The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

RENAISSANCE HOSPITAL GROVES 5500 39TH ST GROVES, TX Feb. 9, 2012
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observations, records review, and interviews, the facility:

A. failed to assure that cardboard packing boxes were not present in critical patient care areas. There were thirty-six (36) cardboard packing boxes found in the surgery sterile processing area; twelve (12) were found in Operating Room #6 (cardiovascular operating room); six (6) were found in the recovery room; two (2) were found in the recovery room isolation room; four (4) were found in the cardiac catheterization lab. The facility also failed to provide adequate storage for endoscopes. Four (4) "clean" endoscopes were found hanging on an IV pole within 4 feet of the endoscope washer, where soiled scopes are processed. Five (5) "clean" endoscopes were found hanging, exposed in an open cabinet in the endoscope storage area. These findings present a risk of cross-contamination of equipments and pose a risk for hospital-acquired infection to all patients in the operating room and cardiac catheterization lab.

Refer to Tag A0749

B. failed to assure that expired medications were removed from patient care areas. The facility also failed to require necessary documentation of the date that multidose vials were opened and accessed. This lack of date makes it impossible to determine if the medications are beyond the safe use date as defined by the United States Pharmacopeia. There were fifty-nine (59) expired medications and seventeen (17) non-dated opened medications in multi-dose vials found in the operating rooms and recovery room.

Refer to Tag A0505

C. failed to maintain a level of safety and quality of emergency and surgical supplies available for patient use in the emergency room , Surgical Department, and Cardiac Catheterization Lab. Expired items were found in the Surgical Operating Room Suites, Pre- op Holding area, Recovery Room, emergency room , and the Cardiac Catheterization Lab.

Refer to Tag A0724

These findings pose an immediate jeopardy to patients' health and safety.
VIOLATION: CONTROLLED DRUGS KEPT LOCKED Tag No: A0503
Based on observation and interview, the facility failed to properly secure narcotics. A 10mg vial of morphine was found in an unlocked anesthesia cart in operating room #4.

Findings include:
Review of Pharmacy Policy #15.01, " Controlled Drugs: Distribution and Accountability (General), " revealed the following: " The Director of Pharmacy, acting as the facility ' s agent, shall ensure adequate storage and security for controlled drugs in accordance with federal laws and the laws of this state. "

During a tour of operating room #4 on 2/7/2012 at 4:00pm, staff #20 and a surveyor discovered a 10mg vial of morphine in an unlocked anesthesia cart, accessible to all operating room staff. The morphine was disposed of according to facility policy.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on records review, observations, and interviews, the facility:

A. failed to ensure that appropriate terminal cleaning was done in the surgical suites.

B. failed to ensure that preventative maintenance on patient care equipments were up to date and broken equipments were removed from patient care areas.
Refer to Tag A0724
C. failed to ensure that emergency and surgical supplies were readily available for usage in the Surgical Department, and Cardiac Catheterization Laboratory. Expired items were found in the Surgical Operating Room Suites, Pre- op Holding area, Recovery Room, and the Cardiac Catheterization Laboratory.

Refer to Tag A0724

D. failed to ensure that single-use sterile supplies for surgery were not reprocessed for patient use.

E. failed to ensure that the policy for biological testing in the use of the Attest Ampoules for the maintenance of quality patient care was being followed. Nine of nine readings for the biological testing were not read according to facility policy.

F. failed to ensure adequate storage for endoscopes. There were four (4) "clean" endoscopes found hanging on an IV pole within 4 feet of the endoscope washer, where soiled scopes are processed. There were five (5) "clean" endoscopes found hanging, exposed in an open cabinet in the endoscope storage area.

Refer to Tag A0749

G. failed to ensure that expired medications were removed from patient care areas. The facility also failed to require necessary documentation of the date multidose vials were opened and accessed. This lack of date makes it impossible to determine if the medication is beyond the safe use date as defined by the United States Pharmacopeia. There were fifty-nine (59) expired medications and seventeen (17) non-dated opened medications in multi-dose vials found in the operating rooms and recovery room.

Refer to Tag A0505

Review of surgical cases from November 1, 2011 thru February 6, 2012 totaled 136 cases. During these procedures, the surgical suites contained expired supplies, expired medications, and equipment that had not been monitored, inspected, tested , and maintained by the biomedical department.

The condition and practices found pose an immediate jeopardy to patient's health and safety.

A. Findings include:
Review of policy Surgery Department titled "Environmental Cleaning of the Surgical Practice Setting" revealed:" MONTHLY CLEANING

1. The following will be scheduled cleaning by the Engineering Department:
a. ducts and filters, including high-efficiency particulate air filters;
b. air conditioned equipment;
c. return ventilation and heating grills;
d. recessed ceiling tracks (eg, overhead lighting tracks);

2. The following will be scheduled for cleaning by Surgery Personnel:
a. closets, cabinets and shelves
b. storerooms;
c. sterilizers, warming cabinet, refrigerators;
d. ice machines (CLEANED BY DIETARY DEPARTMENT)
e. walls and ceilings; and
f. offices, lounges, lavatories, and dressing rooms

3. Floors will be stripped and waxed periodically by the Environmental Services Department."

An interview with staff #32 on 2/9/2012 at 11:00 AM confirmed terminal cleaning of surgical suites were not being done due to lack of supplies for two years. Staff #32 reported she has been asking for the mop head that fits on a long handle which allows her to clean the walls and ceilings of the operating room suites for two years.


D. Findings include:
Review of Surgery/SPD policy titled, "Storage and Shelf Life of Hospital Processed Sterile Items," revealed:

"PURPOSE:
To provide criteria and guidelines for the use of hospital-processed sterile items.
POLICY:
1. Event-Related Sterility Standards will be used for all sterile items in this facility.
Supplies, items, trays, and sterilized instruments will not have an expiration date on the
package, and will be considered sterile unless the integrity of the package is
compromised by tearing, wetness, damage, or suspicion of tampering.
2. All items, trays, supplies, etc. processed by the Manufacturer that contain an expiration
date will he considered "EXPIRED" when the date on the package is reached.
3. " Opened but unused " supplies will not he reprocessed under any circumstances. Any item marked as " Single Use " , " One-time Use " , or " Disposable " will not be reprocessed.

STERILE DEPARTMENT RESPONSIBILITY: The Sterile Processing Department
is responsible for:
a. Assuring the integrity and sterility of all hospital reprocessed items leaving SPD
b. The following procedure when an item whose sterility has been compromised is
returned to the SPD.
? the tray and/or package is completely dismantled
? contents are washed in germicidal solution, rinsed, dried, and reassembled
? all linen and cloth material, such as gauze sponges, are replaced with fresh materials which have not previously been sterilized the package is wrapped, re-dated, re-labeled, and then sterilized.
c. applying dust covers to items/trays that are infrequently used,
d. taking sterile items back to each department after reprocessing
e. assuring that items labeled as "Disposable", "One Time Use", or "Single Use Only" are not reprocessed and reused."

A tour of the Operating Room #6/Cardiovascular Room on 2/8/2012 at 4:00PM with another surveyor and staff #20 revealed that the surgical department was reprocessing single-use items. Surveyors and staff #20 observed 24 packages of reprocessed single-use items.

Reprocessed single use item x 24 (a partial listing includes the following)
Bovie (disposable electrosurgical instrument)
Nasal Gastric tube
Red Rubber catheter
Staple Gun
Cardiac Marker
Sternal Blades

E. Findings include:
Review of Surgery/SPD policy titled, "Attest Ampoule Biological Spore Testing," revealed:

"PURPOSE:
To provide written guidelines for Sterile Processing personnel to follow in the use of Attest Ampoules for the maintenance of quality patient care.

POLICY:

STEAM
1. Saturated steam under pressure will be the method of sterilization for all items, unless
specifically contraindicated by the manufacturer. On a daily basis, a 3M Attest pack
which includes a Attest Ampoule will be placed with the first load of the day. The Attest should he marked according to which autoclave it is being tested in.
2. After the "test " pack is removed from the autoclave, a 1 minute cooling period should elapse before the ampoules are removed for incubation. Crush the ampoules before placing them into the incubation chamber. A non-autoclaved ampoule should be clearly marked crushed, and placed in the incubation chamber at the same time.
3. After twenty four (24) hours, the Attest ampoules are checked to test the validity of sterility. The control or un-autoclaved ampoule should always show a POSITIVE growth while the autoclaved ampoule should always show a NEGATIVE growth. If results of either Attest are not as indicated above, the S.P.D. Tech and Director of Surgery must be notified immediately for appropriate action.
4. When the results reveal a problem, a Variance report will be initiated by the Director of Surgery and immediate notification of the attending physician of patients for whom any of these supplies may have been used on will be notified.
5. All Attest readings are logged weekly at the time the reading is taken.

Review of 3M Steam Sterilization record revealed that nine of nine readings for the biological testing were not read within twenty-four (24) hours, according to facility policy. Review of the biological readings from 1/2/2012 thru 2/6/2012 are as follows (Date Sterilization load was run--->Date biological test was read):
1/2/2012---> 1/10/2012
1/9/2012---> No date of biological test read
1/12/2012---> 1/16/2012
1/16/2012---> 1/19/2012
1/18/2012---> 1/20/2012
1/24/2012---> 1/27/2012
1/27/2012---> 1/30/2012
2/1/2012---> 2/6/2012
2/6/2012---> No date of biological test read

Review of the manufactures recommendation for use of 3M Attest Biological Monitoring System Technical Product Profile revealed, "When examining the processed indicator at regular intervals such as 8, 12, 18, 24 and 48 hours, also examine the control indicator for a color change toward yellow (evidence of bacterial growth). Record results and discard indicators in accordance with your healthcare facility's policy. The Attest (Trademark) monitoring system provides separate color coded vials for steam indicators. This one spore per vial system provides the user with the best assurance of sterility. If both indicator organisms are on the same spore strip (e.g., as in a two spores per vial system), a positive growth control could be obtained if incorrect incubation conditions existed (e.g., incubator not functioning, or vials inadvertently incubated at wrong temperature). If the test biological indicator came from a cycle with a sterilization process failure, a false positive control and false negative test would result.
Incubation
Attest (Trademark) System for SteamAttest (Trademark) Indicator Cap Color Incubation time
1261P Blue 24 hours
1262P Brown 48 hours"
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
Based on records review, observations, and interviews, the facility failed to assure that expired medications were removed from patient care areas. The facility also failed to require necessary documentation of the date that multidose vials were opened and accessed. This lack of date makes it impossible to determine if the medication is beyond the safe use date as defined by the United States Pharmacopeia. There were fifty-nine (59) expired medications and seventeen (17) non-dated opened medications in multi-dose vials found in the operating rooms and recovery room.

Findings include:
The nationally accepted standards of practice by the US Pharmacopeia (USP 2008), General Chapter 797, Pharmaceutical Compounding/ Sterile Preparations, requires multidose vials to be discarded 28 days after initial stopper penetration unless the manufacturer specifies otherwise. The vial should be labeled to reflect the penetration date or the beyond-use date (United States Pharmacopeia (USP) 797: Guidebook to Pharmaceutical Compounding - Sterile Preparations. Second Edition, June 1, 2008).

Review of Pharmacy policy #09.03, "Expiration Dates," revealed the following: "Expiration dates of drugs and devices shall be checked during the routine area inspections and all drugs and devices scheduled to expire during the next month shall be removed from stock."

During the facility survey from February 7-9, 2012, the following expired and opened medications with no date-labels were found. All of these medications were readily available for patient use.

Anesthesia Cart Medications (OR #1)
Opened with no indication of date opened:
Atracurium
Xylocaine-MPF 1% x2
Lidocaine HCl 1%
Neostigmine 1:1000
Droperidol

Expired (by manufacturer's date on bottle or by more than 28 days since opened):
Esmolol 100mg/10ml- expired 12/2011
Metoprolol Tartrate 5mg/5ml- opened 6/15/?? (no year noted)
Dopram 400mg/20ml- opened 6/12/2011
Labetalol HCl 100mg/20ml- opened 9/16/2011
Claforan 1gm- expired 06/2011
Epinephrine 1mg/ml- expired 11/1/2011

Operating Room #1- Expired Medications
Silver Nitrate Applicators- expired 07/2010

Operating Room #4- Expired Medications
Normal Saline 1000ml bag- expired 05/2011
Normal Saline 1000ml bag- expired 09/2011 x2 bags
Sterile Water 3000ml bag- expired 02/2010

Anesthesia Cart Medications (OR #6)
Opened with no indication of date opened:
Atropine Sulfate 1mg/0.1 mg/ml
Glycopyrrolate 0.4mg/2ml

Expired (by manufacturer's date on bottle or by more than 28 days since opened):
Lasix 10mg/ml-expired 8/2011 (opened 11/30/2011)
Papaverine HCl 30 mg/ ml- expired 08/2011
Anzemet Injection 100mg/5ml- expired 10/2011
Adenosine injection 6mg/2ml- expired 11/2011
Enlon Plus 10mg/ml- expired 07/2011
Epinephrine 30 ml (1mg/ml) - expired 12/2011
Epinephrine 30ml (1mg/ml) - expired 06/2011 x2 vials
Esmolol 100mg/10ml- expired 12/2011
Terbutaline 1mg/ml- expired 03/2011
Procainamide 500mg/ml- expired 09/2011
Neosinephrine 10ml (1mg/ml) - expired 06/2011
Labetalol 100mg/20ml- expired 08/2011
Glycopyrrolate 0.4mg/2ml- expired 10/2011
Verapamil 5mg (2.5mg/ml)- expired 01/2012 x2 vials
Amiodarone 130mg/3ml- expired 01/2012
Dextrose 5% Water 100cc- expired 10/2011 x2 bags
Dobutamine 250cc/400mg- expired 01/2012

Operating Room Refrigerator- Expired Medications
Regular Insulin- expired 10/02/2011
Adrenalin Topical with Lidocaine 1:1000- expired 10/2011

Operating Room Respiratory Box- Expired Medications
Naloxone 1cc- expired 01/2012
Phenylephrine 1%- expired 01/2012

Physician's Personal Box
Opened with no indication of date opened:
Epinephrine 10ml
Lidocaine1% with Epinephrine 1:100,000
Adrenalin Chloride 30 ml x2 vials
Lidocaine 1% with epinephrine 1:100,000 x2 vials
Nasal spray (labeled for a patient)

Expired (by manufacturer's date on bottle or by more than 28 days since opened):
Adrenaline Chloride 30 ml- opened 08/10
Lidocaine 1% with epinephrine 1:100,000- expired 01/2012
Lidocaine 1% with epinephrine 1:100,000- expired 08/2011 x2 vials
Kenalog 40mg- expired 06/2011
Acetlycystine 200mg/ml- expired 08/2011
Ofloxacin Otic solution- expired 08/2011 x2
Oflaxacin Otic solution- expired 04/2011 x2


Operating Room Eye Cart
Opened with no indication of date opened:
Timolol Ophthalmic Solution
Tetracaine 0.5%

Expired (by manufacturer's date on bottle or by more than 28 days since opened):
Miostat Intraocular Solution- expired 10/2010 x4 vials
Miostat Intraocular Solution- expired 05/2011 x3 vials
Miostat Intraocular Solution- expired 01/2012
Pilopine HS Gel- expired 09/2011
3% Chloroprocane HCl- expired 02/2010
2% Lidocaine- expired 10/2009
Sodium Chloride 10ml- expired 02/2010
Ephinephrine 1mg- expired 11/2011
TetraVisc- expired 02/2010

During an interview on 2/9/12 at 11:13am in the pharmacy, staff #22 reviewed these medications and confirmed the expired and non-dated medications. Staff #22 also confirmed that lack of documented date the medications were opened required the medications to be removed from stock.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observations and interviews, the facility failed to assure that cardboard packing boxes were not present in critical patient care areas. There were thirty-six (36) cardboard packing boxes found in the surgery sterile processing area; twelve (12) were found in Operating Room #6 (cardiovascular operating room); six (6) were found in the recovery room; two (2) were found in the recovery room isolation room; four (4) were found in the cardiac catheterization lab. The facility also failed to provide adequate storage for endoscopes. Four (4) "clean" endoscopes were found hanging on an IV pole within 4 feet of the endoscope washer, where soiled scopes are processed. Five (5) "clean" endoscopes were found hanging, exposed in an open cabinet in the endoscope storage area. These findings present a risk for cross-contamination of equipments and a risk for hospital-acquired infection to all patients in the operating room and cardiac catheterization lab.

Findings include:

During a tour of the cardiac catheterization lab on 2/7/2012 at 10:00am, 4 cardboard packing boxes were found inside the cardiac catheterization lab procedure area.

During a tour of the cardiac catheterization lab on 2/7/2012 at 10:00am, staff #20 confirmed the presence of the cardboard packing boxes inside the cardiac catheterization lab procedure area.

During a tour of the operating rooms, sterile processing area, and recovery room on 2/8/2012 at 11:00am, cardboard packing boxes were found in the following areas:
-Surgery sterile processing area- 36 boxes
-Operating Room #6 (cardiovascular operating room)- 12 boxes
- Recovery room- 6 boxes
- Recovery room isolation room- 2 boxes

During a tour on 2/8/2012 at 4:30 PM, the Administrator, Director of Nursing, Director of Surgery, and Hospital House Supervisor observed and confirmed the presence of cardboard packing boxes in the surgery sterile processing area, operating room #6 (cardiovascular operating room), and the recovery room.

Review of the document, "Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes," by The Society of Gastroenterology Nurses and Associates revealed the following: "K. STORAGE
1. Hang the endoscope vertically with the distal tip hanging freely in a clean, well-ventilated, dust-free area."

During a tour of the endoscope cleaning and storage area on 2/9/2012 at 2:30pm, four (4) "clean" endoscopes were found hanging on an IV pole within 4 feet of the endoscope washer, where soiled scopes are processed. Five (5) "clean" endoscopes were found hanging, exposed in an open cabinet in the endoscope storage area.

During the tour on 2/9/2012, staff #19 confirmed that four (4) "clean" endoscopes were found hanging on an IV pole within 4 feet of the endoscope washer, where soiled scopes are processed and five (5) "clean" endoscopes were found hanging, exposed in an open cabinet in the endoscope storage area.

During a tour of the endoscope cleaning and storage area on 2/9/2012 at 3:15pm, staff #3 also confirmed that four (4) "clean" endoscopes were found hanging on an IV pole within 4 feet of the endoscope washer, where soiled scopes are processed and five (5) "clean" endoscopes were found hanging, exposed in an open cabinet in the endoscope storage area.
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observations, records review, and interviews the facility:

A. failed to maintain a level of safety and quality of emergency and surgical supplies available for patient use in the emergency room , Surgical Department, and Cardiac Catheterization Lab. Expired items were found in the Surgical Operating Room Suites, Pre- op Holding area, Recovery Room, emergency room , and the Cardiac Catheterization Lab.

B. failed to ensure preventative maintenance on patient care equipments were up to date and broken equipment were removed from patient care areas.

A. Findings include:

Expired Items on Cardiac Cath Lab
Suture Mersiline 2-0 09/2011 x 21
Guide wire 0.014 04/2011 x 5
Williams Right Coronary Catheter 6Frenc 01/2012
Angiographic -Guide wire (Opened and on the shelf)
ProWater 180cm Asahi PTCA Stent 01/2012 x 5
Coronary Stent 3.5 01/2012 x 1
Micro-introducer kit 7cm 10/2011 x 1
Epidural Needle 01/2011 x 1
Spinal Needle 09/2010 x 1
Glide Catheter 4 French 12/2011 x 4
Mach 1 Guide Catheter 3.0 01/2012
Mach 1 Guide Catheter 3.5 01/2012
Mach 1 Guide Catheter AR1 01/2012
Mach 1 Guide Catheter RCB 01/2012
Mach 1 Guide Catheter LCB 01/2012
Mach 1 Guide Catheter IM 90cm 01/2012
Pressure Monitoring Kit 11/2011
Swanz Ganz Catheter 01/2012 x 1
Atlantis SR Pro Coronary Imaging Catheter 11/2011 x 1
Disposable Pullback Sled MD5 08/2011 x 1
Coronary Catheters (various sizes) 10/2011 x 45
Cold Set Kit 10/2011 x 1
Guide Wire Right 1.25 11/2011 x 3
IV catheter 18 gauge 12/2010 x 25
IV catheter 22 gauge 12/2010 x 8
IV catheter 20 gauge 06/2011 x 3
Needle Free Valve Port 08/2011 x 8
Sterile IV Start Kits 2 x 7
Sterile Scalpels #15 11/2011 x 7

Expired Items in Operating Room # 1
Extension tubing 11/2008 x 9
Surgical Blades # 11 07/2009 x 20
Lite Glove 11/2011 x 1
Tracheotomy size 6 01/2012
Tracheotomy size 8 10/2010
Gloves size 7-1/2 08/2011 x 1
Gloves size 7 11/2011 x1
Gloves size 7 12/2009 x1

Expired Items in Operating Room # 2
Orthopedic Shavers
Resector Shaver 3.5 02/2011 x 16
Resector Shaver 5.5 05/2009 x 10
Resector Shaver 4.0 04/2009 x 10
Double Bite 4.0 04/2009 x 7
Round burr 4.0 04/2009 x 10
Aggressive 2.5 08/2011 x 4
Barrel burr 4.0 02/2010 x 5
Blades #11 09/2009 x 20
Sterile Q-Tips 09/2010 x 3

Expired Items in Cystoscopy Room #3
3000cc, 1.5% glycine irrigation solutions 02/2010 x 7
3000cc sterile water 02/2010 x 3
Boxes of foley catheters, multitude of expired sizes, to numerous to count 2011
Foley Catheter Kits, multitude of expired sizes, to numerous to count 2011

Expired Items in Operating Room #4
Scalpels #12 05/2006 x 6
Culture tubes (red) 10/2011 x 2
Culture tubes (green) 09/2011 x 10
Gloves Size 8 12/2011 x 5
Safety Needles 20 gauge 09/2011 x 22
Safety Needles 22 gauge 09/2011 x 15
Fribrin Sealant Duploject 10cc 10/2011 x 1
I-Stat testing cartridges 04/2010 x 6

Expired Items in Operating Room # 5
Mesh 6x6 11/2010 x 1
Mesh 6x6 03/2011 x 2
Prolene Hernia Mesh 07/2011 x 1box
Hernia Patch 04/2011 x 2

Expired Items in Operating Room # 6 /Cardiovascular Room

Thoracic catheter 36 Fr 10/2010 x 41
Thoracic catheter 32 Fr 10/2010 x 18
Thoracic catheter 24 Fr 09/2010 x 29
Thoracic catheter 20 Fr 04/2011 x 15
Pressure Monitor Kit 10/2009 x 4
Central Venous Multi-lumen Catheter Kit 02/2011 x 3
Percutaneous Arterial kit 06/2009 x 1
Embolectomy Catheter 6 Fr 05/2011 x 5
Embolectomy Catheter 5 Fr 05/2011 x 5
Embolectomy Catheter 4 Fr 05/2011 x 4
Embolectomy Catheter 3 Fr 05/2011 x 2
Formulin buffered 09/2011 x 7
Stainless steel suture 18 inch 05/2011 x 9
Blood warming tubing 08/2010 x 1
Arterial catheter set 11/2011 x 31
Antimicrobial dressing 8 in X 12 in 08/2008 x 5
Defibrillator pacer pads 10/2011 x 16
Defibrillator pacer pads 10/2008 x 4
Defibrillator pacer pads 07/2009 x 2
Defibrillator pacer pads 03/2010 x 20
Scope cradle 02/2011 x 4
Monitoring electrode, 3 per pack 07/2011 x 3 packs
Suture removal kit 02/2011 x 2
Sclerosol intra pleural aerosol 09/2011 x 4
Sterile Talcum Powder 09/2011 x 4
Protect IV Catheter 24-gauge 04/2011 x 3
Protect IV Catheter 22-gauge 10/2009 x 1
Protect IV Catheter 20-gauge 05/2010 x 6
Protect IV Catheter 18-gauge 10/2009 x 5
Protect IV Catheter 16-gauge 09/2011 x 10
Protect IV Catheter 14-gauge 12/2009 x 16
Spinal needle 22-gauge 01/2010 x 2
Spinal needle 18-gauge 02/2010 x 2
Blunt access cannula 10/2010 x 1
Needless access rubber stopper top 08/2011 x 34
Mini spike IV bag 03/2006 x 1
Lure lock 01/2009 x 3
Culturette swab tubes 08/2009 x 9
Blood Filter 01/2011 x 2
Mepilex wound dressing 10/2011 x 11
Carbon dioxide indicator 01/2012 x 7
Pressure tubing 01/2012 x 5
IV tubing 02/2009 x 2
3x4 inch gauze 06/2011 x 4
Surgical blades 08/2011 x 6
Fibrin Sealant prep and applicator 08/2011 x 3 sets
Blood tubing 05/2011 x 2
Surgicel 4 in x 4 in 07/2011 x 6
Internal irrigation mister 09/2010 x 2
Vascular probe 04/2011 x 1
Dual site venous drainage cannula 03/2010 x 10
Steri strips ? in 07/2010 x 5
Gauze 2 in x 2 in 10/2011 x 10
Tubing adaptor 07/2010 x 50
Ioband 04/2011 x 1
Tegaderm 20 in x 30 in 02/2009 x 5
Surgical clamps 12/2010 x 3
Data scope catheters 7.5 / 30 cc balloon 08/2010 x 1
Data scope catheter 7.5 / 40cc balloon 08/2010 x 1
Embol-X glides 09/2010 x 4
IV start kit 12/2008 x 1
Suture Prolene 6-0 01/2011 x 10
Suture Prolene 7-0 01/2011 x 36
Suture Prolene 3-0 01/2011 x 36
Suture Ethicon 4-0 01/2011 x 36
Suture Vicryl 3-0 01/2011 x 36
Cardiac Atrial pacing wire 03/2011 x 24
Ethicon endoscopic linear stapler 06/2011 x 1
Linear cutter 08/2011 x 1
Vascular probe 04/2011 x 4
Flexible Venous reservoir 03/2011 x 2
Falope Ring band kit 12/2010 x 30
Trocar 5mm 12/2011 x 5
Internal stapler reloads pack 11/2011 x 12
Internal stapler reloads pack 07/2010 x 5
Internal retrograde cardiac catheter 10/2008 x 1
Coronary catheter profusion cannula 10/2011 x 1
Surgical gloves 08/2011 x 4 pair
Coronary sinus profusion cannula 11/2011 x 1
Cover Derm adhesive dressing 08/2011 x 2
Red rubber catheter 16 Fr 09/2010 x 1
Expandable LeMaitre Valvulotome 06/2011 x 2
Disposable Bipolar Forceps Endopath 04/2011 x 1
Betadine Solution expired 11/2011 opened and labled 1/13/2012

Expired Items on Cast Cart
Micro SMT 71/2 gloves 06/2009 x 1
Cotton tip applicators 06/2007-06 x 13 packages
Fluid filter 07/2007 x 1
Providone-Iodine swabs 08/2011 x 1
Casting tape 3 " 09/2011 x 3
Tegaderm dressing 11/2008 x 1
Providine ointment (1-tube), dated at the time it was open 11-24-2008
Ortho Cast 4 inch 2009

Expired Items on Suture Cart
Various sizes and type of Sutures 24 Boxes all expired 2011

Expired Items on Orthopedic Cart
Inflatable Bone Trap (additional) 09/2011
Inflatable Bone Trap (First Fracture) 08/2011
Suture Anchor 2.4 09/2011 x 5
Suture Anchor 5.5 10/2011 x 5
Suture Anchor 7.5 06/2011 x 5
Scorpion Needle 10/2011 x 10
Crystal Cannula 5.75 09/2011 x 5
Depuy Tibial Tray size 4 02/2011 x 1
Depuy Femoral Left Tray 02/2011 x 1
Depuy Patella Tray 05/2011 x 1
Bio Suture 3.0 10/2011 x 1
Corkscrew 3.5 05/2011 x 15
Bench Chair Shoulder 12/2011 x 1

Expired Items in Pyxis for Supplies
Mesh Plug Extra Large 05/2011 x 4
Betadine Solution x 13 07/2011

Expired Items on [DIAGNOSES REDACTED] Cart
Medivac Tubing Connector 06/2009 x 2
IV Start Kit 09/2006 x 1
IV Start Kit 06/2007 x 2
Edwards Pressure Monitoring Kit 04/2006 x 2
Infusion Set 09/2010 x 2
2oz. (60ml) Syringe 12/2009 x 1
2oz. (60ml) Syringe 02/2010 x 1
Arrow Triple Lumen Catheter Kit 04/2007 x 1
Bard Urinary Catheter Tray 06/2007 x 1
Bard Urinary Catheter Tray 12/2007 x 1
4x4 Gauze Sponge Pack 02/2010 x 1
4x4 Gauze Sponge Pack 09/2010 x 1
Arrow Arterial Catheter Set 10/2005 x 2
Roche Blood Gas Kit 04/2006 x 3
Roche Blood Gas Kit 09/2007 x 3
Blood Glucose Test Strips 12/2005 x 1
Purple Top Vacutainer 08/2006 x 12
Blue Top Vacutainer 02/2006 x 6
Blue Top Vacutainer 07/2006 x 6
Green Top Vacutainer 11/2006 x 5
Red Top Vacutainer 01/2007 x 1
Red Top Vacutainer 04/2007 x 6
Tiger Top Vacutainer 06/2006 x 12
Tuberculin Syringe 04/2009 x 5
16-gauge IV Catheter 03/2007 x 1
16-gauge IV Catheter 07/2007 x 1
18-gauge IV Catheter 02/2008 x 2
20-gauge IV Catheter 02/2008 x 2
22-gauge IV Catheter 01/2008 x 1
22-gauge IV Catheter 02/2008 x 4
24-gauge IV Catheter 08/2006 x 2
24-gauge IV Catheter 01/2007 x 4
Providone-Iodine Gel 08/2006 x 1
Providone-Iodine Swab sticks Packs 12/1999 x 6

Expired Items on emergency room Crash Cart
Triflex #7 sterile gloves 08/2011 x 2
Syringes 3cc 10/2002 x 5
Deliberator pads 01/2012 x 2 packs

On tour of the Surgical Department on 2/8/2012 at 3:30 PM with another surveyor and staff #19, the surveyors found a 28 French thoracic catheter (expired 07/2011) on the cardiovascular emergency case table that was available for immediate patient use . Staff #19 confirmed that if an emergency case arrived in to the surgical department these items would be used on a patient.

A tour of the Operating Room # 6/Cardovascular Room on 2/8/2012 at 4:00PM with another surveyor and staff #20 revealed that the surgical department was reprocessing single-use items. Surveyors and staff #20 observed 24 packages of reprocessed single-use items.

Reprocessed single use item x 24 (Examples)
Bovie (electrosurgical instrument)
Nasal Gastric tube
Red Rubber catheter
Staple Gun
Cardiac Marker
Sternal Blades

During a tour on 2/8/2012 at 4:30 PM, the Administrator, Director of Nursing, Director of Surgery, and Hospital House Supervisor observed and confirmed the large amount of expired items were located in the surgical area (Recovery Room) for immediate use on surgical patients.

During an interview on 2/9/2012 at 2:00 PM, staff #19 reported that the staff had cleaned the Endoscopy Room of expired supplies. In the Endoscopy room on the endoscopy cart was a 1000cc bottle of sterile water available for immediate use for patient care. The bottle was opened and labeled with the date of 12/19/2011.

On tour of the Cardiac Catheterization Lab from February 7-9, 2012, large amounts of expired supplies were left in the corner of the Cath Lab. On 2/8/2012 at 8:45 while procedures were being performed the expired supplies were available for patient use. The area was not identified as storage for expired supplies.

On tours of the Surgical Department from February 7-9, 2012, large amounts of expired supplies were found in the Recovery Room Area. The space with expired supplies covered 143 square feet. The supplies were available to any employee for immediate use on a patient. The space was not identified as storage for expired supplies and unusable equipment.




B. Findings include:
During the tour of the Cardiac Catheterization Laboratory on 02/07/2012 at approximately 11:45AM with staff #20, the surveyor observed the C-Arm (X-ray equipment used to view the arteries of the heart) was past due for preventative maintenance, date of maintenance was due June 2011. The C-Arm continued to be used for patient care. During the inspection of the cardiac balloon pump (equipment used to perfuse vital organs during a potentially fatal cardiac event and to prevent death) it was observed the preventative maintenance was due 03/2010. Surveyor was unable to confirm when the balloon pump was last used for patient care.

During an interview with staff #20 during the tour of the Cardiac Catheterization Laboratory on 02/07/2012 at approximately 11:45AM, staff #20 confirmed the expiration dates of the preventative maintenance for the C-Arm and the cardiac balloon pump. Staff #20 confirmed the C-Arm was still in use and confirmed the balloon pump would be used in the event of an emergency.

During the tour of the Cardiovascular Surgical Room on 02/08/2012 at approximately 3:00PM with staff #20, the Cardiovascular Perfusion Machine (a bypass machine patients are placed on while under going cardiac surgery) was observed and the preventative maintenance was due 11/20/2011.

An interview with staff #20 during the tour of the Cardiovascular Surgical Room confirmed the Cardiovascular Perfusion Machine's preventative maintenance was due 11/20/2011.

During the tour of the Surgical Recovery Room on 02/08/2012 at approximately 4:00PM, four IV pumps (Pumps used to infuse fluids in a patient's veins) tagged with a label "Broken 12/22/2011" were observed sitting on the nurses' station desk available and could be easily confused in the event of an emergency and used on patients.

Staff #31, when interviewed in the Recovery Room on 02/08/2012 at approximately 4:00PM, confirmed that the pumps were broken and the out of service date on the pumps was correct.

During a tour of the Surgical Decontamination Room (the area where surgical instruments are rinsed and cleaned of visible contamination from the surgeries) on 02/08/2012 at approximately 0900AM with staff #11, there were four ceiling tiles observed to have brown stains and appeared to have been exposed to water. The tour was continued to the Wash Room and upon inspection of the equipment washer, it was observed that the preventative maintenance was due 02/2009.

During the tour of the Surgical Decontamination Room, staff #11 was confirmed, that the four ceiling tiles were exposed to water from a leak in the roof and the preventative maintenance of the equipment washer was due 02/2009. Staff #11 confirmed the washer was being used to process surgical equipment.

During the tour of the Endoscopy Procedure Room on 02/09/2012 at approximately 2:30PM with staff #19, a cart was observed containing one printer, one camera and one water irrigator and the preventative maintenance was due on 05/ 2011. On another cart, the surveyor observed a video monitor with preventative maintenance due 09/2011.
The tour continued to the Endoscopy Scope Washing Room. The Endoscopy Scope Washing Room houses the Olympus (DSD-201 model sterilizer) Scope Washer. The Olympus (DSD-201 model sterilizer) Scope Washer was designed to wash two scopes simultaneously. The right side of the scope washer was filled with what appeared to be old water. The right side of the scope washer was marked with a sign "out of order."

Staff #19 confirmed during the tour of the Endoscopy Procedure Room on 02/09/2012 at 2:30PM that the preventative maintenance should have been done on 05/ 2011 for the one printer, one camera and one water irrigator and the video monitor's preventative maintenance was due 09/2011.

During a phone interview on 02/09/2012 at 2:30PM with staff #9 (this interview was witnessed by staff #19), it was confirmed the right side of the Olympus (DSD-201 model sterilizer) Scope Washer was out of order and had been broken for four months.

Review of surgical cases from November 1, 2011 thru February 6.2012 totaled 136 cases. During these procedures the surgical suites contained expired supplies, expired medications, and equipment that had not been monitored, inspected, tested , and maintained by the biomedical department.
VIOLATION: PHYSICAL ENVIRONMENT Tag No: A0700
Based on observations, records review and interviews the facility:

A. failed to maintain a level of safety and quality of emergency supplies, surgical supplies and equipments available for patient use in the emergency room , Surgical Department, and Cardiac Catheterization Lab. Expired supplies and equipments that had not received preventative maintenance were found in the Surgical Operating Room Suites, Pre- op Holding area, Recovery Room, emergency room , and the Cardiac Catheterization Lab.

Refer to tag A0724

B. failed to assure that expired medications were removed from patient care areas. The facility also failed to require necessary documentation of the date that multidose vials were opened and accessed. This lack of date makes it impossible to determine if the medication is beyond the safe use date as defined by the United States Pharmacopeia. There were fifty-nine (59) expired medications and seventeen (17) non-dated opened medications in multi-dose vials found in the operating rooms and recovery room.

Refer to tag A0505


These findings pose an immediate jeopardy to patients' health and safety.