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Tag No.: A0118
Based on interview, record review and policy review the facility failed to identify and resolve grievances appropriately and/or timely for two (#16 and #56) of seven discharged patients that filed a grievance. This practice had the potential to affect all patients that filed a grievance causing the continuation of the unwanted practice/care. The facility census was 33.
Findings included:
1. Record review of the facility's policy titled, "Grievance," reviewed 01/2016, showed the following direction for staff:
- A grievance is defined as an informal or formal written or verbal complaint that is made to the hospital by a patient, or the patient's representative regarding the patient's care, abuse, or neglect.
- When the complaint is not resolved at the time of the complaint by staff present the issue becomes a grievance.
- All calls/letters obtained after patient discharge regarding patient care issues will be considered a grievance.
-All complaints/grievances should be resolved within 20 business days, with the concerned party being notified by phone or mail within seven days regarding the status of the investigation.
- Upon resolution, the complainant will be contacted either by telephone (contrary to regulation) or in writing regarding the findings of the investigation, with actions taken to resolve the issue.
Record review of the facility's policy titled, "Patient Advocate Guidelines," reviewed 01/2016, showed the department manager, the Director of Nursing (DON), and/or Administrator will investigate the facts, and resolve the concern within ten days (contrary to the policy above). The appropriate manager, DON, or Administrator will notify the concerned party of the resolution to the concern.
2. Record review of a typewritten complaint regarding Patient #16, dated 11/16/15, showed the following:
- Patient #16's family member phoned the facility and complained that it was believed a staff member (Staff L), gave out confidential medical information to another outside party.
- Patient #16 was a patient in the facility from 10/27/15 through 11/13/15.
- Administrative staff investigated this allegation from 11/16/15 through 11/17/15, making this a grievance by policy and regulatory definition; however, the facility failed to identify this as a grievance.
- The complainant called the facility on 11/25/15 to ascertain the status of the grievance as the facility failed to promptly notify the complainant of the resolution.
3. Record review of a typewritten complaint regarding Patient #56, dated 11/17/15, showed Patient #56 phoned the facility with multiple complaints regarding her care during inpatient stays dated 10/01/15 and 10/12/15.
During an interview on 03/10/16 at 10:28 AM, the DON stated that she could not provide evidence of an investigation and that this was classified as a grievance, and could not provide evidence the facility notified the complainant of the resolution.
Tag No.: A0122
Based on interview, record review and policy review the facility failed to follow their policy for appropriately and/or timely investigation or status/resolution response for three (#16, #56, and #55) of seven discharged patients that filed a grievance. This practice had the potential to affect all patients that filed a grievance causing the complainant to be unaware of the status, or resolution, to their grievance. The facility census was 33.
Findings included:
1. Record review of the facility's policy titled, "Grievance," reviewed 01/2016, showed all complaints/grievances should be resolved within 20 business days, with the concerned party being notified by phone or mail within seven days regarding the status of the investigation. Upon resolution, the complainant will be contacted either by telephone (contrary to regulation) or in writing regarding the findings of the investigation, with actions taken to resolve the issue.
Record review of the facility's policy titled, "Patient Advocate Guidelines," reviewed 01/2016, showed the department manager, the Director of Nursing (DON), and/or Administrator will investigate the facts, and resolve the concern within ten days (contrary to the policy above). The appropriate manager, DON, or Administrator will notify the concerned party of the resolution to the concern.
2. Record review of a typewritten complaint regarding Patient #16, dated 11/16/15, showed the following:
- Patient #16's family member phoned the facility and complained that it was believed a staff member (Staff L), gave out confidential medical information to another outside party.
- Patient #16 was a patient in the facility from 10/27/15 through 11/13/15.
- Administrative staff investigated this allegation from 11/16/15 through 11/17/15.
- The complainant called the facility on 11/25/15 to ascertain the status of the grievance as the facility failed to notify the complainant of the status or resolution.
3. Record review of a typewritten complaint regarding Patient #56, dated 11/17/15, showed Patient #56 phoned the facility with multiple complaints regarding her care during inpatient stays dated 10/01/15 and 10/12/15.
During an interview on 03/10/16 at 10:28 AM, the DON stated that she could not provide evidence the facility notified the complainant of the status or resolution of this grievance.
4. Record review of a Patient/Customer Complaint/Grievance Form, dated 12/14/15, showed Patient #55's family member phoned the facility on that date to complain about destruction of hearing aides during a radiological procedure on 11/19/15. This grievance was not resolved until 02/25/16. Facility staff failed to provide written notification to the complainant of the resolution.
Tag No.: A0441
Based on observation, interview and policy review, the facility failed to ensure patient paper medical records were protected against unauthorized access (by individuals who were not providing care for those patients):
- In two areas (Medical-Surgical Unit chart completion room and Central Supply, store room where reserve hospital supplies were stocked) of three areas observed in the main hospital;
- When Maintenance staff and a hospital clinic staff were allowed to shred patient medical records; and
- In the Medical Records storage shed when maintenance staff and a van driver were left unattended with stored medical records.
This deficient practice had the potential to permit unauthorized individuals to access, review, and/or possibly alter the documented health information in patients' paper medical records located in those areas. The facility census was 33.
Findings included:
1. Record review of the facility's undated policy titled, "Corporate Compliance Program - Records Management," showed that all records shall be safeguarded against damage, unauthorized access and unauthorized alteration or destruction utilizing appropriate administrative, physical and technical safeguards, and shall be destroyed in a manner that protects the confidentiality of information.
Record review of the facility's policy titled, "Security Protocol for Morton Building Storage of Medical Records," dated 02/01/12, showed that if Maintenance staff was needed to assist with medical records, the Medical Records Department Manager (Co-Director), or her staff designee, would accompany them at all times.
2. During an interview on 03/08/16 at approximately 9:00 AM, Staff O, Co-Director of Medical Records stated that discarded (to be shredded) medical record information was shredded by Staff X, Maintenance Director, in the Central Supply store room.
3. Observation on 03/08/16 at 10:00 AM of the Central Supply store room, along with concurrent interview with Staff M, Director of Central Supply, showed a large gray trash bag filled with approximately 15 pounds of medical record information to be shredded. The bag, which laid beneath an industrial size paper shredding machine, was located inside the Central Supply store room, and approximately 15 feet from an exterior door that was unlocked. During the observation, staff entered and exited through the unlocked door, which was immediately adjacent to the hospital's loading dock (where food and supplies were delivered to the hospital from outside vendors). Staff M stated that Maintenance staff, couriers and House Supervisors (supervisory nursing staff) had keyed access to Central Supply after hours, and that the exterior door remained unlocked during business hours, even when there were no staff in Central Supply.
The observation showed that staff and/or non-staff had access to the Central Supply store room either through keyed access, or through the unlocked door, and therefore had access to the unprotected medical records.
4. Observation on 03/08/16 at approximately 10:30 AM of the Medical Records storage shed, along with concurrent interview with Staff O, showed a large storage shed which contained greater than 1000 inpatient and outpatient hospital medical records, including films from Radiology (x-ray) and clinic records. Inside the front entrance of the storage shed showed sawdust which covered the floor, and newly constructed, unfinished storage shelves stacked on the floor next to finished storage shelves which contained medical records and x-ray films. Staff O stated that maintenance staff would construct storage shelves in the storage shed, but were always attended by Medical Records staff.
During an interview on 03/08/16 at 1:05 PM, Staff X, Maintenance Director, stated:
- He was responsible for shredding approximately 95% of discarded (to be shredded) medical record information in the facility, which he completed every Monday.
- He shredded approximately 30 bags (large sized trash bags) full of medical records, which took him all day (approximately 5:00 AM until 3:00 PM).
- The gray trash bag of medical record information found in the Central Supply storage area was left by a courier for him to shred, sometime between Monday 03/07/16 at approximately 5:00 PM, and Tuesday 03/08/16, before 10:00 AM (17 hours).
- When he was unavailable to shred medical records, a staff member from one of the hospital clinic staff assumed the responsibility.
- He, along with two maintenance staff, and a hospital van driver, built shelving units in the Medical Records storage shed, while unattended by Medical Records staff.
- Medical Records staff were aware when Maintenance staff were in the Medical Records storage shed, because Medical Records' staff were required to unlock the storage shed for their access.
During an interview on 03/07/16 at 1:50 PM, Staff J, Geriatric Psychiatric (Gero-Psych) Director, stated that once a patient was discharged, the medical record was sent to a providers' dictation room (chart completion room) located on the Medical-Surgical (Med-Surg) Unit. Staff J stated that the chart completion room remained unlocked at all times.
5. Observation on 03/08/16 at approximately 10:15 AM, showed a chart completion room located next to the Med-Surg nurses' station. The door was open and unlocked, and contained 25+ medical records.
Observation on 03/09/16 at 12:20 PM, showed the chart completion room open, unlocked and unattended, and contained 17 medical records.
During an interview on 03/08/16 at 8:25 AM, Staff O, Co-Director of Medical Records confirmed the chart completion room remained unlocked at all times.
The observation showed that staff or non-staff had the ability or potential to access unsecured patient medical records.
Tag No.: A0466
Based on interview, record review and policy review, the facility failed to ensure procedural consent forms (Universal Consent) were authenticated (signed and dated) by the physician authorized to perform the procedure for two of two current patients (#9 and #24 and for one of six discharged patient (#44) records reviewed for authenticated consent forms. This had the potential for incomplete or erroneous information to be provided to the patient as well as the potential for wrong site/wrong surgeries/procedures. The facility census was 33.
Findings included:
1. Record review of the facility policy titled, "Procedural Guidelines Universal Consent," dated 06/15/15, showed the informed consent would be filled out in full, signed by the physician, and placed in the patient chart (medical record) prior to the surgical procedure.
2. Record review on 03/10/16 of current Patient #9's medical record showed a Universal Consent Form for Central Line placement (long, thin, flexible tube inserted into the arm or chest to administer medications or fluids) dated 03/08/16, which was not signed or dated by the physician authorized to complete the procedure.
3. Record review on 03/10/16 of current Patient #24's medical record showed a Universal Consent Form for Central Line placement dated 03/08/16, which was not signed or dated by the physician authorized to complete the procedure.
During an interview on 03/10/16, Staff BB, Licensed Practical Nurse, stated both Patient #9 and Patient #24's Central Line procedures had been completed.
4. Record review on 03/09/16 of discharged Patient #44's medical record showed Universal Consent Forms for the following:
- Central Line Placement dated 11/03/15, which was not signed or dated by the physician authorized to complete the procedure.
- Laparoscopic Cholecystectomy, possibly open (removal of the gallbladder, organ in the body, using small incisions or one large incision) dated 11/10/15, which was not signed or dated by the physician authorized to complete the procedure.
- Esophagogastroduodenoscopy (EGD, a procedure in which a thin scope with a light and camera at its tip is used to look inside the organs of the upper digestive tract) dated 11/15/15, which was not signed or dated by the physician authorized to complete the procedure.
Record review of the physician procedural reports showed that all three procedures were completed prior to the patient's discharge.
During an interview on 03/08/16 at 1:10 PM, Staff GG, Utilization Review, Licensed Practical Nurse, confirmed Patient #44's Universal Consent Forms were not signed by the physician and stated that physicians were required to sign all procedural consent forms prior to the initiation of the consented procedure.
Tag No.: A0621
Based on interview and record review, the facility failed to ensure the Registered Dietitian (RD):
- Provided a nutritional assessment (detailed investigation to identify specific nutritional problems, completed by a RD) for one patient (#48) of one patient reviewed, who showed increased risk for malnutrition;
- Provided follow up nutritional care when one patient's (#49) nutritional needs (inability to eat or drink the minimum required food/liquid intake to maintain well being) were identified, of one patient with nutritional needs reviewed; and
- Collaborated with Nursing Services and the Certified Dietary Manager (CDM) to ensure a consistent nutritional screening process (process of identifying patients who were already malnourished or at risk of becoming so, completed by nursing staff or CDM) for all patients. These failures had the potential to prevent or delay adequate nutritional care to patients who received tray service who were at nutritional risk (risk of malnutrition - defined by high, medium and low risk). The facility census was 33.
Findings included:
1. Record review of the facility's policy titled, "Nutritional Services Department, Nutritional Screening Assessment," dated 01/13/16, showed:
- Upon admission (within 24 hours of admit), nursing staff screened patients for nutritional risk and referred high risk patients to Nutrition Services.
- Patients not referred by nursing (for nutritional risk) were further screened by the CDM or RD within 72 hours of the admission, to further identify patients at risk;
- Acute care patients who were at low nutritional risk were re-evaluated every seven days.
2. Record review of a Service Agreement dated 04/01/2013 between the facility and Staff TT, RD, showed:
- She would monitor the screening of patients for nutrition intervention;
- Perform nutritional assessments;
- Monitor the adequacy of nutritional orders with documented recommendations; and
- Monitor the accuracy of diet service.
3. Record review of Patient #48's medical record showed:
- A History and Physical (H&P) dated 03/01/16 which documented the 95 year old patient was admitted with dementia (mental decline which affects daily life) with agitation and behaviors.
- An "Initial Physical Assessment - Nutrition Services" dated 03/02/16 and documented by Staff YY, CDM, showed that the patient was served a mechanical soft diet (food requires little or no chewing), ate 25-50% of her last two meals, low Albumin (measurement in the blood that can indicate malnutrition) at 3.3 (normal range 3.5-5.0) and high Blood Urea Nitrogen (BUN, measurement in the blood can indicate dehydration) at 23 (normal 7-18), and was at low risk for malnutrition.
- Nurses notes dated 03/02/16 through 03/07/16 showed out of 18 total meals; the patient ate none of her food for five meals, 25% of her food for nine meals and 50% of her meals for four meals.
- A follow up assessment dated 03/07/16 by Staff YY, CDM, showed the patient continued to screen at low risk for malnutrition.
During an interview on 03/09/16 at 2:17 PM, Staff TT, RD, stated the following about Patient #48:
- She consumed only 25-50% of served food;
- Required full assistance with eating;
- She would not be re-evaluated for the potential for malnutrition for another seven days; and
- "We are not meeting nutritional needs of the patient."
4. Record review of current Patient #49's medical record showed:
- An H&P dated 03/01/16, which documented that the 88 year old patient was admitted with dementia and agitation with behaviors.
- An initial assessment dated 03/02/16, documented by Staff YY, showed that the patient was served a mechanical soft diet, with no feeding assistance required, low Albumin of 2.7 and high BUN of 19, and was screened as low risk for malnutrition.
- A Nutritional Services Progress Note dated 03/04/16, documented by Staff EEE, RD, showed that the patient was at risk for malnutrition due to altered consistency (mechanical soft) diet, suboptimal intake at 50% of meals and advanced age, will leave note for doctor and follow up.
- As of 03/09/16 at 2:17 PM, there was no follow up related to the patient's nutritional plan by Staff TT or Staff EEE.
During an interview on 03/09/17 at 2:17 PM, Staff TT, RD, stated that Patient #49's nutritional needs were identified, but there was no follow up, and Nutrition Services was not meeting the nutritional needs of the patient.
During an interview on 03/09/16 at 2:17 PM, Staff YY, CDM stated that the facility had an inconsistent process for the nutritional screening of patients, and no collaboration between nursing staff and the CDM and RD.
Tag No.: A0629
Based on interview and record review, the facility failed to ensure the Registered Dietician (RD) provided a written low sodium (salt) menu with nutrient analysis (process of determining the nutritional content of food) of that menu for the Nutrition Service Department to use as a reference for patients who needed a low sodium diet. This had the potential to lead to poor patient outcomes when patients' sodium intake was not restricted, which could lead to increased blood pressure, heart disease and stroke. The facility census was 33. The therapeutic diet census was 14.
Finding included:
1. Record review of a Service Agreement dated 04/01/13 between the facility and Staff TT, RD, showed she would review and or alter existing menus, or develop new menus and monitor the accuracy of diet service.
2. Record review of current Patient #38's Nutrition Service kardex (quick summary of medical information used as a way to communicate important information about patients) which contained physician orders dated 03/08/16, showed she was prescribed a two gram sodium diet (unit of measure, low or restricted).
During an interview on 03/10/16 at 8:50 AM, Staff YY, Certified Dietary Manager (CDM), along with concurrent record review of therapeutic menus, confirmed that Patient #38 was on a two gram sodium diet. The Nutrition Services did not have a therapeutic menu or nutritional analysis for a two gram sodium diet, and therefore could not accurately provide a two gram sodium diet for that patient. Staff YY added that Staff TT, RD, was responsible for the review and approval of all menus used by the facility, and could not answer why there was not an approved two gram sodium diet.
Tag No.: A0631
Based on observation, interview and policy review, the facility failed to ensure the current Therapeutic Diet Manual was available to patient care staff to use as a diet reference, on three units (Medical-Surgical, Obstetrics and Intensive Care) of three units reviewed for availability. This deficient practice had the potential to permit staff to serve patients on therapeutic diets inappropriate or unapproved foods. The facility census was 33. The therapeutic diet census was 14.
Findings included:
1. Record review of the facility's policy titled, "Therapeutic Diets," dated 01/11/16, showed the facility used the American Dietetic Association Nutrition Care Manual as a guide for prescribed diets. The policy did not indicate if the Nutrition Care Manual was available to patient care staff.
During an interview on 03/09/16 at 8:20 AM, Staff YY, Dietary Manager, stated that the Nutrition Care Manual was available to all patient care staff through a link on the facility computers.
2. Observation and concurrent interview on 03/09/16 at 12:10 PM on the Obstetric Unit, showed Staff PP and Staff QQ, both Registered Nurses (RN):
- Searched through loose-leaf binders on a bookshelf in the Nursery;
- Were unable to locate the Nutrition Care Manual; and
- Stated that they would need to call in their manager to locate the Nutrition Care Manual.
3. Observation on 03/09/16 at 12:20 PM, on the Medical-Surgical (MS) Unit showed Staff D, Licensed Practical Nurse, searched through loose leaf binders on a bookshelf in the MS Nurses Station, but was unable to locate the Nutrition Care Manual without the assistance of Staff T, Registered Dietician (RD).
4. During an interview on 03/09/16 at 12:25 PM, Staff RR, Intensive Care Unit (ICU) RN, stated the Nutrition Care Manual was not located in the ICU.
During an interview on 03/09/16 at approximately 12:15 PM, Staff YY, Dietary Manager verified that the Nutrition Care Manual was located on all patient care computers and stated that she had sent emails to patient care staff to inform them of the Nutrition Care Manual's location.
Tag No.: A0747
Based on observation, interview, record review and policy review, the facility failed to ensure staff developed, implemented and followed infection control policies and standards when they failed to:
- Wear a surgical gown in the surgical suite operating room (OR) while surgical procedures were performed.
- Perform adequate sterilization/disinfection of surgical instruments used for the surgical procedures of tonsillectomy and adenoidectomy (T&A's, glands on each side of the throat and top of mouth behind the nose).
- Provide patient care measures to prevent catheter associated urinary tract infections (CAUTI'S).
- Document the date, time and staff initials on intravenous catheter dressing covers when IV's (small flexible tube inserted into a vein to deliver medications and fluids into the blood stream) were inserted and/or dressing applied.
- Perform hand hygiene (wash hands with soap and water or use hand sanitizer) and change gloves after touching contaminated inanimate objects (surfaces and/or equipment that was not clean) and prior to preparation and/or administration of medications. These deficient practices had the potential to significantly increase the risks of preventable healthcare acquired infections and cause harm by infection to all
patients, visitors and staff.
The cumulative effect of these systemic failures resulted in the facility's non-compliance with specific requirements found under the Condition of Participation: Infection Control. See details at A749.
Tag No.: A0749
Based on observation, interview, record review and policy review, the facility failed to ensure staff followed infection control policies and standards for patient care and Nutrition Services when they failed to:
- Wear a surgical gown in the surgical suite operating room (OR) while surgical procedures were performed on two patients (#34 and #35) of two patients observed in the OR.
- Perform adequate sterilization/disinfection of surgical instruments used for the surgical procedures of tonsillectomy and adenoidectomy (T&A's, surgical removal of small glands on each side of the throat and top of the throat behind the nose) for one of one T&A surgical instrument set observed.
- Obtain physician orders for urinary catheters (a small flexible tube inserted into the body through the opening of the urinary tract to drain urine) and failed to develop and implement policies that ensured patient care met standards to prevent catheter-associated urinary tract infections for three patients (#7, #8 and #9) of three patient's with urinary catheters.
- Document the date, time and staff initials on intravenous (IV) catheter (small flexible tube inserted into a vein through the skin to deliver medications or fluids into the blood stream) dressing covers for three patients (#62, #28, and #57 ) of seven patient IV dressing sites observed.
- Perform hand hygiene (washed hands with soap and water or used hand sanitizer) and change gloves after touching contaminated inanimate objects (areas/equipment that was not clean), and prior to administration of medications for five patients (#14, #20, #24, #29, #30) of 12 patients observed.
The facility also failed to ensure:
- Patient urinals were not placed on bedside tables and near food to prevent cross contamination for three patients (#22, #13 and #20) out of three patients observed.
- Staff cleaned equipment used in patient meal service.
- One of one staff (TT) wore hair restraint while in the kitchen.
- Food was stored to protect against cross-contamination and labeled with the date food was opened for three areas (kitchen, Geriatric-Psychiatric unit and Medical/Surgical unit) of three observed.
- Dishes, eating utensils and trays used in patient meal service, were washed in a dish washing machine at the appropriate water temperatures.
- Kitchen staff wore the minimal allowed jewelry during food service preparation.
- Staff used hand hygiene and gloves, and prepared patient food trays in a manner to prevent contamination or cross contamination of food during food service preparation.
- Staff covered patient eating utensils to prevent contamination of the utensils during meal tray delivery.
These deficient practices had the potential to increase the risk of infection and cross contamination and placed all patients, visitors, and staff at risk for infection. The facility census was 33.
Findings included:
1. Record review of the Center for Disease Control (CDC) Guidelines for Prevention of Surgical Site Infection, 1999, Standards for Attire in the Operating Room showed the following:
- CDC recommended that all healthcare facilities follow the standards of care/processes published by the Association for Advancement of Medical Instrumentation (AAMI) for surgical instrumentation disinfection/sterilization and measures of infection prevention;
- Sterile surgical gowns created a barrier between the surgical field and potential sources of harmful organisms (germs that cause infection);
- Surgical attire included surgical gowns; and
- All scrubbed surgical team members wear surgical attire (sterile surgical gowns).
2. Record review of the facility's policy titled, "Attire in the Operating Room", dated 04/17/14 showed all personnel entering the semi-restricted and restricted areas of the surgical suite shall be in OR attire which provided a barrier between personnel and patients and patients and the personnel, through which contamination may pass. The facility's policy listed the reference as the "Association of peri-Operative Registered Nurses (AORN) Standards, Recommended Practices and Guidelines, 2004 Edition.
3. During observation on 03/08/16 at approximately 8:50 AM through approximately 10:00 AM of surgical procedures and activity in the OR, showed Staff FFF, Surgeon, performed and/or evaluated the surgical removal of tonsil and adenoid tissues (T&A's, tonsillectomy and adenoidectomy, small glands located in the mouth) of Patients #34 and #35. Staff FFF did not wear a surgical gown that covered his scrub top and scrub pants while he performed surgical procedures on Patients #34 and #35.
During an interview at approximately 10:00 AM in the surgical services restricted area, Staff V, Registered Nurse (S) Surgical Services Manager, stated that Staff FFF did not wear a surgical gown during T&A procedures because he considered them "clean", not sterile procedures. She further stated that the facility policy did not provide guidance that, distinguished clean and sterile surgical procedures and gowns should always be worn while in the OR. She stated that staff followed the Surgeons preferences and he preferred to not wear a surgical gown for T&A procedures.
4. Record review of the CDC's, "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008", "Parameters for Flash Sterilization Cycles" (currently known as Immediate Use Steam Sterilization or IUSS, the shortest possible time between a sterilized item's removal from the sterilizer and its aseptic transfer to the sterile field), showed the following:
- Sterilize all surgical instruments according to AAMI (Association for the Advancement of Medical Instrumentation) guidelines;
- IUSS was "the process designated for the steam sterilization of patient care items for immediate use" ... and "only performed for patient care items that would be used immediately (e.g., to reprocess an inadvertently dropped instrument") ... and was not used for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time;
- IUSS ...was not to be used as a routine sterilization method because of the lack of timely biologic indicators (method of testing) to monitor performance, absence of protective packaging following sterilization, possibility for contamination of processed items during transportation to operating rooms, and use of minimal sterilization cycle parameters (i.e. time, temperature, pressure); and
- AAMI parameters for IUSS of non-porous surgical equipment (instruments used for surgical T&A's) included a minimum exposure time and temperature of three minutes at 132°C (degrees Celsius) or 270°F (Fahrenheit)
Record review of the facility's policy titled, "Sterile Processing", dated 02/12/15 showed staff guidance for high level critical cleaning and disinfection, decontamination and drying of surgical instruments with water temperatures of 194°F.
Record review of the Sterile Processing policy showed no guidance for the use of IUSS and did not provide the AAMI standard for temperatures to reach 270°F.
5. Observation and concurrent interview on 03/08/16 at approximately 10:30 AM, in the surgical services unit, showed Staff R, Surgical Sterile Processing Lead and Certified Scrub Technician (CST), performed IUSS for the disinfection and sterilization of one T&A surgical instrument tray. Staff R stated that:
- The facility had only one T&A surgical instrument tray (a specific set of surgical instruments for use during a T&A procedure).
- Staff FFF performed T&A surgeries consecutively (one surgery after the other), which required her to turn the tray around (sterilize quickly) immediately.
- She soaked, scrubbed, and allowed the instruments to air dry for 10 minutes before she single wrapped the tray, autoclaved (process of sterilization with pressure and high temperature steam) at a temperature of 270°F and returned them to the OR for use.
- She performed the same process on the T&A instruments for "years" and "as long as she can remember".
- She did not consider the process as IUSS ... because "the instruments air dried for 10 minutes and not three as defined as IUSS".
- She contacted other hospitals or went online (accessed information on the Internet) when she had a question or concern about surgical instrument sterilization/disinfection.
Staff R did not follow AAMI standards and performed routine IUSS for surgical instrument sterilization. Staff R used other facilities or the Internet for guidance of the sterilization process and not the facility Infection Control Professional (ICP) or Infection Control (IC) committee member(s).
6. During an interview and concurrent review of the facility's Infection Control Manual on 03/09/16 at 8:35 AM, Staff NN, RN, ICP stated that:
- She did not know that Staff FFF, did not wear a surgical gown into the OR during procedures or that he considered the T&A procedures "clean" and not sterile.
- The facility's P&P's for surgical attire applied to all surgical procedures conducted in the operating room.
- Staff FFF did not follow the CDC standards for appropriate OR attire.
- She was not aware of the routine use of IUSS for the T&A surgical instruments.
- IC standards prohibited routine IUSS.
- When IUSS was necessary, staff were required to document the event for IC surveillance purposes.
- Staff had not correctly interpreted IUSS definition which, resulted in a lack of reporting and surveillance of IUSS.
During an interview and concurrent review of the facility's Infection Control Manual on 03/09/16 at 2:20 PM, Staff NN, stated that:
- "We have a lot of old and outdated policies that aren't used", "We try to keep up with current standards of practice", however "we don't get to the policy updates", and ensuring "current standards of practice is in place is important and should be in the policies we actually use".
- She trusted staff to follow current AAMI standards and monitor their processes.
- The facility policies for sterile processing did not meet AAMI standards.
During an interview on 03/08/16 at 3:25 PM, Staff W, Surgeon, Surgical Services Medical Director and Chairman of the Infection Prevention Committee stated that staff discussed survey findings with him related to Staff FFF's failure to wear a surgical gown while he performed a surgical procedure. He was not aware of outdated surgical services policies. He stated that he was "embarrassed".
7. Record review of the "Healthcare Infection Control Practice Advisory Committee (HICPAC) Guidelines for Prevention of Catheter-Associated Urinary Tract Infections, 2009" (CAUTI'S, infections associated with the use of urinary catheters) showed that the CDC recommended HICPAC standards of care and guidance for facility-based criteria to prevent CAUTI's. Review of the standards included:
- HICPAC standards were essential for all healthcare facilities that cared for patients who required urinary catheterization (process of inserting a flexible plastic tube into the patient's bladder to drain urine).;
- Implementation of evidence-based guidelines for staff that addressed indications for catheter use, insertion and maintenance;
- Standard patient record documentation that included catheter insertion date, time and the name of individual who inserted and removed the catheter;
- Documentation of the initial and ongoing indication for use in the patient record for surveillance data collection; and
- Training and policies and procedures (P&P) for staff to support surveillance and evidence based urinary catheter use and outcomes.
8. Record review of facility's policy titled, "Catheterization: Intermittent/Indwelling Urinary ...insertion, removal and care of ..." dated 03/30/10, showed the following guidance for staff:
- General procedures for urinary catheterization insertion and care.
- Physician orders were required for placement of a urinary catheter.
- Review the patients need for continued use five days after insertion (HICPAC standard for review of catheter use is ongoing/daily).
Record review of the facility P&P did not include facility-based criteria/guidance for indications for initial insertion or continued use of urinary catheters or patient medical record documentation requirements that provided assessable surveillance data. HICPAC guidelines to prevent CAUTI's were not included in the facility P&P.
During an interview on 03/07/16 at 3:40 PM, Staff C, Licensed Practical Nurse (LPN), who had been assigned to the care of Patients #7, #8 and #9, stated that she did not know what the clinical indication was for urinary catheters. She stated that all patients admitted from nursing homes had urinary catheters inserted in the Emergency Department (ED). Staff C stated that she was not aware of "anything special" about urinary catheter use. She stated that she thought the facility ICP Nurse monitored urinary catheters for infections.
9. Observation on 03/07/16 at 1:55 PM on the Medical/Surgical (M/S) Unit showed Patient #7 had a indwelling urinary catheter
Record review of Patient #7's medical record showed:
- Date of admission 03/06/16;
- The patient resided in a nursing home prior to date of admission;
- No physician order for urinary catheter placement;
- No documented insertion date and time of the urinary catheter; and
- No documented indication for initial or ongoing need for the catheter.
10. Observation and concurrent interview on 03/07/16 at 2:05 PM on the M/S Unit showed Patient #8 had an indwelling urinary catheter. While in the patient's room, the patient's family, stated that the patient resided in a nursing home and staff at the nursing home had taught the family that urinary catheters were dangerous because they caused urinary tract infections. They stated that while at the nursing home, staff routinely placed the patient on the toilet to urinate or changed urine soiled bedding when necessary. The family stated that they did not know why the patient had a urinary catheter and worried about an infection.
Record review of Patient #8's medical record showed:
- Date of admission 02/29/16;
- The patient resided in a nursing home prior to admission;
- No documented date and time the urinary catheter was inserted;
- No documented indication for use;
- No physician order for urinary catheter insertion; and
- No documented initial or continued need for the catheter.
11. Observation on 03/07/16 at 2:55 PM on the M/S Unit showed Patient #9 had an indwelling urinary catheter.
Record review of Patient #9's medical record showed:
- Date of admission 03/01/16;
- The patient resided in a nursing home prior to admission;
- Nursing documentation on 03/01/16 of "Foley (brand name of urinary catheter) catheter placed";
- No physician order for urinary catheter insertion; and
- No documented indication for initial or continued need for the urinary catheter.
The facility staff failed to obtain a physician order for placement, document the date and time of catheter insertion and document indications for initial or continued need for catheters for Patients #7, #8 and #9.
12. During an interview and concurrent medical record reviews for Patients #7, #8 and #9 on 03/07/16 at approximately 4:00 PM, Staff F, RN Utilization and Review (UR, staff who review documentation as a a safeguard against unnecessary and inappropriate medical care from perspectives of medical necessity, quality of care and length of hospital stay) Manager, stated that she was responsible for the management of utilization review staff (nurses) who routinely reviewed medical records for patient care. She verified that patient care documentation was not found in the medical records related to urinary catheter insertion or indications for initial placement or need for continued use. She stated that UR staff did not collect and report urinary catheter use data.
13. Record review of the CDC Guidelines for the Prevention of Intravascular Catheter-Related (IV's, sterile tube inserted through the skin into a vein to deliver medications and/or sterile fluids into the bloodstream) Infections, 2011 showed the following standards and guidance to prevent blood stream infections associated with IV's:
- Maintain aseptic technique (procedure used to reduce the chance of contamination) for the insertion and care of intravascular catheters (applicable for tape when used to secure IV's).
- Perform hand hygiene and aseptic technique by washing hands with conventional soap and water or with alcohol-based hand rubs.
- Wear clean or sterile gloves when changing the dressing on IV catheters.
- Use sterile gauze or sterile, transparent, semipermeable dressings to cover the catheter site and catheter site dressings (applicable for tape use).
- Hand hygiene should be performed before and after ... inserting, replacing, accessing, repairing, or dressing an IV (applicable for all activity that requires accessing the IV including IV fluid and/or medication administration).
14. Record review of the facility's policy titled, "Intravenous Therapy (IV)," revised on 06/01/09, showed that all labeling of IV dressings should include date, time, and initial of nurse performing dressing placement.
15. Observation on 03/08/16 at 9:05 AM in Patient #62's room showed no date, time or initials on dressing covering IV site.
16. Observation and concurrent interview on 03/08/16 at 10:10 AM in Patient #28's room showed no date, time or initials on dressing covering IV site. Staff I, RN, stated that the IV dressing should have been dated.
17. Observation and concurrent interview on 03/09/16 at 11:37 AM in Patient #57's room showed no date, time or initials on dressing covering IV site. Staff AA, RN, stated that she didn't start the IV, but there should have been a date on the dressing.
During an interview on 03/09/16 at 3:07 PM, Staff WW, M/S Floor Manager, stated that all IV dressings should have been dated.
During an interview on 03/10/16 at 1:57 PM, Staff VV, Director of Nursing, stated that the IV dressings should have been dated, timed and initialed.
18. Record review of the facility's policy titled, "Hand Washing," dated 01/08/07, showed directives for staff to wash hands before and immediately after contact with each patient and after each and every contact with material that may be contaminated and/or potentially infectious.
19. Observation and concurrent interview on 03/09/16 at 11:27 AM, in Patient #29's room, showed Staff Z, LPN:
- Washed hands;
- Applied gloves;
- Picked up trash off of bedside table;
- Touched patient phone and contaminated computer;
- Scanned patient wristband; and
- Took patient's blood sugar with no hand washing or glove changes in between touching contaminated objects and the patient.
- Staff Z stated that he didn't notice that he picked up trash, touched computer and touched patient with the same gloves.
20. Observation and concurrent interview on 03/07/16 at 3:33 PM, in Patient #14's room, showed Staff I, RN, prepared to give an Intramuscular (IM) Injection of Decadron (steroid used to treat inflammation). Staff I:
- Washed hands and put on gloves;
- Placed medication vial on the contaminated computer keyboard;
- Typed on keyboard;
- Opened band-aid and laid band-aid on keyboard;
- Retrieved the medication vial from the contaminated keyboard and drew up the medication;
- Touched patient and gave IM injection; and
- Placed band-aid on patient's injection site.
- Staff I stated that she didn't know she couldn't place medications or patient care items on the computer keyboard.
21. Observation and concurrent interview on 03/08/16 at 9:40 AM, in the Rehabilitation Unit, showed Staff DDD, RN:
- Placed Patient #30's medications, including an insulin pen, needle, pill packets and a pill cutter, on the keyboard of the computer.
- Administered the medications to Patient #30, touching the keyboard of the computer many times, without sanitizing her hands, or the keyboard.
- Staff DDD stated that this was standard procedure for her. Staff DDD stated that the computer keyboard was shared by other nurses and it was cleaned one time daily; however, it had not been cleaned yet this day.
22. Observation and concurrent interview on 03/09/16 at 10:27 AM, in Patient #24's room, showed Staff B giving IV Merrum (antibiotic). Staff B:
- Washed hands and puts on gloves;
- Touched contaminated computer;
- Placed IV tubing on patient's bed;
- Touched patient;
- Wiped IV site with alcohol; and
- Started the IV Merrum.
Staff B stated that she didn't know that the computer was contaminated.
23. Observation and concurrent interview on 03/09/16 at 11:15 AM, in Patient #20's room, showed Staff Z hanging IV Erythromycin (antibiotic). Staff Z:
- Washed hands but failed to put on gloves;
- Flushed IV tubing;
- Labeled IV bag;
- Touched contaminated computer;
- Touched patient; and
- Started IV Erythromycin.
Staff Z stated that he realized later that he didn't put gloves on.
24. Observation and concurrent interview on 03/09/16 at 10:20 AM, in Medication room, showed Staff B, RN:
- Dropped medication vial on the floor;
- Picked it up but did not put on gloves or wash hands: and
- Drew up medication from vial with no alcohol preparation (cleaning top of vial with alcohol), breaking aseptic technique.
Staff B, RN, stated that she was nervous and should have had gloves on and prepared medication with alcohol.
25. Record review of the facility's policy titled, "Universal/Standard Precaution Guidelines," (blood and certain body fluids of all patients are considered potentially infectious) dated 02/2014 showed the directive for staff to use universal precautions to prevent cross contamination with the rational that all body fluids may be infected with an unknown pathogen.
26. Observation and concurrent interview on 03/07/16 at 2:10 PM in Patient #22's room showed the patient's urinal on the bedside table next to patient's water container. Staff Z, LPN stated that he normally didn't leave urinals on the bedside tables.
27. Observation on 03/07/16 at 3:33 PM in Patient #13's room showed the patient's urinal on the bedside table next to the food tray.
28. Observation on 03/09/16 at 11:15 AM in Patient #20's room showed the patient's urinal, with urine in it, on the bedside table next to the food tray.
During an interview on 03/09/16 at 2:37 PM, Staff WW, RN Department Manager, stated that she expected staff to keep the urinals off of the bedside tables.
During an interview on 03/09/16 at 4:00 PM, Staff VV, Director of Nursing, stated that she expected staff to keep the urinals off of the bedside tables and away from the food trays.
During an interview on 03/09/16 at 8:35 AM, Staff NN, ICP, stated that;
- UR staff reviewed patient urinary catheter placement and utilization through data collected during medical record review (the statement conflicted with information provided by Staff F, UR Manager during an interview on 03/07/16 at about 4:00 PM).
- She expected all staff to follow "all P&P's" while they maintained infection control practices.
- All staff received initial, annual and as needed infection control training that included hand hygiene, glove use as well as measures to prevent infection with IV placement, access, and medication administration.
- Medications placed or dropped onto a contaminated (not clean and designated for medication storage) surface were contaminated and were not to be administered.
- She was "embarrassed" and that she "failed to do a good job" ... and she knew "what needs to be done", ...but did not have the time.
- Infection control surveillance was conducted through daily meetings, reports and general "talking to each other" about patients;
- Much of the IC day-to-day multidisciplinary surveillance activity was informal and conducted through continuous communication, laboratory reporting, to physicians, patient care units, department managers and the IC staff.
During an interview on 03/08/16 at 3:25 PM, Staff W, Physician and Chairman of the Infection Prevention Committee stated that staff discussed survey findings with him related to infection control problems. He stated that he was "embarrassed".
29. Record review of the "Missouri Food Code for the Food Establishments of the State of Missouri," (MO Food Code) Chapter 4-601.11(A), dated 06/03/13, showed directives for Dietary staff to ensure food contact surfaces of equipment were clean to sight and touch.
30. Observation on 03/09/16 at approximately 9:30 AM in the kitchen food preparation area, showed a table mounted can opener with food debris on the blade and on the plate holding the can opener to the table, as well as metal can shavings on the gears.
During an interview on 03/09/16 at approximately 9:30 AM, Staff YY, Certified Dietary Manager (CDM), verified there were debris and metal shavings on the can opener. She stated that she did not realize the plate holding the can opener could be removed from the table for cleaning, and added that the can opener should be "cleaned after each use".
31. Record review of the "MO Food Code," Chapter 2-402.11 dated 06/03/13, showed the directive that dietary staff should wear effective hair restraints to prevent hair from contacting uncovered food, clean equipment and utensils.
32. Observation on 03/09/16 at approximately 11:30 AM, showed Staff TT, Registered Dietician (RD) entered the kitchen with chin length hair that was not restrained.
During an interview on 03/09/16 at approximately 8:20 AM, Staff YY, CDM, stated that anyone who entered the kitchen was required to secure their hair with a "hair net".
33. Record review of the "MO Food Code," Chapter 3-305.11 dated 06/03/13, showed the directive for Dietary staff to store foods protected against cross contamination and not exposed to splash, dust, or other contamination.
34. Observation on 03/09/16 at approximately 9:30 AM of the kitchen and food preparation area showed an uncovered plastic container which contained bulk onions, located beneath and adjacent to grills.
During an interview on 03/09/16 at approximately 9:30 AM, Staff YY stated that the container of bulk onions should have been covered with a lid to prevent contamination.
35. Observation on 03/07/16 at 3:50 PM, of the Geriatric-Psychiatric (Geri-Psych) Unit along with concurrent interview with Staff J, Geri-Psych Director, showed the patient refrigerator contained an opened, unsealed package of meat (appeared to be ham), which was undated, and fluid dripped from the meat to milk cartons stored on the shelf below. Staff JJ stated that the meat should be in a sealed container and dated with the time it was opened.
36. Observation on 03/09/16 at 12:20 PM, of the Medical-Surgical patient refrigerator, along with concurrent interviews with Staff TT, RD, and Staff YY, CDM, showed opened, undated cheese stored in a loosely wrapped plastic wrap that was not airtight. Staff TT and Staff YY confirmed that the cheese should be dated with the date it was opened, and stored in an airtight container.
37. Record review of the "MO Food Code," Chapter 4-203.12 (B) dated 06/03/13, showed directives for the Dietary staff to ensure water temperature measuring devices were accurate to plus or minus three degrees F of the intended range for use and Chapter 4-501.112 showed directive for staff to ensure ware washing equipment (dish washer), with hot water sanitization, reached 180 degrees F.
38. Observation on 03/09/16 at approximately 9:30 AM of the dish washing area, and concurrent interviews with Staff LL and Staff MM, Nutrition Service Staff, and Staff YY, showed the following:
- Staff LL operated the dishwasher and was unable to determine which temperature gauge to read for the wash cycle and for the rinse cycle without prompts from Staff YY;
- Staff LL was unable to read the temperatures gauges without significant difficulty;
- Staff LL stated that the rinse temperature should be between "150 -165" F;
- Staff MM stated that the rinse temperature should be between "160-170" F;
- Staff LL and Staff MM stated that they never needed to call maintenance due to out of range dishwasher temperatures; and
- Staff YY informed Staff LL and Staff MM that the temperature should be "180" F.
39. Record review of "Dishwasher Temperatures" from 01/01/16 through 03/08/16, showed of the 100 (copy readable) temperatures recorded:
- Seven temperatures ranged between 150-159 degrees F;
- Nine temperatures ranged between 160-169 degrees F; and
- Thirty temperatures ranged between 170-176 degrees F.
40. Record review of the "MO Food Code," Chapter 2-303.11 dated 06/03/13, prohibited dietary staff from wearing jewelry on their hands, except for a plain ring, such as a wedding band, while preparing food.
41. Observation on 03/09/16 at 11:35 AM, of the kitchen food preparation area, showed Staff OO, Cook, wearing a ring with a raised stone, while preparing patients' meal trays.
During an interview on 03/10/16 at 8:30 AM, Staff OO stated she was unsure of what jewelry she was allowed to wear during food preparation.
Observation on 03/09/16 at 8:20 AM of the kitchen showed Staff MM, Nutrition Service staff, wore a long, beaded lanyard (long cord or wire passed around the neck used to hold an object, such as an identification badge or reading glasses).
During an interview on 03/09/16 at approximately 8:20 AM, Staff YY stated that staff were allowed to wear minimal jewelry, such as a wedding band or wedding ring, and small earrings. Staff YY added that staff should not wear long, dangled jewelry (such as lanyards) because of the risk of food contamination and because she was unaware of how often the items were cleaned.
42. Observation on 03/09/16 at 11:37 AM, of the kitchen food service line, along with concurrent interview, showed Staff OO, Cook:
- Pulled reading glasses out from the inside of her shirt with gloved hands, grab a patient's plate, touched the patient's plate to her shirt, set down the plate on the food service counter and said, "I've got stuff all over my glasses and I can't see".
- Washed the palms of her hands with soap and water in a circular motion, and did not wash between her fingers.
- Continued to contaminate the food service plating process (process by which a patient's requested food is placed on the plate), when she repeatedly touched her gloved hands to her pants then touched plates, touched her glasses, failed to wash her hands between glove changes and touched the patients' plates to her employee badge.
During an interview on 03/10/16 at 8:30 AM, Staff OO stated:
- She should wash her hands before and after any task that would contaminate her hands;
- She should "probably" wash her hands between glove changes;
- She confirmed she contaminated the food service plates when she touched her badge to patient plates during the plating process; and
- She confirmed she contaminated the food service plates when she repeatedly touched her gloved hands to her pants, "I have a bad habit of doing that".
43. Observation on 03/09/16 at 11:37 AM, of the kitchen food service line showed Staff MM, Nutrition Service staff, drug her sleeve across milk cartons and wrapped food items when she reached into a refrigerator, which contaminated the tops of the food items. Staff MM also placed contaminated patient menus (menus that had been placed in each patient room for food selection, then collected by staff and sent to the kitchen) on top of the patient's eating utensils, then proceeded to the next patient tray and repeated the process without glove change or hand hygiene.
During an interview on 03/10/16 at 8:39 AM, Staff MM stated she was not concerned with contamination of milk and food products when she drug her sleeve across those items in the reach in refrigerator.
44. Observation on 03/09/16 at 11:45 AM, showed patient food trays were transported by open, mobile racks to four patient care units. The meal trays contained eating utensils that were not covered or sealed in a manner to protect from contamination when the trays were transported.
During an interview on 03/09/16 at approximately 9:30 AM, Staff YY, CDM stated patients' eating utensils were always delivered uncovered. "We never had a process for that (covering the eating utensils)".
During an interview on 03/09/16 at 10:45 AM, Staff NN, Infection Prevention Patient Advocacy and Assistant Director of Nursing stated:
- She made random observations of dietary staff, but had no concerns with hand hygiene or glove use;
- She made environmental rounds every other week, but found no uncovered food storage;
- She observed the dishwashing process, but had no concerns with dishwashing;
- She reviewed the dishwasher temperat
Tag No.: A0951
Based on observation, interview and policy review, the facility failed to ensure surgical services policies and procedures (P&P) were developed, implemented, followed and monitored to ensure they met recommended guidelines and standards of care for surgical services related to adequate supply of surgical instruments and guidance for disinfection/sterilization processes. The facility failed to ensure staff:
- Followed the Center for Disease Control (CDC) recommended standards and the facility policy for attire in the surgical suite operating room (OR) for two patients (#34 and #35) of two patients observed for tonsillectomy and adenoidectomy (T&A's, surgical procedures performed in the OR to remove small glands on each side of the throat and back of top of the throat behind the nose).
- Developed, followed and monitored adherence to P&P's that met the CDC's recommended standards of care for Immediate Use Steam Sterilization (IUSS, a sterilization process intended for emergency use only, a process that used the shortest possible time between a sterilized item's removal from the sterilizer and re-use in the OR) for T&A trays (a specific set of surgical instruments used during a T&A) .
- Developed, followed and monitored adherence to P&P's that met the CDC's recommended standards of care for the adequate supply of surgical instruments for T&A's.
- Provided comprehensive review and oversight of surgical services P&P's available for use by staff.
These deficient practices had the potential to cause harm through infection by the increased risks of cross contamination (spread germs) to staff and all patients who received surgical services. The facility census was 33. An average of two and one half T&A surgical procedures were performed monthly.
Findings included:
1. Record review of the CDC Guidelines for Prevention of Surgical Site Infection, 1999, Standards for Attire in the Operating Room showed the following:
- CDC recommended that all healthcare facilities follow the standards of care/processes published by the Association for Advancement of Medical Instrumentation (AAMI) for surgical instrumentation disinfection/sterilization and measures of infection prevention;
- Sterile surgical gowns created a barrier between the surgical field and potential sources of harmful organisms (germs that cause infection);
- Surgical attire included surgical gowns;
- All scrubbed surgical team members wore complete surgical attire (included sterile surgical gowns); and
- Adequate numbers of surgical instruments were to be maintained to meet the needs of patients and staff (to avoid delay in surgery and provide time for appropriate sterilization).
2. Record review of the facility's policy titled, "Attire in the Operating Room" dated 04/17/14 showed all personnel who entered the semi-restricted (area outside of the OR) and restricted areas (inside the OR) of the surgical suite shall be in OR attire which provided a barrier between personnel and patients and patients and the personnel, through which contamination may pass. The facility's policy listed the reference as the "Association of Peri-Operative Registered Nurses (AORN) Standards, Recommended Practices and Guidelines, 2004 Edition.
3. During observation on 03/08/16 at approximately 8:50 AM through approximately 10:00 AM of surgical procedures and activity in the OR, showed Staff FFF, Surgeon, did not wear surgical gowns when he performed and/or evaluated the T&A's for Patients #34 and #35.
4. During observation and concurrent interview on 03/08/16 at approximately 10:00 AM in the surgical services unit, Staff V, Registered Nurse (RN) Surgical Services Manager, stated that Staff FFF did not wear a surgical gown during T&A procedures because he considered them "clean", not sterile procedures. She further stated that the facility policy did not provide guidance that, distinguished clean and sterile surgical procedures and that gowns should "probably" be worn while in the OR. She stated that staff followed the Surgeon's preferences and he preferred to not wear a surgical gown for T&A procedures.
5. Record review of the CDC's Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, Parameters for Flash Sterilization Cycles (currently known as IUSS), showed the following AAMI guidance:
- Sterilize all surgical instruments according to AAMI guidelines;
- Flash sterilization/ IUSS was "the process designated for the steam sterilization of patient care items for immediate use" ... and "only performed for patient care items that would be used immediately (e.g., to reprocess an inadvertently dropped instrument) ... and was not used for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time;
- Flash sterilization/IUSS ... "was not to be used as a routine sterilization method because of the lack of timely biologic indicators (method of testing) to monitor performance, absence of protective packaging following sterilization, possibility for contamination of processed items during transportation to operating rooms, and use of minimal sterilization cycle parameters (i.e., time, temperature, pressure); and
- AAMI parameters for flash sterilization/IUSS of non-porous surgical equipment (instruments used for T&A's) included a minimum exposure time and temperature of three minutes at 132°C (degrees Celsius) or 270°F (degrees Fahrenheit.)
6. Record review of the facility's policy titled, "Sterile Processing", dated 02/12/15 showed staff guidance for high/level critical cleaning and disinfection, decontamination and drying of surgical instruments with water temperatures of 194°F.
Record review of the facility's P&P's did not provide AORN and/or AAMI standards and guidance for the use of IUSS, sterilization processes (temperature of 270°F) or adequate surgical supplies.
During an interview on 03/08/16 at approximately 10:30 AM, Staff R, Surgical Sterile Processing Lead/Scrub Technician (ST), stated that the facility had only one T&A surgical instrument tray (a specific set of surgical instruments for use during a T&A). T&A's were performed consecutively (one surgery after the other), and required her to turn the one T&A tray around (sterilize) quickly.
- The instruments were soaked, scrubbed, single wrapped, autoclaved (sterilization process by pressure, steam and high heat) at a temperature of 270°F and air dried for 10 minutes before the tray was returned to the OR for use.
- She had performed the same process on the T&A instruments for "years" and "as long as she can remember" and did not consider the process "IUSS because ... the instruments air dried for 10 minutes and not three as defined as IUSS".
- She requested additional T&A surgical instruments and they weren't ordered.
7. Record review of facility policies, CDC's recommended standards of care and observation of surgical procedures on 03/08/16 at approximately 8:15 AM through 10:30 AM, showed surgical services activity and P&P's did not meet CDC's recommended AORN and AAMI standards of practice related to surgical/OR attire and sterilization of surgical instruments.
8. During an interview and concurrent review of the facility's Infection Control Manual on 03/09/16 at 8:35 AM, Staff NN, RN Infection Control Professional (ICP) stated that:
- She did not know Staff FFF did not wear surgical gowns into the OR during T&A procedures and that there was not a separate definition for "clean" (not sterile) techniques in the OR.
- The facility's P&P's for surgical attire applied to all surgical procedures conducted in the operating room.
- She was not aware of the routine use of IUSS for T&A surgical instruments or that the facility only had one T&A set;
- Staff had not correctly interpreted IUSS definition.
During an interview and concurrent review of the facility's Infection Control Manual on 03/09/16 at 2:20 PM, Staff NN, stated "We have a lot of old and outdated policies that aren't used", "We try to keep up with current standards of practice however,... "we don't get to the policy updates",... and "ensure current standards are in place... it is important to prevent infections". She had "trusted" staff to know what the AORN and AAMI standards were, develop their own P&P's and follow them.
During an interview on 03/08/16 at 3:25 PM, Staff W, Surgeon, Surgical Services Medical Director and Chairman of the Infection Prevention Committee, stated that he was "embarrassed" because staff discussed survey findings with him related to the failure to wear a surgical gowns in the OR, routine use of IUSS, the lack of needed T&A trays and outdated P&P's that did not meet surgical services standards.
Tag No.: A1537
Based on observation, interview, record review and policy review the facility failed to:
- Assess specific activity interests of two (#2, and #20) current Swing Bed (SB-post-acute, skilled nursing care) patients of six reviewed.
- Assess specific activity interests within the policy timeframe of 48-hours from admission for two (#18 and #19) patients of six reviewed.
- Develop an activity care plan based on the activity assessment for six (#2, #17, #18, #19, #20, and #21) current Swing Bed patients of six reviewed.
- Develop and/or provide a monthly activity calendar to six (#2, #17, #18, #19, #20, and #21) patients of six reviewed.
- Provide specific activities, based on the patient's specific interests, to six (#2, #17, #18, #19, #20, and #21) current Swing Bed patients of six reviewed.
This had the potential to deny all Swing Bed patients of their physical, mental and social functionality. The total facility census was 33. The Swing Bed census was six.
Findings included:
1. Record review of the facility's undated policy titled, "Swing Bed -The Activities Program," showed the following:
- Every patient admitted to the SB program is individually assessed for activities.
- The Activity Director/Activity Coordinator (AD/AC) will discuss, with the patient, the type of activities the patient would like to be offered during their stay.
- The AD/AC will document the activity assessment and place in the patient's chart.
- Activities are offered daily by the AD/AC, nurses and/or nurse aides.
- Activities are documented daily.
- The activity program is continuously modified to meet the patient's needs.
Record review of the facility's document titled, "Patient's Rights," revised 02/2012, showed the patient had the right to participate in activities that meet their interest, physical, mental and social well-being. And, the right to a calendar of activities.
2. During an interview on 03/08/16 at 1:05 PM, Staff Q, SB Activity Director, stated the following:
- The activity assessment was to be completed in 48-hours of the patient's admission.
- Assessments were not completed over the weekend.
- Nursing staff were to offer activities over the weekend, and document provision of them.
- Staff Q did not develop an activity care plan for the patients, and never had.
- Activity calendars were not developed and/or provided to the patients.
During an interview on 03/08/16 at 1:55 PM, Staff K, SB Coordinator, stated that there was no activity calendar developed and/or given to the patients.
3. Record review of Patient #2's History and Physical (H&P), dated 03/05/16 showed the patient was admitted to the SB program on 03/04/16.
Observation, in the patient's room, and concurrent interviews on 03/07/16, showed the following:
- The patient was lying in bed, crying.
- The patient's family stated the patient was, "In here with nothing, crying for three days, and TV doesn't work from the remote." "She loved Christian music, liked to watch Dr. Phil on TV, and had a dog she missed."
- The patient repeatedly stated she wanted to "go home" (back to nursing home where she lived).
- Per observation and interview of the family, the patient was not provided with an activity calendar.
Record review of the patient's activity assessment, dated 03/07/16, showed no documentation of activity interests. An individual visit was documented; however, staff failed to provide an activity that met the patient's particular interest.
Record review of the patient's interdisciplinary care plan dated 03/04/16, showed on 03/07/16, staff failed to develop an activity care plan based on the patient's activity assessment, interests or needs.
4. Record review of Patient #20's H&P, dated 02/28/16 showed the patient was admitted to the SB program on 02/28/16.
Record review of the patient's activity assessment, dated 02/29/16, showed the patient's employment history, and mobility status. Staff failed to identify specific activity interests of this patient.
During an interview and concurrent observation on 03/09/16 at 11:02 AM, Patient #20 stated that staff had not interviewed him regarding his activity interests. He stated that he was, "laying there looking at the four walls." He stated that he had a history of being a farmer and running a bulldozer. He enjoyed western movies, reading a newspaper, watching the news and weather on TV, gardening, shopping on the Internet, and had a pet cat. There was no evidence of activity materials such as magazines, newspapers, movies, computer, etc.
Record review of the patient's activity documentation, from 02/29-03/08/16 showed staff failed to provide and/or document any activities that met the patient's particular assessed interests. Staff failed to document activities were provided over the weekend of 03/05-06/16.
Record review of the patient's interdisciplinary care plan dated 02/25/16, showed on 03/08/16, staff failed to develop an activity care plan based on the patient's activity assessment, interests or needs.
5. Record review of Patient #18's H&P, dated 02/28/16 showed the patient was admitted to the SB program on 02/27/16.
Record review of the patient's activity assessment, dated 03/01/16 showed staff failed to complete an activity assessment within the 48-hour timeframe. Individual and group visits were documented; however, staff failed to provide and/or document any activities that met the patient's particular assessed interests. Staff also failed to document any activities were provided over the weekend.
Record review of the patient's interdisciplinary care plan dated 02/29/16, showed on 03/08/16, staff failed to develop an activity care plan based on the patient's activity assessment, interests or needs.
6. Record review of Patient #19's H&P, dated 03/05/16 showed the patient was admitted to the SB program on 03/04/16.
Record review of the patient's activity assessment, dated 03/07/16 showed staff failed to identify specific activity interests until 03/09/16, or five days after admission. The patient had a history of being a farmer. Staff failed to provide and/or document any activities that met the patient's particular assessed interests.
Record review of the patient's interdisciplinary care plan dated 03/04/16, showed on 03/08/16, staff failed to develop an activity care plan based on the patient's activity assessment, interests or needs.
Observation on 03/09/16 at 10:58 AM, showed the patient in bed, resting. the room was quiet and dark. There was no evidence of activity materials such as magazines, newspapers, games, puzzles, etc.
7. Record review of Patient #17's H&P, dated 03/01/16 showed the patient was admitted to the SB program on 02/29/16.
Record review of the patient's activity documentation from 03/02-03/08/16 showed staff failed to provide and/or document any activities that met the patient's particular assessed interests. Staff also failed to document any activities were provided on a daily basis, on at least four occasions, including over the weekend.
Record review of the patient's interdisciplinary care plan dated 03/01/16, showed on 03/08/16, staff failed to develop an activity care plan based on the patient's activity assessment, interests or needs.
8. Record review of Patient #21's H&P, dated 03/01/16 showed the patient was admitted to the SB program on 02/29/16.
Record review of the patient's activity documentation from 03/01-08/16 showed staff failed to provide and/or document any activities that met the patient's particular assessed interests. Staff failed to document activities were provided over the weekend of 03/05-06/16.
Record review of the patient's interdisciplinary care plan dated 02/29/16, showed on 03/08/16, staff failed to develop an activity care plan based on the patient's activity assessment, interests or needs.