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Based on observation, staff interview, facility document review (including the facility Quality Program) and clinical record review, it was determined the Governing Body did not meet this condition by failing to provide oversight to ensure that the safety and needs of patients were promoted and protected.

Conditions of Participation Cited:

§482.13 Condition of Participation: Patient's Rights

§482.21 Condition of Participation: Quality Assessment and Performance Improvement Program

Governing Body Standards Cited:

§482.12(e)(1) The governing body must ensure that the services performed under a contract are provided in a safe and effective manner.

§482.21 The hospital's governing body must ensure that the QAPI program reflects the complexity of the hospital's organization and services and involves all hospital departments and services (including those services furnished under contract or arrangement.

Based on observation, staff interview, clinical review and review of facility documents, it was determined the facility did not meet this condition by failing to ensure the rights of each patient were protected and promoted and that care was delivered safely.

§482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care.

§482.13(b)(3) The patient has the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives.

§482.13(c)(2) - The patient has the right to receive care in a safe setting.

§482.13(e)(16)(ii) - A description of the patient's behavior and the intervention used is required for Restraint or Seclusion.

Based on observation, staff interview, and facility document review, it was determined the facility did not meet this condition by failing to ensure the Quality Program reflected the entirety of the facility's services, and the Quality Program failed to identify and adequately address areas of deficient practice.

During the survey conducted 6/11/19 through 6/14/19 and continuing 6/17/19 through 6/21/19 and 6/24/19 through 6/25/19, the applicable Conditions of Participation for the facility were reviewed by the survey team. The surveyors identified concerns in multiple areas which were discussed with the facility during the review process.

The multiple issues and concerns related to the Quality oversight and monitoring were discussed on 6/25/19 at 9:25 a.m. The survey team also discussed the multiple concerns relating to the Electronic Health Record (EHR) documentation and difficulty of staff in locating information and documentation. Staff Member #1 stated the program had been "live since June of last year and we have experienced lots of problems with it. We are working hard to correct those problems..." The survey team discussed other areas of concern related to infection control, patient safety, contract services and facility maintenance along with current performance improvement projects.

The survey team discussed the concerns that the facility had not done a ligature risk assessment for the facility and that the staff were unaware that the "services agreement" with (name of hospital) did not include any Legionella evaluation or risk/prevention for the facility.
The surveyors discussed the concern of the observation of the liquid oxygen delivery, which was done at the front entrance to the facility and that no contract/agreement existed regarding the vendors and the facility's responsibilities to ensure safety and appropriateness for the delivery of the service.

Based on the scope and severity of physical environment deficiencies identified during the life safety code and health and safety surveys, the facility failed to substantially comply with this condition.

Based on observation, staff interview, clinical record review and facility document review, it was determined the Governing Body failed to ensure services performed under a contract or agreement (namely respiratory services and ice machine maintenance/cleaning) were provided safely and effectively and that each service was evaluated by the Quality Program.

The findings include:

The surveyor requested the contract for the Respiratory Services for the facility. Staff Member #2 (Quality) stated there was no "contract" but there was a "Services Agreement". The surveyor reviewed the "Services Agreement" effective September 1, 2008. Under "Scope of Services" "Respiratory Therapy, Pulmonary Lab" was listed and documented the services provided, however no other information regarding: Provision of Services, Staff Qualifications, Oversight, Contract Obligations, Treatment Responsibilities, Patient Education, and Orientation or Competencies/Credentialing.

The surveyor interviewed the Supervisor of Respiratory Services for the "contract" services utilized by the facility on 6/13/19 at 11:20 a.m. The Supervisor (To be referred to as Staff Member #14 for this report) stated, "Our staff provide respiratory services to (facility name) when they call us that they have a patient. It is rare that we have staff over here. I am not aware of any orientation that is done for the staff. We have a staff member assigned every shift twenty-four hours a day seven days a week to be on call for this facility just in case they need us. We do not participate in any Quality Meetings. I (Staff Member#14) was not aware that the facility had a quality program. If we were notified we would participate, but we have not received any notification of meetings...any equipment needed would be provided by my staff and brought over to (name of facility)..."

Staff Member #2 (Quality) stated on 6/13/19 at 2:20 p.m. that the Respiratory services are used so infrequently that "there is nothing for Quality to review".

On 6/20/19 at 9:50 a/m/ Staff Member #2 stated, "We haven't done a good job of keeping up with the contracts. Ultimately the COO (Chief Operating Officer) is responsible for all contracts."

On 6/25/19 at 11:00 a.m., the surveyors discussed the concerns with Staff Members #1, 2, 4, and 6.

The facility had two (2) ice machines that served the patient population that did not have the Manufacturers recommended cleaning and maintenance. The facility did not have a contract with the vendor providing services and was not aware of the specifications for the Manufacturers Directions for Use regarding what services would be taken care by the vendor and what services would/should be performed by the facility.

On 6/20/19 at 1:30 p.m., the surveyor observed the two ice machines (1) located in the nurses station area on the patient unit and (2) in the Rehab gym. The surveyor inquired as to the cleaning schedules of both machines and requested the manufacturer's directions for use for both machines. During an observation at 2:30 p.m., the air filter located on the machine (1) was examined and contained an excessive build up of debris, lint and dirt. Staff Member #7 (Director of Facilities Management) stated, "I did not know there was an air filter on the machine. The vendor (name) does the cleaning and I thought they would have taken care of it." Staff Member #1 (Nurse Manager) and #2 (Quality) stated, "We do not clean the filter".

On 6/20/19 at 1:40 p.m. Staff Member # 2 (Quality) stated, "There is not a contract for the cleaning of the machines. We use an email. They (vendor) were supposed to come twice a year per the manufacturer's directions but we weren't doing them twice a year..." At 1:45 p.m., Staff Member # 7 (Director of Facilities Management) was interviewed and stated "I will call the vendor who does the cleaning." After the phone conversation with the vendor, Staff Member #7 stated, "There is no checklist for the cleaning and no medical testing (cultures) is done. They (vendor) say they go by the manufacturers guidance for the cleaning of the machines in the owners manual. They (name of vendor) say they do not clean the air filters."

A review of the Manufacturer's Directions for Use (MDFU) for (1) revealed "Hoshizaki Instruction Manual - Cublet Icemaker/Dispenser Models DCM-270BAH (-OS) : ...Every two weeks: Air Filter- Inspect. Wash with warm water and neutral cleaner if dirty... Every 6 (six) months- Icemaker and Ice Storage Bin- Clean and sanitize per the cleaning and sanitizing instructions provided in this manual...The second dispenser (2) "MDT5N25 & MDT5N40" MDFU evidenced: ... Cleaning and Sanitizing: ...Maintenance should be scheduled for a minimum of twice per year. Sanitizing of the ice storage bin should be scheduled for a minimum of four (4) times a year." Staff Member #7 and #2 stated on 6/20/19 at 2:30 p.m. that the Ice Machine storage bin is not cleaned by staff. "The only cleaning that is done is by the vendor (name) and we have them coming now twice a year, but did not know the ice bin had to be cleaned four times a year."

A discussion was held with Staff Members #1, 2 and 7 regarding the cleaning and sanitizing of the ice machines on 6/20/19 at 2:30 p.m.

On 6/25/19 at 11:00 a.m., the surveyors again discussed the concerns with Staff Members #1, 2, 4, and 6.

Based on staff interview, a review of nineteen (19) medical records, and review of facility documents, it was determined facility staff failed to ensure that steps were taken to ascertain whether patients wished to designate a representative for their health care.

Findings included:

A review of nineteen (19) medical records revealed that the designation of an emergency contact for patients was documented, but no designated health care representative. Staff Member (SM) #2, Quality Director, was interviewed on 6/24/19 at 3:50 p.m., and asked how the facility staff determined if a patient had appointed a health care representative, and who that person was, if one had been designated. SM #2 stated "We thought the emergency contact took care of that". SM #2 gave the surveyor a document for "Emergency Contact Information", which he/she stated was completed at the time of admission. The emergency contact document also included a section for "Legal decision maker", and "Other persons who can be contacted if above cannot be reached". "The surveyor requested a copy of the facility's policy and procedure related to appointed health care representatives.

On 6/25/19 at 3:00 p.m. SM #2 stated "I think we need to make a differentiation between emergency contact versus Patient Representative".

Two copies of the facility's administrative policy entitled "Admission/Registration" were presented to the surveyor on 6/25/19, on one, the review/revised date was dated 4/19; at the bottom of the second policy of the same title, there was a revised date of 6/24/19.

The policy revised 4/19 lacked information related to the IP registration card, which included information related to emergency contacts, patient representative, and power of attorney.

The policy revised on 6/24/19 included the same information as the first policy revised 4/19, but had additional information typed in red about an IP registration card and "Appendix A", as well as the following: "Procedure...iii. IP registration card (see Appendix A). This form is to be completed by patient or patient representative. Place this form in front of the physical chart.
a. Ask the patient to fill out Emergency Contact. Emergency contact is someone who is notified immediately when there is an emergency.
b. Ask the patient to identify a Patient Representative. A Patient Representative is someone who participates in the care of the patient and can have co-decision making when a patient is not incapacitated. The explicit designation of a representative takes precedence over any non-designated relationship and continues throughout the patient's inpatient stay or outpatient visit, unless expressly withdrawn, either orally or in writing, by the patient.
c. Ask the patient if there is any Power of Attorney. If there is, then note that on the card...Documentation:...5. The case managers will complete transition planning initial assessment powerform in electronic medical record within 3 days of admission and note the emergency contact, patient representative, and power of attorney (if provided by the patient). If the electronic medical record is down, follow downtime policy...".
Appendix A, included at the end of the document was a piece of paper which had four boxes under the heading "Patient Contacts", and had spaces for 1) Emergency Contact Name and information, 2) Patient Representative Contact Name and information, 3) Power of Attorney Contact Name and information, 4) Other Persons who can be contacted if above cannot be reached".

Concerns related to the lack of documentation that patients were being given the opportunity to designate a health care representative was discussed with SM #2 as noted above, and again on 6/25/19 at 9:30 a.m. with SM's # 1, 2, 4, 11, and 6.

Based on staff interview, a review of nineteen (19) medical records, and review of facility documents, it was determined facility staff failed to ensure that information regarding advance directives was provided to one (1) patient who indicated on admission paperwork that he/she wished to execute an advanced directive (Patient #13), and that an advanced directive was included as part of the record of one patient (Patient #8) who indicated on admission paperwork that he/she already had an advance directive.

Findings included:

A review of the medical record for Patient #13 revealed that he/she was admitted to the facility 5/26/19, and at the time of the record review, was listed as a current patient. Patient #13's diagnoses included, but was not limited to acute ischemic stroke, pneumonia, diabetes type II, hypertension, and gout.

On the admission paperwork Patient #13 had marked a box under the "Advance Directives" which stated "I wish to execute an Advance Directive and information has been provided: Yes___ No___. Neither yes or no were marked. The "Adult Patient History" for Patient #13 has a section with the heading "Advance Directive", which included a box with four (4) options: 1) Yes; 2) No; 3) No Advance Directive, information given; 4) Unable to answer at this time". The box marked was "No". The surveyor attempted to interview Patient #13 to determine whether or not the information requested on Advance Directives was provided; however, the patient had been discharged from the facility earlier in the day.

There was no advance directive in the medical record, and no documentation available in the record which evidenced that Patient #13 had received the requested information. On 6/19/19 at 10:30 a.m. Staff Member (SM) #1, Nurse Manager, stated "We go over areas if something comes up. When they have questions, we go over it with them. It would be crazy for us to explain everything to them. I wish I could find something that said (the patient) was handed the information".

At 10:50 a.m. on 6/19/19 SM #27, Case Manager, was interviewed and stated "What we do as Case Managers, we also ask about Advance Directives. If it was indicated (the patient) wanted that, it would me indicated. We document that. Personally I always go over this information".

A review of the medical record of Patient #8 evidenced that he/she was admitted to the facility on 6/5/19, and a current inpatient. Patient #8's diagnoses included, but was not limited to neurogenic bladder due to an old spinal cord injury, with paraplegia, pyelonephritis, sepsis, colostomy, and new urostomy.

Documentation in the record was that Patient #13 had an Advance Directive in place. On 6/18/19 while reviewing the record, a copy of the Advance Directive was noted to not be in the record. SM #1, Nurse Manager, approached the surveyor on 6/19/19 at 10:15 a.m. to discuss Patient #8's advance Directive. SM#4 stated "We got (Patient #8's name) advance directive from (Hospital name) and scanned it into the record yesterday. His/her family said they would bring it, we asked several times, and they never brought it. His wife said yesterday that we should just get it from (Hospital name)".

Concerns related to documentation of Advance Directives were discussed with SM #1, Nurse Manager on 6/18/19 at 9:30 a.m., on 6/19/19 at at 9:30 a.m. with SM #1, and between 10:30 a.m. and 10:50 a.m. with SM's #1 and #27, Case Manager. Concerns were again discussed on 6/25/19 at 9:30 a.m. with SM's# 1, 2, 4, 11, and 6.

Based on observation, staff interview and facility document review, it was determined that facility staff failed to ensure patient's received care in a safe setting, namely:

Patients assessed as "high fall risk" had no evidence of 1:1 monitoring per the facility policy for patient safety.

A metal tank of oxygen was observed sitting, unsecured in the corner of an occupied patient (Patient #3) room.

An environmental assessment for ligature risk was not implemented for the facility.

The physical environment of the facility was not safe as related to filling of liquid oxygen tanks.

The findings included:

A review of the clinical records for Patient # 7, 9, 10, 11, and 12 revealed the following:
Patient #7 - admission date 5/13/19 with diagnoses that included but were not limited to: acute kidney injury, acute CVA (stroke), and frequent falls. Patient #7 had been assessed as "high fall risk. Under "interventions" was "q1h (every one hour) safety check- visual check"

Patient # 9- was admitted 2/14/19 with diagnoses that included but were not limited to: Acute bilateral basal ganglia strokes, schizoaffective disorder and stage 2 decubitus ulcer. Patient # 9 had been assessed as "high fall risk" with a score of "16" on 2/14/19 and "30" on 2/25/19. Under "interventions" was "q1h (every one hour) safety check- visual check"

Patient #10 admitted on 2/19/19 with diagnoses that included, but were not limited to: nontraumatic intracerebral hemorrhage and diabetes. On 2/19/19 the patient had a fall score of "17". Under "interventions" was "q1h (every one hour) safety check- visual check"

Patient #11 admitted 5/18/19 with, not limited to: right side weakness, dementia and hypertension was assessed on 5/25/19 with a fall score of "12". Under "interventions" was "q1h (every one hour) safety check- visual check"

Patient #12 was admitted on 6/12/19. Under "interventions" was "q1h (every one hour) safety check- visual check".

The surveyor was unable to locate evidence of any hourly monitoring checks in the above patient's records. According to information from the clinical records/computer system the rating scale for the fall risk was as follows: "0"- Monitor group. "1-5"- Fall Risk Group. "6" and above- High Fall Risk Group.

A review of the facility policy and procedure: Patient Fall Program for Inpatient" evidenced, in part: "...4. The following are the fall risk group and the specific interventions related to those groups: C. High Fall Risk Group: These are at risk for a fall due to poor or unreliable judgement or memory. This would be patients that need frequent safety cues or displays unsafe behavior, like a CVA (stroke) or Brain injured patients. These patients require specific interventions in addition to the High Fall Risk Interventions in addition to the Standard Fall Risk Interventions...ix. 1:1 supervision or restraints may be necessary...

On 6/18/19 at 1:30 p.m., Staff Member #1 (Nurse Manager) stated, "Everyone is on the one hour visual checks. We have forms (paper) in the room but we do not save them and staff think that since they are documenting on the form they don't need to put it in the chart but we do not save the forms. This is a work in progress and we are revising a lot of things..."

On 6/19 19 at 11:30 a.m., the surveyor again discussed the concern that there was no documentation of the visual safety checks in the patient's clinical records. Staff Member #1 and #2 (Quality) stated, "We do not keep the log sheets. We shred them. They do not go into the patient's charts."

On 6/25/19 at 11:00 a.m., the surveyors discussed the concerns with Staff Members #1, 2, 4, and 6.

On 6/12/19 at 2:10 p.m., the surveyor was observing a treatment in room 119 (Patient #3). In the corner of the room (to the right) was a metal oxygen cylinder which was unsecured. The tank had what appeared to be tubing with a nasal cannula attached wrapped around the top and on the floor. The surveyor pointed out the unsecured cylinder to Staff Member #11 (Staff Development) who was present at the time. The surveyor requested the Staff Member #11 immediately get a cart to properly secure the tank.

The surveyor reviewed the facility policy "Life Safety Management Program Training Information" which evidenced, in part: "...9. Oxygen cylinders are under high pressure; handle them with care...Cylinders, whether empty or full, must be properly secured and capped when not in use. While in use, they must be secured in place."

A discussion was held with Staff Member #1 (Nurse Manager), 2 (Quality) and 4 (Chief Nursing Officer) on 6/12/19 at 3:45 p.m. regarding the oxygen observation.

On 6/25/19 at 11:00 a.m., the surveyors discussed the concerns with Staff Members #1, 2, 4, and 6.


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The surveyor interviewed Staff Member (SM) #2, the Director of Quality on 6/13/19 at 1:45 p.m. in regards to the facility's environmental assessment for ligature risk. SM #2 stated "We don't have a ligature risk assessment, we realized we needed that about a month ago, but we haven't had the chance to get one done yet. SM 7, the Director of Facilities, has a template and is working on that. We don't keep suicidal patients, they would have a one-on-one (1:1) sitter until they were transferred. A suicide risk assessment is part of the admission nursing assessment".

The surveyor asked for a copy of the facility's policy for ligature risk, and was given an administrative policy titled "Suicide alert", reviewed/revised 5/19, which at the bottom of the document included "Suicide Alert Policy DRAFT 06/11/2019. The policy stated, in part "Purpose: To assure proper management of patient exhibiting self-injurious behavior or suicidal ideation/behavior. Situations involving potential for self-injurious behavior through suicidal gestures or attempts represent unique crises and require special management in the rehabilitation setting. Policy:
1. Patient will receive proper medical and psychological management. 2. Patient safety will be maintained. 3. In managing situations where hospital any and all staff must be vigilant for possible suicidal behavior and upon determining patient has suicidal ideation/behavior, 1:1 sitter will be initiated and physician will be contacted immediately. 4. Physician order required for suicidal precaution, psychology consult, and 1:1 sitter. 5. Initiate checklist for environmental safety immediately. 6. Patient will be transferred to Emergency Department or Psychiatric Facility immediately as soon as arrangement is completed...2. Environmental Precautions: patients will be placed in a room free of environmental hazards. b. Trash cans with plastic liners will be removed from the room. c. Cords (telephone, call bells, etc) will be removed if possible from the room. If not removable, patient will be placed on a 1:1 supervision. d. Cleaning items, disinfectants and potentially hazardous materials will be removed from the room. e. Remove glass containers and sharp utensils from the room..."

When entering the facility via the front (main) door at 8:15 a.m. on 6/12/19, two surveyors observed a van pulled up near the front (main) door of the facility and appeared to be filling a tank; white vapor was swirling around the tank and area where the man was working. The tank was being filled while sitting on pavement just beside a walkway to the front door used by staff, visitors, and patients, and in a covered area where surveyors noted cars and ambulances dropped off and picked up patients during the course of the survey 6/11/19 to 6/14/19, 6/17/19-6/21/19, and 6/24/19-6/25/19. The surveyors also noted cigarette butts lying on the ground in the area described.

During the entrance conference with SM's #1, the Nurse Manager, and #2, Director of Quality, the surveyors inquired as to what was taking place outside the front door at the van. SM #1 stated "he is filling the liquid oxygen tanks. They are usually filled once a week on Friday". The surveyors asked for the policy and procedure related to filling the liquid oxygen tanks, the contract with the supplier of the liquid oxygen, and asked to interview the facility staff responsible for oversight of that service. SM's #1 and 2, the Nurse Manager and Director of Quality acknowledged, during the discussion with surveyors, on 6/12/19 that patients and visitors smoke on the premises and discard cigarette butts on the ground near the entrance to the facility.

On 6/12/19 at 9:45 a.m., SM #28, Manager of Materials Management, arrived to discuss the filling of the liquid oxygen tanks. SM #28 stated "There are three (3), plus a spare, liquid oxygen tanks; they are usually filled about twice a month, but that varies depending on use. We own five (5) portable tanks, which staff fill from these larger tanks. East Coast Oxygen is our supplier. SM #28 and the surveyor went on a tour in order to observe the area where oxygen tanks were stored.

The "oxygen closet" was on a hallway of the facility, and had an oxygen sign posted on the door. The room contained four (4) liquid oxygen tanks, shelving for supplies, and some oxygen cylinder tanks. SM #28 told the surveyor that staff fill the portable tanks in the "oxygen closet". The surveyor noted that lighting inside the room was very dim, making it difficult to see. There was a vent along the wall going through the ceiling, but SM #28 was unable to say where the vent ended. There was no PPE observed to be in the room readily available for use by staff while filling the tanks. SM #28 stated "the lighting hasn't been this dim, I'll put in a work order to have it fixed". The surveyor asked if there was an area, other than the front entrance to the facility, where oxygen tanks could be filled. SM #28 stated "I guess they could go to the loading dock area, they have always filled them in the front since I've been here; I started in December".

On 6/12/19 at 1:40 p.m. interviews were conducted with SM #11, Staff Development, SM #6, Therapy Manager, and SM #28, Manager of Material Management to discuss training of staff responsible for filling liquid oxygen portable tanks for patient use, and preventative maintenance (PM) required for equipment.

SM #11 stated "There is an inpatient orientation with staff. They tour the facility on their first day, when they are shown the oxygen room and how to fill the oxygen tanks. We go over safety, and the green cylinders; there is no return demonstration. All RN's (registered nurses), LPN's (licensed practical nurses, and CNA's ( certified nursing assistants) go through that orientation".

SM #6 stated "For therapy, filling the portable oxygen tanks with the liquid oxygen is part of the initial orientation, there is no training after that. Therapy does have a list of return demonstrations for all therapists".
SM #28 stated "I have a repair log, there is no required maintenance, only if they aren't working properly".

The surveyor asked for, and was given, a copy of the technical service manual for the "Sprint and Stroller", the operating instruction manual for the type of portable liquid oxygen tanks utilized by the facility for patients. The maintenance schedule listed two schedules for "routine maintenance" of the portable oxygen tanks, which the manual states "allow the distributor maximum flexibility while assuring that the equipment is working properly..Schedule A-Biennial...3. Check Efficiency of Unit: a. Allow the unit to stabilize after filling (10-15 minutes). b. Inspect the bottle for cold sweaty condition, and for excessive venting from relief valve (some venting is normal). c. If either condition is observed, conduct NER test...4. Flow test..." Schedule B-Continuous: Continuous maintenance is a set of tests and inspections performed periodically to ensure the equipment is functioning properly. It can be done with equipment in service by drivers or other personnel...1. If a unit fails a given test, it should be taken out of service. Refer to the Troubleshooting section (Section XI) or contact Technical Service. 2. Schedule B-Checks are made when the driver visits patients and when equipment is transferred between patients...B. Procedure: These inspections are to be performed at least once per year by the driver or other personnel when the Sprint/Stroller is in use by the patient (LOX in the unit)...1. Visual inspection...These inspections/tests are to be done between patients...".

On 6/12/19 at 3:30 p.m., the surveyor interviewed SM #31, a Licensed Practical Nurse (LPN), to discuss filling portable oxygen tanks for patient use, including what personal protective equipment (PPE) was used while working with the liquid oxygen tanks. SM #31 stated "I have worked here for ten (10) years, and was trained by other nursing staff who had experience with filling the portable oxygen tanks. I wear a mask and latex gloves, but gloves are optional. When the tanks are being filled steam comes out because of the cold".

The Material Safety Data Sheet (MSDS) Version 1.11, Revision Date 1/26/2015, provided to the surveyor by facility staff included the following information, in part:
"Hazards not otherwise classified: Extremely cold liquid and gas under pressure. Direct contact with liquid can cause frostbite. May react violently with combustible materials. Keep oil, grease, and combustibles away..."."...7. Handling and Storage: Handling:...Only experienced and properly instructed persons should handle compressed gases/cryogenic liquids...8. Exposure Controls/Personal Protection:...Hand protection: Loose fitting thermal insulated or leather gloves. Gloves must be clean and free of oil and grease. Wear working gloves when handling gas containers...Eye protection: Safety glasses recommended when handling cylinders. Wear goggles and a face shield when transfilling or breaking transfer connections...Skin and body protection:...Never allow any unprotected part of the body to touch uninsulated pipes or vessels which contain cryogenic fluids. The extremely cold metal will cause the flesh to stick fast and tear when one attempts to withdraw from it...".

Administrative policies entitled "Safety in Oxygen Enriched Atmosphere", Number 334, with a Revised/Review date of 5/19 , "Compressed Gas Cylinders", Number 332", with a Revised/Reviewed date of 7/18, and a 15 step document titled "Steps for Transfilling Liquid Oxygen Vessels" were provided to the surveyor by facility staff.

Policy number 334, "Safety in Oxygen Enriched Atmosphere" evidenced in part the following: "Purpose: Oxygen-enriched atmospheres present a unique safety hazard for patients, staff and visitors. In order to minimize such hazards, all hospital departments which administer or are otherwise connected with the use of oxygen will have written policies and procedures relating to oxygen safety...Policy: It is the policy of the (Facility's Name) to ensure proper procedures when working in an oxygen enriched environment...". Policy number 332 "Compressed Gas Cylinders" stated in part: "...Procedure: ...VII Oxidizing gases, such as nitrous oxide and oxygen, must be stored separately from flammable gases, liquids, or combustibles; VIII Oil, grease, or other flammable or dust-retaining materials must not be used with any oxygen-related equipment; IX Smoking is not to be permitted in any area used for the storage of compressed gas cylinders...".

At 11:00 a.m. on 6/12/19 SM #28 told the surveyor that the supervisor for East Coast oxygen told him "there is no written policy and procedure (P&P) for delivery and filling of the liquid oxygen".

On 6/19/19 at 11:10 a.m. SM #7, Director of Facilities stated "They've been coming at least seven (7) years. There has to be something written somewhere that has that information, I'll keep looking".

On 6/20/19 between 10:20 a.m. and 10:45 a.m., SM #7, Director of Facilities stated "I have been digging through documents and emails I could see that the previous person had a contract with a liquid oxygen company. I feel certain training was provided to our staff. There are so many layers to this. East Coast sent me an email with guidelines for filling tanks, but what he sent me is unacceptable and unclear; the Vice President of East Coast oxygen and hydrotesting told me via email that they never received instructions or requests as to where to fill the liquid oxygen at the facility, and that liquid oxygen has always been filled at curbside. Training is hands on for East Coast Staff, and they are supposed to wear gloves, apron, and fill the tanks outside of the home or facility. I couldn't come up with who trained our employees to work with the liquid oxygen. I do not have any documentation specifically for staff being trained to handle the liquid oxygen. If the staff aren't wearing the gloves and other equipment, then they don't know the potential for harm. Going forward, vessels will be filled off site and brought to the facility filled. I told staff if they want to keep using liquid oxygen, there has to be education and training. We are not transferring liquid oxygen currently, and going forward, anyone touching it in any way, shape, or form will be trained".

On 6/19/19 at 11:10 a.m. SM #2, Quality Director, presented the surveyor with an incomplete document titled "Independent Contractor Agreement", which identified East Coast Oxygen as the "contractor", the "contracting party" was blank. The section of the contract to be signed and dated by the "Contracting Party" and "East Coast Oxygen & Hydro Testing, Inc." sections were blank. SM #2 further stated "We don't have a signed contract, we just call them when we need to be refilled".

On 6/20/19 at 9:50 a.m. SM #2 told the surveyor that from 7/1/2010 through 6/30/2013 the facility had a contract for liquid oxygen with Health First, who subcontracted with East Coast oxygen.
Health First then bought Freedom. The facility received liquid oxygen from Freedom between 7/2013 and 4/2019, a contract could not be found for those services per SM #2.
Freedom separated from East Coast in May 2019, and the facility has received liquid oxygen services from East Coast Oxygen since May 2019.
There was no signed contract with East Coast Oxygen available for the surveyor to review. SM #2 stated "I'd say we haven't done a very good job of keeping up with the contracts. Ultimately, the C.O.O. (Chief Operating Officer) is responsible for all contracts".

Based on clinical record review, staff interview and document review, it was determined the facility staff failed to ensure documentation of the description of the patients' behavior warranting the use of a restraint for five (5) of five (5) restraint records reviewed. Patient # 7, 9, 10, 11, and #12.

The findings included:

A review of the clinical records for the above patient's evidenced the following:

Patient #7 had physician's orders for the use of restraints (four siderails, wheelchair belt) on 5/10/19. The initial order documented "Impaired safety and judgement". During the review of the record with Staff Member #1 (Nurse Manager) on 6/17/19, the surveyor requested to view any documentation which described the behaviors the patient was exhibiting that justified the use of the restraint. Staff Member #1 stated, "We do not write notes or any free text about it. We just choose from the drop-down box on the order and for the documentation. You can find it in multiple places in the record (Electronic Health Record) because they (computer program) does not want you to document in only one place and every place has different choices. You are not going to find anything other than whatever is in the drop down box."

Patient #9's clinical record was reviewed on 6/18/19. The patient had a physician's order for the use of restraints (four siderails, wheelchair belt) on 2/25/19. The physician's order documented: "Reason for restraints non-violent behavior- "other". Special instructions: Impulsive behavior". The surveyor inquired as to the documentation of the description of "impulsive behavior". Staff Member #1 stated on 6/18/19 at 10:10 a.m., "The nurse didn't document anything under the safety assessment. I cannot find anything documented, just that (he/she- Patient #9) was impulsive and easily distracted."

Patient #10 had a physician's order dated 2/20/19 for the use of restraints (four siderails, roll belt, wheelchair belt). The documentation included the description "impaired safety judgement". The surveyor inquired as to what behaviors led to the initiation of the restraints and the description of "impaired safety judgement". The surveyor reviewed under "clinical justification- specific patient safety behavior: memory issues, impaired safety judgement and agitation", however there was no documentation in the clinical record of a description of the patients behaviors that described "memory issues, impaired safety judgement" and any "agitation". Staff Member #1 on 6/19/19 at 11:30 a.m. stated, "There is nothing documented other than what you see here. We do not write notes. We only use the drop down boxes."

Patient #11 had an order written for the use of restraints (four siderails, roll belt, wheelchair belt) on 5/25/19. The "reason" documented was : "Impaired safety judgement" and "memory issues". There was no documentation contained in the clinical record of a description of the behaviors that warranted the use of a physical restraint other than the above. Staff Member #1 on 6/19/19 at 11:30 a.m. stated, "There is nothing documented other than what you see here. We do not write notes. We only use the drop down boxes."

Patient #12 had an order for the use of restraints (four siderails, roll belt, wheelchair belt) on 6/13/19 with the reason documented as "Impaired safety judgement". There was no documentation of the description of the behavior for "impaired safety judgement". There was a note written on 6/13/19 at 8:39 a.m., that evidenced: "Spoke to (name of patient spouse) after patient's fall...Family is unable to sit with patient today and no staff available to provide one on one at this moment. Proposed use of blue belt, roll belt and 4 (four) siderails..."

For the five (5) patient records reviewed for the use of restraints, there was no clear documentation as to a description of the patient's behavior that warranted the use of a restraint.

In an interview with Staff Member #1 and #2 on 6/19/19 at 11:30 a.m., the surveyor discussed the concern that there was no description of the behaviors for each of the patients that led up to the use of the restraints. Staff Member #1 stated, "Most all of our patients are impaired with their judgment, or are impulsive and have memory issues due to a stroke or brain trauma. We do our best to keep them safe from falling. We use restraints to keep them safe when they display unsafe behaviors." The surveyor expressed concern that there was no documentation of the behaviors that were of a "concern" to the staff and warranted the use of a restraint and based on the documentation provided, there was no clear justification for the use. Staff Member #1 and 2 stated they were working on the "problem" and that their EHR (Electronic Health Record) did not allow them to document other than from the "drop down boxes".

The facility policy and procedure "Restraints" was reviewed and evidenced, in part: "...3. Assessment and Patient Monitoring- A. An assessment to identify a patient's need for restraints will be completed on each patient in question. 2. Clinical justification for each episode must be substantiated in the medical record. 3. Patients shall have their behavior assessed, monitored and documented every 2 (two) hours or more frequently as needed...."

On 6/25/19 at 11:00 a.m., the surveyors discussed the concerns with Staff Members #1, 2, 4, and 6.

Based on observation, staff interview, facility document review, Quality Program Review and clinical record review, it was determined the Governing Body failed to ensure the Quality Program included and evaluated all services rendered by the facility.

During the survey conducted 6/11/19 through 6/14/19 and continuing 6/17/19 through 6/21/19 and 6/24/19 through 6/25/19, the applicable Conditions of Participation for the facility were reviewed by the survey team. The surveyors identified concerns in multiple areas which were discussed with the facility during the review process.

The findings included:


The facility Quality Program was discussed with Staff Member #1 (Nurse Manager) and Staff Member #2 (Quality Director) on 6/25/19 at 9:25 a.m. The multiple issues and concerns related to the Quality oversight and monitoring were discussed. The survey team also discussed the multiple concerns relating to the Electronic Health Record (EHR) documentation and difficulty of staff in locating information and documentation. Staff Member #1 stated the program had been "live since June of last year and we have experienced lots of problems with it. We are working hard to correct those problems..." The survey team discussed other areas of concern related to infection control, patient safety, contract services and facility maintenance along with current performance improvement projects. Staff Member #2 stated that there was no Quality documentation regarding the Respiratory Services, as the facility "rarely has a patient which needs them (respiratory), so the service was not reviewed." The surveyors discussed the concerns that there was no Quality evaluation, contract or documentation regarding the Oxygen delivery service, an assessment of the facility ligature risk or legionella assessment. Staff Member #2 stated that "We thought (name of facility) was providing that(legionella) and taking care of that through our services agreement". The survey team discussed the concern that the facility was not aware of the specifics of their contract or services agreements and that the information was not available in the Quality Meetings for audits and tracking.

A performance Improvement project regarding wound care was reviewed and Staff Member #2 stated the facility had identified areas of needed improvement for this in February 2019, however there had been meetings that were "ad-hoc and we didn't write minutes. We were just brainstorming and decided to form a group in May (2019)." Staff Member #1 stated "We identified in June that we had a spike in incidents related to wound care; we have partially completed the problem. We were deciding what to work on and reviewing trends. We also had difficulty with finding a wound care nurse.." Staff Member #2 added, "We had a wound care committee in the past but (Staff Member #24- wound care nurse) changed (his/her) role and stopped leading the group...We looked at why we have more issues with documentation, and found that staff aren't familiar with Cerner (the facility's electronic health record (EHR) system)". Staff Member #1, when asked, stated that the Cerner EHR was implemented in June 2018, and that "it is a work in progress". We were deciding what to work on and reviewing trends. We also had difficulty with finding a wound care nurse...we had a wound care committee in the past but (Staff Member #24- wound care nurse) changed (his/her) role and stopped leading the group..." Staff Member #2 also stated (re: the ad-hock meetings)"We put our findings in "FEMA" (failure mode effect analysis). It's hard to meet, because Staff Member #24 is only here once a week. All of the wound care nurses are part time." Staff Member #4 added "the problem is that wound care nurses are hard to find".

The survey team discussed the concerns that the facility had not done a ligature risk assessment for the facility and that the staff were unaware that the "services agreement" with (name of hospital) did not include any Legionella evaluation or risk/prevention for the facility.
The surveyors discussed the concern of the observation of the liquid oxygen delivery, which was done at the front entrance to the facility and that no contract existed regarding the vendors and the facility' responsibilities to ensure safety and appropriateness for the delivery of the service.

Staff Member #2 and #4 discussed that through the recent Joint Commission Accreditation inspection that areas had been identified that the facility was currently working on. These areas were not discussed at this time with the survey team. The survey team also discussed the concern that the Respiratory contracted service was not a part of the Quality review process.

Concerns identified were reviewed with Staff Members #1, 2, 4 and 6 on 6/25/19 at 11:00 a.m.

Based on staff interviews, the review of nineteen (19) medical records, and review of facility documents, it was determined facility staff failed to ensure that wound care was included in the plan of care for two (2) patients (Patient #6), and it was determined that wound care documentation was conflicting and inconsistent.

Findings included:

A review of the medical record revealed that Patient #6 was admitted to the facility on 5/28/19 s/p (status post) right laparoscopic colectomy and placement of ureteral stents on 5/23/19. Patient #6 was discharged from the facility on 6/7/19.

The skin assessment performed by two (2) nurses on admission documented that Patient #6 had 2 wounds: 1. Right hip-"Healed", and 2. Midline incision "improving, incision flat, pink, and open to air".

Patient #6 had an order dated 5/28/19 at 3:36 p.m. to "follow the wound care protocol", and for "wound care constant", but no details entered for wound care; the order was cosigned by the attending physician, but no treatment was specified. On 6/14/19 at 9:40 a.m., the surveyor discussed the documentation "wound care constant" with Staff Member (SM) #11, the chart navigator, who stated "that doesn't mean anything to me, I have never seen on order like that. We have a wound care protocol, which a nurse can write as an order; the wound care nurse has approved the order set. The doctor signs the order, anything beyond what is covered on the wound care protocol requires the wound care nurse, who does see every patient on admission."

The record review for Patient #6 revealed that for the period between 5/28/19 and 6/7/19 there was conflicting documentation as to what wounds were present, whether or not wounds had a dressing, what treatment was being performed, and wound care was not documented as part of Patient #6's plan of care.

A new patient visit note by SM #22, the wound care nurse, on 5/29/19 at 9:32 a.m. documented the following information regarding Patient #6:
Assessment: Pressure areas assessed; sacral area/buttocks-intact; scarring noted on left lateral buttock. Bilateral heels-intact, no redness. Abdomen-well approximated incisions with adhesive closure; open to air.
Recommendations: Off load pressure areas with repositioning while in chair and bed routinely. Off load heels using pillows while in bed. Manage moisture: Keep skin folds dry; promote continence with toileting; incontinence skin care with SAGE wipes if incontinent.
Plan: Please consult if any WOC needs or concerns arise".

On 6/17/19 at 4:20 p.m., the surveyor and SM #18, chart navigator, were discussing the inconsistent wound care documentation in Patient #6's record, and he/she stated "Even if we could argue which site the dressing was on, it was a surgical site which isn't covered by the wound care protocol, and (the nurse) should have gotten an order for the Allevyn dressing".
On 6/17/19 at 3:15 p.m. the surveyor asked SM #18 if the wound care protocol order was considered standing orders, and SM #18 stated "I would call that a standing order, but I don't know the process for the doctor ordering wound care protocol".

A review of the medical record for Patient #8 revealed that he/she was admitted to the facility on 6/5/19, and was still a current patient at the time of the record review. Patient #8's diagnoses include, but are not limited to neurogenic bladder with paraplegia, due to an old SCI (spinal cord injury), pyelonephritis with sepsis, colostomy, and (new) urostomy. It was also noted that Patient #8 had a deep tissue injury to the sacrum, an unstageable ulcer on the left heel present on admission, and a healing open abdominal incision s/p wound vac, wound care nurse following.

The nurse who admitted Patient #8 documented the following wounds on 6/5/19 at 7:59 p.m. :
1) Left heel Allevyn foam dressing, changed
2) Left lateral foot, silicone foam dressing, changed
3) Left buttock-not documented.
At 11:00 a.m. on 6/18/19, SM #18, chart navigator, stated "The nurse didn't open that (left buttock) dynamic-I'm thinking either it was not noted, or it occurred later".

Documentation by the wound care nurse, SM #22, on 6/7/19 included the following wound care orders: 1) Allevyn foam to sacral area/buttocks, change Monday-Wednesday-Friday (M-W-F); 2) Allevyn foam to left heel/left lateral foot, change M-W-F; 3) Acticoat Flex and dry gauze and tape to abdominal wound, change daily until reassessment on Monday (6/10/19); 4) Nutrition consult; 5) off loading boots; 6) air mattress, turn every two (2) hours.

"Nursing team goals" identified on Patient #8's plan of care included the goal that "current skin areas will heal. no new breakdown will occur. pt will be educated of wound care...Goal date 6/20/19, Interventions-assess wounds at least q (every) shift and PRN (as needed): provide wound care according to MD orders..." The Nursing team goals lacked documentation or collaboration by a wound care nurse.

The facility's nursing policy entitled "Rehabilitation Standards of Patient Care" included the following under the heading "Standards": Nursing plan of care will be individualized to accommodate patient, family, or caregiver needs. Consider the following general teaching strategies:...7) Collaborate with other disciplines so that patient receives consistent, reinforcing instruction...".

During a discussion at 9:30 a.m. on 6/18/19 SM # 1, Nurse Manager, stated "One of the things we have been working on with staff is updating care plans. Now our goals are more specific".

On 6/18/19 at 3:30 p.m., SM #18 was interviewed about wound assessment, including measurements of wounds to assess for healing. SM #18 stated "The floor nurses don't take wound measurements. The wound care nurse does the measurements when he/she does the weekly assessment"

The facility's nursing policy entitled "Wound Care Treatments" was reviewed, and included the following information:
Policy: 1) The licensed nurse is responsible for notifying Attending Physician of wound present on admission or for one that occurs during admission and for consult to wound Specialist for wound care. 2) The licensed nurse is responsible for initiating the wound protocol for wound care based on wound care until order obtained by physician for specific wound....4) The licensed nurse is responsible for weekly documentation in the Carelinks on all wounds to include length x width x depth and describe wound base, drainage, color, odor, wound edges, and peri wound skin. 5) The licensed nurse is responsible for taking Photo and uploading to carelinks: on admission, weekly and with any deterioration in wound. This excludes any surgical incision without complications...Documentation: 1) Record in Electronic Health Record (EHR), daily interventions taken to treat/prevent skin breakdown.
2) Date and time of procedure.
3) Wound care documentation in Wound Assessment template in Carelink should include:
a) Location of wound; b) Type of wound. Only stage pressure ulcers. c) Measure and document size of wound. Measure wound longest length (head to toe) and longest width (side to side) and depth. Look for a undermining, and tunneling effect below the skin surface, take appropriate measurements. d) Indicate type and percentage of tissue in wound bed. e) Document pain associated with wound care. f) Document exudate for amount, type and odor. g) Document condition of surrounding skin. h) Document if wound located on lower extremity. Include presence of edema and if compression used. i) Document support surfaces patients on (bed and wheelchair). j) Wound Care Specialist consult. k) Document if the wound is being actively debrided. l) Write out all wound care provided.
4) Document location and type of wound, type and percentage of tissue in wound bed, pain, exudate, surrounding skin, lower extremity status, support surface use, and wound care provided in Wound assessment template in Carelinks with each dressing change.
5) If dressing is not changed, document location, type, last dressing change and status of dressing...".

On 6/25/19 at 9:00 a.m. a discussion related to wound care was held with SM #1, Nurse Manager, SM #4, the Chief Nursing Officer (CNO), and SM #2 Director of Quality. The surveyors were told that the facility has a "wound care team" consisting of SM #11, Staff Development, SM #1, Nurse Manager, and an IT (information technology) staff person. We started talking in February, and met in March. We immediately started working to fix educating nurses, documentation, had a skills fair for re-education, pressure injuries, and PPS to extract data to submit to CMS (Centers for Medicare and Medicaid Services). SM #2 stated "In February, March, and April, SM #24 and I brainstormed, and in May we formed a group. We had a wound care committee in the past, but when SM #24 changed her role, cutting his/her hours, the committee went away.

During the discussion, SM #1 stated "We identified in June that we had a spike in incidents related to wound care; we have partially completed the problem". SM #2 added "We looked at why we have more issues with documentation, and found that staff aren't familiar with Cerner (the facility's electronic health record (EHR) system)". SM #1, when asked, stated that the Cerner EHR was implemented in June 2018, and that "it is a work in progress".

SM #2 also informed the surveyors that "A subgroup of myself and (wound care nurse's name) was formed to analyze what's going on. We don't write minutes, it is done in ad-hock committees, we have only had one meeting. We put our findings in "FEMA" (failure mode effect analysis). It's hard to meet, because SM #24 is only here once a week. All of the wound care nurses are part time. SM #4 added "the problem is that wound care nurses are hard to find".

Concerns related to wound care assessment, orders, and documentation were discussed with SM's 1, 2, 4,11, and 18 at multiple times throughout the survey process, and again with SM's #1, 2, 4, 11, and 6 on 6/25/29 at 9:30 a.m.

Based on observation, staff interview and document review, it was determined the facility staff failed to ensure:

Non-employee (contract) staff adhered to the proper policies and procedures for the administration of dialysis treatment for one (1) of one (1) dialysis patient reviewed and observed (Patient #12), and;

Contract respiratory staff received facility orientation that included, emergency and safety procedures, facility policies and procedures and an evaluation by the hospital at least annually.

The findings included:

On 6/18/19 at 3:20 p.m., the surveyor observed Patient #12 receiving dialysis treatment. The surveyor observed as (contract) Staff Member #20 entered the room carrying packets of supplies. The staff member was observed to lay the supplies down on the table next to the dialysis machine and, without washing or sanitizing hands, donned gloves. The surveyor observed as the Staff Member #20 obtained a sample from the dialysis machine to check the chlorine and Ph. The Staff Member took a test strip from the container and "swished it around" in the sample cup and removed the strip stating "its negative". The surveyor at no time observed the staff member to look at a watch, clock or timer in order to "time" the strip reading. Staff Member #20 then proceeded to continue to set up the dialysis machine in preparation for the patient treatment. The surveyor observed as another sample was taken to test for conductivity. The Staff member was observed to take a bottle of calibration liquid and fill the meter cell with the liquid, drop the plunger into the cell and press the button the check the calibration of the machine. The liquid in the meter was then discarded. The staff member, without rinsing the meter with dialysis quality RO water, then poured the sample taken from the dialysis machine into the meter in order to check the conductivity reading of the dialysate. The staff member was observed to drop the plunger into the sample (only once) and press the balck button on the machine to obtain the conductivity reading. While still wearing gloves, and after touching the patient equipment, the staff member retrieved a computer tablet from a black fabric case and entered information into the tablet. The staff member was observed to remove gloves and without washing or sanitizing hands, donned another pair of gloves and took a strip in order to take the patient's oral temperature. After taking the patients oral temperature, the staff member removed the gloves and without washing or sanitizing hands, picked up a notebook and entered information into the pages. Staff Member #20 then went to the door and asked a passing staff member to obtain some face masks. When the staff member brought the masks back, Staff Member #20 hung the extra masks on the attached IV pole of the dialysis machine. Staff Member #20 then, without washing or sanitizing hands, donned gloves and continued to set up the dialysis machine. Staff Member #20 them took a stethoscope that was hanging on the attached IV pole and used it to assess Patient #12. After the assessment, Staff Member #20 removed the gloves and without washing or sanitizing hands, charted on the clipboard available with patient information. Staff Member #20 then sanitized hands and put a mask on Patient #20 and on (him/herself- Staff Member #20). Staff Member #20 then donned gloves , reset the dialysis machine and charted on the computer still wearing gloves; then reset the alarm on the dialysis machine, removed gloves and without washing or sanitizing hands, donned gloves. Staff Member #20, proceeded to obtain a package of lab tubes and supplies and remove the tubes and label them. Staff Member #20 laid all the tubes and supplies on the bed with the patient and proceeded to take a blue pad and place it underneath the patient's central line tubing and cleaned the ports to the central line (CVC), Staff Member #20 unwrapped the syringes and drew blood from the ports of the CVC and after discarding the first blood syringes, drew additional blood and paced it in the lab tubes. Staff Member #20 reset the machine, primed the blood lines and attached the lines to the patient's CVC ports. Staff Member #20 did not change gloves nor sanitize hands during the observation of the blood draw and initiating the dialysis treatment.

The policy and procedure "Infection Control in the Hospital Dialysis Setting" was reviewed and evidenced, in part: "...3. Medication vials, syringes, tape, alcohol swabs, dressings, gloves or other supplies will not be carried in pockets or placed on the patient's bed...4. Hand hygiene is to be performed per hand hygiene policy...11. Gloves should be changed when: ...going from a "dirty" area or tasks to a "clean" area or task..."

According to The Centers for Disease Control- Dialysis Safety (www.cdc.gov/dialysis/safety), "...Hand hygiene is the single most important thing you an do to prevent the spread of infection...when to use hand hygiene:...before you touch a patient, before you put on gloves- NOTE- take gloves out of the box after you have washed your hands...between tasks and procedures on the same patient, after you remove gloves, after you touch any body fluid or mucous membrane, after you touch machines, equipment or computer keyboards... alcohol based hand rub can be used in place of washing your hands as long as there has been no contact with blood or body fluids (even while wearing gloves) or the hands/gloves are not visibly soiled..."

According to the policy and procedure "Total Chlorine Monitoring of Portable Reverse Osmosis (RO) Water Treatment Systems" the following was evidenced in, part (concerning the treating of the sample for chlorine) "...If using RPC Ultra Low Total Chlorine Test Strips, and a water temperature is not available, teammates should use a 60 (sixty) second dip time..." According to the RPC Water Hardness Test Strips procedure: "Insert the pad of the test strip in the water sample for 5 (five) seconds and remove....gently shake off liquid. After 15 seconds immediately compare the test pad to the color chart on the bottle..." (Staff Member # 2 (Quality Manager) stated on 6/19/19 at 9:30 a.m., that this was the procedure for the timing of the chlorine test strips as well.)

For the testing of the Conductivity using the Myron-L meter, the following was evidenced from the procedure "Operation of Portable Myron-L Conductivity Meter (D1)"..."Verify that the container of fresh dialysis quality water used to rinse the DI meter cell is labeled with today's date and the initials of the teammate if applicable...2. Obtain proportioned dialysate sample per delivery system manufacturers recommendations utilizing the DI meter differ side of the plunger or clean disposable collection cup. 3. Fill meter cup with sample so upper electrode is immersed, insert plunger. 4. Agitate sample with plunger by moving up and down 3 or 4 times and then discard sample. 5. Repeat steps #3 and #3 at least 3 (three) times. 6. Obtain another proportioned dialysate sample and fill the meter, drop plunger in the solution and press the black button. When the pointer stops, immediately read and release the button. 7. Repeat step #6 twice and press Read/Check button and record conductivity reading...10. When you are finished with the DI meter, RINSE thoroughly with dialysis quality water. Clean the exterior of the meter with 1:100 (one to one hundred) bleach solution..."

The contract titled "Hospital Services Agreement" was reviewed and evidenced, in part: "...Provision of Services: 3.1 Performance of Services. Company will perform the Services in accordance with generally recognized standards of care as outlined by applicable federal, state and local laws, and regulations...3.5 (b) Additional Orientation or Training. Company staff assigned to each facility shall complete an initial orientation of the facility..."

On 6/19/19 at 11:15 a.m., Staff Member #1 (Nurse Manager) stated, "They (contract company) provide the service and they do all the education for their staff. We do not provide any education for them. The Infection Control Nurse monitors them for dressing changes and procedures that they do them correctly. We do go over the policies and procedures with them and they get the computer training. I don't know if there is any check off list for competency of the staff but Infection Control does check on them."

On 6/19/19 at 12:40 p.m., Staff Member #11 (Staff Development) was interviewed and stated, "I do not do anything with contract services. They get site orientation and all orientation through the nurse coordinator and nurse manager. (Contract Company) do the site orientation the first time they (contract staff) arrive. The service they work for is contracted to ensure their employees are credentialed...the charge nurse coordinator or manager for the patient would provide supervision for the contracted staff."

At 12:50 p.m., on 6/19/19, Staff Member # 12 (Infection Control/Preventionist) stated, "I go in and audit them quarterly. They have their own educator that does their competency audits." At this time, the surveyor discussed with Staff Member #12 the observations and concerns that occurred on 6/18/19 with the contract staff.

The surveyor requested the contract for the Respiratory Services for the facility. Staff Member #2 (Quality) stated there was not "contract" but there was a "Services Agreement". The surveyor reviewed the "Services Agreement" effective September 1, 2008. Under "Scope of Services" "Respiratory Therapy, Pulmonary Lab" was listed and documented the services provided, however no other information regarding: Provision of Services, Staff Qualifications, Oversight, Contract Obligations, Treatment Responsibilities, Patient Education, and Orientation or Competencies/Credentialing.

The surveyor interviewed the Supervisor of Respiratory Services for the "contract" services utilized by the facility on 6/13/19 at 11:20 a.m. The Supervisor (To be referred to as Staff Member #14 for this report) stated, "Our staff provide respiratory services to (facility name) when they call us that they have a patient. It is rare that we have staff over here. I am not aware of any orientation that is done for the staff. We have a staff member assigned every shift twenty-four hours a day seven days a week to be on call for this facility just in case they need us. We do not participate in any Quality Meetings. I was not aware that (facility name) had a quality program. If we were notified we would participate, but we have not received any notification of meetings...any equipment needed would be provided by my staff and brought over to (name of facility)..."

Staff Member #2 (Quality) stated on 6/13/19 at 2:20 p.m. that the Respiratory services are used so infrequently that "there is nothing for Quality to review".

On 6/25/19 at 11:00 a.m., the surveyors discussed the concerns with Staff Members #1, 2, 4, and 6.

Based on clinical record review, staff interview and facility document review, it was determined the facility staff failed to ensure:

Medications were administered per the physician's orders for one (1) of three (3) Patients (Patient # 5) who received a jet nebulizer treatment, and;

Staff adequately monitored three (3) of three (3) patients who received the jet nebulizer treatments. Patient # 3, 4, and 5.

The findings included:

A review of the clinical record for Patient #5 revealed a physician's order dated 6/6/19 for "Albuterol-ipratropium 2.5-0.5/3ml QID (per three milliliters four times a day)". Review of the MAR (medication administration record) revealed the following: On 6/7/19 only two (2) doses were documented as administered, on 6/8/19 only two (2) doses were documented as administered, on 6/10/19 (3) three doses, and on 6/12/19 (3) three doses. There was no documentation in the clinical record for any of the dates as to why the medication was not administered as ordered. At 8:50 a.m. on 6/13/19, Staff Member # 15 (South Hospital Nurse Manager), who was assisting the surveyor to navigate the EHR (Electronic Health Record) stated, "I have looked and I cannot find anything. I don't know why the medication was not given as ordered."

The facility policy and procedure "Jet Aerosol/Jet Nebulizer" was reviewed and evidenced: "...Documentation: 10 Record in Electronic Health Record (EHR) 20 Date and time of treatment...

On 6/25/19 at 11:00 a.m., the surveyors discussed the concerns with Staff Members #1, 2, 4, and 6.

A review of the clinical record for Patient #3, 4 and 5 revealed orders for the administration of jet nebulizer treatments. Patient #3's order was dated 6/10/29 and ordered QID (four times a day). Patient #4 had a PRN (as needed) q4h (every four hours) order on 6/5/19 and Patent #5's order was 6/6/19 for QID (Every four hours). Further review of the clinical records revealed the following:

Patient #3 did not have a complete pre or post assessment on 6/11/19 at 5:01 a.m. to include assessment of breath sounds and cough, a post assessment on 6/12/19 at 10:30 a.m. did not include the assessment of breath sounds or cough, at 2:00 p.m., no tolerance to treatment was documented, and on 6/13/19 at 6:26 a.m. no post treatment assessment was documented.

Patient #4 had a treatment administered on 6/10/19 at 10:35 a.m., however no pre or post treatment was documented. The treatment was administered as a PRN (as needed), however there was no documentation as to why the treatment had been administered.

Patient #5 had no pre or post treatment assessment documented on 6/7/19 at 1906 (7:06 p.m), 6/9/19 all treatments administered had no pre or post assessment, on 6/10/19 at 6:14 a.m., and 8:51 a.m. (patient requested the treatment at this time and no reason was documented) no pre or post treatments were documented, on 6/11/19 at 6:19 a.m., 9:07 a.m., and 1802 (6:02 p.m.) no post treatment assessments were documented and on 6/12/19 at 1424 (2:24 p.m.) no pre or post treatment assessment was documented.

Review of the facility policy and procedure "Jet Aerosol/Jet Nebulizer" was reviewed and evidenced, in part: "... Policy: 4. Nursing will perform and document both pre and post heart rate, respiratory rate, dosage of medication, breath sounds, description of cough including character of any sputum, tolerance of treatment SPO2's (pulse oximetry reading) or other pertinent information in the EHR...12. For future treatments, assess pre- and post- heart rate, respiratory rate, O2 (oxygen) saturation, breath sounds, cough, tolerance to procedure, and any pertinent patient information...Documentation: 1) Record in Electronic Health Record (EHR) 2) Date and time of treatment 3) Document breath sounds 4) Patient's tolerance and reaction to procedures 5) Any teaching to patient and/or family and the response."

On 6/13/19 at 9:05 a.m., Staff Member # 15 (South Nurse Manager) stated, "We definitely need some education..."

On 6/25/19 at 11:00 a.m., the surveyors discussed the concerns with Staff Members #1, 2, 4, and 6.

Based on observations, staff interview, and review of facility documents, it was determined facility staff failed to ensure that patient medical information was maintained in a confidential manner to prevent access by unauthorized individuals.

Findings included:

At 10:35 a.m. on 6/12/19 during a tour of the facility accompanied by Staff Member #1, Nurse Manager, the surveyor observed a cart, which had a computer mounted on the top, pushed just inside the door of
Patient #3. The cart drawers were locked, but the computer on the cart was open, with patient information showing on the screen. There was no facility staff in the room or hallway near where the open computer was setting. The open computer was shown to SM #1 at the time of discovery, and he/she closed the open screen on the computer.

At 10:40 a.m. on 6/12/19 the surveyor noted a Kardex book lying on top of a cart outside of room 121. There was medical information related to multiple patients in the Kardex book which was setting unattended on top of the cart, in the hallway. The Kardex was shown to SM #1, who stated "it isn't open"; the surveyor demonstrated that anyone could open and access private health information for multiple patients.

The facility's Administrative policy titled "Release of Protected Health Information -HIPPA" Developed 11/87, last revised/reviewed 4/19 was reviewed, and revealed in part: "...General Requirements: 1. Staff Responsibility: A. All individuals engaged in the collection, handling or dissemination of protected health information (PHI) shall be specifically informed of their responsibility to protect the patient's health information. PHI will only be provided to those employees who have a need to know in order to carry out their job responsibilities as outlined in their job description. PHI will never be left unattended or in clear view of the public. This responsibility will be made known to all employees at the time of employment and each employee shall indicate understanding of this responsibility through a signed statement at the time of employment, kept with employees personal record...E. Paper and electronic-based protected health information shall be maintained in a secure area...".

Concerns were discussed with SM #1 at the time of discovery, and again on 6/25/19 at 9:30 a.m. with SM's# 1, 2, 4, 11, and 6.

Based on clinical record review, staff interview and facility document review, it was determined the facility staff failed to ensure:

Pre and post treatment assessments were documented for three (3) of three (3) patients who received jet nebulizer treatments (Patient # 3, 4, and 5), and;

That nursing assessment of patient wounds were complete, and that physician orders for wound care were entered per the facility's policy in the electronic health record for one (1) patient (Patient #8).

The findings included:

A review of the clinical record for Patient #3, 4 and 5 revealed orders for the administration of jet nebulizer treatments (Albuterol-Ipratropium) Patient #3's order was dated 6/10/29 and ordered QID (four times a day). Patient #4 had a PRN (as needed) q4h (every four hours) order on 6/5/19 and Patent #5's order was 6/6/19 for QID (Every four hours). Further review of the clinical records revealed the following:

Patient #3 did not have a complete pre or post assessment on 6/11/19 at 5:01 a.m. to include assessment of breath sounds and cough, a post assessment on 6/12/19 at 10:30 a.m. did not include the assessment of breath sounds or cough, at 2:00 p.m., no tolerance to treatment was documented, and on 6/13/19 at 6:26 a.m. no post treatment assessment was documented.

Patient #4 had a treatment administered on 6/10/19 at 10:35 a.m., however no pre or post treatment was documented. The treatment was administered as a PRN (as needed), however there was no documentation as to why the treatment had been administered.

Patient #5 had no pre or post treatment assessment documented on 6/7/19 at 1906 (7:06 p.m.), 6/9/19 all treatments administered had no pre or post assessment, on 6/10/19 at 6:14 a.m., and 8:51 a.m. (patient requested the treatment at this time and no reason was documented) no pre or post treatments were documented, on 6/11/19 at 6:19 a.m., 9:07 a.m., and 1802 (6:02 p.m.) no post treatment assessments were documented and on 6/12/19 at 1424 (2:24 p.m.) no pre or post treatment assessment was documented.

A review of the facility policy and procedure "Jet Aerosol/Jet Nebulizer" was reviewed and evidenced, in part: "... Policy: 4. Nursing will perform and document both pre and post heart rate, respiratory rate, dosage of medication, breath sounds, description of cough including character of any sputum, tolerance of treatment SPO2's (pulse oximetry reading) or other pertinent information in the EHR...12. For future treatments, assess pre- and post- heart rate, respiratory rate, O2 (oxygen) saturation, breath sounds, cough, tolerance to procedure, and any pertinent patient information...Documentation: 1) Record in Electronic Health Record (EHR) 2) Date and time of treatment 3) Document breath sounds 4) Patient's tolerance and reaction to procedures 5) Any teaching to patient and/or family and the response."

On 6/13/19 at 9:05 a.m., Staff Member # 15 (South Nurse Manager) stated, "We definitely need some education..."

On 6/25/19 at 11:00 a.m., the surveyors discussed the concerns with Staff Members #1, 2, 4, and 6.



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A review of the medical record for Patient #8 revealed that he/she was admitted to the facility on 6/5/19, and was still a current patient at the time of the record review. Patient #8's diagnoses include, but are not limited to neurogenic bladder with paraplegia, due to an old SCI (spinal cord injury), pyelonephritis with sepsis, colostomy, and (new) urostomy. It was also noted that Patient #8 had a deep tissue injury to the sacrum, an untraceable ulcer on the left heel present on admission, and a healing open abdominal incision s/p wound vac, wound care nurse following.

The nurse who admitted Patient #8 documented the following wounds on 6/5/19 at 7:59 p.m. :
1) Left heel Allevyn foam dressing, changed
2) Left lateral foot, silicone foam dressing, changed
3) Left buttock-not documented.
At 11:00 a.m. on 6/18/19, SM #18, chart navigator, stated "The nurse didn't open that (left buttock) dynamic-I'm thinking either it was not noted, or it occurred later".

Documentation by the wound care nurse, SM #22, on 6/7/19 included the following wound care orders: 1) Allevyn foam to sacral area/buttocks, change Monday-Wednesday-Friday
(M-W-F); 2) Allevyn foam to left heel/left lateral foot, change M-W-F; 3) Acticoat Flex and dry gauze and tape to abdominal wound, change daily until reassessment on Monday (6/10/19); 4) Nutrition consult; 5) off loading boots; 6) air mattress, turn every two (2) hours.

On 6/18/19 at approximately 2:00 p.m., SM #23, Information Technology, Cerner "expert" was interviewed by phone while attempting to locate information related to physician orders for Patient #8 in the EHR. SM #23 stated "I see the consult to wound care specialist on the wound care orders under consult and referrals, they (nurses) should be opening that. The idea is that the order is the protocol. The nurse is authorized to initiate the wound care protocol. Checking the box is the correct way to do it. I assume our nurses know how to place an order-what they would do is add orders/plans, pull up wound care and would then check what was needed". SM #18 added "The physician relies on the nurse to assess skin, the nurse should initiate wound care order set based on their assessment, and would perform appropriate wound care per his/her assessment, based on the order set. If SM #25 had gone back and put in the order set, SM #25 could, and I imagine would have looked at it as a formality. If the doctor orders the wound care order set, the wound care nurse is obligated to see the patient".

SM #18 added "It doesn't look like the wound care nurse was notified by the admitting nurse. The "power plan" wound care protocol was ordered by the doctor. It looks like for this patient, wound care orders put in by the admitting nurse were put in and include pressure relief measures, float heels, and consult dietitian. In most, not all cases, wounds are assessed. If the dressing is complicated, or done earlier in the day, it may not be changed. Dressing orders were not written until 6/7/19 when the wound care nurse saw (the patient)".
A blank copy of the facility's "Skin and Wound Care Protocol Orders" was provided to the surveyor upon request. In review, the document included "check boxes" which the nurse could choose, based on his/her assessment. The document included boxes which could be marked for "Consult Wound Nurse Specialist", and "Hanover (only) may use Alternating air mattress for high risk patients".

On 6/24/19 at 4:00 p.m. SM #1, Nurse Manager, approached the surveyor to discuss the wound care protocol orders and stated, "I think what is happening is the doctors order the protocol, and the nurse opens it on Cerner and picks the boxes. A lot of the time the boxes don't match what they are doing. Unfortunately, they are looking at the wound care paper, but not putting it in the computer".

It was noted that the wound care protocol order by SM #26 documented "no co-sign required". SM #1, Nurse Manager, was interviewed on 6/24/19 at 4:00 p.m., and stated "I think the nurse just thought there is a box that says "co-sign" required or "not required". I don't think we were teaching them (nurses) to have the orders signed if they were protocols".

Concerns related to wound care assessment, orders, and documentation were discussed with SM's 1, 2, 4,11, and 18 at multiple times throughout the survey process, and again with SM's #1, 2, 4, 11, and 6 on 6/25/29 at 9:30 a.m.

Based on observation, interview and hospital document review, it was determined that staff failed to ensure medications were stored in such a way that would ensure outdated or otherwise unusable drugs were not available for patient use.

The findings include:

On 6/12/19 at 10:20 a.m., an inspection of the medication storage area was conducted with the assistance of Staff Member (SM) #29. During the inspection of the storage area located on Unit 1, the surveyor noticed a container labeled with "Physicians Injection Box", taped to the container was the business card for SM #26 (a physician). SM #29 informed the surveyor that SM #26 used the injection box when administering joint injections while on the unit.

Inspection of the "injection box" found the contents to include but not be limited to multiple unopened empty syringes, unopened syringes containing normal saline, two opened 30 ml vials of Bupivacaine (an anesthetic) which were in date and 1 opened 10 ml vial of Bupivacaine with an expiration date of 2/19. All of the aforementioned medication vials were in vials designated for single use. Upon this discovery, SM #29 stated "they know they are not supposed to do this" SM #29 stated that he/she had been inspecting the medication storage area but had not checked the "injection box" recently. SM #28 stated the physicians remove the medication from the Pyxis system and should have returned any unused medication.

The above findings were discussed with SM #2 and SM #29 when discovered. SM #29 and SM #2 agreed that medications are not to be stored in the "injection box" and verified the contents listed above. SM #2 and SM #29 agreed the finding of opened single use vials (still containing medication) created the possibility the opened vials were available for use by multiple patients. SM #2 and SM #29 also agreed the outdated medication was available for use and should have been removed from stock.

Facility policy No..4.3.5 "Storage of Outdated Items" revised 3/19 reads in part as follows: "Expired or outdated medication should be given to a pharmacy staff member for prompt removal from active stock."

Facility policy No. 192 "Pyxis and Controlled Substance Management" revised 8/17 reads in part as follows: "11) Medication Return a) Unit-dose medications removed from Pyxis which are not administered and still in original unopened packaging should be retuned using the "Return" function.

Based on staff interview and observation, it was determined that facility staff failed to ensure that information entered into the pharmacy Pyxis system for insulin administration was accurate and reflected the actual dose administered.

Findings included:

On 6/13/19 at 11:45 a.m. the surveyor observed Staff Member (SM) #33, RN (Registered Nurse) draw up and administer a sliding scale insulin dose of four (4) units to Patient #12, based on a blood glucose result of 300, reported to SM #33 by SM #32.

The surveyor noted that SM #33 documented the insulin dose as one (1) unit in the Pyxis system, rather than the 4 unit dose which had been drawn from the insulin vial, and based on the sliding scale ordered by the physician. SM #33 stated "The units we put into the Pyxis do not match what we give. It only happens with insulin, if we put in the actual units we administer, rather than 1, it makes the count off in the Pyxis. The pharmacy knows, and tells us to do it this way".

On 6/18/19 at 9:30 a.m. an interview was held with SM #29, Pharmacist, to discuss the inconsistencies between the amount of insulin administered and how insulin was documented in the Pyxis system. SM #29 stated: "It's a technical thing, it doesn't affect the medication dose ordered by the doctor. In Cerner, medications can be ordered by strength, unit dose, or milliliters. Ideally, the two should always match (Pyxis and Cerner), or so we were taught. I have learned better ways to do it with insulin. If the insulin unit of measure used is "unit", it asks in Cerner and Pyxis, that's the word on the screen for the nurses-it works for inventory to put "1" for inventory-consider a full vial to be ten (10) doses; techs put in 10 units for the count, so each dose given, no matter, how many units is administered, it is documented as 1 unit, for inventory purpose. I learned a couple of months ago that we do have the option of changing this in Pyxis, and if we make it in doses rather than units, it should still work right. I didn't know that at first, when we started using Cerner. I haven't changed the issue yet, because it will change every Bon Secours Pyxis System-wide, and we have to get them to agree, since it lives on their Pyxis server, which connects to [this facility's] program".

Concerns were discussed as above with SM #29 related to the inconsistent documentation of the amount of insulin withdrawn in the Pyxis system versus what is documented as administered in the Cerner Electronic Medical Record, on the Medication Administration Record. The concerns were again discussed with SM's #1, 2, 4, 11, and 6 on 6/25/29 at 9:30 a.m.

Based on observation, staff interview and facility document review, it was determined that facility staff failed to ensure:

Two icemakers which served the patient population, were maintained per the Manufacturer's Directions for Use,

That liquid oxygen tanks were filled in an area which assured safety of patients, visitors, and staff, and;

That portable liquid oxygen equipment was maintained per the directions for use in order to ensure that the equipment was operating properly.


The findings included:

On 6/20/19 at 1:30 p.m., the surveyor observed the two ice machines (1) located in the nurses station area on the patient unit and (2) in the Rehab gym. The surveyor inquired as to the cleaning schedules of both machines and requested the manufacturer's directions for use for both machines. During an observation at 2:30 p.m., the air filter located on the machine (1) was examined and contained an excessive build up of debris, lint and dirt. Staff Member #7 (Director of Facilities Management) stated, "I did not know there was an air filter on the machine. The vendor (name) does the cleaning and I thought they would have taken care of it." Staff Member #1 (Nurse Manager) and #2 (Quality) stated, "We do not clean the filter".

On 6/20/19 at 1:40 p.m. Staff Member # 2 (Quality) stated, "There is not a contract for the cleaning of the machines. We use an email. They (vendor) were supposed to come twice a year per the manufacturer's directions but we weren't doing them twice a year..." At 1:45 p.m., Staff Member # 7 (Director of Facilities Management) was interviewed and stated "I will call the vendor who does the cleaning." After the phone conversation with the vendor, Staff Member #7 stated, "There is no checklist for the cleaning and no medical testing (cultures) is done. They (vendor) say they go by the manufacturers guidance for the cleaning of the machines in the owners manual. They (name of vendor) say they do not clean the air filters."

Review of the Manufacturer's Directions for Use (MDFU) for (1) revealed "Hoshizaki Instruction Manual - Cublet Icemaker/Dispenser Models DCM-270BAH (-OS) : ...Every two weeks: Air Filter- Inspect. Wash with warm water and neutral cleaner if dirty... Every 6 (six) months- Icemaker and Ice Storage Bin- Clean and sanitize per the cleaning and sanitizing instructions provided in this manual...The second dispenser (2) "MDT5N25 & MDT5N40" MDFU evidenced: ... Cleaning and Sanitizing: ...Maintenance should be scheduled for a minimum of twice per year. Sanitizing of the ice storage bin should be scheduled for a minimum of 4 (four) times a year." Staff Member #7 and #2 stated on 6/20/19 at 2:30 p.m. that the Ice Machine storage bin is not cleaned by staff. "The only cleaning that is done is by the vendor (name) and we have them coming now twice a year, but did not know the ice bin had to be cleaned four times a year."

A discussion was held with Staff Members #1, 2 and 7 regarding the cleaning, maintanance, and sanitizing of the ice machines on 6/20/19 at 2:30 p.m.

On 6/25/19 at 11:00 a.m., the surveyors again discussed the concerns with Staff Members #1, 2, 4, and 6.


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2. When entering the facility via the front (main) door at 8:15 a.m. on 6/12/19, two surveyors observed a van pulled up near the front (main) door of the facility and appeared to be filling a tank; white vapor was swirling around the tank and area where the man was working. The tank was being filled while sitting on pavement just beside a walkway to the front door used by staff, visitors, and patients, and in a covered area where surveyors noted cars and ambulances dropped off and picked up patients during the course of the survey 6/11/19 to 6/14/19, 6/17/19-6/21/19, and 6/24/19-6/25/19. The surveyors also noted cigarette butts lying on the ground in the area described.
During the entrance conference with SM's #1, the Nurse Manager, and #2, Director of Quality, the surveyors inquired as to what was taking place outside the front door at the van. SM #1 stated "he is filling the liquid oxygen tanks. They are usually filled once a week on Friday". The surveyors asked for the policy and procedure related to filling the liquid oxygen tanks, the contract with the supplier of the liquid oxygen, and asked to interview the facility staff responsible for oversight of that service. SM's #1 and 2, the Nurse Manager and Director of Quality acknowledged, during the discussion with surveyors, on 6/12/19 that patients and visitors smoke on the premises and discard cigarette butts on the ground near the entrance to the facility.

SM #28 and the surveyor went on a tour in order to observe the area where oxygen tanks were stored on 6/12/19 at 9:45 a.m.
The "oxygen closet" was on a hallway of the facility, and had an oxygen sign posted on the door. The room contained four (4) liquid oxygen tanks, shelving for supplies, and some oxygen cylinder tanks. SM #28 told the surveyor that staff fill the portable tanks in the "oxygen closet". The surveyor noted that lighting inside the room was very dim, making it difficult to see. There was a vent along the wall going through the ceiling, but SM #28 was unable to say where the vent ended. There was no PPE observed to be in the room readily available for use by staff while filling the tanks. SM #28 stated "the lighting hasn't been this dim, I'll put in a work order to have it fixed". The surveyor asked if there was an area, other than the front entrance to the facility, where oxygen tanks could be filled. SM #28 stated "I guess they could go to the loading dock area, they have always filled them in the front since I've been here; I started in December".

On 6/12/19 at 1:40 p.m. an interview was conducted with SM #28, Manager of Material Management to discuss filling liquid oxygen portable tanks for patient use, and preventative maintenance (PM) required for equipment. SM #28 stated "I have a repair log, there is no required maintenance, only if they aren't working properly".

The surveyor asked for, and was given, a copy of the technical service manual for the "Sprint and Stroller", the operating instruction manual for the type of portable liquid oxygen tanks utilized by the facility for patients. The maintenance schedule listed two schedules for "routine maintenance" of the portable oxygen tanks, which the manual states "allow the distributor maximum flexibility while assuring that the equipment is working properly..Schedule A-Biennial...3. Check Efficiency of Unit: a. Allow the unit to stabilize after filling (10-15 minutes). b. Inspect the bottle for cold sweaty condition, and for excessive venting from relief valve (some venting is normal). c. If either condition is observed, conduct NER test...4. Flow test..." Schedule B-Continuous: Continuous maintenance is a set of tests and inspections performed periodically to ensure the equipment is functioning properly. It can be done with equipment in service by drivers or other personnel...1. If a unit fails a given test, it should be taken out of service. Refer to the Troubleshooting section (Section XI) or contact Technical Service. 2. Schedule B-Checks are made when the driver visits patients and when equipment is transferred between patients...B. Procedure: These inspections are to be performed at least once per year by the driver or other personnel when the Sprint/Stroller is in use by the patient (LOX in the unit)...1. Visual inspection...These inspections/tests are to be done between patients...".

Concerns related to the area utilized to fill tanks of liquid oxygen, and the lack of routine PM for the portable liquid oxygen tanks were discussed with SM #28 on 6/12/19 between 9:45 a.m. and 10:00 a.m., and at approximately 1:40 p.m. Concerns were also discussed on 6/25/19 at 9:30 a.m. with SM's# 1, 2, 4, 11, and 6.

Based on observation, staff interview and facility document review, the facility staff failed to ensure:

Proper infection control practices were carried out for hand hygiene and the care of a Foley catheter for two patients, Patient #12 and Patient #17,

The proper cleaning and sanitization of ice machines per the manufacturers directions for use for two (2) of two (2) ice machines (dispenser type) located in the facility for patient use, and;

The proper cleaning and disinfection of equipment designated for patient use and that the facility Legionella Monitoring Program was implemented.

The findings included:


On 6/18/19 at 3:20 p.m., the surveyor observed Patient #12 receiving dialysis treatment. The surveyor observed as (contract) Staff Member #20 entered the room carrying packets of supplies. The staff member was observed to lay the supplies down on the table next to the dialysis machine and, without washing or sanitizing hands, donned gloves. While still wearing gloves, and after touching the patient equipment, the staff member retrieved a computer tablet from a black fabric case and entered information into the tablet. The staff member was observed to remove gloves and without washing or sanitizing hands, donned another pair of gloves and took a thermometer strip in order to take the patient's oral temperature. After taking the patients oral temperature, the staff member removed the gloves and without washing or sanitizing hands, picked up a notebook and entered information into the pages. Staff Member #20 then went to the door and asked a passing staff member to obtain some face masks. When the staff member brought the masks back, Staff Member #20 hung the extra masks on the attached IV pole of the dialysis machine. Staff Member #20 then, without washing or sanitizing hands, donned gloves and continued to set up the dialysis machine. Staff Member #20 them took a stethoscope that was hanging on the attached IV pole and used it to assess Patient #12. After the assessment, Staff Member #20 removed the gloves and without washing or sanitizing hands, charted on the clipboard available with patient information. Staff Member #20 then sanitized hands and put a mask on Patient #20 and on (him/herself- Staff Member #20). Staff Member #20 then donned gloves, reset the dialysis machine and charted on the computer still wearing gloves; then reset the alarm on the dialysis machine, removed gloves and without washing or sanitizing hands, donned gloves. Staff Member #20, proceeded to obtain a package of lab tubes and supplies and remove the tubes and label them. Staff Member #20 laid all the tubes and supplies on the bed with the patient and proceeded to take a blue pad and place it underneath the patient's central line tubing and cleaned the ports to the central line (CVC), Staff Member #20 unwrapped the syringes and drew blood from the ports of the CVC and after discarding the first blood syringes, drew additional blood and paced it in the lab tubes. Staff Member #20 reset the machine, primed the blood lines and attached the lines to the patient's CVC ports. Staff Member #20 did not change gloves nor sanitize hands during the observation of the blood draw and initiating the dialysis treatment.

The policy and procedure "Infection Control in the Hospital Dialysis Setting" was reviewed and evidenced, in part: "...3. Medication vials, syringes, tape, alcohol swabs, dressings, gloves or other supplies will not be carried in pockets or placed on the patient's bed...4. Hand hygiene is to be performed per hand hygiene policy...11. Gloves should be changed when: ...going from a "dirty" area or tasks to a "clean" area or task..."

According to The Centers for Disease Control- Dialysis Safety (www.cdc.gov/dialysis/safety), "...Hand hygiene is the single most important thing you an do to prevent the spread of infection...when to use hand hygiene:...before you touch a patient, before you put on gloves- NOTE- take gloves out of the box after you have washed your hands...between tasks and procedures on the same patient, after you remove gloves, after you touch any body fluid or mucous membrane, after you touch machines, equipment or computer keyboards... alcohol based hand rub can be used in place of washing your hands as long as there has been no contact with blood or body fluids (even while wearing gloves) or the hands/gloves are not visibly soiled..."

On 6/25/19 at 11:00 a.m., the surveyors again discussed the concerns with Staff Members #1, 2, 4, and 6.

On 6/11/19 at 9:45 a.m., the surveyor observed Patient #17 lying in bed. The patient had a Foley catheter which was attached to bedside drainage. The surveyor observed that the bed had been lowered to a position which caused the Foley catheter bag and tubing to be lying on the floor beside and underneath the bed.

The facility policy and procedure "Urinary Catheter Management and CAUTI (Catheter associated urinary tract infections) Prevention" was reviewed and evidenced, "...5. Appropriate care and Maintenance of Indwelling Catheter...c) Positioning: Maintain closed drainage system with an unobstructed urine flow...iii)Kept off the floor..."

At 12:50 p.m., on 6/19/19, Staff Member # 12 (Infection Control/Preventionist) stated, "I go in and audit them quarterly. They have their own educator that does their competency audits." At this time, the surveyor discussed with Staff Member #12 the observations and concerns that occurred on 6/18/19 with the contract staff and the observation of the Foley catheter. Staff Member #12 stated, "I make rounds and check on those things..."

On 6/25/19 at 11:00 a.m., the surveyors again discussed the concerns with Staff Members #1, 2, 4, and 6.

On 6/20/19 at 1:30 p.m., the surveyor observed the two ice machines (1) located in the nurses station area on the patient unit and (2) in the Rehab gym. The surveyor inquired as to the cleaning schedules of both machines and requested the manufacturer's directions for use for both machines. During an observation at 2:30 p.m., the air filter located on the machine (1) was examined and contained an excessive build up of debris, lint and dirt. Staff Member #7 (Director of Facilities Management) stated, "I did not know there was an air filter on the machine. The vendor (name) does the cleaning and I thought they would have taken care of it." Staff Member #1 (Nurse Manager) and #2 (Quality) stated, "We do not clean the filter".

On 6/20/19 at 1:40 p.m. Staff Member # 2 (Quality) stated, "There is not a contract for the cleaning of the machines. We use an email. They (vendor) were supposed to come twice a year per the manufacturer's directions but we weren't doing them twice a year..." At 1:45 p.m., Staff Member # 7 (Director of Facilities Management) was interviewed and stated "I will call the vendor who does the cleaning." After the phone conversation with the vendor, Staff Member #7 stated, "There is no checklist for the cleaning and no medical testing (cultures) is done. They (vendor) say they go by the manufacturers guidance for the cleaning of the machines in the owners manual. They (name of vendor) say they do not clean the air filters."

Review of the Manufacturer's Directions for Use (MDFU) for (1) revealed "Hoshizaki Instruction Manual - Cublet Icemaker/Dispenser Models DCM-270BAH (-OS) : ...Every two weeks: Air Filter- Inspect. Wash with warm water and neutral cleaner if dirty... Every 6 (six) months- Icemaker and Ice Storage Bin- Clean and sanitize per the cleaning and sanitizing instructions provided in this manual...The second dispenser (2) "MDT5N25 & MDT5N40" MDFU evidenced: ... Cleaning and Sanitizing: ...Maintenance should be scheduled for a minimum of twice per year. Sanitizing of the ice storage bin should be scheduled for a minimum of 4 (four) times a year." Staff Member #7 and #2 stated on 6/20/19 at 2:30 p.m. that the Ice Machine storage bin is not cleaned by staff. "The only cleaning that is done is by the vendor (name) and we have them coming now twice a year, but did not know the ice bin had to be cleaned four times a year."

A discussion was held with Staff Members #1, 2 and 7 regarding the cleaning and sanitizing of the ice machines on 6/20/19 at 2:30 p.m.

On 6/25/19 at 11:00 a.m., the surveyors again discussed the concerns with Staff Members #1, 2, 4, and 6.



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On 6/13/19 at 11:30 a.m., the surveyor observed Staff Member (SM) #32 perform assisted blood glucose monitoring for Patient #12. SM #32 carried a caddy of supplies into the patient's room, and sat it down on the bedside table without first placing a clean barrier beneath the container. SM #32 donned gloves, touched the patient , opened the container to retrieve an alcohol pad, cotton ball, and lancet. SM #32 placed the glucose monitor in the bed beside the patient, collected and tested the sample (result 300).While wearing the contaminated gloves, SM #32 cleaned the glucometer using sanitizing wipes, placed the glucometer on top of the container of supplies, and cleaned his/her hands. SM #32 then exited the room, carrying the glucometer and container of supplies, and replaced both in the area where that equipment was stored. SM #32 reported the glucose result to Patient #12's nurse.

The surveyor asked for a copy of the facility's policy and procedure for performing assisted blood glucose monitoring which addressed cleaning of equipment, and was given Nursing policy 125 titled "Glucometer" and Nursing policy 125 "Hypoglycemia Protocol for the Adult Diabetes Patient". Neither policy addressed cleaning of the supply caddy.
On 6/21/19 at 9:05 a.m., SM #15, Nurse Manager, stated "A competency for glucose testing is done during orientation for new staff. There is no procedure that says how to do blood sugars and includes cleaning the supply caddy".
Nursing policy #143 did address cleaning the glucose monitor, but did not include any other items taken into the room during blood glucose monitoring.

On 6/13/19 at approximately 11:40 a.m., SM #1, Nurse Manager, asked about the surveyor's observation. The surveyor discussed concern related to taking the supply caddy into the patient's room, setting it on the bedside table, accessing the caddy to retrieve clean supplies while wearing contaminated gloves, and returning the caddy to a clean area without first cleaning and disinfecting the equipment. SM #1 acknowledged that SM #32 should not have worn gloves used to touch a patient while getting clean supplies from the caddy, and that the caddy should have been cleaned prior to removing it from the room and placing it in an area with clean equipment.
Concerns were again discussed on 6/25/19 at 9:30 a.m. with SM's# 1, 2, 4, 11, and 6.

A review of the facility's Legionella Policy was conducted. The surveyor asked for the facility's P&P for Legionella monitoring, and to interview the facility staff responsible for monitoring the program.

The surveyor was given two (2) copies of an Administrative Policy Number 351. One of the policies evidenced that it was Developed 5/19, with no revision date. The second copy evidenced that it was developed 6/19, with no revision date; both policies appeared to include the same information. The policy included the following information, in part: "Purpose: To minimize Legionella bacteria an pathogenic biological agents in cooling towers, domestic water systems, decorative fountains and aerosolizing water systems...Policy: [The facility engages another facility] for the chemical treatment of all cooling towers, decorative fountains and boilers {sic}systems. This includes chemical acquisition, establishment of feed rates, periodic tests and reporting. 1) Chemical treatment logs will be maintained in the Engineering Office. 2) A Hazard Analysis is conducted & reviewed annually. 3) Memorial Regional Medical Center conducts annual water testing for Legionella bacteria. a. Samples are collected at fifteen (15) identified control point locations by a third party and sent to an independent lab for results. i. Results are located in the MRMC Engineering Department 4) Environmental Services runs water in showers and sinks when cleaning the patient rooms at each patient discharge. a. This is to flush out fixtures that may not be in regular use by patients or during holiday periods. b. Engineering will flush lines in any areas that are unoccupied or shutdown at least once a week...MRMC Engineering maintains a water quality log for the decorative fountains...".

On 6/24/19 at 3:10 p.m. SM #21, Engineering Supervisor for [contract facility] was interviewed regarding that facility's role in Legionella testing for [this facility].
SM #21 stated "There are four (4) cooling towers that are all Legionella related. Water treatment is done for [this facility] are quoted off our [contract facility] policy. We do not do any sampling for [this facility]. We do not do 15 control points for [this facility], we do 15 points for [contract facility]. We are only responsible for cooling towers (4) for [this facility]. The decorative fountains in front of the hospital are not tested for Legionella, that is rainwater runoff, and wouldn't be treated, because there are things living in them. The fountains in the gardens are sampled, because they are part of our building, the outside ones are not. There is quite a bit of work maintenance required, but that is done by the county. We do not handle any inspections for [this facility]. We do not do any sampling at [this facility]for Legionella. That is quoted off our [contract facility] policy". The 15 control points include the [contract facility] courtyard fountain, ice machines, cooling towers, patient room faucets and shower heads. Weekly at [contract facility] we do random temps, monitor cleanliness, and do preventative maintenance. Eye wash station checks are done by my maintenance, but I would guess he isn't cleaning them. They look at drippy faucets, light bulbs, air filters, steam powered water. We do not get a water report from Hanover County. I am responsible for the hospital, not the fountain-that is Hanover. The condo association repairs the grounds and parking lot".

SM #7, the Director of Facilities, was present during the interview conducted with SM #21, and acknowledged that he/she was unaware that the condo association was responsible for the decorative fountains outside the building, and believed that the hospital was taking care of those fountains, as well as the [this facility]15 point checks, "I didn't know that wasn't part of our maintenance agreement".

On 6/25/19 at 8:55 a.m., SM #7, the Director of Facilities, told the surveyor that he/she had contacted the Vice President of (the condo association's name), and they are going to check to see when the last time the outside fountains were checked for Legionella, and how often they are cleaning the outside fountains".

Concerns related to patient safety were discussed as noted above, and again on 6/25/19 at 9:30 a.m. with SM's# 1, 2, 4, 11, and 6.