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Based on observation, policy review, review of manufacturer directions for use, and staff interview, the facility failed to monitor random hand sanitizers for expiration, maintain infection control practices for food storage, monitor staff handling of single use vials, and periodically monitor staff cleaning of equipment and terminal cleaning of the surgical suites. Hand hygiene sanitizers were expired in random areas of the facility. One of 3 patient care areas had food storage in a dirty utility room. One of 1 observation of a single dose vial previously used for patient care was available for use. Staff failed to follow disinfection instructions when cleaning a glucose monitoring device during 1 or 1 observation. Staff failed to follow acceptable practices for cleaning during 1 of 1 observation of terminal cleaning of a surgical suite. The findings were:

1. Observation and tour of the radiology department on 9/21/11 at 12:20 PM revealed two separate desks with alcohol-based hand sanitizers in pump bottles. Observation of each bottle showed an expiration date of February 2011. The radiology department manager at that time confirmed each was expired and discarded each bottle.
During tour of the operation (OR) areas and suites on 9/21/11 at 1:33 PM, observation showed an expired canister of alcohol-based hand sanitizer in the utility room near the emergency exit. The OR charge nurse present at the time, confirmed the product was expired and discarded the canister.

2. Observation of the dirty utility room in the outpatient surgery area on 9/19/11 at 2:52 PM revealed approximately 29 cases of soda pop (24 cans per case) stored on the counter in the dirty utility room between the sink and the hopper (a flushing sink similar to a toilet, used to dispose of body fluids and other wastes). Interview at that time with the surgery charge nurse revealed the cases were for patient use and should not have been stored in a dirty utility room. Review of the facility policy titled, "Storage of Food," appropriate storage of food will be maintained in order to prevent contamination.
According to the Food and Drug Administration, Food Code 2009, Chapter 3, 3-305.12,Food Storage, Prohibited Areas, "Food may not be stored: (A) In locker rooms; (B) In toilet rooms; (C) In dressing rooms; (D) In garbage rooms;..."

3. Observation during the facility tour on 9/19/11 at 2:52 PM with the medical/surgical nurse manager and the outpatient services charge nurse revealed a supply refrigerator located in the procedure room. The observation revealed a vial of Duraclon, which the outpatient charge nurse identified as a medication used for epidural procedures. Observation of the vial showed the cap off, and two puncture marks in the rubber stopper. The vial had a handwritten date, "9/14" on the label. Observation showed the manufacture label was for "single use". The outpatient charge nurse stated the facility required the vial to be discarded after one use. She confirmed the rubber stopper had two puncture marks.
Interview with the facility's pharmacy director on 9/22/11 at 8:51 AM confirmed that single used vials should be discarded after use.
According to Elkin, Perry, Potter, "Nursing Interventions & Clinical Skills," 4th edition, copyright 2007, Chapter 17, Administration of Injections, Page 420: "A single-dose vial is entered and then discarded, regardless of the amount of medication used."
According to the Centers for Disease Control and Prevention (CDC) website, www.cdc.gov/injectionsafety/providers/provider_faqs_singlevials.html, Vials labeled as single use should be used for a single patient and single case/procedure/injection. They cite occurrence of multiple outbreaks resulting from healthcare personnel using single use vials for multiple patients. They instruct the safest practice was to enter a single use vial once to prevent inadvertent contamination. They direct not to combine (pool) leftover contents of a single use vials or store single used vials for later use. They stated single use vials should be discarded after used.

4. Observation on 9/20/11 at 4:48 PM revealed certified nurse aide (CNA #1) used a glucose monitoring device. Prior to returning the device to its case, the CNA used a single "Santi Wipe", over the device and placed it in its container. The time to clean and store the device was approximately 30 seconds and observation and touching the device rendered it was dry. Review of the manufacturer's directions for use instructed for disinfection, the surface required wet contact for a full 2 minutes. It further instructed that multiple wipes may be required to maintain a wet surface for 2 minutes. When interviewed on 9/23/11 at 7:12 AM, the infection control coordinator confirmed disinfection required the manufacturer's instructions for use.

5. During a tour of the surgical suites and, interview with the surgical charge nurse on 9/21/11 at 1:33 PM showed terminal cleaning of the surgical suites was done by housekeeping after hours. The surgical charge nurse confirmed that they were not periodically monitored regarding technique. Interview with housekeeper #1 on 9/21/11 at 4:55 PM confirmed the surgical staff did not monitor the cleaning process. Observation of the terminal cleaning of OR #1 (operating room) from 5:02 PM to 5:52 PM showed the following infection control concerns:
a. Housekeeper #1 redipped a velcro head mop twice while using it to damp dust ceilings and walls, and then damp swept the room prior to floor mopping. Interview with housekeeper #1 after the ceiling cleaning which was the first time the velcro mop was re-dipped, the housekeeper stated she considered the ceiling and walls as clean. The floor mopping process was completed using a string mop head. This mop was redipped without changing the mop head or bucket water multiple times during the floor mopping process.
b. A second staff member, housekeeper #2, cleaned equipment. Observation showed, she wiped down part of the anesthesia machine, and knocked a plastic enclosed facemask onto the un-mopped floor surface. She then picked the mask up, and without cleaning the packaged mask surface, placed it on the cleaned surface of the anesthesia cart. She then cleaned an electrical cord contacting the un-mopped floor surface. It was attached to an intervenous (IV) pump device. She ran her cleaning cloth along the cord to the IV pump. Using the same cloth, she then cleaned the device and pole.
Interview with the infection control coordinator on 9/23/11 at 7:12 AM confirmed staff should change mop heads when mopping and should not re-dip the head. She stated when cleaning, the floor surface was considered the dirty surface. Surfaces should be cleaned from the most clean to dirty to prevent contamination.
Review of the facility's policy titled, "Operating Room Cleaning", instructed to double mop floor and disinfect all equipment and furniture. It instructed not using a double dip method.
According to AORN Recommended Practices for Environmental Cleaning in Perioperative Setting: Recommendation 1.c.1 "Reusable string and microfiber mops and cleaning cloths should be changed after each use. Used cleaning mops or cloths should not be returned to the cleaning solution container."

Based on observation, policy review, and staff interview, the facility failed to follow recognized dietary practices when storing food products in 1 of 3 random observations of patient care areas. The findings were:

Observation of the dirty utility room on the outpatient surgery area on 9/19/11 at 2:52 PM revealed approximately 29 cases of soda pop (24 cans per case) stored on the counter in the dirty utility room between the sink and the hopper (a flushing sink similar to a toilet, used to dispose of body fluids and other wastes). Interview at that time with the surgery charge nurse revealed the cases were usable and should not have been stored in a dirty utility room. Review of the facility policy titled, "Storage of Food," appropriate storage of food will be maintained in order to prevent contamination.
According to the Food and Drug Administration, Food Code 2009, Chapter 3, 3-305.12,Food Storage, Prohibited Areas, "Food may not be stored: (A) In locker rooms; (B) In toilet rooms; (C) In dressing rooms; (D) In garbage rooms;..."

Based on observation, staff interview, and medical record review, the facility failed to ensure an error free medication pass, the use of single use vials for one patient at one time, a tracking system of sample medications use in physician offices, and to ensure expired supplies were discarded. Medication errors were found for 2 of 45 random observations. The facility failed to ensure 1 of 1 single dose vial previously used for patient care was properly disposed. The facility failed to ensure a tracking system for sample medications in case of manufacturer recall for 2 or 2 physician offices visited that used samples. In addition, random observations throughout the facility revealed the availability of expired supplies. The findings were:

1. Observation on 9/20/11 at 10:03 AM revealed patient #1 received Celebrex 200 mg (milligrams) (used for arthritis) by mouth. Observation revealed the medication administration record (MAR) documented this medication and dose to be given daily. Review of the physician orders showed on 9/16/11 at 7:15 PM the physician had stopped the medication. No other orders to resume the medication were found. In addition, the same physician orders documented an increase in 'Protonix' (helps prevent acid erosion in the stomach/esophagitis) to 40 mg twice a day from a once a day schedule. Review of the MAR showed Protonix was never increased and remained at once a day. Interview at 10:35 AM on 9/20/11 and medical record review with the patient's registered nurse (RN) #1, confirmed the Celebrex had been discontinued and the Protonix should have been scheduled for a dose increase. Review of the MAR with the RN confirmed the patient received four doses of Celebrex after the discontinued order and the patient lacked four morning doses of Protonix. Review of the orders showed the medications were never transcribed to correct the MAR and to notify pharmacy of the changes.

2. Observation during tour of the facility on 9/19/11 at 2:52 PM with the medical/surgical nurse manager and the outpatient services charge nurse showed a supply refrigerator in the procedure room of the surgical area. The observation revealed a vial of Duraclon, which the outpatient charge nurse identified as a medication used for epidural procedures. Observation of the vial showed the cap off, and two puncture marks in the rubber stopper. The vial had a handwritten date, "9/14" on the label. The manufacture label was for "single use". The outpatient charge nurse stated the facility required the vial be discarded after one use. She confirmed the rubber stopper had two puncture marks.
Interview with the facility's pharmacy director on 9/22/11 at 8:51 AM confirmed that single used vials should be discarded after use.
According to Elkin, Perry, Potter, "Nursing Interventions & Clinical Skills," 4th edition, copyright 2007, Chapter 17, Administration of Injections, Page 420: "A single-dose vial is entered and then discarded, regardless of the amount of medication used."
According to the Centers for Disease Control and Prevention (CDC) website, www.cdc.gov/injectionsafety/providers/provider_faqs_singlevials.html, Vials labeled as single use should be used for a single patient and single case/procedure/injection. There have been multiple outbreaks resulting from healthcare personnel using single use vials for multiple patients. The safest practice is to enter a single use vial only once so as to prevent inadvertent contamination. So not combine (pool) leftover contents of a single use vials or store single used vials for later use. Single use vials should be discarded after used.

3. Interview with the medical surgical manager on 9/19/11 at 2:24 PM revealed the facility included physician offices and services. She stated the physicians and staff were hospital employees. Interview with hospital pharmacy director on 9/22/11 at 8:51 AM revealed if the physicians used medication samples, they would need a system to track them in case of recall. Tour and physician offices was done on 9/22/11. Interview with registered nurse (RN) #4 who worked in physician office "A" at 11:56 AM revealed samples were used by the physician. She stated they did not track lot numbers or samples given to patients. Interview with RN #5 who worked in physician office "B" at 12:14 PM confirmed the use of patient samples. She stated the sample information was documented in each patient record, but the office had no way of knowing which patients were given samples, or which samples, without going through each medical record. She stated they did not log medication samples.

4. Concerns related to outdated supplies available for patient use:
a. Observation of the procedure room housed in the outpatient area on 9/19/11 at 2:52 PM with the surgery charge nurse revealed Betadine skin preparations with an expiration date of June 2009.
b. Observation of the endoscope cleaning area on 9/20/11 at 11:16 AM revealed a container of reagent testing strips. Review of the label showed the strips were good for up to 90 days after opening the container, yet no open date was found. Interview at that time with the scrub technician and the surgery manager revealed neither knew when the container was opened or how long the strips had been used. The manager stated the unlabeled container need to be discarded and a new container obtained and dated.
c. Observation and tour of the radiology department on 9/21/11 at 12:20 PM revealed two separate desks with alcohol-based hand sanitizers in pump bottles. Observation of each bottle showed an expiration date of February 2011. The radiology department manager at that time confirmed each bottle was expired and discarded both bottles.
d. During tour of the operation (OR) areas and suites on 9/21/11 at 1:33 PM, observation showed an expired canister of alcohol based hand sanitizer in the utility room near the emergency exit. The OR charge nurse present at the time, confirmed the product was expired and discarded the canister.
e. Tour of physician offices owned by the facility and run by facility staff on 9/22/11 at 12:20 PM revealed an item labeled "Hand Piece Sheath" with an expiration dated of October 2006. Interview at that time with the medical assistant confirmed the sheath was used for equipment in the office and it had expired.

Based on observation, medical record review, staff interview and review of medical staff rules and regulations, the facility failed to safeguard the confidentiality of health information by restricting access to only those employees involved in patient care, quality assessment and utilization review, and health information management (C308). The facility also failed to ensure timely documentation and/or additions to history and physicals (C305); and to ensure medical records had timed and dated physician orders (C307). The cumulative effect of these deficiencies resulted in a determination the facility failed to meet the requirements for the condition of participation for clinical records.

Based on observation, review of medical staff rules and regulations, medical record review and staff interview, the facility failed to ensure timely documentation and/or additions to the history and physical (H&P) for 3 of 22 patient records (#8, #14, #22) who required an H&P. The findings were:

1. Medical record review for patient #8 showed s/he admitted on 9/20/11 at 5:48 AM for a right total knee surgery. A hand written H&P dated 8/16/11 was on the medical record prior to the surgery but additions or changes to the H&P were not found. The operating room record showed the patient went to surgery at 8:02 AM. A dictated H&P, done after the surgery on 9/20/11 at 11:01 AM, was present. Interview with medical/surgical nurse manager on 9/20/11 at 4:33 PM confirmed the H&P needed to present prior to surgery and updated if not documented 7 days before admission.

2. Review of the medical record for patient #14 documented s/he entered through the emergency department due to transieat ischemic attack on 4/7/11 and was admitted. Review of the H&P information showed it was dictated on 4/21/11 at 4:23 PM. Review of the medical record also showed the patient was discharged on 4/8/11, approximately 24 hours after admission. Review of the medical record with the registered nurse clinical application specialist on 9/23/11 at 9:45 AM confirmed the H&P was completed after the discharge.

3. Review of the medical record for patient #22 showed an H&P dated 7/5/11. The record showed the patient entered the hospital on 9/19/11 for right shoulder surgery. A review of the medical record with the charge nurse on 9/20/11 at 2:40 PM and interview at that time revealed she could find no evidence of a more current or an updated H&P in the record. She confirmed the H&P in the record was the only one available to staff. At 4:17 PM on 9/20/11 observation showed the physician for patient #22 delivered a hand written update to the H&P. It was dated 9/19/11 at 10 AM.

4. Review of the medical staff rules and regulations (dated May 2005), section 6.2, showed H&Ps needed entered in the record in a timely manner, needed to be written or dictated no more than seven days prior to admission, but within twenty-four hours after admission and if performed within 30 days prior to admission an "...interval admission note that includes all additions to the history and any subsequent changes in the physical findings must be recorded...."

Based on medical record review and staff interview, the facility failed to ensure 3 of 24 medical records (#14, #17, #20) reviewed had dated and timed physician orders. The findings were:

1. Review of the medical record for patient #14 revealed emergency department orders were not dated or timed for a 4/7/11 visit. Review of the record and interview with the registered nurse clinical application specialist on 9/23/11 at 9:45 AM confirmed the order lacked a date and time.

2. Review of the medical record for patient #17 revealed emergency department orders were not timed for a 4/18/11 visit. Review of the record and interview with the registered nurse clinical application specialist on 9/23/11 at 9:45 AM confirmed the order lacked a time.

3. Review of the medical record for patient #20 revealed emergency department orders were not dated or timed for a 5/10/11 visit. Review of the record and interview with the registered nurse clinical application specialist on 9/23/11 at 10:55 AM confirmed the order lacked a date and time.

Based on observation and staff interview, the facility failed to safeguard the confidentially of health information by restricting access to only those employee involved in patient care, and quality assessment and utilization review. The findings were:

Observation of the medical records department on 9/19/11 at 4:26 PM revealed it had a keyed lock for entry. The observation also revealed shelves of medical records. Interview with the medical records department manager at that time revealed newer records were electronically stored. The present records viewed were not locked. She dated that along with the medical record staff, both maintenance and housekeeping staff had keys to the department. She further explained maintenance needed access for life safety code reasons as well as maintenance issues that occurred when the area was not staffed. She stated housekeeping accessed the area after hours for cleaning responsibilities. She confirmed no staff were present while housekeeping worked.

Based on staff interviews and review of facility documentation, the facility failed to ensure all services were involved in the facility quality assurance program. The findings were:

Interview with the outpatient surgical charge nurse on 9/19/11 at 2:52 PM revealed the nurse anesthetists were a contracted service. Review of the facility's quality programs with the vice president of quality and support on 9/23/11 at 12:47 PM and interview at that time confirmed the nurse anesthetists were contracted services and had not provided nor were currently involved in any quality assurance.

Interview with the rehabilitation receptionist on 9/19/11 at 4:26 PM revealed the therapies department was a hospital contracted service. Review of the hospital's quality programs with the vice president of quality and support on 9/23/11 at 12:47 PM and interview at that time confirmed the therapies were contracted services. She stated they had not participated in nor had they provided the hospital with a quality improvement program.

During the facility tour on 9/19/11 with the medical surgical manager at 2:45 PM she stated that the physician offices housed on the fourth floor were services owned and billed by the hospital. She further stated the staff were hospital employees. Interview on 9/22/11 at 11:56 AM with registered nurse #4, who worked in physician office "A", revealed they had not participated in any facility quality program and were just getting started. When interviewed on 9/23/11 at 12:47 PM, the vice president of quality and support confirmed the physician offices service were not involved in any facility program for quality assurance.

Based on medical record review and staff interview, the facility failed to ensure an annual comprehensive assessment for 1 of 1 resident (#23) who required an assessment. The findings were:

Review of the medical record for resident #23 showed s/he was a swing bed resident who resided in the facility. Record review and interview with the registered nurse clinical application specialist on 9/22/11 at 10:15 AM confirmed the record did not contain an annual comprehensive re-assessment. Although the facility provided an indepth physical assessment, the facility was unable to provide evidence of interdisciplinary assessment information regarding psychosocial/mental well-being, activities, therapy needs, and nutrition since May of 2010. A second interview with the application specialist on 9/22/11 at 1:59 PM confirmed, after she review the medical records available, no recent comprehensive annual assessment was found.