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Based on records reviews and interviews, the Condition Participation for Patient Rights was not met as evidenced by the hospital's failure to ensure a patient was free from abuse for 1 of 1 incidents reviewed.

Finding:

1. Standard: §§482.13(c)(3) Patient Rights: Free from Abuse/Harassment also known as A-0145 - Based on record reviews and interviews, the hospital failed to ensure a patient was free from abuse for 1 of 1 incidents reviewed. Please see A-0145 for details.

The cumulative effect of the deficient practice resulted in noncompliance with this Condition of Participation.

Based on record reviews and interviews, the hospital failed to ensure a patient was free from abuse for 1 of 1 incidents reviewed.

Findings:

On April 15, 2019 the Division of Licensing and Certification received the following complaint: "On 4/12/19 at approximately 2 pm Inland Hospital VP [Vice President] Quality became aware of an allegation of unwanted sexual contact in the form of touching the genital area of a female patient during an ultrasound exam. Patient informed VP she does not want to report incident to law enforcement. Patient is aware of hospital obligation to report incident to DHHS [Department of Health and Human Services]."

A grievance was entered into the hospital's system which stated the following: "Patient #1G stated [he/she] had an appointment on 2/28/19 for an ultrasound of abdomen which was performed by a male. [He/She] stated everything was done very professionally he was kind and courtesy. Exam was simple and direct. [He/She] stated [he/she] had a CT [Computed Tomography] that same day and again staff were great. On March 1st [he/she] states [he/she] received a voicemail from who [he/she] believes was the male ultrasound sonographer stated the receives [results] of [his/her] CT scan were ready and left a number [phone number indicated] to contact the department. Patient played voicemail to writer. Writer listened to the message and noted the voice was male and had a noted accent. Patient attempted to return call on the following Monday morning and afternoon and again on Tuesday but there was no answer at that number. Patient went to see [an identified Physician] in Bangor who ordered an Ultrasound of the abdomen and pelvis complete. Patient returned to Inland radiology on April 3rd for the exam. Patient states [he/she] called in to ask about prep for test, [he/she] was told "no need to fast". Patient stated [he/she] had the same male sonographer and he made a comment ' Didn't I just see you? Were the images not ok?' Patient explained [he/she] saw a different MD [Medical Doctor] who ordered the repeat. Patient states [he/she] asked the employee "Do I take my clothes off?" [He/She] states the employee stated, "take them off" [he/she] did receive a gown and was told to have it open in the front. Patient stated [he/she] remembers him asking [him/her] multiple times if [he/she] was comfortable. Patient says [he/she] was wearing brief and he asked if [he/she] had smaller panties and [he/she] stated no. [He/She] stated, "I can take off my underwear of [if] needed?" and [he/she] did take off [his/her] underwear. Patient stated [he/she] had many position changes and [he/she] was placed on the edged [sic] of the table. [He/She] stated at one point he had his hand under [his/her] left buttock, [he/she] stated, "he was going down the inside of my leg with the probe" [he/she] said he stated that [he/she] was an easy person to deal with which [he/she] found funny because [his/her] previous PCP [Primary Care Provider] "said I was challenging" [He/She] was a bit concerned why he spent so much time "examining my belly" [He/She] stated he moved [his/her] right arm off the table and into his lap about 3-4 inches from his private area. [He/She] noted he had lots of praise for [him/her] "such as how beautiful I am and he would never know I was 76, what is it about you?". [He/She] stated [he/she] in [sic] not trying to be critical but [he/she] never knew where the conversation was going. [He/She] stated he told [him/her] that [he/she] had a defect in a hernia with fluid moving through the break in the hernia and asked [him/her] to come for additional images. [He/She] stated he asked if [he/she] could come back on Friday but when he checked his calendar it was full. [He/She] informed him [he/she] could come back the next day. Patient arrived back in radiology on 4/4 she stated "he seemed pleased to see me and made it a point of letting her know they had 45 minutes together". [He/She] states [he/she] went to exam room and the employee instructed [him/her] that [he/she] had to say yes loud and clear that [he/she] consents to the treatment, patient stated [he/she] did say yes loudly. [He/She] stated [he/she] was told the hernia can be pushed back in and [he/she] stated [he/she] was placed in multiple positions on the table; stomach, back, side and standing. [He/She] states [he/she] remembers the computers had gone down. [He/She] stated that [he/she] was told that [he/she] would not have to pay for the extra visit. [He/She] stated he left the room and when he returned the visit began to feel more sexual. Patient stated the way the appointment ended on 4/4 was he had [him/her] stand up next to him and [he/she] stated he want to go down the leg with the wand, patient stated he told [him/her] to get closer twice and moved [his/her] foot and moved [his/her] hips so [he/she] was facing the exam table. [He/She] stated "he grabbed my gown and asked me to hold it. [He/She] stated he took some gel and lubricated the pelvic area [he/she] stated he requested [him/her] to take his hand to move where the pain is located. [He/She] stated the pain is always at the lump and never goes down the leg. Patient stated employee with his bare right hand, using his third finger, began touching the right side of [his/her] vagina lightly and slowly four or five times Patient stated [he/she] responded in a loud voice "the pain was never on the right!" [He/She] stated he told [him/her] to get dressed and he left the room. When he came back in the room and was "acting like he lost his mind" per patient. Patient stated he made a comment that they had 15 minutes remaining and what did [he/she] want to do? [He/She] was leaving the room and was asked by the employee if [he/she] wanted a disc containing the images and he escorted [him/her] to the registration desk and gave [him/her] a disc which [he/she] brought to [Primary Care Provider MD] and [Primary Care Provider NP]'s office. Patient states [he/she] "knows the employee would have moved mountains for me and I think it is just infatuation" Patient stated [he/she] felt the last visit was sexual and per the patient the employee continued to ask [him/her] to come back and see him. The patient expressed to writer [he/she] does not want this reported. Writer explained the hospital is mandated to report events such as this and we will conduct a full investigation. Patient stated "I made a report in my past and paid dearly for it" patient states the only follow up [he/she] wants is [to] know his credentials."

On 4/30/2019 at 2:05 PM, the Vice President (VP) for Quality Risk and Compliance Officer was interviewed. She confirmed that on 4/12/2019 at approximately 2:00 PM, Patient #1G called her and shared that he/she experienced "unwanted sexual contact in the form of touching the genital area ...during an ultrasound exam". She confirmed she wrote the above information during the phone call with Patient #1G.

On 5/01/2019 at 09:30 AM, Patient #1G was interviewed, via the telephone, with the VP for Quality Risk and Compliance Officer present per Patient #1G's request. Patient #1G indicated the following:

- He/She called the VP for Quality Risk and Compliance Officer on 4/12/19 and reported that he/she received unwanted sexual contact during ultrasound exams on 4/3/19 and 4/4/19 and named a specific male individual [Sonographer #1].

- He/She did not want to have to explain the whole story again but that he/she had explained explicitly to the VP for Quality Risk and Compliance Officer what had happened, during their phone conversation on 4/12/19.

- He/she has been so upset by the incident that he/she has contacted a sexual assault center for emotional support.

- "One of things that is important is that the last visit [4/4/19] was not scheduled, it was completely planned and scheduled by [Sonographer #1]."

- He/She had since called medical records asking for "the report for the 4th [4/4/19] and there is no report for the 4th".

On 5/01/2019 at 11:15 AM during a discussion with the VP for Quality Risk and Compliance and she indicated the following:

- During a phone call, "On 4/19/2019 [Patient #1G] asked me if he/she had to have another exam [at Hospital] would [he/she] be safe?

- She stated that there is a consent form on record that was signed on 4/04/2019 by Patient #1G for receiving a disc with her imaging results but no record of any images that were performed on 4/04/2019.

On 5/01/19 at 12:23 PM, the Sonographer #2 was interviewed. Sonographer #2 indicated that when Sonographer #1 needed to perform a transvaginal/internal exam on a female patient it was policy that he had a female chaperone with him.

On 5/01/19 at 12:40 PM, the Team Leader for the Imaging Department was interviewed. She stated, "Whenever he does a Transvag [Transvaginal Ultrasound] he has to have a [female] chaperone right bedside and we don't leave until he steps out ... usually walk out together."

On 5/01/19 at 1:00 PM, the VP for Quality Risk and Compliance Officer stated she spoke to the Radiologist and asked him if he ordered a repeat ultrasound for Patient #1 for 4/04/19. She states he confirmed that he interpreted the results of the ultrasound on 4/03/19 as a straight forward hernia; he reported his results that afternoon; and there was no request for a an additional follow up. She stated that the Radiologist did not tell Sonographer #1 that he wanted Patient #1G to come back for further imaging after his/her ultrasound on 4/03/19.

On 5/02/19 at 4:00 PM, Patient #1G called the surveyor indicated he/she wanted to share additional information that he/she didn't feel comfortable saying with the VP for Quality Risk and Compliance Officer listening in. Patient #1G indicated the following:

- Before Sonographer #1 "asked [him/her] to say 'yes' that I gave permission for 'treatment', I said it (thinking it was a strange request) and then he told me to say it again because I wasn't saying it loud enough."

- "I was touched in places [vagina & buttocks on 4/04/19] that did not have to do with the ordered exam" and "I never gave him consent for".

- "I thought when these tests were done his hands should be gloved ...his [Sonographer #1] never were."

- "If you can't be safe there [Hospital] then where can you be safe".

- On 4/04/19 after the ultrasound was done, Sonographer #1 left the room so he/she could get dressed; he/she barely had a chance to remove his/her johnny shirt when Sonographer #1 came back in to the exam room; he didn't knock; , looked at him/her as he/she stood there completely naked then walked over to the computer and began talking about "issues with the images ... computers are down".

On 5/01/19 at 11:30 AM, the surveyor reviewed Patient #1G's hospital records in relation to visits for ultrasounds. There was no evidence of a visit on 4/04/19.

The hospital's "Patient's Rights" Policy, revised 10/26/2018, was reviewed and indicated the "[Hospital] recognizes the patient's right to receive care in a safe setting as well as the right to be free from all forms of abuse and harassment. The hospital strives to protect those rights by promoting safety ...".

The hospital's "Abuse, Neglect or Exploitation - Adults" Policy, revised 10/19/2018, defines abuse as "the infliction of injury, unreasonable confinement, intimidation or cruel punishment that causes or is likely to cause physical harm or pain or mental anguish; sexual abuse or sexual exploitation ... Abuse includes acts and omissions."

On 5/01/19 the "Checking Exclusion Status of Prospective and Active Employees, Vendors, and Ordering Providers", last revised 12/01/17, was reviewed and the following information was obtained:

- "I. Initial Exclusion Checks: A. Prospective Employees 1. [Hospital Health Systems] Talent Acquisition must check each prospective Employee against the OIG [Office of Inspector General] LEIE [List of Excluded Individuals/Entities], SAM [Site Automate Monitoring], and State LEIE databases prior to hire....."

- "II. Ongoing Exclusion Checks: A. Current Employees 1. [Hospital Health Systems] and [Hospital Health Systems] Member Organization must check all current Employees against the OIG LEIE, SAM and State LEIE databases monthly by one of the following methods: a. [Hospital Health Systems] HR [Human Resources] must check all current Employees of each [Hospital Health Systems] Member Organization that uses [Payroll company] for Employee payroll purposes against the OIG LEIE, SAM and State LEIE databases monthly. [Hospital Health Systems] HR will conduct these checks unless and until another department is designated to take over this function ..." 2. [Hospital Health Systems] HR will notify each local Member Organization Compliance Officer upon completion of the active monthly Employee exclusion check."

Documentation of an interview, conducted by the hospital on 4/12/19 at 4:00 PM, with Sonographer #1 indicated that he indicated that he told Patient #1G to come back on 4/4/19 and that the Radiologist wanted the patient to come back.

Documentation of an interview, conducted by the hospital on 4/19/19 at 1:30 PM, with Sonographer #1 indicated they asked him about his job application which indicated that his employment previously had been terminated; he indicated it was in Norfolk Virgina 18 years ago; that he had been accused of sexual assault by misusing a wand as a probe [a wand is part of the sonogram machine]; and he indicted "I was told by my attorney that this was expunged, and I would not have to share it"; On 5/01/19 at 8:30 AM, the surveyor reviewed Sonographer #1's employee record with the Regional Director of Human Resources. A document titled, "Criminal Court Records" was reviewed and indicated the following two background checks were done on 09/07/2007: "Maine, Kennebec County 7 Year Felony" and "Maine, Somerset County 7 Years Felony". The document indicated the results were "No Record found based on the Applicant Data Provided".

An internet search on 5/2/19 revealed that Sonographer #1 had been charged with two felonies and one misdemeanor alleging sexual battery of a female patient during an ultrasound procedure in the past (2006) while employed at a Norfolk Virginia hospital; he was was fired from the hospital; and he sought expungement of the charges.

Based on the above information, the hospital failed to ensure Patient #1G was free from abuse. In addition, the hospital failed to ensure a policy related to "Checking Exclusion Status of Prospective and Active Employees, Vendors, and Ordering Providers" was followed. The Regional Director of Human Resources confirmed that no background check had been done on Sonographer #1 since 9/7/2007.