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Based on record review and policy review, the facility failed to ensure required on-going training was part of the credentialing process upon the re-credentialing of four staff (BBBBB, CCCCC, DDDDD and EEEEE) of four staff physicians' credentialing files reviewed. This had the potential for physicians to provide care for patients without proper training. The facility census was 221.

Findings Included:

1. Record review of the facility's policy titled, "Medical Staff Procedural Policy," dated 08/20/15, showed the Credentials Committee was to examine evidence of professional competence and qualifications to establish and satisfy all of the necessary qualifications for appointment and for the clinical privileges requested

Record review of Staff BBBBB, CCCCC, DDDDD and EEEEE physician credentialing files showed no evidence of on-going training for the re-credentialing process.

Based on observation, interview, record review and policy review, the facility failed to ensure staff followed facility policies when they failed to perform urinary catheter (a small flexible tube inserted into the body through an opening of the urinary tract to drain urine) care for two patients (#20 and #49) of four patients reviewed with urinary catheters. The facility also failed to ensure staff followed facility policy for obtaining vital signs post-operative (post-op, after surgery) for two patients (#7 and #42 ) of two patients observed post-operatively. These failures had the potential to place all patients with urinary catheters at risk for infection and placed all patients at risk for post-operative complications when their vital signs were not being monitored. The facility census was 221.

Findings included:

1. Review of the facility policy titled, "[brand name] Catheter Insertion and Care," revised 05/17/18, showed the following:
- Most urinary tract infections (UTI) in the acute care setting are caused by instrumentation (manipulation of) of the urinary tract, including indwelling bladder catheters. Although not all catheter related urinary tract infections can be avoided, the incidence of these infections can be significantly reduced by proper techniques in the insertion, care and removal of urinary catheters.
- Catheter care will be performed daily and as needed (prn).
- Catheter care consists of washing perineum (the area between the anus and the vaginal area of a woman and the scrotal area of a man) as per routine hygiene care.
- Once perineum is cleaned, cleanse catheter insertion site and catheter tubing.
- Repeat this process with any episode of bowel incontinence or when catheter is visibly soiled.
- Catheter care will be documented in the patient's medical record.

Observation on 05/15/18 at 3:20 PM showed Patient #20 with an indwelling urinary catheter.

During an interview on 05/16/18 at 9:35 AM Patient #20 stated that she hadn't received any urinary catheter care since admission.

Review of Patient #20's electronic medical health record (EMHR) showed she was admitted to the facility on 05/07/18, with a urinary catheter inserted on admission. The EMHR showed no documentation of urinary catheter care since the patient's admission.

Observation and concurrent interview on 05/16/18 at 1:40 PM showed Patient #49 with an indwelling urinary catheter. Patient #49 stated that he hadn't received any urinary catheter care since admission.

Review of Patient #49's EMHR showed he was admitted on 05/09/18 with a urinary catheter inserted on 05/10/18. The EMHR showed no documentation of urinary catheter care since the patient's admission.

During an interview on 05/16/18 at 4:30 PM Staff C, Vice President of Nursing verified that there was no documentation of urinary catheter care for Patient's #20 and #49. She stated that there was a problem with the EMHR system that allowed staff to proceed with their assessment/care documentation without documenting if the patient had received urinary care or not.

During an Interview on 5/16/18 at 9:30 AM, Staff RRR, Nurse Technician (NT), stated that urinary catheter care was to be:
- Completed at least every shift;
- Performed after the patient had soiled (bowel movement), and with bathing; and
- Documented by the Registered Nurse (RN), in the EMHR

2. Review of the facility's policy titled, "Vital Signs," revised 03/2018, showed the directive for staff to obtain vital signs on post-surgical patients within five minutes of return to room and then every hour for four hours. Vital signs are to include the patient's temperature, oxygen saturation (the amount of oxygen in the blood stream, measured in percentage), heart rate, respiration (how many breaths taken per minute), blood pressure (BP, a measurement of the pressure of blood flow, during the pumping and resting phase of the heart), and pain level.

Review of Patient #7's medical record on 05/14/18 at 3:00 PM showed that he had surgery on this day for gallbladder (an organ in the body that stores bile) removal and had returned to his room on the General Surgery Third floor at 1:35 PM. No order for vital signs post surgery was found in the medical record.

During an interview on 05/14/18 at 3:15 PM, Staff K, RN, General Surgery Third Floor Charge Nurse stated that every post-surgical patient had vital signs taken every hour for four hours, when they returned from surgery. The Patient Care Technician (PCT) was responsible for taking the vital signs and they informed the nurse of any abnormal vital signs.

During an observation and concurrent interview on 05/14/18 at 3:30 PM in Patient #7's room, vital signs were posted on a board in the patient's room. Staff M, PCT who was assigned Patient #7, stated that she had not taken any vital signs on the patient since 1:35 PM, and she did not know how often she should be taking them. She worked in the float pool and did not know the vital sign policy on this floor.

Review of Patient #7's medical record on 05/15/18 at 10:30 AM, showed that post-surgical vital signs on 5/14/18 were obtained at the following times:
- 1:15 PM, when the patient arrived to his room.
- The second set of vital signs were not taken until 4:00 PM, two hours and 45 minutes later.
- The third set of vital signs were not taken until 8:00 PM, four hours later.
- The fourth set of vital signs were not taken until 11:59 PM, another four hours later.

Review of Patient #42's medical record on 05/15/18 at 10:00 AM showed that she had surgery on 05/14/18 for a laparoscopic left colon resection (an operation performed in the abdomen through small incisions with the aid of a camera to remove part of the intestine). She was brought to her room on the General Surgery floor at 12:20 PM. Vital signs were obtained at 12:20 PM, 1:20 PM, 4:00 PM (two hours and 40 minutes had passed since her last set of vital signs) and 8:00 PM (four hours since the last set of vital signs).

Vital signs were not obtained every hour for four hours, upon return to the surgical floor post surgery and put both of these patients at risk for post operative complications when their vital signs were not monitored.

During an interview on 05/15/18 at 10:30 AM, Staff HHH, General Surgery Third Floor Clinical Coordinator, stated that her expectation was for staff to obtain vital signs on post-surgical patients as the policy stated, every hour for four hours, and then every four hours, or as ordered.



39562

Based on interview, record review, policy review and Medical Staff Bylaw review, the facility failed to ensure that Post Anesthesia Care Unit (PACU) Anesthesia Standing Orders were signed, dated and timed by the physician within the specified time frame for three patients (#7, #42, and #65) of eight patient records reviewed. This failure had the potential to allow orders to be carried out on patients without timely review by the physician, which could be unsafe for all patients who received care per standing orders. The facility census was 221.

Findings included:

1. Review of the facility's Medical Staff Bylaws dated 02/15/18 and the facility's policy titled, "Physicians' Orders," revised 11/2017, showed conflicting information. The Medical Staff Bylaw directive was for the practitioner to countersign all transcribed standing orders on their next hospital visit, and in all cases, within 24 hours. The facility policy stated that the nurse initiating the pre printed standing orders shall check off items requested by the physician and sign as for any verbal order or phone order. The date and time initiated shall be placed in the left hand column at the top of the order. The orders should be flagged for the physician to sign, date and time within 48 hours.

2. Review of Patient #7's medical record on 05/16/18 showed the following:
- He was admitted to the facility on 05/13/18 for right upper quadrant abdominal pain and had surgery on 05/14/18 to remove his gallbladder (an organ in the body that stores bile).
- The PACU Anesthesia Post-Operative (Post-op) standing orders was initiated without the physician signature on 05/14/18 at 11:52 AM and medications were administered by the Registered Nurse (RN).
- The physician had not signed the order as of 05/16/18 at 3:00 PM, which was over 48 hours since the order was initiated.

Review of Patient #42's medical record on 05/16/18 showed the following:
- She was admitted to the facility and had surgery on 05/14/18 for a laparoscopic left colon resection (an operation performed in the abdomen through small incisions with the aid of a camera to remove part of the intestine).
- The PACU Anesthesia Post-Op standing orders was initiated without the physician signature on 05/14/18 at 9:07 AM and medications were administered by the RN.
- The physician had not signed the order as of 05/16/18 at 3:00 PM, which was over 48 hours since the order was initiated.

Review of discharged Patient #65's medical record on 05/16/18 showed that PACU Anesthesia Post-Op standing orders was initiated without the physician signature on 05/04/18 at 11:01 AM and medications were administered by the RN. The physician electronically signed the order on 05/15/18 (11 days after the order was initiated).

3. During an interview on 05/17/18 at 9:30 AM, Staff WWWW, Anesthesiologist, stated that he did not know if there was a time frame on when standing orders needed to be signed. If he missed signing an order, medical records would let him know in a week what orders needed to be signed.

Based on observation, interview, record review and policy review, the facility failed to ensure sttaff followed infection control policies and infection prevention standards when they failed to:
- Perform hand hygiene and glove change after the removal of contaminated dressing during wound care dressing change for one patient (#19) of two dressing changes observed.
- Perform hand hygiene and glove changes after touching inanimate (non-living) objects and prior to touching the patient for seven patients (#7, #9, #11, #20, #40, #41, and #42) of 25 patients observed during nursing procedures.
- Clean and/or disinfect inanimate objects such as mobile computer carts, computer keyboards, computer mouse and scanners as directed by facility policy.
- Wash hands with soap and water before exiting a patient room with suspected Clostridium difficile (C-diff, a bacteria of the colon that can be spread from person to person by touch or by direct contact with contaminated objects and surfaces) for one patient (#41) of two patients observed.
- Wear appropriate Personal Protective Equipment (PPE, protective clothing, goggles, masks, gloves designed to protect the wearer's body from injury or contamination) and clean patient surroundings from contamination after tracheal suctioning (removal of secretions from an artificial airway) for one patient (#48) of two patients observed for tracheal suctioning/care.
- Ensure that endoscopy staff followed manufactures guidelines for enzymatic cleanser (detergent specifically formulated for use with medical instruments) concentration when soaking and cleaning contaminated endoscopes (an instrument used to view the inside of the throat,stomach and intestines), prior to automated high-level disinfection.
- Label intravenous (IV, within the vein) tubing as directed by policy, for three patients (#36, #41 and #42) of 10 patients with IVs observed for labeling.
- Clean storage rack trays of debris and place lids on trash cans.
These deficient practices had the potential to increase the risk of cross contamination and placed all patients, visitors, and staff at risk for infection. The facility census was 221.

Findings included:

1. Review of the facility's policy titled, "Hand Hygiene," revised 04/2018, showed directives for staff to::
- Perform hand hygiene before having direct contact with patients;
- Perform hand hygiene after contact with a patient's intact skin;
- Perform hand hygiene after contact with body fluids or excretions, mucous membranes, non-intact skin, and wound dressings;
- Perform hand hygiene after contact with inanimate objects (medical equipment, environmental surfaces, including keyboards) in the immediate vicinity of the patient;
- Perform hand hygiene before donning (to put on) and after removing sterile or non-sterile gloves;
- Wash hands with antimicrobial soap and water when caring for patients known or suspected to be colonized (infected) with Clostridium difficile (C-diff, a bacteria of the colon that can be spread from person to person by touch or by direct contact with contaminated objects and surfaces);
- Remember that wearing gloves is not a substitute for hand hygiene, dirty gloves can soil hands;
- Change gloves, and perform hand hygiene during patient care if the hands will move from a contaminated body-site to a clean body-site; and
- Remove gloves after contact with a patient and/or surrounding environment (including medical equipment) using proper technique to prevent contamination of the hands and/or surrounding environment.

2. Observation on 05/15/18 at 10:40 AM, on the Fifth floor Cardiac Medical Floor (CMU) showed Staff HH, Registered Nurse (RN) and Staff GG, RN, Wound Care Nurses in Patient #19's room for placement of a negative pressure wound therapy vacuum (NPWT, a therapeutic technique that uses a vacuum dressing to promote healing in acute or chronic wounds). Staff GG removed the bloody dressing/packing from the patient's abdominal surgical wound and placed it into Staff HH's gloved hands. Staff HH then reached across the patient and handed the soiled dressing/packing back to Staff GG for her to throw away. Staff HH then touched the patient's bed linens, the bed controls, the TV control, and used the phone. Staff HH touched the patient and inanimate objects while wearing her contaminated gloves. Staff HH then removed her gloves and touched the bed railing and retrieved a pen out of her pocket without performing hand hygiene.

During an interview on 05/15/18 at 11:25 AM, Staff HH stated that she usually removed her gloves once they were dirty and performed hand hygiene, and added that she should have done so after she touched the dirty dressing.

3. Observation on 05/14/18 at 3:30 PM, on the Third Floor General Surgery, showed Staff N, RN, scanned Patient #7's armband with an ungloved hand, put on gloves without performing hand hygiene and administered IV medication to Patient #7.

Observation on 05/14/18 at 4:10 PM, on Fourth Floor Orthopedic/Neurology, showed Staff O, Patient Care Technician (PCT), put on gloves and removed Patient #9's right hand IV. Staff O removed gloves to obtain a needed supply and did not perform hand hygiene before putting on another pair of gloves.

Observation on 05/15/18 at 8:45 AM, on Third Floor General Surgery showed Staff MM, RN, entered Patient #40's room with a mobile computer cart. Staff MM touched the computer monitor and scanner with ungloved hands. Staff MM then put on gloves without performing hand hygiene and administered Patient #40's oral medications and subcutaneous (under the skin) insulin (medication to lower the amount of sugar in the blood).

4. Observation on 05/15/18 at 9:45 AM, on the Third Floor General Surgery showed the following:
- Staff NN, RN, outside of Patient #41's room with a mobile computer cart;
- Signage on the outside of the door showed that Patient #41 was on contact precautions (techniques used to prevent infection spread through contact) with bleach precautions (room and surface cleaning requires the use of bleach to prevent further contamination) because of suspected C-diff;
- Staff NN, put on gloves and gown;
- Before she entered room, she answered a phone call on the portable phone, returned the phone to her pocket and did not change gloves or perform hand hygiene;
- Assisted Patient #41 to a sitting position in bed and administered oral medications to her;
- Exited the room and used foam for hand hygiene outside of Patient #41's room, instead of washing hands with soap and water inside the patient's room.
- Staff NN, then wheeled the mobile computer cart to Patient #42's room without cleaning the cart, computer monitor and scanner, entered the room again, used the scanner and keyboard and administered oral medications; and
- Staff NN, then changed Patient #42's IV bag and did not perform hand hygiene or put on gloves before the IV bag was changed.

During an interview on 05/15/18 at 10:00 AM, Staff NN, RN stated that she should have used soap and water to wash hands before she exited a patient's room with C-diff precautions, but forgot.

During an interview on 05/15/18 at 10:30 AM, Staff HHH, Third Floor Surgical Clinical Coordinator, stated that her expectation of staff was to always use soap and water to wash their hands before exiting a C-diff patient's room, to clean the mobile computer carts, scanners and keyboards between patient rooms and follow hand hygiene policy.

5. Observation on 05/15/18 at 9:30 AM on the Medical One Unit showed Staff I, RN in the room of Patient #11. She administered oral pain medication and then flushed the left anticubital (inside the elbow) IV with saline (a solution of salt and water). She opened drawers and documented on the computer keyboard. She did not change gloves or perform hand hygiene between caring for the patient and touching inanimate objects.

During an interview on 05/15/18 at 10:00 AM, Staff I confirmed that she had not changed gloves or performed hand hygiene and should have done so.

Observation on 05/15/18 at 8:15 AM, on the Sixth Floor Transitional Care Unit (TCU), showed Staff KK, RN in the room of Patient #20. Staff KK put on gloves, administered oral medications, touched the patient's abdomen, the mobile computer's keyboard and mouse, the patient's abdomen again then touched the computer keyboard. Staff KK then removed her gloves, performed hand hygiene, put on new gloves, and then proceeded to administer an injection. Staff KK then opened drawers on the mobile computer cart, cleaned trash off of the cart, touched the hand held scanner, the IV line and programmable medical machine, the computer mouse, and the patient's bandaged foot. Staff KK then exited Patient #20's room with the mobile computer cart without cleaning the computer keyboard, mouse or hand held scanner. Staff KK failed to change gloves or perform hand hygiene between caring for the patient and touching inanimate objects.

During an interview on 05/15/18 at 9:30 AM, Staff KK, RN stated that the mobile computer carts should be wiped down one time per shift and that she usually didn't wipe it down in between patients. She also stated that gloves were to be changed if they were soiled.

6. Observation and concurrent interview on 05/15/18 at 1:45 PM, on the Sixth Floor TCU showed Staff PPP, Respiratory Therapist (RT) prepared to perform tracheal (windpipe) suctioning on Patient #48. Upon entering the contact isolation room, the patients' family stated the patient had a very strong, productive cough, and usually coughed secretions out through his tracheostomy (surgical hold made through skin, into the windpipe) especially when he was suctioned. Staff PPP had a gown and gloves on. During the tracheal suctioning/care, Patient #48 forcefully expelled thick, green sputum (drainage) three separate times with the sputum visibly landing on the footboard of the bed, the bed linens and on his personal blanket. Staff PPP did not wipe down the footboard or change the patient's linens prior to leaving the room. Staff PPP stated that it did not occur to her to change the linens because she hadn't noticed the sputum on them. Staff PPP stated that she didn't think the patient's sputum had any bacterial (potentially harmful microorganisms) growth identified, but that the patient had to be suctioned several times a day and through report she was aware that he had a lot of secretions. She stated that the patient was on isolation because of his C-diff, not because of an infection within his respiratory system.

Staff PPP did not wear a face shield or goggles to protect herself from the patient's productive cough and sputum production during tracheal care/suctioning. She also failed to recognize the potential for cross contamination when the patient coughed secretions onto the footboard and bed linens.

Review of Patient #48's lab results dated 05/13/18 showed sputum culture results contained moderate gram positive and gram negative (groups of bacteria that can be identified by their shape and color when stained) rods.

Patient #48's sputum contained bacteria that increased the risk for cross contamination and placed anyone that came into contact with his surroundings at risk for infection.

During an interview on 05/16/18 at 10:15 AM, Staff BBBB, RT Assistant Director, stated that the expectation was for staff to always obtain and maintain universal precautions (an approach to infection prevention/control to treat all human blood and body fluids as if they were known to be infectious) by wearing goggles, mask, face shield, gown, and gloves when indicated. Staff BBBB further stated that the expectation was for staff to know their patients. If patients had a history of or were reported to have had projectile (propelled forward) mucus plugs (the buildup of thick body fluid/secretions in the airways) with previous respiratory treatments, staff should heed the advanced notification and cover the patient and their bedding.

7. Review of the facility's policy titled, "Manual Disinfection of Endoscopes," revised 01/2018, showed the directive for staff to fill the sink with water to allow the scope to be completely submerged. Add hospital approved enzymatic cleaner (cleaner specifically formulated for use with medical instruments including immersible endoscopes, an instrument that can be introduced into the body to give a view of the intestinal parts). Clean the entire scope with detergent soaked sponge including entire insertion tube, distal (most distant) end and handle.

Review of the facility's enzymatic detergent's manufacturer's manual, showed the directive for staff to add one ounce (oz., unit of measure) of enzymatic detergent to three gallons (gals, unit of measure) of water for cleaning of fully immersible endoscopes.

Observation and concurrent interview on 05/16/18 at 11:40 AM, in the high level disinfection endoscopy room, showed Staff UUUU, Endoscopy Technician, prepared to clean a dirty endoscope, and mixed three pumps of enzymatic detergent and an unknown amount of water. Staff UUUU stated that she cleaned them the way she was trained and filled the sink until the scope was immersed and was not sure how much water was in the sink.

This had the potential to lead to high levels of bacteria to remain on the scope which could lead to contamination and infection when the correct ratio of water and detergent was not used.

During an interview on 05/16/18 at 11:50 AM, Staff VVVV, Endoscopy Charge Nurse, stated that there used to be a fill line on the sink for staff to measure the correct amount of water, but recently installed a new sink and it was not marked. Her expectation of staff was to accurately measure the amount of water in the sink.

During an interview on 05/17/18 at 1:00 PM, Staff AAAAA, Infection Control Officer, stated that her expectation of the Endoscopy staff was to clean the scopes with correct ratios of water and detergent as directed by the manufacturer of the detergent.

8. Review of the facility's policy titled, "Clinical Care," dated 10/2017 showed the following directives:
- Replace IV tubing and add on devices (additional tubing connected to the IV) every Monday and Thursday.
- Stickers should be placed on the IV indicating the next interval for changing the IV tubing.
- Consider short extension tubing connected to the IV catheter (small flexible tube) to be a portion of the device. Replace such extension tubing when the catheter is changed.

Observation on 05/15/18 at 2:37 PM, in Patient #36's room, showed three IV bags hung on an IV pole. The tubing on the three IV bags were not stickered to indicate the next interval for IV tubing change, or labeled with a date and time staff hung them.

Observation on 05/15/18 at 9:45 AM, in Patient #41's room, showed two IV bags hung on an IV pole. The tubing on the two IV bags were not stickered to indicate the next interval for IV tubing change, or labeled with a date and time staff hung them.

Observation on 05/15/18 at 10:00 AM, in Patient #42's room, showed two IV bags hung on an IV pole. The tubing on the two IV bags were not stickered to indicate the next interval for IV tubing change, or labeled with a date and time staff hung them.

During an interview on 05/15/18 at 10:15 AM, Staff NN, Surgery Third Floor RN, stated that IV tubing should be changed and labeled every Monday and Thursday.

During an interview on 05/15/18 at 2:47 PM, Staff BBB, Pediatric Clinic Coordinator, stated that IV tubing should be changed every Monday and Thursday. Staff BBB stated that staff were expected to change IV tubing every Monday and Thursday, and staff were to place a sticker on the tubing with the date and time the tubing was initiated. Staff BBB stated that Patient #36's three IV tubings did not have a sticker on them. Staff BBB stated that the pediatric unit had stickers available for staff to use.

During an interview on 05/17/18 at 1:00 PM, Staff AAAAA, Infection Control Officer, stated that her expectation of staff was to follow the facility's policy and to change and label IV tubing as directed.

9. Observation and concurrent interview on 05/16/18 at 11:30 AM in the kitchen showed three large trash cans without lids and three bottom shelves of storage racks with visible thick fuzzy dust and debris on the surface where pots, pans and other food utensils were kept. Staff FFFFF, Senior Director of Food Service, stated that all surfaces should be free of any debris and should be cleaned weekly by the dietary staff.



















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39841

Based on observation, interview, record review, policy review and review of the Association for the Advancement of Medical Instrumentation (AAMI), the facility failed to:
- Ensure that the Sterile Processing Department staff (SPD, where contaminated surgical equipment and instruments were cleaned and sterilized) followed AAMI guidelines and use nonlinting cloths (cloths that do not shed lint) to dry instruments and containers.
- Maintain a sterile (free of harmful contaminants) environment in the SPD clean room, by eliminating dust, residue, and debris in four sterilizers (machines that use high heat and steam to kill harmful organisms).
- Clean the sterilizers in the SPD weekly as directed in the facility policy.
- Maintain a dust free environment by hanging a dry erase board, eraser and cloth in the instrument packaging area.
- Ensure properly executed informed consents were signed, dated and timed by the physician prior to surgery.

This had the potential to affect the health and safety of all patients who underwent surgical procedures.

The cumulative effect of these failures resulted in non-compliance with 42CFR 482.51 COP: Surgical Services. The facility census was 221.

Please refer to A-0955 for additional information.

Findings included:

1. Review of the facility's policy titled, "Sterilization Policy," revised 02/2018, showed that AAMI ST79:2017 and CMS guidelines are followed for all decontamination and sterilization processes.

Review of AAMI ST79:2017 guidelines showed that only nonlinting cloths or instrument air should be used to dry instruments and containers. Drying instruments before they are packaged can reduce the incidence of wet packs after sterilization and can help prevent corrosion of instruments. Cloths with lint can leave lint on instrumentation. Lint and airborne particles can carry microorganisms. Using appropriate cleaning reduces the bioburden (the number of bacteria living on a surface that has not been sterilized).

Observation on 05/16/18 at 10:15 AM in the clean work area/room where instruments are prepped and packaged showed the following:
- A large stack of white hospital linting washcloths;
- A linting washcloth laid at two of the workstations;
- Staff QQQQ, Sterile Processing Lead Technician, used a linting washcloth to dry off instruments; and
- A dry erase board hung with an eraser and cloth on top of the board.

During an interview on 05/16/18 at 3:00 PM, Staff QQQQ, Sterile Processing Lead Technician, stated that she used the white wash cloths to dry off the instruments and the inside of containers. She did not know the washcloths should be lint free.

During an interview on 05/16/18 at 3:05 PM, Staff OOOO, Sterile Processing Department Supervisor, stated that the white wash cloths were used by the staff to dry the inside of the instrument containers. The cloths were not lint free and should not be used to wipe off the instruments.

2. Review of the facility's policy titled, "Cleaning Sterilizer Chambers and Autoclave Carts," revised 04/2018, showed the following:
- Sterilizer chambers will be cleaned weekly, drains should be cleaned daily;
- Spray interior with Spectra-clave (sterilizer cleaner);
- Using a stiff nylon bristled brush, aggressively scrub chamber walls;
- Rinse with moist clean towels;
- Wipe dry with dry towels; and
- Once cleaning is complete, sign and date appropriate log record.

Review of the facility's Sterile Processing Department Sterilizer Cleaning Log showed no documentation of cleaning on the following dates:
- February 2018, the sterilizers were not cleaned on 02/04/18 and 02/25/18;
- March 2018, the sterilizers were not cleaned on 3/18/18;
- April 2018, the sterilizers were not cleaned on 04/8/18 and 04/22/18; and
- May 2018, Sterilizer's #1, #2, and #4 were not cleaned on 05/14/18.

Sterilizer's in the Sterile Processing Department were not cleaned weekly according to the facility policy. This had the potential to expose all surgical patients to infection.

Observation on 05/16/18 at 10:15 AM in the SPD clean room, inside Sterilizer #3 showed white liquid residue throughout the bottom of the sterilizer. Sterilizer #4 showed white residue in the bottom of the sterilizer and discoloration around a circular opening in the top of the sterilizer with brown streaks. There was residue and dust around the perimeter of the inside of Sterilizer #4.

Observation on 05/17/18 at 8:30 AM in the SPD clean room, inside Sterilizer #1 showed white residue in the bottom of the sterilizer, discoloration on the bottom rack, a black mark in the back of the sterilizer, and dust on the top of the sterilizer door. Sterilizer #2 showed white residue in the bottom of the sterilizer, discoloration on the bottom rack, a black mark in the back of the sterilizer, and dust on the top of the sterilizer door.

During an interview on 05/17/18 at 8:45 AM, Staff OOOO, Sterile Processing Department Supervisor, stated that the sterilizer's are cleaned every Sunday. There should not be dust on the top of the doors and they should do a better job of cleaning the sterilizers.

During an interview on 05/17/18 at 1:00 PM, Staff AAAAA, Infection Control Officer, stated that the Sterile Processing Department is an extension of the Operating Room and her expectation was for that area to be as clean as the Operating Room and to follow facility policies and AAMI guidelines in regards to cleaning and using non-lint cloths.

Based on observation, interview, record review, and policy review, the facility failed to ensure that a properly executed informed consent form for surgery was signed, dated and timed by the physician prior to surgery for two patients (#37 and #64) of eight charts reviewed. This failure had the potential to place all surgical patients at risk when necessary information was not provided to them before agreeing to the surgery. The facility census was 221.

Findings included:

1. Review of the facility policy titled, "Pre-Surgical ID of Patient and Verification of Operative Procedure," dated 09/2017, showed that it is the surgeon's responsibility to obtain and document in the patient's record the informed consent for the operative procedure.

Review of Patient #37's Electronic Medical Health Record (EMHR), showed the following:
- The patient was admitted to the facility on 05/04/18 for a lesion on his back;
- The form, General Consent to Surgical and Medical procedures, and other services to do the following operation or procedures was filled out with: wide local excision skin tumor back (remove a skin growth on the patient's back), bilateral axillary lymph node biopsy (remove a piece of tissue from a small gland underneath both armpits) and indicated procedures was dated 05/4/18 at 10:25 AM and signed by Patient #37 and a witness.
- The Physician Statement which reads: the procedure, risks, benefits, and alternatives (including the probable consequences if no treatment is pursued) have been explained to the patient/patient legal guardian representative. All of the patient's questions have been answered, and to the best of my knowledge I believe the patient has been adequately informed had no physician signature, time, or date documented.
- A separate General Consent for Anesthesia for the same above procedure was dated 05/04/18 at 10:25 AM and signed by Patient #37 and a witness, but was not signed, dated and timed by the Anesthesiologist.
- A General Consent to Surgical and Medical Procedures, and other services to do the following operation or procedures: split thickness skin graft on back and infuse-a-port (a small device containing a thin tube that is placed under the skin to administer medication) placement was dated 05/09/18 at 7:59 AM and signed by Patient #37 and a witness.
- The physician Statement was not signed, dated or timed by the physician.

Review of Patient #64's EMHR showed the following:
- She was admitted to the facility on 05/16/18 for complaints of left hip degenerative joint disease and was scheduled for left total hip arthroplasty (the surgical reconstruction or replacement of a joint).
- A General Consent to Surgical and Medical Procedures, and other services for a Left Total Hip Arthroplasty was signed by Patient #64 and a witness on 05/16/18 at 6:20 AM.
- The Physician Statement was not signed, dated or timed by the physician.

During an interview on 05/16/18 at 2:00 PM, Staff SSSS, Surgery Director, stated that his expectation of the staff in the Pre-Operative area was to make sure the physician had signed the consent before the patient leaves the pre-op area. He expects all pre-op staff and operating room staff to review the preoperative safety checklist which includes correct surgical permit and make sure the consent is signed by the physician before the surgery begins.