HospitalInspections.org

Based on observation, staff interview, and review of sterile processing procedures and records, the facility failed to ensure sterilization and HLD processes were performed and documented appropriately. The facility further failed to maintain a sanitary environment in patient care areas or enforce current guidelines for safe injection and hand hygiene practices (refer to A749). The cumulative effect of these deficiencies resulted in a determination that the hospital failed to meet the Condition of Participation for Infection Control.

Based on medical record review, policy and procedure review, and staff interview, the facility failed to ensure the right to formulate advanced directives was provided to 4 of 17 sample patients (#9, #13, #17, #18). The findings were:

1. Review of the 7/19/13 admission Consent for Service and Financial Responsibility for patient #9 showed the area of the form to determine the patients advanced directive status was blank.

2. Review of the 6/28/13 admission Consent for Service and Financial Responsibility for patient #17 showed the area of the form to determine the patients advanced directive status was blank.

3. Review of the 4/25/13 admission Consent for Service and Financial Responsibility for patient #18 showed the area of the form to determine the patients advanced directive status was blank.

4. Review of the 2/20/13 admission Consent for Service and Financial Responsibility for patient #13 showed the area of the form to determine the patients advanced directive status was blank.
5. Review of the facility policy and procedure for advanced directives showed it was last revised on 4/2008 and expired on 4/2009. According to this policy and procedure, "There shall be documented in the individual's medical record whether the individual has executed any advanced directives...in the event the individual does not have any advanced directives but would like to execute one or more, or would like additional information, the nursing coordinator will provide such information..."

6. Interview with the quality director on 8/1/13 at 8:25 AM verified the information on the consents was lacking for patients #9, #13, #17, and #18. He stated the documentation to verify whether the patients had advanced directives was in the EMR. However, after he reviewed the information in the EMR, he stated the documentation only showed each of the four patients did not have advanced directives; there was nothing further to show whether they were provided additional information if they wished to formulate advanced directives. At that time the director also confirmed the expired policy and procedure for advanced directives was the most current policy and procedure.

Based on observation, medical record review, staff interview, and review of QAPI activities, the facility failed to ensure all essential services were integrated into the QAPI program. The findings were:

1. Interview on 8/1/13 at 11:15 AM with the quality director revealed the facility had not had a structured QAPI program for over a year. He stated he collected and analyzed data related to core measures and this information was reported to the medical executive committee. He stated the medical executive committee "serves" as the QAPI committee. Review of the 10/3/12, 11/7/12, 12/5/12, 3/6/13, and 7/18/13 medical executive committee meeting minutes revealed the list of attendee's in the "members present" group were physicians and the attendees in the "other members" group was the quality director, CEO, director of credentialing and physician relations and CNO. Review of the meeting minutes failed to show how department and disciplines, other than physicians, participated, provided input, or demonstrated involvement in the overarching QAPI program. The minutes failed to include any assessment activities related to infection control, sterile processing, and information systems.

2. Lack of monitoring for quality improvement regarding infection control and sterile processing was noted during the following observations and review of logs (Refer to A749 for detailed evidence related to infection control concerns):
a. On 7/30/13 at 3:55 PM, improperly sterilized and stored instruments used in restorative dental procedures were observed.
b. On 7/30/13 from 7:15 AM to 7:45 AM, inaccurate and incomplete documentation for immediate-use sterilization procedures were noted during review of the sterile processing logs.
c. An accumulation of dust and debris was observed on an overhead air vent in substerile room A on 7/30/13 at 7:25 AM.
d. Observation on 7/30/13 at 2:25 PM of processed endoscopes revealed they were stored in a manner that exposed the instruments to contaminants.
e. Observation of the HLD process for a vaginal ultrasound probe on 7/31/13 at 3:05 PM revealed staff used an unclean sink that had not been disinfected for rinsing the probe.
f. On 7/30/13 from 10:35 AM to 1:20 PM, two anesthesiologists were observed using unsafe injection practices during the provision of care.
g. Three RNs were observed on 7/30/13 between 7:50 AM and 8:40 AM during the provision of care and each nurse failed to perform hand hygiene between glove changes.
h. Observation on 7/30/13 at 7:50 AM and 10:08 AM showed RN #4 did not immediately dispose of the needle after inserting an IV.
i. Unpackaged laryngeal scopes and guide-wires were observed in two anesthesia carts on 7/30/13 from 3:14 PM to 3:50 PM.
j. Interview with the outpatient surgery director and observation on 7/30/13 at 8:55 AM revealed the facility did not have a system for ensuring the portable computers in the pre and post-operative areas were routinely cleaned and disinfected.
k. The IP stated in interview on 7/31/13 at 9:20 AM that the infection control committee developed goals for its quality assessment processes; these goals were monitored at the committee-level and did not extend to hospital-wide QAPI activities.

3. Evidence regarding the lack of monitoring for quality improvement was noted during the following interviews and observations related to difficulties with accessing information through the EMR (Refer to A438 for detailed evidence related to EMR access concerns):
a. On 7/30/13 and 7/31/13 at various times during the day during review of medical records, the surveyors requested EMR information that included consent forms, advanced directives, discharge planning documentation, nursing notes, admission and nutrition assessments, history and physicals and care plans. The information systems technician, clinical informaticist, quality regulatory coordinator, and quality director were observed as they made unsuccessful attempts to find the information in the EMR.
b. On 8/1/13 at 9:20 AM the clinical informaticist acknowledged existing problems with the software and accessing information in the EMR. She also stated the information systems was not integrated into the hospital-wide QAPI program.

Based on staff interview and review of QAPI activities, the governing body failed to ensure an effective on-going QAPI program was developed and implemented. The findings were:

In an interview on 8/1/13 at 10 AM, the interim CNO revealed the facility's "Process of Improvement Plan" was outlined in the "Master Plan- Provision of Patient Care, 15-00 Policy and Purpose" document, approved October 2012. Review of the plan showed the facility objectives included annual review of the performance improvement program for appropriateness and effectiveness, and a requirement to establish yearly program goals. However, interview on 8/1/13 at 11:15 AM with the quality director revealed the facility had not had a structured QAPI program for over a year. He stated he collected and analyzed data related to core measures and this information was reported to the medical executive committee. He stated the medical executive committee "serves" as the QAPI committee. Review of the 10/3/12, 11/7/12, 12/5/12, 3/6/13, and 7/18/13 medical executive committee meeting minutes revealed the list of attendee's in the "members present" group were physicians and the attendees in the "other members" group were the quality director, CEO, director of credentialing and physician relations and CNO. This review revealed the committee's primary focus was issues and concerns that directly and indirectly impacted medical services. Review of the meeting minutes failed to show how department and disciplines, other than physicians, participated, provided input, or demonstrated involvement in the overarching QAPI program.

Based on observation and staff interview, the facility failed to ensure acceptable standards of practice for prompt disposal of used needles were followed during random observations of 2 of 4 patients (#25, #26) who received IV therapy. The findings were:

1. Observation of patient #25 during pre-operative care on 7/30/13 at 7:17 AM revealed RN #4 inserted the patient's IV and placed the used needle on the arm of the patient's chair. The RN connected the IV fluids, discarded other used supplies, and then moved the used needle from the chair arm to the sharps container.

2. Observation of patient #26 during pre-operative care on 7/30/13 at 10:08 AM revealed RN #4 inserted the patient's IV and placed the used needle on the arm of the patient's chair. At that time the needle fell from the chair arm to the seat cushion before the RN was able to retrieve it.

3. Interview with the interim CNO on 8/1/13 at 8 AM revealed the nurses were expected to follow the Lippincott standards of nursing practice. At that time she acknowledged the above observed practices were not an acceptable standard according to Lippincott.

4. According to Lippincott's Nursing Center.com, "Evidence Based Practice Network", Nursing 2013, accessed on 8/7/13, after an IV has been inserted, the nurse should "Dispose of the syringe and needle immediately into an approved sharps container."

Based on medical record review, review of policies and procedures and staff interview, the facility failed to ensure care plans for 18 of 18 sample patients (#1 through #18) were individualized, complete with measurable goals, updated when changes occurred and periodically evaluated. The findings were:

1. Review of the policies and procedures entitled "Provision of Patient Care, 15-00", approved 10/2012 showed "The nursing process (assessment, diagnosis, planning, intervention, and evaluation) provides the framework for the delivery of care and is documented for each hospitalized patient from admission through discharge." Review of the medical records for patients #1 through #18 revealed all had incomplete care plans. This review revealed one or more of the following elements were missing from the care plans:
a. Measurable goals and objectives.
b. Individualized care needs.
c. Revisions based on changes in condition and psychosocial needs.
d. Evaluation of the effectiveness of patient care interventions.

2. During an interview on 7/30/13 at 5 PM the director of clinical services verified the care plans were incomplete and lacked the required elements. She stated the care plan development problems were due to the EMR software and had been a concern for over a year. She also stated the nursing staff had discussed the problem, but there were no immediate plans to address these concerns.

3. On 8/1/13 at 9:20 AM the clinical informaticist stated she was responsible for staff education regarding the EMR system and staff were to report all EMR problems to her. At that time, she acknowledged existing problems with the software and accessing information in the EMR; but she was not aware of any problems with care plans.


27095

Based on observation, staff interview, and review of hospital policies and procedures, the facility failed to ensure hospital medical records were easily accessible. The findings were:

1. Interview with medical records director on 7/30/13 at 1 PM revealed the hospital began the initial stages of converting to an EMR system approximately 3 years ago. The director further stated all hospital departments were now contributing to the EMR system.

2. On 7/31/13 at 2 PM the director of quality provided a written copy of all hospital policies and procedures (P/P), numbered from 101 to 113, pertaining to medical records. Review of policy #102 (Access to Medical Records) revealed the last revision to the policy was 04/2008 with an expiration date of 05/2011. Review of two other policies (#104, #107) also revealed an expiration date of 05/2011. Review of all other P/P revealed no effective date, approval date, last reviewed date or expiration date. Specific review of policy #102 and a general review of all other P/P revealed none included information about the implementation of a hospital-wide EMR system.

3. On 7/30/13 and 7/31/13 at various times during the day, during review of medical records, the surveyors requested EMR information for 18 sample patient records (#1 through #18) including consent forms, advanced directives, discharge planning documentation, nursing notes, admission and nutrition assessments, history and physicals and care plans. The following staff were observed as they attempted to utilize the EMR system to retrieve the requested information: The information systems technician was observed on 7/30/13 at 2 PM. The quality regulatory coordinator was observed on 7/31/13 at 10:40 AM. The quality director was observed on 7/31/13 at 11:05 AM. At the time of the observations all acknowledged they were unable to access the requested information.

4. During an interview on 7/30/13 at 5 PM the director of clinical services verified the care plans were incomplete and lacked the required elements. She stated the care plan development problems were due to the EMR software and had been a concern for over a year. She also stated the nursing staff had discussed the problem, but there were no immediate plans to address these concerns.

5. On 8/1/13 at 9:20 AM the clinical informaticist stated she was responsible for staff education regarding the EMR system and staff were to report all EMR problems to her. At that time, she acknowledged existing problems with the software and accessing information in the EMR. She stated it was an on-going challenge as staff adjusted to the system. She also stated the information systems and current software problems were not integrated into the hospital-wide QAPI program.

Based on observation and staff interview, the facility failed to ensure adequately trained staff used appropriate hand hygiene while preparing food. The improper technique was noted during 1 of 1 observation of food preparations. The findings were:

1. Observation on 7/30/13 from 1:55 PM to 2:50 PM revealed two staff members who were working with food at that time. The following hand hygiene issues were identified:
a. At 2:15 PM cafeteria aide #1 was putting food away after the noon meal. During this task the aide wore disposable gloves. The aide handled the door knob of the kitchen entry door, the walk-in refrigerator door handle, and the dry store room door knob while putting items away. Although the gloves the aide wore became contaminated by these sources she failed to dispose of the gloves and perform hand hygiene. Instead she proceeded to handle additional food items and clean the cafeteria counters and tables wearing the same soiled gloves.
b. At 2:25 PM cook #1 was wearing disposable gloves while slicing tomatoes. While wearing the gloves, the cook handled the walk-in refrigerator door and returned to the preparation table with cold cuts to make sandwiches. Without removing the soiled gloves, the cook handled the bread and other ingredients to assemble the cold cut sandwiches.
c. Interview with the certified dietary manager (CDM) on 7/30/13 at 2:50 PM revealed she provided education monthly to staff and hand hygiene was covered. The CDM verified the staff members should always dispose of soiled gloves and wash their hands when contaminated. The manager further revealed there was no routine monitoring for checking the techniques; however, she stated she occasionally monitored hand washing when she worked in the kitchen.

2. According to Food Code 2009, U.S. Public Health Service, 2-301.14 When to Wash: FOOD EMPLOYEES shall clean their hands and exposed portions of their arms... "(E) After handling soiled EQUIPMENT or UTENSILS...(H) Before donning gloves for working with FOOD; and (I) After engaging in other activities that contaminate the hands."

Based on observation, staff interview, and review of sterilize processing records, the facility failed to ensure instruments used in restorative dental procedures were properly sterilized and stored between uses. The facility further failed to accurately and completely document immediate-use sterilization procedures in 2 of 2 substerile areas used for intraoperative sterilization. In addition, the hospital failed to maintain a sanitary environment in 1 of 2 substerile rooms, during 2 of 2 HLD observations, and 2 of 2 observations of anesthesia practices in the OR. The findings were:

1. Observation on 7/30/13 at 3:55 PM revealed a wheeled cart in a utility room located at the end of a corridor in the surgery area. The second drawer from the top of the cart contained surgical instruments; the following concerns were subsequently identified:
a. Of 55 surgical instruments discovered in the cart drawer, 36 were loose (unpackaged) and 19 were contained in transparent peel-open pouches ("peel packs"). Neither the instruments nor cart contained any information to document the dates, load numbers, autoclave numbers, or identification of the technician that sterilized the surgical instruments. Neither did any of the 19 peel packs contain an indicator to verify sterilize processing. Further, there were no partitions or rigid barriers in the drawer to protect the integrity of the packaged instruments from sharp or abrupt edges on the loose instruments.
b. The surgical services director stated in interview on 7/30/13 at 4:05 PM that the instruments in the wheeled cart were used for dental restoration procedures performed at the hospital; the cart was kept in the utility room until needed for a procedure, then rolled into the OR. He further stated that dental technicians were responsible for cleaning and autoclaving the instruments after their use in a dental procedure. He acknowledged that the lack of documentation to verify sterilize processing was not an acceptable practice and, further, was not consistent with facility policies and procedures. In addition, the director stated he was not sure if the loose instruments were cleaned and sterilized after each trip to the OR as is the facility policy for other surgical instruments; he affirmed his expectation that all instruments used in the OR should be packaged in peel packs or rigid instrument containers.
c. On 7/30/13 at 3:55 PM, a yellow plastic bag containing dirty linens was observed in the utility room housing the dental instrument cart. The surgical services director stated in interview during the observation that used linens from the day's surgery cases had been deposited in the linen bag. He acknowledged that commingling dirty linen and surgical instruments failed to safeguard the cleanliness of items intended for use in an OR.

2. Observation on 7/30/13 beginning at 7:15 AM revealed the facility maintained 2 separate substerile rooms for immediate-use autoclaves, cleaning supplies, and warming cabinets to service adjacent OR suites. The following deficiencies were discovered in the substerile areas:
a. A logbook was found in each substerile room and each contained record-keeping forms designed to capture information from immediate-use sterile processing. The forms included spaces, check boxes, and other cues to elicit data entry by staff. However, review of the logbooks on 7/30/13 beginning at 7:45 AM showed staff failed to accurately and completely document 4 of 14 records to verify that instruments were pre-cleaned prior to autoclaving, 2 of 20 records lacked lot numbers to track biological indicators, and 2 of 14 records failed to identify the patient(s) or cases involved in the immediate-use sterile processing. In addition, there were 3 records annotated with "dental instruments" that failed to identify the types and quantity of instruments processed through an immediate-use cycle.
b. Observation on 7/30/13 at 7:25 AM showed a significant accumulation of dust and debris on an overhead air vent located in substerile room A. The vent was located immediately above a warming unit for blankets and IV solutions. Horizontal surfaces on the warmer were also observed to have an accumulation of dust and debris. The substerile room opened into ORs #1 and #2.
c. The surgical services director stated in interview on 7/30/13 at 8:40 AM that immediate-use sterilization was controlled and monitored to ensure all processes were validated and controlled. He confirmed the lack of documentation and acknowledged the potential for problems if tracking specific instruments, cases, and patients was necessary to investigate post-operative infections or system failures. In addition, the director stated his expectation that substerile rooms be clean and free of dust and debris on all surfaces. The director further stated incomplete documentation was an on-going problem with the surgery staff.

3. Breaches in sanitary practices were observed in the endoscopy reprocessing work area and in a HLD process for a vaginal ultrasound probe. The following deficiencies were discovered:
a. On 7/30/13 at 2:35 PM while observing endoscopy reprocessing, the storage cabinet housing post-HLD endoscopes was observed with the door open (rolled up into the top of the cabinet); 5 post-HLD processed endoscopes were hanging in the cabinet. The clean storage cabinet was located in the same area used for reprocessing dirty endoscopes and, without the door closed, there were no other barriers to prevent liquid splatter or aerosols from entering the storage cabinet. The IP acknowledged in interview on 7/30/13 at 2:50 PM that the cabinet door should be kept closed to prevent contaminating clean endoscopy equipment.
b. Observation of the HLD process for a vaginal ultrasound probe on 7/31/13 beginning at 3:05 PM revealed staff #6 completed the disinfection process by rinsing the probe with tap water. She rinsed the probe in a shallow hand washing sink and the probe repeatedly touched the sides and bottom of sink. The sink had not been cleaned and disinfected after it was used by staff #6 to wash her hands. The IP acknowledged in interview on 7/31/13 at 3:30 PM that hand washing sinks are dirty and should not be used as a site for the final rinse of disinfected equipment.

4. According to the Center for Disease Control and Prevention (CDC) recommendations for Safe Injection Practices, updated 2011, the septum on the medication vial and intravenous ports should be disinfected before piercing. The following concerns were noted:
a. On 7/30/13 from 10:35 AM to 11:40 AM before and during the procedure for patient #26, anesthesiologist #1 was observed drawing up and administering intravenous medications to the patient. The observation revealed the anesthesiologist did not disinfect the septum on the medication vials prior to withdrawing medication into the syringe; nor did he disinfect the intravenous ports prior to administering each medication. Further observation revealed the anesthesiologist also inserted a needle into a medication vial and withdraw medication three times from the vial by reconnecting the syringe to the inserted needle.
b. On 7/30/13 from 12:52 PM to1:20 PM anesthesiologist #2 did not disinfect the septum on the medication vial and intravenous ports before piercing during observations of intravenous medication administration for patient #8.
c. During an interview on 8/1/13 at 8:25 AM the IP acknowledged the failure to disinfect the vials and intravenous ports according to the CDC recommendations was not an acceptable standard of practice.

5. The CDC Guideline for Hand Hygiene in Health-Care Settings, published in Mortality & Morbidity Weekly Report, RR-16, October 25, 2002, pp 32-33, strongly recommends healthcare workers perform hand hygiene after contact with patients, after contacting environmental surfaces in the vicinity of the patient, before and after potential contact with non-intact skin [such as a wound], and after removing gloves. The failure to follow the CDC guidelines for hand hygiene was noted during the following observations on 7/30/13:
a. At 7:50 AM RN #1 inserted an IV in patient #21's arm. The RN removed her gloves after the insertion was completed, donned another pair of gloves, and then discarded the used supplies, gauze and needle without performing hand hygiene.
b. At 8:28 AM after the physician completed an isotope injection for patient #8, RN #2 donned gloves to do the massage. The RN completed the massage, donned another pair of gloves, and then discarded the used vials, needles and gauze on the over-bed table. Hand hygiene was not performed between glove changes.
c. At 8:40 AM RN #3 was unable to insert an IV in patient #8's arm during the first attempt, but was successful in the second attempt. The RN changed gloves between the first and second attempts and after the second time. She wore the third pair of gloves to discard the used supplies. Hand hygiene was not performed between glove changes.

6. The following breeches in infection control practice were observed during IV insertion procedures on 7/30/13:
a. Observation of patient #25 during pre-operative care on 7/30/13 at 7:17 AM revealed RN #4 inserted the patient's IV and placed the used needle on the arm of the patient's chair. The RN connected the IV fluids, discarded other used supplies, and then moved the used needle from the chair arm to the sharps container.
b. Observation of patient #26 during pre-operative care on 7/30/13 at 10:08 AM revealed RN #4 inserted the patient's IV and placed the used needle on the arm of the patient's chair. At that time the needle fell from the chair arm to the seat cushion before the RN was able to retrieve it.
c. Interview on 8/1/13 at 8:25 AM with the IP revealed the above observations were not an acceptable standard of practice.

7. Observation with the surgical services director of two anesthesia carts on 7/30/13 from 3:14 PM to 3:50 PM revealed a drawer containing six unpackaged laryngeal scope blades intermingled with the packaged sterile blades. Further observation revealed a drawer in the second anesthesia cart contained two unpackaged laryngeal scope blades and two unpackaged guide-wires intermingled with the packaged sterile items. Interview with the surgical services director at that time revealed the unpackaged items should have been removed to ensure they were not used before they were reprocessed.

8. On 7/30/13 from 7:18 AM to 12:52 PM, three portable computers were observed in the hallway near the nurses' desk in the pre- and post-operative areas. Periodic observations revealed the nurses used the computers and the location of the computers allowed easy contact with family and visitors who walked in the hallway. Interview on 7/30/13 at 8:55 AM with the outpatient surgery director revealed there were policies and procedures and a schedule for disinfecting the portable computers in the post-acute care unit, but not for the computers in the pre and post-operative area. The outpatient surgery director also stated she did not know when the computers had been cleaned and/or disinfected.

Based on medical record review, staff interview and review of policy and procedure, the facility failed to ensure a discharge evaluation was completed for 4 of 4 sample patients (#1, #7, #11, #18) who required this evaluation. The findings were:

1. Review of the facility Utilization/Case Management Plan dated 2/12/13 showed the procedures for discharge planning included the admission nurse initiating a discharge assessment and planning process within 24 hours of admission. The plan further showed, "The hospital will develop a discharge plan for any patient with identified post-discharge needs and/or if the physician or patient/family requests that a discharge plan be developed." The plan failed to show an evaluation procedure to determine the likelihood of a patient needing post-hospital services and of the availability of the services. In addition, the plan failed to describe how the patient would be evaluated to show the patient's capacity for self-care or of the possibility of the patient being cared for in the environment from which he or she entered the hospital.

2. Interview with the director of case management on 8/1/13 at 9:45 AM revealed she was not aware of an evaluation or further assessment being done between the initial nursing assessment that identified anticipated discharge needs and the plan being started as documented in nursing notes. The director further checked the electronic medical record and identified a case management assessment that she stated should be completed when a patient was identified as having discharge planning needs. Review of this case management assessment showed an evaluation was also part of the care planning process. This review showed the evaluation contained documented information including the patient's social history, functional screen, place of residence, psychosocial status, level of independence, and discharge needs. The director verified this assessment/evaluation was currently not in use.

3. The following patients were identified as having anticipated discharge planning needs, and had no evaluation completed to aid in or provide directions for developing the discharge plan:
a. Review of the 4/25/13 admission patient assessment report for patient #18 showed anticipated discharge planning needs included "medications" and "transportation." Review of a nursing note dated 5/3/13 showed planning for transportation and medications was in process; however, the required evaluation was lacking.
b. Review of the 7/25/13 admission patient assessment report for patient #7 showed anticipated discharge planning needs were home health care as requested by the patient and/or family. Further review of the medical record failed to show any evaluation or further assessment of the patient's situation related to this need.
c. Review of the 7/21/13 admission assessment for patient #1 showed anticipated discharge planning needs for him/her included medications and transportation. Review of nursing notes showed on 7/23, 7/25 and 7/30/13, discharge planning related to medications, a home health agency, and long term care facility were in the planning process. However, review of the record failed to show the evaluation or further assessment related to the discharge needs and the patient's situation.
d. Review of the 7/29/13 admission assessment for patient #11 showed s/he had no anticipated discharge planning needs at that time. However review of the 7/29/13 history and physical, and a 7/30/13 nursing note showed the patient was removed from the heart transplant list, and s/he requested Hospice care. Review of the medical record failed to show further evaluation of the requested discharge need.