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Tag No.: A0167
Based on policy and procedure review, clinical record review and interview, it was determined nursing staff failed to follow policy and procedure in that staff failed to assess one of one (#26) restrained patient every one hour. Failure to assess every one hour did not allow staff to be in compliance with facility policy and procedure. The failed practice affected Patient #26 on 11/04/17 and 11/05/17. Findings follow:
A. Review of the policy and procedure titled, "Restraint Management Nursing Protocol," received from the Chief Nursing Officer (CNO) at 10:40 AM on 11/16/17 showed that each restrained patient was to be assessed at least every one hour for level of consciousness/orientation, mental/emotional status, restrained extremity for color, pulse, movement, sensation, skin integrity and evidence of edema in restrained extremity.
B. Review of nursing notes, nursing narratives and restraint documentation showed that Patient #26 was placed in soft wrist restraints at 5:30 PM on 11/04/17 and remained in them until discontinued at 5:00 AM on 11/05/17. Staff assessments were performed every two hours at 8:00 PM, 9:59 PM, and 11:55 PM on 11/04/17 and 2:00 AM, 4:00 AM and 5:00 AM on 11/05/17.
C. During an interview with the CNO at 10:57 AM on 11/16/17, she verified the findings in A and B.
Tag No.: A0168
Based on policy and procedure review, clinical record review and interview, it was determined staff placed one of one (#26) restraint patient in two different types of restraints without physician's orders; failed to follow physician's orders for restraints; and failed to obtain a physician's order every four hours for restraints as required by policy and procedure. Failure to follow and obtain physician's orders did not allow the physician to be in control of the patient's care and did not allow the facility follow its policy and procedure. The failed practice affected Patient #26 on 11/04/17. Findings follow:
A. Review of the policy and procedure titled, "Restraint Management Nursing Protocol," received from the Chief Nursing Officer (CNO) at 10:40 AM on 11/16/17 showed that restraint orders should include the specific restraint to be used and each written restraint order was limited to four hours for adults.
B. Review of Patient #26's clinical record showed:
1) A restraint order authored by Physician #1 at 4:32 PM on 11/04/17 for a vest restraint.
2) Review of nursing notes, nursing narrative and restraint documentation showed that Patient #26 was placed in soft wrist restraints at 5:30 PM on 11/04/17 and remained in them until discontinued at 5:00 AM on 11/05/17. Review of physician's orders showed no order for the soft wrist restraints.
3) Review of nursing notes and nursing narratives showed that four side rails were raised at 1:29 AM on 11/05/17 in order to keep Patient #26 from eloping again. Review of physician's orders showed no order for four side rails raised.
C. During an interview at 10:57 AM on 11/16/17, the CNO verified the findings in A and B.
Tag No.: A0490
Based on observation, review of policy, review of manufacturer's instructions and interview, it was determined the facility failed to store anesthesia medications according to manufacturer's recommendations in one (Anesthesia) of six (Anesthesia, Emergency, Post Anesthesia, Intensive Care, Labor and Delivery and Medical/Surgical) medication refrigerators observed in that the temperature was higher than the recommended 36-46 degrees Fahrenheit. By storing the medications in a higher temperature then manufacturer's recommendations, the facility could not assure their safety or efficacy. The failed practice had the likelihood to affect all surgical patients admitted for procedures. Findings follow:
A. Review of policy titled,"Drug Inventory Control," showed that medications were to be stored under conditions stated by the manufacturer to assure stability of that medication.
B. During a tour of the facility on 11/13/17 from 1:01 PM to 3:05 PM, observation of the refrigerator that Anesthesia used showed:
1) #48 vials of Rocuronium Bromide 100 mg (milligram)/ml (milliliter);
2) #19 vials of Rocuronium Bromide 50 mg/ ml;
3) #25 vials of Succinylcholine 200 mg/ 20 ml.
4) There was not a functioning thermometer inside the refrigerator; and
C. A thermometer was obtained and placed in the Anesthesia refrigerator. The temperature of the refrigerator was 51 degrees Fahrenheit.
D. Review of package insert for Succinylcholine showed that it was to be stored at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit).
E. Review of package insert for Rocuronium Bromide showed that it was to be stored at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit).
F. During an interview on 11/13/17 at 2:57 PM, the Director of Surgery and Endoscopy verified the temperature in the refrigerator was 51 degrees.
Based on observation, review of policy and interview, it was determined the facility failed to monitor temperatures for one (Anesthesia) of six (Anesthesia, Emergency, Post Anesthesia, Intensive Care, Labor and Delivery and Medical/Surgical) medication refrigerators observed in that there was no evidence the refrigerator was inspected daily (per policy) and there was not a functioning thermometer in the refrigerator. By not monitoring the refrigerator temperatures, the facility could not assure medications were stored at the proper temperature (2 to 8 degrees Celsius or 36 to 46 degrees Fahrenheit). The failed practice had the likelihood to affect all surgical patients admitted for procedures. Findings follow:
A. Review of policy titled, "Refrigerated Drug Storage," showed that all refrigerated drug storage areas were to be inspected daily and the temperatures should be between 2 to 8 degrees Celsius or 36 to 46 degrees Fahrenheit.
B. During a tour of the facility on 11/13/17 from 1:01 PM to 3:05 PM, observation of the Anesthesia refrigerator showed:
1) #48 vials of Rocuronium Bromide 100 mg (milligram)/ml (milliliter);
2) #19 vials of Rocuronium Bromide 50 mg/ ml; and
3) #25 vials of Succinylcholine 200 mg/ 20 ml.
C. Observation at the time of the tour showed there was no functioning thermometer in the refrigerator.
D. During an interview on 11/13/17 at 2:36 PM, CRNA #3(Certified Registered Nurse Anesthetist) verified the refrigerator was not being monitored daily for temperature compliance.
Based on observation, review of policy, review of manufacturer's package insert and interview, it was determined the facility failed to date Succinylcholine and Rocuronium when removed from refrigerated storage and stored in three of three anesthesia carts. By not dating the medications once removed from the refrigerator, the facility could not assure the medications wouldn't still be available for patient use beyond the Manufacturer's recommended expired date. The failed practice had the likelihood to affect all patients admitted for surgical procedures. Findings follow:
A. Review of policy titled, "Medication Process," showed that nurse anesthetists were responsible for monitoring the stability of refrigerated drugs removed from refrigerated storage and stored on their carts. It also showed that medications removed from the refrigerator and placed on the anesthesia carts would be dated with the day removed from refrigerator on the vial.
B. During a tour of the facility on 11/13/17 from 1:01 PM through 3:05 PM, the following was observed:
1) Anesthesia Cart #1 showed two vials of Succinylcholine and one vial of Rocuronium not dated with the day removed from refrigerator;
2) Anesthesia Cart #2 showed two vials of Succinylcholine not dated with the day removed from refrigerator; and
3) Anesthesia Cart #3 showed one vial of Succinylcholine and one vial of Rocuronium not dated with the day removed from refrigerator.
C. Review of package insert for Succinylcholine showed that multi-dose vials were stable for up to 14 days at room temperature without significant loss of potency.
D. Review of packaging for the Rocuronium Bromide showed that upon removing from refrigerator to room temperature, use within 60 days.
E. During an interview on 11/13/17 at 2:36 PM, CRNA #3 (Certified Registered Nurse Anesthetist) verified the medications were not dated with the day removed from refrigerator.
Tag No.: A0502
Based on observation, review of policy and interview, it was determined the facility failed to secure medications in one (Anesthesia) of six (Anesthesia, Emergency, Post Anesthesia, Intensive Care, Labor and Delivery and Medical/Surgical) medication refrigerators in that the refrigerator did not lock and its contents were accessible to unauthorized individuals. By not locking the refrigerator, the facility could not assure the safety and efficacy of the medications. The failed practice had the likelihood to affect all surgical patients. Findings follow:
A. Review of policy titled, "Medication Security," showed that all drugs and biologicals stored within the hospital shall be kept in a secure area, locked when appropriate and accessible only to licensed personnel.
B. During a tour of the facility on 11/13/17 from 1:01 PM to 3:05 PM, observation of the refrigerator that Anesthesia used showed:
1) #48 vials of Rocuronium Bromide 100 mg (milligram)/ml (milliliter);
2) #19 vials of Rocuronium Bromide 50 mg/ ml; and
3) #25 vials of Succinylcholine 200 mg/ 20 ml.
4) There was not a locking mechanism on the refrigerator.
C. During an interview on 11/13/17 at 2:36 PM, CRNA #3 verified the refrigerator was not locked.
Tag No.: A0619
Based on review of policy and procedure, temperature logs and interview, it was determined the facility failed to perform remedial action to ensure the temperature of one of one walk-in freezer was maintained at 0 (zero) to - (minus) 20 degrees per policy and procedure. The failed practice created the potential to allow spoiled foods to be served to patients, visitors and staff. The failed practice affected all patients, visitors and staff who were served items stored in the walk-in freezer. Findings follow:
A. Review of the policy and procedure received from the Director of Food and Nutrition Services on 11/13/17 titled, "Procedure For Storing Frozen Foods," showed that:
1) Frozen fruits and vegetables were to be held at a temperature of 0 degrees or below.
2) Frozen meats, fish and poultry were to be held at a temperature of 0 degrees to -20 until removed from the freezer for thawing and cooking.
3 Frozen eggs were to be held at 0 to -20 degrees. Defrost eggs by setting in pan of cold water. Use immediately after thawing.
4) Ice cream should be held at 0 to -20 degrees.
B. Review of the walk-in freezer temperature logs for August, September and October 2017 showed temperature readings recorded as follows:
1) August 2017- the temperature was above 0 degrees for 31 of 31 days in the morning (AM), 26 of 31 days at noon and 16 of 31 days in the evening (PM).
2) September 2017-the temperature was above 0 degrees for 30 of 30 days in the AM, 26 of 30 days at Noon and 17 of 30 days in the PM.
3) October 2017-the temperature was above 0 degrees for 7 of 31 days in the AM, 20 of 31 days at Noon and 24 of 31 days in the PM.
C. Review of the walk-in freezer temperature logs from August 2017 to October 2017 showed that there was no evidence maintenance was notified of the temperatures above 0 degrees.
D. The Director of Food and Nutrition verified the findings in A, B and C during an interview at 10:35 AM on 11/15/17.
Based on observation and interview, it was determined the facility failed to ensure prepared food items were dated with the date of preparation and the date of expiration for 71 of 71 individual cups of Jell-O. Failure to date prepared food had the potential to allow spoiled food items to be served to patients, visitors and staff. The failed practice affected all patients, visitors and staff who were served Jell-O on 11/15/17. Findings follow:
Four trays of prepared Jell-O (71 individual cups) observed in the reach-in cooler were not labeled with the preparation and expiration dates. The Director of Food and Nutrition Services stated in an interview at 10:30 PM on 11/15/17 that each lid of the individual cups should have the preparation and expiration dates written across the lid.
Tag No.: A0709
Based on observation and interview, it was determined the facility failed to maintain the fire and smoke rated barrier in 4 (above the fire-rated doors labeled #4 central corridor of Building 01, #5 south corridor Building 01, #6 in the north corridor near the lobby Building 01, and #16 in the west corridor of Building 02) of 10 areas observed by protecting penetrations in the barrier with a system or material capable of limiting 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 with the Director of Maintenance and Engineering on 11/14/17 at 12:50 to 1:30 PM, observation showed:
1) Fire alarm cables in one penetration in the fire-rated barrier above the fire-rated doors labeled #5. The penetration was not sealed with a system or material capable of limiting the transfer of smoke from one side of the barrier to the other.
2) A black pipe in one penetration in the fire-rated barrier above the fire-rated doors labeled #4. The penetration was not sealed with a system or material capable of limiting the transfer of smoke from one side of the barrier to the other.
3) A black pipe in one penetration in the fire-rated barrier above the fire-rated doors in the north corridor labeled #6. The penetration was not sealed with a system or material capable of limiting the transfer of smoke from one side of the barrier to the other.
4) Three electrical conduits in three penetrations of the fire-rated barrier above the fire-rated doors labeled #16. The penetrations were not sealed with a system or material capable of limiting the transfer of smoke from one side of the barrier to the other.
B. During the tour, the Director of Maintenance and Engineering verified the penetrations were not sealed with a material capable of limiting 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
Tag No.: A0722
Based on record review and interview, the facility failed to provide documentation of an inventory of all source systems, control valves, alarms systems, manufactured assemblies, and outlets in order to perform a risk assessment and develop a maintenance program for gas and vacuum piped systems for medical gas, vacuum, Waste Anesthesia Gas Disposal (WAGD), or support gas systems as required by NFPA 99, Section: 5.1.14.2. Failure to develop and implement a program for the periodic inspection and maintenance of the facility's medical gas and vacuum piped systems had the potential to affect all patients requiring medical gas, vacuum, and support gas systems because it could not be assured the systems would have operated correctly to serve the patients' needs. Findings follow:
A. Review of policies and procedures and preventative maintenance records on 11/13/17 at 12:30 PM showed that there were no evidence of an inventory of the facility's source systems, control valves, alarm systems, manufactured assemblies, and outlets to perform a risk assessment in order to develop a maintenance program for their medical gas, vacuum, WAGD, or support gas systems.
B. During an interview on 11/13/17 at 12:30 PM, the Director of Maintenance and Engineering stated that the facility had not developed a maintenance program for their nitrogen, vacuum, WAGD, and support gas systems.
C. See K907.
NFPA 99, 2012 Edition, Sections: 5.1.14.2.1, 5.1.14.2.2, 5.1.15, 5.2.14, 5.3.13.4.2
Tag No.: A0749
Based on policy and procedure review and interview, it was determined the infection control officer failed to ensure there was a system to identify and control infections in that there was no evidence the room temperature was monitored where the cleaning cartridges were stored for 11 of 11 (January 2017 through November 2017) months. Failure to monitor the room temperature to ensure it stayed between 59 and 77 degrees Fahrenheit had the potential for the cleaning cartridges to be ineffective. The failed practice had the potential to affect any patient whose care required the use of a vaginal ultrasound probe. Findings follow:
A. Review of the policy and procedure titled, "Trophon EPR," received from Ultrasound Technician #1 at 1:45 PM on 11/14/17 showed that the cartridges containing the chemical cleaner used to disinfect vaginal ultrasound probes were to be stored at temperatures between 59 and 77 degrees.
B. Ultrasound Technician #1 stated during an interview at 1:50 PM on 11/14/17 that the Trophon EPR system had been in place since the first of the year and monitoring of the temperature of the room where the ultrasounds were performed and the cleaner cartridges were stored had never been performed.
Based on observations and interview, it was determined the infection control officer failed to ensure only currently dated and clean supplies were available for patient use in one (Emergency Department) of four (Intensive Care Unit, Medical Surgical Unit, Emergency Department, Surgical Services) areas. Failure to ensure expired supplies and supplies used by previous patients were not available for patient use had the potential to compromise efficacy of treatment and for patient cross contamination. The failed practice had the potential to affect any patient in the Emergency Department. Findings follow:
A. Observation in Exam Room #7 at 1:45 PM on 11/13/17 showed a used updraft mouthpiece hanging on the oxygen tree. During an interview at 1:45 PM on 11/13/17, the Emergency Department Director verified the above finding.
B. Observation of the crash cart located between Trauma Rooms 9 and 10 showed two of two packages of Softtrace EKG pads expired 1/2014. During an interview at 1:50 PM on 11/13/17, the Emergency Department Director verified the above findings.
Based on observation and interview, it was determined the infection control officer failed to prevent the spread of infection in that patient care equipment had rips, tears, holes and missing paint in two (Inpatient Rehabilitation Unit and Surgical Services) of six (Inpatient Rehabilitation Unit, Surgical Services, Emergency Department, Medical Surgical Unit, Intensive Care Unit, and Women's Services) areas observed. The openings in the surfaces had the potential for blood and body fluids to soak into the openings which could not be cleaned. The failed practice had the potential to affect patients and staff in the Operating Room (OR) and the Inpatient Rehabilitation Unit. Findings follow:
A. Observation in the Inpatient Rehabilitation Unit at 12:25 PM on 11/15/17 showed one of one vinyl treatment table mat with a 1-2 inch tear in the covering and one of two vinyl covered stools with two approximately 1.5 inch tear. The above findings were verified by the Director of Inpatient Rehabilitation Unit at 12:29 PM on 11/15/17.
B. Observation in OR #3 showed the surgical table base had two openings on the corners of the foot end of the table base; the right corner had an approximately 3 by 1.5 inch hole and the left corner had had an approximately 2 by 1.5 inch hole. The surgical table safety strap was observed to be lying on the right corner of the base with the tip touching the floor. The black chair used by anesthesia was observed to have multiple rips and tears on the left side.
C. Observation in OR #2 showed the black chair used by anesthesia had an approximately 2 by 1 inch rip on the left side.
D. Observations in OR #1 showed multiple paint chips with rusted areas on the metal panels on the right and left sides of the surgical table.
E. During an interview with the Director of Surgery and Endoscopy at 2:15 PM on 11/13/17, she verified the findings in B, C and D.
38994
Based on observation, policy and procedure review and interview, it was determined the Infection Control Officer failed to identify and control infections in that 21 of 21 laryngoscope blades were unwrapped in the Medical Surgical Unit, labor and Delivery Unit and the Emergency Room. The failed practice did not assure that the equipment had been cleaned or sterilized and stored in a manner to ensure protection from damage or contamination. The failed practice had the potential to affect all patients in the Medical Surgical Unit, Labor and Delivery Unit and Emergency Room who needed the use of a laryngoscope for intubation. Findings follow:
A. Review of the policy and procedure titled, "Storage of Sterile Supplies," showed that all sterile supplies would be stored in a secure location which maintained the integrity of the sterile item.
B. Review of the policy and procedure titled, "Reprocessing of Semi Critical Equipment," showed that after high-level disinfection devices would be stored in a manner to protect from damage or contamination.
C. During tour of the Medical Surgical Unit, Labor and Delivery and the Emergency Room, 7 unwrapped laryngoscope blades were found in each unit's crash carts for a total of 21 laryngoscope blades.
D. During interview with the Director of Nursing (DON) on 11/13/17 at 1:42 PM, she stated that the only area where laryngoscope blades where wrapped was in the Operating Room Suite.
E. The findings in A,B and C were verified with the DON on 11/13/17 at 1:42 PM.
Based on observation and manufacture's recommendation, it was determined the oxygen extension tubing was not being changed after each patient in the Endoscopy Suite. 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 Patient #31 on 11/18/17. Findings follow:
A. Observation in Procedure Room 1 of the Endoscopy Suite on 11/15/17 at 1:18 PM showed Registered Nurse #1 did not change the oxygen extension tubing after cleaning and preparing the room for the next patient. The oxygen extension tubing was wrapped around the overhead equipment in a manner which rendered it permanently attached for use with all patients.
B. Review of the manufacturer's packaging of the oxygen extension tubing showed that it was for single patient use and not intended for reprocessing.
C. The above finding in A and B was verified by the Director of Surgery and Endoscopy on 11/15/17 at 1:18 PM.
Based on observation and interview, it was determined the Infection Control Officer had not identified or controlled infections in that Sterile Water for Inhalation USP Prefilled Humidifier was being used for more than one patient in one of one procedure room (#1) in the Endoscopy Suite. The failed practice affected Patient #31 on 11/15/17. Findings follow:
A. Observation of the Endoscopy Suite on 11/15/17 at 1:18 PM showed:
1) Sterile Water for Inhalation USP Prefilled Humidifier dated 10/23/17 was attached to the oxygen flow meter being used for more than one patient.
2) RN #1 did not remove and replace the Sterile Water for Inhalation USP Prefilled Humidifier Based on observation, manufacturers recommendations and interview it was determined the after cleaning and preparing the room for the next patient.
B. Review of the label for Sterile water for Inhalation USP Prefilled Humidifier label showed that it was for "Single use."
C. Interview with the Director of Surgery and Endoscopy on 11/15/17 at 1:18 PM, she stated that the Sterile Water for Inhalation USP Prefilled Humidifies was routinely changed every week.
D. The findings in A and B were verified with the Director of Surgery and Endoscopy on 11/15/17 at 1:42 PM.
Tag No.: A1005
Based on clinical record review and policy and procedure review, it was determined the Post Anesthesia Evaluation on 1 (#9) of 10 (#1-10) patients was completed before the patient entered the Surgical Suite. In 1 (#10) of 10 (#1-10) patients there was no evidence the Post Anesthesia Evaluation was completed. Failure to assess and document the Post Anesthesia Evaluation after the patient left the Surgical Suite did not allow the patient was free of complications and safe to discharge home. The failed practice had the potential to affect all patient receiving anesthesia services.
A. Review of the policy and procedure titled, "Pre and Post Anesthesia Evaluation," showed that all patients receiving general, regional or monitored anesthesia shall have a post anesthesia evaluation completed and documented by a practitioner qualified to administer anesthesia.
B. Review of Patient # 9's Post Anesthesia Evaluation on 11/16/17 at 10:00 AM showed that Certified Nurse Anesthetist (CRNA) #2 documented the Post Anesthesia Evaluation at 7:30 AM on 08/03/17 and the patient did not enter the Surgical Suite until 9:37 AM on 08/03/17.
C. Review of Patient # 10's clinical record on 11/16/17 at 10:30 AM showed no evidence of a Post Anesthesia Evaluation.
D. The findings in A, B and C were verified with the DON on 11/16/17 at 10:45 AM.