DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION		 (X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER		 (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED
101545 A. BUILDING __________
B. WING ______________ 		07/17/2020
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP
VITAS HEALTHCARE CORPORATION OF FLORIDA 4450 W EAU GALLIE BLVD STE 250, MELBOURNE, FL, 32934
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.
Any deficiency statement ending with an asterisk (*) denotes a deficiency which the institution may be excused from correcting providing it is determined that other safeguards provide sufficient protection to the patients. (See reverse for further instructions.) Except for nursing homes, the findings stated above are disclosable 90 days following the date of survey whether or not a plan of correction is provided. For nursing homes, the above findings and plans of correction are disclosable 14 days following the date these documents are made available to the facility. If deficiencies are cited, an approved plan of correction is requisite to continued program participation
LABORATORY DIRECTOR’S OR PROVIDER/SUPPLIER REPRESENTATIVE’S SIGNATURE

 TITLE

 (X6) DATE
FORM CMS-2567 (02/99) Previous Versions Obsolete
(X4) ID
PREFIX
TAG		 SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY SHOULD BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
L0574      
13640 Based on inteview, record review and a review of hospice documentation, the hospice failed to ensure that the policy for providing an effective delivery of services in terms of equipment safety were implemented in regards to its expactation for thr reporting of incidents involving medical equipment and the hospice failed to ensure that policies on equipment safety had been developed to withraw equipment from use in incidents involving malfunctions of unknown origin in one of six sampled patients (#1). Findings: A review of the medical record of patient #1 was performed. The patient had a diagnosis of "Malignant neoplasm of thyroid gland". Physician orders of 6/22/20 included, "10 L (liters) concentrator". Admission orders of 6/23/20 included, "Oxygen 28% aerosol inh (inhaled) cont (continuous) SOB (for Shortness of Breath)." Orders also indicated home medical equipment including, "Concentrator...." Regarding the oxygen concentrator, documentation revealed that the final oxygen concentrator (serial number 900-109760) which the patient used through his eventual death on 6/28/20 was delivered on 6/23/20, as an exchange for the original one which was delivered on 6/22/20 at 2:30 PM. A Respiratory Therapist (RT) note of 6/23/20 at 2:46 PM read, "Patient arrived safely at home. Equipment is at home and set up properly." The "Addendum Interdisciplinary Note" of 6/27/20 by licensed practical nurse (LPN) A at 2 PM read, "Duoneb vial by nebulizer. ..." During an interview with LPN A at 4:07 PM on 7/15/20, she confirmed that there was an issue with the oxygen concentrator at this time, which was during the nebulizer treatment. She stated that during the nebulizer treatment, the oxygen concentrator just stopped. She heard a very loud oxygen concentrator alarm at this time, which warned of the stoppage. She stated that in her efforts to restore oxygen through the oxygen concentrator, she thought to double-check the place where the oxygen concentrator had been plugged in. She went to the plug, put it into another wall outlet, and the oxygen concentrator turned on again. Regarding the possibility of the oxygen concentrator having a malfunction, she was asked if she reported it to anybody. She stated that she did not file any reports. This oxygen concentrator remained with the patient through his death on 6/28/20. Regarding any policies on what staff should do if a device presented with potential problems or malfunctions, a review of policy "VMS Patient/Family/Visitor Incident Report Form Process" was performed. It required the reporting of incidents of any type regarding equipment. Specifically, it read, "If the incident was Medical Equipment Related (check all that apply): Check whether the incident was a result of: user error, non-compliance, HME malfunction/failure, or 'Other', specify. Write in the type of equipment involved and manufacturer's name. Describe details of the incident, including outcome of incident in the narrative." In the case of patient #1, there was no evidence that the incident was reported. This policy required the filing of an incident report for any type of equipment incident. Per this policy, there was no requirement that any removal of service action needed to be taken with the device, or any other device which briefly stops working for an unknown reason, but, due to a short non-working duration, does not cause harm. This lack of a any requirement for removal of service may keep a developing mechanical problem from being addressed and, as a result, increase the risk of exposing the same involved patient to a mechanical failure of a degree that causes harm. During an interview of the Patient Care Administrator at 3 PM confirmed that that LPN A did not report the difficulty she encountered with the oxygen concentrator on 6/27/20 to anyone.
L0701      
13640 Based on interview, record review and a review of hospice documentation, the hospice failed to ensure that routine maintenance policies in the form of a contract or agreement with an outside provider were followed with respect to expectations for the delivery of properly operating equipment with one of six sampled patients (#1). Findings: A review of the medical record of patient #1 was performed. The patient had a diagnosis of "Malignant neoplasm of thyroid gland". Physician orders of 6/22/20 included, "10 L (liters) concentrator." Admission orders of 6/23/20 included, "Oxygen 28% aerosol inh (inhaled) cont (continuous) SOB (for Shortness of Breath)." Orders also indicated home medical equipment as including: "Concentrator...." Regarding the oxygen concentrator, documentation revealed that the final oxygen concentrator (serial number 900-109760) which the patient used through his eventual death on 6/28/20 was delivered on 6/23/20, as an exchange for the original one which was delivered on 6/22/20 at 2:30 PM. A Respiratory Therapist (RT) note of 6/23/20 at 2:46 PM read, "Patient arrived safely at home. Equipment is at home and set up properly." Regarding the suitability of delivered oxygen concentrators for patient use, such as their maintenance status just prior to delivery, a review of the 1/01/18 contract between Vitas Healthcare Corporation of Florida and Vitas HME Solutions, Inc., the provider of all oxygen concentrators (and other equipment) to the hospice, was performed. It revealed the following: "Provider (Vitas HME Solutions, Inc.) shall repair or replace any item of equipment that does not operate properly...." If Vitas HME Solutions, Inc. does not provide an oxygen concentrator which has been tested (after prior use by another patient), it cannot attest with reasonable assurance that it has provided Vitas Healthcare Corporation of Florida with an oxygen concentrator which will "operate properly". Thus, patients of Vitas Healthcare Corporation of Florida may be at risk of receiving improperly functioning equipment if the equipment is not tested at some point prior to delivery, particularly if it had been used by another patient in the interval after any other tests had been performed. This excerpt from the contract is an expectation by Vitas Healthcare Corporation of Florida for their receipt of properly operating equipment. Vitas HME Solutions' policy "Oxygen Concentrator Cleaning/Maintenance Standards" read, "All oxygen concentrators will be tested for purity after running for 45 minutes. Purity levels must meet or exceed 90%." During an interview of the Senior Director of Field Operations of Vitas HME on 7/17/20 at 9:45 AM, she stated the "purity" is the FIO2 (Fraction of Inspired Oxygen) level. Thus, VITAS HME Solutions required that oxygen concentrators be tested. This contributes to the understanding of what is a "properly" working piece of equipment. The hospice produced documentation which indicated that the patient was given a "New Life...." 10-Liter oxygen concentrator, by Air Sep (serial number 900-109760) on 6/23/20. As for whether this specific oxygen concentrator was suitable for use, such as having up to date maintenance, a review of documentation did not reveal any evidence of testing after its use on the immediately preceding patient, #4. A review of documentation for patient #4 revealed that she used the oxygen concentrator from 5/11/20 through 6/04/20. During an interview of the Senior Director Florida Oerationps, of Vitas HME of 7/16/20 at 1:45 PM, she stated that when an oxygen concentrator comes in after having been used with a patient, it is cleaned and tested. She stated that documentation confirming the purity results is generated. She stated on 7/17/20 at 9:45 AM that the results are first entered in the Daily Maintenance log (handwritten) by the warehouse employee. Then, at some point in time, they are entered in the computer by the Manager. She stated that this generates an "Item Maintenance Note". She stated in the 7/16/20 and 7/17/20 interviews that a non-numbered green tag is applied after the log entry which reflects its suitability to be used again. She stated that in the case of the oxygen concentrator used with patient #1, which she confirmed was sent to patient on 6/23/20, there was no available documentation (log or Item Maintenance Note) confirming it had been tested after its prior use with patient #4. She stated that prior to being used with patient #1, it had been used on patient #4 until 6/04/20. Since there was no evidence available from any source to indicate that the oxygen concentrator that was ultimately used with patient #1 had been tested after its use on a prior patient, #4, the contract/agreement was not fulfilled in its expectation for delivered equipment with a reasonable expectation of being properly functioning. During an interview of the Patient Care Administrator at 3 PM on 7/16/2020 confirmed that they did not have any evidence that the involved oxygen concentrator had been tested in the interval between its use on patient #4 and patient #1.