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Based on observation, interview and record review the facility failed to store pharmaceuticals used in the Radiology department according to the manufactures instructions and the facility was not monitoring the temperatures of the warming cabinet where the pharmaceuticals were stored.

Findings include:

Observations made on 7/26/16 at 12:05 p.m. in the facility's Radiology department revealed medications in a warming cabinet. The medications were to be used with the Radiology's CT (Computed tomography) scanner procedures. The following medications were in the warmer, they were not dated when they were placed in the warmer:

(7) Bottles of Visipaque 320 mg (milligram)/100ml (milliliters), radiographic contrast medium. It is administered by intravascular injection.
(4) Boxes of Loversol [OPTITRAY] Injection solution 68%, intended for intravascular administration as diagnostic radiopaque media.
(12) Boxes of Sodium Chloride Injection Solution 0.9 125 ml, intended for intravascular administration.

Review of the drug manufacturer's package label inserts reflected "VISIPAQUE should be stored at controlled room temperature, 20°C (Celsius) -25°C (68°F (Fahrenheit) -77°F); excursions permitted to 15°C-30°C (59°F-86°F). ..VISIPAQUE Injection in all presentations may be stored in a contrast media warmer for up to one month at 37°C (98.6°F)."

"OPTIRAY may be stored at 37°C for up to one month in a contrast media warmer utilizing circulating warm air. For periods longer than one month, store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F)"

Review of the facility provided document Storage General (dated 8/2002) reflected "POLICY...Drugs...shall be stored to ensure their stability and integrity....Drugs shall be stored under the proper conditions...temperature...Drugs shall be stored according to the...manufacturer so that their integrity, stability, and effectiveness are maintained. When in conflict, the Director of Pharmacy shall ascertain whether the ...specifications of the manufacturer take precedence..."

Review of the facility provided document Storage (dated 10/2000) reflected "POLICY...All drugs shall be stored at appropriate temperatures that do not exceed manufacturer's recommendations or warnings..."

During an interview on 7/26/16 at 12:05 p.m. Staff # 3, Radiology Director stated, "We keep the warmer at 98 degrees ....We don't monitor or record the temperatures of the warmer ...I don't have a policy for storing the contrasts in the warmer ....We don't date when we put them in the warmer..."

Based on observation, interview and record review the facility failed to store pharmaceuticals used in the Radiology department according to the manufactures instructions and the facility was not monitoring the temperatures of the warming cabinet where the pharmaceuticals were stored.

Findings include:

Observations made on 7/26/16 at 12:05 p.m. in the facility's Radiology department revealed medications in a warming cabinet. The medications were to be used with the Radiology's CT (Computed tomography) scanner procedures. The following medications were in the warmer, they were not dated when they were placed in the warmer:

(7) Bottles of Visipaque 320 mg (milligram)/100ml (milliliters), radiographic contrast medium. It is administered by intravascular injection.
(4) Boxes of Loversol [OPTITRAY] Injection solution 68%, intended for intravascular administration as diagnostic radiopaque media.
(12) Boxes of Sodium Chloride Injection Solution 0.9 125 ml, intended for intravascular administration.

Review of the drug manufacturer's package label inserts reflected "VISIPAQUE should be stored at controlled room temperature, 20°C (Celsius) -25°C (68°F (Fahrenheit) -77°F); excursions permitted to 15°C-30°C (59°F-86°F). ..VISIPAQUE Injection in all presentations may be stored in a contrast media warmer for up to one month at 37°C (98.6°F)."

"OPTIRAY may be stored at 37°C for up to one month in a contrast media warmer utilizing circulating warm air. For periods longer than one month, store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F)"

Review of the facility provided document Storage General (dated 8/2002) reflected "POLICY...Drugs...shall be stored to ensure their stability and integrity....Drugs shall be stored under the proper conditions...temperature...Drugs shall be stored according to the...manufacturer so that their integrity, stability, and effectiveness are maintained. When in conflict, the Director of Pharmacy shall ascertain whether the ...specifications of the manufacturer take precedence..."

Review of the facility provided document Storage (dated 10/2000) reflected "POLICY...All drugs shall be stored at appropriate temperatures that do not exceed manufacturer's recommendations or warnings..."

During an interview on 7/26/16 at 12:05 p.m. Staff # 3, Radiology Director stated, "We keep the warmer at 98 degrees ....We don't monitor or record the temperatures of the warmer ...I don't have a policy for storing the contrasts in the warmer ....We don't date when we put them in the warmer..."

During an interview on 7/27/16 at10:00 a.m. in the Radiology CT room, when asked if the Pharmacy included the Radiology department in their quality assurance monitoring rounds Staff #22, Pharmacy Manager stated, "No, I wasn't aware they were storing the medications in the warmer...They will be now." When asked if the Pharmacist had approved or written a policy for the storage of the medications used in the Radiology department Staff #22 stated, "No."



35725

Based on a tour of the facility, review of facility policies, and staff interview, the facility failed to ensure that drugs were stored in accordance with accepted professional principles. Three opened multi-dose medication vials did not have the dates they were opened were available for patient use.
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Findings were:

"Centers for Disease Control and Prevention Injection Safety Multi-dose vials," states in part, "Medication vials should always be discarded whenever sterility is compromised or questionable. In addition, the United States Pharmacopeia (USP) General Chapter 797 recommends the following for multi-dose vials of sterile pharmaceuticals:
· If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial.
· If a multi-dose vial has not been opened or accessed (e.g., needle-punctured), it should be discarded according to the manufacturer ' s expiration date.
The manufacturer ' s expiration date refers to the date after which an unopened multi-dose vial should not be used. The beyond-use-date refers to the date after which an opened multi-dose vial should not be used. The beyond-use-date should never exceed the manufacturer ' s original expiration date."

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Facility document entitled, "Pharmacy Policy: Surveillance, Prevention and Control of Infection: Subject Infection Control: Multiple-Use Sterile Drugs, Effective/Review Date: 10/2000," stated in part,
"Policy: Multiple-use sterile drugs (e.g. vials) shall be used and disposed of in accordance with this policy.
Examination for Evidence of Contamination: Multiple-use sterile drugs shall be examined prior to use for evidence of contamination.
Length of Use of Multiple-Use Sterile Drugs: After the initial entry, multiple-use drugs may be used up to the manufacturer's expiration if they contain a preservative and show no evidence of contamination or deterioration. They shall not be used beyond the time specified in the manufacturer's product information (if it specifies a shorter date for opened containers) or a time limit, if any, established by the facility for the specific drug or product.
Multiple-use sterile drugs not meeting these specifications shall be discarded (in accordance with facility policies) or returned to the pharmacy for disposition."

During a tour of the facility on the morning of 07/26/2016, the following multi-dose drug vials were available for immediate patient at the outpatient service area:

· Procrit (Epoetin Alfa) 20,000 units no open date
· Xylocaine 2% (20 millimeter) vial no open date
· Xylocaine 1% (10 millimeter) vial no open date
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The above findings were confirmed on 07/26/2016 by the Manager of Outpatient Services staff #12.

Based on observation, record review and interview the facility failed to educate and monitor staff for exposure to Radiation when (1) one of (5) five Radiology staffs were not wearing a Dosimeter badge (used to monitor cumulative radiation exposure through work). (Staff # 2, Radiology Technician)

Findings Include:

An observation on 7/26/16 at 12:00 p.m., in the facility's Radiology department, revealed Staff #2, Radiology Technician (RT) was not wearing a Dosimeter badge.

During an interview on 7/26/16 at 12:00 p.m., in the Radiology department, Staff #2, RT stated, "I've been working here for a week ...I do X-rays and CT scans( Computed tomography) ....I haven't received a Dosimeter badge yet ...Staff # 3 has ordered it."

Review of Staff #2's Personnel records reflected a hire date of 7/19/16. Staff #2's training records did not reflect training on the appropriate use of the monitoring badges.

During an interview on 7/26/16 at 12:15 p.m., in the Radiology department, Staff #3, Radiology Director stated, "I haven't ordered the Dosimeter for Staff #2." When asked for a policy and training on the appropriate use of the monitoring badges, Staff #3 stated," I don't have a policy for the Dosimeter use ...I don't have to train the staff, they are all RTs and have gone to school ....I check for overexposure on a quarterly basis."

Based on observation, record review and interview the facility failed to protect supplies from deterioration and maintain equipment reliability when;

a.) (2) Two Quick Combo defibrillation pads (used to cardio convert and or pace a patient's heart in an emergency situation) were opened and available for use; and
b.) (2) Two Emergency Crash Carts and Defibrillators were not inspected, tested, and maintained to ensure their safety, availability and reliability.

Findings Include:

a.) Review of the facility provided Physio Control Quick Combo Defibrillator pad manufacturer's instructions (undated) reflected:
- Do not open package until immediately prior to use.
- Do not use beyond Use By date.

Observations on 7/26/16 at 11:30 a.m. in the facility's Emergency Department revealed:

- The Emergency Crash Cart in patient's Trauma room #3 had a Defibrillator pad package that had been torn open and was available for use. The package did not have an opened time or date.

- The central Emergency Crash Cart, in front of the nursing station, Defibrillator pads had been removed from the packaging and was available for use. The packaging was not available; there was no way to know if the pads were expired.

During an interview on 7/26/16 at 12:00 p.m., in the facility's emergency room, Staff #26, Safety Officer stated, "We had opened it to check to see if they fit our monitors ...I didn't know they couldn't be opened."

b.) Review of the facility provided policy Crash Cart (reviewed 6/16/15) reflected " ...It is the policy ...to provide a fully equipped crash cart accessible to each area dealing with patient care ....a designated person will inspect the crash carts on each shift ....Expired equipment or supplies will be immediately replaced ...so as not to leave any cart without emergency equipment...cardiac monitor/defibrillator ...will be checked ...for ...ability to discharge defibrillator ..."

Review of the facility Emergency room's Crash Cart and Defibrillator Check List for July 2016 reflected missing checks on the following dates:
Central crash cart- 7/1/16, 7/2/16, 7/3/16, 7/4/16, 7/11/16, 7/12/16, 7/16/16, 7/18/16, 7/22/16, 7/24/16, 7/25/16, and 7/26/16
Trauma room #3 crash cart- 7/1/16, 7/2/16, 7/3/16, 7/4/16, 7/11/16, 7/12/16, 7/15/16, 7/16/16, 7/17/16, 7/20/16, 7/22/16, 7/25/16, and 7/26/16.

During an interview on 7/26/16 at 12:00 p.m., in the facility's emergency room, Staff #26, Safety Officer confirmed the findings.

Cross refer to:

A0748
A0749

Based on review of personnel files, review of facility documents, and interview, the facility failed to ensure the infection control officer developed and implemented policies governing control of infections and communicable diseases in all areas of the hospital.

Findings included:

Facility employee health, infection control director job description stated in part, "Essential duties and responsibilities:
B. Infection Control Program:
12. Establish accepted standards and develop, implement monitor [sic] and revise Infection Control Policy and procedures to assure compliance with the standards. Review and initial policies annually ...
E. Other Significant Requirements:
1. Maintains care of equipment and supplies."

In an interview with staff #15, the infection control nurse, on the morning of 7/27/16, when asked about the infection control plan, she stated, "I've been working on it." She provided a policy titled "Infection Control Plan" with a revised date of 1/26/2016 and approved by the chief executive officer that stated in part, "Procedures:
1. The Goals of the Infection Prevention and Control Plan are as follows:
1.6 Monitor risks of transmitting infections associated with procedures and with the use of medical equipment and services ...

5. Infection Control Nurse
5.1. Employment of a license Registered Nurse with appropriate infection control and prevention knowledge to manage the program.
5.2. Implement all required regulatory and government guidelines into the facility.
5.3. Maintain knowledge from relevant organizations in regard to current acute care hospital infection control practices (CDC [Centers for Disease Control], NSHN [National Healthcare Safety Network], APIC [Association for Professionals in Infection Control and Epidemiology], etc.) ...

8. Surveillance
8.1. Infection Control Nurse shall round through the facility at least weekly and/or as necessary to maintain quality management and maintain infection control standards."

In an interview with the infection control nurse on the morning of 7/27/16, when asked if she oversees the surgery department and sterilizer use, she stated, "I go back there. I don't know much about it." She stated she recently went to a conference and learned "there's a lot to it."

When asked for policies regarding decontamination and sterilization activities, none were provided.

The above was verified in a final interview with the CEO and other administrative staff on the afternoon of 7/27/16 in the facility conference room.

Based on review of personnel files, review of facility documents, observation and interview, the facility failed to ensure:

A. A sanitary and well-maintained environment which avoided all sources and transmission of infections and communicable diseases.

B. Patient instruments were sterilized in accordance with regulatory requirements for sterile processing for hospitals in the State of Texas as delineated in 25 TAC (Texas Administrative Code) §133.41(v). The facility failed to follow established policies and procedures for sterilization, failed to ensure that the staff member responsible for sterile processing had completed appropriate training in the method and techniques for the sterilization of instruments and patient care equipment, and failed to follow nationally recognized standards of practice for the sterilization of instruments.

These deficient practices placed all patients at risk for infection.

Findings included:

A. "OSHA/Blood Borne Pathogen Regulations Policy #138-030-060" stated in part "The facility provides sufficient housekeeping and maintenance personnel to maintain the interior and exterior of the facility in a safe, clean, orderly, and attractive manner."

During a tour of the facility with the chief operating officer on the morning of 7/26/16, the following were observed:
· The exterior door at the end of both inpatient hallways had exterior light shining through, which could allow for outdoor pests to enter patient rooms
· A living hanging plant was sitting in the nurse's station in the sterile core of the operating room (OR), which could allow for pests to enter the operating rooms and sterile areas
The above was verified on the tour with the Chief Nursing Officer and the OR Manager on the morning of 7/26/16.

B. Patient instruments were not sterilized in accordance with regulatory requirements for sterile processing for hospitals in the State of Texas as delineated in 25 TAC §133.41(v).

1. 25 TAC §133.41(v) stated: "The sterilization of all supplies and equipment shall be under the supervision of a person qualified by education, training and experience. Staff responsible for the sterilization of supplies and equipment shall participate in a documented continuing education program; new employees shall receive initial orientation and on-the-job training."

A review of the personnel record for staff #11, the individual identified as responsible for sterile processing for the facility, revealed this employee had not completed any training for the sterile processing of instruments since 7/27/2006.

In an interview with staff #11 on the afternoon of 7/26/16, when asked if staff #11 had received any recent training on the autoclaves or system 1E liquid chemical sterilant processing system for the facility's endoscopes, staff #11 stated, "No."

In an interview with staff #12, the OR manager on the afternoon of 7/26/16, when asked if they had received any training on the autoclaves or the system 1E liquid chemical sterilant processing system for the facility's endoscopes, staff #12 stated, "No."

In an interview with staff #15, the infection control director on the morning of 7/27/16, when asked if they had received any training on the autoclaves or system 1E liquid chemical sterilant processing system for the facility's endoscopes, staff #15 stated, "No."

2. TAC §133.41(v)(2)(B) stated: "Written policies and procedures for the decontamination and sterilization activities performed shall be adopted, implemented and enforced. Policies shall include the receiving, cleaning, decontaminating, disinfecting, preparing and sterilization of reusable items, as well as those for the assembly, wrapping, storage, distribution and quality control of sterile items and equipment. These written policies shall be reviewed at least every other year and approved by the infection control practitioner or committee."

In an interview with staff #11 on the afternoon of 7/26/16, when asked if there were policies related to sterilizing instruments, staff #11 stated they were unsure.

Facility policy titled "Autoclave use" was found and addressed "Quality control tests ... Sterilization cycle ... and flash autoclave."

Facility policy titled "Sterilizer failure" was found and stated in part, "The Scrub Tech will be responsible for reporting to the Infection Control Person in the event that an indicator reveals sterilizer failure."

No policies were provided addressing the receiving, cleaning, decontaminating, disinfecting, preparing and sterilization of reusable items.

3. 25 TAC §133.41(v)(I)(iii) stated in part: "Flash sterilizers shall be used for emergency sterilization of clean, unwrapped instruments and porous items only."

Facility policy titled "Autoclave use" stated in part: "Flash Autoclave - shall only be used when events occur and does not allow time for a full sterilization cycle ...
F. All items flashed shall be logged in a FLASH LOG."

In an interview with staff #11 on the afternoon of 7/26/16, when asked if immediate use sterilization was used, staff #11 stated, "We do flash." When asked how often they flash, staff #11 stated, "We don't do it often. Maybe once or twice a year ... We don't keep a log." When asked for facility policy regarding which instruments were able to be flashed, none was provided.

4. 25 TAC §133.41(v)(K) stated: "(i) Performance records for all sterilizers shall be maintained for each cycle. These records shall be retained and available for review for a minimum of five years.
(ii) Each sterilizer shall be monitored continuously during operation for pressure, temperature, and time at desired temperature and pressure. A record shall be maintained and shall include:
(I) the sterilizer identification;
(II) sterilization date;
(III) cycle number;
(IV) contents of each load;
(V) duration and temperature of exposure phase (if not provided on sterilizer recording charts);
(VI) identification of operator(s);
(VII) results of biological tests and dates performed;
(VIII) time-temperature recording charts from each sterilizer;
(IX) gas concentration and relative humidity (if applicable); and
(X) any other test results."

In an interview with staff #11 on the afternoon of 7/26/16, when asked for performance records for each sterilizer (the facility had two sterilizers) from January 2016 to the current date, staff #11 provided envelopes with dick-bowie tests stapled to contents of each load and a separate envelope with a roll of paper readouts from one sterilizer. Staff #11 stated, "We just let the paper run out, then we put the roll in the envelope." When asked how staff knew a specific load reached the desired temperature and pressure, staff #11 stated, "The system would alert us if something was wrong ... I would have to look through [the pieces of paper and paper roll print out]."

No performance records were provided for the month of May 2016. When asked if instruments were sterilized in May 2016, in an interview with staff #11 on the afternoon of 7/26/16, staff #11 stated, "Yes." When asked where the performance records were, staff #11 stated, "I don't know."

In an interview with staff #11 on the afternoon of 7/26/16, when asked how the facility keeps track of endoscope use and sterilization, staff #11 stated, "It gets charted in the patient record." When asked for a log of endoscope use and sterilization, staff #11 stated, "We don't have one."

No policies were found regarding performance records.

5. 25 TAC §133.41(v)(M) stated: "Preventive maintenance of all sterilizers shall be performed according to individual adopted, implemented and enforced policy on a scheduled basis by qualified personnel, using the sterilizer manufacturer's service manual as a reference. A preventive maintenance record shall be maintained for each sterilizer. These records shall be retained at least two years and shall be available for review."

The Steris Amsco manual stated in part, "Maintenance procedures described in this section must be performed regularly at the indicated intervals ...
Daily: 1. Clean chamber as follows:
a. Wash inside of chamber and loading equipment with a mild detergent solution ...
b. Rinse with tap water; dry with a lint free cloth.
c. Remove chamber drain strainer ... Clean out lint and sediment; reverse flush under running water.
d. Place strainer back in chamber drain.

Weekly: 1. Flush chamber drain as follows:
a. Turn off steam supply valve ...
b. Remove chamber drain strainer ..."

The System 1E Liquid Chemical Sterilant Processing System manual stated in part, "Part 1: Daily cleaning and checks:
Step 1: Clean external surfaces ...
Step 2: Open lid
Step 3: Clean processing tray ...
Step 4: Wipe the aspirator assembly and sterilant compartment with a soft cloth dampened with 70% isopropyl alcohol.
Step 5: Check aspirator assembly ...
Step 6: Check drain screen ...
Step 7: Remove processing tray from chamber
Step 8: Clean chamber ...
Part 2: Changing 0.1 micron MaxPure filter ... Warning: the 0.1 micron MaxPure Filter must be changed every 90 days ..."

In an interview with staff #11 on the afternoon of 7/26/16, when asked for a preventive maintenance record, staff #11 stated, "We don't have one." When asked for the manual for the sterilizers, a Steris product catalog was provided. The manual was provided later and the recommended daily maintenance was discussed with staff #11. Staff #11 stated, "The guy that comes to do the preventive maintenance told me I don't have to clean the drain out." When asked if staff #11 discussed this with a supervisor or if there was a policy that verified this, staff #11 stated, "No."

No proof preventive maintenance was done on any sterilizers were provided.

The above was confirmed in an interview with the chief executive officer and other administrative staff on the afternoon of 7/27/16 in the facility conference room.

Based on record review and interview the facility failed to provide (3) three out of (3) three patients on the facility's Swing Bed unit an opportunity to participate in their care plan conference. (Patient #1, #2, and #3)

Findings Include:

Review of Patient #1's medical records reflected an 82 year old female admitted on 4/22/16 for rehabilitation following a left ankle fracture.

Review of Patient #1's Physician's Certification dated 4/22/16 reflected, " ...12. Is patient capable of participation in care plan? Yes ..."


Review of Patient #2's medical records reflected a 69 year old male admitted on 5/18/16 with a diagnosis of generalized weakness post gastrointestinal bleed.

Review of Patient #2's Physician's Certification dated 5/18/16 reflected, " ...12. Is patient capable of participation in care plan? Yes ..."


Review of Patient #3's Admission History and Physical reflected an 85 year old male admitted on 3/1/16 for strength and conditioning.

Review of Patient #3's Physician's Certification dated 3/1/16 reflected, " ...12. Is patient capable of participation in care plan? Yes ..."


During an interview on 7/27/16 in the afternoon, in the facility conference room, Staff #27, Swing Bed Coordinator stated, "The patient's aren't invited to attend the care conferences."

During a review of Patients #1, #2, and #3's medical records, Staff # 21, Clinical Informatics stated, "We don't have anything to show that Patients #1, #2 and #3 were invited or attended the care conference."

Based on record review and interview the facility failed to provide an activities program for (3) three out of (3) three patients reviewed for an admission to the facility's Swing Bed unit.
(Patient #1, #2, and #3)

Findings Include:

Review of Patient #1's medical records reflected an 82 year old female admitted on 4/22/16 for rehabilitation following a left ankle fracture.

Review of Patient #1's Physician's Certification dated 4/22/16 reflected " ...11. Patient may attend planned activities ..."

Review of Patient#1's Activity Assessment dated 4/22/16 reflected likes "...crochet sewing, music, reading, and church services ..."


Review of Patient #2's medical records reflected a 69 year old male admitted on 5/18/16 with a diagnosis of generalized weakness post gastrointestinal bleed.

Review of Patient #2's Physician's Certification dated 5/18/16 reflected " ...11. Patient may attend planned activities ..."

Review of Patient #2's Activity Assessment reflected likes "... music, reading Large print, and church services ..."


Review of Patient #3's Admission History and Physical reflected an 85 year old male admitted on 3/1/16 for strength and conditioning.

Review of Patient #3's Physician's Certification dated 3/1/16 reflected " ...11. Patient may attend planned activities ..."

Review of Patient #3's Activity Assessment reflected likes "... music, watching 'Wheel of Fortune' ..."


During an interview on 7/27/16 in the afternoon, in the facility conference room, Staff #27, Swing Bed Coordinator stated, "The activities director is contracted and only works as needed....I can't say we offer activities."

During a review of Patients #1, #2, and #3's medical records, Staff # 21, Clinical Informatics stated, "We don't have anything that shows we are offering activities ....We don't have a policy for providing activities."