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Tag No.: C0222
Based on observation, interview, and review of manufacturer's instructions for use, it was determined the facility failed to ensure safety and quality for three of three point of care blood glucose testing devices by not documenting open dates on 11 of 11 glucose control solution bottles to assure they were not beyond the use date of 90 days. The failed practice did not assure the glucose devices were safe for patient testing.
A. Record review on 8/13/18 of the manufacturer's instructions for the ACCU-CHEK Inform II glucose control solutions for one (gray cap-low blood glucose) and two (white cap-high blood glucose) showed that once the control solution bottles were opened they were stable for up to three months (90 days) or until expirations date.
B. Emergency Department
1) Observation on 08/13/18 at 2:05 PM showed two of two ACCU-CHEK Inform II two of two control solutions of one and two were in use with no open date on the bottles.
2) The findings in B1 were verified by Registered Nurse (RN) #1 on 08/13/18 at 2:05 PM.
C. Medical Surgical Unit
1) Observation of the Medical Surgical Nurses Station on 08/13/18 at 2:15 PM showed two of two ACCU-CHEK Inform II control solutions one and two were in use with no open date on the bottles.
2) The findings in C1 were verified by the Director of Nurses on 8/13/18 at 2:15 PM.
3) Observation of the Medical Surgical Nurses Station on 08/13/18 at 2:25 PM showed seven of seven ACCU-CHEK Inform II one and two control solution bottles in various stages of use with no date opened.
4) Findings in C3 were verified by RN #2 and #3 on 8/13/18 at 2:27 PM.
Tag No.: C0276
Based on observation and interview, the facility failed to ensure medications were stored and controlled in two of two (Room #1 and #2) Operating Rooms in that medications were found unlocked and available to unlicensed personnel. By not assuring only licensed personnel have access to the medications, the facility could not assure the medications' safety, efficacy and inventory. The failed practice had the likelihood to affect all patients who receive medications from the facility. Findings follow:
A. Record review of the facility's policy titled, "Drug Security," showed that medications were to be locked when not in use.
B. During a tour of Surgical Services on 08/14/18 from 08:54 AM to 11:10 AM, observation showed the following examples of medications found on or in unlocked drawers of the anesthesia medication carts in the Operating Rooms. Observation also showed unlicensed cleaning personnel in both operating rooms, cleaning, while no licensed personnel supervised:
1) Operating Room #1 -#1 Bupivacaine 150 mg (milligram)/ ml(milliliter) sitting on top of the anesthesia medication cart.
2) Operating Room #2- Drawers 1, 5, 6, 7 and 8 of the anesthesia medication cart were unlocked and the following were examples of the medications unsecured in drawers:
a) Drawer #1:
1. Two Invanz 1 gm (gram) vial;
2. Three Ceftazidime 1 gm vials; and
3. Two Metoprolol 5 mg/5 ml vials.
b) Drawer #5:
1. Six Bupivacaine .75 mg ampules;
2. Four Atropine .4 mg/ml vials; and
3. Four Dexamethasone 10 mg/ml vials.
c) Drawer #6:
1. Thirteen Keterolac 30 mg/ml vials;
2. Six Sensorcaine .5%/10 ml vials; and
3. Fourteen Glycopyrolate .2 mg/ml vials.
d) Drawer #7: #15 Propofol 200 mg/ 20 ml vials.
e) Drawer #8: #8 Propofol 500 mg/50 ml vials.
C. During an interview on 08/14/18 at 11:02 AM, the Operating Room Manager verified the findings at B.
Based on observation, review of manufacturer's recommendations and interview, it was determined the facility failed to follow manufacturer's recommendations in the temperature storage of medications in two (Emergency and Surgical Services) of three (Emergency, Surgical Services and Medical/Surgical) areas toured. By not following manufacturer's recommendations for use, the facility could not assure the safety and efficacy of the medications. The failed practice had the likelihood to affect all patients that receive medications. Findings follow:
A. Review of manufacturer's recommendations for the storage of Mannitol injection showed it was to be stored between 68 and 77 degrees Fahrenheit.
B. Review of manufacturer's recommendations for the storage of IV solutions showed the solutions should not have been stored in temperatures higher than 104 degrees Fahrenheit.
C. Review of manufacturer's recommendations for the use/storage of .9% Sodium Chloride 50 ml bags showed the bags were to remain in its protective pouch until ready to use.
D. During a tour of the Emergency Department on 08/13/18 from 1:47 PM to 2:09 PM observation showed a warmer with the following items being stored at 122 degrees Fahrenheit:
1) Five Mannitol 12.5 gm (gram)/ 50 ml (milliliter) for injection;
2) Two Sodium Chloride .9% 1000 ml IV (Intravenous Solutions); and
3) Two Lactated Ringers 1000 ml IV solutions.
E. During a tour of Surgical Services on 08/14/18 from 8:54 AM to 11:10 AM observation showed one Sodium Chloride .9% 50 ml IV solution stored in the anesthesia medication cart outside of its protective pouch and available for patient use.
F. During an interview on 08/13/18 at 2:02 PM, the Director of Pharmacy verified the findings at E.
G. During an interview on 08/14/18 at 9:50 AM, CRNA #1 verified the findings at A.
Tag No.: C0278
Based on observation, review of policies and procedures, Guidelines for Perioperative Practice by the Association of Perioperative Registered Nurses (AORN) and interviews, it was determined the facility failed to have a system in place to identify practices that were infection risks and implement infection prevention interventions in the surgical area as follows:
1) Three of three soiled instrument sets observed on 08/14/18 and 08/16/18 were not transported to the decontamination area in a transport cart or closed container that was leak proof, puncture resistant, and labeled with a biohazard label.
2) Two of two surgical services staff (#2 and #3) on 08/16/18 were cleaning soiled surgical instruments in the decontamination area without wearing personal protective equipment (PPE) of: a fluid-resistant gown with sleeves, general purpose utility gloves with a cuff that extended beyond the cuff of the gown, a mask and eye protection or a full face shield and shoe covers.
3) Five of five chairs, located in the sterile processing room, were upholstered in a porous type material, had a soiled overall appearance, and was likely to harbor microorganisms that could transfer harmful bacteria to staff and sterile processes.
4) In one of one clean utility storage room, in the surgical area, there were heavy sterilized packs of instruments stacked on top of the other.
5) One of one steam sterilizer between operating room (OR) #1 and #2 did not have weekly maintenance as required by policy.
6) In one (#1) of two (#1 and #2) operating rooms (OR) cleaning did not progress from clean to dirty areas.
(See C-0320)
Based on record review of policy, reportable disease list and interview, it was determined the facility failed to maintain the most current list (12/01/16) of Mandatory Reportable Disease list by the Arkansas Department of Health (ADH) to report communicable diseases. The failed practice did not ensure significant health diseases and infections would be reported to the ADH. The failed practiced was likely to affect any patient who had a reportable disease. Findings included:
A. Record review of the facility's policy titled, "Infection Control Surveillance," dated revised 01/2011, showed that the Infection Control Nurse (ICN) reviewed the admission diagnosis of all patients admitted and reports contagious disease to the ADH and to see attached sheet for instructions for reporting.
B. Review of the ADH Mandatory Reportable Diseases List and instructions provided by the facility showed a form dated 09/01/14. During an interview on 08/17/18 at 10:40 AM, the Director of Nursing and Infection Prevention Nurse stated that the mandatory reportable disease list used for reporting required diseases and infection was dated 09/01/14.
C. Review of the current ADH Mandatory Reportable Diseases List and instructions showed a date of 12/01/16.
31039
Based on observation, review of APIC (Association for Professionals in Infection Control and Epidemiology) position paper and interview, it was determined the facility failed to mitigate risks of healthcare related infections by not identifying the practice of storing SDV (Single Dose Vial) and MDV (Multiple Dose Vial) once opened in immediate patient treatment areas in two of two (Room #1 and #2) OR (Operating Rooms) toured. By not identifying the risk this practice carries, the facility could not assure their patients safety. This failed practice has the likelihood to affect all patients receiving procedures in the facility. Findings follow:
A. Review of APIC position paper titled "Safe Injection, Infusion, and Medication Vial Practices in Health Care (2016)," showed MDV should never enter the immediate patient care area, they must be dedicated for single patient use and discarded immediately after use.
B. During a tour of Surgical Services on 08/14/18 from 08:54 AM to 11:10 AM, observation showed the following on the anesthesia medication carts:
1) Anesthesia Cart in OR #1:
a) One Bupivicaine 150 mg (milligram)/ml (milliliter) SDV, opened, dated 08/14/18 08:00 AM, stored on the cart, available for another patient's use. Dating the vial indicates it was to be kept and used; and
b) One Neostigmine 10 mg/10 ml MDV, opened, and stored in the cart, available for another patient's use.
2) Anesthesia Cart in OR #2: One Neostigmine 10 mg/10 ml MDV, opened, and stored in the cart, available for another patient's use.
C. During an interview on 08/14/18 at 11:02 AM, the Operating Room Manager verified the findings at B.
Tag No.: C0301
Based on observation, review of policy, review of Arkansas Department of Health, Rules and Regulations for Critical Access Hospitals 2016, Section 61, and interview, it was determined the facility failed to store medical records per policy in that the paper medical records were stored in one of one building that was not protected from fire by either one-hour fire rated enclosure or protected by a sprinkler system. By not storing medical records properly, the facility could not assure the integrity of the records. The failed practice had the likelihood to affect all patients' records stored by the facility. The findings follow:
A. Record review of the facility's policy titled, "General Requirements of the Department," showed all patient records, whether stored within the Health Information Management Department or other areas, either within the facility or away from the facility, shall be protected from destruction by fire, water, vermin, dust, etc.
B. During a tour of Medical Records on 08/14/18 at 1:46 PM, observation showed the paper medical records were stored in two rooms upstairs of Medical Records Department. The Medical Records Department was in a seperate building from the hospital. Neither room were one-hour fire rated enclosures or protected by sprinklers per Arkansas Department of Health, Rules and Regulations for Critical Access Hospitals 2016, Section 61: Physical Facilities, Health Information Unit.
C. During an interview on 08/14/18 at 2:00 PM, the Director of Medical Records verified the paper medical records stored in both rooms were not protected from fire.
Tag No.: C0302
Based on Medication Incident Documentation, review of clinical records and interview, it was determined in one (#1) of two (#1 and #2) incidents of 'wrong medication' errors they were not documented in the clinical record for Patient #22 who received the medication in error. By not documenting the medication errors, the facility was not keeping an accurate record of the patient's course of treatment and care. The failed practice had the potential to affect all patients that are treated at the facility. Findings follow:
A. Review of Medication Incident Documentation for Incident #1 showed Patient #22 had an order for Potassium IV (Intravenous) and was given Levaquin IV in error.
B. Review of clinical records showed Patient #22's clinical record did not have Levaquin documented as given, but had the Potassium IV documented as given.
C. During an interview on 08/14/18 at 01:21 PM, the Director of Pharmacy verified the findings at A and B.
Tag No.: C0305
Based on review of surgery clinical records, review of policy and interview, it was determined the facility failed to have medical history and physical (H&P) examinations updated prior to any surgical or invasive procedure performed except in an emergency in 4 (#16, 17, 19 and 20) of 5 (#1-#5) surgery clinical records. By not having the information in the chart, the facility could not assure the patient's course of treatment was not compromised by the lack of information. The failed practice had the likelihood to affect all patients. Findings follow:
A. Record review of the facility's policy titled, "Record Content," showed a history and physical was to be done up to 30 days prior to admission if the physician updates the examination at the time of admission.
B. Review of surgery clinical records showed the following:
1) Patient #16 was admitted on 08/08/18 at 6:43 AM and had surgery at 8:32 AM. The H & P was done on 08/07/18 at 11:45 AM and was not updated on admission for surgery.
2) Patient #17 was admitted on 08/01/18 at 9:40 AM and had surgery at 10:36 AM. The H & P was done on 007/24/18 at 10:05 AM and was not updated on admission for surgery;
3) Patient #19 was admitted on 005/30/18 at 10:12 AM and had surgery at 11:12 AM. The H & P was done on 05/29/18 at 11:41 AM and was not updated on admission for surgery: and
4) Patient #20 was admitted on 05/29/18 at 7:30 AM and had surgery at 8:50 AM. The H & P was done on 05/02/18 at 11:56 AM and was not updated on admission for surgery.
C. During an interview on 08/16/18 at 3:15 PM, Clinical Informatics Analyst #1 verified the findings at B.
Tag No.: C0320
Based on observation, review of policies and procedures, Guidelines for Perioperative Practice by the Association of Perioperative Registered Nurses (AORN) and interviews, it was determined surgical services did not have processes in place to assure procedures were carried out in a safe manner to protect the health and safety of surgical patients in accordance with standards of practice and policy. The cumulative effects of the failed practices did not ensure surgical services was performed in a safe manner. See citations below for cumulative effects:
Based on observation, review of policies, procedures, Guidelines for Perioperative Practice, 2016, by the Association of Perioperative Registered Nurses (AORN) and interviews, it was determined the facility failed to assure surgical services were performed in accordance with standards of practice in that three of three soiled instrument sets observed on 08/14/18 and 08/16/18 were not transported to the decontamination area in a transport cart or closed container that was leak proof, puncture resistant, and labeled with a biohazard label. The facility could not be assured operating room (OR) staff would be protected from exposure to likely sources of infection and had the likelihood to affect patents safety due to infection. The failed practice affected all OR staff and any patient in contact with Surgical Services Staff #1 and #2. Findings included:
A. Record review of facility's policy titled, "Decontamination Point of Use Preparation and Transport," dated reviewed 01/2018, showed staff were to be trained in the safe handling, preparation and transport of soiled instruments to the Central Sterile decontamination room and placed in biohazard containers for transport.
B. The Director of Nursing, Infection Control Nurse and the Surgical Services Manager, were interviewed together on 08/17/18 at 10:40 AM and confirmed the facility followed AORN guidelines for surgical services.
C. Review of AORN Guidelines, 2016 for instrument cleaning, recommendation IV showed soiled instruments must be transported to the decontamination area in a closed container or enclosed transport cart. The container or cart must be: leak proof, puncture resistant, large enough to contain all contents and labeled with a fluorescent orange or orange red label containing a biohazard symbol.
D. Observation of Surgical Services staff on 08/14/18 and 08/16/18 showed instruments were transported from OR #1 and #2 into the decontamination area and were not transported in leak proof, puncture resistant containers with biohazard label as follows:
1) 08/14/18 at 9:00 AM showed surgical services Staff #1 transported soiled instruments by hand carrying on an instrument tray covered with a blue surgical towel.
2) 08/16/18 at 12:45 PM showed Surgical Services Staff #2 transported soiled instruments by hand carrying on an instrument tray covered with blue surgical towel.
3) 08/16/18 at 1:24 PM showed Surgical Services Staff #3 transported soiled instruments by hand carrying an instrument tray covered with a blue surgical towel.
E. The findings in D. were confirmed by interview with the Manager of OR/Surgical Services at 2:45 PM on 08/16/18.
Based on observation, review of policies, procedures, Guidelines for Perioperative Practice, 2016, by the Association of Perioperative Registered Nurses (AORN) and interviews, it was determined the facility failed to assure Surgical Services were performed in accordance with standards of practice and facility policies in that two of two Surgical Services Staff (#2 and #3) on 08/16/18 were observed cleaning soiled surgical instruments in the decontamination area and did not wear personal protective equipment (PPE) of: a fluid-resistant gown with sleeves, general purpose utility gloves with a cuff that extended beyond the cuff of the gown, a mask and eye protection or a full face shield, and shoe covers. The facility could not be assured staff in the decontamination area would be protected from likely sources of infection from exposure to splashes, skin contact, punctures or cuts and contamination. The failed practice affected Surgical Services Staff #2 and #3 and all patients and staff who work in surgical services. Findings included:
A. Review of facility policy, "Receiving and Decontamination of Supplies and Equipment," revised 02/2011 showed personnel working in the decontamination area of the surgery department should at all times have on personal protective equipment when working with contaminated items. Review of the policy, "Care and Handling of Instruments," reviewed 02/2011, showed protective equipment was to be worn at all times when handling contaminated instruments. Review of the policy, "Surgical Attire/Dress Code," showed personal protective equipment (protective eyewear, gloves, gowns, masks, etc ...) was to be worn when contact with blood or body fluids are anticipated. Fluid-resistant shoe covers are to be worn when splashing or spills are anticipated.
B. The Director of Nursing, Infection Control Nurse and Surgical Services Manager were interviewed together on 08/17/18 at 10:40 AM and confirmed the facility followed AORN guidelines for surgical services.
C. Review of AORN Guidelines, 2016 instrument cleaning, Recommendation VI showed that personnel working in the decontamination area and handling contaminated instruments must wear PPE consistent with the exposure risks. The PPE that must be worn include a fluid-resistant gown with sleeves; general purpose utility gloves with a cuff that extends beyond the cuff of the gown; a mask and eye protection or a full face shield and shoe covers or boots designed for use as PPE.
D. Observations of surgical services staff on 08/16/18 showed:
1) 12:45 PM: Surgical Services Staff #2 was in the decontamination room and cleaning soiled instruments at the sink. Staff #2 did not have on a fluid resistant gown with sleeves, or general purpose utility gloves with a cuff that extended above the cuff of the gown. Surgical Services Staff #2's arms were exposed and the uniform was exposed to likely sources of contamination from soiled instrument cleaning. Surgical Staff Staff #2 did not change the uniform and was observed to return to an orthopedic surgical case after cleaning the soiled instruments.
2) 1:24 PM: Surgical Services Staff #3 was in the decontamination room and cleaning soiled instruments at the sink. Staff #3 did not have on a mask, eye protection, a fluid-resistant gown with sleeves or general purpose utility gloves with a cuff that extended above the cuff of the gown. Observation of Surgical Services Staff #3 showed upon completion of instrument cleaning, a wet area approximately three inches in length was present on the front of the uniform top. Surgical Services Staff #3 stated that it was time for lunch and was finished with the cases for the day when Surveyor #1 asked about the wet spot on the front of the uniform top.
E. The findings in D. were confirmed by interview with the Manager of OR/Surgical Services at 2:45 PM on 08/16/18.
Based on observation, Guidelines for Perioperative Practice, 2016, by the Association of Perioperative Registered Nurses (AORN) and interviews, it was determined the facility failed to assure surgical services were performed in accordance with standards of practice for terminal cleaning and disinfection of the sterile processing room. The surfaces of five of five chairs located in the sterile processing room were upholstered in a porous type material, soiled in overall appearance, and likely to harbor microorganisms that could transfer harmful bacteria to staff and sterile processes. The failed practice was likely to affect surgical services staff and all patients who had surgery at the facility. Findings included:
A. The Manager for Support Services was interviewed on 08/14/18 at 3:30 PM and confirmed there was no specific policy for Environmental Services staff to utilize for cleaning the surgical services area.
B. The Director of Nursing, Infection Control Nurse and Surgical Services Manager were interviewed together on 08/17/18 at 10:40 AM and confirmed the facility followed AORN guidelines for surgical services.
C. Review of AORN Guidelines, 2016 Environmental Cleaning, Recommendation IV showed that terminal cleaning and disinfection of perioperative areas, including sterile processing, should be performed daily when the areas were being used.
D. Observation on 08/16/18 at 12:48 PM showed five of five chairs being used in the sterile processing room were overall soiled and discolored with drip spots on the seats that were discolored. The cover to the chairs were cloth type and porous.
E. The findings in D. were confirmed by interview with with the Manager of OR/Surgical Services at 2:45 PM on 08/16/18.
Based on observation, review of policies, procedures, Guidelines for Perioperative Practice, 2016, by the Association of Perioperative Registered Nurses (AORN) and interviews, it was determined the facility failed to assure sterile instrument storage was in accordance with standards of practice and facility policy in that large, heavy sterilized packs of instruments were stacked one on top of the other in one of one clean utility storage room in surgical services. Stacking multiple heavy instrument sets on top of each other were likely to crush the sterile packaging and compromise the sterility of the contents. The failed practice had the likelihood to affect all surgical patients. Findings included:
A. Review of the facility policy, "Sterilization and Disinfection Guidelines for Surgical Supplies and Instrumentation," revised 02/2011 showed all wrapped sterilized packages were to be handled as little as possible and stored in a way to minimize stress and pressure and that heavy trays would be placed on bottom and smaller ones on top.
B. The Director of Nursing, Infection Control Nurse and Surgical Services Manager were interviewed together on 08/17/18 at 10:40 AM and confirmed the facility followed AORN guidelines for surgical services.
C. Review of AORN Guidelines, 2016 Sterilization and Disinfection, Recommendation XV showed that events may compromise the sterility of a package include multiple instances of handling that leads to seal breakage or loss of package integrity.
D. Observation on 08/16/18 at 12:06 PM showed multiple sterilized instrument trays that were heavy and stored stacked one on the other. Removal of the sterile instrument trays from the stacks was likely to cause tears or holes in the sterilization wrap and compromise the sterility of the sterilized instruments. Examples included in the Clean utility area, Total Knee Arthroplasty instrument trays stored in stacks, six and seven trays on top of the other.
E. Staff #1 was interviewed at 12:28 PM and confirmed large, heavy sterile instrument trays were stacked one on top of the other.
F. The findings in D. were confirmed by interview with the Manager of OR/Surgical Services at 2:45 PM on 08/16/18.
Based on observation, review of facility policy and interview, it was determined the facility failed to assure weekly equipment maintenance was performed according to policy for one of one steam sterilizer located in the hallway between operating room (OR) #1 and #2. The facility could not be assured the equipment would be ready to use and functional without performance of routine and preventive cleaning. The failed practice had the likelihood to affect all patients who have surgery at the facility. Findings included:
A. Record review of facility policy,"Cleaning and Decontamination of Equipment and Sterilizers Procedure," reviewed 02/2011 showed the steam sterilizer was to be cleaned weekly with a mild detergent and soft cloth and to clean the filter weekly when the inside of the sterilizer was cleaned.
B. Observation on 08/14/18 of the Steris AMSCO pre-vac steam sterilizer in the hallway between OR #1 and #2 at 9:40 AM showed an accumulation of white material and discoloration in the bottom of the sterilizer.
C. The findings in B. were verified by the Manager of OR/Surgical Services at 11:06 AM on 08/14/18. On 08/16/18 at 11:00 AM the Manager of OR/Surgical Services stated that there was no documentation of routine cleaning of the sterilizer.
Based on observation, interview, review of policies and Association of Perioperative Registered Nurses (AORN) Guidelines it was determined the facility failed to follow established methods and standards of practice for reestablishing a clean environment in one (#1) of two (#1 and #2). The failed practice did not ensure items were not omitted in the cleaning process and that all OR patients would be protected from likely sources of infection. Findings included:
A. Record review of facility policy, "Patient Area Cleaning Procedures," revised 07/2014 showed the policy applied to all areas of the hospital. There was no specific process listed for surgical services in this policy as provided. Record review of the facility policy, "Cleaning of Surgery Suites," effective 05/05/13 showed it was for cleaning of the OR between surgery case and to see the attached check list. The check list did not include specific procedures to follow for cleaning each item or area.
B. The Director of Nursing, Infection Control Nurse and Surgical Services Manager were interviewed together on 08/17/18 at 10:40 AM and confirmed the facility followed AORN guidelines for surgical services.
C. Review of AORN Guidelines, 2016 Environmental Cleaning, Recommendation II showed that a clean environment should be reestablished after the patient was transferred from the area. Reusable non-critical, non-porous surfaces should be cleaned and disinfected after each patient use. Recommendation VI, Aseptic Practice, showed cleaning activities and disinfection should be performed methodically from clean to dirty areas; top to bottom surfaces and clockwise or counter-clockwise to ensure items were not omitted in the cleaning process and limit infection transmission.
D. Observation on 08/14/18 at 09:08 showed Environmental Services Aide #1 and #2 cleaning OR #1 after a surgical procedure. A white cloth was used to wipe down multiple pieces of equipment. The intravenous (IV) poles, air control panel, x ray viewer, medication and anesthesia cart were cleaned with the same cloth from top to bottom and back up to the top on each surface. Environmental Services Aide #1 then proceeded to wipe the anesthesia keyboard, then wiped an open laryngoscope handle and blades (four curved and one straight) that were left on the anesthesia cart using the same cloth. A clean cloth was obtained and changed by Environmental Services Aide #1 at 9:17 AM. Environmental Services Aide #1 proceeded to clean the remainder of the room. Environmental Services Aide #2 also cleaned equipment along the edge of the room going from top to bottom and back up to top. Environmental Services Aide #1 was asked what the process was for cleaning the OR and stated that it varied; sometimes the cleaning started in the corner and sometimes in the middle. Environmental Services Aide #1 stated that they tried to make sure everything was wiped down. Environmental Services Aide #2 stated that today was her second day and she was in training. Environmental Services Aide #1 confirmed the process at the time of observation.
E. The Manager of Support Services was interviewed on 08/14/18 at 3:30 PM and stated that there was no specific policy or process for cleaning the operating room and that staff followed the general cleaning policy of the facility.
31039
Based on observation and interview, it was determined the facility failed to follow acceptable standards of practice for patient safety in that they did not have a policy and procedure, training nor the recommended number of vials of Dantrolene available to treat a Malignant Hyperthermia Emergency in one of one (Surgical Services) area toured that used depolarizing muscular relaxants. 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. The failed practice had the potential to affect all patients admitted for surgical procedures. Findings follow:
A. During a tour of the facility on 08/14/18 from 8:54 AM to 11:15 AM, observation showed the facility stored 24 vials of the emergency medication Dantrolene. MHAUS recommends 36 vials of Dantrolene, or 18 and the ability to obtain the other 18 within 10 minutes.
B. During an interview on 08/14/18 at 09:50 AM, CRNA #1(Certified Registered Nurse Anesthetist) was asked where the Malignant Hyperthermia emergency medication was, and CRNA #1 was unaware and could not answer the question.
C. During an interview on 08/14/18 at 2:28 PM, the Director of Pharmacy verified there were 24 vials of Dantrolene throughout the facility. The Director of Pharmacy also verified the facility did not have a policy or procedure or training for a Malignant Hyperthermia event.