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Based on a tour of the facility, observation, documentation review and staff interviews, the facility failed to maintain an effective system to prevent and control the transmission of infections. Widespread infection control issues were identified throughout the facility.


These system failures placed all patients at risk for the development of serious, possibly life-threatening health-care associated infections. Evidence of these systemic problems were demonstrated by the facility's failure to:

* provide a sanitary environment

* promptly initiate isolation precautions on a patient positive with a multi-drug resistant organism

* ensure all employees wore appropriate personal protective equipment when providing care

* for patients with multi-drug resistant organisms

* appropriately clean scopes and ensure all staff who cleaned scopes were appropriately trained

* ensure contract wound vac services provider was appropriately cleaning and maintaining equipment

* ensure wound care nursing was provided in an appropriate manner


Cross refer Standard 482.12(e)(1): Contract Services.
Cross refer Standard 482.42(a): Infection Control Officer(s).
Cross refer Standard 482.42(a)(1): Infection Control Program

Based on a tour of the facility, review of documentation and staff interviews, the governing body failed to ensure the services performed under contract were provided in a safe and effective manner. There was no oversight of how contract wound V.A.C. (vacuum assisted closure) therapy units were cleaned or of how contract ice machines were maintained and cleaned.

Findings were:


In an interview with the facility chief executive officer and chief nursing officer (CNO) on the afternoon of 8/31/15, in the facility meeting room, they stated the facility had a contract with KCI, a company providing wound vac equipment and services. When a copy of the contract was requested, the facility was unable to provide documentation of such a contract.


Though the facility had become aware of concerns regarding the cleaning of KCI's equipment through a community-wide outbreak of Acinetobacter baumannii, and resultant discussion of problems at a meeting of local healthcare facilities, there was no follow-up on the cleaning issue and the facility continued to use KCI services and equipment.


In an interview with Staff #1, the facility CNO, on the afternoon of 8/31/15, in the facility meeting room, she said that the facility had been involved in a community-wide outbreak and discussion of Acinetobacter baumannii (MDR-A) in Amarillo. She stated, "We had a meeting with a state epidemiologist on June 1st. It was at another health care facility in Amarillo. Quality management people from the area attended. We discussed the lack of adequate cleaning of KCI wound vacs. I shared information from the meeting with my representative from KCI and hospital staff and we had an in-service on it. I spoke to the KCI rep and he said he thought the wound vacs were appropriately cleaned. That was a phone conversation with the KCI manager back in June...We now have a new contract with a new wound vac company...It's not in effect yet. We're still using KCI...I can't say we tried to tell whether they were cleaning the wound vacs correctly." She stated they hadn't observed KCI's cleaning process or researched the issue any further.

In an interview with Staff #3, Wound Nurse, on the morning of 9/1/15, in the facility meeting room, she stated, "Our equipment policy doesn't mention wound vacs...I believe KCI comes in a van with a dirty side and a clean side. [The vac] is wiped off on the dirty side and then moved to the clean side. I think they use Caviwipes." When asked about whether Caviwipes clean C. diff., she stated she didn't think so. "It was appropriate enough for the Acinetobactor though, I think... "


In an interview with Staff #4, Infection Control Coordinator, on the morning of 9/1/15, in the facility meeting room, she was asked if she had followed up after the area-wide meeting regarding Acinetobacter baumannii with KCI to find out what the company's cleaning process was, she stated, "The lady from [another healthcare facility in the area] said she would let us know what her follow up with KCI was. She was going to report at next PANIC (Panhandle Area Infection Control) meeting, but I couldn't attend that meeting. I've been meaning to get the minutes from that meeting, but I haven't yet. I just assumed that when you sent the wound vac back that they did what they needed to do and when you got it back it was a sterile product..." When asked if she had followed up with the infection control nurse with [the other healthcare facility] to ask what she found out, she said, "No. I dropped the ball. I talked to her at that initial meeting. I was told they hadn't received anything yet. At the PANIC meeting on June 27th, they hadn't received anything in writing yet. When I talked to KCI rep about what happened with the vacs, I didn't get much of an answer...KCI apparently was just using a purple-top wipe. Ours is a red top. It's a tuberculocidal - I think Microkill is the brand. The epidemiologist said if it was a tuberculocidal, it would kill anything, including Acinetobactor... "


A review of Caviwipes microorganism kill information on the Metrex, the manufacture of Caviwipes, website did not include C. diff. or Acinetobactor baumannii. Caviwipes1 did include Acinetobacter baumannii, but did not include C. diff.


An ice machine outside the facility meeting room for the use of staff, visitors and patients had corroded areas and appeared to be generally unkempt.


In an interview with Staff #13, Maintenance Director, on the afternoon of 9/1/15, in the facility meeting room, he was asked about the upkeep of the facility's ice machines. He stated, "We only own the one that's between the two units. The others are run through a contract with Reddi Ice." When asked if he had something which showed when maintenance was done by Reddi Ice, he stated, "I just asked Reddi Ice to come out and do maintenance. They're going to do it this week." He supplied a request to Reddi Ice for a scheduled cleaning of ice machines on 9/8/15.


The ice machine issues were discussed during a tour of the facility with the CEO on the afternoon of 8/31/15, who acknowledged the problems with the cleanliness and maintenance of the machines. All the above findings were confirmed in several interviews with the facility CEO and CNO on the morning and afternoon of 9/1/15 in the facility meeting room.

Based on a facility tour, staff interviews and document review, the facility failed to ensure expired medications were not available for patient use.

Findings were:

On a tour of the facility on the afternoon of 8/31/15, with Staff #6, the facility CEO, and Staff #2, Nursing House Supervisor, the following items were noted:

· In the medication room of the med/surg unit, a bottle of hydrogen peroxide was found which had expired 3/15. A grouping of medications identified as a bleeding kit had a sticker which included expiration date 8/1/15.
· In the medication room of the high observation unit, approximately 12 French catheters hanging in front of a window had expired between the dates of 4/4/2015 and 7/2015. In addition, two of the catheter packages had reddish brown stains on the paper of the package.


Policy #07.0-03 entitled Drug Storage Unit Inspection, effective date 4/2005, stated in part: "A Pharmacy Services designee shall be responsible for monthly inspections of all drug storage areas in the hospital...Drugs shall not be kept in stock after the expiration date on the label..."


These findings were acknowledged and agreed upon by the CEO and House Supervisor during the tour of the facility on the afternoon of 8/31/15. They were again confirmed in the exit interview with the CEO and other administrative staff on the afternoon of 9/1/15 in the facility meeting room.

Based on observation, staff interview and a review of documentation, the facility failed to ensure the person designated as infection control officer had training necessary to effectively develop and implement policies governing control of infections and communicable diseases.


Findings were:


In an interview with Staff #4, the facility Infection Control Coordinator, on the morning of 9/1/15, in the facility meeting room, she stated she had been in the position of Infection Control Coordinator for "the last year or so...Or maybe it was the year before. I was the quality person then I became the infection control nurse when I went back to floor and it became my baby." When asked about any training she had that was specific to infection control, she stated, "I've been a member of the PANIC (Panhandle Area Infection Control) group, and then there's another city-wide group we go to get education. There are occasional in-services that we go to with them sometimes. I have not become infection control certified." When asked if she'd had any formal training in infection control beyond the basic training supplied to all staff at the facility, she said, "Just belonging to PANIC and the area-wide group."


A review of the personnel record of Staff #4, Infection Control Coordinator, revealed no specialized training in the overarching issues of infection control beyond the basic training received by all employees or beyond basic continuing education credits.


These findings were discussed with her during an interview on the afternoon of 9/1/15 in the facility meeting room. She stated she had no further training in infection control, and was aware that the continuing education classes were not training which addressed the supervision of the hospital's infection control program.

Based on a tour of the facility, documentation review and staff interviews, the facility failed to mitigate risks contributing to healthcare-associated infections and communicable diseases.


Findings were:


A tour of the facility with Staff #6, the chief executive officer, and Staff #2, nursing house supervisor, on the afternoon of 8/31/15, revealed the following items:

· The physical therapy room was identified as being shared between Plum Creek Specialty Hospital and Plum Creek Health Care Center, a 99-patient bed nursing home and skilled nursing facility (SNF) physically connected to the hospital. A patient and physical therapy assistant, Staff #5, were in the physical therapy room. Staff #5 stated the patient using the equipment was from the skilled nursing side of the facility and was on isolation precautions for C. Diff. She also stated she worked for the SNF. She said, "According to the nurse, he wasn't having diarrhea, so he was OK to come over here." When asked how she would clean the equipment after the patient's use, she stated, "I'd use the wipes over there." She indicated a container of Micro-Kill + wipes. She stated she believed the contact time for the wipes to be effective was two minutes. The product information for Micro-Kill + wipes did not indicate that it was effective against C. Diff.

· The physical therapy room had a fan sitting in the window which was turned on and blowing air about the room. Staff #6, the facility CEO, stated the fan "probably shouldn't be there. "

· The occupational therapy room had a refrigerator/freezer with approximately six ice packs in the freezer. These were identified by the Staff #6, CEO, as being used for patients. The refrigerator/freezer also held food items, both in the freezer and refrigerator sections of the unit, also identified as being used for both staff and patients.

· The pharmacy had a small side room which housed IV medications and solutions, as well as other patient supplies on two wire shelving racks. Directly adjacent to one section of wire shelving were cleaning supplies, including a broom, bucket and spray mop. On the other wire rack, a used paper gown and hair covering had been hung on the front right pole. On the top wire shelf were two pairs of used latex gloves, above clean patient supplies. Dishes, including plates and forks, were sitting next to the sink in the room. These were identified by Staff #8, the interim pharmacy director, as having been used by staff for eating, then washed in the sink in that room, and placed there to dry. He stated this was also the sink in which pharmacy personnel washed their hands, including when washing to enter the IV prep room. The problems noted in this room were pointed out to hospital staff. The room was again toured on 9/1/15. The only changes made to the room as a result of the previous day's tour were that the used gloves and paper hair covering had been thrown in the trash can, and the used paper gowns had been moved to hooks on a closed metal shelving unit at the back of the room.

· An ice machine shared between the west and east units was dripping water and had standing water in the tray bottom. The wire grill over the tray was corroded and had rusty areas.

· The med/surg unit had 12 patients with 4 patients on isolation. The patient in room 325 was noted on the patient census as being on contact precautions. A nurse, Staff #10, was observed in the room silencing the patient's pump. She wore no gown, though she did have on gloves. When she exited the room the nurse was still wearing the gloves. When the surveyor asked the nurse if the patient was on precautions. She said "Yes, contact precautions for MRSA." When asked if she should be wearing a gown, she stated, "I didn't touch anything." When asked if there should be a sign on the door stating the patient was on precautions and what type of precautions, she said, "It just didn't get put up there." She then discarded the gloves and washed her hands.

2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings - Healthcare Infection Control Practices Advisory Committee (available: CDC website: http://www.cdc.gov/hicpac/2007IP/2007isolationPrecautions.html), states in part: "Healthcare personnel caring for patients on Contact Precautions wear a gown and gloves for all interactions that may involve contact with the patient or potentially contaminated areas in the patient ' s environment. Donning PPE upon room entry and discarding before exiting the patient room is done to contain pathogens, especially those that have been implicated in transmission through environmental contamination..."

· In the medication room of the med/surg unit, the spout of the faucet had an approximate inch-long solid calcium deposit around it, and the faucet dripped. When the surveyor touched the area on the faucet at the drip, it felt slimy. The cabinets beneath the sink appeared to be screwed shut, but one side could be opened. Under the sink were old patient supply items identified by the CEO as "needing to be thrown out."

· On the west side med/surg unit there was a refrigerator in which patient food items were kept. A review of the temperature log for this refrigerator revealed the following note:

" If temperature is not within the acceptable range of 36 to 44 deg F...(no further part of note visible)" It also included the following August 2015 entries:

o 48 degrees for the following dates: 8/1, 8/2, 8/9, 8/10, 8/14, 8/15, 8/22, 8/23

o 62 degrees on 8/3

o 46 degrees on 8/8, 8/16, 8/17, 8/18, 8/19, 8/20, 8/21, 8/24

The log did not include actions taken to address these anomalies.

· A patient shower room off the hall area connecting the west and east units had a cart containing clean patient linen. The cart had an open-weave mesh covering. Found on top of the mesh cover over the clean linen were dirty used gloves, dirty linen, discarded EKG lead packages and other trash items.

· A drain pipe in the floor of the patient shower room had an approximate 10"x10" area around it which had no tile. Old stained, crumbled foam insulation filled the hole around the pipe. The hole included a small dead bug carcass. Holes in the tile and a gaping area in the tile around an electrical plug opened to the area behind the wall, allowing entry of pests and dirt.

· In the medication room of the high observation unit, a number of French catheters hanging in front of a window had expired between the dates of 4/4/2015 and 7/2015. In addition, several of the catheter packages had reddish brown stains on the paper of the package.

· The dialysis area had a dripping faucet and an entry desk which several large chips out of the side laminate. The area was not in current use, though Staff #4, the Infection Control Coordinator, stated services were to resume through DaVita that week.

· The hospital had one bronchoscope and one endoscope. The area where the scopes were cleaned was a former patient bedroom and bathroom, Room 303 on the east unit. The room had three plastic tubs, one labeled "Germicide" and the other two unlabeled - one each for soaking (water) and cleaning (cleanser). As a result of the two tubs not being labeled, it was unclear which tub had been used in the past for which process. In addition, when Staff #9, the Director of Respiratory Therapy, was asked how the tubs were cleaned, he said they were "wiped down." The table on which the tubs resided had holes and scratches in the Formica top into the permeable oriented strand board (OSB) below it, making cleaning impossible. A cloth office chair in front of the table appeared to provide seating for staff in the cleaning area. The cloth covering was permeable, and thus could not be adequately cleaned. The area had no clear delineation of "clean" to "dirty," meaning clean items crossed into the dirty area, and vice versa. Clean scopes were hung in the room in a cabinet. A small tile room, formerly a shower, housed the chemical cleaning agents used for the scopes. The two rooms had no external lock on the door to the hallway. The rooms were on the unit, and though a reception area/nurses desk was near the front entry, the cleaning rooms were otherwise accessible to staff, patients and visitors.

· A sign stating "Eye Wash Station" with an arrow pointing toward a sink was seen in the hall area between the west and east units. The arrow pointed to a sink now being used as a kitchen area. The CEO stated, "I guess the eye wash station isn't there anymore."

· A small room housing respiratory therapy supplies included 6 boxes of aqua packs used for respiratory therapy procedures. Of the 6 boxes, only 1 had not expired. One of the boxes had an expiration date of 3/2015; the other 4 boxes had expiration dates of 7/2015.

· An ice machine outside the facility meeting room for the use of staff, visitors and patients had corroded and ill-fitting areas, making thorough cleaning impossible.


Technical Data for Micro-Kill + Wipes stated, in part:
"With quick room turnovers required in many areas of a facility, healthcare staff often lacks the time to wait the 10 minutes required by many disinfectants to kill organisms left behind on hard surfaces. Medline Micro-Kill + addresses this issue with its ability to kill 12 different infectious microorganisms, including Tuberculosis, E. coli, Hepatitis B and C, Salmonella and VRE within two minutes...
Micro-Kill Kill Times
Contact time for a disinfectant is the amount of time a surface must remain wet with the product to achieve disinfection.
Micro-Organism
· Escherichia coli (E.Coli)
· Hepatitis B Virus (HBV)
· Hepatitis C Virus (HCV)
· Herpes Simplex Type 2
· HIV-1
· Influenza A2/Hong Kong
· Methicillin Resistant Staphylococcus aureus (MRSA)
· Mycobacterium bovis (TB)
· Pseudomonas aeruginosa
· Salmonella enterica
· Staphylococcus aureus
· Trichophyton mentagrophytes (Athlete's foot fungus)
· Vancomycin-resistant enterococcus (VRE)..."


The contact time for each micro-organism was listed as 2 minutes with the exception of HIV-1, which had a contact time of 1 minute, and Trichophyton mentagrophytes which had a contact time of 5 minutes.


A review of medical records revealed that 1 of 10 patients (Patient #1) with a multi-drug resistant organism experienced a delay in the initiation of isolation precautions despite a positive lab result for Acinetobacter. A lab result for Patient #1 was positive for Acinetobacter on 6/5/15 at 1:52 p.m. The physician made rounds at 4:00 p.m. on 6/5/15. A physician's note was dictated at 4:02 p.m. on that date which stated the patient had a positive Acinetobacter result. The physician did not order isolation until 6/6/15 at 4:30 p.m. Staff interviews which followed noted that nurses had the authority to place the patient on contact and isolation precautions without a physician's order. The patient record included no nursing documentation of his being on isolation precautions until 6/7/15.


In an interview with Staff #4, Infection Control Coordinator, on the morning of 9/1/15 in the facility meeting room, she was asked about issues noted on the tour. She stated, "I monitor any labs that come back for infections (cultures), if have a patient who has a history of MRSA, then we'll put them on contact precautions - things like that...I round with maintenance and different people each month. We look in all the nooks and crannies to see if there are any issues." When asked about a patient on isolation or contact precautions, she stated, "There will always be a sign on the door." When asked what type of personal protective equipment (PPE) a staff member would wear for such precautions, she stated, "They should have on a gown and gloves for contact precautions. They should take the equipment off as they leave the room, and wash their hands." When asked if they should always be gowned, she stated, "Should be." The infection control coordinator also stated, "When we get labs back, the unit clerk notifies the charge nurse if there's any hint of a multi-drug resistant organism. I get a copy of it. If it's something that requires isolation, we'll put the patient on isolation immediately until we get the final back. If we get a preliminary screening of anything that might need isolation, we'll put them on it." When asked about the situation where the specialty hospital shares the physical therapy area with the skilled nursing facility/nursing home, she stated, " Our policies are different from theirs. We can ' t tell them that a patient from over there on contact precautions (as observed by surveyors) can ' t be over here. They ' re supposed to wipe it all down once they ' re through ..."


In an interview with Staff #2, House Supervisor, and Staff #1, Chief Nursing Officer, on the afternoon of 9/1/15 in the facility meeting room, the chart of patient Patient #1 was discussed. Staff #2 stated, "He should have been placed on isolation precautions." The CNO confirmed, "The nurse can absolutely start contact precautions..."


In an interview with Staff #13, Maintenance Director, on the afternoon of 9/1/15 in the facility meeting room, he discussed the temperature anomalies for the refrigerator on the west side med/surg unit. He stated, "Yes, we were having problems with that refrigerator. There were work orders in on that and we'd go check on it, but just couldn't get it within range. We're getting a new refrigerator in there today."


When asked about the ice machines, he stated, "We only own the one that's between the two units. The others are run through a contract with Reddi Ice." When asked if he had something which showed when maintenance was completed on the ice machine owned by the facility, and maintenance done by Reddi Ice, he stated, "On the log it'll show what was done by us...I just asked Reddi Ice to come out and do maintenance. They're going to do it this week." He supplied a request to Reddi Ice for a scheduled cleaning of ice machines on 9/8/15. One entry on the maintenance request log dated 8/10/15 read, "Ice machine off/broken." There was no entry in the column entitled "Completion Date." The Maintenance Director did provide a log on the facility-owned ice machine with the following entries:
· 1/15/15 cleaned machine
· 4/12/15 cleaned & tightened valve
· 7/15/15 cleaned grate


In an interview with Staff #9, Director of Respiratory Therapy, on the afternoon of 9/1/15 in the facility meeting room, he agreed that the endoscope and bronchosocpe cleaning area did not flow from dirty to clean, and needed much attention. In addition, he admitted that the personnel files of individuals who performed scope processing did not have adequate documentation of training and skills or competencies.


A review of personnel identified as trained to perform scope cleaning/processing included only a statement from the Director of Respiratory Therapy that the individuals were competent to perform this function. The personnel files included no documentation of regular training or of processing competencies.


Wound care observation of Staff #3, Wound Care Nurse, on the afternoon of 9/1/15: Staff #3 placed clean wound care supplies on the patient bed. She proceeded to use the supplies. Without the procedure being completed, the nurse took a spray bottle of skin cleanser which she had used on the patient and put it in the patient bedside table. She did not clean/disinfect/sanitize bottle prior to placing it in the bedside table. She cleaned the scissors used during the procedure with a disinfecting wipe, then laid them on the patient's overbed table. The table had not been cleaned with anything.


Policy #QM-IC-H-0001 entitled Hospital Approved Disinfectants, dated 01/01/2009, stated in part: "All non-critical items coming in contact with intact skin will be subjected to low level disinfection with an appropriate disinfectant solution approved by the Infection Control Committee..." When the list of committee-approved disinfectant solutions was requested, the facility could provide no such list to the surveyors.


Policy #QM-IC-H-0017 entitled Standard Precautions, dated 01/01/2009, stated in part:
"8. Personal Protective Equipment (PPE) - specialized clothing or equipment including medical gloves, gowns, lab coats, masks, glasses, goggles, and clothing worn by an employee for protection against an anticipated hazard. General work clothes such as uniforms, pants, shirts, or blouses are not intended to function as protection against a hazard [and] are not considered personal protective equipment...It is the responsibility of all employees at this facility to adhere to the policy and procedure contained in this document..."


Policy #QM-IC-H-0023 entitled Isolation Precautions, dated 01/01/2009, stated in part:
"It is the policy of this Hospital to follow the CDC and HICPAC recommendations for isolation precautions in hospitals...

2. Transmission of infection within hospital requires three elements:...
2.1.9 Inanimate environmental objects that have become contaminated, including equipment and medications...
2.4.1 Contact transmission - the most important and frequent mode of transmission of nosocomial infection:...

B. Indirect contact - involves contact of a susceptible host with a contaminated intermediate object, usually inanimate, such as contaminated instruments, needles, dressings...

3.3 Isolation precautions may make frequent visits by nurses, physicians, and other personnel inconvenient, and may make it more difficult for personnel to give the prompt and frequent care that is sometimes required.

8.1 Gowns are worn to prevent contamination of clothing and protect the skin of personnel from blood and body fluid exposures..."


Policy #QM-IC-H-0011 entitled Multi-Drug Resistant Organisms, dated 01/01/2009, stated in part: "It is the policy of this facility to recognize the significant infection risk that multi-drug resistant organisms such as MRSA, VRE, Acinebacter etc. pose to the patient population. Precautions will be taken in the treatment, control and transfer of patient infected or colonized with the organisms...

1. Resistant organism precautions will be instituted by the charge nurse immediately:
1.1 Upon receipt of positive culture of a resistant organism...

4. Resistant organism precautions will be maintained by the hospital staff until three (3) negative cultures are obtained...

8. All staff, nursing, Occupational Therapy (OT), Physical Therapy (PT), Respiratory Therapy (RT), and other departments involved in the care of patient will follow specific precautions listed in the Resistant Organism Precautions Guidelines when a patient is placed on isolation precautions. In addition, the following procedures will be followed:
8.1 Isolation precautions sign will be posted outside the patient's door...
8.6 Gowns, masks or protective eyewear should be worn as necessary for procedures or patient contact...

9. In the health-care setting, the presence of MRSA, VRE, or other resistant organisms should not be a basis for restricting patient's activity...Decontamination of surfaces should follow after contact with affected patients..."


Policy #QM-IC-H-0013 entitled Infection Control Rounds, dated 01/01/2009, stated in part:
"It is the policy of this hospital to identify, find and correct improperly executed infection control practices to show on-going assessment of compliance to standards set forth by CDC, JCAHO and OSHA...The Infection Control Round findings will be shared during Infection Control Committee meetings and reflected in the minutes."



Policy #07.0-03 entitled Drug Storage Unit Inspection, effective date 4/2005, stated in part: "A Pharmacy Services designee shall be responsible for monthly inspections of all drug storage areas in the hospital...Drugs shall not be kept in stock after the expiration date on the label..."


The above findings were confirmed during the facility tour on the afternoon of 8/31/15 with the facility CEO and House Supervisor. They were also confirmed in several interviews with the CEO and CNO on 9/1/15. Finally, findings were again discussed and agreed upon in an exit interview on the afternoon of 9/1/15 with the CEO, CNO and other administrative staff.