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Based on observation, interview and review of procedure for Rapid Sequence Intervention, it was determined the facility failed to meet the condition of Participation for Emergency Services and there was an immediate Jeopardy to patient health and safety related to the use of Succinylcholine as evidenced by:

1) Failure to have available Dantrolene to treat a Malignant Hyperthermia Emergency with the use of Succinylcholine (a drug used for intubation). (Refer to C-0202)
2) Failure to have a policy and procedure for the management of a Malignant Hyperthermia Emergency as set forth by the Malignant Hyperthermia Association of the United States (MHAUS). (Refer to C-0276)
3) Failure to assure staff was trained to respond to a Malignant Hyperthermia Emergency and knowledgeable of the location of emergency supplies to treat Malignant Hyperthermia. (Refer to C-0203)

The cumulative effect of these failed practices resulted in an Immediate Jeopardy to patient health and safety in that the facility was not prepared to treat Malignant Hyperthermia and could not assure a positive patient outcome in the event of the emergency.

The Immediate Jeopardy was abated with the following plan on 04/25/18 at 5:15 PM:
1. The Pharmacist removed Succinylcholine form all locations on 04/25/18 at 3:30 PM
2. A memo has been sent to Medical Staff/Charge Nurse that Succinylcholine will not be available until further notice. The ED [Emergency Department] Director (RN) has informed staff and signed memo. The staff will sign memo as they are informed.
3. Dantrolene has been ordered and estimated time of arrival has been noted as 3-5 business days from 04/25/18.
4. Education for staff on malignant Hyperthermia as started immediately and will continue on a quarterly basis and with each new hire. The Hospitalist and Pharmacist will be responsible for the on-going continuing training. The Pharmacist will do additional training at 9:00 AM on 04/26/18 and the Hospitalist will do additional training upon arrival. All present staff have been educated on changes by the Assistant Director of Nursing (ADON) on 04/25/18 at 4:30 PM.
5. The Pharmacist will be responsible for ensuring a supply of Dantrolene is in date and in stock, while Succinylcholine is listed on formulary.
6. Revised policies and Malignant Hyperthermia emergency procedures will be reviewed for approval by the Pharmacy and Therapeutics Committee, the Medical Staff and the Governing Board at the net scheduled meeting times.

Based on interview and review of in-service documentation, it was determined the facility failed to assure staff was trained to respond to life-saving procedures for Malignant Hyperthermia Emergency and failed to assure staff was knowledgeable of the of availability of emergency supplies required to treat Malignant Hyperthermia. The facility could not ensure patients would receive emergency treatment if needed. The failed practice affected any patient who required treatment for Malignant Hyperthermia. Findings included:

A. During an interview on 04/25/18 at 1:29 PM, the Emergency Department Manager stated that there was no recent training for staff in managing the emergency condition of Malignant Hyperthermia and that approximately 13 years ago she recalled the staff had received training on Malignant Hyperthermia. The Emergency Department Manager stated staff received training in 2016 on Rapid Sequence Intubation in which Succinylcholine was an option for use in intubation but nothing recent. There was no in-service documentation provided of staff training in the management of Malignant Hyperthermia.
B. The Director of Nursing was interviewed on 04/25/18 at 12:49 PM and was asked where Dantrolene was located for the treatment of Malignant Hyperthermia and stated she believed it was located on the crash cart in the Emergency Department.
C. The Emergency Department Manager was interviewed on 04/25/18 at 12:55 PM and was asked where Dantrolene was located for the treatment of Malignant Hyperthermia. The Emergency Department Manager stated that she believed it was located on the crash cart in the Emergency Department or in the Pharmacy.
D. The Emergency Department physician on duty 04/25/18 was interviewed at 2:00 PM and stated he had never used the Succinylcholine in 15 years and he used a different drug. He stated that if he had to treat Malignant Hyperthermia, he assumed the Dantrolene would be on the crash cart.
E. The Director of Pharmacy was interviewed on 04/25/18 at 1:10 PM and stated that the facility did not stock Dantrolene and there was none in the facility at this time.

Based on observation, interview and review of manufacturer's instructions for use, it was determined the point of care blood glucose testing device was not maintained in safe operating condition for one (Procedural) of two (Procedural, Medical Surgical) areas observed in that Level 1 and II control solutions were not dated as to when opened to assure they were discarded in three months. The failed practice did not assure the point of care blood glucose device was safe for patient testing. The failed practice was likely to affect all patients who required point of care blood glucose testing in the Procedural Area of the facility. Findings included:

A. Record review of manufacturer's instructions for the Accu-Chek Inform II control solutions on 04/27/18 showed the date the bottle was opened was to be written on the bottle label. The control solution was stable for three months from the date opened or until the use by date, whichever came first. Testing of known levels of glucose (controls) ensured the system and the individual technique used in testing provided accurate results. No policy for the use of the Accu-Chek Inform II was provided at the time of the survey.
B. Observation on 04/23/18 at 1:54 PM showed opened Accu-Chek Inform II control solutions, Level I and Level II, in the sterile supply room of the Procedure Area. The Level I and Level II control solution bottles were not dated when opened, therefore the three-month expiration date after opening could not be determined.
C. The Outpatient and Sterile Supply Manager was interviewed on 04/23/18 at 1:56 PM and verified the control solutions were not dated by staff at the time of opening.


Based on observation and interview, it was determined the facility failed to assure medical equipment used for intubation (laryngoscope handle batteries) was inspected, tested and maintained to assure it was functional and available for use on one of one Emergency Cart located in the Emergency Department. The facility could not assure medical equipment (laryngoscope) would be functional and available if needed for patients. The failed practice was likely to affect any patient who required intubation and received treatment in the Emergency Department. Findings included:

A. Observation of the second drawer of the Emergency Cart on 04/23/18 at 1:58 PM, in the Emergency Department, showed two of two batteries with a substance leaking from the ends of the batteries. The batteries were located in a plastic try beside a laryngoscope handle and two laryngoscope blades. The leakage of material from the ends of the batteries rendered the batteries non-functional.
B. The Director of Nursing confirmed the finding and that the batteries were for the laryngoscope blade handle on 04/23/18 at 1:59 PM.

Referenced Code: 42 CFR 485.623(c) & (d)

Based on observation and interview, the facility failed to maintain one (rear corridor near Receiving) of eight means of egress free from all obstructions and impediments to full and instant use in case of fire or other emergency. The failed practice had the potential to affect all patients, visitors, and staff because travel through the means of egress was impeded in the event of fire or other emergencies. Findings follow:

A. While on tour of the facility on 04/24/18 at 2:05 PM, observation showed a patient table, a cart with boxes loaded on it, and a hand truck obstructing the available travel space of the exit corridor near Receiving.
B. During the tour, the Director of Plant Operations verified the means of egress was obstructed.
C. See K211

Referenced code: NFPA 101; 2012 edition, Section 7.1.10.1

Based on observation and interview, it was determined the facility failed to maintain the fire and smoke rated barrier in three (above the fire-rated doors near Room 112, above the fire-rated doors near Room 110, and above the fire-rated near the entrance to the X-Ray Hall) of six areas observed by protecting penetrations in the barrier with a system or material capable of restricting the transfer of smoke. The failed practice had the potential to affect all patients, visitors, and staff because it could not be assured that smoke would not spread from one side of the barrier to the other in the event of a fire and smoke event. Findings follow:

A. While touring the facility on 04/24/18 at 2:30 PM, observation showed penetrations in the fire-rated barriers which were not sealed with a material capable of limiting the transfer of smoke from one side of the barrier to the other in the following locations:
1) A sleeve (conduit) for wire penetrating the fire barrier above the fire-rated doors near Room 112;
2) A group of IT cables penetrating the fire barrier above the fire-rated doors near Room 110;
3) One of seven pipes penetrating the fire barrier above the fire-rated doors near the entrance to the X-Ray Hall.
B. During the tour, the Director of Maintenance verified the penetrations were not sealed with a material capable of restricting the transfer of smoke from one side of the barriers to the other.
C. See K300

Referenced code: NFPA 101; 2012 edition, Section 8.4.4.1

Based on observation and interview, it was determined the facility failed to comply with all provisions in the National Electric Code [(NEC) NFPA 70, 2011 Edition) in that two (entrance to Emergency Room and Emergency Room waiting area) of four electrical junction boxes did not have covers as required. The failed practice had the potential to affect all patients, visitors, and staff because of the potential fire hazard absence of covers presents. Findings follow:

A. While touring the facility on 04/24/18 at 2:45 PM, observation showed two electrical junction boxes with no cover in the following locations:
1) Located above the drop down ceiling near the fire-rated doors at the entrance to the Emergency Room;
2) Located above the drop down ceiling near the Emergency Room waiting area.
B. During the tour, it was verified by the Facilities Management Director the electrical junction boxes did not have covers.
C. See K911.

Referenced Codes: NFPA 99, 2012 edition; Section: 6.3.2.1; NFPA 70, 2011 edition; Section: 110.26

Based on observation, interview and document review, it was determined the Organization failed to have an effective Governing Body to oversee it's total operation to ensure the health and safety of every patient related to infection control practices of laryngoscope blades and treatment of Malignant Hyperthermia as evidenced by:

A. Failure to have available Dantrolene to treat a Malignant Hyperthermia Emergency with the use of Succinylcholine (a drug used for intubation). (Refer to C-0202)
B. Failure to have a policy and procedure for the management of a Malignant Hyperthermia Emergency as set forth by the Malignant Hyperthermia Association of the United States (MHAUS). (Refer to C-0276)
C. Failure to assure staff was trained to respond to a Malignant Hyperthermia Emergency and knowledgeable of the location of emergency supplies to treat Malignant Hyperthermia. (Refer to C-0203)
D. Failure to have a current policy for the HLD (high level disinfection) of laryngoscope blades. (Refer to C-0271)
E. Failure to follow manufacturer's instructions and CDC (Centers for Disease Control) guidelines for HLD for 22 of 22 laryngoscope blades. (Refer to C-0278)
F. Failure to assure Respiratory staff was knowledgeable of CDC guidelines and manufacturer's instructions for HLD of semi-critical items. (Refer to C- 0278)
G. Failure to have a system to monitor infection prevention procedures related to HLD, adherence to manufacturer's instructions and CDC guidelines. (Refer to C-0278)

The failed practices had the likelihood to affect the health and safety of any patient who required treatment for Malignant Hyperthermia or treatment with a laryngoscope.

Based on observation, interview and review of policy and procedure for high level disinfection (HLD) of laryngoscope blades, and review of Center for Disease Control and Prevention (CDC) guidelines, it was determined the facility failed to meet the Condition of Participation for Provision of Services and there was an Immediate Jeopardy to patient health and safety related to failure to perform HLD of semi-critical patient-care equipment according to manufacturer's instructions and CDC guidelines for 22 of 22 laryngoscope blades as evidenced by:

1) Failure to have a current policy for the HLD of laryngoscope blades. (Refer to C-0271)
2) Failure to follow manufacturer's instructions and CDC guidelines for high level disinfection for 22 of 22 Laryngoscope blades. (Refer to C-0278)
3) Failure to assure Respiratory staff was knowledgeable of CDC guidelines and manufacturer's instructions for HLD of semi-critical items. (Refer to C- 0278)
4) Failure to have a system to monitor infection prevention procedures related to HLD, adherence to manufacturer's instructions and CDC guidelines. (Refer to C-0278)

The cumulative effect of these failed practices resulted in an Immediate Jeopardy to patient health and safety in that failure to follow manufacture' instructions for HLD of laryngoscope blades did not assure patients would be protected form likely sources of infection.

The Immediate Jeopardy was abated with the following plan on 04/26/18 at 4:25 PM
1. Laryngoscope blades at (hospital named) have been removed by department for high level disinfection by the Infection Preventionist and assistance from Sterile Supply. This process started on 04/26/18 at approximately 2:45 PM. The high level disinfection required will be obtained by MetriCide, following the manufacturer's guidelines of the product. As of 4:11 PM on 04/26/18 supplies for the Emergency Department have been properly disinfected and four infant blades, two handles, and three adult blades are available for use. The medical surgical area has four adult blades available for use at this time. The staff will stay on-site until all blades are disinfected properly.
2. The Infection Preventionist will be responsible for training all personnel in the Respiratory Therapy Department on proper high level disinfection of the laryngoscope blades. The training started on 04/26/18 and will continue until all required staff has been trained properly.
3. Going forward, the Infection Preventionist will be responsible for ensuring that the laryngoscope blades are being cleaned according to CDC guidelines and following all manufacturer's guidelines. The Infection Preventionist will also be responsible for ensuring the storing and packaging are being handled in the proper manner, according to CDC guidelines.
4. The policy and procedure manual for Respiratory Therapy will be updated immediately to reflect all current guidelines and recommendations that are required and will be used going forward. The updated policies and procedures will be reviewed by the Clinical Director, The Medical Director for Respiratory Therapy and will be presented for approval by the Medical Staff and Governing Board at their next scheduled meeting times.

Based on review of policy and interview, it was determined the facility failed to have a current policy to guide staff in the high level disinfection of 22 of 22 laryngoscope blades. The facility could not be assured patients would be protected from likely sources of infection and affected any patient who required intubation. Findings included:

A. Review of policies and procedures for the Respiratory Therapy Department on 04/26/18 at 1:54 PM showed no title or policy number for decontamination of respiratory equipment that included the statement that if no automatic machine is available, reusable items must be properly washed with disinfectant and rinsed. The items were to be rinsed under hot running water to remove gross contamination, remove and soak 30 minutes in glutaraldehyde. Using clean disposable gloves, bag and seal disinfected equipment.
B. Respiratory Therapist #1 was interviewed on 04/26/18 at 1020 regarding the procedure for cleaning the laryngoscope blades. RT #1 stated that the laryngoscope blades were sprayed down with a product called "TB-Cide Quat" and allowed to soak for three minutes and allowed to air dry then bagged. The RT stated the product was from housekeeping and covered "everything".
C. Review of the manufacturer's label for TB-Cide Quat showed the directions for use statement that the product was not to be used as a terminal sterilant/high-level disinfectant on any surface or instrument that is introduced directly into the human body, either into or in contact with the blood stream or normally sterile areas of the body, or contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body.
D. The Infection Control Nurse was interviewed on 04/26/18 at 2:02 PM and confirmed laryngoscope blades should be high level disinfected (HLD) at a minum and there was no current policy for HLD, and that gluteraldehyde had not been available in the facility for use since 2009.


Based on observation, interview and review of policies and procedures, it was determined the facility failed to assure policies and procedures reflected current practice and processes in five (Respiratory services, Outpatients, Infection Prevention, Swing Bed, and Sterile Supply) of seven (Respiratory services, Outpatients, Infection Prevention, Swing Bed, and Sterile Supply Medical Surgical, and Emergency Services) areas observed. Failure to have up to date policies did not ensure staff would be knowledgeable of facility standards and current practices. The failed practice was likely to affect any patient who received care in the facility. Findings follow:

A. Review of facility policies and procedures provided on 04/23/18 - 04/27/18 showed policies in the following departments that were no longer current to facility practices or were outdated:
1) Outpatients- A policy for the Recovery Room that included a revision that patient must stay in the recovery for 30 minutes minimum when receiving IV conscious sedation. The original effective date of the policy was 12/05/78, and revised 2010.
2) Respiratory - A policy for high level disinfection of laryngoscope blades with glutaraldehyde that is not in use currently by the facility and Centers for Disease control and prevention reference from 1983.
3) Infection Prevention - the method of surveillance listed as an Infection Prevention Case Report sheet that is placed on the patients chart. The policy does not include the electronic clinical record processes.
4) Swing Bed - The employee orientation policy referenced an in-service that is held monthly for orientation. The policy effective date is 09/12/00 and does not include revisions. The policy does not reference the current process of computer based training.
5) Sterile Supply - A policy that includes sterile supply attire and a 30 second hand washing to precede movements between locations. The policy effective date is 08/11/80 and does not show revision.
B. The outdated policies were confirmed on 04/27/18 at 10:32 AM by the Assistant Director of Nurses.

Based on observation and interview, it was determined Pharmacy Services failed to adhere to acceptable professional standards of practice for medication administration in that the facility failed to have a policy and a process in place to treat a Malignant Hyperthermia Emergency. The facility had Succinylcholine available for patient use in one (Emergency Department) of three (Emergency Department, Out Patient Services and Medical Surgical) areas toured, but did not stock Dantrolene, which is the medication recommended to treat Malignant Hyperthermia, in case of the emergent event. By not adhering to the acceptable standards of practice as set forth by the Malignant Hyperthermia Association of the United States (MHAUS), the facility could not assure they were prepared for a Malignant Hyperthermia Emergency, and therefore could not assure a positive patient outcome in the emergency. The failed practice had the likelihood to affect all patients admitted for procedures. Findings follow:

A. During a tour of the facility on 04/23/18 from 1:42 PM to 3:54 PM, observation showed two vials of Succinylcholine stocked in the medication refrigerator in the Emergency Department.
B. During a tour of the pharmacy on 04/25/18 from 1:05 PM to 2:20 PM, the Director of Pharmacy Services stated there were addition vials of Succinylcholine in the Pharmacy refrigerator available for patient use if needed.
B. During an interview on 04/25/18 at 10:53 AM, The Director of Pharmacy verified the facility did not have a policy or process in place to treat a Malignant Hyperthermia Emergency and the facility stocked Succinylcholine.

Based on review of manufacturer's recommendations, observation and interview, it was determined the facility failed to adhere to storage of medications and acceptable professional standards in that they did not follow manufacturer's recommendations for length of storage and temperature for two of two intravenous (IV) solutions observed in one of one (Emergency Department) fluid warmer. By not following manufacturer's recommendations for storage, the facility could not assure the safety and efficacy of the solutions available for patient use. The failed practice had the likelihood to affect all patients that have had procedures in the Emergency Department that required warm fluids. Findings follow:

A. Review of the manufacturer's recommendations showed large volume intravenous solutions could be warmed to temperatures not exceeding 104 Fahrenheit, and for a period of time no longer than 14 days.
B. During a tour of the facility on 04/23/18 from 1:42 PM to 3:34 PM observation showed the fluid warmer in the Emergency Department to be 112 degrees Fahrenheit. Inside the fluid warmer were two 1000 ml (milliliter) bags of IV solutions (one each of Lactated Ringers and Normal Saline) that were dated when they were put in the warmer on 04/02/18.
C. During an interview on 04/23/18 at 2:46 PM, the Emergency Department Manager verified the manufacturer's recommendations and that the facility was not following them.


Based on interview, the facility failed to handle medications and adhere to acceptable professional standards in that they did not have policies and procedures in place to ensure annual re-certification of Intravenous (IV) Admixture technique for one of one (Director of Pharmacy) personnel trained to compound medications in the Laminar Flow Hood per United States Pharmacopeia Chapter 797, 2008. By not evaluating the competencies of the personnel, the facility could not assure the sterility or accuracy of the medications compounded. The failed practice had the likelihood to affect all patients who received medications compounded in the Laminar Flow Hood. Findings follow:

During an interview with the Director of Pharmacy on 04/04/25/18 at 1:05 PM, the Director verified they do not have policies and procedures in place to ensure annual re-certification of IV Admixture technique for personnel trained to compound medications in the Laminar Flow Hood.

Based on observation, review of Intravenous (IV) Hood certification label, and interview, the facility failed to adhere to acceptable professional standards in that they failed to ensure one of one IV Hood was able to maintain a sterile environment since the certification expired 01/2016. The potential existed for any IV medication prepared in the hood after 01/2016, not to be sterile. Findings follow:

A. During a tour of the pharmacy on 04/25/16 at 1:05 PM, a certification label on the IV Hood showed the hood was due to be re-inspected 1/16.
B. During an interview on 04/25/18 at 2:20 PM, the Director of Pharmacy verified there was no inspection since 01/16.

Based on observation, review of policy and interview, it was determined the facility failed to store medications to ensure undated opened MDVs (Multiple Dose Vials) were not available for patient use beyond 28 days once opened (per policy) in two (Emergency Department and Medical Surgical) of three (Emergency Department, Medical Surgical and Outpatient Services) patient care areas toured. By not dating the MDVs once opened, the facility could not ensure the medication would not be used beyond the 28 days. The failed practice had the potential to affect any patient who received these medications. Findings follow:

A. Record review of the facility's policy titled, "Expiration of Open Multiple Dose Vials," dated 02/10/10, showed that staff were to discard a MDV after 28 days, once opened.
B. A tour of the facility 04/23/18 from 1:42 PM until 3:34 PM showed the following MDVs opened and not dated:
1. Emergency Department:
a) Two Rocuronium Bromide 10 mg(milligram)/ml (milliliter); and
b) One Humulin R Insulin.
2. Medical Surgical:
a) One Levimir Insulin;
b) One Humulin R Insulin;
c) One Humulog Insulin; and
d) One Tubersol 1 ml.
C. During an interview on 04/23/18 at 2:39 PM, the Emergency Department Manager verified the MDVs in the Emergency Department.
D. During an interview on 04/23/18 at 3:20 PM, the Assistant Director of Nurses verified the MDVs in the Medical Surgical Unit.

Based on review of Daily Temperature Record and interview, it was determined the facility failed to store medications and adhere to acceptable professional standards in that they did not take steps to notify the department supervisor and document corrective action when the medication refrigerator temperatures were too cold for 18/82 days in one (Emergency Department) of three (Emergency Department, Medical Surgical and Outpatient services) areas toured. By not haven taken steps to notify the department supervisor and document corrective action, the refrigerator continued to store medications and biologicals too cool. The failed practice had the likelihood to affect all patients that were to receive medications out of the medication refrigerator. Findings follow:

A. Review of the Daily Temperature Record for 02/01/18 through 04/23/18 the following dates showed to be below the 36-46 degree Fahrenheit temperature range as stated on the sheet: February 17,18, 21-25 and 28; March 5; and April 3,5,7,9,11, and 19-22.
B. During an interview on 04/23/18 at 3:00 PM, the Director of Pharmacy verified the dates the temperatures were below range, and there was no documentation that corrective action had occurred.

Based on observation and interview, it was determined the facility failed to maintain a sanitary environment to prevent and control likely sources of infection in one of one Medical Surgical Unit in that the ends of call light cords were on the floor; dust accumulation was observed on vents, over bed lights and linen carts and multiple rips in a clean linen cart cover. The failed practice did not ensure patients would be protected from sources of infections and was likely to affect all patients in the facility. Findings included:

A. Observation on the Medical Surgical Unit on 04/23/18 at 3:15 PM showed the following in rooms identified as clean and ready for use:
1) Room 104: An accumulation of dust on the overbed light above Bed A. The heating and air vent had an accumulation of dust.
2) Room 101: Accumulation of dust on the heating and air vent.
3) The bottom portion of the Emergency pull cord in restrooms were resting directly on the floor surface in Rooms 104, 102, 101, 119.
4) The clean linen cart located on 100-111 Hall was observed had an accumulation of dust and debris on the wheels and around the bottom of the cart. The clean linen cart cover had multiple rips that exposed the clean linen.
B. The findings in A were verified at the time of observation by the Director of Nursing.


Based on observation and interview it was determined the Infection Control Officer failed to ensure expired foods were not available for patient use. Failure to remove items according to the manufacturer's date of expiration did not ensure the integrity of the package or contents. The failed practice was likely to affect any patient who received the expired items. Findings included:

A. A tour of the kitchen was conducted on 04/26/18 from 9:30 AM - 10:11 AM. The following items were observed:
1) Cream of wheat - seven of seven one pound boxes expired 01/04/18
2) Grits - seven of seven one pound boxes expired 02/10/18.
B. The Dietary Manager confirmed the findings in A on 04/26/18 at 9:53 AM.

Based on observation, interview, review of Centers for Disease Control and Prevention (CDC) guidelines and manufacturer's instructions for use, it was determined the facility failed to perform high level disinfection according the CDC guidelines and manufacturer's instructions for use for 22 of 22 laryngoscope blades. The failed practice did not protect patients from likely sources of infection and affected any patient who required intubation. Findings included:

A. Review of CDC guidelines for disinfection showed that respiratory equipment such as laryngoscope blades were to be high level disinfected at a minimum
B. Review of manufacturer's instructions for use showed the laryngoscope blades were to be disinfected and the blades are compatible with a 2% solution of gluteraldehyde. For recommended exposure times and solution strength, follow solution manufacturer instructions.
C. Respiratory Therapist (RT) #1 was interviewed on 04/26/18 at 10: 20 AM regarding the procedure for cleaning the laryngoscope blades. RT #1 stated that the laryngoscope blades were sprayed down with a product called "TB-Cide Quat" and allowed to soak for three minutes and allowed to air dry then bagged. RT #1 stated the product was from housekeeping and covered "everything".
D. Review of the manufacturer's label for TB-Cide Quat showed the directions for use statement that the product was not to be used as a terminal sterilant/high-level disinfectant on any surface or instrument that is introduced directly into the human body, either into or in contact with the blood stream or normally sterile areas of the body, or contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body.
E. The Infection Control Nurse was interviewed on 04/26/18 at 2:02 PM and confirmed laryngoscope blades should be high level disinfected (HLD) at a minimum and there was no current policy for HLD, and that gluteraldehyde had not been available in the facility for use since 2009.


Based on interview and review of CDC guidelines and manufacturer's instructions for use, it was determined the infection control nurse failed to assure respiratory therapy staff was trained to process laryngoscopes according to manufacture's instructions and CDC guidelines and failed to monitor the process of high level disinfection. Patients were not protected from likely sources of infection. The failed practice affected any patient who required intubation and the use of any of the 22 of 22 laryngoscope blades in the facility. Findings included:

The Infection Control Officer was interviewed on 04/26/18 at 2:02 PM and stated she had not observed or trained staff in high level disinfection of laryngoscope blades and following the manufacture's instructions for high level disinfection.


Based on observation and interview, it was determined the facility failed to identify and control infections in that expired supplies were available for use in one (#2) of five (#1-#5) Emergency Department (ED) treatment rooms. The facility could not assure the integrity of the expired supplies. The failed practice is likely to affect all patients treated in the Emergency Department. Findings included:

A. Observation on 04/23/18 from 2:38 PM to 2:56 PM of ED treatment Room #2 showed the following supplies were expired and available e for use:
1) Epistaxis and Post Op Nasal packing, one of two expired 04/2017
2) Braided suture, 3-0, one opened box of 31 expired 01/2018
3) Ethyl Chloride, one of two, 3.5 fluid ounces expired 01/2018
4) Hema-screen stat, two of three expired 01/31/18
5) Lidocaine Hydrochloride for injection, 1%, 10 milliliters, labeled as opened 03/15/18 and available greater than 28 days after opening
B. The findings in A1-5 were verified by the Director of Nursing at the time of observation.




31039

Based on review of policy, review of Certified Registered Nurse Anesthetists'(CRNA) Tuberculosis (TB) records, and interview, the Infection Control Officer failed to control communicable disease and mitigate risks of TB transmission to patients and staff by not annually screening one (#2) of two (#1 and #2) CRNAs for TB. By not assuring the Healthcare workers were screened annually, the facility couldn't assure they were controlling infections and communicable diseases of patients and personnel. The failed practice had the likelihood to affect all of the employees and patients in the facility. Findings follow:

A. Record review of the facility's policy titled, "Quality Assurance for Infection Control," showed that all employees would be tested and or screened for TB upon hire and annually thereafter.
B. Review of CRNA #2's TB records showed CRNA #2 did not have evidence of any TB screens.
C. During an interview on 0404/24/18 at 2:44 PM, the Infection Control Officer verified CRNA #2 did not have evidence of TB screening upon hire or annually thereafter.

Based on observation and interview, it was determined the facility failed to control potential infections in that one of one Anesthesia Cart had needles and syringes opened and no longer sterile and were stored for future use. By not using immediately when removed from sterile packaging, the facility cannot assure the sterility of the needles and syringes. The failed practice has the likelihood to affect all patients who receive anesthesia services. Findings follow:

A. During a tour of the facility on 04/23/18 from 1:42 PM until 3:34 PM, observation showed four 3 ml (milliliter) syringes opened with needles attached.
B. During an interview on 04/23/18 at 2:08 PM, the Director of Outpatient Services verified the syringes and needles were out of their sterile wrappers.

Based on observation, review of policy and interview, it was determined the facility failed to control infections in that eight of eight walkers, in the Rehabilitation Equipment Room, had stickers/peeling tape on them (the sticky residue harbors bacteria) which did not allow effective cleaning/ disinfection. By not maintaining therapy equipment in a way that allowed them to be thoroughly cleaned, the facility could not assure the sanitary environment when patients used these items. The failed practice had the likelihood to affect all patients that receive therapy services using the therapy equipment. Findings follow:

A. Record review of Rehabilitation Services policy titled, "Infection Control," showed that all walkers were cleaned by wiping thoroughly with a germicidal agent.
B. During a tour of Rehabilitation on 04/24/18 at 1:24 PM, observation showed eight walkers that had stickers/peeling tape on them in the Rehabilitation gym.
C. During an interview on 04/24/181:46 PM, the Physical Therapy Technician verified the walkers had stickers/peeling tape on it.


38994

Based on observation and interview, it was determined the facility failed to control infections in that one of one (#1) Certified Registered Nurse Anesthetist (CRNA) failed to clean the septum of a vial of Propofol prior to entering the vial multiple times for use on one of one (#21) patient during a moderate sedation procedure. Failure to clean the septum of the medication vial prior to each puncture did not ensure the vial was free of contaminants. The failed practice affected Patient #21 and any patient the Propofol could or would have been used on. Findings follow:

A. During observation on 04/25/18 at 10:05 AM, CRNA #1 failed to clean the septum of the vial of Propofol on 3 entries for the delivery of intravenous (IV) medication to Patient #21. CRNA #1 failed to use a new and separate alcohol swap on Patient #21's IV port with each IV injection. CRNA #1 kept the same alcohol swab in the palm of his hand as he used it for all three entries into Patient #21's IV port for IV injection.
B. During interview on 04/25/18 at 1:15 PM with the Director of Outpatient and Sterile Supply, the above findings in A were verified.


Based on observation review of product label and interview, it was determined the facility failed to control infections by using one of one single use bottle of gastrografin contrast medium for multiple patients in the Computerized Tomography (CT) room. The failed practice did not ensure the gastrografin solution was free of contaminants and had the potential to affect all patient requiring oral gastrografin contrast. Findings follow:

A. During tour of the Radiology Department's CT Room on 04/24/18 at 10:25 AM showed a single use open bottle of gastrografin oral contrast medium in the cabinet ready for use with the next patient.
B. Review of the gastrografin label showed "single dose bottle."
C. During interview with the Radiology Manger on 04/24/18 at 10:27 AM, she stated that they were administering 20 milliliters of gastrografin to each patient out of one 120 milliliter bottle of gastrografin labeled single use.
D. The above findings in A, B, and C were verified with the Radiology Manager on 04/24/18 at 10:30 AM.


Based on observation, interview and review of the CDC recommendations for hand hygiene, it was determined the facility failed to control infections in that one of one (1) Licensed Practical Nurse (LPN) did not wash their hands during the provision of care for one of one (#21) patient. Failure to ensure staff performed hand hygiene had the potential to allow cross contamination. The failed practice affected Patient #21 on 04/25/18 and could affect any patient care for by LPN #1. Findings follow:

A. Review of the CDC guidelines showed:
1) Decontaminate hands before having direct patient contact with patients
2) Decontaminate hands after contact with a patient's intact skin.
3) Decontaminate hands after removing gloves.
B. During observation of LPN #1 providing patient care on 04/25/18 at 9:20 AM, the following showed :
1) LPN #1 entered Patient #21's room without performing hand hygiene. LPN #1 then donned non-sterile gloves to perform a blood pressure.
2) LPN #1 then pulled a tissue out of her pocket to remove a roll of tape with her gloved hand.
3) LPN #1 then removed the first pair of gloves and replaced them with a pair from her pocket without performing hand hygiene.
4) LPN #1 attempted intravenous catheter placement without success. LPN #1 changed gloves for the second attempt without performing hand hygiene.
C. During interview with the Director of Outpatient and Sterile Supply on 04/25/18 at 10:30 AM, she verified LPN #1 did not perform hand hygiene and that CDC guidelines were the guidelines the facility followed.
D. The above finding in A was verified with the Director of Outpatient and Sterile Supply on 04/25/18 at 10:35 AM.


Based on observation, review of policy and procedure and interview, it was determined the facility failed to control infections in contaminated instruments were transported from point of use to the soiled cleaning area in a warning labeled container for transport. The failed practice did not assure that contaminated instruments were identified as used and were not inadvertently used on another patient. The failed practice had the potential to affect all patients requiring reusable medical instruments in the procedure area. Findings follow:

A. Review of the policy and procedure showed
1) Warning labels should be affixed to all bags and containers used for medical waste.
2) Rigid containers for contaminated sharps and treated sharps shall be colored or labels as listed.
B. During observation while on tour of the procedural area on 04/23/18 at 2:00 PM, showed 7 of 7 rigid containers (used to transport used medical instruments) did not have a warning or biohazard label affixed to them.
C. During interview with the Director of Outpatient and Sterile Supply on 04/24/18 at 3:10 PM, she confirmed the rigid containers did not have any warning labels affixed to them prior to transporting them to the soiled area.
D. The above finding in A was verified with the Director of Outpatient and Sterile Supply on 04/24/18 at 3:15 PM.


Based on observation, review of the CDC recommendations, review of manufacturer's recommendation and interview, it was determined the facility failed to control infections in that one of one transvaginal ultrasound probe was not cleaned according to manufactures guidelines or document the disinfection of the probe itself. The failed practice did not ensure all remaining organic material had been removed from the transvaginal probe prior to its next use. The failed practice had the potential to affect all patients requiring an ultrasound using the transvaginal probe. Findings follow:

A. Review of the CDC recommendations for cleaning semi-critical devices stated that vaginal probes should be high-level disinfected due to the very high rate of probe cover perforation.
B. Review of T Spray II (disinfectant cleaner) instructions for use showed the disinfectant was not for use on critical or semi-critical medical device surfaces.
C. Review of the manufacturer's recommendation for the transvaginal probe showed:
1) The transducer was to be immersed in the cleaning solution shown in the table to dissolve or remove all remaining organic material.
2) The transducer was to be disinfected with a disinfectant listed in the table below.
D. Observation while on tour of the Ultrasound Room on 04/24/18 at 1:35 PM showed the transvaginal ultrasound probe was unwrapped inside a drawer with no evidence of its last cleaning.
E. During Interview with Ultrasound Technician #1, he stated he cleaned the transvaginal probe by wiping the gel off with a Cavi Wipe, then spraying the probe down with T- Spray II disinfectant cleaner and left to soak 20 minutes, then rinsed and placed in drawer for next use.
F. The above findings in A, B and C were verified with the Radiology Manager on 04/24/18 at 1:40 PM.


Based on observation and interview, it was determined the facility failed to identify and control infections in that expired cathelons were expired and available for patient use in two of two (Procedure Room #1 and #2) areas observed. The failed practice had the potential to allow less effective supplies to be utilized in the course of patient care. The failed practice had the potential to affect any patient whose care required the use of the expired supplies. Findings follow:

A. Observation Outpatient Procedure Area on 04/23/18 at 2:00 PM showed:
1) Procedure Room #1:
a) Ten 18 gauge cathelons expired 11/2016;
b) Two 18 gauge cathelons expired 8/2015;
c) Two 18 gauge cathelons expired 02/2016; and
d) One 24 gauge cathelon expired 11/2016.
2) Procedure Room #2:
a) Ten 18 gauge cathelons expired 11/2016;
b) Seven 18 gauge cathelons expired 01/2017
c) Two 18 gauge cathelons expired 06/2015
d) Two 18 gauge cathelons expired 02/2016;
e) Three 18 gauge cathelon expired 05/2017; and
f) One 20 gauge cathelon expired 09/2017.
B. The above findings in A were verified by interview with the Director of Nursing on 04/23/18 at 2:05 PM.


Based on observation, interview and manufacturer's recommendation, it was determined the facility failed to control infections in that oxygen extension tubing was not being changed after each patient in the two of two (CT Room and X-ray Room) areas observed. Failure to change the oxygen extension tubing after each patient use did not allow staff to ensure the oxygen tubing was free of airborne contaminants. The failed practice affected all patients requiring oxygen while having a CT scan or X-ray. Findings follow:

A. Review of the manufacturer's packaging of the oxygen extension tubing showed that it was for single patient use and not intended for reprocessing.
B. Observation in CT Room #1 and X-ray Room #1 on 04/24/18 at 10:10 AM showed oxygen extension tubing hanging from the oxygen flow meter. The Radiology Manager stated that piece of tubing was not changed between patients.
C. The above findings in A and B were verified with the Radiology Manager on 04/24/18 at 10:15 AM.

Based on observation and interview, it was determined the facility failed to assure seven of seven boxes of expired cream of wheat and eight of eight boxes of grits were not available for use in the Dietary Department past the manufacturer's expiration date. Failure to remove items according to the manufacturer's date of expiration did not assure the contents of the expired food items were suitable for patient consumption. The failed practice was likely to affect all patients admitted to the facility. Findings included:

A. Observation on 04/26/18 at 9:53 AM in the dry storage area of the Dietary Department showed seven of seven one pound boxes of cream of wheat that expired 01/04/18 and eight of eight one pound boxes of grits that expired 02/10/18.
B. The Dietary Manager confirmed the findings in A at the time of observation.

Based on clinical record review, review of policy, job description and interview, the facility failed to:
1) Assure reports of physical examination for four of four (#1- #4) Swing-Bed patients.
2) Assure there was an admission order for one (#1) of four (#1-#4) Swing-Bed patients.
3) Assure discharge planning was performed for four of four (#1-#4) Swing-Bed patients.

The failed practice did not assure information pertinent to care for Swing Bed patients would be available for use. The failed practice affected Patient #1-#4 and was likely to affect any patient admitted to Swing-bed. Findings included:

A. Review of the policy titled, "Swing-bed Discharge Planning Policy," on 04/27/18 showed that each patient was to have a planned program of continuing care to meet his post-discharge needs. The Discharge Planning Coordinator or designee was responsible for evaluating patients for needs that required intervention and for documenting the evaluation and pertinent information on the Discharge Planning Progress notes.
B. Clinical record review on 04/27/18 showed Patient #1 was admitted to Swing-Bed on 04/21/18 at 7:00 AM. There were no physician order to admit Patient #1 to the Swing-Bed. The finding was verified by the Assistant Director of Nursing on 04/27/18 at 9:05 AM.
C. Clinical record review on 04/27/18 showed Patient #1-#4 did not have a History and Physical for the admission to Swing-bed. The finding was verified by the Assistant Director of Nursing on 04/27/18 at 9:30 AM.
D. Clinical Record review on 04/27/18 showed Patient #1-#4 did not have discharge planning needs documented in the clinical record. The finding was verified by the Assistant Director of Nursing on 04/27/18 at 9:30 AM.

Based on review of contracted personnel files of Certified Registered Nurse Anesthetists (CRNAs), review of Anesthesia Services Contract, review of Arkansas Department of Health Rules and Regulations for Critical Access Hospitals (2016) and interview, Surgical Services failed to ensure one (#2) of two (#1 and #2) CRNAs had current Life Support Certification. By not assuring all certifications were current and up to date, did not assure CRNA #2 would be competent in an emergency situation. The failed practice had the likelihood to affect all patients admitted into the facility for procedures. Findings follow:

A. Record review of Anesthesia Services Contract showed CRNAs were to comply with the Arkansas Department of Health Rules and Regulations for Hospitals.
B. Record review of the Arkansas Department of Health Rules and Regulations for Hospitals, Section 11.B.6, showed that all licensed nursing personnel shall be competent in life support measures.
C. Review of contracted personnel files on 04/24/18 showed CRNA #2 did not have evidence of current competencies in life support measures. The latest certifications expired 12/31/17.
D. During an interview on 04/24/18 at 2:52 PM, Human Resources Representative verified the findings at C.