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Based on observation, interview, and policy review, the provider failed to ensure the keys for two of two medication refrigerators used to store vaccines were maintained in a secured location for one of one provider-based clinic. Findings include:

1. Observation and interview on 12/21/16 at 10:40 a.m. with the accreditation and certification coordinator revealed:
*Keys for the two medication refrigerators were stored in unlocked drawers at the clinic nursing station.
*The clinic normally closed around 5:00 p.m., but cleaning staff did have access to that area.
*She agreed all staff entering that area would have had access to the medication keys stored in the drawer.

Review of the provider's May 2014 Vaccine Storage and Handling policy revealed "Only authorized personnel should have access to the vaccine supply."

A. Based on record review, interview, review of manufacturer's instructions for use, and policy review, the provider failed to dispose of one of one Rapicide high level disinfectant (HLD) when the twenty-eight day reuse period had expired. Findings include:

1. Review of the Rapicide HLD log book, manufacturer's instructions for use, and interview on 12/21/16 at 3:14 p.m. with employee A who assisted with endoscope reprocessing revealed:
*The Rapicide HLD was new on 11/10/16 and had been in-use for forty-one days on 12/21/16.
*The manufacturer's reuse period was twenty-eight days from being placed in-use.
*The Rapicide HLD had expired on 12/8/16 and should have been discarded.
*After 12/8/16 the following endoscopes had been reprocessed on 12/13/16.
-Nine endoscopes had been reprocessed and were high level disinfected.
-Each time a scope was reprocessed the strength of the Rapicide was tested and passed for those nine scopes.
*Employee A agreed the Rapicide HLD had expired on 12/8/16 and should not have been used after that date.

Review of the provider's 8/4/16 High Level Disinfection policy revealed "Dispose and replace expired solution per manufacturer's instructions."



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B. Based on observation, interview, record review, and policy review, the provider failed to ensure:
*A method had been implemented to identify surgical site infections for 1 of 1 operating suite.
*The supervisor of inpatient nursing services documented an investigation for 1 of 1 inpatient (38) identified with a hospital acquired urinary tract infection (UTI).
*Expired medical supplies and medication were not stored in 1 of 1 stress test room.
*Medical supplies were stored in a manner to prevent cross-contamination in 3 of 3 patient care areas (stress test room, procedure room, and clinic area).
*Environmental surfaces were disinfected after a patient's discharge in 1 of 12 examination (exam) rooms (2) in one of one clinic area.
*Hand hygiene and glove usage was appropriate to prevent cross-contamination of supplies and environmental surfaces during a urine test in 1 of 1 clinic area.
*Sanitary conditions were maintained by 1 of 1 laboratory (lab) tech (B) during the collection of a specimen for sampled patient (2).
*Proper hand hygiene during personal care for 2 of 2 sampled patients (1 and 5).
*Hinged surgical instruments in 1 of 1 emergency department (ED) had been sterilized appropriately in the opened position.
Findings include:

1a. Interview on 12/20/16 at 10:41 a.m. with the supervisor of inpatient nursing services revealed:
*She was responsible for surgical services at the hospital.
*The hospital's surgical cases consisted of endoscope procedures of the stomach and colon, and cataract surgeries.
*The hospital depended on the outpatient clinic to provide information on any patients that might have a surgical site infection after their procedures.
*Several years ago she had sent clinic providers questionnaires to collect data on surgical site infections. She no longer sent that questionnaire out.
*The vast majority of patients were seen at the clinic for their postoperative follow-up appointments. The clinic would call her if a patient returned with an infection.
*She had access to patient charts and reviewed labs and medications on a monthly basis, but she did not document that review.

b. Review of the physician's daily progress note for patient 38 dated 12/6/16 revealed:
*The patient had been admitted into the hospital on 11/25/16 with diagnoses of weakness, biliary acute pancreatitis, arteriosclerotic cardiovascular disease, and arthritis.
* The patient had experienced urinary frequency, signs of a UTI, and a urine culture was ordered.
*The patient was on Cipro and that antibiotic treatment was continued.

Review of patient 38's medical record laboratory results revealed:
*A clean catch urine specimen collected on 12/4/16 revealed greater than 100,000 colonized forming units of Klebsiella pneumoniae (bacteria) was found in the urine.
*The physician had documented that was an inpatient on Cipro.

Review of the infection control meeting minutes dated 12/14/16 revealed hospital acquired infection - UTI of an inpatient. The proper antibiotic had been ordered for patient 38. No further documentation of the UTI was noted.

Interview and review on 12/22/16 at 10:15 a.m. with the supervisor of inpatient nursing services regarding infection control revealed:
*In November 2016 inpatient 38 was diagnosed with a hospital acquired UTI.
*The patient had received appropriate antibiotic treatment.
*There was no documentation completed for the investigation of the hospital acquired UTI.

c. Interview on 12/22/16 at 10:30 a.m. with the supervisor of inpatient nursing services and the hospital infection preventionist consultant revealed:
*The hospital should have been querying the clinics where patients received follow-up care for potential surgical site infections.
*The hospital should have been documenting their investigation on any nosocomial infections (hospital acquired infection).

Review of the provider's May 2016 Infection Prevention Control Surveillance policy revealed:
*One purpose was to record and evaluate descriptive statistics of hospital-associated infections in patients cared for at the hospital.
*Daily laboratory reports should have been reviewed by the infection prevention nurse.
*The infection prevention professionals should have applied predetermined criteria to identify nosocomial infections, compiled statistics, and reported findings to the infection prevention committee each quarter.
*The infection prevention committee should have evaluated statistical reports and determined appropriate action for further evaluation or intervention relative to the prevention or control of healthcare associated infections.
*A record of positive patient cultures should have been reviewed.

2. Observation and interview on 12/20/16 with the supervisor of inpatient nursing services revealed the following medication and supplies were expired:
*At 8:53 a.m. in the stress test room:
-One package of stress test electrodes had expired on 2/28/16.
-One package of Red Dot electrodes had expired on 11/20/16.
-One bottle of Purell Advance hand gel had expired on December 2015.
*At 10:00 a.m. in the operating room:
-One box of 8.4% sodium bicarbonate had expired on 7/1/16.
-Eight Cloraprep skin disinfectants had expired August 2016.
-Eight containers of Avagard Hand Antiseptic had expired on 9/28/16.
*She had recently removed outdated supplies from the operating room.
*It was everyone's responsibility to check for outdated supplies. There was no set schedule.

3a. Observation and interview on 12/20/16 at 9:03 a.m. with the supervisor of inpatient nursing services revealed:
*In the stress test room three Stress Vue Velcro Belts were stored in a cabinet. Observation of those belts revealed two of the three belts had several long and short hairs captured in the foam padding.
*The Stress Vue Velcro Belts were reusable but were not on a washing schedule.
*She was not sure when the belts were last washed.
*There was not a policy in place for washing the Stress Vue Velcro Belts.

Review of an email dated 12/21/16 from the manufacturer's representative to the supervisor of inpatient nursing services revealed:
*The manufacturer had not provided specific recommendations for cleaning the Stress Vue Velcro Belts.
*Based on similar product the manufacturer's senior product manager suggested "Wiping down with mild soap & water when needed. The belt is made from a polyester foam which should stand up to a conventional washing machine as long as the Velcro ends are paired together. In most cases, we find each hospital has their own procedures and policies when it comes to disinfecting and cleaning reusable products."

b. Observation and interview on 12/20/16 at 9:35 a.m. with the supervisor of inpatient nursing services in the procedure room revealed:
*The endotower had a small hairball on the bottom shelf.
*The three tiered cart used to hold supplies had a small accumulation of dust.
*The staff disinfected the procedure room after each case.
*There were no scheduled cases this week; last week there had been scheduled cases.

Review of the provider's 3/8/16 Cleaning of the GI (gastrointestinal) Rooms policy revealed:
*To keep bacteria count to a minimum the procedure rooms were cleaned by department personnel between each case and at the end of the day.
*All equipment was washed with a disinfectant to include the TV monitor and cart (endotower).

c. Observation on 12/21/16 at 9:42 a.m. revealed patient 37 entered exam room 2. The patient had complained of having a cold. At 10:01 a.m. RN L was observed disinfecting the exam table with a SaniCloth disinfection wipe. No other furniture or equipment (blood pressure cuff, table, chair) were wiped down after the patient had exited the room.

Interview on 12/21/16 at 10:45 a.m. with the corporate accreditation and certification coordinator revealed the exam table, side table, and chair should have been disinfected after the patient had left the room.

4. Random observation in the clinic area on 12/21/16 at 8:20 a.m. of unoccupied exam rooms 4, 5, 8, 9, and 12 revealed vaginal swabs were stored unwrapped in a bin in the cabinet.

Interview on 12/22/16 at 10:15 a.m. with the supervisor of inpatient nursing services and the corporate accreditation and certification coordinator revealed:
*They were unaware vaginal swabs were stored in the clinic exam rooms unwrapped.
*To prevent potential bacterial cross-contamination the vaginal swabs should not have been stored unwrapped.
*There was no policy that covered that issue.

5. Observation on 12/21/16 at 10:13 a.m. in the clinic area revealed while wearing gloves RN L:
*Prepared a urine sample for slide testing, placed the urine cup in a plastic bag, wrote on the slide, and then opened several drawers for additional supplies.
*Removed her contaminated gloves and performed hand hygiene.

Interview on 12/21/16 at 11:30 a.m. with RN L regarding glove usage and hand hygiene revealed:
*She confirmed after handling the cup with urine she had kept her contaminated gloves on and opened several drawers for additional supplies.
*There was a potential for cross-contamination of clean supplies in the drawer and the work area.
*It might have been better to have gotten all supplies ready at the start of testing.
*During the test preparation you might not know which supplies would be needed and could end up doing hand hygiene and changing gloves many times.

Review of the provider's July 2015 Hand Hygiene - Enterprise policy revealed use a hand antiseptic "After contact with a patient's intact skin, body fluids or excretions, mucous membranes, nonintact skin, and wound dressings if hands are not visibly soiled."



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6. Observation on 12/20/16 at 8:35 a.m. in patient 2's room with laboratory technician (LT) B revealed:
*LT B entered the room and placed a caddy containing lab equipment (test tubes, tourniquets, bandaids, and needles) on top of an opened garbage can. She then:
-Performed hand hygiene and put on a pair of gloves.
-Removed lab supplies (test tubes, cotton ball, needle, and alcohol wipes) from the caddy and without a barrier placed the items directly on the patient's bed.
-Obtained the blood sample from the patient.
-Placed the blood filled test tubes and capped needle directly on the patient's bed linen.
-Discarded the needle into the sharps container.
-Labeled each of the blood test tubes and placed them into the caddy.
-Removed her gloves and performed hand hygiene.

Interview on 12/21/16 at 2:10 p.m. with lab manager F regarding the above observation revealed:
*The LTs placed the caddy wherever they could find a place to put it.
*They had never discussed where to place the caddy in a patient's room.
*That was not part of their policy.

Interview on 12/22/16 at 9:30 a.m. with the supervisor of inpatient nursing services/infection control registered nurse (RN) and the corporate accreditation and certification coordinator regarding the above observation revealed:
*The supervisor of inpatient nursing services/infection control RN's expectations would have been:
-Not to have placed the caddy on top of the garbage can.
-Would have expected some sort of a barrier to have been put down on the bed before laying supplies on top of it.
-Not to place dirty items on top of a patient's bed linen.
*The corporate accreditation and certification coordinator agreed with the above comments.

Review of the provider's 4/7/15 Laboratory Standard Operating Procedure Venipuncture policy had not included where to place laboratory supplies in a patient's room.

Review of the provider's 4/7/15 Laboratory Standard Operating Procedure Specimen Collection, Processing, and Storage policy revealed:
*"Purpose:
-1.1 To ensure proper specimen collection and proper storage of specimens."
*It had not included where to place laboratory supplies in a patient's room during a procedure or blood draw.

7a. Observation on 12/20/16 at 9:10 a.m. in patient 1's room with RN D and nursing assistant (NA) C revealed:
*They both performed hand hygiene and put on gloves.
*Assisted the patient using a mechanical lift from the bed to the chair.
*RN D then:
-Placed the Foley drainage bag and tubing onto the side of the chair.
-With the same gloved hands went over to the counter and:
--Used the computer to look at information on the patient.
--Placed several syringes filled with normal saline into a drawer.
--Scanned the patient's identification band.
--Took three pre-filled syringes of normal saline.
--Flushed the three intravenous (IV) ports.
--Layed the empty syringes and alcohol wipes on the blanket covering the patient.
--Adjusted his IV site.
--Discarded the empty syringes and alcohol wipes.
-Removed her gloves and performed hand hygiene.

Interview on 12/21/16 at 2:00 p.m. with the chief nursing officer (CNO) regarding the above observation revealed her expectations would have been to change gloves and perform hand hygiene after touching the catheter tubing.

Interview on 12/22/16 at 9:30 a.m. with the supervisor of inpatient nursing services/infection control RN and the corporate accreditation and certification coordinator regarding the above observation revealed their expectations would have been to change gloves and perform hand hygiene between tasks.

b. Observation on 12/20/16 from 10:03 a.m. through 10:10 a.m. in patient 5's room with RN D and NA C revealed:
*Both RN D and NA C had performed hand hygiene and put gloves on.
*Transferred the patient into the bathroom using a mechanical lift.
*At 10:06 a.m. RN D operated the mechanical lift raising the patient to a standing position.
*NA C:
-Took toilet paper and cleaned the patient's anal area.
-With the same gloved hands changed the sheets on the patient's bed.
*RN D pushed the mechanical lift with the patient to the chair and lowered the patient into the chair.
*At that time the IV pump began to alarm.
*RN D with the same gloved hands:
-Touched the IV pump.
-Touched the IV tubing.
-Touched the IV site on the patient's right forearm.
-Continued to touch the IV tubing, tape on the patient's IV insertion site, and IV pump.
-Removed her gloves and performed hand hygiene.

c. Interview on 12/21/16 at 2:00 p.m. with the CNO regarding the above observations revealed her expectations would have been to change gloves and perform hand hygiene before touching the IV site.

Interview on 12/22/16 at 9:30 a.m. with the supervisor of inpatient nursing services and the corporate accreditation and certification coordinator regarding the above observations revealed their expectations would have been to change gloves and do hand hygiene between tasks.

Review of the provider's 7/13/15 Hand Hygiene policy revealed:
*"Policy:
-Hand hygiene will be performed by employees at appropriate time and in the proper manner.
*Procedure:
-Before direct contact with patients.
-Moving from contaminated body site to clean body site during patient care.
-After contact with contaminated surfaces and/or objects/medical equipment in the immediate vicinity of the patient."

Review of the provider's November 2011 Nursing Standard Operating Procedure Medications: Intravenous policy revealed:
*"III. Procedure:
-3.2.1 Perform hand hygiene."



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8. Observation on 12/20/16 at 10:00 a.m. in the ED's suture supply cart revealed:
*Multiple packages of sterilized hinged surgical instruments.
*Those instruments were in the closed position and included:
-Three scissors.
-Four forceps.
-One speculum.

Interview on 12/20/16 at the time of the above observation with paramedic K revealed he:
*Confirmed the instruments were sterilized in the hospital.
*Was not aware hinged instruments should have been sterilized in the opened position.

Interview on 12/21/16 at 10:10 a.m. with the CNO revealed and confirmed:
*The instruments were sterilized in the hospital.
*Hinged instruments should not have been sterilized in the closed position.
*The sterility of those instruments could not have been guaranteed.

Review of the provider's 5/4/16 Preparing Items for Sterilization policy revealed "Parts and pieces will be disassembled as much as possible and all lock boxes or hinged items packaged in open position."

Based on record review, interview, and policy review, the provider failed to ensure the care plan initiated for 1 of 20 sampled patients (20) included interventions for his diagnosis of pleural effusion (respiratory problem). Findings include:

1. Review of patient 20's electronic medical record revealed:
*He was admitted on 11/29/16 with diagnoses of bilateral pleural effusion, hypoxia, congestive heart failure, and bradycardia.
*His care plan was initiated on 11/29/16 and addressed falls and skin integrity.
*The care plan did not address interventions to assist a patient that had breathing difficulty.

Interview and review on 12/21/16 at 2:50 p.m. with the accreditation and certification coordinator of patient 20's care plan confirmed:
*The care plan initiated on 11/29/16 had not addressed the patient's breathing problem.
*The care plan throughout his hospital stay addressed the problems of fall and skin integrity.
*There were care plans in the electronic medical record that could have been selected for patients with breathing problems.

Review of the provider's March 2016 Documentation System policy revealed:
*"The Plan of Care is to be initiated within the first 24 hours and updated throughout the stay as needed.
*The following process is to be used to initiate a Plan of Care:
-Initiate the Problem Diagnosis based on assessment or evaluation as well as other available data (History and Physical, lab data, physical assessment, etc.).
-Determine the outcome(s) or goal(s).
-Determine the interventions which will help the patient progress toward the outcome(s)...)"

Based on record review, interview, and policy review, the provider failed to ensure:
*A physician's order was obtained for 1 of 2 sampled patients (12) who had required a blood transfusion.
*A systematic method of documentation had occurred for 4 of 37 patients' (21, 22, 23, and 32) electronic medical record reviews.
Findings include:

1. Review of patient 12's electronic medical record revealed she:
*Had been admitted to the hospital on 8/5/16.
*Had diagnoses of a recent right hip replacement on 8/2/16, history of anemia, chronic kidney disease, and weight gain.
*Was admitted for ongoing physical and occupational therapy for strengthening post-surgery.
*Had her hemoglobin level checked on 8/13/16.
-That level had been low at 7.9 (normal 11.7 to 13.8).
*Had received one unit of packed red blood cells on 8/13/16.

Review of patient 12's 8/12/16 through 8/13/16 physician's orders revealed:
*On 8/12/16 the medical doctor (MD) had ordered the following:
-"Protime/INR."
-"Complete blood count with differential."
-"Basic metabolic panel."
-"Occult blood diagnostic testing for three different specimens."
*On 8/13/16 the MD had ordered the following:
-"Complete blood count with differential."
-"Verify informed consent has been signed for blood transfusion."
-"Notify provider and blood bank for signs of potential blood transfusion reaction."-"If suspected hemolytic reaction, order transfusion reaction."
-"Type and screen."
-"Prepare and hold red blood cells - blood bank."
-"EKG."
-"Troponin I."
*No documentation the MD had ordered the patient to have a blood transfusion on 8/13/16.

Interview on 12/21/16 at 8:35 a.m. with RN G revealed and confirmed:
*The above electronic medical record review.
*The MD had not ordered a blood transfusion for patient 12 on 8/13/16.
*There should have been an order for a blood transfusion prior to the administration.

Interview on 12/21/16 at 10:15 a.m. with the chief nursing officer (CNO) confirmed the above interview with RN G.

Interview on 12/22/16 at 9:05 a.m. with RN H revealed she:
*Had administered the blood transfusion to patient 12.
*Was not aware the MD had not put an order for the blood transfusion in the electronic medical record.
*Agreed:
-There should have been an order for the blood transfusion prior to the administration.
-She should have checked the electronic medical record for the order prior to administration.

Review of the provider's February 2015 Administration of Blood or Blood Components policy revealed "Check physician order for blood or blood components to be given. Order will be entered into the electronic medical record."

2. Review of patient 32's electronic medical record revealed she:
*Was admitted to the emergency department (ED) on 10/27/16.
*Had arrived by private car and was having increased shortness of breath.
*Had been recently hospitalized with the following diagnoses:
-Urinary retention.
-Pain from a L-spine compression fracture.
-Exacerbation of congestive heart failure.

Review of patient 32's 10/27/16 electronic patient care timeline documentation from the ED department revealed at:
*8:00 a.m., an unidentified staff member had completed a medical screen on her appearance and condition.
*8:01 a.m., the patient had arrived in the ED.
*8:02 a.m., the patient registration had been completed.
*8:02 a.m., the patient had been placed in an ED overflow room.

Interview on 12/21/16 at 8:35 a.m. with registered nurse (RN) G revealed she:
*Confirmed patient 32's timeline documentation had not been in a systematic method.
*Agreed the timeline documentation should have identified when the patient had arrived at the ED prior to the assessment.

Interview on 12/21/16 at 10:10 a.m. with the CNO confirmed the above interview with RN G.

Review of the provider's January 2016 Emergency Department Standard Operating Procedure policy revealed "To provide a means whereby the condition and treatment of the patient presenting to the ED can be documented in a systematic method."



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3. Review of surgical patients 21 and 23's outpatient records revealed:
*Patient 23 had an esophagogastroduodenoscopy (EGD) and colonoscopy on 8/9/16 and patient 21 had a colonoscopy procedure on 11/1/16.
*Review of the postoperative report for both patients revealed one diagnosis. The physician had not indicated if the diagnosis was a preoperative or postoperative diagnosis.

Interview on 12/20/16 at 3:22 p.m. with the clinical quality specialist revealed:
*The diagnosis listed on patients 21 and 23's postoperative reports were not identified as preoperative or postoperative diagnoses.
*She was unable to locate a final diagnosis on the patients' postoperative reports.

Review of the undated General Rules and Regulation for Canton, page 13 of 21 revealed the operative or high-risk procedure note should have included a preoperative and postoperative diagnosis.

4. Review of the medical records for patients 21 and 23 revealed the intraoperative documentation did not contain a wound classification.

Interview on 12/20/16 at 3:22 p.m. with the clinical quality specialist revealed she was unable to locate a wound class for the patients.

Interview on 12/20/16 at 3:52 p.m. with the chief nursing officer revealed the wound classification was not documented for outpatient colonoscopy procedures.

5. Review of patient 22's medical record revealed:
*He had been admitted for an outpatient surgical procedure on 10/11/16.
*His surgical procedure had stated at 9:25 am. and had ended at 9:33 a.m.
*The physician's operative note of the procedure revealed there were no complications from the surgery.
*The physician's operative note of the procedure was electronically completed and signed on 10/11/16 at 9:16 a.m.
-That was nine minutes before the surgical procedure had began.

Interview and review with the clinical quality specialist on 12/20/16 at 4:34 p.m. of patient 22's physician's operative note confirmed the entry had been made before the patient's surgical procedure had started.

Interview on 12/21/16 at 2:32 p.m. with the CNO confirmed
*The operative note had been completed prior to the start of the patient's surgical procedure.
*The expectation was to complete the post operative note immediately after the procedure.

Review of the undated General Rules and Regulation for Canton, page 13 of 21, revealed the operative note should have been completed immediately after the surgical procedure had ended.