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Based on review of Board of Directors (Governing Body) Meeting Minutes for October 2014 through July 2015, Performance Improvement Plan, and interview, it was determined the facility failed to ensure the current QAPI (Quality Assessment Performance Improvement) Plan was approved by the Governing Body. The failed practice did not ensure the Governing Body was responsible for the QAPI program in the facility, and had the potential to affect any patient in the facility. Findings follow.

A. Review of Performance Improvement Plan revealed, "At least annually, the program is completely reviewed by the Quality Assurance Committee, the Medical Executive Committee, and the Governing Board ...Authority to conduct a Performance Improvement program is derived from the hospital's Governing Board which accepts ultimate responsibility for the program."
B. Review of the Board of Directors (Governing Body) Meeting Minutes for October 2014 through July 2015 revealed no evidence of the current QAPI Plan having been approved by the Governing Body.
C. During an interview on 10/06/15 at 1045, the Administrator confirmed there was no evidence the QAPI Plan had been approved.

Based on review of Performance Improvement Plan, QA (Quality Assurance) Meeting Minutes, Board of Directors (Governing Body) Meeting Minutes, and Medical Executive Committee (Medical Staff) Meeting Minutes for October 2014 through August 2015, and interview, it was determined the facility failed to ensure Medical Records was included in the facility's QA program. The failed practice did not ensure the Governing Body was responsible for all aspects of the facility and effected the Medical Records department. Findings follow.

A. Review of the Performance Improvement Plan revealed, "The program included all appropriate hospital services ...The program encompasses the following services and functions ...Medical Record Review."
B. Review of QA Meeting Minutes, Board of Directors Meeting Minutes, and Medical Executive Committee Meeting Minutes for October 2014 through August 2015 revealed no evidence of Medical Records being included in the QA program.
C. During an interview on 10/05/15 at 1020, the Quality Director stated each department should report quarterly and confirmed the lack of Medical Records QA.

Based on review of Board of Directors (Governing Body) Meeting Minutes for October 2014 through July 2015, Performance Improvement Plan, and interview, it was determined the facility failed to ensure the current QAPI (Quality Assessment Performance Improvement) Plan was approved by the Governing Body. The failed practice did not ensure the Governing Body was responsible for the QAPI program in the facility, and had the potential to affect any patient in the facility. Findings follow.

A. Review of Performance Improvement Plan revealed, "At least annually, the program is completely reviewed by the Quality Assurance Committee, the Medical Executive Committee, and the Governing Board ...Authority to conduct a Performance Improvement program is derived from the hospital's Governing Board which accepts ultimate responsibility for the program."
B. Review of the Board of Directors (Governing Body) Meeting Minutes for October 2014 through July 2015 revealed no evidence of the current QAPI Plan having been approved by the Governing Body.
C. During an interview on 10/06/15 at 1045, the Administrator confirmed there was no evidence the QAPI Plan had been approved.

Based on observation, interviews and review of policies of procedures, it was determined one of one Registered Nurse (#3) observed, failed to verify sliding scale insulin coverage prior to administering insulin to Patient (#5). The failed practice did not protect the patient from the risk of increased harm in the event of dosage error. The failed practice affected Patient #5 and was likely to affect any patient who received insulin by Registered Nurse #3. The findings were:

A. Observation on 10/06/15 at 1100 revealed Insulin sliding scale dosage of 3 units was prepared and administered to Patient #5 by Registered Nurse #3. On 10/06/15 at 1110 Registered Nurse #3 confirmed she did not verify the insulin dosage with a second licensed person prior to administering.
B. The Director of Nursing was interviewed on 10/08/15 at 1240 and stated " Nurses should double check insulin doses before giving it to the patient with another nurse. This is what is taught in Nursing School for safety."
C. Review of the facility policy "High Alert and Look-Alike/Sound-Alike Medications" revealed "The Institute for Safe Medication Practices (ISMP) defines high alert medications as drugs which have a heightened risk of causing significant patient harm when used in error." The hospital list of High alert Medications included insulin, subcutaneous and intravenous. The facility Targeted Medications list included insulin and potential error and consequences were: "Inappropriate insulin given due to look-alike and sound-alike errors, confusion of dose, incorrect sliding scale interpretations/order entry leading to dosing errors. Insulin errors have the potential to cause severe hypo/hyperglycemia. These effects may require extra monitoring, require treatment, or in severe cases may be fatal."

Based on clinical record review and interview, it was determined the facility failed to ensure verbal orders were dated and timed when they were signed for 27 (#1-#4, #7-#14, and #16-#30) of 30 (#1-#30) Patients. The failed practice did not ensure the physician signed the orders within 48 hours as stated in the Medical Staff Rules and Regulations and had the potential to affect any patient admitted to the facility. Findings follow.

A. Review of Medical Staff Rules and Regulations revealed, "Within 48 hours, verbal orders must be dated, signed, and authenticated by the ordering practitioner or other practitioner who is responsible for the care of the patient."
B. Review of clinical records revealed the following verbal orders were not dated and timed as to when they were signed:
1) Patient #1-10 of 10 orders
2) Patient #2-21 of 21 orders
3) Patient #3-17 of 17 orders
4) Patient #4-four of four orders
5) Patient #7-three of three orders
6) Patient #8-eight of eight orders
7) Patient #9-10 of 10 orders
8) Patient #10-13 of 13 orders
9) Patient #11-18 of 18 orders
10) Patient #12-24 of 24 orders
11) Patient #13-nine of nine orders
12) Patient #14-38 of 38 orders
13) Patient #16-four of four orders
14) Patient #17-21 of 21 orders
15) Patient #18-36 of 36 orders
16) Patient #19-19 of 19 orders
17) Patient #20-41 of 41 orders
18) Patient #21-51 of 51 orders
19) Patient #22-18 of 18 orders
20) Patient #23-25 of 25 orders
21) Patient #24-29 of 29 orders
22) Patient #25-16 of 16 orders
23) Patient #26-12 of 12 orders
24) Patient #27-29 of 29 orders
25) Patient #28-18 of 18 orders
26) Patient #29-48 of 48 orders
27) Patient #30-13 of 13 orders
C. During an interview on 10/09/15 at 1245, the Director of Nursing confirmed the verbal orders were not dated and timed when they were signed.

Based on clinical record review and interview, it was determined the facility failed to ensure History and Physicals were signed by the physician within 24 hours as stated in the Medical Staff Rules and Regulations for 17 (#3, #10-#12, #16, #18-#24, and #26-#30) of 31 (#1-#31)Patients. The failed practice did not ensure the physician had reviewed the History and Physical to ensure accuracy and had the potential to affect any patient admitted to the facility. Findings follow.

A. Review of Medical Staff Rules and Regulations revealed "The entire H&P (History and Physical) (including any applicable update) must be performed and documented and in the record within 24 hours, including the update to a previously performed H&P ...All history and physicals shall be authenticated."
B. Review of clinical records revealed the following:
1) Patient #3 was admitted on 09/18/15, the H&P was not signed at the time of record review on 10/09/15.
2) Patient #10 was admitted on 09/22/15, the H&P was not signed at the time of record review on 10/09/15.
3) Patient #11 was admitted on 09/02/15, the H&P was signed on 09/08/15.
4) Patient #12 was admitted on 09/04/15, the H&P was signed on 09/10/15.
5) Patient #16 was admitted on 08/31/15, the H&P was signed on 09/07/15.
6) Patient #18 was admitted on 07/22/15, the H&P was signed on 08/24/15.
7) Patient #19 was admitted on 07/21/15, the H&P was signed on 07/29/15.
8) Patient #20 was admitted on 06/08/15, the H&P was signed on 07/10/15.
9) Patient #21 was admitted on 07/02/15, the H&P was signed on 07/23/15.
10) Patient #22 was admitted on 08/03/15, the H&P contained no date as to when it was signed.
11) Patient #23 was admitted on 07/21/15, the H&P was signed on 07/29/15.
12) Patient #24 was admitted on 07/17/15, the H&P contained no date as to when it was signed.
13) Patient #26 was admitted on 08/26/15, the H&P was signed on 09/07/15.
14) Patient #27 was admitted on 08/27/15, the H&P was signed on 09/07/15.
15) Patient #28 was admitted on 08/28/15, the H&P was signed on 09/07/15.
16) Patient #29 was admitted on 07/04/15, the H&P was signed on 07/23/15.
17) Patient #30 was admitted on 08/17/15, the H&P was signed on 09/07/15.
C. During an interview on 10/09/15 at 1245, the Director of Nursing confirmed the History and Physicals were not signed within 24 hours.

Based on review of the Controlled Substance Audit Records (CSAR), review of Policy #9.2 (Pyxis Medstation 4000-Nursing), and interview, the facility failed to ensure two nurses ran a discrepancy report and documented whether controlled substance discrepancies were present at the change of shifts for one of one Pyxis Medstation 4000 located on the medical/surgical nursing unit. Lack of evidence of this review and documentation affected accountability of controlled substances. Findings follow:

A. A tour of the facility was conducted on 10/05/15 between 1000 and 1110. The CSAR for Pyxis Medstation 4000 located on the medical/surgical nursing unit was reviewed on the tour for the time period 09/01/15-09/30/15. The review revealed sixteen of sixty shifts lacked two signatures of nurses reviewing the presence of controlled substance discrepancies at the change of shifts as required by hospital policy.
B. Policy #9.2 (Pyxis Medstation 4000-Nursing) was reviewed on 10/06/15 at 1000. The policy revealed two nurses were to run and document a discrepancy report at the change of shifts.
C. During an interview on 10/06/15 at 1015, the Director of Pharmacy verified sixteen shifts lacked evidence two nurses ran and documented a discrepancy report.

Based on observation and interview, the facility failed to ensure outdated intravenous (IV) solutions were not available for patient use on one of two emergency carts located in the facility. The potential existed for outdated IV solutions to be administered to 10 patients, if ordered, on the medical/surgical nursing unit. Findings follow:

A. A tour of the facility was conducted on 10/05/15 between 1000-1110. Three of three IV solutions of Sodium Chloride 0.9% 1000 milliliters (ml) were observed to be outdated on the emergency cart maintained on the medical/surgical nursing unit. Two of the IV solutions expired 11/01/14 and one IV solution expired 01/01/15.
B. An interview on 10/05/15 at 1055, the Nurse Educator/Procedure verified the IV solutions were outdated and available for patient use.

Based on observation, review of MetriCide 30 plus Solution Log, MetriCide Plus 30 manufacturer's directions for use, policies and procedures and interview, it was determined the facility failed to follow manufacturer's guidelines for use to ensure the test strips were not used past 90 days of opening and failed to ensure the MEC (minimum effective concentration) was checked prior to each use. Failure to ensure manufactures guidelines were followed did not assure the efficacy of the test strips or the MEC of the high level disinfectant solution prior to each use. The failed practice affected 23 patients listed on the Procedure log from 04/01/15 through 10/05/15 and was likely to affect any patient who has a procedure at the facility. The findings were:

A. Observation on 10/05/15 at 1035 revealed a MetriCide Test Strip bottle in the reprocessing area that was identified by the Procedure Nurse as in use. The MetriCide Test Strip bottle was not dated when opened. Review of the MetriCide 30 Plus Solution Log revealed the statement on the back of the log "09/09/15 New Strips (positive) full strength and (negative) one-half strength test results." The log did not include information that identified the test strip bottle open at the time of observation as the same one listed as opened 09/09/15. Review of MetriCide Plus test strip manufacturer's directions for use revealed: "Warning: Use test strips within 90 days of opening bottle."
B. Review of the policy "Endoscope Cleanser and Disinfectant" on 10/05/15 revealed "Procedure: ...Test Strips ...The test strips must be in date and labeled as having been opened less than ninety days prior to use."
C. The Procedure Nurse confirmed the MetriCide Test Strip bottle was not labeled and the log did not include information to identify the test strip bottle that was open at the time of observation 10/05/15 at 1035.
D. Review of the MetriCide 30 Plus Solution Log on 10/05/15 and 10/07/15 revealed MEC testing of the solution from 04/08/15 through 10/07/15 was documented one time per day when the procedure room was in use. Review of the Procedure Room Log on 10/07/15 at 1645 revealed 23 patient names listed on the log from 04/01/15-10/07/15. There were two procedures documented as performed on the same day on: 04/30/15, 07/24/15, and 08/31/15. The Procedure Nurse confirmed by interview on 10/05/15 at 1015 that testing of the MEC was not performed prior to each use of the high level disinfectant solution, MetriCide 30 Plus.
E. Review of manufacturer's guidelines for MetriCide Plus 30 (glutaraldehyde 3.4%) 28 day sterilizing and disinfecting solution on 10/05/15 revealed "...in addition it is recommended that the MetriCide 30 plus solution be tested with 1.8% glutaraldehyde concentration indicator prior to each usage. This is to ensure that the appropriate concentration of glutaraldehyde is present and to guard against a dilution which may lower the effectiveness of the solution its MEC."


Based on observation, review of policy and procedure, Centers for Disease Control and Prevention (CDC) Guidelines and interview, it was determined the facility failed to assure laryngoscope blades were not contaminated while stored in that they were not packaged or protected from potential sources of contamination for six of six laryngoscope blades observed in the Procedure Room. Patients would not be protected from sources of infection and the failed practice is likely to affect any patient who required intubation in which the laryngoscope blades were used. The findings were:

A. Observation on 10/06/15 from 1445-1500 revealed a crash cart in the Procedure Room. The crash cart had a hanging clear plastic bag that contained forceps, batteries, endotracheal tubes and three laryngoscope blade holders. Also in the bag, not packaged or protected and among the other items listed, were three laryngoscope blades: (two) three millimeter and (one) four millimeter blade. The plastic bag had a hole torn in the bag. In the top sliding airway drawer of the cart were three laryngoscope blades. The blades were not packaged or protected from potential sources of contamination. The Procedure Nurse and Respiratory Therapist confirmed the observed manner of laryngoscope blade storage at the time of observation.
B. In an interview with the Procedure Nurse and Respiratory Therapist on 10/06/15 at 1500 they stated they were not aware of what infection control standards were followed regarding storage/processing of the laryngoscope blades. The Infection Control Nurse was interviewed 10/06/15 at 1510 and stated the facility followed the CDC guidelines and training was conducted 04/22/15.
C. Review of CDC "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008" revealed "Semi critical Items ...this category includes respiratory therapy and anesthesia equipment, some endoscopes, laryngoscope blades ..." "After rinsing, items should be dried and stored (e.g., packaged) in a manner that protects them from recontamination."


Based on observation and interview, it was determined four of four Airtraq Guided Video Intubation supplies in the Respiratory Storage area were expired. Failure to ensure only currently dated supplies were available did not assure the integrity of the product. The failed practice was likely to affect any patient that was intubated using the product. The findings were:

Observation on 10/05/15 at 1025 revealed four of four Airtraq Guided Video Intubation supply packages expired 05/11/14. The expired supplies were confirmed by Respiratory Therapist #1 at the time of observation.


Based on observation and interview it was determined the facility failed to assure items identified as clean and packaged sterile items were stored to prevent contamination in one of one area across from the Procedure Room. Prevention of possible contamination and maintenance of a sanitary environment could not be assured. The failed practice likely affected any patient who had a procedure at the facility. The findings were:

Observation on 10/05/15 at 1005 revealed storage in an alcove area across from the Procedure Room that included a mixture of clean, sterile and a wooden items such as: shoe covers, hair covers, two large carts with positioning pads, restraints, cushions, bed equipment, x-ray protectors, four walkers and carts with sterile supplies. On one of the carts with boxes of shoe covers and hair covers, a long piece of unfinished wood with nails was observed. The Procedure Nurse stated the area was "storage" from one of the patient rooms and confirmed the findings at the time of observation.


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Based on observation and interview, it was determined one of one surgical hand scrubs, ten of ten Micro-organism Collection and Transport Systems, and seven of seven Wound Vac (Vacuum) Tubing Caps were expired. Failure to have currently dated surgical hand scrub available for physician use did not ensure the cleanliness and adequacy of the physician ' s surgical hand scrub; failure to have currently dated Micro-organism Collection and Transport Systems available for use had the potential to effect culture results; failure to have current Wound Vac Tubing Caps available had the potential for non-sterile items to be introduced into a wound. The failed practices affected all patients whose procedure was performed in the procedure room since 07/01/2015, patients whose care required any equipment cultured in the Processing Room and any patient whose care required a wound vac system. Findings follow:

A. During the tour of the facility the following items were found to be expired:
1) In the Procedure Room at 1000 on 10/05/15 the Chlorhexidine Gluconate Surgical Hand Scrub was observed to have expired 06/15. During an interview with the Nurse Educator/Procedures at 1010 on 10/05/15 she verified the above findings.
2) In the Processing Room at 1330 on 10/05/15 ten of ten Micro-organism Collection and Transport Systems were observed to have expired 06/13/13, 09/22/14 and 07/31/14. During an interview with the Nurse Educator/Procedures at 1330 on 10/05/15 she verified the findings in 1. and 2.
3) In the Wound Vac/Clean Mattress Room seven of seven Wound Vac Tubing Caps were observed to have expired 08/12.
B. During an interview with the Nurse Educator/Procedures at 1335 on 10/05/15, she verified the Wound Vac Tubing Caps were expired.

Based on observation, policy and procedure review and interview, it was determined the facility failed to ensure only currently dated Lidocaine was available for patient use in one of one Lidocaine bottle. Failure to ensure only currently dated medication was available for patient use had the potential to decrease the efficacy of the medication. The failed practice affected any patient whose PICC (Peripherally Inserted Central Catheter) was placed after 09/15/15. Findings follow:

A. During the facility tour at 1350 on 10/05/15 a multidose vial of Lidocaine 1% (percent) was observed in the PICC insertion tray with a date of 08/17/15 handwritten indicating the date the vial was opened. 09/17/15 was handwritten on as the expiration date, and the manufacturer ' s expiration date was 10/01/15.
B. Review of the policy and procedure titled multidose vials received from the Chief Nursing Officer at 1445 on 10/07/15 revealed the following under Procedure: "...#3. Multidose containers are used until the earlier of (a) expiration of container unless contamination noted (b) twenty eight (28) days after opening ..."
C. During an interview with the Nurse Educator/Procedures at 1350 on 10/05/15 she verified the findings in A and B.


Based on review of manufacturer's guidelines, observation and interview, it was determined the facility failed to ensure the cleaning agent used for high level disinfection of gastroscopes and bronchoscopes was kept at 25 degrees Celsius (C) as per manufacturer's guidelines from 08/28/15 through 09/25/15. Failure to ensure the cleaning solution was kept at 25 degrees C did not ensure the efficacy of the solution therefore the cleanliness of the equipment could not be ensured. The failed practice had the potential to affect any patient whose care required the use of gastroscopes or bronchoscopes from 09/23/15 to 10/06/15. Findings follow:

A. Review of the manufacturer's guidelines received from the Nurse Educator/Procedures at 1400 on 10/05/15 revealed the following under "A) Indications for Use: 1) ... High-Level Disinfectant: MetriCide 28 and MetriCide Plus 30 solutions are high-level disinfectants when used or re-used, according to Directions for Use, at full strength for a maximum of 28 days at 25 (degrees) C with an immersion time of at least 90 minutes."
B. Review of the MetriCide 30 Plus Solution Log from 08/28/15 through 09/25/15 revealed no documentation of the solution temperature.
C. During an interview with the Nurse Educator/Procedures at 1010 on 10/07/15 she stated she was not checking and documenting the temperature of the solution and verified the findings of A and B.


Based on observation and interviews, it was determined the facility failed to protect patients, visitors and staff in that one of one patient on contact precautions for C-difficile was not isolated in his room. Failure to isolate patients with C-difficile had the potential to allow the spread of C-difficile in the facility. The failed practice affected all patients who were in the hallway of the facility at 1250 on 10/06/15. Findings follow:

A. While observing hand washing in and out of patient rooms at 1251 on 10/06/15, Patient #1 was observed to come out of his room, wearing two gowns and pushed his walker to the other end of the building without staff assistance, presence or support.
B. During an interview with RN (Registered Nurse) #2 at 1350 on 10/06/15 he was asked if it was ok for Patient #1 to ambulate in the hall since Patient #1 was in contact isolation for C-difficile. RN #2 stated it was ok for Patient #1 to ambulate in the hall as long as he performed a 30 second hand scrub prior to leaving his room.
C. During an interview with the Infection Control Nurse at 1420 on 10/06/15, she was asked if it was ok for Patient #1 to be ambulating in the hall. The Infection Control Nurse stated Patient #1 was not supposed to be out of his room.
D. Review of the policy and procedure titled Isolation Guidelines received from the Infection Control nurse on 10/06/15 revealed the following under "E. Enteric Contact precautions are required with confirmed or suspected infectious diarrhea such as C-Diff or NORVIRUS. Caring for these patients require the use of both Contact and Enteric precautions and both signs should be placed on the door. Strict Handwashing with Chlorhexidine Gluconate is required as alcohol is ineffective for killing these pathogens. Environmental Services is to be notified of Enteric precautions since the cleaning procedure for these rooms requires the use of chlorine (bleach) cleaner." The policy and procedure does not address Enteric precautions.


Based on observation, interview, and manufacturer's guidelines, it was determined one of one Registered Nurse (RN #3) observed failed to ensure the glucometer was cleaned after use on Patient #9 and prior to docking the glucometer at the nursing stations. Failure to clean the glucometer after use had the potential for cross contamination from one patient to the other and the nursing station. The failed practice had the potential to affect any patient whose treatment required the use of that glucometer after 1101 on 10/06/15. Findings follow:

A. Observation of the finger stick performed by RN #3 on Patient #9 at 1101 on 10/06/15 revealed RN #3 did not clean the glucometer prior to docking it at the nursing station and did not clean the bottle of test strips prior to returning them to the nursing station. During an interview with RN #3 at 1110 on 10/06/15 she confirmed the above findings.
B. Review of manufacturer's guidelines received from RN #4 at 1115 on 10/06/15 revealed the following under Important Safety Information: "...Disinfect the meter after use on each patient."

Based on clinical record review and interview, it was determined the facility failed to ensure the time of the operation was included in the operative report for four of four (#14, #15, #21, and #29) surgical patients. Failure to include the time of surgery did not allow knowledge of which surgical procedure was performed in what order in the event of multiple surgeries in one day. Findings follow.

A. Review of operative reports revealed the time of surgery was not documented for Patients #14, #15, #21, and #29.
B. During an interview on 10/09/15 at 1245, the Director of Nursing confirmed the time of surgery was not on the operative report.