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Tag No.: C0276
Based on review of policy, observation, and interview, it was determined the facility failed to ensure outdated medications were not available for patient use in three (Medical/Surgical, Surgical Services and Out Patient) of four (Medical/Surgical, Surgical Services, Outpatient and Emergency Department) areas toured. By not removing medications from stock once they expire, the facility could not assure their safety or efficacy. The failed practice had the likelihood to affect all patients who received medications at the facility. Findings follow:
A. Record review of the policy titled, "Drug Procurement, Inventory and Control," dated 06/26/16, showed that all expired medications would be removed from drug storage areas during the pharmacy inspection and would be returned to pharmacy for proper disposal.
B. A tour of the facility on 12/04/17 from 12:55 to 3:09 PM showed the following expired medications in stock and available for patient use:
1) Medical/Surgical:
a) One Lidocaine 2 mg (milligram)/500 ml (milliliter) IV (intravenous) expired 11/17;
b) One Diltiazem 25 mg/ 5 ml vial expired 03/17; and
c) One Pneumococcal Vaccine 0.5 ml syringe expired 07/17.
2) Surgical Services:
a) Two Sodium Chloride 1000 ml IV bags expired 04/17;
b) One Epinephrine 1 mg/10 ml syringe expired 02/17;
c) One Atropine 1 mg/10 ml syringe expired 07/16;
d) Two Metoprolol 5 mg/5 ml vials expired 08/16;
e) Two Hydralazine 20 mg/ ml vials expired 06/17;
f) One Epinephrine 1 mg/ ml ampule expired 06/01/17;
g) One Bupivacaine 0.75%/ 2 ml ampule expired 06/01/17;
h) One Lidocaine 5%/7.5% Dextrose 2 ml ampule expired 10/01/16; and
i) Three Albuterol Sulfate 2.5% 3 ml vials for inhalation expired 11/16.
3) Outpatient Services:
a) Two Atropine 0.4 mg/1 ml vials expired 10/17;
b) One Metoprolol 5 mg/5 ml vial expired 07/16;
c) One Epinephrine 0.1 mg/10 ml syringe expired 02/17;
d) One Atropine 0.1 mg/10 ml syringe expired 07/16;
e) One Amidate 20 mg/ 10 ml vial expired 01/01/17; and
f) One Sodium Chloride 1000 ml IV bag expired 11/17.
C. During an interview on 12/04/17 at 3:01 PM, the Regional Rural Administrator verified the expired medications found during the tour of the facility.
Based on observation, review of policy and interview, it was determined the facility failed to store 36 vials of Dantrium to treat a Malignant Hyperthermia Emergency per policy. By not stocking the full amount of Dantrium, the facility could not assure they were prepared for a Malignant Hyperthermia Emergency. The failed practice had the likelihood to affect all patients admitted for surgical procedures. Findings follow:
A. Record review of the policy titled, "Medication Storage Dantrium," dated 06/16/2016, showed that the facility was to have had 36 vials of Dantrium available in case a Malignant Hyperthermia emergency had occurred.
B. A tour of the facility on 12/04/17 from 12:55 PM to 3:09 PM showed that the facility did not stock any Dantrolene.
C. During an interview on 12/04/17 at 2:40 PM, the Regional Rural Administrator verified the facility did not have 36 vials of Dantrium.
Based on observation, review of manufacturer's labeling instructions and manufacturer's package insert, and interview, it was determined the facility failed to ensure single use Sodium Chloride for Irrigation and single use Sodium Chloride for flushing were not available for patient use in two (Surgical Services and Medical/Surgical) of four (Surgical Services, Medical/Surgical, Emergency Department and Outpatient) area toured. By not disposing of the unused portion and saving it for future use, the facility could not assure the safety and efficacy of the fluids past the initial use. The failed practice had the likelihood to affect all patients admitted to the facility for procedures. Findings follow:
A. Record review of the manufacturer's package insert for 10 ml (milliliter) Normal Saline Flush Syringe stated that the syringe was not to be reused and any unused portion should have been discarded.
B. Record review of the manufacturer's labeling instructions for the 1000 ml bottle of Sodium Chloride for irrigation stated that any unused portion was to be discarded.
C. A tour of the facility on 12/04/17 between 12:55 PM and 3:09 PM showed the following:
1) Surgical Services:
a) One 10 ml Sodium Chloride flush syringe, opened and 6.5 ml remaining in it; and
b) One 1000 ml bottle of Sodium Chloride for irrigation, with 800 ml remaining and dated 12/01/17.
2) Medical/Surgical:
a) One 10 ml Sodium Chloride flush syringe, opened with 6 ml left in it.
D. The findings in Surgical Services were verified by the Regional Rural Administrator at the time of observation and the finding in Medical/Surgical was verified by RN (Registered Nurse) #1 at 1:55 PM.
Based on observation, review of manufacturer's information on Succinylcholine and interview, it was determined the facility failed to ensure Succinylcholine had been dated with the manufacturer's recommended expiration date once removed from the refrigerator in one of one (Surgical Services) Anesthesia Cart observed. The potential existed for the medication to be used beyond manufacturer's guidelines leading to a decrease in potency of the medications upon administration to patients. The practice had the likelihood to affect all patients who received the medication during surgery. Findings follow:
A. Review of manufacturer's information on Succinylcholine showed that the vials were stable for up to 14 days at room temperature once removed from the refrigerator.
B. During a tour of Surgical Services on 12/04/17 from 12:55 PM to 3:09 PM, observation showed the Anesthesia Cart had one unopened vial of Succinylcholine that was not dated to indicate when it was removed from refrigeration or when it would expire.
C. During an interview on 12/04/17 at 2:40 PM, the Regional Rural Administrator verified the Succinylcholine was not dated with information to indicate when it reached the 14 day maximum at room temperature.
Tag No.: C0278
Based on review of manufacturer's label information, observation and interview, it was determined the facility failed to identify and control infections in that expired supplies were available for patient use in four of four (Medical/Surgical, Surgical Services, Outpatient and Emergency Department) areas toured. The integrity of expired supplies could not be assured. The failed practice was likely to affect all patients who received treatment in the affected areas. Findings included:
A. During a tour on 12/04/17 from 12:55 PM to 3:09 PM, observation of the manufacturer's labels showed the expiration dates were not adhered to as follows:
1) Medical Surgical Area-Sterile Gloves, Size 6, 1 of 1 expired 11/2017
2) Surgical Services-Cathlon, 24G (gauge), 4 of 10 expired, 3-07/2016 and 1-05/2017.
3) Outpatient-Introcan, 3 of 3 expired 12/2015
4) Emergency Department
a) Ecolab Scrub Stat 2% chlorhexidine Gluconate, 1 of 3 expired 10/2017.
b) Sponge Forceps, 1 of 1 expired 11/14/15
c) Dean Forceps, 1 of 1 expired 07/20/17
d) Broselow-Hinkle Red Emergency module, 2 of 13 expired 03/2017
e) Bovie High Temp fine Cautery, 3 of 3 expired 10/2017
f) Bard IC Anti-infective Foley Catheter, 3 of 13 expired 04/2017
g) Catheter Guidewire, 2 of 4 expired 01/07/17
B. The findings in A1-4 were confirmed by the Director of Nursing at the time of observation. During an interview on 12/04/17 at 1325, the Director of Nursing stated that staff were supposed to check for expiration dates on supplies daily.
Based on observation and interview, it was determined the facility failed to identify and control infections in that clean patient care equipment (bedside commode) and supplies were stored in a janitor's closet (dirty) in the Emergency Department. The failed practice had the likelihood to spread infection and affect any patient treat in the Emergency Department. Findings included:
A. Observation on 12/04/17 at 1:22 PM showed a bedside commode identified as clean that was stored in the janitors closet (dirty). Clean patient care supplies were also stored on shelves in the closet.
B. The Emergency Department Manager confirmed the presence of clean patient care equipment and supplies in with housekeeping supplies at the time of observation.
Based on observation and interview, it was determined the facility failed to identify and control infections in that:
1. Two of two laryngoscope blades in the Medical/Surgical Emergency Cart were not stored in packaging to prevent contamination.
2. Sterile supplies were not stored to preserve package integrity in that they were compressed with an elastic band.
3. Four of four syringes were removed from their original package and stored for later use in the an anesthesia cart.
The failed practices did not assure patients would be protected from likely sources of infection and was likely to affect any patient treated at the facility. Findings included:
A. Observation on 12/04/17 at 1:35 PM showed one straight and two curved laryngoscope blades in the third drawer of the Medical/Surgical Unit emergency cart. The laryngoscope blades were not stored in a package or protected to prevent contamination. The Director of Nursing confirmed the finding at the time of observation.
B. Observation of sterile peel packaging on Medical Surgical Unit, Emergency Department, Outpatient, and Surgery Departments on 12/04/17 from 12:55 PM-3:09 PM showed sterile peel packages grouped with other sterile packages and secured with elastic bands. The packages were compressed where the elastic band was located and could compromise the integrity of the sterile packaging. The Director of Nursing confirmed the finding at the time of observation.
C. Observation of Outpatient Room #1 on 12/04/17 at 2:45 PM showed one of one anesthesia cart with four syringes with needle, out of the original packaging. The integrity of the syringes could not be assured. The Director of Nursing confirmed the finding at the time of observation.
Based on observation and interview, it was determined one of one Respiratory Therapist (#1) failed to prevent likely sources of infection in that hand hygiene was not performed after removing gloves at the conclusion of a respiratory treatment. Failure to perform hand hygiene did not assure patients were protected from infection and was likely to affect any patient who received respiratory treatments from Respiratory Therapist #1. Findings included:
A. Observation on 12/05/17 at 11:42 AM showed Respiratory Therapist #1 completed an updraft treatment on Patient #19, removed gloves and then proceeded out of the room with the computer cart. Respiratory Therapist #1 stated he had completed the treatment. Hand Hygiene was not performed after glove removal at the conclusion of the respiratory treatment.
B. Respiratory Therapist #1 confirmed he did not perform hand hygiene after gloves were removed on 12/05/17 at 11:42 AM.
Based on interview and review of employee sick log, it was determined the facility failed to have a system in place to monitor infections among hospital personnel. Failure to monitor hospital personnel did not assure infections or communicable diseases would be detected and that patients would be protected. The failed practice affected the average daily census of two patients. Findings included:
A. Review of the employee sick log on 12/05/17 for 2017 showed no evidence of monitoring by facility staff to identify any infections or communicable disease among staff who called in.
B. During an interview on 12/06/17 at 2:59 PM, the Director of Nursing stated that there was not a process for monitoring all staff who called in for infections or communicable disease and each department monitored their own employees.
Based on observation, review of policies and interview, it was determined the facility failed to identify and control infection in that the facility failed to:
1. Ensure one of one (#2) Registered Nurse adhered to personal protective equipment (PPE) requirements when performing high level disinfection of endoscopes;
2. Store five of five endoscopes to prevent contamination in that they were stored coiled after high level disinfection in a reusable case. The was no evidence of the facility had the manufacturer's directions of use on the storing and transporting endoscopes in a reusable case.
3. Assure one of one Anesthesia Cart in the Endoscopy Procedure Room was free of tape residue and
4. Assure 12 of 12 pieces of equipment and furnishings (stools, suction machine, Instrument stand, Linen bins, IV pole, etc) within Operating Room (OR)#1 were free of rust.
The failed practice did not protect patients from likely sources of infection. The failed practice was likely to affect all patients treated at the facility. Findings included:
A. Record review of undated policy titled, "Endoscope Cleaning," showed that Personal Protective Equipment must always be worn when handling contaminated instruments and equipment. Personal protective equipment included: gloves, eye protection and fluid repellant gown. Disinfected equipment should be used immediately or stored in a manner to minimize recontamination.
B. Record review of policy titled, "Disinfection of Endoscopes," revised 11/2014, showed that endoscopes were not to be stored coiled. They were to be stored hanging in a manner which would protect the endoscope and to always follow the manufacturer's recommendations.
C. Observation on 12/06/17 at 10:47 AM showed that Registered Nurse (RN) #2 wore a plastic type apron, a mask and face shield, and exam gloves to pre-clean a soiled endoscope. RN #2's arms were exposed from elbow to wrist and rested on the edge of the sink multiple times throughout the pre-cleaning process. The bilateral upper shoulder areas of RN#2's uniform were exposed. At 11:02 AM, RN #2 changed gloves and apron, then retrieved an endoscope from the Olympus MediVator (MV)-1 that had completed the high level disinfection cycle. RN #2 held the coiled endoscope against her uniform at the left upper shoulder that was unprotected by the plastic type apron. The findings were confirmed at the time of observation by RN #2.
D. Observation on 12/06/17 at 10:47 AM showed:
1) Five scope cases on the floor of the work room. RN #2 was interviewed and stated that there were five scope cases carried back and forth (from another facility) each week. RN #2 stated that the scopes were used at the other facility on Mondays, high level disinfected, and then hung to dry. The scopes were then packaged in the reusable cases and brought to this facility. RN #2 stated the endoscopes were stored (coiled) in the cases until used.
2) RN #2 was observed taking a scope case to Outpatient Procedure Room #1 and stated that it was to be used for the next patient. RN #2 stated at the time of observation there was no re-processing of the scopes done once transported to the facility because they were stored in the cases "clean."
3) The finding was confirmed at the time of observation by RN #2 who stated she did not have the manufacturer's recommendations for storage of the endoscopes.
4) The Director of Nursing and Regional Rural Administrator were interviewed on 12/07/17 at 1:50 PM, and confirmed the endoscopes were transported in cases from one facility to another.
E. Observation and interview on 12/06/17 at 10:47 AM showed the anesthesia cart had an accumulation of tape residue on the front drawer surfaces. The tape residue did not allow the anesthesia cart to be disinfected between patients. The finding was confirmed by the Director of Nursing at the time of observation.
F. Observation on 12/04/17 at 2:36 PM showed an accumulation of rust on equipment in OR #1:
1) Wheel covers on two stools.
2) Wheels and bottom of two suction machines.
3) Wheels and bottom of the Instrument stand.
4) Wheels and bottom of two Linen bins.
5) Guard around edge cracked and rust on wheels of two Kick buckets.
6) Wheels and bottom of IV pole.
7) Drawer front and wheels on Lap Chole Cart
8) The rust created an irregular surface and prevented the equipment from being disinfected between patients. The finding of rust on the equipment was confirmed by the Director of Nursing at the time of observation.
31039
Based on review of Physician's Tuberculosis records, policy review and interview, it was determined the Infection Control Program failed to control infections in that an annual Tuberculin test was not performed on one (#3) of seven (#1-#7) Physicians per policy. By not assuring the Physicians 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 policy titled, "Tuberculosis Skin Testing," dated January 2007, showed that all co-workers will be evaluated for Tuberculosis annually.
B. Review of the Physician's Tuberculosis records showed that Physician #3 had no evidence of an annual screening.
C. During an interview on 12/06/17 at 10:26 AM, the Regional Rural Administrator verified Physician #3 had no evidence of an annual screening.
Tag No.: C0294
Based on interview and review of policy, it was determined the facility failed to provide evidence of staff training or competency for high level disinfection of endoscopes and arterial blood gas (ABG) specimen collection by staff Registered Nurses (RN). The expectations and standards for staff performance of endoscope reprocessing and ABG specimen collection were not assessed. The failed practice affected the average of 15 patients who had blood gas specimen collections per month and average of 21 patients who had endoscopy procedures per month. Findings included:
A. Record review of the policy titled, "Respiratory Care Department," dated 07/17/13 showed that laboratory staff and RN's draw ABGs.
B. Record review of the titled, "Scope of Services," date revised 08/2017, showed that staff competency was assessed on hire and annually.
C. The Director of Nursing confirmed by interview on 12/06/07 at 2:14 PM that all Registered Nurses perform ABG specimen collection and RN #2 and Licensed Practical Nurse (LPN) #1 perform high level disinfection of endoscopes.
D. The Director of Nursing and Regional Rural Administrator stated in an interview on 12/07/17 at 1:50 PM that there were no staff competencies for Registered Nurses who perform ABG's or RN #2 and LPN #1 who perform high level disinfection of endoscopes.
Tag No.: C0304
Based on clinical record review, review of policy and interview, it was determined the facility failed to obtain consent for treatment for 3 (#9, #10 and #14) of 12 (#7-18) Emergency Room patients. Failure to obtain a signed consent for treatment did not afford the patient or their representative the opportunity to make informed decisions regarding his or her care. The failed practice had the likelihood to affect Patient #9, #10 and #14). Findings follow:
A. Record review of facility policy titled, "Registration," stated that Universal Consents were to be sign at the time of registration.
B. Review of clinical records revealed Patient #10 and #14 did not have consent for treatment. Patient #9 signed their consent after treatment in the Emergency Room and at the same time as being admitted into the hospital.
C. During an interview on 12/07/17 at 12:43 PM, the HIM (Health Information Management) Director verified the findings at B.