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WATERBURY, CT 06721

CONTRACTED SERVICES

Tag No.: A0083

Based on a review of clinical records, interview, and policy review, the Governing Body failed to ensure that quality services were rendered by a dialysis contractor for three of five patients' (#32, #26, and #33) reviewed for hemodialysis. The findings included:

a. Patient #32 was admitted to the hospital on 11/2/16 with diagnoses that included hyperkalemia, uremia, and end stage renal disease. A physician's order dated 11/2/16 directed to administer hemodialysis over four hours with a blood flow rate (BFR) of 450 milliliters per minute (ml/min).

i. Review of the treatment record identified that the BFR was delivered at 450 ml/min from initiation of treatment at 2:00 PM, it was decreased to 400 ml/min at 3:00 PM and remained at that rate until treatment was completed at 5:45 PM absent a physician's order. The clinical record failed to reflect rationale as to why the physician's order was not followed.

ii. Review of the treatment record reflected that the patient's blood pressure (BP) was 193/117 pre-treatment and ranged from 168-200 (systolic) /87-110 (diastolic) during treatment. The post treatment note identified that the patient's BP remained high during treatment, however, failed to reflect that a physician was notified of the abnormal blood pressures. Record review and interview with the RN contractor for dialysis services on 11/15/16 at 11:30 AM stated a physician's order should have been obtained for the change in the BFR.

b. Patient #32 had a physician's order dated 11/4/16 that directed to administer hemodialysis over 3.5 hours with a blood flow rate (BFR) of 450 ml/min.

i. Review of the treatment record reflected that the BFR was delivered at 400 ml/min from initiation of treatment (9:18 AM) then decreased to 350 ml/min at 12:20 PM until the treatment completed at 12:49 PM absent a physician's order. The clinical record failed to reflect rationale as to why the physician's order was not followed.

ii. The treatment record failed to reflect that a pre-treatment comprehensive respiratory assessment was completed.

c. Patient #26 was admitted on 10/31/16. A physician's order dated 11/5/16 directed to administer hemodialysis over 3 hours with a BFR of 400 ml/min.

i. Review of the treatment record identified that the BFR was initiated at 400 ml/min at the start of treatment (1:50 PM) then decreased to 300 ml/min at 2:20 PM due to multiple arterial spasms per the nurse's notation. The record failed to contain a physician's order for the BFR change.

ii. At 3:35 PM the patient's BP dropped to 75/43 and 200 cubic centimeters (cc's) of Normal Saline (NS) was administered. Although the RN noted that the physician was aware of the patient's BP with direction to maintain the BP > 90, the record failed to contain an order to administer the NS.

iii. The BFR remained at 300 ml/min from 2:20 PM until decreased to 250 ml/min at 3:50 PM absent a physician's order.

iv. At 3:50 PM, the patient's BP was recorded as 128/47 with 250 ccs of NS administered absent a physician's order.

d. Patient #26 had a physician's order dated 11/7/16 that directed to administer hemodialysis over 3.5 hours with a BFR of 450 ml/min.

i. Review of the treatment record failed to reflect that a pre-treatment comprehensive respiratory assessment was completed.

ii. Review of the treatment record identified that the BFR was delivered at 300 ml/min absent a physician's order.

iii. Review of the post-treatment access section of the treatment record failed to reflect the locking solution instilled in the catheter.

e. Patient #33 had a physician's order dated 8/10/16 that directed to administer hemodialysis over 3.75 hours with a BFR of 400 ml/min. Review of the treatment record reflected that the BFR was delivered at 350 ml/min from initiation of treatment (2:19 PM) then increased to 375 ml/min at 3:10 PM absent a physician's order.
Record review and interview with the RN contractor for dialysis services on 11/15/16 at 11:30 AM stated there was not a protocol to administer saline and/or change the BFR absent a physician's order. Review of the Medication Policy including the use of Volume Replacement and/or Volume Expanders directed that no medications are given without an order from the physician or allied health professional.

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on tour of the facility, review of facility documentation, and interviews, the facility failed to ensure the Labor & Delivery/Maternity Unit was maintained in a safe manner to eliminate risk of newborn abduction. The finding includes:


a. On 11/08/16 at 10:45 AM, the surveyor along with the Director of Safety, Security & Emergency Management observed during tour that when the facility infant abduction system was tested, the main doors would lock. The doors were equipped with magnetic hold opens that could be activated that would hold the door open prior to the tag alarming the infant abduction system and locking the door. The doors adjacent to the main exits into the stairwell failed to lock when the main doors were tested due to the sensor locking for those doors not being activated by the main doors, allowing the door to be opened and used as an exit into the stairwell with an infant security tag. On any alarms security was notified. It was also identified that all doors leaving the unit and by the stairwells were equipped with fire alarm manual pull stations that would release the doors with an infant security band next to the door. The facility was directed to the exceptions in the life safety code for manual pull stations to be located at the nurse station and not by exits and also the exceptions to the locking of doors in a setting that requires a higher degree of security and safety.

On 11/08/16, the facility called in the contractor for the infant abduction system to reprogram the system to correct the issues with locking of doors and is contacting the local fire marshal about removing manual pull stations from the exits. Interview of the Director of Safety, Security & Emergency Management and the contractor for the infant abduction system indicated that the programing and removal of the door hold opens, and the relocation of the manual pull stations would abate these risks

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on a review of clinical records, staff interviews and a review of the Emergency Department's policies and procedures for four of six patient's reviewed for reassessments in the emergency department (Patient #41, #42, #43 and #46), the facility failed to conduct reassessments in accordance with the hospital's policies and procedures. The findings included:

a. Review of the clinical record identified Patient #41 was admitted to the hospital on 11/6/16 at 12:01 PM with a chief complaint of abdominal pain. The patient was triaged at 12:03 PM. The numeric pain scale was identified by the patient as a level nine (9) and the patient was restless. The triage level was assigned as a level two. Interview and review of the clinical record with the Director of the ED on 11/8/16 at 1:15 PM identified a comprehensive nursing assessment was conducted at 12:27 PM however a reassessment of the chief complaint was not completed throughout the patient's stay in the ED. The patient was discharged from the ED on 11/6/16 at 9:34 PM to an inpatient unit for further observation. Further interview with the Director of the ED indicated a focused reassessment failed to be conducted at 2:30 PM, 4:30 PM, 6:30 PM and 8:30 PM in accordance with the hospital policy.

b. Review of the clinical record identified Patient #42 was admitted to the hospital 11/8/16 at 6:38 AM with a chief complaint of severe right upper quadrant abdominal pain. The patient was triaged at 6:40 AM. The triage level was assigned as a level two and the patient was restless. Imaging revealed a large gallstone and the patient was admitted for a cholecystectomy. Interview and review of the clinical record with the Director of the ED on 11/8/16 at 1:30 PM identified a comprehensive nursing assessment was conducted at 7:04 AM and a focused reassessment at 11:36 AM. The patient was discharged from the ED at 12:39 PM. Further interview with the Director of the ED indicated a focused reassessment failed to be conducted at 9:00 AM and 11:00 AM in accordance with the hospital policy.

c. Review of the clinical record identified Patient #43 was admitted to the hospital on 11/6/16 at 6:22 AM with a chief complaint of right upper quadrant pain. The patient was triaged at 6:26 AM. The numeric pain scale was identified as a level ten (10) and the patient was restless. The patient was assigned a triage level of three. Imaging was conducted, the patient was treated for a presumed kidney stone and discharged to home at 10:29 AM. Interview and review of the clinical record with the Assistant Director of the ED on 11/8/16 at 2:00 PM identified a comprehensive nursing assessment was conducted at 7:01 AM however a reassessment of the chief complaint was not completed throughout the patient's stay in the ED and should have been. Further interview with the Director of the ED indicated a focused reassessment should have been conducted at 9:01 AM had the patient been triaged correctly as a triage level two.

d. Review of the clinical record identified Patient #46 was admitted to the hospital on 11/4/16 at 4:41 PM with a chief complaint of abdominal pain. The patient was triaged at 5:10 PM. The numeric pain scale was identified as a level ten (10), and the patient was restless. The patient was assigned a triage level of two. Imaging was conducted and a small bowel obstruction was presumed. Interview and review of the clinical record with the Director of the ED on 11/8/16 at 2:15 PM identified a comprehensive nursing assessment was completed at 5:54 PM however a reassessment of the chief complaint was not conducted throughout the patient's stay in the ED. Patient #46 was discharged from the ED on 11/4/16 at 10:12 PM and admitted to an inpatient unit. Further interview with the Director of the ED indicated a focused reassessment failed to be conducted at 8:00 PM and 10:00 PM in accordance with the hospital policy.

The hospital policy entitled Emergency Department Nursing Documentation Guidelines directed in part that all patients would have documentation that included a chief complaint, pain level, vital signs, a triage level, allergies and a past medical history. After arrival to a treatment room a general primary assessment focusing on the patient's chief complaint would be conducted. Throughout the patient's course in the ED medications, procedures, vital signs and pain reassessments would need to be documented to accurately reflect the patient's condition or changes in condition. Clinical and/or narrative documentation would also include a focused reassessment in accordance with the patient categorization. A reassessment for a level two acuity would be conducted every two hours and a level three acuity reassessment would be conducted every three hours unless otherwise indicated by the patient's clinical status and need to be conducted more frequently.

PHARMACIST SUPERVISION OF SERVICES

Tag No.: A0501

Based on observation, review of facility documentation, interviews, and policy review, the pharmacy failed to maintain the sterile compounding area of the pharmacy in accordance with USP 797. The findings include:


a. During a tour of the pharmacy on 11/07/16 with the Director of Pharmacy and Pharmacist #1, observation of the anteroom (ISO class 7) identified paper notices affixed to walls with adhesive tape in addition to a multiple syringes, needles, labels and miscellaneous supplies stored on the counter. In addition an observation was made in the buffer area whereas shelving in the clean room (ISO class 7) contained paper, multiple intravenous fluid bags, a notebook and a sponge like vial holder, rendering the surfaces and materials within the ISO class 7 areas unable to be properly cleaned and/or sanitized. In addition observation of the compounding room identified that 2 Laminar Air Flow hoods (LAFH) and 1 biological safety cabinet (BSC) were present in the same room.


During an interview with Pharmacist #1 on 11/7/16 at 9:30 AM, Pharmacist #1 indicated the clean room was infrequently used other than for batching however he/she understood that the compounding area was required to meet criteria in accordance with USP 797 unless the room was closed and not in use.


USP 797 indicated only furniture, equipment and supplies required for the compounding activities to be performed shall be brought all surfaces of the compounding area should be non-permeable and able to be properly cleaned and/or sanitized including carts, stool, chairs, shelves and other items.


b. During a review of hospital environmental testing in the compounding area of the pharmacy, the Director of Pharmacy identified pressure and temperature logs were maintained by the Facilities Department however interview with the Director of Quality, the Director of Pharmacy and Pharmacist #1 on 9/9/16 identified that the pharmacy staff and/or facilities department did not monitor the humidity level of the compounding area in accordance with USP 797. According to the Director of Quality, the Facilities Department did have the capability to monitor the humidity levels. Subsequent to surveyor inquiry, the Director of Quality indicated the humidity level within the compounding area of the pharmacy would be monitored by the facilities department. Review of the most recent 2 environmental testing reports, there was no actionable growth.


c. During a review of hospital policies and procedures it was identified that the hospital policy for "Sterile Compounding" failed to address humidity level compliance based on USP 797.

SECURE STORAGE

Tag No.: A0502

Based on observations, staff interviews and a review of the facilities policy, the hospital failed to secure medications in accordance with the hospitals policy. The finding included:

a. Observation of the fluoroscopy room on 11/9/16 at 10:00 AM identified a closet area that stored products administered for barium swallow testing. The items included Barium Sulfate Suspension, Varibar Nectar, and Varibar Pudding. The storage area was unlocked as were the cabinets in which the barium suspensions were located. The storage area was not visible to the technician performing the testing and an additional exit door was accessible from the storage area that led to an alternate room with an exit into the main hallway. Interview with Director #4 on 11/9/16 at 10:30 AM indicated the cabinets should have been locked when the barium products were not in use. The hospital policy entitled Drug Storage in part directed all drugs would be stored securely in lockable areas. All areas containing medication must be locked when not in actual use or when left unattended. Only authorized persons will have access to these areas.

UNUSABLE DRUGS NOT USED

Tag No.: A0505

Based on observation, review of hospital policies and procedures, and interviews, the hospital failed to ensure that multi-dose vials were labeled with the dated of initial access and/or the expiration date. The findings include:

a. Tour of the in-patient BHU and medication room on 11/07/16 at 10:30 AM with the Administrative Director and RN #11 identified one open, multidose vial of Fluphenazine without a date of access and/or expiration date (based upon 28 days, per policy), and one open, unlabeled, nicotine patch. Interview and with RN #11 at 10:35 AM identified that multidose vials should be labeled and dated with the expiration date at the time of initial access and the nicotine patch should have been labeled or discarded when opened.

A hospital policy for Drug storage identified, in part, that multi-dose vials are good for 28 days after initial access and any alteration in a manufacturer's container should be dated according to the prepackaging policy.

PHYSICAL ENVIRONMENT

Tag No.: A0700

Based on observation, review of facility documentation, contracted service reports, interviews, and policy review it was determined that the hospital failed to meet the Condition of Participation for Environment as evidenced by:


1. The Labor & Delivery/Maternity Unit was not maintained in a safe manner to eliminate risk of newborn abduction.


2. The hospital failed to ensure that the facility life safety systems were maintained according to code.


Please refer to A 144, A 701 & Life Safety K 0341, K 0353

MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

Based on observation, review of facility documentation and staff interviews the hospital failed to ensure that the physical environment of the hospital was maintained in a safe manner. The findings include:


a. On 11/10/16 at 9:30 AM, The surveyor was not provided with documentation by the Director of Facilities that when the facility added 12 analog smoke detectors the devices that were added were tested and the software and circuits and panel affected by the programming of the new devices were tested according to NFPA 72 National Fire Alarm Code 14.4.1.2. Interview with the facility electrician on the day of survey confirmed these findings.


b. On 11/10/16 at 9:30 AM, The surveyor was provided with documentation by the Director of Facilities that the facility conducted the required dry pipe sprinkler system full trip test in June of 2014. Documentation review indicated that no times were recorded from the trip of the dry pipe valve to when water reached the test outlet as required by NFPA 25. Interview with the Director of Facilities and Facility Sprinkler fitter on the day of survey confirmed these findings.

INFECTION PREVENTION CONTROL ABX STEWARDSHIP

Tag No.: A0747

This Condition is not met as evidenced by:

Based on review of facility policies and procedures, hospital documentation, manufacturer's recommendations, observations and interviews the Infection Control Department failed to ensure that infection control practices and/or cleaning procedures were followed and/or developed related to duodenoscopes/endoscopes and/or metal equipment carts and/or that a sterile environment was maintained in the central sterile processing department and/or that Infection Control was actively engaged in surveillance activities regarding endoscopic procedures.


Please refer to A748 and A749.

INFECTION CONTROL PROFESSIONAL

Tag No.: A0748

Based on review of facility policies, observations and interviews the facility failed to ensure that a policy for infection prevention was developed for manual cart cleaning in the central sterile processing department and/or for sanitization of the scope reprocessor. The finding includes:


a. A tour of the central sterile processing (CSP) department was conducted on 11/7/16 with the Assistant Director of Surgical Services and the Infection Preventionist (IP). Observations on 11/7/16 at 11:12 AM identified that the cart wash room exit door was located in the clean area of the department and adjacent to shelving that stored sterile supplies. Blue, dampened soaker pads were observed in the area in front of the exit door and inside of the clean area of the department. The observation with the IP identified that the dampened pads could increase the possibility of bacterial growth.

Review of facility documentation identified that the cart wash room was not operational beginning June 2016. Interview with the IP on 11/7/16 at 11:50 AM indicated that he/she performed environmental rounds with Operations Management staff in June and that this included the CSP department. He/she further indicated that he/she believed a policy had been developed for manual cart cleaning (transported packaged sterile items) that would be followed until the machine was repaired. The IP identified that environmental staff were responsible to clean the department each day and this included mopping the floors.

Interview with Central Sterile Technician (CST) #1 on 11/7/16 at 11:30 AM noted that the cart washer had been out of service for a couple of months and staff had to wash and dry carts by hand. He/she further indicated that clean blue pads were placed on the floor each morning to soak up any excess fluid during cart drying. CST #1 identified that staff was verbally educated to decontaminate carts and that this included the application of two different spray disinfectants of which the second spray required a contact time of 5 minutes before wiping. Interview with CST #2 on 11/7/16 at 11:43 AM noted that the second spray required a 10 minute contact time before wiping.

Interview with the IP on 11/7/16 at 11:16 AM indicated that although staff were provided verbal direction for cleaning the carts, a policy had not been developed.

Subsequently, the process of cart washing ceased and the facility submitted an immediate action plan dated 11/7/16 to include policy development (developed 11/7/16) with staff education.


b. A tour of the endoscopy unit was conducted on 11/7/16 with the Assistant Director of Endoscopy. Observations on 11/7/16 at 1:29 AM identified that the facility had an automated scope reprocessor, EVOTECH, with two scope cleaning bays. Printout sheets from the EVOTECH reprocessor identified that a self- sanitizing cycle was performed on 9/22/16 and next on 10/14/16. Interview with CST#3 on 11/8/16 at 11:34 AM noted that a cleaning cycle (self- sanitizing) was performed monthly on the EVOTECH reprocessor. He/she further identified that the outside of the EVOTECH was wiped down daily. Interview with the Assistant Director of Endoscopy on 11/8/16 at 2:30 PM indicated that he/she spoke with an EVOTECH Representative and was informed that the self- sanitizing cycle had to be performed at least weekly and this had not been performed by staff. The facility did not have a policy to direct staff regarding sanitizing the scope reprocessor. The manufacturer's recommendations for the EVOTECH scope reprocessor identified that the self- disinfect procedure be run at least weekly and failure to follow the self- disinfect reminder may result in contamination or bacterial growth and lead to inadequate disinfection of subsequent loads. The recommendations further instructed to clean edge seals with alcohol after the last cycle of the day.

The 2016 IP risk assessment identified a plan to control the potential transmission of microorganisms related to endoscopic retrograde cholangiopancreatography (ERCP) procedures (endoscope used) by ensuring that policies are written to comply with manufacturer's recommendations.
The facility submitted an immediate action plan on 11/7/16 to include staff education, policy development and future discussion regarding scope disinfection validation. The facility was found to have initiated the plan beginning 11/7/16. In addition, the facility reprocessed all scopes to be used on 11/8/16 with a plan to reprocess all scopes prior to being used.

INFECTION CONTROL PROGRAM

Tag No.: A0749

1. Based on review of facility policies, observations and interviews the hospital failed to ensure that staff donned surgical attire in accordance with facility policy. The finding includes:

a. A tour of the operating room (OR) was conducted with the Assistant Director of Surgical Services on 11/7/16. Observation on 11/7/16 from 9:20 AM to 10:05 AM identified the performance of a thyroid procedure in OR #3, a neurological case in OR #7 and an orthopedic procedure in OR #11. Although the surgeon in OR #3, the scrub technician on OR #7 and the physician's assistant in OR #11 donned a surgical cap and/or mask, facial hair and/or hair at the back and/or sides of the head was exposed during the procedures. Interview with the Assistant Director of Surgical Services on 11/7/16 at 9:20 AM and/or 10:07 AM identified that all hair and/or facial hair must be covered when in the surgical suite. The facility policy for surgical attire directed to put on surgical head cover or hood and ensure that all hair and facial hair are covered.


2. Based on review of facility policies, observations and interviews the hospital failed to ensure that the surgical and/or central sterile processing (CSP) departments were maintained to ensure proper sanitization of the environment and/or equipment. The finding includes:

a. A tour of the OR was conducted with the Assistant Director of Surgical Services on 11/7/16. Observations at 9:50 AM identified that the storage cabinets in ORs #1 through #5 had older metal doors that were rusted, had chipped paint that rendered the cabinets unable to be properly sanitized. Inside each cabinet were various items stored and used during surgical procedures. Interview with the Assistant Director of Surgical Services on 11/7/16 at 10:05 AM noted that ORs were cleaned between cases and at the end of the surgical day. The facility policy for surgical area cleaning identified that daily terminal cleaning included damp wiping horizontal and vertical surfaces to include cabinets.

A tour of the CSP department was conducted on 11/7/16 with the Assistant Director of Surgical Services and the Infection Preventionist (IP). Observations on 11/7/16 at 11:12 AM identified that the cart wash room exit door was located in the clean area of the department and adjacent to shelving that stored sterile supplies. Blue, dampened soaker pads, missing floor tiles and a heavily rusted floor drain and threshold were observed in the area in front of the exit door and inside of the clean area of the department. The rust and integrity of the flooring rendered the area unable to be cleaned. The observation with the IP identified that the dampened pads could increase the possibility of bacterial growth.


In addition, missing pieces of floor tiles were also observed in the clean storage area of the department during the tour.

Review of facility documentation identified that the cart wash room was not operational beginning June 2016. The environmental rounds dated 6/2/16 noted that major repairs were not needed in the CSP department and that the floors were clean. Interview with the IP on 11/7/16 at 11:50 AM indicated that he/she performed environmental rounds with Operations Management staff in June and that this included the CSP department. He/she further indicated that he/she believed a policy had been developed for manual cart cleaning (transported packaged sterile items) that would be followed until the machine was repaired.

Interview with Central Sterile Technician (CST) #1 on 11/7/16 at 11:30 AM noted that the cart washer had been out of service for a couple of months and staff had to wash and dry carts by hand. He/she further indicated that clean blue pads were placed on the floor each morning to soak up any excess fluid during cart drying. CST #1 identified that staff was verbally educated to decontaminate carts and that this included the application of two different spray disinfectants of which the second spray required a contact time of 5 minutes before wiping. Interview with CST #2 on 11/7/16 at 11:43 AM noted that the second spray required a 10 minute contact time before wiping.

Interview with the IP on 11/9/16 at 11:16 AM indicated that although staff were provided verbal direction for cleaning the carts, a policy for staff reference had not been developed. The facility policy for sterile processing included daily dust and damp mopping of floors.

Subsequently, the process of cart washing ceased and the facility submitted an immediate action plan dated 11/7/16 to include policy development for the manual cleaning of the carts, staff education and environmental repairs/replacements. Immediate repairs were initiated by the facility on 11/7/16 and 11/8/16, repairs were observed on 11/8/16 and the facility was able to resume the manual cart washing procedure. In addition, the facility purchased a new cart washer to be installed at a later date.



3. Based on a tour of the facility, observations and interviews the facility failed to ensure that infection control practices for endoscope reprocessing were performed in accordance with manufacturer's instructions and/or policies and/or that infection control staff provided surveillance and oversight regarding the reprocessing of duodenoscopes/endoscopes. The finding includes:

a. A tour of the endoscopy unit was conducted on 11/7/16 with the Assistant Director of Endoscopy. Observations on 11/7/16 at 1:29 AM identified that the facility had an EVOTECH scope reprocessor with two scope cleaning bays. Interview with Certified Scope Technician (CST) #1 on 11/7/16 at 11:29 AM indicated that after he/she submerged the soiled scope in the water with enzymatic cleaner, he/she cleaned the scope and did not perform a manual leak test first because the EVOTECH performed two leak tests. Interview with the Infection Preventionist (IP) on 11/7/16 at 3:00 PM identified that a manual leak test was required prior to cleaning. Interview with the Director of Performance Improvement on 11/8/16 at 8:22 AM noted that he/she was made aware that the other two CSTs who performed scope reprocessing also reported the failure to complete a manual leak test prior to cleaning scopes. The facility policy for scope cleaning and/or manufacturer's recommendations for the Olympus scopes utilized by the facility directed to perform a manual leak test of the scope prior to cleaning. The manufacturer's recommendations for the EVOTECH scope reprocessor identified that the automated leak test is not a substitute for the manufacturer's manual leak test.

A tour of the endoscopy unit was conducted on 11/7/16 with the Assistant Director of Endoscopy. Observations on 11/7/16 at 1:29 AM identified that the facility had an automated scope reprocessor, EVOTECH, with two scope cleaning bays. Printout sheets from the EVOTECH reprocessor identified that a self- sanitizing cycle was performed on 9/22/16 and next on 10/14/16. Interview with CST#3 on 11/8/16 at 11:34 AM noted that a cleaning cycle (self-sanitizing) was performed monthly on the EVOTECH reprocessor. He/she further identified that the outside of the EVOTECH was wiped down daily. Interview with the Assistant Director of Endoscopy on 11/8/16 at 2:30 PM indicated that he/she spoke with an EVOTECH Representative and was informed that the self- sanitizing cycle had to be performed at least weekly. The manufacturer's recommendations for the EVOTECH scope reprocessor identified that the self- disinfect procedure be run at least weekly and failure to follow the self- disinfect reminder may result in contamination or bacterial growth and lead to inadequate disinfection of subsequent loads. The recommendations further instructed to clean edge seals with alcohol after the last cycle of the day.

In addition, interview with the IP on 11/9/16 at 8:30 AM identified that the facility did not perform monitoring for the effectiveness of the scope cleaning process that might include follow- up with gastrologists to ascertain post procedure patient infections and/or random culturing of scopes to ensure proper disinfection.

The facility submitted an immediate action plan on 11/7/16 to include staff education, policy development and future discussion regarding scope disinfection validation. The facility was found to have initiated the plan beginning 11/7/16. In addition, the facility reprocessed all scopes to be used on 11/8/16 with a plan to reprocess all scopes prior to being used.




4. Based on a tour of the facility, review of facility policies, observations and interviews the facility failed to ensure that glucometers were adequately sanitized between patient use and failed to ensure glucometer controls were dated according to policy in 2 of 7 clinical areas. The finding includes:

a. A tour of the preoperative area was conducted on 11/7/16 with the Assistant Director of Perioperative Services on 11/7/16. Observation on 11/7/16 at 10:34 AM identified that the preoperative area had one Nova StatStrip glucometer. Interview with Preoperative RN on 11/7/16 at 10:34 AM noted that he/she used 70% isopropyl alcohol wipes to sanitize the glucometer between patients. The facility policy for cleaning the Nova StatStrip glucose meter identified that cleaning and disinfecting of the blood glucose meter is required after each patient with the hospital approved germicidal wipe (not alcohol wipe).

b. Tours of the cardiac intensive care unit (CICU) and medical intensive care unit (MICU) were conducted with the Chief Nursing Officer (CNO) and Manager of Critical Care Areas on 11/7/16 at 9:10 AM. A review of glucometer control solutions failed to contain/identify a date indicating when the control solutions would expire and/or were opened. Upon surveyor identification the glucose control solutions were discarded and replaced. According to Facility entitled POC Whole Blood Glucose, Using the Nova Statstrip Glucose Meter once opened, control solutions are stable when stored as indicated for up to three months or until the expiration date printed on the vials, whichever comes first.


5. Based on a review of the clinical record, staff interviews and a review of the facilities policies and procedures for one of two sampled patients (Patient #28), the facility failed to properly store human breast milk. The finding included:

a. Review of the clinical record identified Patient #28 was admitted to the hospital on 11/3/16 at thirty eight weeks gestation following a normal spontaneous vaginal birth. The baby was cared for in the special care nursery as the pregnancy was complicated by maternal Methadone use. Physician orders dated 11/3/16 directed breast feeding. Further review of the physician's order dated 11/3/16 directed expressed breast milk or Similac every three hours after Patient #28's mother was discharged to home. Observation of the breast milk refrigerator in the special care nursery on 11/7/16 at 10:00 AM identified two bottles of fresh breast milk labeled for Patient #28 absent the date and time of when the milk was collected. Interview with the Director of Woman's Health on 11/7/16 at 10:15 identified without a date and time of the milk collection the breast milk would be rendered unusable. Subsequent to the surveyors inquiry the expressed breast milk for Patient #28 was discarded.
The hospital policy entitled Human Milk Reserves directed in part that proper storage of human milk was important when providing infants with nutrition. Fresh milk may be stored in the refrigerator for forty eight hours for babies in the special care nursery. Breast milk would be labeled with mothers and baby's names, date and time of collection. All milk would be placed and retrieved from the storage area by nursing personnel. Any unlabeled milk would be discarded.






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