The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.
|CONTRA COSTA REGIONAL MEDICAL CENTER||2500 ALHAMBRA AVENUE MARTINEZ, CA 94553||April 7, 2017|
|VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING||Tag No: A0144|
|**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**
Based on observation, interview and record review, for two (Patients 13 and 14) of 30 sampled patients the hospital failed to implement their policies and procedures to ensure that Patient 13 and 14 were protected from all types of abuse.
These failures resulted in physical and emotional harm when:
1. Patient 13 was emotionally abused by Patient 12.
2. Patient 14 was physically abused by patient 12.
1. Record review of Patient 13 showed she was admitted on [DATE] with medical diagnoses that included abdominal pain, history of CVA (Stroke, blood flow to a part of the brain is stopped) with right sided weakness, COPD (chronic obstructive pulmonary disorder, lung disease with poor airflow), and cognitive decline/dementia (brain disease that cause a decrease in the ability to think and remember). Patient 13's medical record showed she communicated her needs well.
In an observation and concurrent interview on 3/30/17 at 3:02 p.m., Patient 13 ambulated slowly with a walker. Patient 13 was well groomed. Patient 13, stated that Patient 12 was her roommate and that Patient 12 was "a terror, mean, and rude all the time, I fear for my well-being ". She (Patient 12) makes me nervous, scared and feel unsafe I want to move to a different room". Patient 13 added that she had told the staff about her concern several times and wanted to move to a different room. Patient 13 stated she had not received a response from staff since her request a few weeks ago. Patient 13 stated "I don't care where I go, anywhere is fine but not in the same room with her". Patient 13 stated, "I am scared to sleep at night because of her. There is no staff staying in our room all the time to watch her (Patient 12). The hospital needs to do something about this situation, she aggravates patients and staff, and I hope they can control her physical aggressiveness. I don't see the staff following her when she walks out of the room". Patient 13 stated that she saw Patient 12 physically attacked CNA 2 "this morning." Patient 13 added "She had no right to put her hand on the staff, now she did it".
2. Record review of Patient 14 showed she was admitted on [DATE] with medical diagnoses that included Huntington's disease (HD inherited disorder that results to death of brain cells), dementia, gait instability, and inability to care for self. Patient 14's medical record showed that she had the ability to make self be understood.
In an observation and concurrent interview on 3/30/2017 at 12:30 p.m., Patient 14 was seen curled up in bed. Patient 14 had continuous jerky movements of head, both arms and talked very slowly. There was an unopened lunch tray on the bedside table of Patient 14. She stated she did not have an appetite. Patient 14 stated that Patient 12 entered her room alone late at night about two weeks ago, went through her closet and took her belongings. Patient 14 stated that Patient 12 slapped her hard across the face and hit her knees when she tried to stop Patient 12 from taking her belongings. Patient 14 showed where she had been injured and stated that she had pain on her face and knees. Patient 14 stated that Patient12 made her angry, scared and she had to defend herself as Patient 12 attacked. Patient 14 stated there was no staff in her room during her altercation with Patient 12. Patient 14 stated that she yelled for help then the staff came to her room and removed Patient 12. Patient 14 stated that her sleep had not been good since this incident and that she was afraid that Patient 12 may come back to her room and attack her again. Patient 14 stated that she frequently saw Patient 12 outside Patient 14's room. Patient 14 stated that, "It makes me angry and afraid thinking about the incident, the hospital should do something and move her away from me". Patient 14 stated, "I'm very afraid of her (Patient 12)".
Record review of Patient 14's plan of care dated 3/6/17, did not show documentation for ongoing patient assessment, supervision and monitoring for patient 14's safety.
Record review on 3/30/17 showed that Patient 12 was admitted on [DATE] with medical diagnoses that included history of dementia with behavioral disturbance, paranoid delusions (misinterpretation of perceptions or experiences), and was admitted on a 5150 (involuntary psychiatric hold, this is the 7th 5150 to CCRMC with history of being aggressive toward the hospital staff).
In an interview on 3/30/2017 at 1:35 p.m., RN (Registered Nurse) 3, stated that Patient 12's mood alternates between "nice and friendly to more aggressive and very labile, curses a lot and had outburst of aggression that happened more last week". RN 3 stated that patient 12 was placed on four point restraints (application of limb restraints on both arms and legs at once) after she had physically attacked and pulled the hair of CNA (Certified Nursing Assistant) 2 this morning (3/30/17).
In an interview on 3/30/17 at 1:50 p.m., CNA 2 stated that today at 7:00 a.m., Patient 12 walked over to Patient 13's bed (who was asleep) and pulled out Patient 13's blankets. CNA 2 told Patient 12 that it was not ok to do that and covered up Patient 13 who was awakened. CNA 2 stated Patient 13 was upset that Patient 12 took her blankets off. Patient 12 went back to her bed and sat on her bed. CNA 2 stated Patient 12 got up, walked over to Patient13 and pulled out her blankets again. CNA 2 told Patient12 in a slow speech that it was not ok to pull Patient 13's blankets off. CNA 2 stated that Patient 12 got angry, became verbally hostile and called her "fat, black bitch, funny bitch" and that "everyone at the nurse's station heard". Patient 12 then took her pillowcase off her own pillow and threw the pillow at patient 13. Patient 13 was upset and shook her head side to side. CNA 2 stated that at 7:50 a.m., she was writing on the white board in the room of Patient 12 and 13 with her back to them and suddenly Patient12 grabbed CNA 2's pony tail and wrapping CNA 2's hair around her (Patient 12) hand a couple of times. CNA 2 stated her hair was pulled hard backward by Patient 12 that she screamed loud. CNA 2 stated the staff came in the room and grabbed Patient 12's hand to let go of her pony tail and then the staff put Patient 12 back to her bed and was placed on four point restraints. CNA 2 added the hospital did not provide training to staff on how to handle aggressive patients and stated this was a big safety issue. CNA 2 stated that Patient 12's roommate, Patient 13, told her last week that she would like to move to a different room because Patient 13 was afraid of Patient 12. CNA 2 stated that she notified her charge nurse of Patient 13's concern and request.
In an interview on 3/30/17 at 2:18 p.m., RN 4 stated that there were problems with Patient 12's "labile" behavior and being "mean and racist". RN 4 stated Patient 12 had history of verbal and unpredictable physical aggression and added that this was a safety issue with regards to the management of Patient 12's behavior.
In an interview on 3/30/17at 4:25 p.m., RN 5 stated that Patient 12's "moods go up and down very quickly and escalate for no reason". RN 5 stated that that "Patient 12 is very paranoid and there is a safety issue with regards to the management of Patient 12's behavior".
In an interview on 3/30/17 at 5.35 p.m., MD (Physician) 4 stated that in the last two weeks Patient 12's behavior had decompensated (lost ability to maintain normal or appropriate defenses) a lot and that Patient 12's paranoid ideation had increased as well as become unpredictable. MD 4 stated that Patient 12 manifested combative behavior without bodily warning for physical aggression.
Record review of Patient 12's progress notes dated 3/6/17, MD 4 indicated that Patient 12's medications will be reviewed and possibly changed. "The disposition plan for Patient 12 will be likely in a locked dementia unit vs. SNF [Skilled Nursing Facility] with wander guard" (signaling device or departure alert system for wandering management).
Record review of Patient 12's progress notes dated 3/31/17, MD 4 indicated that Patient 12 "continues to be threatening, shows poor impulse control, wanders into other patients rooms, is verbally abusive to the roommate, and when redirected by sitter threatened to punch the RN".
Record review of the Physician progress notes dated 3/5/17, MD 5 indicated that per RN "Patient 12 was restrained then fell asleep then was taken off restraints". Patient awoke and walked to Patient 14's room. Patient 12 "kicked this patient in the right foot and smacked her on left side of the face. Patient 14 " then kicked" Patient 12 back.
Review of the hospitals Policy and Procedure titled, "Patient Rights and Responsibilities" revised 6/10 showed, "Procedure: D.4. Receive care in a safe setting, free from all forms of abuse and harassment".
Review of the hospitals Policy and Procedures titled, "Adverse Event reporting" revised on 8/13 showed, "Serious disability means a physical or mental impairment that substantially limits one or more of the major life activities of an individual".
Review of the hospitals Policy and Procedure titled "Standards Escalation Process" dated 2/23/17 showed, "Address patient safety concerns and report to front line staff, CN (charge nurse) and Physician of final resolution, direct communication of changed care plan to care team: ensure patient/family needs are met. Provide concise, discreet communication between DON (Director of Nursing), patient and family about status of patient safety issue"
|VIOLATION: PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT||Tag No: A0145|
|Based on interview and record review, the facility failed to escalate an allegation of abuse to the appropriate staff and authorities for further investigation for Patient 27. This failure placed Patient 27 at risk for continued abuse by the perpetrator and violated her right to be free from abuse.
In an interview on 4/3/17 at 11:15 a.m., RN 1 stated she had Patients 27 & 28. RN1 proceeded to report that Patient 27 had been a 5150 admission with altered mental status (AMS) and delusions. Patient 27 had reported to ER physician that her husband had been abusing her. RN1 stated Patient 27 was on 1:1 observation by a sitter.
Review of the clinical record (History & Physical 4/1/17) showed the facility admitted Patient 27 on 4/1/17 on 5150 Psychiatric hold, chronic pain on multiple medications (Soma, Ativan, Valium, Oxycodone, and Dilaudid), depression history of accidental overdose, and grandmal seizures who presented for complaints of AMS, and Psychosis, reportedly new in past four days per her husband. It further Read:
"She has been claiming her husband is abusing her and had tried to get him arrested. Here, she reports he is a "felon" and "got the death penalty" for assaulting her. She does not consistently live with her husband though seems to have been recently. The ER Dr indicated that her husband has recently been in rehabilitation for pain meds and is now 40 days clean."
In an interview on 4/3/17 at 11:35 a.m., when asked regarding P27's allegation of abuse, the 4B Nurse Manager (NM) and the Inpatient Director of Nurses (IDON) both stated the allegation of abuse by her husband should have been escalated as the Physician is a mandated reporter. They said they would have social services look into the matter.
Review of the Social Worker's (SW) Notes showed on 4/4/17 at 5:21 p.m., the SW documented, "She described herself as a victim of domestic violence but simultaneously talked tough about her ability to get on without her husband and how he is the one dependent upon her. Patient 27 stated her husband had convinced her that she was having seizures and hitting her head when in reality he was beating her unconscious and pushing her down stairs for the past six years. She maintains she has made many reports to the police who does nothing and don't validate her claims so she plans to sue the department. Patient 27 said she have never been through this before and didn't know who to call."
In the notes SW made a report/confirmed report made by the patient herself for Domestic Violence with the Local Police Dept. SW spoke with an officer who confirmed Patient 27 called the police on 3/31/17 at 4:00 a.m.
In an interview on 4/6/17 at 3:00 p.m., the Hospital's Chief Operating Officer (COO) and DQM (Director of Quality Management) said any allegation of abuse should be escalated to the advocacy agencies and reported to the local authorities
|VIOLATION: NURSING CARE PLAN||Tag No: A0396|
|**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**
Based on observation, interview, and record review, the facility failed to follow current nursing care plans based on an ongoing assessment of one patient out of 29 who needs to follow contact isolation guidelines ordered by MD 1. Failure to follow the nursing care plans program for controlling infections and communicable diseases through use of appropriate PPE (personal protective equipment) was not uniformly followed for Patient 6, and this failure could cause severe complications up to and including death.
During an observation on 4/3/17 at 2:00 p.m., Patient 6 was found seated in a chair in the hallway outside of her room wearing a cloth patient gown. Patient 6 was not wearing PPE. Patient 6 scratched the inside of her nose and then held the hand of the surveyor before her diagnosis of MRSA (methicillin-resistant Staphylococcus aureus) was known by the surveyor.
During an interview on 4/3/17 at 2:10 p.m., RN 1 said Patient 6 had MRSA ("a type of staph bacteria that is resistant to many antibiotics. In a healthcare setting, such as a hospital or nursing home, MRSA can cause severe problems such as bloodstream infections, pneumonia and surgical site infections. If not treated quickly, MRSA infections can cause sepsis and death."<cdc.gov>). RN 1 was asked if Patient 6 should be out of her room. RN 1 said that the staff got Patient 6 out of bed and out sitting in the hall daily since she had been there a long time and the staff wanted to get her out of her room.
In an interview on 4/3/17 at 2:10 p.m., Registered Nurse RN 1 confirmed that patients who were on contact isolation were allowed to sit outside of their room and out in the hallway of the unit with gloves donned. RN 1 stated Patient 6 would sit outside of her room and in the hallway during the day time. RN 1 confirmed there was no care plan developed for Patient 6 to address Patient 6 ' s contact isolation precautions and that there should have been one developed when the contact isolation precaution was ordered on [DATE].
In an interview on 4/3/17 at 2:25 p.m., Medical Doctor (MD) 1 confirmed that she expected Patient 6 's nurses to follow her physician order to maintain. MD 1 stated that Patient 6 could give MRSA to someone else by sitting outside of the room unless Patient 6 wore the proper PPE MD 1 ordered. MD 1 confirmed that she expected Patient 6's nurses to follow her physician order. MD 1 stated that Patient 6 could give MRSA to someone else by sitting outside of the room without the proper PPE as ordered.
During an interview with on 4/3/17 at 3 p.m., the Chief quality officer (CQO) was asked for care plans for contact isolation. No care plans were found.
In an interview on 4/3/17 at 3:10 p.m., the Infection Control Preventionist (ICP) confirmed that staff should instruct anyone who had come into contact with Patient 6 to wash their hands.
In an interview on 4/3/17 at 3:20 p.m., the Infection Control Preventionist (ICP) stated she would advise that Patient 6 be taken back into her room since she was on contact isolation precautions.
During an interview on 4/3/17 at 3:45 p.m. NM said that she was not sure what type of isolation was needed for contact isolation (the type of isolation needed for MRSA. She said that she would have to look at the paper on the door.
During an interview on 4/3/17 at 3:35 p.m., CNO said that under no circumstances would the patient (Patient 6) with a positive MRSA culture be allowed out of the room without PPE. Said that staff is given yearly training in isolation procedures.
During an interview on 4/3/17 at 2:25 p.m., MD 1 said that the order for contact isolation was still active. MD 1 said that the patient should not be outside of her room unless she had a mask on and it was for medical necessity.
During a review of the clinical record for Patient 6, the Culture results report collected 2/6/17 indicated positive growth for MRSA.
During a review of the clinical record for Patient 6, the contact isolation status order dated 2/8/17 at 10:21 a.m. indicated, "Private Room if available or can share w (sic) same organism, Strict hand washing, no shared equipment, Gowns, gloves for all contact, Out of room for medically necessary reasons only (must wear mask). Place appropriate sign on door." MD 1 is the attending provider who wrote this order.
During a review of the computer medical record with NM for Patient 6 on 4/3/17 at 3:05 p.m., no care plans were found in Patient 6's chart for contact isolation.
|VIOLATION: INFECTION CONTROL||Tag No: A0747|
|**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**
Based on observation, interview and record review the hospital failed to maintain an infection control program for the management and control of potential infectious processes as evidenced by: the failure to:
1. The failure to maintain negative air pressure for the isolation rooms.
2. The failure to provide gloves outside the isolation rooms for the staff to wear before entering the isolation rooms.
3. The failure of staff to dawn gown and gloves prior to entering an isolation room.
4. The operating room 3 and 4's temperature and humidity were out of range.
5. The failure to clean and maintain the interior of the sterilization chamber of Autoclaves (a machine used to sterilize surgical instruments) 1 per hospital policy and procedure.
6. The failure to clean and maintain the backroom of Autoclave 1 and Autoclave 2.
7. The failure to follow manufacturer's instructions of the disinfectant used to disinfect the Operating Room (OR) table, the bovie pad (a pad placed under a patient in surgery that uses a high frequency electric current to heat biological tissue in order to cut) and the Operating Room sterile field table located in OR 2.
8. The failure to keep the vents in Operating Suite 3, Operating Suite 4, and Cystoscopy (a procedure that allows the examination of the lining of the bladder and tube that carries urine out of the body) Room free from dust.
9. The failure of the staff to perform hand hygiene after taking off used gloves.
The cumulative effect of this organization's major systematic problem resulted in the hospital's inability to ensure the safe provision of patient care by qualified individuals to perform the assigned duties by placing the patients, the hospital staff, and the public at risk for the spread of infection and communicable disease.
1- During the observation on 4/5/17 at 10:30 a.m., the negative air pressure alarms for the isolation rooms at the nursery department and also in the 4th floor did not go off after leaving the doors open for 5 minutes. Patient A with the diagnoses of active tuberculosis was in the 4th floor's negative air pressure room. The result of the smoke test showed both rooms had negative air pressure.
During an interview with the Infection Control Preventionist (ICP) and the Facilities Manager (FM) on 4/6/17 at 1:40 p.m., it was revealed that just one of the doors, door number two (the one that directly opens to the patient's room) sets the alarm off. They also stated the alarm goes off when door number 2 is open for less than a minute (about 56 seconds). Both the FM and ICP stated that the alarm should have not taken 5 minutes to go off and that there was something wrong with the alarm equipment or settings.
Review of the hospitals policy and procedure on 4/6/17, dated April 2017, under the title "Verifying the Operation of Negative Pressure Isolation Rooms at [the hospital's name]", heading "Procedure", showed:
"Negative pressure isolation room ventilation will be tested monthly by the stationary engineers to verify negative pressure.
Negative pressure isolation room alarms both at the isolation room and at the nurses station will be tested monthly for adequate operation.
Monthly negative pressure room testing procedure:
Stationary engineer shall open the door to the isolation room ante room (if equipped) and close it behind them. The engineer shall then open the patient the patient room door. The wall mounted alarm and the central alarm at the nurse's station shall sound within 1 minute ..."
2- Observation of the 5th floor of the hospital on [DATE] at 11 a.m. showed the hospital stored gloves inside the patient's room including the hospital isolation rooms. In an interview with the Quality Manager (QM) on 4/5/17 at 11:50 a.m., the QM acknowledged that the gloves were stored inside the patient's room including isolation rooms on the 5th floor.
Review of the hospital's policy and procedure on 4/5/17, dated January 2009, under the title "Transmissions Based Precautions-Contact Precautions", heading "Procedure" ,showed:
"A. General Guidelines
... 2. Barriers...
1) Should be applied when entering the room (located on wall as you enter the door)...
3) Wear a gown when entering the room if it is anticipated that your clothing will have substantial contact with the patient, environmental surfaces or item in the patient's room...
3- During the observation on 4/5/17 at 11:40 a.m., the hospital staff (RN 2) entered the contact isolation room that Patient B with diagnosis of MRSA (Methicillin-resistant Staphylococcus aureus) was there without having a gown or gloves on. In an interview on 4/5/17 at 11:45 a.m., RN 2 acknowledged that before entering the contact isolation rooms, staff need to have a gown and gloves on and there is also a sign on every isolation room door with theses instructions.
Review of the signs by the isolation room doors on 4/5/17 showed pictures of gown and gloves and read: "Put on these items before entering the room"
3. During observations on Monday 4/3/17 from 11a.m. to 1 p.m. the following was noted on Unit 4B:
Registered Nurse (RN) 6 was observed leaving Patient Care Room 4B12-1 with a mask (Personal Protective Equipment- PPE) and entering 4B24 wearing the same mask.
The Review of the "Influenza Immunization or Wear A Mask Policy" last revised August 2012 read, "PURPOSE: Mask: For seasonal Influenza a standard mask will be used. POLICY: A new mask must be worn for each patient Contact. Masks should be put on when entering the room and removed when leaving the room.
In an interview on 4/3/17 at 11:15 a.m., RN 6 said she had the flu and still had some residual symptoms and did not want to come close to this writer. When questioned regarding her patient assignment, RN 6 stated she was caring for Patient (P) 28, who was immuno-compromised receiving chemotherapy.
In a concurrent interview, the Nurse Manager of 4B (4BNM) and the Inpatient Director of Nurses (IDON) were asked regarding their expectations of staff with the flu and the IDON stated we expect them to stay home until they are well and fully recovered.
A review of the same "Influenza Immunization or Wear A Mask Policy" Policy & Procedure (P&P) showed "PURPOSE: Mask: For seasonal Influenza a standard mask will be used. POLICY: A new mask must be worn for each patient Contact. Masks should be put on when entering the room and removed when leaving the room.
In an interview on 4/3/17 at 1:15 p.m., the Hospital's Infection Control Preventionist stated that the nursing assignment should be done to prevent spread of Hospital Acquired Infection (HAI).
RN 7 was observed accessing P28's Porta Cath wearing a mask that was pulled down in a fashion to only cover the mouth and not the nose.
In an interview on 4/3/17 at 11:25 a.m., RN 7 stated he meant to pull the mask up after starting the peripheral IV and before accessing P28's Central Venous access port.( A porta Cath is an implanted venous access device for patients who need frequent or continuous administration of chemotherapy. Drugs used for chemotherapy are often toxic, and can damage skin, muscle tissue, and sometimes veins.)
Review of the Vascular Access Port P&P last revised 11/16, showed the P&P instructed Hospital nursing staff to place a mask on the patient and for the nurse to wear a mask to prevent the port from becoming infected.
Physician (MD 4) was seen walking in the hallway to nurse's station wearing a mask after leaving a patient's room on Contact Isolation. The NM 2 went over to MD 4 and assisted her to remove the mask.
4. During an Observation of the Operating Room (OR) 3 and 4 and concurrent interview of the Nurse Program Manager of Perioperative services, RN 8, the Charge Nurse, the facilities manager and RN 9 on 4/5/17 at 10 a.m., when asked regarding Temperature and Humidity in the OR, the Nurse Program Manager of Perioperative Services replied, "I'm not sure I think the temperature is 65-70 and I'm not sure of the humidity. The Facilities Management checks this along with Engineering and we nurses aren't responsible for this monitoring."
The OR Charge Nurse (CN) replied, "I think the temperature is between 64-68 and I'm not clear on the Humidity."
RN 8 Replied "Temperature is 64-68 and I will have to double-check humidity."
RN 9 replied, "Temperature is 68-72 and the humidity is 40-60."
The facilities Manager replied 30-60 humidity and temperature 68."
According to the Association of Operating Room Nurses (AORN) March 2015:
The recommended temperature range in an operating room is between 68F and 75F. Collaborate with infection prevention and facility engineers when determining temperature ranges. Each facility should determine acceptable ranges for temperature in accordance with regulatory and accrediting agencies.
The recommended humidity range in an operating room is 20% to 60% based upon addendum d to ANSI/ASHRAE/ASHE Standard 170-2008. Each facility should determine acceptable ranges for humidity in accordance with regulatory and accrediting agencies and local regulations. The center for Medicaid and Medicare systems has modified their requirements to allow for the 20% lower limit effective June 2013.
5. An observation of the sterile processing room and concurrent interview with the Lead Sterile Processing Technician (LST) and Nurse Program Manager of Perioperative Services (NPS)on 4/5/17 at 11:45 a.m., revealed and was confirmed by both that there was white/ yellow discolored matter that was described by the LST as "calcium" buildup located on the left interior chamber wall and the interior chamber floor of Autoclave 1. The LST also confirmed there was grey matter that was described as "dust" located along the outside edges of Autoclave 1's door. The LST stated that the interior sterilization chamber of Autoclave 1 was cleaned and maintained quarterly (four months) by the Biomed department. The LST could not provide any evidence on when the last time the interior sterilization chamber of Autoclave 1 was cleaned.
In an observation and concurrent interview on 4/6/17 at 9:45 a.m., in the presence of the Infection Control Preventionist (ICP), the LST, the NPS and the Sterile Processing and Distribution Supervisor (SPS), the ICP confirmed that interior sterilization chamber of Autoclave 1 continued to have "calcium and lime" build up on the left interior wall, the interior floor, and there was what appeared to be round, brown "rust" along the bottom lining of the inner door of the Autoclave 1 (refer to pictures 001.JPG, 002.JPG, and 005.JPG). The ICP indicated Autoclave 1 was not to be used until the interior sterilization chamber was cleaned properly. The ICP stated that the heat in the interior sterilization chamber of the autoclaves had the potential to break off the "calcium and lime" build up and damage the surgical instruments which would make the surgical instruments susceptible to contamination. Both the NPS and SPS confirmed "dust" continued to build up along the outside edges of Autoclave 1's door (refer to pictures 003.JPG and 004.JPG) even after it had been cleaned the previous day (4/5/17). The NPS and SPS could not determine where the source of the "dust" originated from and could not determine whether or not the "dust" could have contaminated any of the surgical instrument packs taken out of Autoclave 1.
In an interview on 4/6/17 at 3:20 p.m., the Chief Operation Officer (COO) confirmed that the Sterile Processing Department (SPD), which included the Lead Sterile Processing Technician (LST) and the SPS, were responsible for cleaning the interior sterilization chamber of the two autoclaves per the hospital's policy and procedure. The COO stated the interior of the Autoclaves were to be internally cleaned on a weekly basis per the hospital's policy and procedure.
Review of the hospital's policy and procedure titled, "Cleaning of Steam Sterilizer", revised on 11/2016 and approved by OR staff, PACU (Post-anesthesia care unit) and SPD (Sterile Processing Department) indicated as followed: "II. Policy: Sterilizers will be cleaned on a weekly basis according to the following procedure. IV. Authority/Responsibility: SPD staff."
Review of the manufacturer's (STERIS) instructions titled, "Technical Bulletin. STERIS Steam Sterilization Cleaning Procedure", with a copy right date of 2005 indicated as followed: "General Guidelines: 3. Due to differences in water and steam quality, frequency of use, boiler additives and other load variations, no specific time interval is recommended. Rather, operators must determine an appropriate cleaning interval based on local conditions and chamber appearance.
According to AORN (Association of Operating Room Nurse) Guidelines for Perioperative Practice: published on January 2017, "Guideline for Sterilization" indicated as followed: "XX.i. Preventive maintenance on sterilizers should be performed by qualified personnel on a scheduled basis. Periodic inspections, maintenance, and replacement of components that are subject to wear (eg, recording devices, steam traps, filters, valves, drain pipes, gaskets) help maintain proper functioning of sterilizer. XX.i.1. Inspection and cleaning should be performed as outlined in the manufacturer's written instructions." [Reference: http://www.aornstandards.org/content/1/SEC38.body]
6. In an observation and concurrent interview on 4/6/17 at 9:45 a.m., the back room where the two Autoclaves were housed in and in the presence of the ICP, the NPS, the LST, the SPS and the Facilities Manager (FM) all agreed the back room was not properly cleaned and maintained and that it should have been. There were grey matter, which the FM described as "dust" located on the top, right, back corner of Autoclave 2 (refer to picture 014.JPG). There were debris and dark stains on the floor in between the two Autoclaves (refer to picture 009.JPG). The back of Autoclave 1 and Autoclave 2 had multiple openings along the sides and exposed material (refer to pictures 006.JPG, 007.JPG, 008.JPG and 013.JPG). There was one vent located on the mid, upper, right side wall of the room that had dark matter covering the whole surface (refer to picture 012.JPG). There were multiple storage containers, which the FM stated were for the equipment used for the Autoclaves, stored all around Autoclave 1 and Autoclave 2 (refer to pictures 007.JPG, and 010.JPG). The FM, the LST and SPS could not answer as to whom or what department was responsible for the cleaning and maintenance of the room. The FM, the LST and SPS could not provide any evidence of when the last time the room was cleaned.
7. In an observation and concurrent interview on 4/5/17 at 11:25 a.m., in Operating Room Suite 2 Environmental Services Staff Member (EVS) 1 was observed using two wet cloths to wipe down the surfaces of the Operating Room table (used for the patient to rest on for surgery), the bovie pad, and the Operating Room sterile field table (used for surgical instrument to lay on). After three minutes of contact/wet time EVS 1 proceeded to wipe down the surfaces of the Operating Room table, the bovie pad, and the Operating Room sterile field table with a dry cloth.
In an interview and concurrent record review on 4/5/17 at 10:35 a.m., the Institutional Services Worker-Generalists (ISW) stated that the disinfectant used to disinfect the equipment in the Operating Room Suite was A-456 II Disinfectant Cleaner. The ISW stated and showed the manufacturer's instruction which indicated that the contact/wet time was ten minutes. The ISW confirmed the A-456 II Disinfectant Cleaner needed to stay visibly wet on the surface for 10 minutes.
In an interview on 4/5/17 at 11:35 a.m., EVS 1 confirmed the two wet cloths he used to wipe down the Operating Room table, the bovie pad, and the Operating Room sterile field table had disinfectant, A-456 II Disinfectant Cleaner. EVS 1 stated the contact/wet for the A-456 II Disinfectant Cleaner time was 10 minutes. EVS 1 confirmed he did not follow the manufacturer's instructions for contact/wet time needed to disinfect the surfaces of the Operating Room table, the bovie pad and the Operating Room sterile field table.
Review of the hospital's policy and procedure titled, "Operating Room Cleaning", last review on 11/2016 indicated as followed: "III. Policy: Environmental cleaning is performed on a regular basis to reduce dust, organic debris, and the microbial load in the surgical environment. O.R. (Operating Room) rooms should be cleaned before and after each surgical procedure and at beginning and end of the day. V. Procedure: A. General Guidelines. Whenever cleaning is performed, the following general principles must be observed: An EPA (Environmental Protection Agency) approved disinfectant is utilized (Ecolab A-456 II Disinfectant). The disinfectant is diluted according to the manufacturer's directions via provided dispenser. Follow the manufacturer's instructions regarding contact time for the disinfectant solution used. C. Between Case Cleaning - Environmental Services. 3. Clean and disinfect all items used during patient care, such as monitors, furniture, table straps, back table, mayo stand, ring stands, suction, bovie, kick buckets, and positioning devices, per the manufacture's cleaning instructions."
Review of the "Facilipro" manufacturer's for the disinfection product "A-456 II Disinfectant Cleaner", instructed as followed: "USE. Contact time: Leave surface wet for 1 minute (60 seconds) for HIV-1 and 10 minutes for HBV () and HCV () with fl. (fluid) oz. (ounce) per gallon use-solution. Use 2 fl. Oz per gallon of water to kill Adenovirus Type 5 and Type 7. Use a 10-minute contact time for disinfection against all other viruses, bacteria and fungi claimed."
8. In an observation and concurrent interview on 4/5/17 at 9:55 a.m., in the presence of the Nurse Program Manager of Perioperative Services (NPS) there was visible multiple, grey colored matter, which the NPS described as "dust", located on and inside the vents of Operating Room Suite 3 (total of four vents), Operating Room Suite 4 (total of four vents), and the Cystoscopy Room (total of two vents).
In an observation and concurrent interview on 4/6/17 at 9:45 a.m., in OR Suite 4 and in the presence of the Infection Control Preventionist and the NPS, both placed their hand over the vents and confirmed they were able to feel air flow into the OR Suite 4 from the vents, which would indicate the potential for the "dust" to be blown into the OR Suite. The hospital could not provide any policy and procedure that would indicate who or what department was responsible to ensure the vents of the OR Suites and Procedure Rooms were cleaned and the hospital could not provide any evidence when the last time the OR Suites and Procedure Room vents were cleaned.
9. In an observation and concurrent interview on 4/5/17 at 11:25 a.m., Surgical Technician (ST) 1 was in Operating Room Suite 2 with gloves donned and proceeded to collect a used suction canister (a disposable unit used to collect fluids from a patient by a suction device), the suction tubing and the Yankauer (an oral suctioning tool used in medical procedures). ST 1 then disposed the suction canister, the suction tubing and the Yankauer in the trash container. ST 1 took off her gloves and disposed of them in the trash container. ST 1 proceeded to touch the door handle of the sterile supply room's door located in the rear of the Operating Room Suite #2 without performing hand hygiene. ST 1 took airway supplies from the sterile supply room and brought them back into OR 2, again without performing hand hygiene when in the sterile supply room. The Nurse Program Manager of Perioperative Services (NPS) stated staff was to perform hand hygiene after they don gloves and that ST 1 should have performed hand hygiene after she had donned gloves and prior to entering the sterile supply room.
Review of the hospital's policy and procedure titled, "Donning (put on) and Doffing (take off) Personal Protective Equipment (PPE)", last reviewed on 6/14 instructed as followed: "PPE is defined by OSHA (Occupational Safety and Health Administration) as specialized clothing or equipment worn by an employee for protection against infectious materials. PPE include gloves, gowns/aprons, masks and respirators, goggles or face shields. In addition to using this equipment, it is important to put the equipment on and take it off in a manner that prevents contamination of hands or clothing. V. Procedure: Doffing Sequence. A. Gloves. 1. Remember the outside of the glove is contaminated. 2. Grasp the outside of the glove with other gloved hand; peel off the glove. 3. Hold removed glove in the palm of the gloved hand. 4. Slide the fingers of the ungloved hand under the wrist area of the remaining glove. 5. Peel glove off over the glove (in palm). 6. Discard gloves into the appropriate trash container. Perform HAND HYGIENE IMMEDIATELY AFTER REMOVING PPE."
Review of the hospital's policy and procedure titled, "Hand Hygiene", last reviewed on 4/15 indicated as followed: "III. POLICY: Handwashing is the single most important means of preventing the spread of nosocomial infection; therefore all employees will follow the procedures in this policy. V. Procedure: A. PERSONEL. 2. All personnel, whatever their duties, should wash or sanitize their hands frequently with soap and running water or if not visibly soiled an alcohol based hand rub. Hand hygiene should be performed: b) Before gloving and After removing gloves."
|VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES||Tag No: A0749|
|Based on observation, interview, and record review, the facility failed to assure that an effective program for controlling the spread of infections and communicable diseases was practiced through the use of appropriate PPE (personal protective equipment: gowns, gloves, masks and eye protection devices). This failure had the potential to cause a spread of infection in the hospital, as well as an increased in illness related to infections in other patients in the facility.
During an observation on 4/4/17 at 10:35 a.m., the Institutional Social Worker (ISW) was in Patient 6's room dressed in a disposable gown and gloves. ISW exits Patient 6's room carrying a clear plastic bag full of the MRSA ("a type of staph bacteria that is resistant to many antibiotics. In a healthcare setting, such as a hospital or nursing home, MRSA can cause severe problems such as bloodstream infections, pneumonia and surgical site infections. If not treated quickly, MRSA infections can cause sepsis and death."<CDC.GOV>) positive patient's trash and deposited it in a non-hazardous waste bag/container. Then ISW took her PPE off while in the hallway and placed it in the same non-biohazard container. She did not wash her hands until prompted.
During an interview on 4/4/17 at 10:40 a.m., ISW did not give a clear answer as to why she entered the hallway with trash and PPE and deposited the trash in a non-biohazard bag and removed her PPE in the public hallway.
During an interview on 4/3/17 at 3:35 p.m., Chief Nursing Officer (CNO) stated that under no circumstances would the patient (Patient 6) with positive MRSA in the nose be allowed out of the room without PPE. Said that staff is given yearly training in isolation procedures.