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Based on observation, interview and document review, it was determined the governing body failed to ensure data is collected, analyzed, monitored, policies and procedures are communicated to staff provided through a contract for environmental services.

The findings include:

Observations were conducted during a tour of the facility on 12/21/2015, with the Chief Operating Officer (COO) and the Nursing Supervisor (Staff #3) present.

An observation was conducted on 12/21/2015 at approximately 1:15 p.m. with the Nursing Supervisor present upon entering the 2 West Unit. A contracted Environmental Services (EVS), Staff #44, was observed in the hallway with personal protective equipment (PPE) emptying trash for a contact isolation patient. The surveyor requested to review the contract for EVS. The Nursing Supervisor confirmed PPE should be removed at the door of any isolation room and the infection control policy and procedure followed.

On 12/22/2015 the Chief Executive Officer (CEO) presented the surveyor with the EVS contract. A review of the facility's environmental service contract dated June, 15, 2015 read in part: "A. (Name of Contract Service) management personnel will oversee the management of the Housekeeping and Food Services Departments. (Name of Contract Service) Area Vice President will ensure that management personnel fulfill the obligations of this Agreement and will visit the Hospital at a frequency necessary to achieve and maintain the desired results. D. (Name of Contract Service) management personnel are expected to adhere to Hospital and (Name of Contract Service), policies, procedures and documented codes of conduct.....G. (Name of Contract Service) will administer a comprehensive, ongoing training program for the Housekeeping and Food Services Departments in compliance with industry standards and applicable state and federal law, this shall include training regarding Hospitals's HIPAA and Compliance Program policies and procedures....III. Duties To Be Performed B. Housekeeping Service Operation 1. (Name of Contract Service) will use the best practices known to the industry, operate the Housekeeping Department in accordance with the standards and requirements established by the Joint Commission, Hospital, federal, state and local authorities."

On 12/29/2015 the EVS Director (Staff #25) was interviewed in the 1st floor conference room. The EVS Director acknowledged that all of the EVS services are through a contract. The EVS Director acknowledged that the EVS services provided at the hospital are controlled by the contractor not the hospital directly.

On 12/29/2015 a review of personnel records found evidence of one (1) of fourteen (14) employees (Employee #7) having an annual performance evaluation being implemented for a contracted staff member with performance improvement in the area of infection control. There was no evidence in Employee #7's personnel record of any coordination of care from the hospital in regards to the contractor's services in a safe and effective manner within the hospital.

On 12/30/2015 at approximately 8:45 a.m., the EVS Director was interviewed regarding the facility's contract with Environmental Services. The EVS Director stated, "We have had (Name of the EVS Contract) in place since June 2015, but it has not been approved by the governing body nor have the policies and procedures. We have policies that have been implemented."

On 12/30/2015 at 8:55 a.m., the surveyor inquired to the Infection Preventionist (Staff #8) if he/she was aware Contract Employee #7 had violated infection control breeches and been given written warnings. The Infection Preventionist (IP) stated he/she was not aware of this; however he/she does not oversee the EVS services, but does have the authorization to govern anyone regarding infection control if the need is observed.

The surveyor inquired to the IP and EVS Director that if the EVS policies were not approved by the governing body, what polices were implemented and are being utilized by staff. The Infection Preventionist stated, "For the hospital staff they would be able to pull the hospital's policies up and the contracted staff would have access to their own policies." The surveyor again inquired to the IP and the EVS Director for clarification that the hospital staff have one set of policies and the contract staff have another set of policies. The IP stated, "Yes." The EVS Director stated, "Yes."

Review of a facility's policy that the hospital employees have access to titled "Cleaning Up Blood Spills," which read in part: "Policy: All major blood spills will be handled according to this policy and procedure. Scope and/Or Responsibility: Environmental services, nursing, respiratory care services, and any other departments that come in contact with a major blood spill are responsible for following the protocol set forth in this policy in regard to cleaning up blood spills. Procedure: Retrieve blood spill kit from one of Clean Supply Rooms. Use rubber gloves, protective goggles and gown when cleaning blood or other body fluid spills......."

Review of a contracted Environmental Services policy that the contracted employees have access to titled "Blood or Infectious Material Spills" which read in part: "Purpose: To remove, clean, disinfect, and dispose of any blood or potentially infectious material spills in a safe manner. Equipment & Supplies: Hospital-approved/EPA-registered intermediate-level disinfectant in a flip top bottle with a TB claim, Hospital-approved/EPA-registered intermediate-level disinfectant disposable wipes with a TB claim, Disposable absorbent material, Alcohol-based hand rub, Disposable gloves, Extractor (if applicable), Carpet cleaner, enzyme-protein-based (if applicable), Mop bucket, wringer, and mop, Utility pail, "Caution, Wet Floor" signs, Caution tape or chains when handling large spills (2 inches in diameter or greater). Note: When handling any blood or infectious material spills that initial objective is to contain the area with caution signs, tape, or chains (depending on the severity and the scope of the spillage surface) in a manner that will protect the public and staff from contaminating themselves or other areas. Blood Spots (less than 2 inches in diameter)......Major Blood Spills (larger than 2 inches in diameter):....Carpet Area-Blood Spills:......"

The CEO provided the Quality Assurance and Performance Improvement (QAPI) Committee meeting minutes held monthly for 2015. The minutes failed to contain the evidence that the QAPI Committee coordinates and supervises the EVS contractor and their services in a safe and effective manner within the hospital since the contract began in June 2015.

Based on observation, interview and document review it was determined the facility staff failed to ensure a non-verbal patient received the care in accordance with acceptable nursing standards related to an incorrect placement of a peripherally inserted central catheter (PICC) line for one (1) of eighteen (18) patients included in the survey sample. (Patient #9)

The findings included:

An observation conducted on December 21, 2015 beginning at 9:30 a.m., with Staff #9 during the administration of medication for Patient #9. Staff #9 administered the Lasix 40 mg IV (intravenous) through Patient #9's peripherally inserted central catheter (PICC) line located in the patient's left arm.

Review of Patient #9's paper and electronic medical record (EMR) indicated the patient's diagnoses included: acute respiratory failure, bilateral pneumonia, chronic obstructive pulmonary disease, gastrointestinal bleed, percutaneous gastrostomy tube and tracheostomy. Patient #9's medical record included a radiology report dated "12/16/2015" at 2:59 p.m. "Respiratory Failure" was the reason for the radiologic study.. The report read in part: "4. LEFT-SIDED PICC TIP NOW APPEARS TO EXTEND INTO THE AZYGOS VEIN AND SHOULD BE REPOSITIONED FOR OPTIMAL PLACEMENT [Sic]. Tracheostomy tube overlies the middle."

Patient #9's medical record included a form titled "[Name of the facility] Invasive Procedures Without Sedation" dated December 17, 2015 with the procedure "Start Time" documented as "2000 (8:00 p.m.)" and a finish time of "2100 (9:00 p.m.)." The procedure form documented a PICC line was placed in the patient's right upper basilic vein using modified Seldinger technique.

A radiology report dated "12/17/2015" at "2115 (9:15 p.m.)" performed to check "PICC PLACEMENT [Sic]." The radiologic study indicated the right PICC line terminated in SVC (superior vena cava.) The radiology report documented "3. The upper left extremity PICC again appears to terminate in the azygos vein, recommended repositioning."

Review of electronic nursing documentation dated December 17, 2015 at 10:12 a.m. read in part: "[Physician's name] relays cxr (chest x-ray) info (information) from 12/16 concerning piccline [Sic] placement- concerning picc repositioning - info relayed to [Attending Physician's name] via phone by re [Sic]." Patient #9's medical record did not contain further documentation related to repositioning the patient's PICC line or the continued use of a PICC line that needed to be repositioned.

An interview and review of Patient #9's electronic medical record was conducted on December 30, 2015 at 11:00 a.m., with Staff #28. Staff #28 and the surveyor reviewed the radiology studies related to the placement of Patient #9's left PICC line currently utilized for medication administration. Staff #28 could not find documentation by the attending physician regarding the repositioning of Patient #9's PICC line. Staff #28 verified the radiology studies performed on December 16 and 17, 2015 indicated the left PICC line needed to be repositioned. Staff #28 verified Patient #9's medical record as of December 30, 2015 did not have evidence the patient's left PICC line had been repositioned. Staff #28 verified staff failed to follow through to ensure Patient #9's PICC line was repositioned for safe use or document the physician's response.

According to Lippincott Manual of Nursing Practice " Eighth edition, Chapter 2, page 17:
" The Standards of Professional Nursing Practice: 1. The standards of professional nursing practice include standards of care and standards of professional performance. 2. The standards of care for professional nursing include assessment, diagnosis, outcome identification, planning, implementation, and evaluation. 3. The standards of professional performance include quality of care, performance appraisal, education, collegiality, and collaboration, ethics, resource utilization, and research ..."

According to the CDC Guidelines for the Prevention of Intravascular Related Infections 2011: "The peripherally inserted central venous catheter (PICC) is inserted into basilic, cephalic, or brachial veins and enters the superior vena cava ..."

Based on observations, interviews and document review it was determined facility staff failed to obtain physician's orders for restraints and follow physician restraint orders for five (5) of nine (9) restrained patients included in the survey sample. (Patients #3, #5, #7, #14, and #15)

The findings included:

1. An observation was conducted on December 21, 2015 at 10:19 a.m., with Staff #10 as he/she prepared medications for Patient #7. On entering Patient #7's room the observation revealed the patient had bilateral soft limb restraints in place.

Review of the Patient #7's medical record revealed a form titled "Restraint Order and Flow Record, Medical." Staff #2 reported the physician's order and the nursing monitoring documentation was included on the same form. The "Restraint Order and Flow Record, Medical" in Patient #7's medical record was dated December 20, 2015 and indicated the physician had ordered bilateral soft limb and mitt restraints for Patient #7

The second observation conducted on December 22, 2015 at 8:17 a.m. revealed Patient #7 had bilateral soft limb restraints in place. The "Restraint Order and Flow Record, Medical" in Patient #7's medical record was dated December 21, 2015 and indicated the physician had ordered bilateral mitts. The observations on December 21 and 22, 2015 revealed Patient #7 did not have on the physician ordered bilateral mitt restraints. Nursing staff had documented on December 21, 2015 from 0700 until 0659 December 22, 2015 that Patient #7 had bilateral mitts in place. The physician's order did not include bilateral soft limb restraints. The surveyor requested the "Restraint Order and Flow Record, Medical" for December 22, 2015, Staff #3 informed the surveyor the nurse caring for the patient kept the order/monitoring form on his/her clipboard. A second request was made at 1:46 p.m. to Staff #3 regarding the need to review Patient #7's "Restraint Order and Flow Record, Medical" for December 22, 2014. Staff #3 reported the nurse was off the unit for lunch and should be returning shortly. A request was made to have a copy of Patient #7's "Restraint Order and Flow Record, Medical" dated December 22, 2015. The copy was not provided prior to exit on December 30, 2015.

A review was conducted of Patient #7's medical record on December 22, 2015. The findings included the physician failed to include a date and time with his/her signature on December 17, 2015. The "Restraint Order and Flow Record, Medical" dated December 4, 2015 the physician signed a discontinuation at 1030 a. m. for the ordered bilateral soft limb restraints. Nursing staff did not sign to acknowledge the discontinuation order. Nursing documented the continuation of monitoring of Patient #7 in bilateral limb restraints. Review of Patient #7's electronic medical record (EMR) was conducted on December 23, 2015 at approximately 11:00 a.m. with Staff #21. Patients #7's EMR included a nursing note for December 4, 2015 that nursing staff removed Patient #7's restraints, but reapplied them when the patient attempted to pull at lines. Staff #21 verified the review that Patient #21's EMR did not contain documentation the physician had been notified related to the need to reapply the patient's restraints and the receipt of a new physician's order for restraints.

2. An observation and interview was conducted on December 22, 2015 at 9:22 a.m., with Staff #3 related to patients in restraints. The list provided to the surveyors indicated Patient #5 was in restraints. On entering Patient #5's room the observation revealed Patient #5 was enclosed in a fully zippered restraint bed, left hand mitt, a yellow fall prevent sock on his/her right hand and a right mid-arm restraint. Patient #5 had his/her right index finger extended through a hole in the yellow fall prevent sock. Patient #5 was making repeated agitated verbal sounds and was thrashing against his/her limb restraints. Staff #3 unzipped the restraint bed on the right side and repositioned Patient #5, rearranged the yellow fall prevent sock to encompass all of the patient's right hand fingers. Staff #3 made reassuring statements which seem to calm the patient. During the repositioning of Patient #5; Staff #3 indicated the mid-arm restraint was a "Freedom splint." Staff #3 checked Patient #5's bilateral soft limb restraints, which had not been immediately visible when entering the patient's room. The surveyor inquired why a yellow fall prevention sock had been placed over the Patient #3's right hand. Staff #3 reported the patient had a history of chewing on his/her fingers and "we are trying not to restrain both of [his/her] hand." Staff #3 reported he/she would clarify with the patient's nurse why the yellow sock was in place. The surveyor informed Staff #3 the yellow fall prevention sock was considered a restraint, especially if the patient had a mid-arm Freedom splint and a right arm soft limb restraint. Staff #3 verified the observation revealed Patient #5 had the following restraints: a fully zipped restraint bed, bilateral soft limb restraints, left hand mitt, a right mid-arm Freedom splint, and a yellow fall prevention sock over the patient's right hand.

A review was conducted with Staff #3 of Patient #5's medical record, the current "Restraint Order and Flow Record, Medical" was dated December 20, 2015. The surveyor requested the "Restraint Order and Flow Record, Medical" for December 21 and 22, 2015. Staff #3 reported the December 21, 2015 was probably in his/her office waiting to be filed. At 9:44 a.m. Staff #20 handed the surveyor Patient #7's "Restraint Order and Flow Record, Medical" dated December 21, 2015, which indicated staff were to place Patient #5 in "Soft Limb x (times) 2; Mitts x 2; Freedom splints x 2" and the use of a zipped restraint bed. The surveyor made a second request for the "Restraint Order and Flow Record, Medical" dated December 22, 2015. Staff offered the surveyor a copy the December 22, 2015 "Restraint Order and Flow Record, Medical" at approximately 1:30 p.m. The "Restraint Order and Flow Record, Medical" the order indicated Patient #5 should have been in "Soft Limb x (times) 2; Mitts x; Freedom splints x 1" placement was indicated as "Right arm" and "Left Arm." The order also indicated the use of a zipped restraint bed. Staff #3 and the surveyor reviewed the restraint order; Staff #3 verified staff had not followed the physician's order as written by placing a yellow fall prevention sock over the patient's right hand.

3. Patient #14 was admitted to the facility on October 13, 2015 and discharged on November 20, 2015. Review of Patient #14's medical record documented the first "Restraint Order and Flow Record, Medical" form was dated October 27, 2015. The physician failed to date and time his/her signature on October 27, 2015, October 29, 2015, November 15, 2015 and November 16, 2015.

Patient #14's EMR was reviewed on December 30, 2015 at approximately 9:59 a.m., with Staff #21 and Staff #28. Patient #14's EMR did not reveal documentation by the physician related to the restraint orders in order to establish a time the orders had been written. Staff #21 reported without a date and time by the physician it would be impossible to verify when the restraint order had been signed and if the order had been completed within twenty-four (24) hours for continuous restraints.

4. Patient #15 was admitted to the facility on December 11, 2015 and transferred to an acute care facility on December 16, 2015. According to the "Restraint Order and Flow Record, Medical" form in Patient #15 medical record, the patient was placed in restraints December 13, 2015. Review of the "Restraint Order and Flow Record, Medical" forms revealed a form dated December 15, 2015. The form did not indicate the number of soft limb restraints to be employed the order was initiated at 7:00 a.m. and at 4:30 p.m. discontinued.

Patient #15's EMR was reviewed on December 30, 2015 at approximately 9:00 a.m., with Staff #28. Review of Patient #15's EMR revealed nursing staff removed the patient's restraints at 11:10 a.m. on December 15, 2015 related to the patient's family being present and the patient was calm. The nursing documentation did not indicate when the restraints were reapplied. The "Restraint Order and Flow Record, Medical" form for December 15, 2015 did not show a break in the monitoring of Patient #15's restraints. Staff #28 verified if the restraints were reapplied within the two hour assessment window, the staff still needed a new physician's order.

Review of the facility's policy titled "Restraint Use" read in part: "... Use of Restraints must be in accordance with the order of a physician who is responsible for the care of the patient and authorized by [Name of the facility] to order restraints. A physician's order is required to initiate, change, continue, and discontinue restraints. The order must include the type and number of restraints and duration. Additional documentation of alternative interventions considered/attempted and the behavior warranting restraint use is required ..."

An interview was conducted on December 30, 2015 at approximately 11:30 a.m., with Staff #20. Staff #20 was aware of the above findings and verified the facility staff failed to implement the restraint policy and follow the procedures.


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5. Patient #3:
On December 21, 2015 at approximately 11:25 a.m. a review of Patient #3's medical record revealed the following: The patient was admitted from another medical facility for continued care due to respiratory dependency with a tracheotomy, after a stroke. On December 20, 2015, the documentation included the addition of one (1) mitt with the one (1) soft limb restraint due to the patient pulling at tubing/dressing, being unable to follow safety instructions and to prevent disruption of life sustaining interventions. The order signed by the physician did not include a date and time.

An interview with Staff #3 revealed there was lack of documentation for the restraints for this patient and the RN assessment needs to be documented every two (2) hours.

Based on interview and document review it was determined the facility staff failed to perform the required every two hour assessment of a restrained non-violent patient for one (1) of nine (9) restrained patients included in the survey sample (Patient #3) and failed to document the continued reason for restraints for one (1) of nine (9) restrained patients included in the survey sample. (Patient #14)

The findings include:

1. Patient #3:
On December 21, 2015 at approximately 11:25 a.m. a review of Patient #3's medical record revealed the following: The patient was admitted from another medical facility for continued care due to respiratory dependency with a tracheotomy, after a stroke. On December 19, 2015 at 7:00 p.m. one (1) soft limb restraint was applied due to the patient pulling at tubing/dressing, being unable to follow safety instructions and to prevent disruption of life sustaining interventions. The order is signed, dated and timed by the physician on December 19, 2015 at 1900 (7:00 p.m.) The RN signature is dated and timed for December 19, 2015 at 0700 ( 7:00 a.m.). The history and physical (H&P) on December 19, 2015 did not include a behavior assessment to indicate the need for restraints.

The registered nurse (RN) failed to perform the required every two-hour assessment on December 21, 2015 from 0045 (12:45 a.m.) to 0440 (4:40 a.m.).

An interview with Staff #3 revealed there was lack of documentation for the restraints for this patient and the RN assessment needed to be documented every two (2) hours.


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2. Patient #14's medical record revealed the facility's "Restraint Order and Flow Record, Medical" forms that document physician orders for the type of restraint and nursing documentation of the required at least every two (2) hour assessment. The form includes a section for each shift (day and night) to document the "Precipitating/Continued Reason for restraints"; a section that list the "Patient Specific Interventions," which included check off boxes for various "Treatment", Diversional", "Comfort" and "Other" interventions staff employed; and a "Plan of Care" section to indicate if the restraints were continued, discontinued or other updates to the plan of care. Review of Patient #14's medical record revealed a "Restraint Order and Flow Record, Medical" dated November 13, 2015. The November 13, 2015 form sections for "Precipitating/Continued Reason for restraints," "Patient Specific Interventions," and "Plan of Care" were blank. Although day shift nursing staff had initialed in the sidebar, the nurse failed to complete the form.

Patient #14's EMR was reviewed on December 30, 2015 at approximately 9:59 a.m., with Staff #21 and Staff #28. Staff #21 and Staff #28 verified the day shift nursing staff had failed to document the reason for the continued need for restraints, the interventions employed rather than restrain Patient #14 and failed to make a daily notation related to the patient's plan of care.


Review of the facility's policy titled "Restraint Use" read in part: "... Restraints Used For Medical Reasons (Medical Restraint) ... b) A face to face assessment of the patient by the attending physician is documented daily following initiation of restraint and before renewal of restraint orders ... 2) Patient Monitoring: a) Individuals with documented competency acting within their scope of practice may assess clinical condition and on-going needs for restraints, monitor safety, address physical needs, apply restraints and remove restraints at the earliest opportunity ... c) On-going assessment includes: Minimally every two hours or more frequently if the condition warrants, the patient's safety and other needs are assessed and documented on the Restraint Order and Flow Record, Medical or in the Electronic Medical Record (EMR) ... "

An interview was conducted on December 30, 2015 at approximately 11:30 a.m., with Staff #20. Staff #20 was aware of the surveyors' findings and verified the facility staff failed to implement the restraint policy and follow the procedures.

Based on interview and document review, it was determined the facility's governing body failed to ensure the quality program involves all hospital departments and contracted environmental services offered. The hospital failed to maintain sufficient evidence of a hospital-wide QAPI program that collects, analyzes, monitors and communicates data to staff members related to the contracted environmental services.

The findings included:

On 12/23/2015, the surveyor reviewed the information on services offered by the hospital. Information was provided to the surveyor on the Hospital/CAH Data Base Worksheet. No further evidence of the involvement of other departments was provided during this review. Evidence of quality assessment of services provided by contract was provided. The hospital failed to maintain evidence of a hospital-wide Quality Assurance and Performance Improvement (QAPI) program provided for the contracted environmental services.

On 12/29/2015 the EVS Director (Staff #25) was interviewed in the 1st floor conference room. The EVS Director acknowledged that all of the EVS services are through a contract. The EVS Director acknowledged that the EVS services provided at the hospital are controlled by the contractor not the hospital directly.

On 12/30/2015 at approximately 8:45 a.m., the EVS Director was interviewed regarding the facility's contract with Environmental Services. The EVS Director stated, "We have had (Name of the EVS Contract) in place since June 2015, but it has not been approved by the governing body nor have the policies and procedures. We have policies that have been implemented."

The CEO provided the QAPI Committee meeting minutes held monthly for 2015. The minutes failed to contain the evidence that the QAPI Committee coordinates, monitors and supervises the EVS contractor and their services in a safe and effective manner within the hospital since the contract began in June 2015. There was no evidence revealing any documentation was shared with the committee to ensure data is collected, analyzed, monitored and communicated with other staff members.

Based on interview and document review, it was determined the facility's Quality Assurance and Performance Improvement (QAPI) Committee failed to implement and maintain their plan and improvement actions, including evaluating steps to improve patient quality of care and safety if positive results are not collected and continued to actively review the results of the data, making decisions based on such review.

The findings included:

A phone interview was conducted on 12/21/2015 with the Interim Quality Management Director (Staff #6) and the new Quality Management Director (Staff #7) who was present but new to his/her position. Staff #6 was asked about the hospitals' current performance improvement projects, the surveyor was provided with documentation of seven (7) projects: relating to falls, wound improvement, updating care plans related to restraints, unplanned discharges, discharge to community, duplicate lab orders and an increase in infection rate.

From the list of performance improvement projects provided by the facility, the surveyor chose "Updating care plans related to restraints" as one of the quality indicator tracers to complete the questions in the Hospital Quality Assessment Performance Improvement (QAPI) Worksheet during the on-site survey requirement to determine compliance with the QAPI Condition of Participation.

During a phone interview with Staff #6, he/she stated the project related to "Updating care plans" started in February 2015 during an audit of patient restraints. Staff #6 stated once it was recognized that this was a hospital-wide problem, it was determined that the project would include all patient's care plans, not just patients with restraints. Staff #6 stated the project was initiated hospital wide in May 2015.

The Chief Executive Officer (CEO) provided the QAPI Committee meeting minutes held monthly for 2015. The minutes dated 06/30/2015 reveal the documentation: "Care plan weekly monitoring tools to be completed and turned into DQM on Monday morning (initiated 05/19/2015). The results documented in the May 2015, July 2015, August 2015, and October 2015 each showed a decline in the percentage of compliance. The documentation included contributing factors to the decline to be" include large turnover in staff and large amount of agency use, lack of staff educator, DON (Director of Nursing) new to (his/her) position." The minutes dated 08/25/2015 reveal the following documentation: "Care plan reflects use of restraints compliant continue to show a problem in updating care plans upon initiating of the restraint. Nurse assigned to the patient is not updating the care plan. Care plan updates being done primarily by nurse supervisor. Concurrent auditing needs to occur in order to keep track of the need to update care plans." The minutes dated 09/22/2015 reveal the following documentation: "...compliant continue to show a problem. Care plan update being done primarily by nursing supervisor. Staff nurse are rarely updating care plan as the patient's condition changes." The minutes dated 10/27/2015 reveal the following documentation: "...compliant dropped...continuing to show a problem in updating care plans upon initiation of nurse assigned to patient is not updating the care plan upon initiation of the restraint; supervisor are not concurrently auditing the restraints. Weekly care plan and restraint monitoring audit is being introduced to the nursing supervisor by CCO. Restraints reviewed daily at morning Flash meetings and alternative to the restraint explored. Monthly audit to be conducted on an ongoing basis."

The surveyor inquired to Staff #6 if the QAPI minutes for the November meeting were available. Staff #6 stated 11/24/2015 was the last QAPI meeting conducted but he/she is unaware the reason the minutes have not been completed to review, but the meeting will reflect the previous month's data.

The surveyor inquired to Staff #6 if he/she knew the reason eight (8) out of twenty-six (26) medical records reviewed by the survey team from 12/21/2015 through 12/28/2015 did not have the restraint care plans updated. Staff #6 stated he/she started in a new role at a different location effective 11/30/2015, but was under the impression the issue with updating the care plans was going to continue to be ongoing.

An interview was conducted 4:30 p.m. on 12/22/2015 during the end of the day meeting. The facility staff were informed of the findings and a policy/procedure was requested.

Review of the facility's policy on 12/22/2015 revealed a limited policy acknowledging a QAPI program would be maintained; however no documented evidence regarding collection of data, monitoring, interventions, or evaluation were revealed.

The surveyor could find no evidence the facility was addressing implementing and maintaining their plan and improvement actions, including evaluating new steps to improve patient quality of care and patient safety to get positive results. QAPI data was reviewed from the initiation of the plan on 05/19/2015 through 12/28/2015 when eight (8) of twenty-six (26) medical records were reviewed by the survey team and showed no evidence the care plans were updated.

Based on interview, document review and a part of a complaint investigation it was determined nursing staff failed to develop a plan of care for a patient admitted to the facility with a pressure ulcer for one (1) of three (3) patients with pressure ulcers included in the survey sample. (Patient #1)


The findings included:

Patient #1 was admitted to the facility with the diagnoses of acute respiratory failure with mechanical ventilator dependency, acute kidney failure with hemodialysis, pressure ulcers, hypotension, anxiety, percutaneous endoscopic gastrostomy (PEG) tube for feeding, and a fecal management system for bowel incontinence.

A review was conducted of Patient #1's electronic medical record on December 23, 2015 beginning at 8:05 a.m., with Staff #21. Staff #21 verified Patient #1 was admitted to the facility with pressure ulcers: Staff #21 verified the admitting nurse's documentation regarding Patient #1 had bilateral "Stage 2" on his/her "buttocks approximately 9 cm (centimeter) by 9 cm, an area not staged in the upper gluteal fold measuring approximately 10 cm, and a sacral area pressure ulcer. Review of the wound care pictures revealed by 12/14/2015 Patient #1's sacral and bilateral pressure ulcers had merged and were unstageable related to necrotic tissue. Review of Staff #23's documentation dated "12/15/15" read in part: "... [He/she] has an antibiotic resistant infection most likely related to a necrotic wound of buttock and sacrum ..."

Staff #21 and the surveyor reviewed Patient #1' EMR for a plan of care to address the patient's pressures and initiated intervention to relieve pressure and promote healing. After the review Staff #21 state, "We failed to do a plan of care related to the patient's skin and wounds."

Based on observations, staff interviews, and record review, the facility staff failed to ensure that medication was administered in response to an order from a practitioner, that a time critical anticonvulsant medication was omitted, and that medication that includes manufacturer instructions not to crush were crushed and administered for four (4) of eight (8) patients observed for medication administration. (Patients #5, #7, #10 and #19)

The findings include:

1. The surveyor observed Staff #34 perform a medication pass for Patient # 7, Patient #10 and Patient # 19 on 12/29/2015 between 10:00 AM and 11:30 AM. While administering medications to Patient #19, the surveyor observed 3 unlabeled bottles of Nystatin Powder 15 grams in the brown cabinet in Patient #19's room where bulk medications are stored. At 11:30 AM on 12/29/2015 Staff # 3, a nursing supervisor, was shown the 3 bottles of Nystatin powder, and was interviewed regarding the labeling requirement for medications.

Staff # 3 searched the eMAR (electronic medication administration record) and the physician orders for Patient 19, and stated "I don't see an order for Nystatin powder, I don't know how they pulled it out of the Pixis because you can't pull without an order, and (patient's name) doesn't have one. I have no idea, I've looked everywhere, there's no order".

At 1:30 PM on 12/29/2015, while reviewing Patient #19's medication administration record (MAR) for 12/29/2015 with Staff #28, a nursing supervisor, the surveyor noted an order for Vimpat (an anticonvulsant medication) 100 mg (one hundred milligrams) by mouth twice daily, with administration times scheduled for 10:00 AM and 10:00 PM. The surveyor observed the 10:00 AM medication pass for Patient #19, and Vimpat was not administered. Documentation on Patient #19's MAR was that Vimpat had been administered on 12/29/2015 at 13:40 (1:40 PM), with an administration comment "scanner not working". The surveyor interviewed Staff #28 regarding documentation of Vimpat administration at 1:30 PM on 12/29/2015, and he/she called the pharmacy to ask what time Vimpat was pulled from the Pixus; the pharmacy was unable to provide information, and stated they would call back. Staff #28 then went to the floor to talk with Staff #34, who administered 10:00 AM medications to Patient #19. At 3:00 PM, after talking with Staff #34, Staff #28, the nursing supervisor, stated the following to the surveyor " When (Staff #34's name) realized that Vimpat had not been given, he/she communicated with the physician who said to hold the 10:00 AM dose, and give the next scheduled dose". Staff #28 provided the surveyor with a nursing note for Patient #19 dated 12/29/2015 at 14:46 (2:46 PM) written by Staff #34 which stated "Patient had Vimpat due, attempted to administer but was out of window. Communicated on if the medication can be given. MD stated to skip and resume next dose.. The patient was left up in chair, no distress was present. Denied any pain. Will continue to monitor." A physician order to skip dose and resume with next scheduled dose was not written.


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2. Observations were conducted on December 21, 2015 beginning at 9:30 a.m., with Staff #9 during the administration of medication for Patient #9. Staff #9 entered the medication room; he/she did not perform hand hygiene prior to retrieving medications from the automated medication dispensing system. Staff #9 pulled the following medications:
Carvedilol 3.125 mg (milligrams) tab two tabs for one dose 6.25 mg [*Carvedilol (Coreg) is used to treat heart failure and hypertension (high blood pressure).]
Detrol LA 2 mg capsule [*Detrol is used to treat overactive bladder symptoms of urinary frequency, urgency, and incontinence.]
Heparin Sodium 5000 u (units) one vial [*Heparin is used to treat and prevent blood clots in the veins, arteries, or lungs.]
Lasix 40 mg injectable vial [*Lasix (furosemide) is a loop diuretic (water pill) that prevents your body from absorbing too much salt, allowing the salt to instead be passed in your urine.]
Lisinopril 10 mg four tabs for one dose of 40 mg [*Lisinopril is used to treat hypertension, congestive heart failure and to improve survival after a heart attack.]
Magnesium Oxide 400 mg one tab [*Magnesium oxide is a mineral supplement used to treat or prevent low levels of magnesium in the blood.]
Amlodipine Besylate 5 mg tab [(Norvasc)-a calcium channel blocker used to treat high blood pressure and angina.]
Potassium Chloride 20 mEq (milliequivalent) liquid [*Potassium Chloride is a mineral supplement used to treat or prevent low levels of potassium in the blood.]
Staff #9 and the surveyor exited the medication room and entered Patient #9's room. Staff #9 entered an area marked off with red tape on the floor. Staff #9 placed the medications retrieved from the automated medication dispenser on a flat surface. Staff #9 informed the surveyor that Patient #9 was on contact precautions. Staff #9 did not perform hand hygiene prior to donning his/her personal protection equipment (PPE) and offering a gown and gloves to the surveyor. Staff #9 opened a small cabinet adjacent to the flat surface and gathered additional supplies to prepare Patient #9's medications. Staff #9 retrieved a bottle of topical Nystatin powder from the cabinet, the bottle had been opened but did not have a date it had been opened.
Staff #9 placed the Carvedilol 3.125 mg two tabs, Lisinopril 10 mg four tabs, Amlodipine Besylate 5 mg tab, and Magnesium Oxide 400 mg one tab into a pill crusher. Staff #9 left one capsule (Detrol LA) on the flat surface not opened amongst the empty single dose pill packages. Staff #9 crushed the tablets and poured the powdered mixture into a cup, poured the Potassium Chloride 20 mEq liquid into the cup. Staff #9 obtained a 60 cc (cubic centimeter) syringe from the patient's supplies next to the patient's bed, opened the packaging laying the contents on a contaminated field within the patient's space. Staff #9 used the 60 cc syringe to add tap water to the crushed pill mixture. Staff #9 used the tip of the syringe to stir the mixture prior to drawing the pinkish-orange mixture into the syringe. Staff #9 stopped Patient #9's tube feeding pump, disconnected the patient's percutaneous gastrostomy tube from the feeding line. Staff #9 placed the tip of the 60 cc syringe into Patient #9's percutaneous gastrostomy tube and used the plunger of the syringe to push the medication mixture through the patient's percutaneous gastrostomy tube. Staff #9 removed the syringe drew up an additional "about 30 cc" of tap water from a cup and attempted to flush the remaining pinkish-orange medication mixture from the syringe, with minimal success. Staff #9 reconnected the patient's percutaneous gastrostomy tube to the feeding line and restarted the pump. Staff #9 laid the cup and the 60 cc syringe with the remaining pinkish-orange medication residue in the syringe's original container and placed it on the flat surface used to prepare the patient's medications for administration.
Staff #9 administered the Lasix 40 mg IV (intravenous) through Patient #9's peripherally inserted central catheter (PICC) line located in the patient's left arm. Staff #9 administered Patient #9's Heparin Sodium 5000 u subcutaneously in the patient's right lower quadrant abdomen.
Staff #9 repositioned Patient #9, applied the patient's heel/foot drop protectors bilaterally, and straightened the patient's bedding. Staff #9 returned to the medication preparation area and started to discard the empty single does pill packages. Staff #9 stated, "I forgot a dose" identified the dose as Detrol. Staff #9 did not change gloves prior to opening the Detrol package, opening the capsule, pouring the contents in the previously used cup, and directly adding water from the tap. Staff #9 drew up the beads and water into the previously used syringe, the pinkish-orange medication mixture left in the syringe did not mix with the newly added water and medication. Staff #9 used the same procedure to administer the medication and water through Patient #9's percutaneous gastrostomy tube.
Staff #9 replaced the Nystatin powder within the cabinet in Patient #9's room. When the surveyor questioned regarding whether the Nystatin bottle had been dated when opened, Staff #9 rotated the bottle and stated, "No, there is no date." Staff #9 tossed the bottle in the trash receptacle, the surveyor questioned whether a second nearly empty bottle of Nystatin powder within the patient's cabinet had been dated when opened. Staff #9 retrieved the second bottle from the cabinet and stated, "This one was not dated." Staff #9 threw the second bottle of Nystatin powder in the trash receptacle and reported that whenever staff opened a multi-dose medication they were supposed to put an open date on the medication.
Staff #9 removed his/her PPE within the area marked off with red tape on the floor and utilized the hand sanitizer on the way out of the room.
Staff #9 reported the physician's orders and medication administration record (MAR) were included within the electronic medical record (EMR). The surveyor requested a copy of Patient #9's medication orders at 10:05 a.m. on December 21, 2015 and then continued the initial tour. At approximately 2:10 p.m. on December 21, 2015 the surveyor requested, from Staff #3, a copy of Patient #9's orders and to view Patient's #9's electronic MAR (eMAR).
On December 22, 2015 Staff #28 informed the surveyor in order to print the physician's orders from the facility's EMR system there was a need to figure out what type of report to run. By the end of the day on December 23, 2015 the surveyor had not received a copy of Patient #9's MAR or the physician's orders.
Review of Patient #9's physician order on December 29, 2015 did not include the same medications the patient had been administered on December 21, 2015. A request was made for the physician's orders for the medications that were to be administered on December 21, 2015.
On December 30, 2015 at 11:30 a.m. an interview and review of Patient #9's physician orders and eMAR was conducted with Staff #28. Review of Patient #9's physician orders and eMAR revealed the administration route for the following medications were listed as "PO (by mouth)": Carvedilol 3.125 mg tab, Detrol LA 2 mg capsule, Lisinopril 10 mg four tabs, Magnesium Oxide 400 mg one tab, Amlodipine Besylate 5 mg tab and Potassium Chloride 20 mEq solution. Patient #9's EMR did not contain a physician's order to crush, mix, and administer the above medications through the patient's percutaneous gastrostomy tube. Staff #28 and the surveyor reviewed Patient #9's EMR for documentation that the patient was safe to administer oral medications. Documentation revealed Patient #9 was "NPO (nothing by mouth)." Patient #9's EMR included a Speech Therapy (ST) document dated December 1, 2015 at 10:33 a.m., which read in part: " ST Screen: Pt [Patient] not able to wake for evaluation. Chart reviewed and nurse consulted. Pt is not appropriate for skilled ST at this time s/t [such that] hx [history] of dysphagia [difficulty with swallowing] with recurrent aspiration pneumonia ..." Staff #28 stated, "[Patient #9's name] would not be someone I would attempt to administer oral medications." Staff #28 verified nursing staff should have asked for a change in the physician's orders to reflect administering the medications through the patient's "feeding tube." The surveyor questioned whether the medications administered on December 21, 2015 by Staff #9 should have been crushed. The surveyor inquired whether the nursing staff had a list of medications that should not be crushed. Staff #28 reported generally the pharmacy would list if a medication should not be crushed, the surveyor added that if the medications were listed as oral administration the pharmacy might not be aware that nursing staff was crushing the medications prior to administering through the patient's percutaneous gastrostomy tube. Staff #28 reported he/she would see if the units had a list of medications, which should not be crushed. The facility staff did not provide the surveyor with evidence of a list related to medications that should not be crushed prior to exit on December 30, 2015.
Review of ISMP (Institute for Safe Medication Practices) on-line list titled "Oral Dosage Forms That Should Not Be Crushed 2015" included one medication (Coreg), which should not have been crushed.
*The description for the commonly prescribed usage of medications was taken from www.Drugs.com.
3. An observation was conducted on December 21, 2015 at 10:19 a.m., with Staff #10 as he/she prepared medications for Patient #7. Staff #10 sanitized his/her hands prior to using the automated medication dispensing system. Staff #10 retrieved the following single dose medications for Patient #7:
Amlodipine Besylate (Norvasc) 5 mg two tabs;
Flomax 0.2 mg two tabs [*Flomax (tamsulosin) is used to improve urination in men with benign prostatic hyperplasia. Hyperplasia is defined as the enlargement of an organ or tissue caused by an increase in the reproduction rate of its cells, often as an initial stage in the development of cancer.];
Magnesium Oxide 400 mg one tab; and
Venlafaxine 75 mg one tab [*Venlafaxine is used to treat major depressive disorder, anxiety, and panic disorder.]
Staff #10 carried the medications into Patient #7's room and laid them down on the flat surface used for medication preparation within the patient's room. Staff #10 washed his/her hands and proceeded to the computer. Staff #10 announced "I forgot [Patient #7's name] [his/her] computer isn't working. I can't give the medications right now." Staff #10 picked up Patient #7's medications from the medication preparation area in the patient's room, placed them in a Styrofoam cup, and placed the cup in his/her uniform pocket. Staff #10 did not return the medications to the medication room.
An observation was conducted on December 21, 2016 at 11:15 a.m. of Staff #10 on the opposite unit of his/her assigned patients. Staff #10 continued to carry Patient #7's medications in a cup in his/her uniform pocket. The surveyor inquired if Patient #7 had received the medications pulled from the automated medication dispensing system. Staff #10 stated, "No, [his/her] computer is still not fixed." Staff #10 had pulled medications for another patient and entered the patient's room with Patient #7's medications still in his/her pocket.
After the performance of additional medication passes on December 28 and 29, 2016, the surveyor requested the facility's policy for medication administration from Staff #3 and Staff #21. Staff #21 asked for specifics related to medication administration, the surveyor presented the above scenario. Staff #21 stated, "We are not going to have a policy that states you can or should not carry medications in your pocket. That's nursing 101." Staff #21 reported the nursing staff is aware that medications are not to carried in the pocket of their uniform.

Based on interview and document review it was determined the facility's physicians failed to date and time restraint orders for four (4) of nine (9) restrained patients included in the survey sample. (Patient #3, #7, #14 and #15)

The findings included:

1. Patient #7 was admitted to the facility on November 17, 2015 and was a current patient during the survey. A review was conducted of Patient #7's medical record on December 22, 2015. The findings included the physician failed to include a date and time with his/her signature on December 17, 2015.

2. Patient #14 was admitted to the facility on October 13, 2015 and discharged on November 20, 2015. Review of Patient #14's medical record documented the first "Restraint Order and Flow Record, Medical" form was dated October 27, 2015. The physician failed to date and time his/her signature on October 27, 2015, October 29, 2015, November 15, 2015 and November 16, 2015.

3. Patient #15 was admitted to the facility on December 11, 2015 and transferred to an acute care facility on December 16, 2015. According to the "Restraint Order and Flow Record, Medical" form in Patient #15 medical record, the patient was placed in restraints December 13, 2015. Review of the "Restraint Order and Flow Record, Medical" forms revealed a form dated December 15, 2015. The physician failed to indicate the number of soft limb restraints to be employed the order was initiated at 7:00 a.m. on December 15, 2015 and at 4:30 p.m. was discontinued.

An interview and review of the above findings was performed on December 30, 2015 beginning at approximately 9:00 a.m., with Staff #21 and Staff #28. Staff #21 and Staff #28 reviewed the above medical records and confirmed the findings.


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4. Patient #3: On December 21, 2015 at approximately 11:25 a.m. a review of Patient #3's medical record revealed the following: On December 20, 2015, the documentation included the addition of one (1) mitt with the one (1) soft limb restraint due to the patient pulling at tubing/dressing, being unable to follow safety instructions and to prevent disruption of life sustaining interventions. The order signed by the physician did not include a date and time.

Based on observation and interview it was determined the facility staff failed to ensure expired and mislabeled medications were not available for administration to patients in one (1) of three (3) crash carts.

The findings included:

An observation was conducted on December 21, 2015 at 10:56 a.m., with Staff #3. The observation revealed one 250 ml (milliliter) bag of 5% Dextrose had expired on "Nov 15." The crash cart also contained a package of "Dopamine HCL" injectable labeled with patient information.

An interview was conducted on December 21, 2015 at 10:59 a.m., with Staff #3 and Staff #46. Staff #3 verified the findings. Staff #46 verified the pharmacy had placed the package of Dopamine HCL injectable into the crash cart. Staff #46 verified the package had a label with a patient's name and account number partially torn off. Staff #46 reported the Dopamine was "probably" in the facility's automated medication dispensing system and had been returned to the pharmacy. Staff #46 initially denied that the medication had entered the patient's space, but reported he/she could not be certain. Staff #46 reported the pharmacy did not have a policy for returned medications with patient information labels to be placed in the crash cart for future utilization.

According to www.Drugs.com: "Dopamine is a medication used in the correction of hemodynamic imbalances present in shock syndrome after MI, trauma, endotoxic septicemia, open heart surgery, and renal failure or chronic cardiac decompensation (e.g., CHF).

Dopamine stimulates beta-1 receptors in the heart, causing more complete and forceful contractions (inotropy). Also acts on alpha receptors (dose dependent) and has dopaminergic effects.

Dopamine also may be used to support hemodynamic status by correcting hypo¿tension. It enhances cardiac output, minimally increasing oxygen consumption and causing peripheral vasoconstriction."

Based on observations and interviews the facility staff failed to ensure:
Supplies utilized in emergency situations were not expired in three (3) of three (3) crash carts;

Respiratory supplies kept in a drawer labeled "Keep Locked" remained locked on one (1) of three (3) units:

Emergency equipment was checked for function /expiration of supplies and documented as completed for two (2) of three (3) crash carts; and

Expired sterile swabs were not not available for use with a patient on one (1) of three (3) units.

The findings include:

1. Observations conducted on December 21, 2015 at approximately 09:30 a.m. during the initial tour of the facility revealed the crash cart on the third floor contained five (5) blue top vials with an expiration date of 10/2015.

Observations conducted on December 21, 2015 during the initial tour on the second floor (2 East) revealed the crash cart contained four (4) blue top vials with expiration date of 10/2015.

Observations conducted on December 21, 2015 during the initial tour on the second floor (2 West) revealed the crash cart contained five (5) blue top vials with expiration date of 10/2015. The crash cart also contained three (3) pair of sterile gloves size 6 1/2, which had expired on 01/2012, two (2) pair of sterile gloves size 6 1/2, which had expired 07/2012 and (1) pair of sterile gloves size 6 1/2, which had expired 01/2013. The crash cart contained one (1) package of suction swabs that had an expiration date of 06/30/2015.

The observation conducted on two west revealed a drawer labeled "Respiratory Supplies - Keep Locked." The drawer was not locked and contained arterial blood gas kits, respiratory probes and nail clippers. The observation was conducted with Staff #1, who tried to lock the drawer, but it would not lock so it was left unlocked.

A review was conducted on December 21, 2016 of the "crash cart checklist" for the month of December 2015 on 2 West. The documentation revealed staff had failed to document that the crash cart had been checked on 12/12/15 and 12/16/2015. The December 2015 "crash cart checklist" did not contain documentation that the crash cart locked box had been checked on 12/7/15, 12/8/15, 12/9/15, 12/11/15, 12/13/15, and 12/17/15. Staff failed to document the crash cart lock number had been checked on 12/1/15 and 12/19/15 to ensure the crash cart's contents had not been tampered with and all medications needed in an emergency were present. Staff had failed to document verification that the cart's cardiac board (utilized during cardiac resuscitation) was present and clean for the following dates: 12/3/15, 12/4/15, 12/7/15, 12/8/15, 12/9/15, and 12/11/15.

An interview was conducted on December 21, 2015 with Staff #19 revealed that the crash carts are checked for supplies and expirations monthly and "typically all are replaced."

An interview was conducted on December 21, 2015 with Staff #3 revealed the crash cart checks are not being completed per facility policy and procedure.


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2. Observations were conducted on December 21, 2015 at 10:00 a.m., with Staff #3 on 2 East. The observation revealed the Aquasonic gel located with the crash cart had expired "2015/09." Staff #3 verified the tube of gel had expired. [Aquasonic gel is used for diagnostic and therapeutic medical ultrasound.]

A review and interview was conducted on December 21, 2015 at 10:00 a.m., with Staff #3 of 2 East's "Crash Cart Checklist" for the month of December 2015. Nursing staff failed to perform any documentation that the crash cart and the emergency equipment had been checked on "12/7/15." The column listing the 24 items that needed to be checked or verified was blank for December 7, 2015. Nursing staff had failed to verify the crash cart was locked on December 7- 9, 2015; December 12, 13, 16, and 17, 2015. The nursing staff failed to document checking for both the earliest expiration of supplies and earliest expiration of medication on December 12-13, 2015. Nursing staff failed to document the "Defibrillator Number" from December 5 -18, 2015. The documentation failed to verify the portable suction was present on December 7-10, 2015 and whether the cardiac board was present and clean from December 7-14, 2015. Staff #3 verified the findings. The surveyor requested a copy of the facility's policy and procedures related to emergency equipment/crash cart.

Staff #3 presented the facility's policy titled "Crash Cart Monitoring" at 1:11 p.m. on December 21, 2015. The policy read in part: " Policy: 2. Crash carts, defibrillators, medications, intubation equipment, and emergency equipment will be maintained properly to assure readiness in emergency situations. 3. All crash carts will be checked every last Thursday of each month and immediately upon usages." Staff #3 clarified the policy regarding the crash cart being checked on the last Thursday of each month. Staff #3 stated, "The monthly check is performed by pharmacy and material management." The facility's policy read in part "8. Nursing will be responsible for the following: a. The Nursing Supervisor will be responsible for checking crash carts once a day to insure [Sic] the integrity of the cart, presence of all required equipment and supplies and the proper function of all equipment..." Staff #3 nursing staff had failed to follow the facility's policy regarding monitoring the crash carts on two (2) of the three (3) units.


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3. On 12/28/2015 at 12:35 PM, in the lab drawer on the third floor, the surveyor observed a Transystem sterile transport swab which had an expiration date of 11/2015. The sterile transport swab was in a plastic bag with other unexpired Transystem sterile transport tubes.

Based on observations, interviews and documents reviewed it was determined the facility staff failed to implement a system to ensure staff practiced infection reducing behaviors as evidenced as:

A. Ensuring proper hand hygiene; failure to clean equipment after patient on contact isolation and before new patient contact;
B. Failure to use personal protective equipment and use it appropriately within an isolation area;
C. Staff storing medications in uniform pocket;
D. Failure to use personal protective equipment appropriately between patients;
E. Failure to handle soiled linens and perform environmental cleaning in a manner to prevent the spread of infectious agents (including inappropriate use of personal protective equipment and failing to perform hand hygiene).
F. Failure to maintain aseptic techniques during wound care:

The findings included:

1. On 12/21/2015 observations were made on 2 East, 2 West and the High Observation Units and the following were noted:

A. Failure to perform hand hygiene and clean equipment:

On 12/21/2015 at approximately 1:15 p.m. a medication pass was observed on the 2 West Unit Room #227 for a patient on "Contact Precautions." During the observation Staff #31 was observed taking the patient's vital signs. Staff #31 was observed crossing the designated clean zone (red tape to designate the area) gowned and gloved after being in contact with the patient into the designated clean area. Prior to crossing from the patient care area into the designated clean area, Staff #31 did not remove his/her gloves or gown. No hand hygiene was observed prior to Staff #31 reaching into the box of gloves on the wall to get another pair and remove the pair he/she had and don another pair of gloves without any hand hygiene. Staff #31 crossed back over from the designated clean area back into the patient care area and was observed completing patient care. Staff #31 was observed removing his/her gown and gloves at the designated clean zone and removing the portable vital sign machine without disinfecting it or performing hand hygiene. Staff #31 did not disinfect the portable vital sign machine prior to entering the next room (Room #225).

An interview was conducted on 12/21/2015 at the 2 East Nursing Station with Staff #12 and Staff #31 in regard to observations of Staff #31 during patient care in Room #227. Staff #12 stated he/she was Staff #31's preceptor during his/her orientation and should have not left him/her alone, but had to take care of another patient and didn't realize he/she would be gone that long. The Nursing Supervisor had brought the concerns of the surveyor's observations to Staff #12 and he/she would re-educate Staff #31 regarding proper hand hygiene and isolation procedures.

B. Failure to use personal protective equipment and use it appropriately within an isolation area:

On 12/21/2015 at approximately 1:30 p.m., Staff #44 was observed removing a trash bag from the patient care area of a patient on "Contact Precautions" in Room #227 crossing the designated clean zone (red tape to designate the area) gowned and gloved. Staff #44 did not remove his/her gloves or gown, and exited Room #227 into the hallway and placed the trash bag into a closed container located in the hallway. Staff #44 entered back into the contact isolation room with the same personal protective equipment (PPE) and failed to perform hand hygiene before and after exiting Room #227.

The Director of Nursing (DON) and Nursing Supervisor were interviewed on 12/21/2015 at approximately 1:30 p.m. and reported the designated clean area (red tape on the floor) in patient's rooms is a visual reminder to staff. The Nursing Supervisor confirmed this area should not be crossed over after being in contact with a patient unless the staff removed their gown and gloves.

C. Risk of cross contamination by carrying medications in uniform pocket:
On 12/28/2015 at approximately 11:20 a.m. during interviewing staff regarding adverse events and their role in Quality Assessment Performance Improvement (QAPI), Staff #27 was observed to have medications in the pocket of the scrub pants being worn. Staff #27 stated, "I have three patients that must have their blood sugars checked every six hours and are on isolation, so I keep extra insulin syringes and normal saline syringes in my pocket. I know I'm not suppose to, but where else can I keep them? Never mind, I will discard of them now."

D. Failure to use personal protective equipment appropriately between patients:

An observation conducted on 12/29/2015 at 1:45 p.m. while on 2 East and 2 West Units revealed Staff #30 wearing a surgical mask. Staff #30 was observed entering Room #227. This patient was on "Contact Precautions." Staff #30 exited Room #227 and performed hand hygiene but did not remove or change surgical mask. Staff #30 entered Room #225 performed hand hygiene before and after exiting Room #225 but did not remove or change his/her surgical mask. Staff #30 entered Room #224 performed hand hygiene before and after exiting Room #224 but did not remove or change his/her surgical mask.

An interview was conducted 4:30 p.m. on 12/29/2015 during the end of the day meeting. The facility staff were informed of the findings and the Chief Operating Officer (COO) reported staff members wearing mask in the facility were staff that did not or could not receive the flu vaccine and were following policy.

E. Failure to handle soiled linens and perform environmental cleaning in a manner to prevent the spread of infectious agents:

The following was observed during environmental cleaning of Room #202 for a patient on "Contact Precautions for C-diff" on 12/29/2015 at approximately 2:30 p.m.:
Staff #44 washed hands, donned gown and gloves and prepared supplies for daily cleaning of patient room. Staff #44 was observed removing all trash. Staff #44 removed gown and gloves in the designated clean zone and placed trash bags in a container located in the hallway. Staff #44 entered back into designated clean zone washed hands, donned gown and gloves then entered into the patient care area and removed soiled linen in tied blue bags. Staff #44 removed gown and transported soiled linen in tied blue bag down the hall to the soiled utility room with the same "dirty" gloves. Removed gloves and sanitized hands (C-diff patient) in the soiled utility room and performed hand hygiene once back in Room #202. Staff #44 donned gown and gloves and observed dusting all high areas and blinds in the patient care area with a dust wand/tool. Staff #44 returned the dust wand/tool back to the top of the work cart located in the hallway with other clean items and without removing gown and gloves. Staff #44 returned to Room #202 to clean the bathroom including scrubbing the toilet. Staff #41 was observed using a separate clean cloth saturated with the disinfectant oxycide for each area. Staff #41 returned to his/her work cart in the hallway without removing gown and gloves to get clean mop, patient care area was observed being mopped back to entrance of the room. After cleaning, Staff #44 placed the dirty cloths in a plastic bag attached to the work cart. Staff #44 then removed gown and gloves at the designated clean zone and performed hand hygiene.
Staff #44 failed to change gloves and perform hand hygiene after cleaning "dirty" areas before touching "clean" areas and failed to follow manufacture's guidelines to ensure surfaces are sanitized between patients.

An interview with Staff #44 revealed that he/she was unsure what the contact/dwell time for oxycide. Staff #44 acknowledged that the cleaning process at the facility was to change the mop water every three (3) rooms except if it was a C-diff patient's room, then it had to be changed every time the room was cleaned. Mop heads had to be changed with every room cleaned.

During an interview with the Assistant Director of Environmental Services (Staff #42) on 12/29/2015 at 1:45 p.m. he/she stated the cleaning process at the facility was to change the mop water every two (2) rooms unless the room was an isolation room and then the mop water must be changed every time the room is cleaned. The mop head must be changed with each room cleaning, no exceptions. Manufacturer's guidelines for oxycide states contact time 5 minutes for all surfaces.

An interview was conducted 4:30 p.m. on 12/29/2015 during the end of the day meeting. The facility staff were informed of the findings and a policy/procedure was requested.

Review of the contract Environmental Services policy titled "Daily Isolation Cleaning" which read in part: "Purpose: To clean and disinfect all contact surfaces in a room when one of the following four precautionary systems applies: Contact, Airborne, Droplet and Protective (Reverse Isolation). Personal Protective Equipment: Use appropriate Personal Protective Equipment such as goggles, masks, face shields, N 95 masks, and gowns in accordance with Hospital Infection Prevention procedures when there is the possibility of contact with infectious material, body fluids or hazardous chemicals. Gloves must always be worn when performing any cleaning procedures. They must be changed after each room or between areas being cleaned. Gloves should also be changes when/if the integrity of the glove becomes compromised or torn. Hands must be washed after removing gloves. Mopping solution must be discarded after mopping any isolation rooms, cleaned, and filled with fresh solution before proceeding to the next assigned area.....Procedure: 1. Position cart near the doorway so that all equipment and supplies can be reached and so that you do not have to leave the room once the cleaning procedures have begun. Do not take anything into the room that cannot be thoroughly disinfected.......27. Dispose of linen and trash in an approved container. 29. Remove isolation clothing using the inside-out method, and dispose of it in a plastic trash liner. Tie all liners individually for proper disposal. 30. Remove gloves and wash hands before proceeding to the next room or area. Supplemental Procedures - Daily Cleaning (C-Diff Rooms) When performing a daily clean on a room where the patient had Clostridium difficile, commonly referred to as C-diff, an EPA-Registered/Hospital-approved disinfectant that has a spore kill claim must be used. The cleaning process for cleaning C-diff rooms is a two-step process. The first step is to remove the bio-burden (organic soil) from all surfaces. The second step is to disinfect the surfaces with a product that carries a kill claim against C-diff spores. First Step (Clean): All contact surfaces must be cleaned with an EPA-registered disinfectant with good cleaning detergents utilizing a minimum of five cleaning rags or disposable wipes in a systematic manner. Second Step (Disinfect): All contact surfaces must be cleaned a second time with an EPA-registered disinfectant that carries a spore kill claim utilizing a minimum of five cleaning rags or disposable wipes in a systematic manner."

According to www.cdc.gov Clostridium difficile (C-diff) is a bacterium that causes inflammation of the colon, known as colitis. The bacteria are found in the feces. People can become infected if they touch items or surfaces that are contaminated with feces and then touch their mouth or mucous membranes. Healthcare workers can spread the bacteria to patients or contaminate surfaces through hand contact. Clostridium difficile spores are transferred to patients mainly via the hands of healthcare personnel who have touched a contaminated surface or item. Clostridium difficile can live for long periods on surfaces.


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2 A. Failure to perform hand hygiene during medication pass:
Observations were conducted on December 21, 2015 beginning at 9:30 a.m., with Staff #9 during the administration of medication for Patient #9. Staff #9 entered the medication room; he/she did not perform hand hygiene prior to retrieving medications from the automated medication dispensing system.
Staff #9 and the surveyor exited the medication room and entered Patient #9's room. Staff #9 entered an area marked off with red tape on the floor. Staff #9 placed the medications retrieved from the automated medication dispenser on a flat surface. Staff #9 informed the surveyor that Patient #9 was on contact precautions. Staff #9 did not perform hand hygiene prior to donning his/her personal protection equipment (PPE) and offering a gown and gloves to the surveyor. Staff #9 opened a small cabinet adjacent to the flat surface and gathered additional supplies to prepare Patient #9's medications. Staff #9 retrieved a bottle of topical Nystatin powder from the cabinet, the bottle had been opened but did not have a date it had been opened.
Staff #9 placed the Carvedilol 3.125 mg two tabs, Lisinopril 10 mg four tabs, Amlodipine Besylate 5 mg tab, and Magnesium Oxide 400 mg one tab into a pill crusher. Staff #9 left one capsule (Detrol LA) on the flat surface not opened amongst the empty single dose pill packages. Staff #9 crushed the tablets and poured the powdered mixture into a cup, poured the Potassium Chloride 20 mEq liquid into the cup. Staff #9 obtained a 60 cc (cubic centimeter) syringe from the patient's supplies next to the patient's bed, opened the packaging laying the contents on a contaminated field within the patient's space. Staff #9 used the 60 cc syringe to add tap water to the crushed pill mixture. Staff #9 used the tip of the syringe to stir the mixture prior to drawing the pinkish-orange mixture into the syringe.
Staff #9 stopped Patient #9's tube feeding pump, disconnected the patient's percutaneous gastrostomy tube from the feeding line. Staff #9 placed the tip of the 60 cc syringe into Patient #9's percutaneous gastrostomy tube and used the plunger of the syringe to push the medication mixture through the patient's percutaneous gastrostomy tube. Staff #9 removed the syringe drew up an additional "about 30 cc" of tap water from a cup and attempted to flush the remaining pinkish-orange medication mixture from the syringe, with minimal success. Staff #9 reconnected the patient's percutaneous gastrostomy tube to the feeding line and restarted the pump.
Staff #9 laid the cup and the 60 cc syringe with the remaining pinkish-orange medication residue in syringe's original container and placed it on the flat surface next to the medications that had not been administered. Staff #9 did not remove his/her gloves or perform hand hygiene prior to handling the two injectable medications.
Staff #9 administered the Lasix 40 mg IV (intravenous) through Patient #9's peripherally inserted central catheter (PICC) line located in the patient's left arm. Staff #9 administered Patient #9's Heparin Sodium 5000 u subcutaneously in the patient's abdominal right lower quadrant.
Staff #9 repositioned Patient #9, applied the patient's heel/foot drop protectors bilaterally, and straightened the patient's bedding. Staff #9 returned to the medication preparation area and started to discard the empty single dose pill packages. Staff #9 stated, "I forgot a dose" identified the dose as Detrol. Staff #9 did not change gloves prior to opening the Detrol package, opening the capsule, pouring the contents in the previously used cup, and directly adding water from the tap. Staff #9 drew up the beads and water into the previously used syringe, the pinkish-orange medication mixture left in the syringe did not mix with the newly added water and medication. Staff #9 used the same procedure to administer the medication and water through Patient #9's percutaneous gastrostomy tube.
Staff #9 returned to the medication preparation space and picked up the Nystatin powder. Staff #9 applied the Nystatin powder using one gloved hand to separate the patient's skin fold in the patient's groin area and the other hand to squeeze the powder from the bottle. Staff #9 performed the task of applying the Nystatin powder to the skin folds on the right and left side of Patient #9's groin area. Staff #9 returned the Nystatin bottle to the medication preparation space.
Staff #9 used the same contaminated gloves to entered information into Patient #9's electronic medical record via mobile work station within the patient's room.
Without changing gloves or performing hand hygiene Staff #9 picked up the multi-dose bottle of Nystatin powder and placed it the within Patient #9's in-room medication cabinet. When the surveyor questioned regarding whether the Nystatin bottle had been dated when opened, Staff #9 rotated the bottle and stated, "No, there is no date." Staff #9 tossed the bottle in the trash receptacle, the surveyor questioned whether a second nearly empty bottle of Nystatin powder within the patient's medication cabinet had been dated when opened. Staff #9 retrieved the second bottle from the cabinet and stated, "This one was not dated." Staff #9 threw the second bottle of Nystatin powder in the trash receptacle and reported that whenever staff opened a multi-dose medication they were supposed to put an open date on the medication.
Staff #9 removed his/her PPE within the area marked off with red tape on the floor and utilized the hand sanitizer on the way out of the room.

2 C. Risk of cross contamination by carrying medications in uniform pocket:
An observation was conducted on December 21, 2015 at 10:19 a.m., with Staff #10 as he/she prepared medications for Patient #7. Staff #10 sanitized his/her hands prior to using the automated medication dispensing system.
Staff #10 carried the medications into Patient #7's room and laid them down on the flat surface used for medication preparation within the patient's room. Staff #10 washed his/her hands and proceeded to the computer. Staff #10 announced "I forgot [Patient #7's name] [his/her] computer isn't working. I can't give the medications right now." Staff #10 picked up Patient #7's medications from the medication preparation area in the patient's room, placed them in a Styrofoam cup, and placed the cup in his/her uniform pocket. Staff #10 did not return the medications to the medication room.
An observation was conducted on December 21, 2016 at 11:15 a.m. of Staff #10 on the opposite unit of his/her assigned patients. Staff #10 continued to carry Patient #7's medications in a cup in his/her uniform pocket. The surveyor inquired if Patient #7 had received the medications pulled from the automated medication dispensing system. Staff #10 stated, "No, [his/her] computer is still not fixed." Staff #10 had pulled medications for another patient and entered the patient's room with Patient #7's medications still in his/her pocket.
After the performance of additional medication passes on December 28 and 29, 2016, the surveyor requested the facility's policy for medication administration from Staff #3 and Staff #21. Staff #21 asked for specifics related to medication administration, the surveyor presented the above scenario. Staff #21 stated, "We are not going to have a policy that states you can or should not carry medications in your pocket. That's nursing 101." Staff #21 reported the nursing staff is aware that medications are not to carried in the pocket of their uniform. Staff #21 reported nursing staff receive training related to infection control. Staff #21 reported that carrying "medications in your scrub (uniform) pocket going around the unit or in and out of other patient's room is unacceptable" and breaches infection control practices.


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3 A. Failure to perform hand hygiene and clean equipment:

Staff #29 was observed by the surveyor while performing blood glucose testing for Patient # 27 at 11:30 AM on 12/28/2015. Staff #29 cleaned Patient #27's finger with alcohol, then wiped across the finger with his/her gloved hand before puncturing the skin with a lancet to obtain a blood sample. Staff #29 failed to clean the glucometer after use and before returning the equipment to the case.

At 11:45 AM the surveyor observed Staff #29 go to Patient #28's room, set the case containing the glucometer on the supply cabinet in the room, don gloves, walk to the bed, touch the patient, open the case, pick up glucometer, go back to the patient's bed where he/she laid the glucometer on the bedside table then on the patient's abdomen, before performing blood glucose testing. After obtaining Patient # 28's blood glucose, Staff #29 set the glucometer in the case, picked up the glucometer , wiped it with sanitizing wipes, and put the glucometer back into the tray. Staff #28 reached around the paper gown he/she was wearing, and without removing or changing gloves, reached into his/her scrub pocket, got a pen, used the computer keyboard to enter data, then reached into pocket again to get a beeper.

At 2:45 PM on 12/28/2015, the surveyor observed Staff #32 perform a glucose check for Patient #26; per the sliding scale insulin ordered by the physician, Patient #26 required sliding scale insulin coverage for a blood sugar (BS) of 305. After obtaining the BS, Staff #32 laid the used 2 x 2's (two by twos) and used glucometer strip on a shelf of the brown cabinet in the room where the insulin vial was stored. There was no insulin syringe in the cabinet, and Staff #32 closed and locked the cabinet while he/she left the room to get a syringe. After gathering all supplies, Staff #32 opened the brown cabinet, picked up the 2 x 2's and glucometer strip with ungloved hands, disposed of them, then sanitized hands, donned gloves, drew up and checked the insulin dose with another nurse, then administered the insulin. Staff #32 did not wipe off the medication preparation area before or after use, and did not put down a protective barrier before drawing up the insulin.

3 B. Failure to use personal protective equipment:

At 2:00 PM on 12/28/2015, the surveyor observed Staff #33 perform tracheostomy care for Patient #9, who was on contact precautions. Staff #33 wore a gown and gloves, and suctioning was performed using a closed system. When the inner cannula of the tracheostomy was changed, Staff #33 did not don face or eye protection in order to protect him/her from potential contamination of body secretions.

3 E. Failure to handle soiled linens and perform environmental cleaning in a manner to prevent the spread of infectious agents.

At 11:25 AM on 12/28/2015 the surveyor observed housekeeping staff mop room 215, a room which had a sign that the patient in that room was on contact precautions. Neither the mop head nor the mop water was changed before the housekeeping staff moved to clean the next room.

Between 2:55 PM and 3:05 PM the surveyor observed housekeeping staff cleaning room 221, an isolation room. The housekeeping staff, while wearing personal protective equipment (PPE), walked outside the door to Room 221 picked up the broom and dust pan from the housekeeping cart outside the isolation room, then, after use, placed it back on the cart. Upon re-entering the room, the housekeeper wiped off the clean sink which staff used to wash hands after removing PPE, went back to the door, got a roll of toilet paper, moved the cart down the hall. Housekeeper then removed the gown but not the gloves, walked out of Room 221, walked down the hall with red bagged trash from the room, entered the access code to the dirty utility room, disposed of the trash, then touched several items in the dirty utility room before removing the gloves and washing his/her hands. At 3:10, two surveyors observed the housekeeping staff enter Room 221, don PPE, replace trash bags, and mop Room 221 using the mop/mop water from the housekeeping cart sitting in the hall outside the door. The housekeeper looked up and saw the surveyors, then changed the mop head.


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4 F. Failure to maintain aseptic techniques during wound care:

On 12/28/15 at 11:50 a.m., the surveyor observed Staff #37 perform wound care for Patient #22 after obtaining permission from the patient to observe the wound care process. Patient #22 had a physician's order to "cleanse with normal saline, pat dry apply therapeutic honey and a Mepilex border dressing" to a decubitus ulcer located on the inner aspect of the left buttock". The wound was identified as a "Stage 2 Pressure ulcer". According to the National Pressure Ulcer Advisory Panel, a Stage 2 pressure ulcer is defined as: "Partial thickness loss of dermis presenting as a shallow open ulcer with a red pink wound bed, without slough. May also present as an intact or open/ruptured serum-filled or sero-sanginous filled blister. Presents as a shiny or dry shallow ulcer without slough or bruising". www. NPUAP. org accessed 12/21/15 at 12:41 p.m.

During the course of the wound care, the surveyor observed Staff #37 to clean the wound. Staff #37 obtained one gauze pad from the container and after applying the normal saline solution, used a wiping motion to cleanse the wound going back and forth over the open area several times.

Staff #37 was observed to wash hands, and then obtain a marking pen from the right pocket of his/her uniform in order to date and initial the clean dressing which was to be applied to the wound. Staff #37 handled the clean dressing after handling the pen he/she obtained from his/her pocket, and then placed the pen back into his/her pocket. The surveyor observed as Staff #37 placed the clean dressing on the blue pad which was underneath the patient and was wrinkled and contained debris, and had not been changed to a new "clean field" prior to the wound care. Staff #37 washed hands and donned gloved and then placed the therapeutic honey on the wound. Staff #37 then picked up the dressing, which was laying on the "dirty" blue pad, and proceeded to place it over the wound. Staff #37 then removed his/her gloves, and without washing hands, retrieved the marker pen from his/her pocket and dated the opened therapeutic honey tube. Staff #37 then lay the marking pen on the patients overbed table and washed his/her hands. Staff #37 then assisted to make the patient comfortable, by adjusting the patient's pillow and retrieving the call light for the patient which was underneath is body. Without washing hands, after assisting the patient, Staff #37 picked up the pen, placed it in his/her pocket, and then picked up the remaining supplies and placed them in Patient # 22's closet. Staff #37 exited the patient room without washing his/her hands.

According to Lippincott, Williams and Wilkins "Principles of Wound Care, Basic Wound Care Techniques" page 428 "When cleaning be sure to move from the least contaminated area to the most contaminated area...For an open wound, such as a pressure ulcer, gently wipe in concentric circles, again starting over the wound and moving outward. Use a separate gauze pad each time the wound is cleaned..."

On 12/29/15 at approximately 4:10 p.m., the surveyor discussed the observations with Staff # 1, #2 and #46.