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.

ST ANTHONY'S HOSPITAL 2807 LITTLE YORK RD HOUSTON, TX Aug. 4, 2014
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
Based on observation, interview, and facility policy review, the facility failed to follow and implement its own policy related to the control of expired medication and pharmaceuticals.

The facility failed to ensure that multiple medications available for patient use in the emergency room (ER) and the Operating Rooms(OR) were reviewed for expiration dates.

This deficient practice presented the serious threat of improper or ineffective administration of expired medications for all patients receiving treatment and services in the ER or OR.

Refer to TAG A-0491

Based on observation, interview, and document review, the facility failed to provide necessary medications to meet the needs of the patients as stated in the facility Formulary.

The facility failed to ensure that multiple medications that included antibiotics, electrolytes, diuretics, and cardiac drugs were available for patient use.

This deficient practice presented a serious threat of harm to patient health and safety due to unavailability of needed medication for all patients presenting to the facility for treatment and services.

Refer to TAG A-0511

It was determined that these deficient practices created an Immediate Jeopardy situation and placed the health and safety of patients in serious Jeopardy.
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
Based on observation, interview and record review, the facility failed to ensure that drugs and biologicals were stored in accordance with manufacture's requirements and facility polices:

Multiple expired drugs were observed in the emergency room (ER) and the Operating room (OR).

Findings include:

Observation on 08-04-14 at 12:50 p.m. in the facility ER medication room revealed multiple expired medications available for patient use in the medication cart and the refrigerator. The following is a listing of the expired drugs:

One (1) vial each: Lantus and Humulin 70/30 insulin: opened , not dated.

Expired January 2014:

one (1)- Morphine 50 milligram (mg)
twelve (12)-Tramadol 50 mg.
six (6)-Versed 2 mg.

Expired February 2014:

three (3) Demerol 75 mg
one (1) Solucortef 100 mg

Expired March 2014:

three (3) Procardia tabs 10 mg
six(6) Metoclorpramide 10 mg.

Expired April 2014:

one (1) Nitrodrip

Expired May 2014:

five (5) Propranolol 1mg.milliter (ml)
nine(9) Promethanzine suppositories 12.5 mg
six(6) Reglan 10/10

Expired June 2014:

nine (9) Magnesium Plus
seven (7) Meperidine 50 mg
one (1) Lopermide 1mg/ 5mg
six (6) vials Infuvite
nine (9) Promethazine suppositories 25 mg.
one(1) Metoporplol 5mg/ml
five(5) vials Digoxin 500 mcg/2ml
one(1) vial Cleocin 900mg/6 ml
four(4) bottles milk of magnesia
one(1) activated charcoal

Expired July 2014:

ten(1) 1 mg vials epinephrine ( 1:1000)
ten (10) Diphnehydramine 12.5/5
three(3) Bumetomide 0.25 mg/ml
four(4) tabs Simethacone 80 mg
two(1) vials Metoprolol 5mg/ml
two(2) vials Ampicillin 2 grams
four (4) vials Haldol 5mg/ml
five(5) vials Heparin flush
eight (8) Digoxin 0.125 mg
six (6) vials Heparin1000 units/ml
four(4) normal saline flushes
eight (8) docusate sodium

Interview at time of observation with ER staff nurse ID # 53 she said the pharmacist checked the drugs monthly for expiration dates.


Observation on 08-04-14 at 2:00 p.m. in the OR area revealed the following expired medications:

two(2) vials Lasix 40 mg --expired February 2014
two( 2) 10 mg vials Lidocaine 1%-expired June 2014
two (2) Atropine 0.4mg/ml -expired May 2014
four (4) vials Narcan 0.4 mg/ml -expired August 1, 2014

*seven (7) vials of Anectine 200 mg/ml improperly stored ( not refrigerated per label instructions)

Review of facility policy titled "Expiration dates, dated 1/2013, read: "...Expiration Date Monitoring: expiration dates of drugs and devices shall be checked during the routine medication area inspections and all rugs and devices scheduled to expire during the next month shall be removed from stock."
VIOLATION: FORMULARY SYSTEM Tag No: A0511
Based on observation, interview, and record review, the facility failed to have medications listed in the formulary available for dispensing and administration.

Findings include:

Observation on 08-04-14 at 10 p.m. in the facility pharmacy revealed multiple empty plastic bins labeled with drug names located on the shelves.

Interview at this time with Pharmacist ID #52, he stated the facility was "out of stock on many drugs. I work with what I have; make therapeutic substitutions when I can."

He went on to say "we are placing patients at risk due to the unavailability of drugs." Pharmacist ID #52 provided an extensive list of critical drugs needed, including IV antibiotics, electrolytes, diuretics, and cardiac drugs. The following drugs were documented on this list provided by the pharmacist. He stated the list was not all inclusive; the drugs were on the facility formulary.

"Injectable antibiotics:

Rocephin 500 milligrams(mg)
Ampicillin 1 gram (gm)
Ampicillin 500 mg
Doribex 500 mg
Doxyclicline 100mg
Zyvox 600mg

Electrolytes:

Potassium acetate
potassium phosphate
sodium acetate
sodium phosphate
trace elements

Misc.

Lasix 20 mg
Lasix 40 mg
Motrin elixir
Diamox 500 mg
Keppra 500 mg/ 5ml
Cerebrex
Atropine 0.4 mg/ml injection
Inderal 10 mg injectable
Vitamin injections/Folic acid

Pharmacist ID # 52 went onto say his last day of work was 08-06-14 because he was having surgery. He stated: "My back-up pharmacist will not work here because he said he won't get paid and it is unsafe due to lack of medications."

Interview on 08-04-14 at 2 p.m. with the Chief Nursing Officer (CNO) ID # 50, she stated "the pharmacist had previously ordered needed drugs but the order was not shipped because of inadequate funds."

Facility CNO/ID # 50 was unable to locate the facility Forumlary but confirmed they had one. CNO provided PAR level lists for medications in all areas of the faclity.
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, interview, and policy review, the facility failed to follow its own policies related to the provision of a sanitary environment to avoid sources and transmission of infections and communicable diseases.

The facility failed to ensure that two (2) of two (2) operating rooms (ORs) were appropriately cleaned and sanitized to prevent the transmission and spread of infection.

The facility also failed to ensure that five (5) of five (5) endoscopes were cleaned, disinfected, and stored according to facility infection control policy and procedures.

These deficient practices created serious threat of transmission of infection to all patients treated in the ORs for surgical procedures and all patients who received endoscopy procedures. Review of OR logs for June and July 2014 revealed 16 patients underwent endoscopy procedures (Patient ID # 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16 )

Refer to TAG A-0748

Based on observation, interview, and document review, the facility failed to ensure that an effective system for identifying, reporting, investigating, and controlling infections was implemented.

The facility failed to implement an effective Infection Control Program. The Infection Control program failed to provide surveillance activities to prevent and control the spread of infections.

This deficient practice presented a seriousthreat of harm to all patients receiving care and treatment services in the facility due to possible transmission and spread of hospital acquired infections.

Refer to TAG A-0749

It was determined that these deficient practices created an Immediate Jeopardy situation and placed the health and safety of patients in serious Jeopardy.
VIOLATION: INFECTION CONTROL OFFICER(S) Tag No: A0748
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review the facility failed to have a designated infection control officer to implement and oversee processes and conditions related to control of infections and communicable diseases.

Multiple serious infection control issues were identified on 08-04-14 including:

Unsanitary operating rooms,

No staff competency/ training for cleaning endoscopes,

Inappropriate storage and tracking of endoscopes,

Expired hand sanitizers throughout facility,

Biohazard containers overfull (no biohazard pick up for 6 months),

Expired supplies.

Findings include:


Interview with Chief Nursing Officer (CNO) ID # 50 on 08-04-14 at 3:30 p.m., she stated the facility had hired a contract person as Infection Control officer. She came to the facility on [DATE] and presented an Infection Control Plan that was approved. CNO / ID #said this person had not returned to the facility since that date. CNO said "her services were suspended due to non-payment." CNO /ID # 50 went to say that although the Infection Control plan had been approved on 07-18-14, it had not been implemented.

Unsanitary Operating Rooms:

Observation on 08-04-14 at 2:00 p.m. in the Operating Room area revealed the following:

*Dirty utility room located in the surgical area: large plastic canister of white thick fluid in sink ; multiple cartons and unknown supplies under sink. Eco lab cleaning bottles (3) unreadable labels for content or expiration dates.

*Four (4) wall -mounted hand sanitizers located in the OR hallway and ORs expired 6/2013.

*OR hallway: (OR on either side): crowded with carts , shelves, & supplies: floor stained, dirty, and linoleum cracked all around the edges of the wall.

*OR # 1: floor dirty and stained. Linoleum cracked on all edges by the walls (uncleanable); two (2) very large red plastic biohazard containers were located on a windowsill. They were overfull ( no lids) with dirty disposable instruments protruding out of the top.

*OR # 2: floor dirty and stained. Linoleum cracked on all edges by the walls (uncleanable); heavy dust on top of equipment and OR lights, rusty oxygen tanks and step stools observed.

Interview at time of observation with Surgical Tech (ST)# 56, she stated she was the person responsible for cleaning the ORs. She went on to say:" The ORs are terminally cleaned monthly; we're not very busy here."

Review of facility policy titled: "Infection Prevention and Control Measures,"dated May 2013, read: "...5. Terminal Cleaning of the operating rooms shall be performed at the end of the day's schedule.."

Endoscopes: cleaning, storage, and tracking:

Further observation in the OR hallway revealed a large clear bin that contained 2 coiled endoscopes located on top of a shelf in the OR hallway. Interview with ST # 54 he acknowledged the scopes were used on patients. He went on to say this was not the proper method of storage. ST # 54 said there more endoscopes stored downstairs in the endoscopy area.

Observation on 08-04-14 at 2; 40 p.m. in the endoscopy area downstairs revealed the following:

*Scrub sink outside Endoscopy procedure room: hand scrub soap (Avagard) expired 2/2013.

*Large pool of water on floor in decontamination area.

Scope cleaning:

*Quality Control (QC) strips used to test concentration of high level disinfectant used for scope cleaning were expired ( 6/2014) .

* Record review of Cidex/OPA Monitoring Log ( high level disinfectant used for scope cleaning) revealed 3 blank spaces on dates ( 6/24/14; 06/30/14, and 6/30/14) in which a total of nine (9) EGDs were performed. The top of the form read:" Test strip QC should be performed with each newly opened bottle of strips and prior to EACH use."

Scope Tracking:

* Incomplete log listing endoscope # and patient name for July, 2014 and no log maintained for June 2014.

Record review on 08-04-14 of facility OR Logs for June and July 2014 revealed :

June 2014: twelve (12) esophagogastroduodenoscopy (EGD ) performed (Patient IDs # 1, 2, 3,4,5,6,7,8,9,10,11,12)

July 2014: four(4) EGD performed ( Patients# 13,14,15,16)

Interview with CNO ID # 50 at this time she stated all patient names dates, and scope numbers should be recorded. She stated that is the only way to track for infections should it become necessary.

Scope storage:

*Large plastic bin located on floor in hallway, contained dirty coiled endoscope. No tech on duty.

*Storage area: 2 covered bins that contained "clean" and coiled endoscopes. CNO/ID # 50 acknowledged the endoscopes were stored improperly, they should be stored vertically in closed, vented cabinet. The facility did not have a storage cabinet for the endoscopes.


Record review of facility policy titled " High level Disinfection of Endoscopes, dated May 30, 2013, read: " ...E. Endoscopes shall be stored in a dry, well-ventilated environment according to the manufacturer's instructions...The endoscopes shall be hung vertically with central valves and biopsy inlet cap removed. This facilitates the movement of air..10. Do not store the endoscopes coiled; hang the endoscopes vertically so they will dry..."

Interview with the CNO/ID # 50, she stated the endoscopes were cleaned manually. She went on to say that Sterile Processing (SP) Tech # 55 cleaned all the instruments. CNO/ID # 50 was unable to locate a competency or training for SP Tech # 55 related to manual cleaning of the endoscopes. SP tech # 55 was unavailable for interview; according to the CNO he comes into the facility in the morning to get ready for the cases and then leaves.

Expired hand sanitizers throughout facility,

Observation on 08-04-14 during tour of the facility between 12:30 and 4:30 p.m. revealed the following expired wall mounted hand sanitizers:

OR area: four(4) expired June 2013

Pre-Op waiting area: one(1) expired June 2013

Recovery Area: two(2): expired June 2013

Ultrasound room: one(1) expired January 2014

Cardiopulmonary: one(1) expired January 2014

Endo /Fluro Area: two(2) expired June 2013

100 hallway: one (1) expired January 2014; two (2) expired February 2014

ICU: one expired February 2014

Biohazard containers overfull (no biohazard pick up for 6 months) : In addition to two(2) overfull biohazard containers observed in the OR, two(2) additional large overfull containers were observed in the endoscopy area. According to CNO; no biohazard pick up for over 6 months due to non-payment of vendor.

Expired supplies:

Multiple expired supplies observed in the OR including five (5) boxes of sutures, IV start kits ( 6)--expired 2/2014; Central line monitoring kit ( expired 10/2013); Bladeless trocars ( 6/2013) and several blood collection tubes.

Record review of facility policy titled "Infection Control Prevention and Control Program, dated 7/2014 read: Infection prevention and Control plan will provide the framework to maintain sufficient surveillance activities to address identified risks ad continuously observe for new risks of infection in order to prevent the spread of infection or communicable disease...core interventions: ..2 Methods to reduce the risk of infection ..including appropriate storage, cleaning, and disinfection , appropriate use and disposal of supplies and equipment, appropriate use of PPE..."
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and record review, the facility failed to ensure that a system for identifying, reporting, investigating, and controlling infections was implemented.

Findings include:


Interview with Chief Nursing Officer (CNO) ID # 50 on 08-04-14 at 3:30 p.m., she stated the facility had hired a contract person as Infection Control officer. She came to the facility on [DATE] and presented an Infection Control Plan that was approved. CNO / ID #said this person had not returned to the facility since that date. CNO said "her services were suspended due to non-payment."

CNO /ID # 50 went to say that although the Infection Control Plan had been approved on 07-18-14, it had not been implemented. There was no organized infection surveillance or monitoring of potential infection control issues.

[* Refer to infection control issues cited in A-747]

Record review on 08-04-14 of facility policy titled "Infection Prevention and Control Program,"dated July 2014, revealed a systematic framework for infection control risk assessment; monitoring scope and type of surveillance; reporting, prevention, and staff education.