HospitalInspections.org

1.Based on observation, interview, and record review, the facility failed to follow its policies regarding infection prevention and control .

Several serious infection control issues were identified throughout the survey process. These included: maintenance of proper humidity levels in the operating /procedure rooms; appropriate storage of sterile supplies; maintenance of proper temperatures and sanitizer levels for the dish machine; safe storage of frozen foods; proper storage of endoscopes and laryngoscope blades. These deficient practices placed all patients at risk of adverse outcomes, serious harm, and even death.
Refer 482.12 (a)(4)
Tag : [ C-0278]

2. .Based on observation, interview, and record review, the facility failed to adhere to it's polices regarding management of medication. Several expired drugs and intravenous fluids were available for patient use .

Refer 482.12 (a)(4)
Tag : [ C-0278]

Based on observation, interview and record review the facility failed to ensure that outdated, or unusable drugs were not available for patient use in use in four (4) of five (5) patient departments observed (Emergency Department (ED), Operating Room (OR), Hyperbaric /Wound Care Unit (HBO), Medical-Surgical Unit (M/S) and Pharmacy).

Finding Include:

Emergency Department:

Observation on 10/19/2016 @ 10:20 am in the ED revealed the following:

Medication Room/ " Antibox "

· Six (6) vials Flumazenil 0.5 milligrams (mg) /5 milliliter (ml) expired 9/2016
· Six (6) bottles Actidose-Activated Charcoal Suspension 25 grams/120 ml. bottles expired 6/2016
· Two (2) packages of four (4) Deferoxamine Mesylate 50 mg expired 6/2016 (8 total)
· Five (5) vials Calcium Gluconate 10% -10 mL expired 9/2016
· Ten (10) vials Sodium Nitrate 30 mg/1ml box expired 9/2016

Interview at the time of observation with Nurse Manager (NM) #12, stated " we don't mess with that box; all the medications we use are now in the Omnicell " .

· One (1) multi-dose bottle of mineral oil was found open in the nurse ' s station of the ED without a date.

Interview at the time of observation with NM #12 , she stated " the mineral oil should have a date on the bottle when it was opened " .

Exam Room # 2:

· Broselow (Trademark) Pediatric Resuscitation System(crash cart) expired 3/2016.


37266

Medical/Surgical Floor

Observation on 10-19-2016 at 9:45 am in the area designated as " Remote pharmacy" on the Medical/Surgical(Med/Surg) floor revealed the following:

(2) Pedi Crash cart trays :

Tray #1

(6) 4.2% Sodium Bicarbonate, expired 8/2016
(1) Epinephrine 1:1000 30 ml (Milliliter) multiple vial dose, expired 8/2016

Tray # 2

(1) Amiodarone injection 150mg/3ml , expired 8/2016
(6) Sodium Bicarbonate 4.2% injectable, expired 8/2016
(7) Soap Suds Enema bags, expired 9/2016

Storage shelf:
(17) 500 ml bags of 0.45% normal Saline Intravenous fluids, expired 9/2016

(15) 500 ml bags of D5% 0.45% normal saline intravenous fluids , expired
9/2016

Interview at time of the tour with RN Unit Manager # 11 RN stated, Yes," they are expired; thought the Omnicel system was going to discouraged expired medications " .

Pharmacy

Observation on 10-20-2016 at 9:00 am in the Pharmacy department of the hospital revealed:

(1) Bromofed liquid 4 fluid ounce bottle expired 9/2016 on the shelf


Interview with Pharm Tech # 9 , saw the expiration date on the bottle and stated, "yes, it is expired and should have been removed back in September 2016".


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Operating Room (OR) :

Observation on 10-19-16 at 11:00 a.m. in the perioperative area crash cart revealed the following expired medications:

*Three (3) 20 milligram (mg) vials of Lasix , expired 08/2016

*One (1) 50 mg/milliliter (ml) vial of Amiodarone , expired 08/2016

Further observation at the same time in OR# 2 revealed :

*Two(2) vials of Flumazenil 0.5 milligrams/5 ml, expired 09/2016 ( anesthesia cart).

Record review of facility policy titled" Unusable Drugs and Devices Disposition " dated 2/2016, read: " Pharmacy, nursing, and other personnel who discover unusable drugs and devices shall return them to the pharmacy for proper disposition " .

Surveyor: Smith, Sandy K.
Based on observation, interview, and record review, the facility failed to implement an effective program for controlling infections and communicable diseases. Several serious infection control issues were identified throughout the survey process. The facility failed to ensure:

* Operating room (OR) and procedure room humidity levels were maintained according to professional standards to prevent microbial growth.

* Sterile supply storage humidity & temperatures were monitored according to professional standards.

* Dish machine temperatures were maintained at manufacturer's required levels.

* Dish machine sanitizer levels were monitored according to manufacturer's recommendation.

* Frozen foods were stored in a safe manner according to professional food standards.

* Endoscopes were stored according to professional standards.

* Operating Room equipment was free of rust and able to be disinfected.

* Laryngoscope blades were packaged and stored according to professional standards.

Findings include:

Humidity Levels: Operating Room (OR) # 1 and Procedure Room # 2 :

Observation on 10-19-16 at 10:30 a.m. in Procedure Room # 2 revealed a humidity gauge on the wall. It was read by OR Director #2 : "it reads 80%".

Observation on 10-19-16 at 10:30 a.m. in Operating Room # 1 revealed a wall mounted humidity gauge on the wall, read by OR Director #2 : "it reads 82%".

Interview at the time of observation with OR Director # 2, she stated the facility followed Association of PeriOperative Registered Nurses (AORN) guidelines. She went on to say AORN acceptable humidity ranges were 20 % to 60 %.

Record review(at time of observation) of 2016 humidity logs for Operating Room # 1 and Procedure Room # 2 revealed humidity levels were consistently recorded in the 70 % and 80 % ranges. OR Director # 2 said the humidity was recorded only on the days cases were done.

2016 Humidity Logs:

OR # 1 : three (3) of 4 humidity levels recorded were out-of-range [only 4 humidity levels were recorded for 2016].

Procedure Room # 2: 42 of 49 humidity levels recorded were out-of-range (most all in the 70 & 80 % ranges).

Continued interview with OR Director # 2 , she stated if humidity was out-of-range the procedure was to "notify maintenance." She went on to say "maintenance was well aware." She said it had been going on for "over a year ; is worse in the summer." When asked what corrective actions had been taken, OR Director # 2 said "they took a special device and measured the humidity once or twice the beginning of the year. My understanding is the cost is too high to repair because it involves many processes. A new hospital is being built; it will be ready in a year or a year and a half."

Record review on 10-20-16 of facility 2015 & 2016 (YTD) "operating room work orders" [provided by Director of Facilities Support # 3] failed to reveal any submitted work orders related to out-of-range humidity levels in the perioperative areas.

Records review of the facility "Surgical Services Scheduling Log" for 2015 & 2016 revealed the following"

Operating Room # 1: approximately 10 + cases performed including open hernia repairs; laparoscopic cholecystectomies ; dilation & curettage ( D & C) ; uterine polyp removal, and a hysterectomy.

Procedure Room # 2 : 180 + procedure performed : most were colonoscopies; esophagogastroduodenoscopy ( EGD); & lumbar epidural steroid injections ( LESI).
Record review of random sampled patient records and humidity logs for 2015 & 2016 revealed the following:
Humidity 85% : Patient # 10: excision of lipoma ( 05-26-15).
Humidity 81%: Patient # 11: D & C, uterine polyp removal ( 07-15-16).
Humidity 77% : Patient # 14: open hernia repair ( 09-28-16); Patient # 15: laparoscopic cholecystectomy (09-28-16).
Humidity 70%: Patient # 16: laparoscopic cholecystectomy ( 10-12-16).

Interview on 10-19-16 at 12 pm with Director of Facilities Support # 3 he stated " The OR humidity is high. The system has a built in dehumidifier but the air conditioner is too large. We did a study several months ago and it confirmed humidity levels up to 80%." Facilities Director # 2 went on to say that he "had spoken with the former Chief Executive Officer (CEO) about the humidity. Quotes for dehumidifiers were obtained ; but no action was taken."

Record review on 10-19-16 of humidity study documents provided by Director of Facilities Support # 2 revealed:

Procedure Room # 2 : humidity levels measured from 11-02-15 to 11-05-15 remained steady between at 78 % to 84%.

Operating Room # 1: humidity level measured from 12-03-15 to 12-06-15 ranged from 59 % to 73 %.

Interview on 10-19-16 at 1:35 p.m.with the Interim CEO # 1 she stated she had been aware of humidity issues in the OR in the past, but was not aware "that it was still this bad."

Interview on 10-19-16 at 1;50 p.m. with facility Infection Control (IC) Nurse #4, she stated she had been in her role since 2009. She went on to say she was not aware of any issues with the humidity in the OR. IC Nurse # 4 said she conducted environmental rounds once a week and depended on the OR / sterile processing staff to let her know of any problems.

Review of AORN Guidelines, 2016, read: "...the recommended humidity range in an operating room is 20 % to 60 % based upon a 2008 addendum to American Society for Heating, Refrigerating, & Air Conditioning Engineers (ASHRAE)..recommendation of relative humidity in anesthetizing locations ..."...AORN : "...High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed......"

Sterile Supply Storage

Observation on 10-19-16 at 11:20 a.m. in the sterile supply storage area failed to reveal a humidity gauge or a thermometer.

Interview at the time of observation with Sterile Processing Tech # 16 she stated the facility did not monitor humidity and temperature of the sterile storage supply room.

Review of AORN "Perioperative Standards and Recommended Practices, "2013:513-540: "Sterile items should be stored under environmentally controlled conditions, which means a temperature of approximately 75°F (24°C), a maximum relative humidity of 70%, a positive air flow pressure in relation to adjacent areas..."

Dish Machine Temperatures:

Observation on 10-21-16 at 10 a.m. in the facility kitchen revealed a PA-HT Puritan model dish machine. Interview at the time of observation with Dietary Director # 10 she stated it was a "low temperature/sanitizing machine;water temperatures were taken and recorded twice a day: morning and afternoon."

Record review on 10-21-16 of facility form titled "Dishwasher Temperature Check Sheet," dated October , 2016 revealed the following:

*"Wash temperatures" were recorded twice daily from Oct. 1 through 19, 2016. From October 11 -19, the words "not working" were handwritten in both the morning and afternoon spaces allotted for temperature recordings.

Continued interview with Dietary Director # 10, she stated the the wash water thermometer was not working properly and she had notified the on October 7, 2016 [verified by review of email sent by Dietary Director.]

Further record review of the facility "Dishwasher Temperature Check Sheets" for August, September, & October 2016 revealed:

* dishmachine rinse temperatures were recorded twice daily every day for all 3 months. Rinse water temperatures ranged form 140 degrees to 170 degrees.

On 10-21-16, at the time of observation, Director of Facilities Support # 3 photographed the dishmachine data plate. It read: " ECOLAB, Model PA-HT: MINIMUM WASH TEMPERATURE : 150 degrees Fahrenheit(F); MINIMUM RINSE TEMPERATURE : 180 degrees F." Director of Facilities Support # 3 acknowledged the rinse temperatures did not meet the minimum manufacturer's requirements.

* Facility took immediate action: changed to all paper products and will not utilize dish machine is fully operational at correct wash and rinse temperatures. Three compartment sink will be utilized for any dish / pan washing needs.

Record review of " PA-HT Puritan Model Dishmachine Installation & Operation Manual," dated 03-06-2008, read: "...page 10. Preventative Maintenance;...1. Ensure that the water temperatures match those listed on the machine data plate..."

Record review of the "Texas Food Establishment Rules (TFER)," dated 10/2015 read: 228.11 (f) Page 102 (e) Warewashing machines, manufactures' operating instructions. (1) A warewashing machine and its auxiliary components shall be operated in accordance with the machine's data plate and other manufacturer's instructions..."

Dish Machine Sanitizer Levels:

Observation on 10-21-16 at 10 a.m. in the facility kitchen revealed a PA-HT Puritan model dish machine. Interview at the time of observation with Dietary Director # 10 she stated it was a "low temperature/sanitizing machine;water temperatures were taken and recorded twice a day: morning and afternoon."

Further observation revealed a large 5 gallon container located under the dish machine. It was tabled "Monogram Low Temp Dishmachine Sanitizer." There was a hose connected from the bucket to the Dishmachine. A black line was marked on the side of the container. Dietary Director # 10 said when the sanitizer level got near the black line, she replaced the entire 5 gallon container. She went on to say she did not ever check the sanitizer concentration levels with test strips.

Record review of the label located on the "Monogram Low Temp Dishmachine Sanitizer" it read: " ..To ensure that available chlorine concentration does not fall below 50 ppm (parts per million) , periodically test the rinse concentration with a suitable test kit and adjust the dispensing rate accordingly..."

Frozen Food Storage:

Observation on 10-21-16 at 10:45 a.m. in the facility kitchen revealed a large walk in freezer. The freezer was clean, well organized. Thermometer attached to one of the shelves read "O degrees F ". Interview with Dietary Director at the time of observation, she stated the freezer should be maintained at 0 degrees.

Further observation revealed a plastic "zip type" bag of pork chops , hand written date of " 07-18-16." When the bag was grasped to inspect, it was noted the pork chops were not frozen. Further inspection revealed none of the food stored in the walk-in freezer was frozen. This was verified by the Dietary Director # 10 and Director of Facilities Support # 3 at the time of observation.

Record review of facility form titled: "Refrigerator & Freezer Temperatures, dated October 2016 revealed the walk in freezer was out-of-range for 37 of the 41 times recorded.

Notations at the bottom of this temperature log:

"10-5-16: walk in freezer temp too high at 10 degrees..( facilities support notified)
10-06-16: walk in freezer temp too high at 10 degrees.
10-12-1-6: fixed: needed freeon,,,has slow leak..
10-19-16: notify ( ) about freezer 34 degrees...."

Record review of a facility vendor work invoice showed the freezer had some repairs made on 10-19-16.

The facility took an immediate inventory of the food located in the freezer. it included : pork chops, pork and beef sausage, chickens breast, beef patties, turkey patties, fish, shrimp, ground turkey,pepperoni, many & various vegetables, cookies, rolls, cheeses, and more( 46 different items). The facility disposed of the food in the freezer & called for a repair.

Review of facility policy titled "Temperature of Refrigerators & Freezers, dated 09-16-05, read:"...freezer temperatures will be less than 10 degrees F."

Record review of U.S. Food and Drug Administration food safety guidelines, June 2011, read" ..freezer temperatures should be maintained at 0 degrees F or below.."

Record review of the "Texas Food Establishment Rules (TFER)," dated 10/2015 read: 228.75: Temperature and Time Control: (a) Frozen food. Stored frozen foods shall be maintained frozen..."

Endoscope Storage:

Observation on 10-19-16 at 11::20 a.m. revealed a storage room that opened from Procedure Room # 2 in the perioperative area. Inside the room, against 2 walls, eight (8) + endoscopes were handing vertically, very near the door, open to the room and not enclosed. There were towels and plastic protective pads on the floor. The end of one endoscope ( approximately 5 inches) was laying curved on the pad and not hanging freely.

Located very near the endoscopes was a large moveable stairway with wheels; and a built in shelving unit that contained various equipment and supplies. In addition, several large equipment towers were stored in this same room.

Interview at the time of observation with Sterile Processing Staff # 16, she stated "all of the endoscopes are reprocessed before they are used on a patient." This was verified through review of facility endoscope log.

Review of AORN "Guideline for Processing Flexible Endoscopes,". dated December 2015 read: " Flexible endoscopes should be stored in a drying cabinet...if a drying cabinet is not available, flexible endoscopes may be stored in a closed cabinet with HEPA-filtered air that provides positive pressure and allows air circulation around the flexible endoscopes. Ventilation promotes drying of the endoscope. Using HEPA-filtered air may help prevent bacterial growth in the endoscope. Positive pressure may help prevent contamination of stored endoscopes...."

Operating Room Equipment:

Observation on 10-19-16 at 10:30 a.m. in the perioperative area revealed the following:

OR # 1:

large amount of rust located on the bases & wheels of two(2) intravenous (IV) poles
large amount of rust located on wheels of two(2) rolling stools
large amount of rust in metal cautery cart

Interview at the time of observation with OR Director # 2 she acknowledged the rust could not be disinfected.

Review of facility policy titled "Environmental Cleaning in the Surgical Suite",dated 09-10-14, read:"...Procedure: ...1. All horizontal surfaces in the OR ( furniture, surgical lights, equipment) should be damp dusted before the first surgical procedure if the day with an EPA registered hospital approved disinfectant..."

Storage of Laryngoscope Blades:

Observation on 10-19-16 at 10:30 a.m. in the perioperative area revealed the following:
Procedure Room # 2 ( anesthesai cart) :

Seven (7) + larynoscope blades, unwrapped
One (1) 1 open LMA( layngeal mask airway)
One (1) opened endotracheal tube


37322


Observation in the Emergency Department on /19/2016 at 10:45 a.m. revealed the following:

Exam room # 2

· Four (4) of eight (8) laryngoscopes blades were stored uncovered.

Exam Room # 4

· Two (2) laryngoscopes blades were found uncovered.

Interview with Nurse Manager #12 at the time of observation stated: "most of the doctors use the glideslope and we have gone to disposal blades " .

Record review of AORN "Recommended Practices for Cleaning, Handling, and Processing Anesthesia Equipment...."2013, read: "..laryngoscope blades should be processed according to manufacturers' instructions by either high-level disinfection or sterilization and protected from contamination until used. Processed blades should be stored in packages, appropriate for the processing method selected, to ensure the blade is protected from contamination. The storage of unpackaged laryngoscope blades is unreliable and leads to questions regarding the safe use of the blades..."

Based on observation, interview, and record review, the facility failed to provide surgical services in a safe manner according to acceptable standards of practice.

The facility failed to adhere to Association of PeriOperative Registered Nurse (AORN) Guidelines regarding:

* Maintenance of acceptable humidity levels in the operating & procedure rooms to prevent bacterial growth.

* Monitoring of temperature and humidity levels in the sterile supply storage area.

* Acceptable storage of endoscopes.

* Proper storage/packaging of layngoscope blades.

These deficient practices placed all patients at risk of adverse outcomes, serious harm, and even death.


Refer to 482.12 (a)(4)
Tag : [ C-0278]