CAH's monthly "Nurse Meeting Minutes" and sign-in sheets for 2019 revealed RN2 received inservice training information titled, "Hand Hygiene Facts and Quiz" during the "Nurse Meeting" held on 04/11/19.

During an interview on 08/08/19 at 12:08 PM, the Assistant Chief Nursing Officer (ACNO) stated his/her responsibilities included oversight of the CAH's Infection Control and Prevention Program. The ACNO stated the nurses receive infection control and prevention training every other month, and he/she assigns various infection control surveillance duties, including hand-hygiene audits, to different staff each month. The ACNO stated he/she does not conduct routine observational competency evaluations with the staff, and further clarified by stating, "I sometimes watch the staff, about once per week, to check for any infection control breeches, but these observations are not documented." Newly hired nurses receive training during orientation on infection control and prevention practices and are observed performing these tasks and "checked-off" by one of the "more experienced RNs." The ACNO stated he/she expected the nursing staff to use an alcohol pad to swab the septum of a medication vial and the injection ports of IV solution bags prior to needle insertion. The ACNO stated he/she expected all staff to perform hand hygiene upon removal of their gloves.

Review of the CAH's policy titled, "Guidelines for Isolation," implemented on 02/10/15, indicated under the heading, "A. Standard Precautions," the policy directed the staff to, "Wash hands . . . after gloves are removed."


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2. Review of the facility's policy titled, "Food Service Equipment Sanitation" dated 08/2011, documented, "all food service equipment is sanitized and maintained to minimize problems with infectious disease." In addition, the policy documented, "All equipment will be sanitized by one of the following methods: 1) Immersion for at least ½ minute in clean, hot water at a temperature of at least 170 degrees Fahrenheit (F), 2) Immersion for a period of at least one minute in a sanitizing solution containing at least 50 parts per million (ppm) available chlorine at a temperature not less than 75 degrees F, or, 3) Use of water based quaternary ammonium sanitizer." However, the policy did not address a procedure for how dietary staff test water to ensure appropriate sanitation levels are met.

An observation in the kitchen area on 08/05/19 at 10:40 AM revealed dietary staff were using expired test strips for testing sanitation levels of water used for cleaning dishes. The observation revealed the test strips expired on 12/2018.

Interview with the Dietary Manager (DM) on 08/05/19 at 10:45 AM, the DM stated she was not aware the test strips used for testing the sanitation levels of water in the kitchen had an expiration date. The DM further stated the expired test strips had been used to test the sanitation levels for at least six months.

Based on interview, record review, and review of facility policy, the Critical Access Hospital (CAH) failed to ensure the inpatient medical records for seven out of 25 sampled patients, (Patient (P)2, P4, P6, P10, P21, P23, and P25), had "Conditions of Treatment/Admission" documentation that were fully completed and signed by the patient or their representative.

Findings include:

1. Review of P2's "Admission Summary Sheet" revealed the CAH admitted the patient to its inpatient unit on 08/05/19.

Review of P2's four-page "Conditions of Treatment/Admission" documentation revealed the patient's representative signed at the bottom of page four, and Registered Nurse (RN)4 signed the form as a "witness." However, further review of the forms revealed the following:

a. Section "14. Advance Directives" failed to select one of the three responses to clarify whether the patient had an Advance Directive, or if not, that the CAH provided them with information on Advance Directives.

b. Section "15. Confidentiality" had neither of the two responses selected to clarify whether the CAH could or could not divulge the patient's "name, room number and general condition to anyone who inquires."

c. Section "19. Notice of Privacy Practices" failed to select one of the three responses to clarify the patient's receipt of the CAH's "Notice of Privacy Practices."

d. Section "20. Power of Attorney/Durable Power of Attorney" (DPOA) had neither response selected to clarify whether the patient had a DPOA for financial decisions, and whether the patient had a DPOA for both financial and medical decisions.

2. Review of P4's "Admission Summary Sheet" revealed the CAH admitted the patient to its inpatient unit on 02/10/19.

Review of P4's four-page "Conditions of Treatment/Admission" documentation revealed sections 14, 15, 19, and 20 had no responses selected. The signature area at the bottom of page 4 was not signed by the patient or the patient's representative, and the "witness" signature area was not signed by a member of the staff.

3. Review of P6's "Admission Summary Sheet" revealed the CAH admitted the patient to its inpatient unit on 07/31/19.

Review of P6's four-page "Conditions of Treatment/Admission" documentation revealed the patient's representative signed at the bottom of page four, and RN5 signed the form as a "witness." However, further review of the forms revealed the following:

a. Section "14. Advance Directives" failed to have one of the three responses selected to clarify whether the patient had an Advance Directive, or if not, that the CAH provided them with information on Advance Directives.

b. Section "15. Confidentiality" had neither of the two responses selected to clarify whether the CAH could or could not divulge the patient's "name, room number and general condition to anyone who inquires."

c. Section "19. Notice of Privacy Practices" had none of the three responses selected to clarify the patient's receipt of the CAH's "Notice of Privacy Practices."

d. Section "20. Power of Attorney/Durable Power of Attorney" (DPOA) had neither response selected to clarify whether the patient had a DPOA for financial decisions, and whether the patient had a DPOA for both financial and medical decisions.

4. Review of P10's "Admission Summary Sheet" revealed the CAH admitted the patient to its inpatient unit on 07/11/19.

Review of P10's four-page "Conditions of Treatment/Admission" documentation revealed the patient signed at the bottom of page four, and the Chief Nursing Officer (CNO) signed the form as a "witness." However, further review of the forms revealed the following:

a. Section "14. Advance Directives" had none of the three responses selected to clarify whether the patient had an Advance Directive, or if not, that the CAH provided them with information on Advance Directives.

b. Section "15. Confidentiality" had neither of the two responses selected to clarify whether the CAH could or could not divulge the patient's "name, room number and general condition to anyone who inquires."

c. Section "19. Notice of Privacy Practices" failed to select any of the three responses to clarify the patient's receipt of the CAH's "Notice of Privacy Practices."

d. Section "20. Power of Attorney/Durable Power of Attorney" (DPOA) had neither response selected to clarify whether the patient had a DPOA for financial decisions, and whether the patient had a DPOA for both financial and medical decisions.

5. Review of P21's "Admission Summary Sheet" revealed the CAH admitted the patient to its inpatient unit on 06/18/19.

Review of P21's four-page "Conditions of Treatment/Admission" documentation revealed the patient signed at the bottom of page four, and RN6 signed the form as a "witness." However, further review of the forms revealed the following:

a. Section "14. Advance Directives" failed to have any of the three responses selected to clarify whether the patient had an Advance Directive, or if not, that the CAH provided them with information on Advance Directives.

b. Section "20. Power of Attorney/Durable Power of Attorney" (DPOA) had neither response selected to clarify whether the patient had a DPOA for financial decisions, and whether the patient had a DPOA for both financial and medical decisions.

6. Review of P23's "Admission Summary Sheet" revealed the CAH admitted the patient to its inpatient unit on 06/13/19.

Review of P23's four-page "Conditions of Treatment/Admission" documentation revealed the patient's representative signed at the bottom of page four, and RN5 signed the form as a "witness." However, further review of the forms revealed the following:

a. Section "14. Advance Directives" failed to have any of the three responses selected to clarify whether the patient had an Advance Directive, or if not, that the CAH provided them with information on Advance Directives.

b. Section "15. Confidentiality" had neither of the two responses selected to clarify whether the CAH could or could not divulge the patient's "name, room number and general condition to anyone who inquires."

c. Section "19. Notice of Privacy Practices" failed to have any of the three responses selected to clarify the patient's receipt of the CAH's "Notice of Privacy Practices."

d. Section "20. Power of Attorney/Durable Power of Attorney" (DPOA) had neither response selected to clarify whether the patient had a DPOA for financial decisions, and whether the patient had a DPOA for both financial and medical decisions.

7. Review of P25's "Admission Summary Sheet" revealed the CAH admitted the patient to its inpatient unit on 06/13/19.

Review of P25's "Conditions of Treatment/Admission" documentation revealed the patient's representative signed at the bottom of page four, and RN1 signed the form as a "witness." However, further review of the forms revealed the following:

a. Pages 1, 2, and 3 were not included.

b. Section "15. Confidentiality" had neither of the two responses selected to clarify whether the CAH could or could not divulge the patient's "name, room number and general condition to anyone who inquires."

c. Section "19. Notice of Privacy Practices" failed to have any of the three responses selected to clarify the patient's receipt of the CAH's "Notice of Privacy Practices."

d. Section "20. Power of Attorney/Durable Power of Attorney" (DPOA) had neither response selected to clarify whether the patient had a DPOA for financial decisions, and whether the patient had a DPOA for both financial and medical decisions.

During an interview on 08/08/19 at 10:00 AM, RN1 stated the admitting nurse is responsible for ensuring the patient's consent forms are completely filled out and signed by the patient or the patient's family member or representative at the time of admission. However, in the case of an unconscious or incapacitated patient with no family present, then the nursing staff are to follow up with the patient or their family during the patient's inpatient stay.

Review of the CAH's policy titled, "Consent," revised 06/05/16, indicated the policy was applicable to the "Inpatient/Swingbed/Emergency Room" units. Further review of the policy revealed: A. Consent for Treatment 1. Whenever possible the patient will be requested to sign the "Authorization for Treatment" consent at the time of their initial quick registration. 2. In a life-threatening situation when item (1) is impossible to obtain, the consent for treatment is implied since the patient presented to the ED [emergency department] for emergency evaluation and treatment. 3. For situations as item (2) the charge nurse/ER nurse or designee will initiate a search to notify the next-of-kin or guardian."

Based on interview and review of facility documentation, the facility failed to meet the Condition of Participation for Periodic Evaluation and Quality Assurance Review.

Findings include:

1. Based on interview and review of facility documentation, the facility failed to conduct an evaluation of the hospital's total program on an annual basis (Refer to C-331 regarding the annual evaluation of the hospital).

2. Based on interview and review of facility documentation, the facility failed to ensure the utilization of services was appropriate, established policies were followed, and determine if any changes are needed (Refer to C-335 regarding the analysis of the facility's annual program evaluation.)

Based on interview and review of facility documentation, the facility failed to conduct an evaluation of the hospital's total program on an annual basis. A review of the facility's most recent annual evaluation and an interview conducted with the Chief Executive Officer (CEO) revealed the facility failed to perform an annual evaluation for the past three years. This failure has the potential to affect all patients receiving care and services at the hospital.

Findings include:

On 08/06/19, a review of facility documentation titled, "Coal County General Hospital Periodic Evaluation for Physical Year Ending June 30, 2015," revealed the facility's most recent annual evaluation of the facility's total program was conducted on 06/30/15.

A review of facility documentation titled, "Coal County General Hospital Performance Improvement Plan," dated 2018-2019, revealed an annual evaluation will be conducted by the Performance Improvement Committee (PIC. The Plan documented, "Each year, the PIC will evaluate the organization's success in achieving the goals and annual objectives of the Performance Improvement Program. The annual report will be a summary of the year's activities
including the role of leadership in the program, the results of the Medical Staff activities, and a review of the quality assessment, quick fix and Pl activities related to each objective established for the year. An assessment of the overall effectiveness of the plan and the program will be made by the PIC and forwarded to the Governing Board with recommendations for improvement."

On 08/06/19 at 11:20 AM, an interview was conducted with the CEO. The CEO stated they hadn't completed the annual review since June 2015. The CEO confirmed he failed to ensure the annual evaluation was completed.

Based on interview and review of facility documentation, the facility failed to ensure the utilization of services was appropriate, established policies were followed, and determine if any changes are needed. A review of the facility's most recent annual evaluation and an interview conducted with the Chief Executive Officer (CEO) revealed the facility failed to ensure an annual evaluation was conducted to determine if the services of the hospital were appropriate to meet the need of the patients receiving care in the facility. This failure has the potential to affect all patients receiving care and services at the hospital.

Findings include:

On 08/06/19, a review of facility documentation titled, "Coal County General Hospital Periodic Evaluation for Physical Year Ending June 30, 2015," revealed the facility's most recent annual evaluation of the facility's total program was conducted on 06/30/15. The evaluation documented, "The purpose of the periodic evaluation is to provide a framework for all quality assessment and performance improvement activities throughout Coal County General Hospital.

The plan specifically addresses all patient care disciplines including contracted services. The objective of the periodic evaluation is to determine whether the utilization of services was appropriate, that established policies were followed, and that any changes that were needed have been made. The periodic evaluation process uses a coordinated, systematic organization-wide approach which includes: planning, measuring, assessing, prioritizing and improving as essential activities. The plan is governed by the Board of Directors and is reviewed annually."

A review of facility documentation titled, "Coal County General Hospital Performance Improvement Plan," dated 2018-2019, revealed an annual evaluation will be conducted by the Performance Improvement Committee (PIC). The Plan stated, "Each year the PIC will evaluate the organization's success in achieving the goals and annual objectives of the Performance Improvement Program. The annual report will be a summary of the year's activities
including the role of leadership in the program, the results of the Medical Staff activities, and a review of the quality assessment, quick fix and Pl activities related to each objective established for the year. An assessment of the overall effectiveness of the plan and the program will be made by the PIC and forwarded to the Governing Board with recommendations for improvement."

On 08/06/19 at 11:20 AM, an interview was conducted with the CEO. The CEO stated the facility had not completed an annual evaluation of the hospital's total program in the past three years. The CEO further stated the hospital had not followed the Performance Improvement Plan of the facility to ensure the Governing Board was provided an analysis of the services provided by the hospital.