HospitalInspections.org

Based on observation, staff interview and facility document review, the facility staff failed to ensure all necessary staff were trained on emergency care for the recognition and treatment of Malignant Hyperthermia in order to meet the needs of its inpatients and outpatients.

During the validation survey conducted 8/22-8/26/16, the survey team identified that the emergency department (ED) and ICU (Intensive Care) staff had not received any training regarding the recognition, treatment, and monitoring of patients for the potential of Malignant Hyperthermia* (MH) with the use of succinylcholine (a paralytic agent used during intubation).

*Malignant Hyperthermia (MH) is a potentially fatal, inherited disorder usually associated with the administration of certain general anesthetics and/or the drug succinylcholine. The disorder is due to an acceleration of metabolism in skeletal muscle. The signs of MH include muscle rigidity, rapid heart rate, high body temperature, muscle breakdown and increased acid content. Immediate treatment with the drug dantrolene usually reverses the signs of MH. The underlying defect is abnormally increased levels of cell calcium in the skeletal muscle. There is mounting evidence that some patients will also develop MH with exercise and/or on exposure to hot environments. Without proper and prompt treatment with dantrolene sodium, mortality is extremely high. Succinylcholine is used for relaxing muscles during surgery or when using a breathing machine (ventilator). It is also used to induce anesthesia or when a tube must be inserted in the windpipe. Succinylcholine is a depolarizing muscle relaxant. It works by keeping muscles from contracting, which causes paralysis of the muscles in the face and those used to breathe and move. www.mhaus.org accessed 8/29/16 at 11:30 a.m.
Dantrolene is a drug used to treat episodes of severe high body temperature (malignant hyperthermia). It is also used to prevent or reduce the risk of malignant hyperthermia in certain patients before or after surgery or anesthesia. It may also be used for other conditions as determined by the doctor. Dantrolene is a muscle relaxant. It works by restoring a normal level of calcium in the muscles, which helps to prevent or reduce severe high body temperature. www.drugs.com/dantrolene/fda accessed 8/29/16 12:00 p.m.

On 8/23/16 at 2:25 p.m. during observations of the ED, the surveyor interviewed Staff Member #7 (A Registered Nurse), regarding the location of the MH cart. Staff Member #7 responded, "MH cart?" The surveyor again repeated, "Yes, where do you keep your MH cart?" Staff Member #7 responded, "Uh, mental heath cart?" The surveyor clarified the question, "No, the malignant hyperthermia cart." Staff Member #7 stated the cart was "kept in PACU (Post Anesthesia Recovery Unit)" and "We don't have a cart here in the ED, we can get the cart from PACU."


On 8/24/16 at 12:15 p.m.,the surveyor requested a list of all staff who work/float to the ED or ICU along with evidence of training for MH. The surveyor was provided a list of all staff who had received the training on 8/25/15, however the list did not contain any staff who were assigned/floated to the Emergency Department or the Intensive Care Unit. Staff Member #1 stated that none of the ED or ICU staff had received training.


On 8/25/16 at 4:00 p.m. the survey team requested to meet with the facility administration and at 4:10 p.m. made the facility Administration aware of the concerns regarding the lack of staff training and recognition of MH.

The concern was again discussed with the facility Administration at the exit conference on 8/26/16 at 5:45 p.m..

Please refer to:
485.618(b)- Equipment, Supplies, and Medications
485.635- Provision of Services
485.635(a)(3)(ii) - Patient Care Policies and
485.635(d)(3) - Nursing Services for further information.

Based on observation, staff interview and facility document review, the facility staff failed to ensure all necessary staff were trained on emergency care for the recognition and treatment of Malignant Hyperthermia (MH) in order to meet the needs of its inpatients and outpatients including the location and use of the MH cart.

During the validation survey conducted 8/22-8/26/16, the survey team identified that the emergency department (ED) and ICU (Intensive Care) staff had not received any training regarding the recognition, treatment, and monitoring of patients for the potential of Malignant Hyperthermia* (MH) with the use of succinylcholine (a paralytic agent used during intubation).

*Malignant Hyperthermia (MH) is a potentially fatal, inherited disorder usually associated with the administration of certain general anesthetics and/or the drug succinylcholine. The disorder is due to an acceleration of metabolism in skeletal muscle. The signs of MH include muscle rigidity, rapid heart rate, high body temperature, muscle breakdown and increased acid content. Immediate treatment with the drug dantrolene usually reverses the signs of MH. The underlying defect is abnormally increased levels of cell calcium in the skeletal muscle. There is mounting evidence that some patients will also develop MH with exercise and/or on exposure to hot environments. Without proper and prompt treatment with dantrolene sodium, mortality is extremely high. Succinylcholine is used for relaxing muscles during surgery or when using a breathing machine (ventilator). It is also used to induce anesthesia or when a tube must be inserted in the windpipe. Succinylcholine is a depolarizing muscle relaxant. It works by keeping muscles from contracting, which causes paralysis of the muscles in the face and those used to breathe and move. www.mhaus.org accessed 8/29/16 at 11:30 a.m.
Dantrolene is a drug used to treat episodes of severe high body temperature (malignant hyperthermia). It is also used to prevent or reduce the risk of malignant hyperthermia in certain patients before or after surgery or anesthesia. It may also be used for other conditions as determined by the doctor. Dantrolene is a muscle relaxant. It works by restoring a normal level of calcium in the muscles, which helps to prevent or reduce severe high body temperature. www.drugs.com/dantrolene/fda accessed 8/29/16 12:00 p.m.
The findings included:

On 8/23/16 at 2:25 p.m. during observations of the ED, the surveyor interviewed Staff Member #7 (A Registered Nurse), regarding the location of the MH cart. Staff Member #7 responded, "MH cart?" The surveyor again repeated, "Yes, where do you keep your MH cart?" Staff Member #7 responded, "Uh, mental heath cart?" The surveyor clarified the question, "No, the malignant hyperthermia cart." Staff Member #7 stated the cart was "kept in PACU (Post Anesthesia Recovery Unit)" and "We don't have a cart here in the ED, we can get the cart from PACU."

On 8/24/16 at 12:15 p.m.,the surveyor requested a list of all staff who work/float to the ED or ICU along with evidence of training for MH. The surveyor requested the documentation again at the end of day meeting on 8/24/16 at 4:50 p.m. from Staff Member# 1 (Director of Quality) and Staff Member #2 (Vice President of Nursing)

On 8/25/16 at 1:55 p.m., Staff Member #1 provided the surveyor with a list of staff who had completed the MH training. The list contained the names of staff who were assigned to Surgical Services (OR) and PACU. No staff members were listed from wither the ED or ICU. Staff Member #1 stated, " None of the staff in ED or ICU have had the training."

On 8/25/16 at 4:00 p.m. the survey team requested to meet with the facility administration and at 4:10 p.m., Staff Members # 1, 2, and 9 (Administrator/President), were made aware of the concerns.

The concerns were again discussed with the facility Administration at the exit conference on 8/26/16 at 5:45 p.m..
.

Based on a review of two observation patient records, staff interview, and a review of policies and procedures, the facility staff failed to ensure that the facility had a policy and procedure governing use of observation services and specific criteria for placement in and discharge from observation status that were clearly distinguishable from those used for inpatient admission and discharge.

Findings include:

1. While on the facility tour with Staff Member #5 between 1:45 PM and 2:50 PM on 8/20/16, the surveyor asked if there were dedicated observation beds at the facility, and Staff Member #5 stated "we follow the same nursing policies that are standard for all kinds of patients. They go into a room on the med-surg floor and the case manager keeps up with when the patient needs discharge. There are interdisciplinary meetings every day to discuss each patient".

2. A review of the record for Patient #29 revealed that he/she was placed in an observation bed after an ED (emergency department) visit on 8/19/16 at 9:13 AM. As of 8/23/16 at 10:10 AM when the medical record was reviewed, Patient #29 remained in the hospital in an observation bed.
Staff Member #47 was interviewed on 8/23/2015 at 1:10 PM regarding Patient #29's observation stay of greater than 48 hours. Staff Member #47 stated "if we are told that a patient doesn't meet inpatient criteria, the doctors can't commit fraud, and if they aren't ready to be discharged, then we keep them on observation, what are we supposed to do? The surveyor asked Staff Member #47 if patients were aware that they may be responsible for charges incurred when kept in observation longer than 48 hours, Staff Member #47 stated "Patient access has the patient sign all the admission paperwork including the acknowledgement of outpatient/observation status, so they should be aware, but the hospital doesn't bill them past the 48 hours anyway, so it's the hospital that loses money".

3. When asked if the facility had criteria for inpatient and observation status and what the facility's policy and procedure for outpatient observations was, Staff Member #47 provided the surveyor with a policy titled "Assessment, Initial Patient" on 8/23/2016 between 1:15 PM and 3:00 PM. The policy states in part:
"Each inpatient or observation patient's physical, psychological, and social status is assessed during an initial assessment, as well as screened for health and safety risk concerns"; "Purpose: 1. To determine the appropriate intensity and setting of care required to meet the patient's initial needs, emerging needs and post hospital care needs..."; "Procedure: 1. An initial assessment will be completed on all hospitalized patients within unit specified time frames as listed below: A. Medical /Surgical Unit-within 12 hours of admission...".
Observation patient and inpatient criteria lists were given to the surveyor; however, both sets of criteria referred the reader to see the "General Criteria: Observation Care guideline", which the surveyor asked to see; however, the document was not available for review as of the end of the survey.
Staff Member #47 told the surveyor that on 8/23/16 between 1:10 PM and 2:30 PM that "case management determines if a patient meets inpatient criteria; if the patient becomes inpatient eligible, the case worker can change the status to inpatient with a verbal order from the physician; the doctor sees the patient regardless of whether they are inpatient or observation".
Staff Member #47 also told the surveyor that "The observation patient policy is in the process of being written, but it is not finalized because staff working on the policy are attending a conference in California this week".

Findings were discussed with Staff Members #1 and 2 on 8/23/16 between 5:00 PM and 5:30 PM.

Based on the deficiencies identified during the Life Safety Code survey (K012, K021, K025, K029, K032, K056, K062, K072, K076, K077, K141, K147, and K211) and standard level findings identified during the health portion of the validation survey (C222 and C234), the Condition for Coverage for Physical Plant and Environment is cited.

Based on observations, interview and document review it was determined:

The facility biomed staff failed to ensure the safety and maintenance of all equipment utilized in patient care for two (2) of three rehabilitation areas, and

That facility staff failed to ensure the documented safety of portable fans used in three (3) of four patient care areas and portable heaters used in one of four (4) patient care areas.


The findings included:

1. Observations and interviews were conducted on 08/22/2016 from 1:55 p.m. to 2:55 p.m. at the facility's in-house rehabilitation area with Staff Member #2 and Staff Member #58. The surveyor observed a multi-pulley and multi-weight device brand named "Matrix", which did not have a preventative maintenance sticker. Staff Member #58 reported biomedicine was responsible for performing the preventative maintenance on the rehabilitation department's equipment.

An interview was conducted on 08/23/2016 from approximately 11:30 a.m. through 12:30 p.m., with Staff Member #17. Staff Member #17 reviewed the facility's preventative maintenance program and the facility's alternative equipment maintenance program. Staff Member #17 reported the facility had three (3) tiers of equipment maintenance life support /Tier 1, pumps and other similar devices /Tier 2 and Tier 3 consisted of equipment the safety committee had deemed not in need of preventative maintenance. Staff Member #17 stated, "Before a piece of equipment goes in the AEM program the manufacturer's directions are reviewed and at least two (2) years of preventative maintenance history is submitted." The surveyor informed Staff Member #17 of the findings regarding the "Matrix" weight and pulley device. Staff Member #17 stated, "We do not perform PMs (preventative maintenance) on exercise equipment." The surveyor requested the facility's determination of what items in the rehabilitation area would not be utilized by a patient as part of physical therapy. Staff Member #17 reported all of the equipment in the rehabilitation area had the potential to be used by a patient. Staff Member #17 stated, "I suppose all the rehab (rehabilitation) equipment needs preventative maintenance."

An interview and observation was conducted on 08/23/2016 at 12:50 p.m., with Staff Member #17. The observation was conducted within the in-house rehabilitation area regarding rehabilitation equipment without preventative maintenance assessment and stickers. Staff Member #17 was able to use the product numbers from the "Matrix" to pull up the computerized history. Staff Member #17 stated, "This has never had a PM (Preventative Maintenance). It has had two repairs one in 2014 a loose nut and in 2013 the same thing. It definitely needs to have a PM because of the pulleys, springs, and all the bolts with nuts." Staff Member #17 verified the "Matrix" multi-weight and multi-pulley device had been available for patient use without having had an initial recorded PM and without a documented two (2) year history of PM assessments.

Observations and interviews were conducted on 08/24/2016 from 1:10 p.m. through 1:42 p.m. with Staff Member #37 and Staff Member #38 of the facility's outpatient physical therapy service location #2 (OPS #2). The observation revealed a weight bench without a visible preventative maintenance sticker. Staff Member #37 and Staff Member #38 moved the bench from its location against the wall and Staff Member #38 turned the bench over to check the underside. Staff Member #37 and Staff Member #38 both verified the weight bench did not have a PM sticker. Staff Member #37 described the function of the weight bench related to its ability to be positioned to support the patient using weights.

Interviews were conducted on 08/24/2016 at 4:55 p.m., with Staff Member #1, Staff Member #2, Staff Member #9, Staff Member #10, Staff Member #37, and Staff Member #51. The facility staff was informed of the findings and policies and procedures were requested. Staff Member #37 stated, "I talked to biomed and the weight bench cost less than one thousand dollars and does not need to have preventative maintenance." The surveyor inquired how the cost of the item related to its safety while being used by a patient. The surveyor requested documentation by the manufacturer related to preventative maintenance (PM) recommendations, the facility's documented determination that patient care equipment that cost less than a thousand dollars did not need preventative maintenance for patient safety, and the facility's policy regarding preventative maintenance on rehabilitation equipment. Staff Member #1 reported the cost of an item should not be a determination of product and patient safety.

A second request was made on 08/25/2016 at approximately 8:18 a.m., with Staff Member #1 and Staff Member #2 for: documentation of the weight bench's manufacturer directions for PM, the facility's documented determination that patient care equipment that cost less than a thousand dollars did not need a PM and the facility's policy regarding performance of PM on rehabilitation equipment. No documents were provided prior to exit on 08/26/2016.

2. Observations and interviews were conducted on 08/22/2016 from 1:55 p.m. to 2:55 p.m. at the facility's in-house rehabilitation area with Staff Member #2 and Staff Member #58. The observation revealed one mounted wall fan and two floor fans in use. The floor fans did not have preventative maintenance (PM) stickers in place. The height of the wall mounted fan did not allow for full view to ensure a PM sticker was applied.

An interview was conducted on 08/23/2016 from approximately 11:30 a.m. through 12:30 p.m., with Staff Member #17. Staff Member #17 reviewed the facility's preventative maintenance program and the facility's alternative equipment maintenance program. The surveyor informed Staff Member #17 that the fan observed in the rehabilitation area did not have PM stickers. Staff Member #17 stated, "Biomed (Biomedicine) only performs electrical checks on items with a ground plug (three prong electrical plug). We only inspect items that touch the patients. Fans don't touch the patient and they don't have ground plugs." Staff Member #17 stated, "I think maintenance looks at the fans." The surveyor asked Staff Member #17 to clarify with the maintenance staff in the next room. Staff Member #17 returned and stated, "Maintenance does not look at the fans either. They said they used to check the fans, but not anymore. I guess nobody is checking the fans."

An interview and observation was conducted on 08/23/2016 at 12:50 p.m., with Staff Member #17 within the in-house rehabilitation area regarding preventative maintenance. Staff Member #17 acknowledged the fans assisted in the circulation of air within the rehabilitation area. Staff Member #17 stated, "I understand your concern that the rehab (rehabilitation) is a patient area, but biomed does not check fans."

Observations and interviews were conducted in the sleep study rooms on 08/25/2016 from 10:48 a.m. through approximately 11:42 a.m. with Staff Member #2 and Staff Member #41. Staff Member #2 reported the sleep study program utilized two (2) rooms (#238 and #240). Staff Member #41 acknowledged that each sleep study room had a fan on the shelf across from the bed. Staff Member #41 reported the fan and the moving air assisted some patients to fall asleep.

An observation within the closet of room #238 revealed to portable electric radiator heaters without PM stickers. Staff #41 reported the portable heaters were available for patients that felt the sleep study room was "too cold." Staff Member #41 acknowledged the portable fans and the portable heaters did not have PM stickers to verify their safe use in a patient care area.



32469


2. Observations were conducted in the Main Rehabilitation (Rehab) Area during the initial tour of the facility on 08/22/16 at approximately 1:40 p.m. The following observations were made:

One (1) of one (1) SCIFIT Pro 1000 machines did not show any evidence preventative maintenance was performed. Staff Member #17 confirmed the SCIFIT Pro 1000 is frequently used in the patient care area when it is needed.

Two (2) of two (2) SCIFIT ISO 100 machines did not show any evidence preventative maintenance was performed on the machines. Staff Member #17 confirmed the machines are frequently used in the patient care areas when it is needed.

One (1) of one (1) Concept 2 Row machines found in the Rehab area was due for preventative maintenance on 04/16 and was not performed. Staff Member #17 stated, "The Row machine was last inspected in April 2015 and was due April 2016 but it did not make it to the PM (Preventative Maintenance) list, but it will be added immediately."

Staff Member #17 was present during the findings on 08/22/16 at 2:35 p.m.

During an interview with Staff Member #17 on 08/23/16 at 12:50 p.m., he/she presented the surveyor with the manufacturer's guidance for the machines. The "Maintenance and Service" guidance for the SCIFIT Pro 1000 read in part, "The PRO2 and PRO1000 are virtually maintenance free. After training, always wipe down your Scifit exercise product. Perspiration that continuously settles on the frame, upholstery, casings, and control console may eventually cause rust or damage. Damage resulting from lack of maintenance in not covered under warranty. PRO2/PRO1000 Maintenance Schedule: Any mechanical or electrical work conducted within the main body of a medical CE class IIa unit MUST BE RECALIBRATED. The generic maintenance schedule below should be applied to medical CE and non-medical CE products. Component: Covers, Seat, Handlebars and Console; When: Daily; Component: Chains; When: Every 6 Months. Component: Base Roller Guide Track; When: Monthly......." The "Maintenance and Service" guidance for the SCIFIT ISO 100 read in part, "The PRO1 is virtually maintenance free. After training, always wipe down your Scifit exercise product. Perspiration that continuously settles on the frame, upholstery, casings, and control console may eventually cause rust or damage. Damage resulting from lack of maintenance in not covered under warranty. PRO1 Maintenance Schedule: Any mechanical or electrical work conducted within the main body of a medical CE class IIa unit MUST BE RECALIBRATED. The generic maintenance schedule below should be applied to medical CE and non-medical CE products. Component: Covers, Seat, Handlebars and Console; When: Daily; Component: Chains; When: Every 6 Months. Component: Base Roller Guide Track; When: Monthly......."

On 08/23/16 at 12:50 p.m. an interview was conducted with Staff Member #17. Staff Member #17 stated there are three (3) tiers to conducting PM. "Tier #1 is for life support equipment, Tier #2 is for monitoring equipment like blood pressure pumps, Tier #3 is for non-critical equipment like fitness equipment. Code #99 states Tier #3 products do not require (Name of third party contract vendor) to conduct a PM, but Valley Health chooses to perform PMs annually. The pieces of equipment in question should have had preventative maintenance performed but were not."

The surveyor held a discussion with the Administrative Team regarding the concern of preventative maintenance during the daily exit conference on 08/23/16 at approximately 5:45 p.m.



34756

3. During a tour of the facility on 3/22/2016 between 1:45 and 3:00 PM, the surveyor observed a vertical fan sitting in ICU (intensive care unit) room #3 which did not have a PM (preventative maintenance) sticker. Staff Member #5 was interviewed regarding PM of the fan and stated "they don't PM the fans; we use those fans for some people with COPD (chronic obstructive pulmonary disease) to help their breathing".

Findings were discussed on 8/20/2015 with Staff Members #1 and 3 between 4:00 PM and 4:30 PM.

Based on staff interview and facility document review, the facility staff failed to ensure there was written evidence of regular inspection and approval by State or local fire control agencies.

The findings included:

On 8/22/16 at approximately 12:45 p.m., the survey team met with the facility Administrative Staff (Staff Member #1 and 2 - Director of Quality and Vice President) during the entrance conference. At that time the surveyor requested the last written fire Marshall inspection report for the facility.

On 8/24/16 at approximately 4:00 p.m., Staff Members #10 and 11 had a discussion with the surveyor regarding the fire inspection. The surveyor was informed that there was "no written fire inspection" from the fire Marshall but the facility had recently "had the sprinkler system and fire panel inspected" due to the new renovation project. Staff #10 stated, "I toured with him (building life safety inspector) when he was here and I took notes and had to do a plan of correction, but I don't have any written report. It was all done by email. He did not give me an inspection report..."

No further information was provided by the end of the survey.

The Condition is not met due to the systematic nature of the condition level and standard level deficient practices related to the implementation of policies, procedures and practices regarding:

EMERGENCY SERVICES
485.618 0200 Condition of Participation
485.618(b) 0202 Equipment and Supplies

NUMBER OF BEDS AND LENGTH OF STAY
485.620(a) 0211 Number of Beds

PHYSICAL PLANT and ENVIRONMENT
485.623(b)(1) 0222 Maintenance
485.623(d)(4) 0234 Life Safety from Fire

ORGANIZATIONAL STRUCTURE
485.627 0240 Condition of Participation
485.627(a) 0241 Governing Body

PROVISION OF SERVICES
485.635 0270 Condition of Participation
485.635(a)(1) 0271 Patient Care Policies
485.635(a)(3)(i) 0273 Patient Care Policies
485.635(a)(3)(ii) 0274 Patient Care Policies
485.635(a)(3)(iv) 0276 Patient Care Policies
485.635(a)(3)(iii) 0278 Patient Care Policies
485.635(d)(3) 0297 Nursing Services
485.635(d)(4) 0298 Nursing Services

CLINICAL RECORDS
485.638(a)(4)(1) 0304 Record Systems
485.638(a)(4)(ii) 0306 Record Systems
485.638(a)(4)(iv) 0307 Record Systems
485.638(b)(1) 0308 Protection of Record Information

PERIODIC EVALUATION and QA Review
485.641 0330 Condition of Participation
485.641(b) 0336 Quality Assurance

SPECIAL REGULATIONS FOR CAH PROVIDERS OF LTC SERVICES
485.638(d)(2) 0379 Content of Transfer Discharge Notice

Based on staff interview and facility document review, the Governing Body failed to ensure that all facility protocols used for the care of patients were specific to the facility and the Governing Body failed to ensure the quality and services provided by the facility was monitored and implemented.



The findings included:

During an interview with Emergency Room Staff (ED) on 8/23/16 at 2:50 p.m., Staff Member #66 explained to the surveyors that they follow "protocols" for triage and care of patients. Staff Member #66 provided the surveyor with a binder which contained various protocols used by the staff in the ED. Staff Member #66 explained, "We can go by these protocols, and it gives us permission to be able to go ahead and start ordering labs and x-rays for certain conditions, like UTI (urinary tract infection) and abdominal pain."

Review of the protocol documents reveled the documents to not contain the name of the facility. There was a small area at the bottom of the document that had an "x" in the space beside the facility initials along with the initials of 5 (five) other facilities. The documents were signed as "approved" by the ED Medical Director and ED Manager, however there was no date as to when the documents were signed. The "Medical Staff Governing Documents" were reviewed and there was no documentation regarding the use of the protocols.

On 8/25/16 at 8:15 a.m. Staff Member #2 stated, "They develop these protocols as a collaborative, each facility adds what is specific to them. They have the initials of our facility on the bottom but that is all..."

During the survey numerous concerns and findings were discussed with facility administration regarding multiple areas. Staff #1 stated that the facility had just gone through a re-organization of the governing body (GB) and that it had been "taken away" from the individual facilities and "now was all under the "umbrella of Valley Health System". The surveyor reviewed GB minutes and although the facility was discussed separately from the other facilities, the concern remained regarding the multiple issues and deficiencies found by the survey team. The survey team identified areas that were not included in the Quality review for the facility and issues involving patient care and practices.

The concern was discussed with the facility Administrative team at the time of discovery on 8/25/16 and again at the exit conference on 8/26/16 ay 5:45 p.m.

Based on observation, staff interview and facility document review, the facility staff failed to ensure all necessary staff were trained on emergency care for the recognition and treatment of Malignant Hyperthermia in order to meet the needs of its inpatients and outpatients and that a policy and procedure was developed which included MH recognition, treatment and staff training.

During the validation survey conducted 8/22-8/26/16, the survey team identified that the emergency department (ED) and ICU (Intensive Care) staff had not received any training regarding the recognition, treatment, and monitoring of patients for the potential of Malignant Hyperthermia* (MH) with the use of succinylcholine (a paralytic agent used during intubation) nor the location and use of the MH cart. The facility also did not have a policy and procedure which addressed MH.

*Malignant Hyperthermia (MH) is a potentially fatal, inherited disorder usually associated with the administration of certain general anesthetics and/or the drug succinylcholine. The disorder is due to an acceleration of metabolism in skeletal muscle. The signs of MH include muscle rigidity, rapid heart rate, high body temperature, muscle breakdown and increased acid content. Immediate treatment with the drug dantrolene usually reverses the signs of MH. The underlying defect is abnormally increased levels of cell calcium in the skeletal muscle. There is mounting evidence that some patients will also develop MH with exercise and/or on exposure to hot environments. Without proper and prompt treatment with dantrolene sodium, mortality is extremely high. Succinylcholine is used for relaxing muscles during surgery or when using a breathing machine (ventilator). It is also used to induce anesthesia or when a tube must be inserted in the windpipe. Succinylcholine is a depolarizing muscle relaxant. It works by keeping muscles from contracting, which causes paralysis of the muscles in the face and those used to breathe and move. www.mhaus.org accessed 8/29/16 at 11:30 a.m.
Dantrolene is a drug used to treat episodes of severe high body temperature (malignant hyperthermia). It is also used to prevent or reduce the risk of malignant hyperthermia in certain patients before or after surgery or anesthesia. It may also be used for other conditions as determined by the doctor. Dantrolene is a muscle relaxant. It works by restoring a normal level of calcium in the muscles, which helps to prevent or reduce severe high body temperature. www.drugs.com/dantrolene/fda accessed 8/29/16 12:00 p.m.
The findings included:

On 8/23/16 at 2:25 p.m. during observations of the ED, the surveyor interviewed Staff Member #7 (A Registered Nurse), regarding the location of the MH cart. Staff Member #7 responded, "MH cart?" The surveyor again repeated, "Yes, where do you keep your MH cart?" Staff Member #7 responded, "Uh, mental heath cart?" The surveyor clarified the question, "No, the malignant hyperthermia cart." Staff Member #7 stated the cart was "kept in PACU (Post Anesthesia Recovery Unit)" and "We don't have a cart here in the ED, we can get the cart from PACU."

On 8/24/16 at 12:15 p.m.,the surveyor requested a list of all staff who work/float to the ED or ICU along with evidence of training for MH. The surveyor was provided a list of all staff who had received the training on 8/25/15, however the list did not contain any staff who were assigned/floated to the Emergency Department or the Intensive Care Unit. Staff Member #1 stated that none of the ED or ICU staff had received training.


On 8/25/16 at 4:00 p.m. the survey team requested to meet with the facility administration and at 4:10 p.m. made the facility Administration aware of the concerns related to the training of staff and recognition of MH.


Please refer to:
485.618- Emergency Services
485.618(b)- Equipment, Supplies, and Medications
485.635(a)(3)(ii) - Patient Care Policies and
485.635(d)(3) - Nursing Services for further information.

Based on clinical record review, staff interview, and facility document review, the facility staff failed to follow policy and procedures regarding patient rights and restraint use for 3 (three) of 3 (three) patients records that were reviewed for the use of restraints. Patient #17, #16 and #18.

Patient #17 was admitted to the facility after an intentional drug overdose and required intubation (a tube placed into the trachea [windpipe] to keep it open in order to maintain the patients ability to breathe. The use of intubation requires the patient be administered medications to sedate and paralyze the muscles in order for the patient to tolerate the use of the mechanical ventilator [breathing machine]. Merriam Webster's Medical Dictionary 2015 pages 370-371) The patient was kept sedated and intubated with no documentation of medical necessity until an Emergency Custody Order (ECO) was obtained.

Patient #16 was placed in restraints on 5/6/16 and the physician's order was not authenticated (signed) until 6/1/16.

Patient #18 was administered a combination of medications (Haldol, an antipsychotic, and Ativan an antianxiety medication) by injection on three (3) separate occasion on 6/5/16. The physicians orders did not contain justification for the use of these medications.

The findings included:

1. Patient #17 was admitted to the facility on 7/16/16 with the diagnosis of intentional overdose. The patient, according to emergency room documents dated 7/16/16, presented as "unresponsive. The patient was intubated in the Emergency Department and then admitted to the Intensive Care Unit (ICU).

Review of the clinical record for Patient #17 while in the ICU revealed the following under "Progress Notes": (in part)

7/17/16 7:45 a.m. Registered Nurse (Staff Member # 65) "Assumed care of pt. (patient. Pt is sedated but does move to painful stimuli but does not follow commands. Pt on *Propofol 40mcg (micrograms) increased to 50mcg as patient is moving legs and head...tolerating vent (ventilator) without a problem...(Name of physician) in to see pt. Informed him pts (patients) (family) requests pt stay sedated until a plan can be formed that keeps the pt here once he/she is extubated (breathing tube removed). (Family) concerned pt will leave AMA (against medical advice) once extubated. (Name of physician) requests (name of community services board) be contact(sic). Tech spoke to (name of community services board) who recommend (family) obtain ECO from police department. (name of physician notified). Bilateral wrist restraints intact..."

7/17/16 11:26 a.m. Registered Nurse (Staff Member #65) "Pt restless and moving about the bed. Propofol increased to 60mcg. Still planning to extubate pt. once ECO is obtained."

7/17/16 11:43 a.m. Registered Nurse (Staff Member #65) "Pt continues to be restless in bed. Propofol gtt (drip) increased to 70mcg. Spoke with (name) in pharmacy to see how high we can potentially go on Propofol."

7/17/16 11:56 a.m., Registered Nurse (Staff Member #65) "Received order for **Versed 1mg (milligram) q2hprn (every two hours as seeded/when necessary) for agitation/restlessness as Propofol is maxed out and pt continues to be restless in bed."

7/17/16 12:26 p.m. Registered Nurse (Staff Member #65) "Received order for Versed gtt (drip) Repeat 1mg Versed IVP (intravenous push) as one time dose while waiting for Versed gtt (drip) to be made. Per (Name of physician) keep pt sedated until police arrive with ECO. Police have called and said they are on their way with the ECO."

7/17/16 12:35 p.m. Registered Nurse (Staff Member #65) "Versed gtt started at 3mg (three milligrams)."

7/17/16 12:50 p.m. Registered Nurse (Staff Member #65) "(Name of police department) officer (name) here to ECO pt. Pt weaned to 70mcg Propofol and 2mg Versed. Preparing for extubation."

7/17/16 1:03 p.m. Registered Nurse (Staff Member #65) "Propofol to 60mcg, Versed to 1mg (one milligram). Pt attempts to open eyes slightly. Tears noted. Pt moving in bed."

7/17/16 1:50 p.m. Registered Nurse (Staff Member #65) "Propofol gtt to 20mcg Pt fighting vent and pulling restraints...RT (Respiratory Therapy)notified pt ready for extubation. Security and Police at bedside."

7/17/16 2:05 p.m. Registered Nurse (Staff Member #65) "Propofol gtt off and pt extubated...pt repeatedly saying "no".

7/17/16 4:50 p.m. Registered Nurse (Staff Member #65) "TDO (Temporary Detaining Order) executed by police."


A "Medicine Progress Note" dated 7/17/16 at 6:42 a.m., documented, in part: "...The patient was intubated for respiratory protection, placed on Propofol for sedation and admitted to ICU. Since admission to ICU, the patient has been stable...Assessment/Plan: "...We will delay extubation until discussing the case with (community services board). The patient may need an ECO to keep him/her in the hospital until he/she can be transferred to a psychiatric facility for treatment..."

On 8/26/16 at 8:15 a.m., the surveyor discussed the concerns that Patient #17 was chemically restrained until an Emergency Custody Order (ECO) was obtained. Staff #1 stated, "I will look at the chart..."

Review of the facility Policy and Procedure for "Patient Rights" revealed the following (in part): "...VII. Patient Safety: B. The patient has the right to be free from restraints of any form that are not medically necessary..."

The facility policy and procedure "Restraints" evidenced the following (in part):
A. Restraints will only be used when it can be clinically justified or when warranted by patient behavior that threatens the physical safety of the patient, staff, or others.
B. The patient has the right to be free fro restraints or restraints of any form that are not medically necessary.
C. The decision to use a restraints driven not by diagnosis, but by a comprehensive individual assessment that concluded at this time, the use of a less intrusive measure poses a greater risk then the risk of using a restraint.
D. Restraints are always the last resort in maintaining the plan of care....
...I. Restraints are not used as a means of coercion, discipline, convenience or staff retaliation...
Definitions:
...F. Chemical Violent restraint (use of medications): unanticipated use of a drug to control behavior or restrict the patient's freedom of movement and is not a preplanned, currently ordered or standard treatment for the patient's medical or psychiatric condition...
Physical and Chemical Violent Behavior Restraint Management:...

On 8/26/16 at 11:40 a.m. Staff Member #1 stated, "We have reviewed the chart and can see what you are saying..."


*Propofol is an intravenous sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation. Intravenous injection of a therapeutic dose of Propofol induces hypnosis with minimal excitation, usually within 40 seconds from the start of injection (the time for one arm-brain circulation). Use of Propofol injectable emulsion has been associated with both fatal and life-threatening anaphylactic and anaphylactoid reactions.
For general anesthesia or monitored anesthesia care (MAC) sedation, Propofol injectable emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. Sedated patients should be continuously monitored, and facilities for maintenance of a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available. Patients should be continuously monitored for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation.
For sedation of intubated, mechanically ventilated patients in the Intensive Care Unit (ICU), Propofol injectable emulsion should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management.
Use of Propofol injectable emulsion for both adult and pediatric ICU sedation has been associated with a constellation of metabolic derangements and organ system failures, referred to as Propofol Infusion Syndrome, that have resulted in death. The syndrome is characterized by severe metabolic acidosis, hyperkalemia, lipemia, rhabdomyolysis, hepatomegaly, renal failure, ECG changes and/or cardiac failure. www.drugs.com accessed 8/31/16 9:19 a.m.
**Midazolam, marketed under the trade names Versed among others, is a medication used for anesthesia, procedural sedation, trouble sleeping, and severe agitation. It works by making people sleepy, decreasing anxiety, and causing a loss of ability to create new memories. It is also useful for the treatment of seizures. Midazolam can be given by mouth, intravenously, by injection into a muscle, sprayed into the nose, or in the cheek. When given intravenously it begins working typically within five minutes, when injected into a muscle it can take fifteen minutes to begin working. Effects last for between one and six hours. www.drugs.com accessed 8/31/16 9:27 a.m.



21876


2. Review of Patient #16's electronic medical record (EMR) documented the 93 year old was placed in non-violent soft bilateral wrist restraints at 00:43 a.m. on 05/26/2016. Patient #16's EMR documented the wrist restraints were removed at 7:45 a.m. on 05/26/2016. Review of the electronic order for soft bilateral wrist restraints revealed the physician did not electronically sign the order until "06/01/2016."

An interview and review of Patient #16's EMR was conducted on 08/26/2016 at 11:57 a.m., with Staff Member #60. Staff Member #60 verified the physician order that placed Patient #16 in soft bilateral wrist restraints on 05/26/2016 had not been electronically signed by the physician until 06/01/2016. Staff Member #60 reviewed the scanned document but did not find a paper/downtime restraint order. Staff Member #60 reported the physician had signed the canceled order for the violent restraints but failed to sign the order for the non-violent restraints.

3. Review of Patient #18's EMR documented on 06/05/2016 the patient was administered Haldol (haloperidol) 2 mg (milligram) injection at 2:17 p.m. and Ativan 1 mg injection at 2:19 p.m. Patient #18's EMR documented on 06/05/2016 at 2:20 p.m. the patient was placed in bilateral soft wrist restraints. Patient #18 was administered Haldol 2 mg and Ativan 1 mg injections at 2:52 p.m. and Haldol 2 mg and Ativan 1 mg injections at 5:40 p.m. on 06/05/2016 prior to transfer to another facility. The medication orders to administer Haldol and Ativan did not document justification for the medication administration. Patient #18's EMR documented the patient was admitted to the emergency department related to altered mental status from a possible drug overdose. Review of Patient #18's medical history did not include the diagnosis of Schizophrenia. Patient #18's EMR did not include documentation that Haldol and Ativan were medications routinely prescribed to the patient.
An interview and review of Patient #18's EMR was conducted on 08/26/2016 at 10:07 a.m., with Staff Member #60. Staff Member #60 reviewed the orders for administrations of Haldol and Ativan and verified the orders did not have justification for their administration. Staff Member #60 stated, "[Patient #18's name] was coming down off the drugs [he/she] had used we were trying to control [his/her] behaviors. The Narcan drip was causing withdrawal symptoms; we didn't chart any of that." Staff Member #60 stated, "I cannot find a physician's order for the soft limb restraints."
The above information was shared with Staff Member #1 at approximately 1:15 p.m. on 08/26/2016. No other information was provided to the surveyor prior to exit on 08/26/2016.
[According to www.drugs.com "Haldol (haloperidol) is indicated for use in the treatment of schizophrenia. Haldol is an antipsychotic agent. Ativan is a benzodiazepine used to treat anxiety disorders or anxiety associated with depression. Naloxone, sold under the brand name Narcan among others, is a medication used to block the effects of opioids, especially in overdose."]

Based on observations, interviews and document review it was determined the facility staff failed to have documented agreements for services provided by outside vendors for sleep study lab, laboratory services, linen transport services and tele-psychiatry/polycom services. The polycom services involved 2 (two) of 2 (two) patients who received polycom services, Patient #'s 29 and 25.

The findings included:

1. On 08/25/2016 at approximately 8:10 a.m. the surveyors asked about the facility's listed services, which included sleep study. Staff Member #2 reported the service was a sister hospital service not a service performed by the facility. Staff Member #2 reported the staff members that conducted the sleep studies were not employees of the facility. Staff Member #2 stated, "We have two rooms here on the medical surgical unit, which are used by [Name of sister facility] staff to perform sleep studies for patient in this geographical area."

An initial tour of the facility's sleep lab rooms (#238 and #240) was conducted on 08/25/2016 at 8:20 a.m., with Staff Member #2. Observations and interviews were conducted on 08/25/2016 from 10:48 a.m. through approximately 11:42 a.m. with Staff Member #2 and Staff Member #41. Staff Member #41 reported he/she and his/her staff were employed by the facility's sister hospital and utilized two rooms within the facility to perform sleep studies. Staff Member #2 reported he/she had felt that the sleep study rooms were really a part of the services supplied by the sister facility and not really a part of his/her facility. Staff Member #2 reported that the two rooms had not been included in the facility's environment of care rounds. The surveyor requested a copy of the agreement between the two separately certified facilities.

An interview was conducted on 08/26/2016 at approximately 8:15 a.m., with Staff Member #1 and Staff Member #2. Staff Member #1 reported the facility did not have an agreement with their sister hospital to perform the sleep studies. Staff Member #1 stated, "We are all under [the Name of the Corporate Health System]. We did not think that we needed an agreement with other hospitals within our system."


32469


2. On 08/23/16 at 2:20 p.m. Staff Member #30 (Director of Laboratory Services) was interviewed regarding the facility's lab services including any contracts or agreements. Staff Member #30 confirmed the lab services offered at the facility. Staff Member #30 provided that the critical access hospital (CAH) has contracts with two (2) outside vendors (name of third party vendors) for lab tests. Staff Member #30 stated, "Our sister hospital (name of facility) provides the carrier service to transport labs and perform blood cultures and microplates." The surveyor requested to review the contracts and agreements.

On 08/23/16 at approximately 4:10 p.m., Staff Member #30 presented the surveyor the requested contracts for the two (2) outside vendors. Staff Member #30 confirmed the sister hospital (name of facility) provided services. Staff Member #30 stated, "We don't have a contract or agreement with our sister hospital (name of facility) because I didn't know we needed one." The surveyor asked Staff Member #30 if that facility had the same provider number as Shenandoah Memorial Hospital. Staff Member #30 stated, "No, they are different so I guess an agreement is needed."

On 08/23/16 during the daily update exit conference at 5:45 p.m., the surveyor discussed the concern regarding no evidence of an agreement for lab services with the Administrative Team.

3. An initial tour of the facility's two (2) outpatient rehabilitation (rehab) therapy departments, which are not located on the main grounds of the main campus, were conducted on 08/24/16 starting at 12:02 p.m. Staff Member #37 (Director of Rehabilitation Services) and Staff Member #38 (Rehabilitation Team Lead) were present with the survey team during each of the tours. An interview was conducted with Staff Member #37 regarding the facility's rehab services including any contracts or agreements. Staff Member #37 confirmed the rehab services offered at the two (2) facilities. Staff Member #37 provided that the outpatient rehab therapy departments have a "Shared Service" for transporting clean and soiled linen. At 1:35 p.m., the surveyor requested to review the agreement or contract for the "Shared Service."

On 08/24/16 at 4:55 p.m., Staff Member #37 confirmed the surveyor had reviewed the contract for the CAH's linen service (name of the contract linen vendor) and that the two (2) outpatient rehab departments were under this contract service with the outside vendor. The surveyor performed a focused review of the third party vendor contract for linen service to confirm the outpatient therapy service was included; however the contract did not include the two (2) outpatient rehab departments in the contract. Staff Member #37 stated, "We have a Shared Service, and I didn't know we needed an agreement because we don't have an agreement. We follow and implement the hospital's linen policy and procedure for all rehab services inpatient or outpatient."

The surveyor held a discussion with the Administrative Team regarding the concern of no agreements for laboratory or outpatient rehab services during the daily exit conference on 08/24/16 at approximately 5:15 p.m.

Surveyor: Stclair, Wendy

4. While reviewing the record of Patient #29, an observation patient, the surveyor asked for a copy of the policy and procedure for observation services. The surveyor was given a copy of the (facility's name) policy and procedure titled "Assessment, Initial Patient"; however it does not differentiate between an inpatient admission and an observation patient. On 8/23/16 between 1:10 PM and 2:30 PM, Staff Member #47 told the surveyor that "The observation patient policy is in the process of being written, but it is not finalized because staff working on the policy are attending a conference in California this week".
On 8/23/2016 at 5:40 PM Staff Member #1 stated "there is no policy and procedure specific for nursing inpatients and observation patients, they are treated the same, they get the same assessments and nursing care".

5. A review of Patient #25's record revealed that he/she had been admitted to the ED (emergency department) on 8/1/2016 due to suicidal ideations. A polycom with (name of facility) was conducted by BHS (behavioral health services) Staff #46, an RN (registered nurse) for intake assessment, and a determination was made to transfer the patient to their inpatient unit. The staff record review for Staff Member #46 lacked documentation of training which provided qualifications to perform behavioral health services evaluations for psych-polycom services. The surveyor asked for a copy of the policy and procedure for behavioral health intake assessment via polycom, and Staff Member # 1 stated "We don't have a policy and procedure for that" on 8/25/2016 at approximately 1:00 PM.

The findings were discussed with Staff Members #47 and 1 at the time of the findings, and again at the exit conference on 8/26/2016 with members of the Administrative Staff.



34756

Based on observation, staff interview and facility document review, the facility staff failed to ensure all necessary staff were trained on emergency care for the recognition and treatment of Malignant Hyperthermia in order to meet the needs of its inpatients and outpatients and that a policy and procedure was developed regarding MH.

During the validation survey conducted 8/22-8/26/16, the survey team identified that the emergency department (ED) and ICU (Intensive Care) staff had not received any training regarding the recognition, treatment, and monitoring of patients for the potential of Malignant Hyperthermia* (MH) with the use of succinylcholine (a paralytic agent used during intubation). The facility also did not have a policy and procedure which addressed MH.

*Malignant Hyperthermia (MH) is a potentially fatal, inherited disorder usually associated with the administration of certain general anesthetics and/or the drug succinylcholine. The disorder is due to an acceleration of metabolism in skeletal muscle. The signs of MH include muscle rigidity, rapid heart rate, high body temperature, muscle breakdown and increased acid content. Immediate treatment with the drug dantrolene usually reverses the signs of MH. The underlying defect is abnormally increased levels of cell calcium in the skeletal muscle. There is mounting evidence that some patients will also develop MH with exercise and/or on exposure to hot environments. Without proper and prompt treatment with dantrolene sodium, mortality is extremely high. Succinylcholine is used for relaxing muscles during surgery or when using a breathing machine (ventilator). It is also used to induce anesthesia or when a tube must be inserted in the windpipe. Succinylcholine is a depolarizing muscle relaxant. It works by keeping muscles from contracting, which causes paralysis of the muscles in the face and those used to breathe and move. www.mhaus.org accessed 8/29/16 at 11:30 a.m.
Dantrolene is a drug used to treat episodes of severe high body temperature (malignant hyperthermia). It is also used to prevent or reduce the risk of malignant hyperthermia in certain patients before or after surgery or anesthesia. It may also be used for other conditions as determined by the doctor. Dantrolene is a muscle relaxant. It works by restoring a normal level of calcium in the muscles, which helps to prevent or reduce severe high body temperature. www.drugs.com/dantrolene/fda accessed 8/29/16 12:00 p.m.
The findings included:

On 8/23/16 at 2:25 p.m. during observations of the ED, the surveyor interviewed Staff Member #7 (A Registered Nurse), regarding the location of the MH cart. Staff Member #7 responded, "MH cart?" The surveyor again repeated, "Yes, where do you keep your MH cart?" Staff Member #7 responded, "Uh, mental heath cart?" The surveyor clarified the question, "No, the malignant hyperthermia cart." Staff Member #7 stated the cart was "kept in PACU (Post Anesthesia Recovery Unit)" and "We don't have a cart here in the ED, we can get the cart from PACU."

On 8/24/16 at 12:15 p.m.,the surveyor requested a list of all staff who work/float to the ED or ICU along with evidence of training for MH. The surveyor requested the documentation again at the end of day meeting on 8/24/16 at 4:50 p.m. from Staff Member# 1 (Director of Quality) and Staff Member #2 (Vice President of Nursing)

On 8/25/16 at 1:55 p.m., Staff Member #1 provided the surveyor with a list of staff who had completed the MH training. The list contained the names of staff who were assigned to Surgical Services (OR) and PACU. No staff members were listed from wither the ED or ICU. Staff Member #1 stated, " None of the staff in ED or ICU have had the training."


On 8/25/16 at 4:00 p.m. the survey team requested to meet with the facility administration and at 4:10 p.m., Staff Members # 1, 2, and 9 (Administrator/President), were made aware of the concerns.

The concerns were again discussed with the facility Administration on 8/26/16 at 5:45 p.m..

Based on observations and staff interviews, the facility staff failed to ensure that someone with authorized access to a cart containing drugs was directly monitoring the cart, that medications for two patients were labeled with all necessary information, and that medications were administered to one patient in accordance with accepted professional principles of medication administration practices. This involved Patient #22 and #30.

Findings include:

1. While observing two medication passes with two different Staff Members between 10:00 AM and 10:30 AM on 8/25/2016, the surveyor watched Staff Member #44 prepare medications for Patient #22 by placing individually packaged medications into a medicine cup. The surveyor noted an unlabeled pre-filled syringe of Lovenox 30 mg lying on top of the WOW (work station on wheels) where Staff Member #44 was pouring the medications, and asked to whom the Lovenox belonged. Staff Member #44 stated "that belongs to (Patient's name) in (room #), I couldn't give it when I was in there, (Patient's name) had a lot of things going on this morning and was upset". Staff Member #44 then wrapped a piece of tape around the end of the syringe cap, wrote Patient #30's name on the tape.
Staff Member #44 walked away from the WOW where Patient #22's medications were sitting, and put the Lovenox into the locked medication drawer outside Patient #30's room, leaving the WOW unattended with medications lying on the top of the WOW unsecured.

At 10:30 AM, after placing the Lovenox in the drawer outside Patient #30's room,
Staff Member #44 returned to the WOW, picked up the medication cup, and entered Patient #22's room. Staff Member #44 did not wash or sanitize his/her hands when entering the room, walked to the bedside, placed the medications on the bedside table, verified the patient's name and date of birth, and began to talk with Patient #22 about the medications.
Patient #22 said "some of those pills are too big and I can't swallow them".
Staff Member #44 opened each pill from the packaging placing them into the medicine cup, then picked up several of the larger pills with ungloved hands,broke them without using a pill cutter, and handed them to Patient #22 to swallow. Staff Member #44 sanitized his/her hands when exiting room.

2. The facility policy titled "Administration of Medication" states in part "...XII. Pill Splitters/crushers/combination products A. When a medication is required to be split or crushed, a patient specific pill splitter/crusher/combination product will be acquired...".

3. The Virginia Department of Health Hand Hygiene fact sheet overview states in part the following: "Clean hands are the most important factor in preventing the spread of disease and antibiotic resistance in settings across the continuum of health care".
The fact sheet states that in the health care setting, hand hygiene should be performed "before putting on gloves, handling or administering medication, before contact with a patient/resident...", and after "... contact with a patient/resident and touching surfaces or objects in a patient or resident's room that may be contaminated (such as bed rails, door knobs, or bedside tables)".

The following was discussed with Staff Members #1 and 2 on 8/25/2015 at approximately 1:00 PM.


21876

4. An observation was conducted on 08/25/2016 at 4:23 p.m. on the medical/surgical unit. On entering the unit the surveyor found a 1 gm (gram) vial of Cefepime along with a 100 ml (milliliter) bag of 0.9% Sodium chloride. The medications were unattended on a desk counter outside of Room #206. The label was partially completed the patient name was filled in [it was later determined to be the name of Staff Member #44]. A staff member approached the surveyor and introduced his/herself. The surveyor asked if the medication belonged to the staff member. Staff Member #44 stated, "No, I am preparing the medication for a patient." The surveyor informed Staff Member #44 that his/her name had been placed as the patient on the medication label. Staff Member #44 stated, "That is an error I will make a new label." Staff Member #44 stated, "I only stepped away to answer a call light. I should have locked the medication up." Staff Member #44 agreed he/she had left the medication unattended on the counter.

Based on observation, staff interview and facility policy review, the facility staff failed to ensure proper infection control and sanitary practices were followed in the facility for the following:

The facility staff failed to ensure sanitary practices were maintained in the food service area regarding the storage of food items.

Failure to store endo- and colonoscopes according to manufacturer's directions to prevent the spread of infectious agents for seven (7) of seven (7) scopes and failure to store intubation equipment used in visually aided intubations in a manner to prevent contamination for one (1) of one (1) Endotracheal tube (ETT) stylet within the anesthesia cart.

Failure to maintain supplies and equipment in a manner to prevent contamination and the spread of infectious agents for two (2) of two (2) anesthesia carts available for observation.

Failure to maintain equipment and supplies in a manner to prevent the spread of infectious agents in one (1) of one (1) sleep lab.

Failure to perform hand hygiene between glove changes and to change personal protective equipment for two (2) of three (3) observations. (Staff Members #52 and #

Failure to ensure positioning devices and other equipment had intact surfaces to prevent the spread of infectious agents at three (3) of three (3) rehabilitation locations and ensure the rehabilitation equipment was cleaned/disinfected between patients and community individuals that utilized one (1) of one (1) rehabilitation areas used by the community.

Items improperly stored on the anesthesia carts to maintain cleanliness and keep free of potential contamination.

Improper ventilation and storage of soiled linen.

Improper use of surgical attire outside the Operating Room.

Improper barrier measures during renovation.

Failure to ensure that proper hand hygiene was used prior to administration of medication to one patient (Patient #22), and that supplies used for blood glucose collection were cleaned appropriately after use (Patient #32)

The findings included:

1. The facility kitchen and food storage areas were inspected on 8/24/16 at 8:20 a.m. Staff Member #62 (Food Service Manager) accompanied the surveyor on the tour and inspection. During the inspection the following was found:

In the dry storage area -
Walnut halves and pieces 32 ounce bag- open and dated 7/17/16 with a "use by" date of 8/17/16
Three bags of hamburger buns, whole wheat sandwich rolls (opened with five remaining) and 1/3 bag of wheat bread which were opened and not completely sealed.
A Plastic container labeled "Beets" which was dated as being opened on 7/26/16 and dated "use by" 7/26/16.
Teriyaki Soy sauce labeled as "prep" 7/19/16 and 8/19/16 "use by".
In the cooks cooler-
Cranberry sauce 6 (six) pound plastic container which had been opened and with approximately 1/3 remaining labeled "prep" 7/2/16 and "use by" 8/2/16
Large plastic container of Salsa (Thick and chunky pre-made) dated "prep" 7/19/16 and "use by" 8/19/16
Chili sauce "prep" 7/19/16 and "use by" 8/19/16
In the Chefs Cooler"-
3 (three) containers of Puree Bread labeled "prep" 8/17/16 and "use by" 8/23/16
Condensed package of Chicken Noodle soup (frozen) open with approximately 1/2 remaining dated "prep' 8/21/16 and "use by" 8/32/16.
Pillsbury Dough box biscuits dated 5/23/16 and "use by" 8/23/16
Also noted during the inspection of the dry storage area underneath the left rack of stored foods, was a large dead cockroach and debris. The surveyor requested the facility pest control plan. Staff Member #62 stated, "The storage area is swept and cleaned weekly, usually at the end of the week."
During the tour and inspection, items that were found out of date were removed by Staff Member #62.

On 8/24/16 at 4:50 p.m. the surveyor reviewed the findings with Staff Members #1, 2, 10, and #51.


21876


2. Failure to store endo- and colonoscopes according to manufacturer's directions to prevent the spread of infectious agents for seven (7) of seven (7) scopes and failure to store intubation equipment used in visually aided intubations in a manner to prevent contamination for one (1) of one (1) Endotracheal tube (ETT) stylet within the anesthesia cart.

Observations were conducted on 08/22/2016 from 3:15 p.m. through 3:46 p.m., with Staff Member #2 and Staff Member #18. An observation was conducted in the "Cleaning Room" for endo-and colonoscopes. Staff Member #2 opened the storage cabinet for scopes utilized during esophagogastroduodenoscopy and colonoscopy procedures. The cabinet contained seven (7) scopes and three (3) connection lines. The scopes were intermingled and touching each other, three (3) of the scopes were stored in a manner that the length of the scope's flexible end and the tube for transporting (air, water, or light) were positioned behind a metal hook. The observation revealed the three (3) connecting lines were draped over a hook and laying on the floor of the cabinet.

An interview was conducted on 08/22/2016 at 3:40 p.m., with Staff Member #18. Staff Member #18 stated, "The scopes should not be touching each other and the connector lines should not be lying on the floor." Staff Member #18 identified the scopes as four (4) scopes used during colonoscopies and three (3) scopes used for gastroscopes.

Observations and interviews were conducted on 08/24/2016 from 10:09 a.m. through 10:50 a.m., with Staff Member #52 in the endo-colonoscopy cleaning room. Staff Member #52 opened the scope storage cabinet to reveal three (3) scopes used for gastroscopy and two (2) scopes used for colonoscopy were each positioned behind a hook. The scopes were not allowed to hang freely to prevent the occurrence of contamination from moisture retention. Staff Member #52 reported he/she thought the scopes could be placed behind the hook in order to prevent the scopes from touching each other. Staff Member #52 acknowledged if moisture was retained in the scope the hook impeded the drying process.

During the observation Staff Member #52 pre-cleaned a colonoscopy scope in the procedure room. Staff Member #52 carried the scope within its disposable pouch into the cleaning room and placed pouch on the counter. Staff Member #52 pealed the red biohazard sticker from the contaminated pouch and placed the sticker on the counter. Staff Member #52 processed the scope and placed the scope in the automated endoscope reprocessing (AER) device. Staff Member #52 sprayed the counter with a disinfectant spray, but did not remove the contaminated sticker. Staff Member #52 reported the disinfectant needed to sit for five (5) minutes before wiping the counter. Staff Member #52 sprayed the sinks and other equipment used during the cleaning of the colonoscope. After five minutes Staff Member #52 wiped the counter allowing it to stay wet and air dry, but did not remove the contaminated sticker from the counter. Staff Member #52 continued his/her cleaning of the sinks. Staff Member #52 reported the room was disinfected and ready for the next scope. The surveyor pointed out the counter where the contaminated sticker had been placed had not been disinfected. Staff Member #52 stated, "I don't know why I put that there, should have just trashed it." Staff Member #52 attempted to peal the sticker from the counter leaving a paper residue from the sticker on the counter.

Interviews were conducted on 08/24/2016 at 4:55 p.m., with Staff Member #1, Staff Member #2, Staff Member #9, Staff Member #10, Staff Member #37, and Staff Member #51. The facility staff was informed of the findings and policies and procedures were requested. Staff Member #2, reported he/she was aware of the findings during the initial tour of the endoscope cleaning room.

Review of the facility's policy titled "Use and Reprocessing of Endoscopes" read in part "VII. Storage of Endoscopes A. Endoscopes are stored in a closed cabinet in a vertically hanging position with all components ... Endoscopes must not touch one another nor touch the bottom of he [Sic] storage cabinet ..."
Preventing Cross-Contamination in Endoscope Processing: FDA Safety Communication: "After reprocessing, store endoscopes in a manner that will minimize the likelihood of contamination or collection/retention of moisture."
[According to the definitions provided through www.medicinenet.com: "Esophagogastroduodenoscopy is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract up to the duodenum. Colonoscopy is a procedure that enables an examiner (usually a gastroenterologist) to evaluate the inside of the colon (large intestine or large bowel)."]
3. Failure to maintain supplies and equipment in a manner to prevent contamination and the spread of infectious agents for two (2) of two (2) anesthesia carts available for observation.
Observations and interviews were conducted on 08/22/2016 from 3:30 p.m., with Staff Member #2 in the "Procedure Room." The observation revealed the anesthesia cart suction apparatus with a line connected and oral suctioning tool attached. The package for the oral suctioning tool was opened. Staff Member #2 verified the observation. Staff Member #2 stated, "Anesthesia is aware they are not supposed to open the package." Staff Member #2 reported the packaging was for the protection and sterility of the oral suctioning tool. Staff Member #2 reported the opened package allowed for any contaminates in the room to potentially be on the oral suctioning tool. Staff Member #2 stated, "Once the package is open there is no way to ensure the [Name of the oral suctioning tool] is even clean." The surveyor requested the facility's policy. Staff Member #2 stated, "I doubt if we have a policy that says the package needs to remain closed."

Recommendation for opening package prior to use from the manufacturer: "Yankauers come sterile in the each packaging, so technically speaking, immediately upon opening, unless in a sterile field, there is a risk you could comprise its sterility. If that is of concern, I would just open up packaging immediately prior to use."

4. Failure to maintain equipment and supplies in a manner to prevent the spread of infectious agents in one (1) of one (1) sleep lab.

On 08/25/2016 at approximately 8:10 a.m. the surveyors asked about the facility's listed services provided, which included sleep study. Staff Member #2 reported the service was a sister hospital service not a service performed by the facility. Staff Member #2 during the discussion reported "sleep studies were performed at the facility by staff from [Name of the facility's sister hospital]."

An initial tour of the facility's sleep lab rooms (#238 and #240) was conducted on 08/25/2016 at 8:20 a.m., with Staff Member #2. Staff Member #2 explained related to the patients arriving at night, they register in the Emergency Department (ED). Staff Member #2 reported the sleep study staff meets the patients in the ED and escorts them to one of the sleep study rooms. The surveyors and Staff Member # 2 entered room #240; Staff Member #2 stated, "It appears that they may have had a patient last night. The bed is not made." On the counter across from the bed four (4) uncovered masks were lined up; there was no indication whether the mask were clean or used. The surveyor opened the bottom drawer next to the closet area. The drawer contained a "CPDA-1 Whole Blood- Volunteer Donor Bag" 450 ml (milliliter) with tubing attached; the bottom of the blood collection bag and the tubing had a golden yellow substance. In the drawer with the blood collection bag was a thermometer with a preventative maintenance sticker dated "2003", loose gauze, an opened yellowing package of 200 non-sterile gauze, four (4) 60 ml syringes, one (1) 12 ml syringe; twelve (12) red top blood collection tube with an expiration date of "12/2012" in a plastic bag, one (1) bottle of Lemon skin prep, which had expired in "05/2006" and one (1) bottle of Betadine that expired in "02/2007." Staff Member #2 stated, "I don't know why these things are in here. I know that some of the rooms were used during skills fair last year." Staff Member #2 verified the items found in the drawer were not marked as educational tools. The surveyor questioned if the mask on the counter across from the bed and the two (2) masks with nose pillows on the counter next to the bed were clean or used. Staff Member #2 reported he/she did not know. The surveyors requested assistance from someone that works in the sleep lab. The tour was stopped after observations in room #238 of multiple masks in a drawer. Staff Member #2 stated, "I will have [Name of Staff Member #41] come over to walk you through what happens in the sleep lab."

An interview was conducted on 08/25/2016 at 10:48 a.m., with Staff Member #2. Staff Member #2 stated, "The room used to be used by lab for therapeutic phlebotomy." The surveyor questioned the last time the room had been used by therapeutic phlebotomy. Staff Member #2 reported he/she would find out. Staff Member #2 reported the room was probably used because there was a bed. Staff Member #2 explained the patient would come in generally as an outpatient related to having "too much blood and the excess was drawn off in the donor bag and the donor bag was then discarded." Staff Member #2 stated, "There's no reason it (donor blood bag) should've been in that drawer."

Observations and interviews were conducted on 08/25/2016 from 10:48 a.m. through approximately 11:42 a.m. with Staff Member #2 and Staff Member #41. Staff Member #41 reported he/she and his/her staff were employed by the facility's sister hospital and utilized two rooms within the facility to perform sleep studies. The observation revealed environmental services had finished cleaning room #240 and were in the process of cleaning room #238. Observations were conducted in room #240 with Staff Member #2 and Staff Member #41. Staff Member #41 was not able to determine if the four (4) masks displayed on the counter across from the bed or the two (2) masks with nose pillows on the counter next to the bed were clean and set up for the next patient or just for display. The surveyor opened the drawer of a small plastic bin on the counter; the drawer held various size nose pillow adapters. Staff Member #41 reported the masks, nose pillows, and head gear [cloth straps with Velcro] were reusable. Staff Member #41 explained the masks, nose pillow adapters, and head gear were washed with soap and water between patients.

Observations and interviews were conducted in the second sleep study room (#238). The closet in the sleep study room contained a discolored greenish foam egg crate mattress. Staff Member #2 stated, "We have not been including these rooms on our environmental tour." Staff Member #2 reported that egg crate mattresses were not in use and "this one looks really old." Staff Member #41 stated, "That's not something that we would use." Both Staff Member #2 and Staff Member #41 verified the egg crate was available for use. Staff Member #2 verified that environmental services had cleaned the room. The surveyor found an opened box of facial tissues in a pink bin on a shelf near the bed. Staff Member #2 reported the pink bin and the opened box of facial tissues should have been discarded by the environmental services staff during the room cleaning. Within one of the drawers was a cuffed trach tube oral/nasal that expired in "2005-01."

The following items were stored non-packaged and unprotected from contaminates:
Room #240 had three (3) areas of storage for "reusable" head gear, "reusable" masks and "reusable" nose pillows: One (1) drawer in a small plastic container held ten (10) masks. In the dresser next to the bed the first drawer held four (4) masks, the second drawer held sixteen (16) masks, and the third drawer held two (2) masks and two (2) nose pillow systems. A four drawer plastic container from the top to bottom drawer held: three (3) full face masks, four (4) masks, one(1) mask mixed with multiple head gear straps, and six (6) nose pillow systems.

Room #238 had two (2) storage areas for "reusable" head gear, "reusable" masks and "reusable" nose pillows: Next to the bed the first drawer held six nose pillow systems, second drawer held twelve (12) nose masks and multiple head gear straps, third drawer held nine (9) masks and the fourth drawer held sixteen (16) masks and multiple head gear straps. The second area of storage was a four (4) drawer plastic container from top drawer to bottom held: five (5) nose pillow systems, twenty (20) masks and one (1) nose pillow system, one (1) mask with multiple head gear straps, and the bottom drawer held eighteen (18) masks.

Staff Member #41 walked the surveyors through the process he/she expected his/her staff to perform after a sleep study. Staff Member #41 explained the equipment used during the study would be collected in a pink bin and transported to the soiled utility area for cleaning. Staff Member #41 did not have a key for the cabinet in the soiled utility room where the "cleaning solution" was housed. Staff Member #41 reported the pink bin used for transport would be cleaned and the mask and other items would be transported to the clean utility room and allowed to air dry. The rack in the clean utility room was located by the door and exposed to traffic entering and leaving the utility room. The surveyor requested the facility's policy for cleaning and transporting of the reusable sleep lab equipment. A second request was made on 08/25/2016 at 2:54 p.m. for the facility's policy related to cleaning reusable sleep lab equipment. Staff Member #2 reported he/she would follow-up because Staff Member #41 had not sent the policy. A third request for the cleaning policy was made at 8:10 a.m. on 08/26/2016.

Review of the "User Guide" for the "Quattro Air full face mask" read in part: "Reprocessing the mask between patients: This mask should be reprocessed when used between patients. Cleaning, disinfection and sterilization instructions are available from [Name of the manufacturer and website address]."

On 08/26/2016 at 12:30 p.m. Staff Member #1 presented a corporate policy, non-specific to the facility titled "Cleaning and Disinfecting Reusable CPAP Masks and CAPAP Hoses" the policy read in part: Purpose: Appropriate procedures for disinfecting reusable masks and hoses that interface with the patient to prevent the spread of infections between patients. Policy: All patient -related, reusable mask and hoses will be cleaned after each patient uses [Sic] consistent with manufacturer recommendations. Procedure: 3. Soak mask in mix of hot water and cleaning solution (eg. Santimaster) for 10 minutes [Sic] ..." The surveyor informed Staff Member #1 that Staff Member #41 explained the cleaning process to include "soap and water," which was not part of the cleaning process described in the policy. The surveyor requested evidence the cleaning solution mentioned in the policy was in accord with the manufacturer's recommendations.

An interview was conducted on 08/26/2016 at 12:50 p.m., with Staff Member #1. Staff Member #1 presented the manufacturer's recommendations for disinfection of the mask, nose pillows and hoses. Staff Member #1 stated, "We have not been cleaning the sleep study equipment according to manufacturer's recommendations." Staff Member #1 acknowledged the manufacturer recommended high level thermal disinfection, high level chemical disinfection (with peracetic acid, orthophtalaldehye, or glutaraldehyde) or sterilization for the mask and nasal pillow systems listed. The surveyor inquired if the mask and nose pillows stored in the drawers within both sleep study rooms were items on the list. Staff #1 acknowledged it would be difficult to determine without a check for model names or numbers.

5. Failure to perform hand hygiene between glove changes and to change personal protective equipment.

Observations and interviews were conducted on 08/24/2016 from 10:09 a.m. through 10:50 a.m., with Staff Member #52 in the endo-colonoscopy cleaning room. During the observation Staff Member #52 pre-cleaned a colonoscopy scope in the procedure room then carried the scope within its disposable pouch into the cleaning room. Staff Member #52 changed gloves four (4) times during the cleaning process of the colonoscope. Staff Member #52 failed to perform hand hygiene between each glove change.

An interview was conducted on 08/24/2016 at 10:50 a.m., with Staff Member #52. The surveyor asked if it was the facility's policy to perform hand hygiene between glove changes. Staff Member #52 stated, "Yes, and I did not wash or use the sanitizer between changing my gloves."

Interviews were conducted on 08/24/2016 at 4:55 p.m., with Staff Member #1, Staff Member #2, Staff Member #9, Staff Member #10, Staff Member #37, and Staff Member #51. The facility staff was informed of the findings and policies and procedures were requested.

On 08/25/2016 at 8:15 a.m. Staff Member #2 presented the facility's policy titled "Hand Hygiene" the policy read in part: "B. Disinfect hands with either an alcohol-based hand sanitizer or soap and water ... 13. after [Sic] removing gloves ..."

6. Failure to ensure positioning devices and other equipment had intact surfaces to prevent the spread of infectious agents at three (3) of three (3) rehabilitation locations and ensure the rehabilitation equipment was cleaned/disinfected between patients and community individuals that utilized one (1) of one (1) rehabilitation areas used by the community:

Observations and interviews were conducted on 08/22/2016 from 1:55 p.m. to 2:55 p.m. at the facility's in-house rehabilitation area with Staff Member #2 and Staff Member #58. Staff Member #2 reported the facility's in-house rehabilitation area also served as a community fitness gym. Staff Member #2 reported the facility had two (2) off-campus locations to provide outpatient physical and occupational therapy. Staff Member #58 explained anyone in the community could utilize the rehabilitation equipment. The observation revealed two (2) porous foam noodles, one (1) 36 inch bolster with porous ends, one (1) balancing pad with a non-intact surface area of approximately 3.5 inches, and one (1) pull down therapy table with multiple tears on three (3) of its four (4) edges. Staff Member #58 verified the findings and acknowledged if the surface of a positioning device was porous or if the surface was not intact the item could not be disinfected between patients. The surveyor requested the facility's policy for cleaning equipment in the rehabilitation area.

An interview and observation was conducted on 08/23/2016 at 12:50 p.m., with Staff #17 within the in-house rehabilitation area regarding preventative maintenance. During the observation a community individual utilized the rehabilitation equipment. The observation did not reveal facility staff members in the area to oversee the use of equipment or to ensure the community individual cleaned the equipment after usage.

An interview was conducted on 08/24/2016 at approximately 11:47 a.m., with Staff Member #37. The surveyor inquired how the rehabilitation staff recognized whether equipment was clean prior to patient using the equipment. Staff Member #37 reported he/she would defer to the policy. A second request was made for the facility's policy related to cleaning/disinfection of equipment between patients. The surveyor shared the observation from 08/23/2016 of a community individual utilizing the rehabilitation equipment with no facility staff present. Staff Member #37 reported the facility staff did not oversee the rehabilitation area when community individuals utilized equipment. The surveyor asked how the rehabilitation staff ensured the preventing the spread of infectious agents. Staff Member #37 reported the community individuals were encouraged to use the "fitness wipe" after using a piece of equipment. Staff Member #37 acknowledged that without facility staff members present, the facility staff did not have knowledge whether a piece of rehabilitation equipment was cleaned and disinfected prior to a patient's use.

Observations and interviews were conducted on 08/24/2016 from 12:02 p.m. to 12:30 p.m., with Staff Member #37 and Staff Member #38 of the facility's outpatient physical therapy service location #1 (OPS #1). Staff Member #37 explained OPS #1 was utilized by outpatient physical and occupational therapy patients only. Staff Member #37 stated, "We do not have the staff here to incorporate the community as a fitness center." The observation revealed one (1) red bolster and one (1) gray) bolster used as positioning devices. Each bolster was enclosed in a vinyl pouch, the inside surface of the pouches were constructed of porous cloth. The exposed end of the bolsters was constructed of vinyl, but the sides of the bolsters consisted of porous cloth. Staff Member #37 acknowledged even if the bolster was placed in a pillow case between patients, the porous surface of the bolster and pouch did not allow for disinfection to prevent the spread of infectious agents. The observation revealed a crutch that no longer had a rubberized cover over the foam covering the top of the crutch. Staff Member #37 verified the crutch was available for use by multiple patients. Staff Member #37 acknowledged the top of the crutch had a porous non-intact surface , which could not be disinfected between patients.


Observations and interviews were conducted on 08/24/2016 from 1:10 p.m. through 1:42 p.m. with Staff Member #37 and Staff Member #38 of the facility's outpatient physical therapy service location #2 (OPS #2). Staff Member #37 explained OPS #2 was utilized by outpatient physical and occupational therapy patients only. The observation revealed a piece of equipment brand named "Total Gym." The surface of the pad across the bottom section was not intact. Staff Member #37 verified the findings and stated, "There is compromised integrity of the pad." Staff Member #37 reported it was the responsibility of the staff to notify him/her regarding the need to replace the pad of the item. Staff Member #37 stated, "This should not be in service. There should have been an orange tag placed to denote out of service." Staff Member #37 verified the "Total Gym" did not have an orange tag in place and was available for use. Staff Member #37 verified the piece of equipment could not be disinfected between patients.

Interviews were conducted on 08/24/2016 at 4:55 p.m., with Staff Member #1, Staff Member #2, Staff Member #9, Staff Member #10, Staff Member #37, and Staff Member #51. The facility staff was informed of the findings. A third request was made for the facility's policies and procedures related to cleaning and disinfecting rehabilitation equipment.

Review of the facility's policy was conducted on 08/25/2016 at 1:30 p.m. after the fourth request for the facility's policy related to cleaning equipment. The policy was titled "Equipment Cleaning & (and) Maintenance." The facility staff had highlighted "VIII. Cleaning Mats, Tables and Gym Equipment: E. Daily cleaning of all large department equipment will be documented on a cleaning log which is maintained [Sic] department for reference." However the policy read in part: "Purpose: ... To establish specific procedures for completing routine cleaning and maintenance of patient care areas and equipment [Sic] means of infection control and prevention in the Rehabilitation Departments. Statement of Policy and Procedure: I. Equipment used for patient care must be kept clean and in proper working condition ... IV. All medical equipment used for patient care must be cleaned and disinfected using an approved disinfectant [Sic] wipe before use on another patient; regardless or [Sic] isolation status ..."


32469


7 . The anesthesia/airway cart, which was located inside the OR (operating room), contained supplies commonly used by the person administering the anesthesia. Access to the cart was limited to only the pharmacist and the person administering the anesthesia (Staff Member #33).

Observation of the contents of the anesthesia/airway cart on 08/24/16 revealed a glide scope used for airway control in an open, clear plastic bag with a label attached that revealed "Clean by CS (Central Sterile) 8/13/16." The open storage bag was confirmed by Staff Member #18 (Director of Surgical Services) and Staff Member #33 (Anesthesiologist). Staff Member #33 stated, "This equipment is needed in case of an emergency situation and needs to be available and easily accessible." The surveyor requested to review the policy and procedure or standard of practice regarding storage of surgical equipment.

On 08/25/16 at approximately 8:15 a.m. Staff Member #1 (Director of Process Improvement) stated, "We don't have a policy related to storing blades in a plastic bag; however we do have a policy related to the cleaning process." Staff Member #1 presented the surveyor a policy titled "Cleaning Procedures" and it read in part the following: "PURPOSE: To state the guidelines for preventing cross-contamination of patients and personnel and for containing and confining organisms to prevent contamination of the OR Suite. These practices are established to control and reduce the possibility of cross-infection of the surgical patient and of personnel in the Operating Room. All surgical cases are to be considered potentially contaminated. STATEMENT OF PROCEDURE: III. Postoperative Procedure A. All items that come in contact with a patient and/or sterile field are considered contaminated and their disposition reflects appropriate contamination control measures. E. Soiled sponges, tapes, suction liners, suction tubing, bovies, and organic debris are placed appropriate bags for disposal as RMW. IV. OR Personnel and Environmental Services Responsibility B. Anesthesia equipment is cleaned and/or replaced after each case. D. Order of cleaning will be from top to bottom, wiping cleanest to dirtiest. Horizontal surfaces, including overhead lights and equipment used during the surgical procedure are cleaned with approved disinfectant solution between all cases. Pour a hospital-approved disinfectant onto surface, wipe, and allow drying. All items not required for the next case are wiped and removed from the room and returned to the appropriate location. The OR bed is cleaned with approved disinfectant solution. All surfaces must be exposed and cleaned after each case...."

Staff Member #1 also presented the surveyor a document titled "What's needed for reprocessing, storage of laryngoscope blades?" A review of this document revealed in part the following: "Laryngoscopes blades, non CSR (Central Sterile Reprocessing) reprocessing [sic]: Place the individual blade in a clear, plastic bag and return it to its clean storage location. Laryngoscopes reprocessed in CSR: After sterilization, CSR personnel will assure the blade has been reprocessed properly and then place the individual blade in a clear plastic bag and return it to its clean storage location."

On 08/25/16 at 8:20 a.m., the surveyor reviewed the documents presented to him/her and stated concerns to Staff Members #1 and Staff Member #2 (Vice President) regarding the policy and the best practice document did not show evidence the plastic bag used for storing the clean glide scope can be stored open.

[According to Centers for Disease Control and Prevention (CDC) sterile items and disposable (single-use) items should be stored in an enclosed storage area (e.g., cabinet or drawer). Supplies and instruments should not be stored under sinks or in other locations where they might become wet. Sterilized items should remain wrapped until they are needed for use.
Unwrapped items are susceptible to contamination. Avoid storing items loose in drawers or cabinets because unwrapped items cannot be kept sterile. Items stored in this manner are subject to contamination from dust, aerosols generated during treatment, and the hands of personnel who must handle them.]
[According to https://obpmedical.com/the-case-for-single-use-larygoscope-blades-and-handles- The CDC lists laryngoscope blades as semicritical items because they come in contact with mucous membranes. They require sterilization or disinfection after each use to reduce the risk of cross contamination. High-level disinfection eliminates all microorganisms except for some bacterial spores. The FDA defines

Based on observation, staff interview and facility document review, the facility staff failed to ensure all necessary staff were trained on emergency care for the recognition and treatment of Malignant Hyperthermia in order to meet the needs of its inpatients and outpatients. The facility did not have a policy and procedure developed which addressed the administration of the high-risk medication succinylcholine and the monitoring of patients who received this medication.

During the validation survey conducted 8/22-8/26/16, the survey team identified that the emergency department (ED) and ICU (Intensive Care) staff had not received any training nor had developed a policy and procedure regarding the recognition, treatment, and monitoring of patients for the potential of Malignant Hyperthermia* (MH) with the use of succinylcholine (a paralytic agent used during intubation).


*Malignant Hyperthermia (MH) is a potentially fatal, inherited disorder usually associated with the administration of certain general anesthetics and/or the drug succinylcholine. The disorder is due to an acceleration of metabolism in skeletal muscle. The signs of MH include muscle rigidity, rapid heart rate, high body temperature, muscle breakdown and increased acid content. Immediate treatment with the drug dantrolene usually reverses the signs of MH. The underlying defect is abnormally increased levels of cell calcium in the skeletal muscle. There is mounting evidence that some patients will also develop MH with exercise and/or on exposure to hot environments. Without proper and prompt treatment with dantrolene sodium, mortality is extremely high. Succinylcholine is used for relaxing muscles during surgery or when using a breathing machine (ventilator). It is also used to induce anesthesia or when a tube must be inserted in the windpipe. Succinylcholine is a depolarizing muscle relaxant. It works by keeping muscles from contracting, which causes paralysis of the muscles in the face and those used to breathe and move. www.mhaus.org accessed 8/29/16 at 11:30 a.m.
Dantrolene is a drug used to treat episodes of severe high body temperature (malignant hyperthermia). It is also used to prevent or reduce the risk of malignant hyperthermia in certain patients before or after surgery or anesthesia. It may also be used for other conditions as determined by the doctor. Dantrolene is a muscle relaxant. It works by restoring a normal level of calcium in the muscles, which helps to prevent or reduce severe high body temperature. www.drugs.com/dantrolene/fda accessed 8/29/16 12:00 p.m.
The findings included:

On 8/23/16 at 2:25 p.m. during observations of the ED, the surveyor interviewed Staff Member #7 (A Registered Nurse), regarding the location of the MH cart. Staff Member #7 responded, "MH cart?" The surveyor again repeated, "Yes, where do you keep your MH cart?" Staff Member #7 responded, "Uh, mental heath cart?" The surveyor clarified the question, "No, the malignant hyperthermia cart." Staff Member #7 stated the cart was "kept in PACU (Post Anesthesia Recovery Unit)" and "We don't have a cart here in the ED, we can get the cart from PACU."

On 8/24/16 at 12:15 p.m.,the surveyor requested a list of all staff who work/float to the ED or ICU along with evidence of training for MH. The surveyor requested the documentation again at the end of day meeting on 8/24/16 at 4:50 p.m. from Staff Member# 1 (Director of Quality) and Staff Member #2 (Vice President of Nursing)

On 8/25/16 at 1:55 p.m., Staff Member #1 provided the surveyor with a list of staff who had completed the MH training. The list contained the names of staff who were assigned to Surgical Services (OR) and PACU. No staff members were listed from wither the ED or ICU. Staff Member #1 stated, " None of the staff in ED or ICU have had the training."

On 8/25/16 at 4:00 p.m. the survey team requested to meet with the facility administration and at 4:10 p.m., Staff Members # 1, 2, and 9 (Administrator/President), were made aware of the findings and concerns.

The concerns were again discussed with the facility Administration on 8/26/16 at 5:45 p.m.

Based on record review and staff interview, the facility staff failed to ensure that the care plan for one patient (Patient #14) of 18 (eighteen) in-patient's whose care plans were reviewed, included information based on the patient's ongoing assessment, nursing care needs.

Findings include:

1. A review of the medical record for Patient #14, admitted 4/18/2016 due to diabetic foot ulcers, revealed that the care plan lacked documentation of individualized wound care/management.
The surveyor noted that a physician order for "PT evaluate and treat wound care on bottom of left foot" was entered at 10:55 AM on 4/19/2016. A physical therapy wound evaluation note dated 4/19/2016 between 11:45 AM and 12:20 PM included a note regarding the wound treatment and dressing provided during that visit. Wound care treatment information and plan was not documented on the care plan under interventions for the problem "damaged tissue is healing and protected", which said only "...3) if compromised provide wound care per wound care algorithm, and 11) Consult/collaborate with wound care nurse".
Staff Member #45, an RN (registered nurse) was interviewed on 8/25/16 at approximately 11:30 AM regarding wound care orders, and he/she stated "Usually therapy puts in what treatment they have done, they put it under their notes, they don't write an order. Sometimes the doctor will disagree with PT (physical therapy) and the doctor will write his/her own order and change the dressing that PT has been doing. Nurses don't do dressing changes, physical therapy changes the dressings because the therapist is a wound care specialist".
Staff Member #37, the Director of Rehabilitation Services, was interviewed on 8/26/16 at 11:45 AM who told the surveyor "wound care therapy would be evaluated by PT if the doctor ordered for PT to evaluate and treat, there would not be an MD order for wound care. The physical therapist is a PhD and can write the wound care orders, but the therapist should write on the care plan".

These findings were discussed with Staff Members #1 and 3 on 8/25/16 in the afternoon.

Based on clinical record review and staff interview, the facility staff failed to ensure consent documents were completed for Patient # 3 and #15

Patient #3 had a two consents for procedures which were not completed.

Patient #15 had one consent document which was not completed.

The findings included:

Patient #3 was admitted on 8/17/16. Included in the patient's clinical record was a document "Consent to Operation or Procedure". This document evidenced: 1. I authorize the performance upon (name of patient) of the following operation or procedure (Nature and Extent/Circle Left or Right when appropriate). The area to document the procedure was blank. 2. I acknowledge my physician has discussed, as appropriate, my health status, diagnosis, prognosis, a description of the proposed operation or procedure, the potential risks and benefits of the procedure, problems related to recovery, the likelihood of success, the potential results of no treatment, and any significant alternative to treatment including any associated risks and benefits of alternative treatments. I understand the risks and unplanned outcomes could include, but not be limited to: this area was blank on the document. On the signature page of this document there was no signature in the space designated for "Signature of Perioperative Nurse Reviewing questions #9-#12."

Another document in the clinical record for Patient #3 was a "Consent to: Transesophageal Echocardiogram" On the signature page of this document there was a section which read; "I hereby certify that I have discussed and explained the facts, risks, the risks associated with the alternatives of the procedure (s) described in this Consent to Operation or Procedure form with the individual granting consent". The area designated "signature of physician" and "date and time" was blank.

The findings were discussed with Staff Member #1 and 2 on 8/24/16 at 4:50 p.m. Staff Member #1 stated the documents should have been completed.

Based on clinical record review and staff interview, the facility staff failed to ensure the clinical record contained information necessary for the treatment of the patient. Patient # 15.

Patient #15 had a surgical procedure for which there was no post-operative diagnosis documented on the operative note.

The findings included:

Patient #15 was admitted to the facility on 3/26/16 and underwent a surgical procedure (Laproscopic cholecystectomy) on 3/30/16. Review of the "Operative Report" dated 3/30/16 at 12:15 p.m., revealed no documentation of a "Postoperative Diagnosis". In the section for the diagnosis was "*no post-op diagnosis entered*".

The surveyor discussed the findings on 8/24/16 at 4:50 p.m.

No further information was provided by the end of the survey.

Based on interview and document review it was determined the facility staff failed to ensure the physician signed the consent for the administration of blood and blood products for one (1) of three (3) blood transfused patients included in the survey sample. (Patient #7)

The findings included:


Observation and review of the blood bank logs was conducted on 08/23/2016 and three (3) names were selected for the patient sample and medical record review.

A review of Patient #7's electronic medical record (EMR) was conducted on 08/25/2016 with the assistance of Staff Member #4. Review of Patient #7's EMR documented the patient received blood transfusions at the facility on 06/01/2016, 06/02/2016, 06/17/2016 and 07/06/2016. Three of Patient #7's blood transfusions (06/01/2016, 06/17/2016 and 07/06/2016) were performed as an "outpatient" through the facility's ambulatory surgery unit (ASU).

Review of Patient #7's "Consent for the Administration of Blood and Blood Products" revealed the consent for "06/17/16" had not been signed by the physician. The physician's signature line documented the consent was a verbal order. The same consent dated "06/17/16" without an authentication by the physician or his/her appointed licensed independent practitioner (LIP) was utilized a second time to administer Patient #7's blood transfusion on 07/06 2016.

Staff Member #4 reviewed Patient #7's EMR for scanned documents and electronic physician's notations for additional documentation related to the authentication by the physician or LIP. Staff Member #4 could not find a physician or LIP authentication for the "06/17/16" "Consent for the Administration of Blood and Blood Products." Staff Member #4 verified the facility had used a consent to administer blood based on a verbal order by the physician's LIP, which had failed to be authenticated after nineteen (19) days after the original date of "06/17/16."

The surveyor requested the facility's policy for verbal orders or verbal authorization by physicians or their LIP.

Review of the facility's policy titled "Telephone and Verbal Orders" read in part: "C. Verbal orders are authenticated as soon as possible after giving the verbal order or telephone [Sic] and in accordance with Virginia State law within 72 hours of giving the order by the prescriber or his/her licensed associate/partner [Sic]."

The above information was shared with Staff Member #1 at approximately 1:15 p.m. on 08/26/2016. No other information was provided to the surveyor prior to exit on 08/26/2016.

Based on observation, staff interview and facility document review, the facility staff failed to ensure the confidentiality of patient information for 2 (two) of 4 (four) psychiatric patients (Patient 3 12 and 17) who were transferred to another facility and 1 (one) of 1 (one) patients (Patient #35) who received out patient stress testing.

Patient # 12 and 17 were transferred to another facility for inpatient treatment. When reviewing the clinical record the surveyor and Registered Nurse Navigator was able to access patient information and notes from the other facility. This documentation was commingled in the clinical record and was not immediately identifiable as being notes from the other facility.

Patient #35's demographic and diagnosis information was left on a counter in the stress test area and the door to the area was not secured.

The findings included:

1. During the clinical record review for Patient #12 and #17, the surveyor had the assistance of a Registered Nurse (Staff Member # 45) in order to navigate the electronic medical records. During the review of the medical records, the surveyor requested to view the progress notes documentation of each of the patients. When Staff Member #45 navigated to the progress notes section, the notes were revealed in chronological order for the date and time written by staff caring for the patient (Physicians, Therapist, Registered Nurse, Respiratory Therapy ect). Upon review of the progress notes, the surveyor and Staff Member #45 were able to access and read the notes from the patient's admission to another "sister" facility after they had been transferred to that facility for a higher level of care. The surveyor and Staff Member #65 were able to read the inpatient behavioral health documentation for these patients.

The surveyor interviewed Staff Member #65 on 8/24/16 at 10:00 a.m. regarding the ability to view the notes from the other facility. Staff Member #65 stated, They have the same medical records system that we do and it is all in the one chart under the patient's record number, so that is why we can see it, I think..."

On 8/24/16 at 4:50 p.m., the surveyor requested the facility policy and procedure or confidentiality of patient records within the electronic medical records system and discussed the observations with Staff Members #1, and 2.

On 8/26/16 at 8:40 a.m., Staff Member #2 stated, "The staff are educated on confidentiality and there is a system where you must "break the glass" in order to see the record..." The surveyor inquired as to why there was no indication of this "breaking the glass" evident when the records were reviewed by the surveyor and the Staff Member #65. Staff Member #2 stated, "We know when staff go into records unauthorized, and randomly audit this... We share the electronic record system with (name of sister facility) so we and they have access to our charts and us theirs. This is common throughout our system. Anyone who has this (electronic system) can access the patient information..." At that time, the surveyor expressed concern that the information for patients could be seen at another facility (after discharge from this facility) without prior authorization or notification that the record for another facility was being viewed. Staff Member #2 stated, "We need a bigger power to fix that..."

2. During a tour of the area defined as the "Stress Test" area, on 8/25/16 at 5:10 p.m., the surveyor entered a treatment room which was unlocked. The surveyor observed a document lying on the counter which was the demographic and patient information for Patient #35, who was scheduled for a stress test. The document contained the patient name, address, date of birth, phone number, diagnosis, and insurance information along with emergency contact information.

On 8/26/16 at 8:00 a.m., the surveyor discussed the concern of patient information which was accessible in an unsecured area with Staff Member #1, 2, and 7.

Review of facility policy "Information System Activity Audit Policy" revealed, in part: "...Valley Health is committed to conducting regular and periodic internal system reviews and audits of records to minimize security violations to electronic protected health information (EPHI)...2. Inappropriate access is defined as any access by a user that was not necessary to perform their job duties as needed for treatment, billing or healthcare operations....7. Random audits will be conducted on no less than 45 patient's records selected using the following guidelines: 15 from (initials of another facility), 5 from (initials of another facility), 5 from (initials of Shenandoah Memorial Hospital), 5 from (initials of another facility), 5 from (initials of another facility), 5 from (initials of another facility), and 5 from (initials of another facility)..."

The CONDITION IS NOT MET as evidenced by: Based on the systematic nature of the standard level deficient practices related to the implementation of policies and procedures and multiple findings of patient care practices during the validation survey, it was determined the facility's staff failed to meet the Condition of Participation for Periodic Evaluation and Quality Assurance Review as evidenced regarding the Conditions of Participation as cited in:

485.618 - Emergency Services
485.627 - Organizational Structure
485.635 - Provision of Services


During the validation survey conducted 08/22/16 through 08/26/16, the survey team identified multiple areas of deficient practice throughout the facility areas and Condition of Participation Requirements.

A review of the facility's policies titled, "Surgical Attire" and "Cleaning Procedures" were reviewed on 08/25/16 and 08/26/16. The policy "Surgical Attire" read in part, "PURPOSE: To define the attire to be worn by anyone entering the semi-restricted and restricted areas of the Operating Room (OR). PROCEDURE: II. Shoes D. Shoe covers can be worn to protect shoes from soiling with body fluids, and should be changed daily. Wash hands after donning and removing shoe covers. III. Head Covering B. Use a clean cap daily...." The policy "Cleaning Procedures" read in part, "PURPOSE: To state the guidelines for preventing cross-contamination of patients and personnel and for containing and confining organisms to prevent contamination of the OR Suite. These practices are established to control and reduce the possibility of cross-infection of the surgical patient and of personnel in the Operating Room. All surgical cases are to be considered potentially contaminated. STATEMENT OF PROCEDURE: III. Postoperative Procedure A. All items that come in contact with a patient and/or sterile field are considered contaminated and their disposition reflects appropriate contamination control measures. E. Soiled sponges, tapes, suction liners, suction tubing, bovies, and organic debris are placed appropriate bags for disposal as RMW. IV. OR Personnel and Environmental Services Responsibility B. Anesthesia equipment is cleaned and/or replaced after each case. D. Order of cleaning will be from top to bottom, wiping cleanest to dirtiest. Horizontal surfaces, including overhead lights and equipment used during the surgical procedure are cleaned with approved disinfectant solution between all cases. Pour a hospital-approved disinfectant onto surface, wipe, and allow drying. All items not required for the next case are wiped and removed from the room and returned to the appropriate location. The OR bed is cleaned with approved disinfectant solution. All surfaces must be exposed and cleaned after each case...."

On 08/26/16 at 9:30 a.m., Staff Member #1 (Director of Process Improvement) was interviewed regarding Surgical Services and the standard of practice implemented from a nationally recognized organization and confirmed the service was being reviewed by the Quality Program. Staff Member #1 stated he/she had confirmed with Staff Member #18 (Director of Surgical Services) regarding the standard of practice utilized in Surgical Services. Staff Member #18 confirmed the policies and procedures reflect the standard of practice by a nationally recognized organization; however the policies and procedures fail to show which nationally recognized organization is being implemented and practiced. Staff Member #1 reported new policies and procedures are being reviewed and the appropriate standard of practice implemented in Surgical Services was being evaluated and going through the appropriate approval process. The organization producing the standards of practice that is being implemented at the facility would be added immediately to the policies.

The surveyor inquired as to the responsibilities of the departments in maintaining their own quality program for each department and how they were overseeing and reporting to the Quality Committee and the Governing Body. Staff #1 stated, "Each department is involved in a daily safety call to report safety issues which is reported to QAPI as well as the Quality Committee monthly meetings in which each department is responsible for reporting on an assigned reporting schedule."

On 08/26/16 at 11:00 a.m., the surveyor discussed the multiple concerns regarding the survey findings with Staff Member #1 and Staff Member #2 (Vice President).

Based on staff interview and document review the quality committee failed to ensure an effective Quality Assurance Program was in place to evaluate the adequacy and appropriateness of services provided by the facility's Surgical and Sleep Therapy services.


The findings included:

1. During the validation survey conducted 08/22/16 through 08/26/16, the survey team identified multiple areas of deficient practice throughout the facility areas and Condition of Participation Requirements.

A review of the facility's policies titled, "Surgical Attire" and "Cleaning Procedures" were reviewed on 08/25/16 and 08/26/16. The policy "Surgical Attire" read in part, "PURPOSE: To define the attire to be worn by anyone entering the semi-restricted and restricted areas of the Operating Room (OR). PROCEDURE: II. Shoes D. Shoe covers can be worn to protect shoes from soiling with body fluids, and should be changed daily. Wash hands after donning and removing shoe covers. III. Head Covering B. Use a clean cap daily...." The policy "Cleaning Procedures" read in part, "PURPOSE: To state the guidelines for preventing cross-contamination of patients and personnel and for containing and confining organisms to prevent contamination of the OR Suite. These practices are established to control and reduce the possibility of cross-infection of the surgical patient and of personnel in the Operating Room. All surgical cases are to be considered potentially contaminated. STATEMENT OF PROCEDURE: III. Postoperative Procedure A. All items that come in contact with a patient and/or sterile field are considered contaminated and their disposition reflects appropriate contamination control measures. E. Soiled sponges, tapes, suction liners, suction tubing, bovies, and organic debris are placed appropriate bags for disposal as RMW. IV. OR Personnel and Environmental Services Responsibility B. Anesthesia equipment is cleaned and/or replaced after each case. D. Order of cleaning will be from top to bottom, wiping cleanest to dirtiest. Horizontal surfaces, including overhead lights and equipment used during the surgical procedure are cleaned with approved disinfectant solution between all cases. Pour a hospital-approved disinfectant onto surface, wipe, and allow drying. All items not required for the next case are wiped and removed from the room and returned to the appropriate location. The OR bed is cleaned with approved disinfectant solution. All surfaces must be exposed and cleaned after each case...."

On 08/26/16 at 9:30 a.m., Staff Member #1 (Director of Process Improvement) was interviewed regarding Surgical Services and the standard of practice implemented from a nationally recognized organization and confirmed the service was being reviewed by the Quality Program. Staff Member #1 stated he/she had confirmed with Staff Member #18 (Director of Surgical Services) regarding the standard of practice utilized in Surgical Services. Staff Member #18 confirmed the policies and procedures reflect the standard of practice by a nationally recognized organization; however the policies and procedures fail to show which nationally recognized organization is being implemented and practiced. Staff Member #1 reported new policies and procedures are being reviewed and the appropriate standard of practice implemented in Surgical Services was being evaluated and going through the appropriate approval process. The organization producing the standards of practice that is being implemented at the facility would be added immediately to the policies.

The surveyor inquired as to the responsibilities of the departments in maintaining their own quality program for each department and how they were overseeing and reporting to the Quality Committee and the Governing Body. Staff #1 stated, "Each department is involved in a daily safety call to report safety issues which is reported to QAPI as well as the Quality Committee monthly meetings in which each department is responsible for reporting on an assigned reporting schedule."

On 08/26/16 at 11:00 a.m., the surveyor discussed the multiple concerns regarding the survey findings with Staff Member #1 and Staff Member #2 (Vice President).


2. An interview and review of the facility's quality program documents were conducted on 08/25/16 at 2:00 p.m. and 08/26/16 at 9:15 a.m. with Staff Member #1 (Director of Process Improvement). Staff Member #1 and the surveyor reviewed the facility's quality program documentation. The facility's documentation did not include the ongoing monitoring, data collection or data analysis to measure improvements to quality on a continuous basis for the Sleep Therapy service provided. Staff Member #1 reported the quality committee had not collected or evaluated data for the Sleep Therapy program. He/she felt that was their sister hospital's (Name of Hospital) program and the staff from that facility just utilized the two (2) rooms allotted to provide the service.

An interview was conducted with Staff Member #2 (Vice President) on 08/25/16 at approximately 8:10 a.m. regarding if Sleep Therapy was a service offered by the facility. Staff Member #2 confirmed that "Yes it is a service and we do have a budget for it."

During an interview conducted on 08/26/16 at approximately 11:00 a.m., the surveyor inquired if Staff Member #1 and Staff Member #2 had any further evidence to provide to the survey team related to effective quality assurance related to the Sleep Therapy service. Staff Member #1 denied awareness of including the service provided under agreement. Staff Member #1 reported the quality committee had not collected, analyzed, or trended data for the required areas to identify unacceptable or unexpected outcomes.

On 08/26/16 at 11:20 a.m., the surveyor discussed the multiple concerns regarding the survey findings with Staff Member #1 and Staff Member #2.

Based on clinical record review and staff interview, the facility staff failed to ensure each patient received written notification/information of their rights concerning Medicare Covered services and the right to appeal (Important Message from Medicare) for 2 (two) of 2 (two) patients who were admitted to the "transitional Care Unit". Patient's # 3 and #15.

Patient #3 and #15 were admitted to the "Transitional Care Unit" (swing bed) of the facility and neither patient received the "Important Message from Medicare" concerning their rights.

The findings included:

During the clinical record review for Patient #3 (admission date 8/17/16) and Patient #15 (admission date 3/26/16), the surveyor was unable to locate any documentation that the patients has received the Important Message from Medicare concerning their rights and the ability to appeal discharge.

On 8/24/16 at 4:50 p.m., the surveyor requested further assistance in locating this information from Staff Member #1 and #2.

On 8/25/16 at approximately 9:20 a.m., Staff Member #1 and #47 explained to the surveyor that "no patient who is admitted to transitional care (swing bed) gets the Important Message, because they are not going to a higher level of care, they are going to a lower level of care, so we don't have to give them one..."

No further information was provided by the end of the survey.