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Based on staff interview and facility document review, the facility staff failed to ensure the protection of each patient's rights to (a) personal privacy regarding the protection of personal information and (b) receive care in a safe setting.

During the complaint investigation conducted 8/28/23, it was evidenced an unauthorized, unlicensed person (minor child) was granted access to the pharmacy and was allowed to access patient information in the form of prescription/medication labels. The (minor child) was allowed to handle medications by removing them from the automated robotic device, place them in a plastic baggie and affix the adhesive printed sticker to the bag which contained the patient name, medication and room number. The (minor child) was allowed to then place the bagged medications in the pneumatic tube device to and send the medications to the nursing unit.

The (minor child) was also allowed to open boxes of medications which had been delivered to the pharmacy and assist in placing the medications in the carousel system for use by the automated robotic device.

State Law as well as facility policy does not allow an unauthorized, unlicensed person to have access to and dispense medications in a pharmacy. (Code of Virginia 54.1-3320 and 3321 and 18 VAC 110-20 Regulations Governing the Practice of Pharmacy.)

Federal Law prohibits the sharing of PHI (Protected Health Information) under The Health Insurance Portability and Accountability Act of 1996 (HIPPA). This act safeguards an individuals right to privacy and protection of personal information from unauthorized persons/entities.

Please refer to A-0143 and A-0144 for further information.

Based on observation, staff interview, facility document review and during the course of a complaint investigation, the facility staff failed to ensure the confidentiality of personal medical information for patients was protected.

The facility staff allowed an unauthorized person access to patient information in the form of prescription labeling which contained the patient name, medication and room number. It is unknown how many patients this affected as this occurred in the pharmacy on multiple occasions over at least four days (not successive days).

The findings included:

On 8/28/23 at 11:10 a.m., the surveyor interviewed Staff Members #1 (Director of Patient Safety and Quality), Staff Member #2 (Director of Pharmacy) and Staff Member #11 (Pharmacy Team Coordinator) regarding the complaint allegation that an unauthorized person (a family member of staff) had access to the pharmacy, medication and patient information. SM #1 stated to SM #11 "You can discuss the situation we became aware of in the pharmacy this morning." SM #11 then stated, " A staff member had their (minor child) here a couple of times and by the time (SM #10 - Pharmacy Manager) and I became aware of it, the (Staff Member - SM #4) had already gone...I had received an email from the privacy department about a concern regarding HIPPA (Health Insurance Portability and Accountability Act of 1996) and child labor laws. We set up a meeting with (SM #4) and 4) there were three members of the privacy group. (SM #4) did admit their (minor child) was in the pharmacy working...that information went to HR (Human Resources) and a counseling was put in for (SM #4). (SM #4) told us that their (minor child) had "tubed" medications to the floors and had put medications away..." The surveyor inquired as to whether SM #10 and 11 had been in the pharmacy and observed that SM #4 had their (minor child) present). SM #11 stated they had on one occasion walked through and saw (minor child) but they were not in a work area and when they (SM #11) returned they did not see (minor child) and assumed they (minor child) was gone.

Staff Member #4 (Lead Pharmacy Tech and parent of minor child) was interviewed on 8/28/23 at 11:35 a.m. and stated, "(Minor Child) didn't want to stay home so I brought (minor child) in. I didn't think it was a big deal. (Minor Child) was curious and spent some time on the computer doing assigned school work. Other times (minor child) tubed things (medications) to the floor. The robot puts the medication in the drawer, somebody unlocks the drawer and gets the medication out and puts it in a bag with the patient sticker label...(minor child) was here I think four days...no one said anything directly...I didn't think that it was a problem...I wish someone would have said something...after (minor child) had been here about four times, the third week, I think, (SM #11) said 'I know (minor child) was here but we can't allow that due to HIPPA'...on Thursday that week (SM #11) told me a complaint had been submitted to corporate compliance and we had a ZOOM meeting. They asked me some questions and said I had to wait to hear the next steps. I was off the next week so when I came back SM #11 said there would be documentation in my workday file if there was any disciplinary action. I haven't heard anything..."

SM #5 (Pharmacy Technician) was interviewed 8/28/23 at 12:45 p.m. and stated, "(SM #4) came in with their (minor child) and I guess (minor child) got bored working on the computer so we let (minor child) put medications away in the carousel when we got in an order...I felt like no one higher up told us (minor child) couldn't be there...(minor child) was putting the medications in the tubes that we send to the floor...marked with the patient name and room number...(minor child) was so cute and I am sorry this got so ugly but no one told us we couldn't..."

SM #6 (Pharmacy Tech) stated on 8/28/23 at 1:09 p.m., "(SM #4) had their (minor child) in. I didn't know if they had permission or not...(Minor child) was at the computer with (SM #4) and then later we received a med order and (minor child) helped put it away. I know (minor child) was at the tube station and robot...I didn't think it was appropriate but I thought they must have had permission..."

The surveyor observed the pharmacy area where (minor child) was described to be "working". The surveyor was shown the carousel section where medications would have been stocked for the robot and also the pneumatic tube system. The surveyor was shown the process where, after the pharmacist entered a medication order, the medication would be selected by the robotic system, a label containing the patient namee, medication information and room number would be printed. The label would be taken off the printer by (staff), placed on a baggie and the medication removed from the automated system (robot) drawer and placed in the baggie. The baggie would then be placed in a tube and sent to the destination by pressing the corresponding area (floor/unit) code. According to SM #4 who was explaining this procedure to the surveyor, (minor child) had been allowed to place the sticker labels on the baggies and place the baggies in the tubes and send them to the units.


The facility policy "Statement of Responsibility and Confidentiality" was reviewed. This was a document provided to all staff members regarding their responsibility for confidentiality. This document evidenced, in part: "...1. In order to protect our patients and their families and to remain competitive, we must protect confidential and proprietary information. I understand and agree that I will learn and have access to confidential and proprietary information regarding: patient/families... 2. I understand this statement covers all passwords issued to or used by me to operate Sentara Healthcare computer system. therefore, I agree not to disclose my passwords...not to permit another person to use them...and not to sign on to any system to allow an unauthorized person to use the system...8. I understand that all patient medical information is confidential and agree to treat it as such. I further agree that I will use and disclose such information only in accordance with state and federal laws, including, but nit limited to the regulations promulgated under the Health Insurance Portability and Accountability Act of 1996..."

The facility policy "Privacy of Protected Health Information" evidenced, in part: "...Only individuals with a legitimate "need to know" may access, use disclose protected Health Information..."

The surveyor was presented a "Colleague Handbook" which evidenced, " Confidentiality: Sentara respects privacy! All Sentara records, transactions and information regarding Sentara, colleagues, customers and their families must be held at the utmost confidence. This applies to all information whether it is paper, electronic, or verbal format..."

The surveyor discussed the concerns with SM #1, 2 and 11 on 8/28/23 throughout the course of the investigation and at approximately 3:10 p.m. and again at an exit conference at approximately 3:30 p.m.

Based on staff interview and facility document review, the facility staff failed to ensure patients received care in a safe setting. An unauthorized, unlicensed person was allowed to handle medications in the pharmacy thus creating the potential for a medication error which could have caused adverse effects for patients. The unauthorized unlicensed person was allowed to do tasks in the pharmacy over multiple days (not successive), so it is unknown how many patients this potentially affected.

The findings included:

On 8/28/23 at 11:10 a.m., the surveyor interviewed Staff Members #1 (Director of Patient Safety and Quality), Staff Member #2 (Director of Pharmacy) and Staff Member #11 (Pharmacy Team Coordinator) regarding the complaint allegation that an unauthorized person (a family member of staff) had access to the pharmacy, medication and patient information. SM #1 stated to SM #11 "You can discuss the situation we became aware of in the pharmacy this morning." SM #11 then stated, " A staff member had their (minor child) here a couple of times and by the time (SM #10 - Pharmacy Manager) and I became aware of it, the (Staff Member - SM #4) had already gone...I had received an email from the privacy department about a concern regarding HIPPA (Health Insurance Portability and Accountability Act of 1996) and child labor laws. We set up a meeting with (SM #4) and there were three members of the privacy group. (SM #4) did admit their (minor child) was in the pharmacy working...that information went to HR (Human Resources) and a counseling was put in for (SM #4). (SM #4) told us that their (minor child) had "tubed" medications to the floors and had put medications away..." The surveyor inquired as to whether SM #10 and 11 had been in the pharmacy and observed that SM #4 had their (minor child) present). SM #11 stated they had on one occasion walked through and saw (minor child) but they were not in a work area and when they (SM #11) returned they did not see (minor child) and assumed they (minor child) was gone.

Staff Member #4 (Lead Pharmacy Tech and parent of minor child) was interviewed on 8/28/23 at 11:35 a.m. and stated, "(Minor Child) didn't want to stay home so I brought (minor child) in. I didn't think it was a big deal. (Minor Child) was curious and spent some time on the computer doing assigned school work. Other times (minor child) tubed things (medications) to the floor; patient medications that we sent. The robot puts the medication in the drawer, somebody unlocks the drawer and gets the medication out and puts it in a bag with the patient sticker label...(minor child) was here I think four days...no one said anything directly...I didn't think that it was a problem...I wish someone would have said something...after (minor child) had been here about four times, the third week, I think, (SM #11) said 'I know (minor child) was here but we can't allow that due to HIPPA'...on Thursday that week (SM #11) told me a complaint had been submitted to corporate compliance and we had a ZOOM meeting. They asked me some questions and said I had to wait to hear the next steps. I was off the next week so when I came back SM #11 said there would be documentation in my workday file if there was any disciplinary action. I haven't heard anything..."

SM #5 (Pharmacy Technician) was interviewed 8/28/23 at 12:45 p.m. and stated, "(SM #4) came in with their (minor child) and I guess (minor child) got bored working on the computer so we let (minor child) put medications away in the carousel when we got in an order...I felt like no one higher up told us (minor child) couldn't be there...(minor child) was putting the medications in the tubes that we send to the floor...marked with the patient name and room number...(minor child) was so cute and I am sorry this got so ugly but no one told us we couldn't..."

SM #6 (Pharmacy Tech) stated on 8/28/23 at 1:09 p.m., "(SM #4) had their (minor child) in. I didn't know if they had permission or not...(Minor child) was at the computer with (SM #4) and then later we received a med order and (minor child) helped put it away. I know (minor child) was at the tube station and robot...I didn't think it was appropriate but I thought they must have had permission..."

The surveyor observed the pharmacy area where (minor child) was described to be "working". The surveyor was shown the carousel section where medications would have been stocked for the robot and also the pneumatic tube system. The surveyor was shown the process where, after the pharmacist entered a medication order, the medication would be selected by the robotic system, a label containing the patient name, medication information and room number would be printed. The label would be taken off the printer by (staff), placed on a baggie and the medication removed from the automated system (robot) drawer and placed in the baggie. The baggie would then be placed in a tube and sent to the destination by pressing the corresponding area (floor/unit) code. According to SM #4 who was explaining this procedure to the surveyor, (minor child) had been allowed to place the sticker labels on the baggies and place the baggies in the tubes and send them to the units.

The surveyor requested, was presented with and reviewed reported medication errors for the estimated time frame the (minor child) was in the pharmacy. There were no reports of any medications that might have been associated with the (minor child) actions, however, the facility had not investigated this so the extent was unknown. Staff Member #1 stated they had not looked at medication errors until the surveyor requested the report.

The facility policy "Inpatient and Outpatient Pharmacy Security" evidenced, in part: "...Only pharmacy authorized personnel shall be permitted to have free access to the pharmacy...The pharmacy shall limit nonessential traffic...Security will be maintained in accordance with federal laws, the laws of the State and local laws...Drugs shall be kept secure from access by unauthorized individuals..."


The surveyor discussed the concerns with SM #1, 2 and 11 on 8/28/23 throughout the course of the investigation and at approximately 3:10 p.m. and again at an exit conference at approximately 3:30 p.m.

Based on staff interview and facility document review, the facility staff failed to ensure policies and procedures for pharmacy services were followed regarding security and access to the pharmacy and medications.

During the complaint investigation conducted 8/28/23, it was evidenced an unauthorized, unlicensed person (minor child) was granted access to the pharmacy and was allowed to access patient information in the form of prescription/medication labels. The (minor child) was allowed to handle medications by removing them from the automated robotic device, place them in a plastic baggie and affix the adhesive printed sticker to the bag. The (minor child) was allowed to then place the bagged medications in the pneumatic tube device to and send the medications to the nursing unit.

The (minor child) was also allowed to open boxes of medications which had been delivered to the pharmacy and assist in placing the medications in the carousel system for use by the automated robotic device.

The supervising pharmacist(s) was not aware the (minor child) was in the pharmacy and was handling medications. The pharmacists on duty at the time were aware the (minor child) was in the pharmacy, but not aware (minor child) was being allowed to handle medications.

At 11:50 a.m. on 8/28/23, SM #8 (Registered Pharmacist) was interviewed and stated, "I saw (minor child) and I questioned why (they) were here but I didn't take it further because (minor child) had been here the day before and that was my day off so I thought maybe (SM #4) had gotten permission for (minor child) to be here...I never saw (minor child) handling any medications or in the med area and was not aware that was going on; but I did see (minor child) in computer in the non work area...no one has talked to me about this prior to this interview."

On 8/28/23 at 12:58 p.m. SM #9 (Registered Pharmacist) was interviewed and stated, "I did not see (minor child) working but I heard (they) were putting away stock medications and that (minor child) was in the tech area sending medications in the pneumatic tube system...I did not say anything because I thought (parent- SM #4) had gotten approval for (minor child). Sometimes we have high school students that observe but they have approval from the department, so I thought they had approval as well. I found out though after, that no one knew (SM #4) brought (minor child)..."

State Law as well as facility policy does not allow an unauthorized, unlicensed person to have access to and dispense medications in a pharmacy. (Code of Virginia 54.1-3320 and 3321 and 18 VAC 110-20 Regulations Governing the Practice of Pharmacy.)

Facility Policy "Inpatient and Outpatient Pharmacy Security" provides for only authorized personnel in the pharmacy.

Please see A-0501 and A-0504 for further information.

Based on staff interview and facility document review, the facility and supervising pharmacist(s) failed to ensure medications were only prepared by authorized personnel and that only authorized personnel had access to medications. It was unknown how many patients were potentially affected.

An unauthorized, unlicensed person (minor child) was granted access to the pharmacy and was allowed to handle medications by removing them from the automated robotic device, place them in a plastic baggie and affix the adhesive printed sticker to the bag. The (minor child) was allowed to then place the bagged medications in the pneumatic tube device to and send the medications to the nursing unit. The (minor child) was also allowed to open boxes of medications which had been delivered to the pharmacy and assist in placing the medications in the carousel system for use by the automated robotic device. The supervising pharmacist(s) was not aware the (minor child) was in the pharmacy and was handling medications. The pharmacists on duty at the time were aware the (minor child) was in the pharmacy, but not aware (minor child) was being allowed to handle medications (according to statements).

The findings included:

At 11:50 a.m. on 8/28/23, SM #8 (Registered Pharmacist) was interviewed and stated, "I saw (minor child) and I questioned why (they) were here but I didn't take it further because (minor child) had been here the day before and that was my day off so I thought maybe (SM #4) had gotten permission for (minor child) to be here...I never saw (minor child) handling any medications or in the med area and was not aware that was going on; but I did see (minor child) in computer in the non work area...no one has talked to me about this prior to this interview."


On 8/28/23 at 12:58 p.m. SM #9 (Registered Pharmacist) was interviewed and stated, "I did not see (minor child) working but I heard (they) were putting away stock medications and that (minor child) was in the tech area sending medications in the pneumatic tube system...I did not say anything because I thought (parent- SM #4) had gotten approval for (minor child). Sometimes we have high school students that observe but they have approval from the department, so I thought they had approval as well. I found out though after, that no one knew (SM #4) brought (minor child)..."

The facility policy "Inpatient and Outpatient Pharmacy Security" evidenced, in part: "...Only pharmacy authorized personnel shall be permitted to have free access to the pharmacy...The pharmacy shall limit nonessential traffic...Security will be maintained in accordance with federal laws, the laws of the State and local laws...Drugs shall be kept secure from access by unauthorized individuals..."

The surveyor discussed the concerns with SM #1, 2 and 11 on 8/28/23 throughout the course of the investigation and at approximately 3:10 p.m. and again at an exit conference at approximately 3:30 p.m.

Based on staff interview and facility document review, the facility and supervising pharmacist(s)failed to ensure only authorized personnel had access to medications and access to the areas where drugs and biologicals were stored.

An unauthorized, unlicensed person (minor child) was granted access to the pharmacy and was allowed access to and to handle medications. The (minor child) was also allowed to open boxes of medications which had been delivered to the pharmacy and assist in placing the medications in the carousel system for use by the automated robotic device.

The findings included:

On 8/28/23 at 11:10 a.m., the surveyor interviewed Staff Members #1 (Director of Patient Safety and Quality), Staff Member #2 (Director of Pharmacy) and Staff Member #11 (Pharmacy Team Coordinator) regarding the complaint allegation that an unauthorized person (a family member of staff) had access to the pharmacy and medication. SM #1 stated to SM #11 "You can discuss the situation we became aware of in the pharmacy this morning." SM #11 then stated, " A staff member had their (minor child) here a couple of times and by the time (SM #10 - Pharmacy Manager) and I became aware of it, the (Staff Member - SM #4) had already gone...I had received an email from the privacy department about a concern regarding HIPPA (Health Insurance Portability and Accountability Act of 1996) and child labor laws... (SM #4) did admit their (minor child) was in the pharmacy working...(SM #4) told us that their (minor child) had "tubed" medications to the floors and had put medications away..." The surveyor inquired as to whether SM #10 and 11 had been in the pharmacy and observed that SM #4 had their (minor child) present). SM #11 stated they had on one occasion walked through and saw (minor child) but they were not in a work area and when they (SM #11) returned they did not see (minor child) and assumed they (minor child) was gone.

Staff Member #4 (Lead Pharmacy Tech and parent of minor child) was interviewed on 8/28/23 at 11:35 a.m. and stated, "(Minor Child) didn't want to stay home so I brought (minor child) in. I didn't think it was a big deal. (Minor Child) was curious and spent some time on the computer doing assigned school work. Other times (minor child) tubed things (medications) to the floor; patient medications that we sent. The robot puts the medication in the drawer, somebody unlocks the drawer and gets the medication out and puts it in a bag with the patient sticker label...(minor child) was here I think four days...no one said anything directly...I didn't think that it was a problem...I wish someone would have said something...after (minor child) had been here about four times..."

At 11:50 a.m. on 8/28/23, SM #8 (Registered Pharmacist) was interviewed and stated, "I saw (minor child) and I questioned why (they) were here but I didn't take it further because (minor child) had been here the day before and that was my day off so I thought maybe (SM #4) had gotten permission for (minor child) to be here..."

On 8/28/23 at 12:58 p.m. SM #9 (Registered Pharmacist) was interviewed and stated, "I did not see (minor child) working but I heard (they) were putting away stock medications and that (minor child) was in the tech area sending medications in the pneumatic tube system...I did not say anything because I thought (parent- SM #4) had gotten approval for (minor child)... I found out after, that no one knew (SM #4) brought (minor child)..."

The facility policy "Inpatient and Outpatient Pharmacy Security" evidenced, in part: "...Only pharmacy authorized personnel shall be permitted to have free access to the pharmacy...The pharmacy shall limit nonessential traffic...Security will be maintained in accordance with federal laws, the laws of the State and local laws...Drugs shall be kept secure from access by unauthorized individuals..."

The surveyor discussed the concerns with SM #1, 2 and 11 on 8/28/23 throughout the course of the investigation and at approximately 3:10 p.m. and again at an exit conference at approximately 3:30 p.m.