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Based on observations and interviews, the facility failed to ensure disposable and sterile supply inventory was monitored to ensure items were not retained past the expiration date to prevent their being used in patient care.

This failure created the potential for supplies and equipment to lose both sterility and effectiveness, leading to avoidable infection or the inability to emergently treat patients timely and effectively.

FINDINGS

REFERENCE

According to the manufacturer's instructions for the ECG Monitoring Electrodes, check the expiration date on the un-opened pouch of electrodes. Electrodes must be used before the expiration date indicated on the package.

1. The facility did not identify and remove expired disposable/sterile supplies from patient care areas. The areas included the Inpatient Unit and the Emergency Room.

a) On 11/30/15 at 3:04 p.m., a tour of the Inpatient Unit was conducted with the Acute Care Services Manager (Manager # 7). Two boxes of Portex D.I.C. Tracheostomy Tubes with Disposable Inner Cannulas were observed with a use by date of 08/2015. Also observed were two boxes of a central port access needle with a manufacturer's expiration date of 08/2013 that were found in a patient supply drawer. Manager #7 stated s/he was unaware of a policy regarding expired supplies. Manager #7 further stated expired supplies were not appropriate for patient use.

b) On 12/01/15 at 9:24 a.m., a tour of the Emergency Department was conducted with Registered Nurse (RN) #24 and RN #25. Patient room #1 revealed a box of Clear Electrode RTL ECG Pediatric patches with the expiration date of 05/2015. RN #24 stated medical staff were supposed to go through and check for expired supplies. However, no set time had been established to determine when to check the supplies for expiration dates.

c) On 12/01/15 at 9:30 a.m., an interview was conducted with the Interim Manager of Emergency Services (RN # 25) who stated crash carts were checked once a month for expired supplies. RN #25 stated staff tried to check for expired supplies in patient rooms.

Based on observations, interviews, and document review, the facility failed to ensure patient care equipment was maintained through a preventive maintenance program.

This failure created the potential for patient harm due to the facility's inability to ensure patient care equipment was maintained and safe for patient use.

FINDINGS

POLICY

According to the policy/procedure Equipment Management, equipment is tracked from purchase to disposal with regularly scheduled preventative maintenance.

According to the policy, Equipment Management; Record Keeping, a preventative maintenance schedule has been established for all biomedical equipment. Qualified biomedical technicians will furnish support by performing safety inspections, calibrations, operational testing, and repair as required. Documentation supporting the activities above is filed in the facility.

1. The facility had patient care equipment, readily available for use by staff, with either missing or overdue preventive maintenance stickers used to indicate when preventative maintenance was due to be performed.

a) On 11/30/15 at 2:37 p.m. and 12/1/15 at 9:24 a.m., a tour of the facility revealed the following pieces of patient care equipment with either missing or overdue preventative maintenance stickers:

i) In the Cardiopulmonary Rehabilitation Unit, one Respironics V60 Ventilator was missing a preventative maintenance sticker and one Respironics V60 Ventilator had a preventative maintenance sticker that stated an electrical test was due on 09/30/15, which was 61 days overdue at the time of the observation.

During an interview with the Respiratory Technician (RT #6) at the time of the observation, s/he stated the Respironics V60 Ventilators were used for Bilevel Positive Airway Pressure (BIPAP) treatments for patients receiving care at the facility. RT #6 then stated s/he was unable to tell if the ventilators were safe for patient use if one ventilator's preventative maintenance was overdue and the second ventilator was missing a preventative maintenance sticker.

ii) In the Medical Surgical Equipment Storage Room, 2 of 4 Spectrum Intravenous Pumps (IV Pumps) were missing preventative maintenance stickers.

During an interview with the Acute Care Services Manager (Manager #7) at the time of the observation the Manager stated s/he did not know when the 2 IV Pumps had last received preventative maintenance. Manager #7 further stated s/he would expect staff to not use equipment if it was unknown when the last preventative maintenance was performed.

iii) In the Obstetrics (OB) Unit, one Infant Warming Bassinet had a preventative maintenance sticker that stated preventative maintenance was due on 07/30/15 and one Pulse Oximeter had a preventative maintenance sticker that stated a maintenance inspection was due on 07/30/15.

During an interview with Registered Nurse (RN) #21 in the OB unit at the time of the observation, the RN stated s/he was unaware of the overdue maintenance on the equipment in the unit. RN #21 stated the equipment should have been maintained and that up-to-date maintenance on equipment in the unit would have been better for patient care.

iv) In the Emergency Department (ED), two cardiac defibrillators had stickers that stated "battery replaced date due 10/30/15."

During an interview with the Interim Manager of Emergency Services (RN #25), the Manager stated s/he was unaware the batteries in the defibrillators were overdue to be replaced. The Manager stated that checking the battery replacement dates for the defibrillators was not included in the daily checks nurses in the ED were required to perform. The Manager stated staff should not use equipment with maintenance that was not up-to-date.

b) On 12/01/15 at 2:00 p.m., an interview with the Biomedical Technician (Biomed Tech #22) was conducted. Biomed Tech #22 stated s/he was the only staff member responsible for the maintenance of patient care equipment in the facility. Biomed Tech #22 stated s/he was behind on performing maintenance on some of the pieces of equipment at the facility and s/he had not been tracking the preventative maintenance schedules of patient care equipment since May of 2015. Biomed Tech #22 further stated s/he would try to keep equipment s/he considered to be critical for patient care updated.

c) On 12/02/15 at 2:09 p.m., an interview with the Facilities Manager (Manager #17) was conducted. Manager #17 stated the facility's expectation was to have all patient care equipment maintained according to the manufacturer's instructions. Manager #17 then stated s/he was aware some patient care equipment was overdue for preventative maintenance and the computer tracking system, to ensure equipment was maintained, had not been working since July, 2015. Manager #17 further stated s/he felt the reason equipment was overdue for maintenance was due to a lack of time to complete the maintenance and that other tasks had taken priority over preventative maintenance.

Based on observation and interviews, the facility failed to ensure all medications intended for patient use were stored in a secured manner to avoid diversion.

This failure created the potential for unauthorized access to medications stored in the facility.

FINDINGS

POLICY

According to the policy, Storage Requirements for Medications (House-Wide), medication storage throughout the facility is designed to minimize the risk of drug diversion (security). Proper environmental controls are maintained to ensure product integrity and stability, to include security.

According to the policy, Proper Storage and Warming of Iodinated Contrast Media and IV Soluntions, all iodinated contrast agents and IV solutions will be stored at room temperature in a locked cabinet. An adequate supply of contrast media and IV solution should be placed and locked in the warmer. The warmer should be locked after each encounter.

According to the policy, Anesthesia Cart, the anesthesia carts will be used, maintained, and cleaned by the Certified Registered Nurse Anesthetist (CRNA).

1. The facility did not ensure medications stored in the obstetrics (OB) supplies room were secured from unauthorized personnel, patients, and visitors.

a) On 11/30/15 at 3:48 p.m., a tour of the OB supplies room was conducted. The door to the supplies room was unlocked and inside the room an unlocked anesthesia cart revealed several medications and supplies including:

One 100 ml vial of Propofol, an anesthetic used for sedating patients;

One 100 ml vial of Ropivacaine, a local anesthetic;

One 50 ml vial of 2% Lidocaine, a local anesthetic;

One 1 ml ampoule of Ephedrine, a stimulant used for treating respiratory issues;

Sixteen 10 ml ampoules of Normal Saline; and

Twelve 25 gauge Spinal Needles.

b) On 11/30/15 at 3:48 p.m., an interview with a Registered Nurse in the OB unit (RN #21) was conducted. RN #21 stated the door to the OB supplies room was always unlocked but closed and a sign stating "authorized personnel only" was posted on the door. RN #21 then stated the anesthesia cart was supposed to be locked at all times. RN #21 further stated there was no way to ensure the security of the medications in the anesthesia cart if s/he was working with a patient and not monitoring the supplies room.

c) On 12/02/15 at 10:45 a.m., an interview with the Certified Registered Nurse Anesthetist (CRNA #11) was conducted. CRNA #11 stated the anesthesia cart should have been locked and that s/he must have forgotten to lock the cart.

d) On 12/02/15 at 1:27 p.m., an interview with the Pharmacist (Pharmacist #16) was conducted. Pharmacist #16 stated s/he was unaware there was an anesthesia cart located in the OB supplies room. Pharmacist #16 further stated the facility's expectation was for anesthesia carts to always be locked.

e) On 12/02/15 at 4:47 p.m., an interview with the Chief Executive Officer (CEO #1) was conducted. CEO #1 stated anesthesia carts should have been locked at all times and there should have been protocols in place to ensure that was done.

2. The facility did not ensure medications in the Computed Tomography (CT) room were secured from unauthorized personnel, patients, and visitors.

a) On 12/01/15 at 9:45 a.m., a tour of the CT room was conducted. The door to the CT room was unlocked and inside the room an unlocked medication warming unit revealed the following medications;

Twelve 50 ml vials of Isovue, an intravenous (IV) contrast, and

Nine 100 ml IV bags of Sodium Chloride.

b) On 12/01/15 at 9:45 a.m. the Imaging Manager (Manager #26) was interviewed. Manager #26 stated the medication warmer was supposed to be locked at all times and the technician working in the CT room had probably just left the room to escort a patient back to his/her room.

c) On 12/02/15 at 4:47 p.m., an interview with the Chief Executive Officer (CEO #1) was conducted. CEO #1 stated the facility's expectation was that all medications should have been locked and secured at all times.

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §485.635, PROVISION OF SERVICES, was out of compliance.

A-0278 - Standard: A system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel.

Based on observations, interviews and document review, the facility failed to maintain appropriate infection control processes in the areas of food storage, disinfection of surgical instruments, reuse of respiratory equipment, security of sterile fields, hand hygiene, and the storage of patient care supplies. This failure created the potential for patients to experience illness due to exposure to food borne pathogens if unlabeled food or expired/unsafe food was served to patients. Additionally, this failure created the potential for patients to be at risk for health care acquired infections.

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Based on observations, interviews and document review, the facility failed to maintain appropriate infection control processes in the areas of food storage, disinfection of surgical instruments, reuse of respiratory equipment, security of sterile fields, hand hygiene, and the storage of patient care supplies.

This failure created the potential for patients to experience illness due to exposure to food borne pathogens if unlabeled food or expired/unsafe food was served to patients. Additionally this failure created the potential for patients to be at risk for health care acquired infections.

FINDINGS

POLICY

According to the Infection Control Plan for 2015, a comprehensive infection prevention and control program will be established to ensure a coordinated process is in place to minimize the risks of Healthcare Associated Infections (HAIs) in patients. Further, all employees will receive ongoing education in infection prevention based on current guidelines, regulations, and standards from the Centers for Disease Control and Prevention (CDC).

According to the policy, The Care and Cleaning of Instruments, items are to be cleaned manually, and decontaminated prior to preparation for sterilization and storage.

According to the policy Hand Hygiene, hand hygiene is practiced to prevent the transmission of healthcare associated pathogens between patients and to reduce the incidence of healthcare associated infections.

According to the policy, Food Services Infection Control, all frozen food packages are labeled and dated. Left over foods are dated, labeled and refrigerated. Small amounts of leftovers are discarded.

According to the Receiving and Storage policy, refrigerated and frozen items food should be rotated and use old stock first.

According to the Continuing Education policy, in-service education will be provided to food service employees on an ongoing basis. All employees will complete annual requirements for safety, fire, infection control etc., on-line with Care Learning. Employees will complete the competency in-services each month.

According to the policy, Preparing, Maintaining and Monitoring a Sterile Field, sterile fields will be prepared in the location where they will be used and, once prepared, will not be moved. Sterile fields will be prepared as close as possible to the time of use. References include the Association of periOperative Registered Nurses (AORN).

REFERENCE

A commentary from the Current Medical Research and Opinion article titled, Critical Analysis of Common Canister Programs: A Review of Cross-functional Considerations and Health Systems Economics (2015), discussed the use of metered-dose (MDI) inhaler canisters by multiple patients as a cost saving approach for hospital respiratory departments. Requirements necessary for an effective Common Canister (CC) program include a shared inhaler, an individual one-way valve holding chamber, and a cleaning protocol.

The article stated 100% adherence to protocols for hand washing and disinfection of the MDI cannot be guaranteed. Without adherence to strict protocols, bacteria and viruses from contaminated devices can enter the respiratory tract through inhalation by patients.

The Centers for Disease Control and Prevention Guideline for Disinfection and Sterilization in Healthcare facilities, 2008 (p.1-3), stated thorough cleaning of instruments is required before sterilization to remove inorganic and organic materials which would interfere with the effectiveness of the sterilization process.
Additionally, enzyme solutions should be used according to the manufacturer's instructions for proper dilution of the enzymatic detergent and contact with equipment for the specified amount of time.

According to the Association of periOperative Registered Nurses (AORN) Guidelines for Perioperative Practice, 2015 edition, Recommendation VII.a., page 83, once created, a sterile field should not be left unattended until the operative or other invasive procedure is completed. Observation increases the likelihood of detecting a breach in sterility.

1. The facility failed to ensure cleaning protocols were instituted for the use of shared MDI canisters and equipment in pulmonary function testing.

a) On 11/30/15 at 2:37 p.m., a tour of the Cardio-Pulmonary Rehabilitation department was conducted. Upon entering the Ante Room where used Cardio-Pulmonary Resuscitation (CPR) training equipment was cleaned and stored, a plastic bin which contained a clear liquid was observed on the counter to the left of the sink. The bin also had a white plastic lid with the word "Cidex" handwritten on it. Respiratory Technician (RT #4) stated the liquid in the bin was for sanitizing actuators, the blue plastic container which holds the MDI canisters for pulmonary function testing. RT #4 further stated "we reuse the canisters and the holders" for multiple patients. RT #4 explained the sanitizing solution in the bin was actually named Revital-Ox. RT #4 stated, "we soak the blue plastic actuators in the sanitizer for 1 hour then rinse them off, and we wipe the canisters off with alcohol pads between patients." RT #4 explained the directions for sanitizing the actuators were taken from the back of the Revital-Ox sanitizing solution bottle.

b) On 12/1/15 at 1:11 p.m., an interview was conducted with RT #13, Supervisor of the Cardio-Pulmonary Rehabilitation Department. RT #13 stated there were no policies or procedures on the reuse or cleaning of the metered-dose inhaler (MDI) canisters or the blue plastic actuators (holders). RT #13 explained the patient's mouth did not touch the actuator because a blue plastic flexible tube was placed on the mouth piece and the patient inhaled from the opposite end. RT #13 stated the pharmacist had approved the reuse of the MDI canisters. RT #13 provided a research article on the reuse of MDI canisters and actuators noted above under references.

c) A second interview was conducted with RT #13 on 12/02/15 at 9:15 a.m. RT #13 stated each MDI canister was supplied with its own actuator. S/he further stated, "we worked with pharmacy and used those articles I gave you to research what other hospitals were doing." RT #13 explained individual, one-way valve holding chambers were not used because the department sanitized the acuators, a step not stated in the referenced article.

d) On 12/02/15 at 1:28 p.m., an interview was conducted with the Pharmacist (Pharmacist #16). Pharmacist #16 stated, s/he was never asked personally about using the inhaler canisters for multiple patients. Pharmacist #16 stated the canisters were not used for multiple patients on the inpatient side. S/he further stated, "we looked up the research yesterday," and s/he had not had time to look into the research enough to know if the sharing of inhaler canisters was a safe patient care practice. Pharmacist #16 stated s/he would only consult with the respiratory department on medications, not equipment use.

e) The Infection Preventionist (Infection Preventionist #23) was interviewed on 12/02/15 at 3:03 p.m. Infection Preventionist #23 stated s/he could not recall being consulted on the reuse of MDI canisters or actuators. Infection Preventionist #23 explained that his/her responsibilities involved monitoring the facility for infections and surveying each department for infection control practices. Infection Preventionist #23 further stated s/he was not aware if the actuator or medicine canister could be reused and s/he would be concerned with cross contamination and germs being spread from patient to patient.

f) On 12/02/15 at 5:13 p.m., an interview was conducted with the Chief Clinical Officer (CCO #5). CCO #5 stated s/he provided oversight of the Cardio-Pulmonary Rehabilitation department. CCO #5 stated the reuse of MDI canisters and actuators was in place before s/he arrived. CCO #5 stated s/he had not done any research into the safety of the process and had "mixed feelings" on the subject. S/he did believe a policy or procedure should have been in place and the facility could "certainly explore if there was another option" available to lower the costs and prevent waste incurred with pulmonary function tests in the department.

The manufacturer's instructions for the metered-dose inhaler and canister and actuator did not provide any instruction on sharing and cleaning for use with multiple patients. Furthermore, the facility provided research document stated the use of an individual one-way valve holding chamber for patient inhalation of medication and strict adherence to established hand hygiene and cleaning protocols was required to prevent the spread of infection amongst patients.

2. The facility failed to ensure the cleaning of surgical instruments was performed in accordance with manufacturer's instructions.

a) On 12/01/15 at 11:22 a.m., the cleaning process of surgical instruments was observed. Scrub Technician (ST #12) was interviewed about the process and stated after completion of surgery, the instruments were placed in a solution of Medical Enzyme Detergent to soak for 2 minutes then transferred to a clean bin of the same enzymatic solution for cleaning. ST #12 stated s/he followed the directions on the label of Medical Enzyme Detergent which specified ½ to 1 ounce of detergent per 1 gallon of water.

ST #12 stated, "I just do about 3 gallons of water," and "I'm not sure how much water that is, I just fill the sink just above the instruments." ST #12 further stated, s/he did not measure the enzymatic detergent.

b) On 12/02/15 at 5:13 p.m., in an interview with CCO #5, s/he stated when cleaning surgical instruments the surgical staff should follow the manufacturer's instructions for diluting the enzymatic detergent.

3. The surgical staff did not perform hand hygiene appropriately when performing patient care.

a) On 12/01/15 at 8:52 a.m., in the surgical pre-op area, Registered Nurse (RN #8) was observed donning gloves without performing hand hygiene, touching a stool using the gloved hand, then initiating an intravenous (IV) catheter into the vein of a surgical patient.

b) On 12/01/15 at 8:55 a.m., RN # 9 was observed in the Post Anesthesia Care Unit (PACU) leaving a patient's bedside wearing gloves to obtain a wheelchair. S/he rolled the wheelchair, with the patient in it, from the bathroom back to the patient's bed. The patient remained sitting in the wheelchair while RN #9, wearing the same pair of gloves, proceeded to remove an IV from the patient's arm. No hand hygiene or glove change was performed by RN #9.

c) An interview was conducted with RN #8 on 12/01/15 at 9:29 a.m. RN #8 stated infection control training was provided during orientation which included hand hygiene. S/he stated the points or times when hand hygiene should be performed included before entering and upon leaving for the day, before and after patient contact, and with each glove change. RN #8 also stated, "if I touch anything in the room with the gloves, you remove them and start again."

d) On 12/01/15 in operating room #1, the Certified Registered Nurse Anesthetist (CRNA #11) was observed throughout the surgical procedure. At 9:56 a.m., CRNA #11 was observed holding a set of keys which s/he placed on the anesthesia cart, then proceeded to don a pair of gloves without performing hand hygiene. CRNA #11 then opened the anesthesia cart to remove a medication vial, withdrew medication, and proceeded to administer medication into the patient's intravenous (IV) port. At 10:34 a.m., s/he removed gloves and donned a new pair of gloves without performing hand hygiene. S/he then removed the patient's breathing tube, changed gloves, picked up the set of keys to unlock the anesthesia cart, retrieved a medication vial, and administered medication into the patient's IV port. No hand hygiene was performed as required by hospital policy.

e) An interview was conducted on 12/02/15 at 10:45 a.m., with CRNA #11. S/he stated, "I didn't even think about touching the keys with gloves on. Yes, hand hygiene should be done with glove change." CRNA #11 further stated, "I wash my hands before I go into the OR and after I come out."

f) In an interview on 12/02/15 at 3:03 p.m., with Infection Preventionist #23, s/he stated all staff members, including physicians, were instructed on hand hygiene and infection control procedures upon hire. Infection Preventionist #23 stated the last hand hygiene surveillance program was completed in March, 2014. Infection Preventionist #23 stated staff should adhere to the five points of hand hygiene.

4. The facility failed to ensure food was identifiable, labeled, and dated with expiration or use by dates. Additionally, the facility failed to ensure food was discarded after the expiration date or use by date.

a) On 11/30/15 at 2:25 p.m., a tour of the kitchen was conducted with the CEO (CEO #1) and the kitchen helper (Employee #20). During the tour, inspection of the Cafe refrigerator and freezer revealed the following items were not dated or labeled with an expiration date and/or use by date:

six beef bean burritos;

seven frozen taquitos;

approximately 50 frozen pretzels;

six frozen sausages with buns in baggies, undated;

26 frozen Danishes placed in baggies;

two single serve vanilla ice cream with the expiration date of 9/13/15;

six single serve strawberry ice cream with the expiration date 8/8/15;

two bags of sweet potato waffle fries;

four bags of frozen cauliflower;

four bags of frozen curly fries;

four bags of frozen potato wedges;

three bags of frozen okra;

six bags of frozen hashbrowns;

three large bags of frozen chicken pieces;

eight large bags of frozen soup.

Inspection of the main kitchen's refrigerators revealed the following items were not dated or labeled with an expiration date and/or use by date:

four wrapped pumpkin pie slices;

five slices German chocolate cake wrapped in plastic;

five small bowls with diced fruit covered in plastic;

two croissants in plastic bags; and

one unopened 2% milk with no manufacture expiration date.

b) On 12/01/15 at 3:30 p.m., an interview was conducted with the Interim Manager (Employee #15) who stated the kitchen staff followed an outdate list that was given to them by their previous manager eight years ago. Employee #15 stated freezer items were dated once they were opened, and stated, "I think it is a good idea to date things but, I don' t want to change too many things." Employee #15 also stated kitchen staff were good about monitoring and watching for outdates. "Before hire, we are required to take a food handler's course; other than that we don't do any other annual computer or infection control training."

c) On 12/02/2015 at 3:03 p.m., an interview was conducted with the Infection Preventionist (Infection Preventionist #23) who stated food borne illness was caused by bacteria and that kitchen staff were expected to date and initial all food items, and if staff took food out of its original container, an expiration date should have been placed on the new container. Infection Preventionist #23 also stated, "none of my training has covered food borne illnesses." The infection Preventionist #23 stated his/her responsibility with food services was to conduct a department inspection survey, monitor food trays intended for patients on isolation precautions and perform annual safety services; other than that s/he did not have much to with the food services department.

d) On 12/02/2015 at 3:38 p.m., an interview was conducted with the Chief Financial Officer (CFO #2), who was responsible for overseeing Employee #15 and Food Services. CFO #2 stated the previous supervisor had set-up and posted guidelines and policies for the kitchen staff to follow. S/he stated all kitchen staff were responsible for checking expiration or use by dates, and were responsible for discarding the outdated food according to these dates. S/he further stated all food should be clearly labeled and dated when removed from the original containers.

CFO #2 stated s/he did not inspect the kitchen nor monitor the foods for outdates. S/he also stated that once a month a meeting was held and all the managers would get together to talk about pressing issues and since the last dietary manager left the first part of October, 2015, s/he had not included Employee #15 in these meetings.

5. The facility stored patient supplies on the floor.

a) On 11/30/15 at 3:48 p.m., a tour of the Obstetrics (OB) Supply room was conducted and a large plastic bag was found sitting on the floor with hand writing on the outside that read "OB PREP KIT." The bag contained a urinary catheter, a package of vaginal packing, a 500 millimeter bag of Normal Saline, a Bakri prep pan, and a urine drainage pan.

b) On 12/01/15 at 9:24 a.m., a tour of the Emergency Room (ER) was conducted and a large clear plastic bag filled with clean linens was located on the floor. The Interim ER Manager (RN #25) stated the reason it was on the floor was because there was a delivery of linen that morning and there was no room in the cabinet to store the clean linen.

c) On 12/02/15 at 2:09 p.m., an interview was conducted with the Facilities Manager (Manager #17) regarding storage of patient supplies on the floor. S/he stated supplies should not be stored on the floor and s/he was not aware of a policy on this topic. S/he further explained staff were aware supplies should not be stored on the floor.

6. The facility did not ensure the sterile integrity of patient supplies intended for labor and delivery procedures.

a) On 11/30/15 at 3:48 p.m., a tour of the OB supplies room was conducted. The door to the supplies room was unlocked and inside the room, observation revealed a table covered with a blue paper cover and a piece of paper with the time of 1:30 p.m. written on it.

b) On 11/30/15 at 3:48 p.m., an interview with a nurse in the OB unit (RN #21) was conducted. RN #21 stated the door to the OB supplies room was always unlocked but closed and a sign stating "authorized personnel only" was posted on the door. RN #21 then stated under the blue cloth on the table were opened sterile supplies intended for patient use during labor and delivery procedures. RN #21 further stated s/he was unable to be certain of the sterility of the supplies under the blue cloth if there was not continuous monitoring of the table.

c) On 12/02/15 at 5:21 p.m., an interview with the Chief Clinical Officer (CCO #5) was conducted. CCO #5 stated s/he was unaware of the table in the OB supplies room being used for a sterile field. CCO #5 further stated the facility's expectation was to never leave a sterile field unattended.

d) On 12/02/15 at 3:03 p.m., an interview with Infection Preventionist #23 was conducted. Infection Preventionist #23 stated s/he rarely went into the OB supplies room and s/he was unaware the table in the OB supplies room was being used for a sterile field. Infection Preventionist #23 further stated s/he did not think leaving a sterile field unattended was appropriate.

Based on interviews and document review, the facility failed to ensure one designated staff member was responsible for the oversight of the entire medical records department.

This failure created the potential for patient medical records to be incomplete and unincorporated within the medical records department.

FINDINGS

POLICY

According to the Position Description for the Health Information Manager (HIM), job summary involves managing all functions of the Health Information Management Department.

1. The director of the medical records department did not ensure an outpatient unit was fully integrated into the facility's medical records department.

a) On 12/02/15 at 9:27 a.m., medical record review was conducted with the Health Information Manager (HIM #19). During the review, HIM #19 stated a separate software system and patient portal was used for patients who received care in the facility's Outpatient Specialty Clinic (Clinic). HIM #19 stated s/he was responsible for the oversight of the facility's medical records and the Clinic Manager (Manager #14) was responsible for the oversight of the Clinic's medical records; however, there was no staff member designated to oversee the entire medical records department.

At 11:00 a.m., a medical records staff member supplied policies and procedures regarding medical records management at the Clinic. HIM #19 stated s/he was not familiar with the supplied policies and procedures because they involved the Clinic only and not the facility.

b) On 12/02/15 at 1:48 p.m., an interview with Manager #14 was conducted. Manager #14 stated the Clinic changed to a separate medical records software program in 2012, due to the preference of the providers at the Clinic. Manager #14 then stated s/he was responsible for the oversight of the medical records at the Clinic and the overall direction of the medical records department was under the responsibility of HIM #19.

Manager #14 then explained that s/he would conduct a quarterly medical record audit review on a sample of 10 medical records per medical provider caring for patients in the Clinic. The medical record audit review involved ensuring the contents of the medical records were accurate; however, s/he did not report the findings of the review to HIM #19, who was responsible for oversight of the entire facility's medical records department.

c) On 12/02/15 at 4:47 p.m., an interview with the Chief Executive Officer (CEO #1) was conducted. CEO #1 stated that although there was a separate software system and medical records staff at the Clinic, the Clinic medical records staff should have been reporting to HIM #19. CEO #1 then stated there should have been one designated staff member overseeing the entire medical records department.