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Tag No.: A0043
Based on, observation, document review and staff interview it was determined that the Governing Body failed to demonstrate it is effective in carrying out the responsibility of the operation and management of the facility. The Governing Body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Condition of Participation:
482.41 Physical Environment
482.42 Infection Control
Tag No.: A0119
Based on staff interview and review of facility policy and procedure, it was determined that the facility failed to implement its grievance policy.
Findings include:
Reference: Facility Grievance Policy states, "... F. Complaints and grievances will be reviewed quarterly by a Grievance Committee which is a subcommittee of the Patient Safety Group to insure issues are addressed. The members include Hospital Counsel, the Customer Service Coordinator, the Director of PI and an individual appointed by the VPMA (Vice President of Medical Affairs). ... B. Grievances... 3. A written response will be sent by Customer Service for any grievances within 7 days with the conclusions and followup actions... Included will be the name of the hospital contact person, steps taken on behalf of the individual to investigate the complaints, the results of the process and the date of completion of the complaint process. ... All documents, including letters sent to the patient will be filed in the Case log. ... ."
1. On 2/7/17, review of Medical Records #37, #38, #39, #40, #41, and #42 in the grievance case log revealed the following:
a. The facility received a complaint from Patient #38 on 2/3/16 in which he/she complained about sleeping on a gurney for two days and was now experiencing back pain.
i. There is no evidence in the grievance case log that Patient #38 received a written response from the facility with the conclusion of the investigation and follow up actions, as specified in the above referenced policy.
b. The facility received a complaint from a family member of Patient #39 on 4/1/16 regarding hygiene issues and the quality of care the patient received by his/her physician.
i. There is no evidence in the grievance case log that the family member received a written response from the facility with the conclusion of the investigation and follow up actions.
2. Upon interview, Staff #4 and Staff #90 identified themselves as the Grievance Committee.
a. Staff #4 indicated that there was no set meeting schedule or meeting minutes for the Grievance Committee.
b. When asked who is a part of the Patient Safety Group, Staff #4 raised his/her hand and stated, "I am the Patient Safety Group."
c. The facility failed to ensure the Grievance Committee reviewed complaints and grievances quarterly.
d. The facility failed to ensure the Patient Safety Group members included Hospital Counsel, the Customer Service Coordinator, the Director of PI, and an individual appointed by the VPMA.
3. Staff #1, Staff #2, and Staff #4 confirmed the above findings.
Tag No.: A0405
A. Based on document review and staff interview conducted on February 8, 2017 it was determined that the facility failed to ensure the implementation of policies and procedures addressing the accountability of controlled dangerous substances.
Findings include:
1. Review of Medical Records #34 revealed that a total of 8 mg of Midazolam was administered to the patient. The removal of two (2) Midazolam 5 mg/5 ml vials were recorded on the Pyxis activity report. There was no documentation of wasting the remaining 2 mg of Midazolam 5 mg/5 ml.
a. The records did not reconcile.
2. This was confirmed by Staff #44.
B. Based on observation, review of Safe Practice guidelines and staff interview conducted on February 8, 2017, it was determined that the facility failed to ensure the implementation of acceptable standards of practice for medication preparation.
Findings include:
Reference: Institute for Safe Medication Practices (ISMP) Safe Practice guidelines for Adult IV Push Medications, Appendix A, states, "3.5 Do NOT withdraw IV push medications from commercially available, cartridge-type syringes into another syringe for administration."
1. Four hundred and fifty (450) carpuject prefilled syringe cartridges of Heparin 5,000 units/0.5 ml were found in the main pharmacy department.
2. Upon interview, Staff #44 stated that the facility withdraws the medication using a syringe and a needle instead of using a carpuject device.
3. These findings were confirmed by Staff #44 and Staff #45.
C. Based observation, document review and staff interview conducted on February 7, 2017, it was determined that the facility failed to ensure that medications are administered in accordance with facility policies.
Findings include:
Reference: Facility policy titled Medication Administration and Documentation states, "...15. If a patient refused a medication: ... (c) Notify the physician of the patient's refusal of medication (d) Document reason for refusal in nursing notes."
1. Review of Medical Record #33 indicated that Heparin 5,000units/0.5 ml was ordered every 8 hours on 2/4/2017 to 3/4/2017. The first dose was administered on 2/4/17 at 12:04 AM and since the first dose, Staff #43 stated that the patient has been refusing his medication.
2. Upon interview, Staff #43 stated that there was no notification to the physician of the patient's refusal of his/her medication and there was no documentation of the reason for refusal in the nursing notes.
3. This was confirmed by Staff #43 and Staff #44.
Tag No.: A0505
Based on observation, review of facility documents and staff interview, it was determined that the facility failed to ensure that expired medications were properly disposed of.
Finding include:
Reference: CSI Cardiovascular Systems, Instructions for use. "...Do not store or use partially-used bags of lubricant as the lubricant is for single used only. If ViperSlide is re-used, it may lead to serious infection and/or harm including death. Dispose of all single-use lubricants according to local environment requirements ... . 9.2. 4. Begin using the admixture within one hour after admixture preparation. The admixture is considered an immediate-use solution with a Beyond-Use-Date (BUD) of one hour, discard the admixture and prepare a new bad of admixture."
1. During a tour of the Cath Lab on 2/10/17, in the presence of Staff #1 and Staff #72, in the equipment room, an IV pole with a 1000 ml bag containing a milky white solution was observed. The bag was not labeled to indicate the contents. On a piece of tape, written in marker, was: "2/8/17, 1145, [nurse's initials]).
2. In an interview with the Staff #72, Director of the Cath Lab, he/she stated, "This solution shouldn't be here. He/She then explained, the solution is ViperGlide lubricant, easily identifiable because of it's milky white color, and is only used for a machine, it is not used for patients.
3. In an interview with Staff #73, whose initials where on the bag, he/she stated that the solution was prepped for the last case of the day (2/8/17), and was not used. He/She stated the the prepped solution was good for 24 hours.
4. As per the instructions for use, the solution is considered an immediate-use solution with a beyond use date of one hour, not 24 hours as Staff #73 stated.
5. The above findings were confirmed by Staff #1.
Tag No.: A0700
Based on observation, document review, and staff interviews between 2/7/17 and 2/10/17, it was determined that the facility failed to ensure it was constructed, arranged, and maintained to ensure the safety of the patients, visitors, and staff.
Findings include:
1. The facility failed to ensure compliance with the 2012 edition of the National Fire Protection Association's Life Safety Code. Refer to Tag 0709.
Tag No.: A0709
Based on observation, document review, and staff interview between 7/8/17 and 7/10/17, it was determined that the facility failed to ensure compliance with the 2012 edition of the National Fire Protection Association's Life Safety Code.
Findings include:
Reference #1: 42 CFR 482.41(b)(9), Buildings must have an outside window or outside door in every sleeping room.
1. On 2/8/17 at 2:08 PM in the presence of Staff #1, patient sleeping rooms #2209, #2213, #2223, and #2224 lacked either a window or a door to the outside. Refer to Reference #1.
Reference #2: 2012 edition of National Fire Protection Association's Life Safety Code 101:19.2.5.7.2.1(D)1(b), Any Patient sleeping rooms without the direct supervision required by 19.2.5.7.2.1(D)(1)(a) shall be provided with smoke detection in accordance with Section 9.6 and 19.3.4.
1. On 2/8/17 between 11:10 AM and 11:30 AM, in the presence of Staff #1, Patient Sleeping Room's #4466, #3439, and #3420 were not located with direct visual supervision from a constantly attended location or provided with automatic smoke detection. Refer to Reference #2.
Reference #3: 2012 edition of National Fire Protection Association's Health Care Facilities Code 99:6.3.2.2.11.1 One or more battery-powered lighting units shall be provided within locations where deep sedation and general anesthesia is administered.
1. During interview on 2/10/17, Staff #1 confirmed no battery-powered emergency lighting was provided in any of the five (5) Operating Rooms. Refer to Reference #3.
Reference #4: 2012 edition of National Fire Protection Association's Life Safety Code 101:9.6.4.1, Where required by another section of this code, emergency forces notification shall be arranged to alert the municipal fire department and fire brigade (if provided) of fire or other emergency.
1. During a review of fire alarm testing documents, dated 6/16/16, the monitoring company was identified as "Self Monitored." Refer to Reference #4.
2. During interview, Staff #1 confirmed the fire alarm signals are not automatically transmitted.
3. Staff #1 confirmed, upon activation of the fire alarm system, the hospital operator must physically call the dispatch center to make notification of the alarm.
During supervisor review, on February 14, 2017, an IJ was identified. The facility was made aware of the IJ at 4:40 PM on February 14, 2017, an immediate plan of correction was requested. An acceptable PoC has been received and the IJ was on removed. February 14, 2017 at 5:00 PM
Tag No.: A0724
A. Based on observation and staff interview, it was observed that the facility failed to ensure that sterilized items are stored to maintain package integrity.
Findings include:
Reference #1: AORN Guidelines for Perioperative Practice, 2016 edition Recommendation XV pages 838-839 states, " ... XV.b.5. Supplies should be stored in a manner that maintains sterility."
Reference #2: AORN Guidelines For Perioperative Practice, 2016 edition Recommendation XV pages 838-839 states, "Sterilized materials should be labeled and stored in a manner to ensure sterility, and each item should be marked with the sterilization date. ... XV.b.5. Supplies should be stored in a manner that allows adequate air circulation and ease of cleaning in compliance with local fire codes and in a manner that reduces the risk of contamination. "
1. During a tour of the Surgical Intensive Care Unit (SICU), rubber bands were observed wrapped around the instruments in the intubation cart drawer.
a. The use of the rubber band compresses the sterile packages and does not allow for adequate air circulation.
b. The use of the rubber band compresses the sterile packages and may cause the package integrity to be compromised.
2. This finding was confirmed with Staff #3.
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B. Based on observation, staff interview and review of nationally recognized organization guideline (AAMI), it was determined that the facility failed to ensure that all facilities, supplies, and equipment are maintained at an acceptable level of safety and quality.
Findings include:
Reference: The Association for the Advancement of Medical Instrumentation (AAMI) Standard 79 section 8.9.2 on Storage Facilities states, "The (sterile) items should be positioned so that packaging is not crushed, bent, compressed or punctured and so that their sterility is not otherwise compromised."
1. During a tour of the SICU on 2/7/17 at approximately 1:30 PM, the following was observed:
a. A size 6.0 Magill uncuffed tracheal tube in a package that was very wrinkled with yellow discoloration. Furthermore, two pieces of tape on both ends of the package contained dark lint.
b. A #5.0 LMA with a small pin hole visible on the back of the yellow stained and wrinkled package.
2. The facility failed to ensure that sterile items are stored in a manner that maintains sterility.
3. These findings were confirmed with Staff #29.
C. Based on observation and staff interview, it was determined that the facility failed to ensure that semicritical items are stored and maintained in a manner that renders it safe for patient use.
Findings include:
Reference #1: AAMI [Association for the Advancement of Medical Instrumentation] ST 79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, 2013 section E.2 (b) states, "Semicritical devices are instruments or objects that contact intact mucous membranes, or nonintact skin of the patient during use, ... Examples include ... laryngoscopes, respiratory therapy equipment ... Semicritical items should be sterilized, if possible. However, ... the device, at a minimum, must be subject to a high-level disinfection process..."
Reference #2: CDC: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 states, "Semicritical items contact mucous membranes or non-intact skin. This category includes respiratory therapy and anesthesia equipment ... These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible."
1. During a tour of the MICU and SICU eight (8) oropharyngeal airways were noted in the intubation cart drawer uncovered and exposed.
a. Storing semi critical items without covers exposes them to possible environmental contamination and does not ensure that the items are safely available for use in an emergency.
2. This was confirmed with Staff #29
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D. Based on observation, it was determined that the facility failed ensure that equipment was maintained.
Findings include:
1. During a tour of Operating Room (OR) #3, a patient transfer roller device was observed with frayed edges on the covering material, exposing the fabric underneath, impeding proper cleaning and disinfection.
Tag No.: A0747
Based on observation, document review and staff interview it was determined that the facility failed to ensure the provision of a sanitary environment to avoid sources and transmission of infections and communicable diseases, and failed to ensure an adequate Infection Control Program that seeks to minimize infections and communicable diseases.
Findings include:
1. The facility failed to provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases, and failed to implement nationally recognized infection control guidelines. (Cross Refer to Tag A-0749).
2. The facility failed to ensure that multi-dose vials accessed in an immediate patient care area were used for one patient and immediately discarded. (Cross Refer to Tag A-0749).
Tag No.: A0749
A. Based on observation, staff interview, review of facility documents and nationally recognized guidelines, it was determined that the facility failed to implement their policies and procedures and recognized infection control guidelines for controlling infections.
Findings include:
Reference #1: AAMI (Association for the Advancement of Medical Instrumentation) "Sterilization in Health Care Facilities, 2014 edition" ST 79 section 7.2.2 states, "Manufacturers' written IFU...The written IFU of the device manufacturer should always be followed."
Reference #2: Facility policy titled, "Sterile Processing Services Policy: Instrument Care and Handling ... 1. ... NOTE: Always refer to the specific manufacturer's instructions for use (IFU) document of detailed cleaning instructions and follow for each particular instrument. ..."
1. On 2/7/17, Staff #7, #8 and #10, confirmed the nationally recognized guidelines the facility follows for infection control are: AAMI, AORN, CDC and OSHA regulations.
2. A tour was conducted of the Sterile Processing Department with Staff #7, #8 and #10, at 10:30 AM.
3. At 10:50 AM, the IFUs for the instruments that are contained in an "A-Gram Tray" was requested to Staff #10.
a. At 11:00 AM, Staff #10 confirmed she/he has to have the actual "A-Gram Tray" to see the individual instruments in that specific tray because they have several different manufacturers that make the same instruments and they obtain the manufacturer's IFU by each individual instrument.
(i) Staff #10 confirmed the facility no longer has a manual that holds IFUs for instruments any longer since putting the manufacturers' IFU on the computer. Not all instrument IFUs are available in a binder/manual for staff and if the computer is not working staff cannot access the IFUs if needed.
(ii) At 11:10 AM, not all IFUs for the instruments that make up a "A-Gram Tray" were available and/or provided. Staff #10 attempted to print out several manufacturer's IFU for instruments that would be part of a "A-Gram Tray" however, the printer was not functioning properly.
b. Staff #10 confirmed the facility does not have IFUs for all individual surgical instrument devices that need to be reprocessed. The facility follows several manufacturer's general IFU guidelines for reprocessing instructions that apply to all instruments that that manufacturer makes.
c. At 1:45 PM, six (6) "Curved Mosquito" instruments were pulled to verify how each is processed by the IFUs for each. Staff #10 confirmed that a total of three (3) manufacturers supply the same "Curved Mosquito" instrument that the facility uses.
(i) Staff #10 explained, they identify and pull the manufacturer's IFU by examining the instrument for the manufacturer's name imprinted on the device and/or by the code # engraved on the instrument.
(ii) Not all instruments had an engraved and/or legible manufacturer's name and/or code # that identifies the individual instrument, therefore, there is no method to identify which manufacturer's or individual devices IFU to follow to accurately reprocess the instrument correctly.
4. On 2/8/17, the facility was unable to provide evidence of IFUs for all surgical instrumentation.
5. The facility failed to ensure that manufacturer's IFU for reprocessing for surgical instruments are available and followed as indicated in recognized guidelines and facility policy and procedure.
6. Staff #8, #10 and #45 confirmed the above findings.
These findings resulted in an Immediate Jeopardy (IJ). The facility immediately curtailed this practice. The IJ was removed on 2/8/17, the day of the survey, upon receipt of an acceptable plan of correction.
Reference #3: Manufacturer's IFU for 3M Quat Disinfectant Cleaner Concentrate 5L and 5H, states in section: "Bactericidal Stability of Use-Dilution: Tests confirm that the use-dilution of this product, ... . If product becomes visibly dirty or contaminated, the use-dilution must be discarded and fresh product prepared. Always use clean, properly labeled containers when diluting this product. Bactericidal stability of the use-dilution does not apply to open containers such as buckets or pails. ... Disinfection/Virucidal/Fungicidal/Mold and Mildew Control Directions: Apply use-dilution to hard, non-porous surfaces, thoroughly wetting the surface with a cloth, mop, sponge, sprayer, or by immersion. Treated surfaced should remain wet for 10 minutes. ..."
Reference #4: Nihon Kohden Manufacturer's IFU for the "Disinfecting and Cleaning" of the anesthesia monitoring equipment in section "Cleaning" states, "Wipe the outside surface with a non-abrasive cloth moistened with disinfecting alcohol or neutral detergent (i.e. ivory) diluted with water. ... Disinfecting: Wipe the outside surface of with a non-abrasive cloth moistened with any of the disinfectants listed below. Use the recommended concentrations to prevent transmitter damage and follow the manufacture recommended contact times to achieve results. ..."
Reference #5: Facility policy titled, "Environmental Services Product Listing Policy I) Product Listing a) Cleaning Products ... iii) 3M Quat Disinfectant Cleaner #5 (Contact Time 10 minutes) ..."
Reference #6: Facility policy titled, "OR Cleaning" states, "... III) Procedures ... ii) Prepare a bucket of hospital approved disinfectant at eh beginning of each day and after each case ..."
1. On 2/7/17 at 11:40 AM, during an observation the breakdown of Operating Room(OR) #3, by Staff #16, #17, #18, #19 and #20, OR technicians, the following was revealed:
a. Staff #19 explained the following process:
i. The cleaning/disinfectant solution used to clean and disinfect the OR is "3M 23H Quat Solution."
ii. The solution supply is located in the janitor closet in a pre-measured dispenser with water, to assured the correct concentration is being used.
iii. The bucket is filled in the morning and used for multiple rooms and cases throughout the day. It is changed if it becomes visibly dirty.
iv. The solution was dispensed into an unlabeled open bucket with clean disposable wipes and placed on a janitor cart in the back hallway, outside of the OR back door, for the staff to use.
v. Each staff with donned gloves immersed clean cleaning clothes into the solution bucket and re-entered the bucket with new clean cleaning clothes but did not change gloves through the process.
vi. Multiple dirty step stools, which had been used during a procedure, containing large remnants of dark soil, were cleaned. The staff failed to inspect the bucket for any visible contaminate.
vii. The above product was also used to clean/disinfect the anesthesthia machine and it's patient monitoring cables; a pulse oximetry, blood pressure, electrocardiogram (EKG) cable and a Flo Trach cable.
viii. During the cleaning/disinfection process, treated surfaces were not clearly wet for the recommended 10 minute contact time by any of the staff during the observation.
2. On 2/8/17, at 10:30 AM, Staff #8 verified, presented and reviewed the following:
a. The "3M Quat Disinfectant Cleaner Concentrate 5L and 5H" is the cleaning and disinfectant solution that the facility uses to clean the ORs and the medical equipment in the ORs between patient cases, not "3M 23H Quat Solution"
i. The IFU was presented and sections, "Bactericidal Stability of Use-Dilution and Disinfection .... Directions" were reviewed for use.
ii. The "3M Quat Disinfectant Cleaner Concentrate 5L and 5H" product was not on the manufacturer's IFU anesthesia monitoring machine approved cable disinfectant product list.
c. The 3M Quat Disinfectant Cleaner was not dispensed into and used from a closed, labeled container, the use-dilution was not tested to confirm the efficienty while being used throughout the clean/disinfection process and discarded when the solution became contaminated by several staff dipping into the product with the same gloves donned and used throughout the cleaning/disinfecting process.
3. Staff #3 confirmed the above findings.
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B. Based on observation, document review and staff interview conducted on February 8, 2017, it was determined that the facility failed to ensure that multi-dose vials of medications that are accessed in the immediate patient care area are discarded immediately after use on a single patient.
Findings include:
Reference #1: Center for Disease Control (CDC) question and answer guidelines for multi-dose vials
1. During an observation at 11:20AM, the following medications were found opened and needle punctured and stored in the anesthesia medication cart located in Operating Room #1:
a. One 20 ml multi-dose vial of Labetalol 100mg (milligram)/20ml (milliliter)
b. One 5 ml multi-dose vial of Flumazenil 0.5 mg/5ml
c. This findings was confirmed by Staff #44 and Staff #45.
These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed on February 8, 2017, the day of survey, upon receipt of an acceptable plan of correction.
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Reference #2: AORN, Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Settings, 2013 edition, pg. 53 states, "... Stethoscopes should be clean and not worn around the neck ... Cleaning stethoscopes in combination with health care personnel washing their hands between caring for patients decreases the possibility of transmission of pathogens to patients and environmental surfaces. ... ."
1. On 2/7/17, during a tour of unit 3 Main in the presence of Staff #3, Staff #36 was observed administering a nebulizer treatment to a patient.
a. Staff #36 entered the patient's room wearing a stethoscope around his/her neck. He/she then used the stethoscope to auscultate the patient's lungs prior to administering the treatment.
b. Staff #36 failed to clean the stethoscope prior to auscultating the patient's lungs.
2. Staff #1 and Staff #3 confirmed the above findings.
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Reference #3: AORN (Association of Perioperative Registered Nurses), Guidelines for Perioperative Practice, 2017 edition, Guideline for Surgical Attire, recommendation I.h.4, states, Surgical masks should not be worn hanging around the neck.
Reference #2: Facility Policy titled, "Operating Room Nursing, Standards of Professional Practice" states, "Standard I - Education... Criteria: ... 3. Maintain standards of practice based on current AORN recommended guidelines."
1. On 2/7/2017, while touring outside the corridor of Operating Room (OR) #3, Staff #12 and #13 were observed with surgical masks hanging around their necks.
a. The filter portion of the surgical mask harbors bacteria collected from the nasopharyngeal airway. The contaminated mask may cross-contaminate the scrub attire top or long-sleeved jacket when hanging around the neck.
2. The above finding was confirmed by Staff #12.
Reference #3: Facility Policy titled, "OR Cleaning" states, "... II) Guidelines: a) Equipment from areas outside the OR should be cleaned before being brought to the OR."
1. On 2/7/2017, while touring, the OR suite, the following was observed:
a. Staff #46 was observed exiting from an ongoing procedure in OR #2 with his/her gown, gloves and mask on.
(i) Staff # 46 went into OR #3, which was in the process of being cleaned, retrieved a suture tree, and wheeled it into OR #2, to be used for the procedure.
2. Staff #46, confirmed that the OR staff share suture trees between OR's.
3. Staff #12, agreed and confirmed that staff should clean the suture tree and identify it as "clean", so that staff know its been cleaned; prior to taking it to a clean OR room.
Reference #4: Facility policy titled, "Hand Hygiene [and Fingernails] With Attached Staff Listing" states, "Policy: "... IV) Procedure a) Handwashing i) Indications for handwashing include: ... (2) After contact with a source of microorganisms [sic]..."
Reference #5: Facility Policy titled, "OR Cleaning" states, "... II) Guidelines: ... e) Principles to follow are 'highest to lowest' and 'top to bottom'
Reference #6: Guideline for Hand Hygiene in Health Care Settings: Recommendation of the Healthcare Infection Control Practices Advisory Committee [HICPAC] and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force, published in the CDC (Centers for Disease Control and Prevention) Morbidity and Mortality Weekly Report at MMWR 2002; 51 (No. RR-16) page 32 states, "Recommendations: 1. Indications for Handwashing and Hand antisepsis ... I. Decontaminate hands after contact with inanimate objects. ... J. Decontaminate hands after removing gloves."
1. On 2/7/17 at 11:40 AM, cleaning and disinfecting of OR #3 between patients was conducted by Staff #16, #17, #18, #19 and #20, OR technicians. The following was observed:
a. Staff #16 donned gloves and cleaned the base of the Mayo stand with a cloth dipped in 3M Quat Disinfectant.
b. The cloth and Staff#16's gloved hands touched the floor.
c. Staff #16, proceeded to clean the inside of the kick bucket, with the same dirty cloth.
d. Staff #16, failed to remove gloves, and perform hand hygiene aqnd reapply gloves after touching the floor.
e. Staff #16, proceeded to use the same dirty cloth to clean the top of another mayo stand.
2. Staff #16 failed to follow CDC hand hygiene guidelines and facility policy.