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303 SANDY CORNER RD

EL CAMPO, TX 77437

CONTRACTED SERVICES

Tag No.: A0084

Based on observation, interview and record review, the facility failed to ensure equipment used for hemodialysis treatment of patients by contracted service personnel follow manufacturer's recommendation in maintaining equipment in 1 of 1 reverse osmosis unit and hemodialysis machine in use in the facility.

Finding:
On 08/08/2016 at 10:50 a.m. a portable Zyra Tech Millennium Reverse Osmosis Machine and a Fresenius K hemodialysis machine were observed stored in the hemodialysis suite. The equipment are used by the contracted staff for hemodialysis treatment of patients.
Observation of the hemodialysis machine revealed a Diasafe plus filter in place. The label on the Diasafe filter revealed the filter was last replaced on 05/03/2016.

Review on 08/10/2016 of the facility's preventative maintenance manual (Repair Maintenance Log) revealed documentation which indicated that the most current preventative maintenance was done on the Zyza Tech Portable Reverse Osmosis Unit # 13207 on 06/2015.

On 08/10/2016 at 2:50 p.m. the Surveyor requested documentation of current preventive maintenance for the Zyza Tech Portable Reverse Osmosis Unit # 13207 on 06/2015.

During an interview on 08/10/2016 at 11:57 a.m. with the Facility's Contract Hemodialysis Nurse Manager revealed the Diasafe Plus filter should have been changed on Wednesday but it was not done.

Interview on 08/11/2016 at 9:00 a.m. with the Facility's Quality Assurance Performance Improvement Director # 61 who oversees the dialysis contract staff revealed, the Preventative maintenance on the Reverse osmosis unit was not done until yesterday 08/10/2016 after the Surveyor identified that the preventative maintenance was not up to date.

Review on 08/11/2016 of the Facility's Current Policy and Procedure on Preventative maintenance Schedules for equipment: Policy # 7-13-09 directed staff as follows: Preventative Maintenance (PM) schedules must be made in accordance with manufacturer's recommendation for all equipment used to perform a patient treatment. A copy of the equipment P.M schedule must be filed in the appropriate Equipment Manual. "

Review on 08/11/2016 of the Manufacturer's recommendation for Routine Maintenance of Millennium 13207 Reverse Osmosis Machine direct users as follows: Semi Annual Maintenance " Check and clean the Millennium cooling fan and grill. Check the Product Recirculation check valve for proper operation. Refer to the check valve test instructions in this chapter. "
Annual Maintenance: " An AAMI or CSA Water Quality of the product water should be conducted yearly. Check the monitoring for accuracy, check the gauges for correct functioning,
Check the ball valve for correct operation, check the tubing and fitting for leaks or wear, check the switches and lights for correct operations. Check all pre- RO devices for correct operations, Lubricate the motor, Refer to lubricating instructions. If equipped, check the pressure switch for correct operations. "

Review on 08/11/2016 of the manufacture's package insert for Diasafe Plus Fluid Filter directed staff as follows: Diasafe Plus Filter must be exchanged after 12 weeks or 100 treatments (ONELINE plus) or earlier if the filter fails the integrity test. "

PATIENT SAFETY

Tag No.: A0286

Based on observation, interview and record review, the Facility's Quality Assessment Performance Improvement Program failed to conduct root cause analysis and implement a plan to address medication errors and blood product error identified by the facility's staff in 2 of 4 variances identified by the facility. Patient #s 30 and 31.

Findings
Review of the Facility's Quality Assessment Performance Improvement Program data dated May 17, 2016 documented the following : " Wrong Medications: The incorrect medication record was sent with the Patient to the ER. The Medication record was used for the medication reconciliation and orders in the ER. Patient received a total of 8 doses of wrong medications. There was one missed dose of Vancomycin.
Recommendation: " Approved with no recommendations. Forward to medical staff. "
July 19, 2016 revealed the following entries:" There were a total of 26 errors with 2 near misses. One occurrence caused 18 errors. There are 12 missed doses. 10 wrong medications, 1 extra dose, 3 wrong routes and two near misses. Six RNs and 7 LVNS were involved in the errors. Of these nurse 1 was a PRN and 5 agency nurse. There were no trends or patterns noted "
Recommendations: " Approved with no recommendations. Forward to Medical staff. "
Review of Medical Staff meeting minutes dated July 2016 revealed no documented recommendation from the Medical Staff body.

Review of Patient (#30's ) clinical record (Medication Administration Record) revealed documentation that the following medications were administered to the patient that were not prescribed for the patient.
Diazide Cap 37.5 -25 mg once daily. Medication administered on 03/15/2016 and 03/16/2016.
Simvastatin 20 mg I tablet by mouth at bedtime. Medication administered on 03/15/2016 and 03/16/2016
Coreg 25 mgs, 4 tablets by mouth twice daily with meals. Medication administered on 03/15/2016 and 05/16/2016.

During an interview on 08/10/2016 at 2:05 p.m with the Facility's Quality Assessment Performance Improvement Director #K61 , the Surveyor reviewed the Facility's Quality Assessment Performance Improvement data and meeting minutes with the Facility's Quality Assessment Improvement Director. The Surveyor requested documentation of a root cause analysis and plans implemented to address the medication errors. The Surveyor informed the Quality Assessment Performance Improvement Director # K61 that she could not find documentation of a root cause analysis of the identified errors and a plan to address the errors.
She said the facility had discussed the errors in a staff meeting with the nurses involved but she could not locate any further documentation.

Interview on 08/10/2016 at 2:05 p.m. with the Facility's Quality Assessment Performance Improvement Director #K61 revealed the only information on the medication error was what was in the occurrence log.

Interview on 08/10/2016 at 2:08 p.m with Utilization Review Director #M63 , she stated that she was aware of the incident. It was discussed in a general staff meeting and a medication reconciliation form was developed. But she cannot find information where the staff involved in the medication incidences were inserviced/ retrained.




37266


Blood Product Error

Record review of a variance report dated 3/16/2016 revealed Patient ID #31 was ordered to receive 2 Units of FFP (Fresh Frozen Plasma) ABO/RH AB Negative on 3/16/2016. Received A-Neg FFP in error.

During Facility interview with Director of Laboratory ID # B-52 on 8/10/2016 at 2.30 pm about wrong type of ABO/Rh (2) Units ordered, and given was A-Neg, missing type B. ID# B-52 stated, "I only have a copy of the situation which I signed and returned to QAPI Director. Also, I spoke with the Tech to re-educate on procedure." Laboratory Director stated, " I have no documentation that other laboratory personnel were inserviced.. Director further stated, "no other investigation, follow up or analysis was performed or preventative measures implemented to prevent reoccurrance."

Record review of facility policy titled "Requistion of Blood Components" dated 2/18/2014 reads:
BLOOD COMPONENTS
D. Fresh Frozen Plasma (FFP)
...3. FFP should be ABO compatible with the recipient. Group A or B patients should receive either their own type or type AB FFP. AB patients can receive only AB FFP and Group O patients can receive any type FFP...

NURSING CARE PLAN

Tag No.: A0396

Based on observation, interview and record review, the facility's nursing staff failed to follow patient's plan of care for 1 of 2 patients observed with wounds from 31 sampled patients. Patient # 11

Findings:

Interview on 08/09/2016 at 11:00 a.m. with the Registered Nurse assigned to the patient ( L62) revealed the patient's buttocks was intact but she has rashes to her vaginal area and wounds to her lower extremities bilaterally.
On 08/09/2016 at 11:05 a.m. Patient #1 was observed in her room with side rails up X2.
The patient had wounds to her lower legs bilaterally. Further observation of the patient's skin after the patient was repositioned by the Registered Nurse revealed 4 broken area on her left and right upper buttocks. The patient was lying on a regular mattress.

Interview with Registered Nurse (L62) who was assigned to the patient revealed she was not aware of the broken areas on the patient's upper buttocks.

Review on 08/09/2016 of the patient's plan of care initiated 08/02/2016 and updated on 08/03/2016, 08/04/2016, 08/08/2016 and 08/09/2016 revealed the Patient's Plan of Care included air mattress to be on the patient's bed.

Interview on 08/09/2016 at 11:40 a.m. with, Facility's Charge Nurse revealed the patient did not have an air mattress on her bed but she was in the process of switching out her bed.

Review on 08/11/2016 of E-Z Graft Skin Assessment Worksheet completed by the facility's staff on 08/09/2016 after the wounds were identified by the Surveyor revealed the following documentation:
Right upper buttock stage 2, 1.4 x 1.9 cm, and 2.0 x 1.5 cm
Left upper buttock: Stage 2, measuring 1.0 x 1.2 cm.

Review of the facility's current policy on Skin Assessment /Wound Care revised 06/2016 directed staff as follows:
" A RN will assess all patients within 8 hours of admission and then every 24 hours using the skin assessment tools and Braden Risk Assessment''.

ADEQUACY OF LABORATORY SERVICES

Tag No.: A0582

Based on observation, interview and record review the facility failed to ensure that the blood bank refrigerator was maintained per hospital policy.

Findings include:

Observation on 8/10/2016 at 2:00 pm during tour of the laboratory services department revealed the following:

* The Blood Bank refrigerator revealed an inspection sticker with a date of 6/2015.

Interview with Director of the Laboratory Services ID # B-52 when asked about the expired sticker stated the following; " I thought they had been out to inspect, but yes I see the date is 6/2015."
Interview with Plant Director ID # E-55 asked for evidence that Blood Bank refrigerator was inspected he responded, " the company that inspected the hospital equipment failed to inspect the Blood Bank refrigerator in June of 2016".

Record revieew of facility policy titled, "Blood Bank Quality Control", dated 8/2000 read,
C. CONTROL OF EQUIPMENT
Preventive maintenance and the documentation of these procedures are part of the overall laboratory Quality Control.

DIRECTOR OF DIETARY SERVICES

Tag No.: A0620

Based on observation, interview and record review the facility failed to ensure there was emergency food supply on hand at the hospital.

The facility failed to provide documentation that dietary staff handling and preparing patient meals have food handlers permit to ensure the safe handling of food in the facility. Citing three (3) of four(4) dietary staff #s (F56,G 57 and H 58).

Findings:

Observation on 8/8/2016 at 11:15 am at the facility revealed the facility had a licensed capacity for forty nine (49) patients with 25 beds actively in use.

Observation on 8/8/2016 at the facility at 11:45 am revealed a kitchen that was set up for food handling and preparation. Staff #s F56, G 57, H58, were observed preparing and handling food and dishware.

Observation in the dry food storage area revealed there were ten (10) cans of salmon , 9 cans of beans 5 dozen 8 ounce cans of soup and 3 cans of corn .

Observation of the food storage refrigerator revealed prepared food with expiration dates stored amongst prepared foods that was available for use included:

Two (2) covered dishes with chicken, carrot and macaroni dated 8/7/2016.

Two (2) covered dishes of chicken pot pie dated 8/5/2016.

During an interview on 8/8/2016 at 2:20 pm with Staff (#J60) Food Service Director, he stated the facility prepares and serves meals to patients and visitors.

According to Staff (#J60) there was supposed to be seven (7) days food on hand but he was running low and his food supply order would be in later that week.

During an interview on 8/11/2016 at 11:10 am with Staff #s (F56, G 57 and H58) in the dietary suite the staffs stated they work in the dietary department handling and preparing food and handling utensils. When asked about food handlers permit the staffs all stated they did not have a food handlers permit .

During an interview on 8/11/2016 at 11: 25 am with Staff (#J 60) Food Service Director, he stated the dietary staff did not have current food handlers permit but were scheduled to obtain permits in September 2016

During an interview on 8/11/2016 at 11:50 am with Staff (#K61) Director of Quality she stated that staffs who prepare patient meals in the facility were required to have food handler's permits which is renewable every two years.

Review of the facility's Dietary policy and procedure dated July 8, 2016 revealed no mention of emergency food supply requirement in the facility.

The policy did not address food permit requirement for dietary staff who handle and prepare food in the facility.

MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

Based on observation, interview and record review, the facilty failed to ensure that the blood bank refrigerator was maintained per hospital policy.

Findings include:

Observation on 8/10/2016 at 2:00 pm during tour of the laboratory services department revealed the following:

* The Blood Bank refrigerator did not have a current inspection sticker indicating inspection was done.

Interview with Director of the Laboratory Services ID # B-52 when asked about the expired sticker stated the following; " I thought they had been out to inspect, but yes I see the date is 2015."

Record revieew of facility policy titled, "Blood Bank Quality Control", dated 8/2000 read,
C. CONTROL OF EQUIPMENT
Preventive maintenance and the documentation of these procedures are part of the overall laboratory Quality Control.

EQUIPMENT AND SUPPLIES

Tag No.: A1044

Based on observation, interview and record review, the facility failed to provide documentation of inspection and testing of nuclear medicine euipment per policy

Findings Include:

R-Wave Trigger machine

Observation on 8/10/2016 at 1:35 pm during initial tour of the nuclear medicine tour with Department Director ID # A-51 revealed an electrical machine identified as a R-Wave Trigger machine placed on the botom shelve of a cart in the nuclear medicne room.

Interview with Director of Radiology, ID # A-51 at the time of the observation witnessed no inspection sticker with a date was present on the R-Wave Trigger. Asked if the equipment in his department is inspected on a regular basis, responded the following: " it is done by contracted personnel, Nu-med." When asked, "as department head are you responsible for "all" equipment utilized in the departmentand that maintained records reflecting that "all" equipment is inspected, he responded "yes".

Record review of facility policy titled " Polices & Procedures, Nuclear Medicine- Safety Guidelines" dated 04/2001, read.. A calibration check will be performed on each survey instrument at two month intervals. A tag giving the date of the test shall be attached to each instrument.