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Based on review of medical records, relevant facility documents, and staff interviews, the facility failed to administer compounded drugs in accordance with acceptable standards of practice in that the facility failed to maintain sufficient records to tract the flow of compounded drugs from entry through dispensation.This deficient practice had potential to cause harm to all patients.


Refer to Tags A-0491, A-0500, A-0501.

Based on review of medical records, relevant facilty documents, and staff interviews, the facility failed to administer compounded drugs in accordance with acceptable standards of practice in that the facility failed to maintain sufficient records to tract the flow of compounded drugs from entry through dispensation.

The findings included:

a. Review of Medical Records on August 9-15, 2013 in the facility conference room revealed the following:

On August 6, 2013, Intravenous Calcium Gluconate 2 grams with lot number 07092013M16, that was compounded at an outside pharmacy was found to be contaminated with Gram Positive Rods (Rhodococcus equi). This lot number was received by the facility on July 12, 2013.

From July 9, 2013, to August 7, 2013, it was noted that (45) patients were given Intravenous Calcium Gluconate 2 grams. The facility was not able to identify which of the 45 patients received lot number 07092013M16 because the facility failed to document the lot number in the patient's medical record.


b. Review of facility contracts (pharmacy contract between the hospital and the outside compounding pharmacy) on August 30, 2013, revealed the following:

Contract dated November 20, 2012 stated (F) Beyond use Dating. The hospital is required to record the lot number and beyond use date in the patient's chart of the compounded preparation administered to a patient.


c. Texas State of Board of Pharmacy Rule 291.133 required that: A pharmacy that provides sterile compounded preparations to practitioners for office use or to another pharmacy shall enter into a written agreement with the practitioner or pharmacy.

The written agreement shall:

(B) require the practitioner or receiving pharmacy to include on a patient's chart, medication order or medication administration record the lot number and beyond-use date of a compounded preparation administered to a patient.


d. Interview conducted with (S3) on August 12, 2013, at 10:30 am, in the administration conference room confirmed that the facility does not document compounded medications lot numbers in the patient's medical record. (S3) stated it was an oversight on their part on following the contract provisions for documenting the lot number and beyond use date on each patient's medical records.

Based on review of medical records, relevant facility documents, and staff interviews, the facility failed to administer compounded drugs in accordance with acceptable standards of principles in that the facility failed to maintain sufficient records to follow the flow of compounded drugs from entry through dispensation.

The findings included:

a. Review of Medical Records on August 9-15, 2013, in the facility conference room revealed the following:

On August 6, 2013, Intravenous Calcium Gluconate 2 grams with lot number 07092013M16, that was compounded at an outside pharmacy was found to be contaminated with Gram Positive Rods (Rhodococcus equi). This lot number was received by the facility on July 12, 2013.

From July 9, 2013, to August 7, 2013, it was noted that (45) patients were given Intravenous Calcium Gluconate 2 grams. The facility was not able to identify which of the 45 patients received lot number 07092013M16 because the facility failed to document the lot number in the patient ' s medical record.


b. Review of facility contracts (pharmacy contract between the hospital and the outside compounding pharmacy) on August 30, 2013, revealed the following:

Contract dated November 20, 2012, stated (F) Beyond use Dating. The hospital is required to record the lot number and beyond use date in the patient's chart of the compounded preparation administered to a patient.


c. Texas State of Board of Pharmacy Rule 291.133 required that: A pharmacy that provides sterile compounded preparations to practitioners for office use or to another pharmacy shall enter into a written agreement with the practitioner or pharmacy.

The written agreement shall:

(B) require the practitioner or receiving pharmacy to include on a patient's chart, medication order or medication administration record the lot number and beyond-use date of a compounded preparation administered to a patient.


d. Interview conducted with (S3) on August 12, 2013, at 10:30 am, in the administration conference room confirmed the facility does not document compounded medications lot numbers in the patient's medical record. (S3) stated it was an oversight on their part on following the contract provisions for documenting the lot number and beyond use date on each patient's medical records.

Based on review of medical records,relevant facility documents, and staff interviews, the supervising pharmacist failed to administer compounded drugs in accordance with acceptable standards of practice in that the facility failed to maintain sufficient records to follow the flow of compounded drugs from entry through dispensation.

The findings included:

a. Review of Medical Records on August 9-15, 2013, in the facility conference room revealed the following:

On August 6, 2013, Intravenous Calcium Gluconate 2 grams with lot number 07092013M16, that was compounded at an outside pharmacy was found to be contaminated with Gram Positive Rods (Rhodococcus equi). This lot number was received by the facility on July 12, 2013.

From July 9, 2013, to August 7, 2013, it was noted that (45) patients were given Intravenous Calcium Gluconate 2 grams. The facility was not able to identify which of the 45 patients received lot number 07092013M16 because the facility failed to document the lot number in the patient ' s medical record.


b. Review of facility contracts (pharmacy contract between the hospital and the outside compounding pharmacy) on August 30, 2013, revealed the following:

Contract dated November 20, 2012, stated (F) Beyond use Dating. The hospital is required to record the lot number and beyond use date in the patient's chart of the compounded preparation administered to a patient.


c. Texas State of Board of Pharmacy Rule 291.133 required that: A pharmacy that provides sterile compounded preparations to practitioners for office use or to another pharmacy shall enter into a written agreement with the practitioner or pharmacy.

The written agreement shall:

(B) require the practitioner or receiving pharmacy to include on a patient's chart, medication order or medication administration record the lot number and beyond-use date of a compounded preparation administered to a patient.


d. Interview conducted with (S3) on August 12, 2013, at 10:30 am, in the administration conference room confirmed the facility does not document compounded medications lot numbers in the patient's medical record. (S3) stated it was an oversight on their part on following the contract provisions for documenting the lot number and beyond use date on each patient's medical records.

Based on interviews with hospital testing personnel, the facility failed to meet the Code of Federal Regulations 493.1283


Based on review of microbiology laboratory reports and interview with testing personnel, it was revealed that the laboratory testing personnel failed to document each step of bacterial isolate identification from media inoculation to organism isolation and identification.

Findings include:

1. Review of microbiology culture reports revealed that not all identification steps are documented in the isolate report for identification.

2. Reference attached microbiology culture reports:
I. Microbiology Culture Report Internal 1
II. Microbiology Culture Report Internal 2
III. Microbiology Culture Report Internal 3
IV. Microbiology Culture Report Internal 4
V. Microbiology Culture Report Internal 5
VI. Microbiology Culture Report Internal 6

3. Interview with testing personnel on 8/14/2013 at 4:45 pm indicated that " We do run necessary additional biochemical tests in order to help identify organism isolates, but it is not always documented because we work so closely together that we usually know what is going on with everyone ' s cultures " .


Based on review of final patient test reports and interview with testing personnel revealed that the laboratory failed to provide the name and address of the laboratory location where the reference lab identification of bacterial isolates was performed.
Findings include:
1. Review of microbiology culture reports revealed that the laboratory will send isolates to a reference lab when they are not able to be identified by the facility. The final reports from the reference lab will be sent back to the facility and then the facility will hand type in the results. The facility failed to enter the name and address of the reference lab where the organism was identified into the final culture report.
2. Interview with testing personnel on 8/14/2013 at 4:30 pm indicated that the name and address of the reference lab that is used to identify bacterial isolates is not routinely provided on the final microbiology culture report.