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Tag No.: C0226
Based on record review, observation, interview, and policy manual review, the provider failed to ensure the humidity for one of one operating room (OR) had been maintained within acceptable parameters of 20 to 60 percent (%) for six procedure days from June 2016 through November 2016. Findings include:
1. Review of the provider's OR log from June 2016 through November 2016 revealed:
*The OR humidity had been documented for all patient procedures performed.
*There were typically two procedure days per month.
*On the following days the OR humidity and number of patient procedures were recorded as:
-6/9/16, 66% for six procedures.
-6/22/16, 62% for five procedures.
-7/20/16, 68% for seven procedures.
-8/11/16, 73% for two procedures and 62% for six procedures.
-8/17/16, 60% for eight procedures.
-9/21/16, 60% for seven procedures.
Observation and interview on 11/15/16 at 2:50 p.m. with patient care coordinator D and director of nursing (DON) E in the OR revealed:
*There was a portable thermometer and humidity meter inside the room that read 42% humidity.
*Staff checked the OR humidity for every patient procedure and documented the reading in the OR log book.
*DON E was unsure what the humidity range should have been.
-She thought it should have been between 35 to 45% but would check into it further.
*A policy was requested on their process related to OR humidity at that time.
Further interview on 11/16/16 at 9:55 a.m. with DON E in the OR regarding the OR humidity revealed:
*They had no policy to address the OR humidity.
*She had looked up what the range should have been, and it should have been between 20 to 60%.
*She confirmed the OR humidity for the above days had been above the acceptable range.
Interview on 11/16/16 at 11:20 a.m. with registered nurse F in the OR regarding the OR humidity revealed:
*She documented the OR humidity in the OR log book on the days she assisted with patient procedures.
*After talking to DON E the humidity should have been between 20 to 60%.
*She confirmed the OR humidity had been above the accepted parameters for those days.
*She was aware it had been above 70% in July and thought she had contacted maintenance.
Interview on 11/16/16 at 1:45 p.m. with maintenance staff I regarding the OR humidity revealed:
*He thought the OR humidity was monitored by maintenance on a computer system.
*He was unsure if the portable humidity meter in the room was accurate.
*He had known the humidity was out of range in the past, and it had been worked on.
-He was unsure when it had been worked on.
Review of the provider's signed 6/13/16 Surgical Services policy and procedure manual revealed no policy on monitoring humidity in the OR.
Tag No.: C0278
25107
35237
Based on observation, interview, record review, professional standards review, and policy review, the provider failed to ensure:
*Single-use patient equipment had remained in the packaging and had been unopened in five of five observed patient care areas (operating room [OR], emergency room [ER], intensive care unit [ICU], recovery room 3, and the clinic).
*The emergency crash cart and intravenous (IV) pump/pole in the ER had been stored in a clean and sanitary area.
*Hinged surgical instruments in four of four storage areas (OR, ER, treatment room 2, and the clinic) had been sterilized appropriately in the opened position.
*Shipping containers were not used for storage, and supplies were not stored on the floor for one of one clinic.
*Proper hand hygiene had been performed by three of five observed surgical staff (physician C and registered nurses [RN] A and B) during patient 34 and 35's pre-operative assessments and care and following two procedures when leaving the OR.
*Proper personal protective equipment (PPE) had been worn by one of five observed surgical staff (RN F) in the operating room for two of two observed patients' (34 and 35) colonoscope procedures.
*Two of five observed surgical equipment carts (a three-shelf metal cart and the cataract procedure cart) had been maintained in a clean condition.
Findings include:
1. Observation and interview on 11/15/16 at 8:55 a.m. with patient care coordinator D in the ICU room revealed:
*An emergency crash cart with suction tubing and a Yankauer suction device opened and attached to the suction machine.
*Four plastic tubs containing oxygen re-breather masks and nasal cannulas.
-Multiple packages had the seals broken and were opened.
*An opened bag containing an oxygen nasal cannula attached to the oxygen supply adapter on the wall.
*An opened Yankauer suction device and tubing attached to the suction unit on the wall.
*She confirmed:
-It was usual practice to set those items up like that to be ready for patient use.
-Those items should have been kept sealed in their packages until ready to use for infection control purposes.
2a. Observation and interview on 11/15/16 at 10:40 a.m. with patient care coordinator D and director of nursing (DON) E in the ER revealed:
*A pediatric ambu-bag and mask in a bag hanging on the emergency crash cart with a large tear down the side exposing the device.
*Two bulk packages of two inch by two inch gauze pads opened and laying in a plastic tray in the north cupboard.
-They confirmed gauze pads for patient use should have been kept clean and free from possible contamination.
*The emergency crash cart and ready to use IV pole/pump had been stored approximately two to three feet across from the hopper.
-They confirmed they had used the hopper in the past to spray and clean soiled items in the ER.
-It was close to the crash cart and IV pole and could have potentially contaminated those items when the hopper was in use.
b. Continued observation and interview with patient care coordinator D and DON E of the ER's north supply cupboards revealed multiple bins containing packages of sterilized hinged surgical instruments in the closed position. The instruments included:
*Towel clips.
*Small, curved, bandage and large scissors.
*Alligator clamps.
*Curved Kellys.
*Babcocks.
*Needle clamps.
*Allis clamps.
*Mosquito forceps.
*Nasal speculums.
*Varying sizes of forceps.
*Patient care coordinator D oversaw the sterilization process for all surgical instruments.
*She confirmed hinged instruments should not have been sterilized in the closed position.
-The sterility of those instruments could not have been guaranteed.
Surveyor: 25107
3. Observation on 11/15/16 from 1:30 p.m. to 2:45 p.m. in the clinic revealed:
*In all fourteen examination (exam) rooms:
-Individual containers with rolls of gauze, tongue depressors, cotton swabs, and two inch by two inch gauze pads.
-Those supplies were not individually wrapped and were stored in containers on the counter.
*In the treatment room:
-Multiple packages of sterilized reusable medical equipment.
-Many of those pieces of equipment were hinged instruments such as scissors.
-All of the hinged instruments had been processed in the closed position.
*In the shot room:
-Needles were stored in needle boxes with the tops cut off.
-The lot numbers on the boxes had not matched the lot numbers on the needles.
-Unwrapped syringes stored in a corrugated cardboard shipping container with the top cut off.
-Wrapped syringes were stored in corrugated cardboard shipping containers.
-One box was labeled with a hand written label 60 cc and 20 cc syringes.
-Fourteen manilla envelope shipping containers stored in the medication refrigerator door.
*On the storeroom floor:
-Four cases of single-use vaginal speculums.
-One box of exam table paper.
-Two cases of drape sheets.
Interview on 11/15/16 at 3:30 p.m. with clinic manager L revealed she was:
*Not aware supplies should have been individually wrapped.
*Not aware instruments should have been sterilized in the opened position
-The instruments were sterilized in the hospital.
*Not aware they were storing supplies in cardboard boxes.
*Not aware they were restocking cardboard boxes.
-Agreed cardboard boxes could not be cleaned.
*Not aware the envelopes were being stored in the refrigerator.
-Agreed the envelopes had come through the mail.
-There was no way to know what was on the outside of those envelopes.
*Not aware supplies were stored on the floor.
-Agreed they should not have been stored on the floor.
Interview on 11/16/16 at 1:15 p.m. with medical technologist K who over saw the infection control of the clinic revealed she agreed:
*They should not have restocked cardboard boxes.
*They should not have stored supplies in cardboard shipping boxes.
*They should not have put the manilla envelopes in the refrigerator.
*They should not have stored patient supplies on the floor.
Review of the provider's February 2012 Infection Prevention and Control policy revealed:
*"Patient supplies would be stored in a manner to protect them from the environment and from contamination."
-"No floor storage unless on a cleanable pallet high enough from the floor to clean underneath."
Surveyor: 35237
4. Observation and interview on 11/15/16 at 2:50 p.m. with patient care coordinator D and DON E of the OR revealed:
*Supply cupboards contained the following sterilized hinged surgical instruments in a closed position:
-Iris scissors.
-Straight Kelly.
-Curved needle holder with a large amount of rust on it.
*Patient care coordinator D confirmed:
-The instruments should not have been sterilized in the closed position.
-The curved needle holder with rust should not have been kept for possible use.
*There was a three-shelf metal cart containing cautery equipment.
-The middle and bottom shelves had rusted areas.
*There was a cataract procedure cart that had rust along four bottom edges and inside the door.
*Patient care coordinator D and DON E confirmed the carts had not been maintained in a cleanable condition with those rusted areas.
5. Observation on 11/16/16 from 8:04 a.m. through 8:30 a.m. with RN A during patient 34's pre-operation assessment and care revealed:
*Prior to and following the IV insertion she had washed her hands.
*After washing both times she turned off the faucet with her bare hands, then dried her hands with paper towels.
*She had not used a protective barrier to turn off the faucet.
Interview on 11/16/16 at 2:00 p.m. with RN A regarding the above observation confirmed she should not have shut off the faucet with her bare hands following handwashing. Touching the faucet handles could have re-contaminated her clean hands.
Surveyor: 32355
6. Observation on 11/16/16 at 9:25 a.m. and at 11:11 a.m. of physician C revealed he had:
*Left the OR after completing two colonoscope procedures.
*Washed his hands, turned off the faucet with his wet hands, and then dried his hands with paper towels.
*Not used a protective barrier to turn off the faucet.
Interview on 11/16/16 at 11:20 a.m. with physician C revealed:
*He agreed he should not have turned off the faucet with his clean hands.
*Turning off the faucet with his hands had caused them to become re-contaminated.
*The potential for cross-contamination of microorganisms from one patient to another could occur when hand hygiene was not completed properly.
7. Observation on 11/16/16 from 9:30 a.m. through 10:12 a.m. of RN B with patient 35 revealed she:
*Gathered supplies to complete a nursing assessment and IV insertion for fluid and medication administration.
*Started an IV in the patient's right hand.
*Disposed of her soiled supplies.
*Removed her gloves and without washing her hands she:
-Retrieved an identification band from the patient's chart and placed it on her left wrist.
-Left the patient's room and returned to the surgical recovery room area.
-Completed charting on several paper documents for the patient.
-Entered recovery room three to assist another patient.
Interview on 11/16/16 at 1:10 p.m. with RN B revealed:
*The above observation had not been her usual process.
*She agreed she should have washed her hands:
-After completing the IV insertion.
-Before assisting another patient.
Interview on 11/16/16 at 2:45 p.m. with patient care coordinator D revealed:
*She agreed:
-A protective barrier should have been used to turn off the faucet after handwashing had been completed.
-Handwashing should have been performed after completing the IV insertion.
*The processes observed had not been sanitary and created the potential for cross-contamination of microorganisms to other patients.
Surveyor: 35237
8a. Observation on 11/16/16 from 9:38 a.m. through 9:55 a.m. of patient 34's colonoscope procedure revealed:*DON E and patient care tech (PCT) J both had gowns and gloves on for PPE during the procedure.
*Physician C wore a gown, gloves, and a face shield for PPE during the procedure.
*RN F wore regular wrist length gloves and no gown or face shield.
-Her scrub top had short sleeves.
-She had a metal watch on her left wrist.
*During the procedure physician C ran the scope controls, and RN F assisted with advancing and removing the scope.
*Throughout the procedure RN F leaned on the patient's body.
-Her bare forearm rested on his buttocks while she used her left hand to hold and maneuver the scope.
*Following the procedure RN F removed her gloves and washed her hands.
b. Observation on 11/16/16 from 10:45 a.m. through 11:10 a.m. of patient 35's colonoscope procedure revealed:
*The same PPE was used by DON E, PCT J, physician C, and RN F.
*During the procedure RN F performed the same process as above.
*Following the procedure RN F removed her gloves and washed her hands.
-She had not washed her forearm area that had touched the patient's buttocks.
Interview on 11/16/16 at 11:20 a.m. with RN G who had been in attendance for part of patient 34's and patient 35's colonoscope procedures revealed:
*She normally performed the scope cleaning and assisted with procedures as needed.
*She was unsure why some staff had worn gowns and face shields and some had not.
*She confirmed RN F should have worn a gown since she was touching the patients.
-RN F could have been contaminated during the procedure due to her close proximity.
Interview on 11/16/16 at 11:22 a.m. with physician C regarding the above observation confirmed:
*RN F had been in close proximity to the patients and participated with the procedures.
*She should have worn proper PPE for the patients' and her protection.
*Proper PPE included a gown, eye protection, and gloves.
Interview on 11/16/16 at 1:40 p.m. with RN F regarding the PPE she had worn in the above procedures revealed:
*Her usual process was to wear only gloves during procedures.
*She would not wear a gown, because she got too hot.
*She had not felt she needed to wear a gown for her part in the procedure.
*DON E and PCT J wore gowns, because they were dealing with chemicals and handling the dirty scope.
9. Interview on 11/16/16 at 2:05 p.m. with patient care coordinator D and medical technologist/infection control officer K revealed:
*Staff had been instructed during their training to place hinged instruments in the opened position before sterilization.
*They had not used any type of positioner to hold the instruments open.
*They could not verify if the instruments remained opened during the sterilization process.
*Patient care coordinator D revealed they used the Association of the Advancement of Medical Instrumentation (AAMI) guidelines.
*A policy on the sterilization of individualized packages of instruments was requested at this time and had not been received by the end of survey.
*RN F should have worn proper PPE during the above procedures that included a gown.
*PPE was worn for the patients' and staffs' protection and not for comfort.
*Proper handwashing included shutting off the faucet with a paper towel, so hands were not re-contaminated.
-RN A and physician C had not performed hand hygiene properly in the above observations.
*The surgical equipment with rust had not been maintained in a cleanable condition.
*Single-use patient items including oxygen nasal cannulas, oxygen masks, and suction tubing should not have been opened until needed for patient use to keep it free from possible contamination.
*Medical technologist/infection control office K stated she:
-Had done the OR environmental rounds that morning.
-Had not done her yearly OR and sterilization rounds since October 2015.
-Usually completed the OR and sterilization rounds in October, but she was unable to complete them in October 2016.
10. Review of the 2015 AAMI guidelines revealed:
*The scrub person should have ensured hinged instruments were opened for proper sterilization.
*Packages should not have been bent, compressed, or punctured.
Review of the provider's revised 8/31/16 Environmental Rounds schedule revealed the OR and sterilizing department rounds should have been completed in October every year.
Review of medical technologist/infection control office K's November 2016 Environmental Rounds worksheet for the OR revealed she had checked:
*The furniture in the procedure room was clean and in good condition.
-There was no mention of the rusted areas on the equipment.
*Gloves and PPE was available and in use per policy.
-There was no mention of RN F not wearing the proper PPE during the procedures above.
*Hand hygiene was observed when appropriate.
-There was no mention of staff not completing hand hygiene appropriately.
*Instruments and devices were being processed correctly.
-There was no mention of instruments not being sterilized in the opened position.
Review of the provider's 2007 Sterile Processing Department - ICP Survey/Assessment rounds sheet the infection control officer used for audits for decontamination and sterilization of equipment revealed:
*"Equipment is loaded properly for cleaning efficiency.
*Hinged instruments are opened.
*Multi-part instruments are disassembled as appropriate."
Review of the provider's revised August 2015 Standard Precautions policy revealed:
*"D. All personnel (Physicians, nurses, technicians, students, and other healthcare providers) must evaluate their own interactions with patients and use appropriate personal protective equipment (PPE) based on anticipated contact with body substances, not the patient diagnosis of infection. PPE is mandatory for any potential exposure to blood, all body fluids, secretions, non-intact skin and mucous membranes."
*"1. Gowns (impermeable, non-sterile) will be worn to protect skin and prevent soiling of clothing during procedures and patient-care activities that are likely to generate splashes or sprays of blood, body fluids, secretions, or excretions. Remove a soiled gown as promptly as possible. Hand hygiene is performed after glove removal."
*"4. Protective eyewear (face shield or goggles) is worn during procedures or patient care activities that may generate splashes or sprays of blood, body fluids, secretions or excretions. Masks and protective eyewear must be worn together. Mask with attached eye shield is the preferred choice."
*"Hand hygiene is the single most important method to prevent the spread of infection and will be performed:
-1. After touching blood, body fluids, secretions, excretions, and contaminated items, whether or not gloves are worn.
-2. Before and after glove removal.
-3. Between each patient contact and when otherwise indicated to avoid transfer of microorganisms to other patients and the environment.
-4. Between different tasks and procedures on the same patient to prevent cross-contamination of body sites.
-5. See Hand Hygiene Policy (IPAC-2)."
*For patient supplies and equipment:
-"a. Patient supplies and equipment will be stored in a manner to prevent cross-contamination and protected from the environment.
-b. Supply carts will have cleanable shelves with solid bottom shelving. Shelving will be routinely cleaned per unit policies.
-c. Clean supplies/equipment are not stored with used/contaminated items.
-d. Supplies will not be stored on the floor."
-"f. Patient supplies stored in patient rooms will be packaged (no open supplies/containers). They will be stored in enclosed cupboards and protected from the environment."
*"All healthcare workers who participate in invasive procedures must routinely use appropriate PPE for all patients."
Review of the provider's revised February 2014 Hand Hygiene policy revealed the procedure included:
*"c. Using friction, wash all areas of hands and fingers for at least 15 seconds, including under the fingernails and between the fingers.
*d. Rinse hands thoroughly.
*e. Dry hands with a paper towel.
*f. Use a dry paper towel to turn off the water."
Tag No.: C0297
Based on record review, policy review, and interview, the provider failed to ensure acceptable standards of practice were followed for handling medications for one of one sampled patient (10). Findings include:
1. Review of patient 10's 5/21/16 physician's orders revealed the following medications were to have been used from the patient's own medication:
*Oxycodone Cr 20 milligrams (mg) every twelve hours.
*Oxycodone/Apap 5/325 mg, one to two tablets every four hours as needed.
Review of patient 10's nurses progress notes on 5/22/16 at 12:00 noon revealed:
*Registered nurse (RN) G charted "Replaced two tabs of patients own supply from Pyxis [medication dispensing system] supply of Oxychodone/APAP 5/325 when counting patients tablets prior to discharge with a second RN, Two tablets of pts [patients] med were dropped on the ground by this RN with witness by another RN and disposal of. Updated family."
*There was no documentation the physician had been notified.
Interview, review of the above incident, and review of the provider's December 2014 Home Medication policy on 11/16/16 at 2:05 p.m. with pharmacist H revealed:
*He confirmed if the medication was not available in the Pyxis a physician would have given an order to use the patient's own medication.
*He confirmed Oxycodone Cr was not in the hospital formulary and would not have been available in the Pyxis.
*Oxycodone/Apap 5/325 mg was in the formulary and was in the Pyxis.
-He was not sure why they were using the patient's own medication.
*It was not an acceptable practice to take from the hospital medication system after RN G had dropped the patient's own pills on the floor.
*Additional information he would have expected to have been documented was:
-The other nurse who witnessed the destruction of the medication.
-If the physician had been notified, because the order read to use the patient's own medication.
*The physician or a pharmacist would have been the only one who could have dispensed that medication from the Pyxis since the physician order was to use the patient's medication.
-A nurse could not do that.
Interview and review of the above incident on 11/16/16 at 2:35 p.m. with director of nursing (DON) E revealed:
*They should never have taken the medication from the hospital medication system to replaced it.
*The nurse should have told the family the medications had been dropped and not replaced them.
*An Incident/Accident Report should have been completed and would have triggered her to notify the physician.
*She had not been made aware of the incident.
Review of patient 10's untitled form that tracked the dispensing of the controlled substance Oxycodone/APAP 5/325 mg tablets with DON E revealed:
*On 5/22/16 "Dropped 2 tabs on the ground--replaced with 2 tabs from Pyxis system. Disposed of 2 tabs in Sharps."
*It had been signed by RN G and RN F.
Review of the provider's December 2014 Home Medication policy revealed:
*"Patient may use their own medications in the hospital under the following circumstances:
-Patient taking a medication that is not on the hospital formulary.
*If using a patient's own medication, the physician will order it as such and a label will be printed by e-Pharmacy so that the medication can be scanned during administration of the medication."
*It had not addressed what to do if a patient's medication needed to have been destroyed.