STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION,
Petitioner,
vs. . Case No.
GINGERbRIVE HEALTH CARE ASSOCIATES, LLC; d/b/a
HERITAGE HEALTH CARE CENTER,
2011010665
Respondent.
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ADMINISTRATIVE COMPLAINT
COMES NOW the Petitioner, State of Florida, Agency for Health Care Administration ("the Agency"), by and through the undersigned counsel, and files this Administrative Complaint against the Respondent, Ginger Drive Health Care Associates, LLC, d/b/a Heritage Health Care Center ("the Respondent"), pursuant to sections 120.569 and 120.57 Florida Statutes, and alleges as follows:
NATURE OF THE ACTION
This is an action to impose an administrative fine in the amount of $4,000.00 based upon one (1) uncorrected Class III deficiency pursuant §400.23(8)(c) and assign conditional licensure status commencing August 31, 2011 and ending September 29, 2011 on the Respondent.
PARTIES
The Agency is the licensing and regulatory authority that oversees nursing homes and enforces the applicable federal regulations, state statutes and rules governing skilled nursing facilities pursuant to Chapters 408, Part II, and 400, Paii II, Florida Statutes, and Chapter 59A-4, Florida Administrative Code.
Filed March 5, 2012 4:03 PM Division of Administrative Hearings
The Respondent was issued a license (License Number 12210961) by the Agency to operate a nursing home located at 3101 Ginger Drive, Tallahassee, Florida 32308, and was at all times material times required to comply with all applicable regulations, statutes and rules.
COUNT I (Tag N0090)
Under Florida law, the facility shall adopt procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals, to meet the needs of each resident. Fla. Admin. Code R. 59A-4.112(1)
That from July 18, 2011 through July 22, 2011, the Agency conducted an unannounced licensure survey of Respondent's facility.
That based on observations, interviews and review of the facility's policy and procedure, the facility failed to provide pharmaceutical services to meet the needs of each resident.
The facility failed to ensure that drugs and biologicals were stored in a safe manner for I of 8 medication carts. The facility failed to ensure that drugs and biological were not expired for 7 of 8 medication carts reviewed, 3 of 4 treatment carts reviewed and 2 of the 3 Medication Storage rooms reviewed.
The facility failed to maintain medications in a secure manner in which only designated staff had access to medications by maintaining the medication, Heparin, in the 300 Unit clean utility room in which ce1tified nurses aides had access to.
On July 19, 2011 beginning at 1:53 PM the medication carts for the 300 hall were inspected in the presence of the staff/medication nurses assigned to each medication cart. Two of the three medication carts inspected revealed the following:
The medication cart for rooms 300-309 revealed:
Three opened bottles of various insulins, each insulin medication package revealeda label which stated to note the date the medication was opened and to discard unused medication after the 28 days.
There was one opened vial ofNovolog 100 units/ml, one open vial of Apidra 100 units/ml and one open vial ofLantus 100 units/ml each with no notation as to
when the vials were opened or when they expired. The findings .were confirmed with the medication nurse at 2:00PM.
Two bottles ofLumigan 0.01% eye drops, each contained a label for notating the open date to discard after 60 days. Neither bottles of eye medication contained the open date of the medication. The findings were confirmed with the medication nurse and the Nurse Manager at 2:03PM.
Haloperidol Lac 5 mg/ml with an expiration date of 05/11. The findings were confirmed with the medication nurse.
Three Novolog Flexpen prefilled Syringes which were unopened and found in the top drawer of the medication cart. Review of the medication labels revealed
the statement "refrigerate until opened." The findings were confirmed with the medication nurse.
The medication cart for rooms 321-330 revealed:
Two NovoLog Flexpen prefilled syringes that were not opened with the label that stated "refrigerate until opened". Interview with the medication nurse at 2: IO PM confirmed that these medications should be refrigerated until opened.
On 07/20/201 I beginning at 2:32 PM the medication carts for the 200 hall were inspected in the presence of the staff/medication nurses assigned to each medication cart. Two of the two medication carts inspected revealed the following:
The medication cart for rooms 201,203, 225-234 and 250-254 revealed:
One unopened vial of Lantus 100 u/ml with a label on the bottle which indicates refrigerate until opened which was located in the medication cart top left. Interview with the medication nurse at 2:36 PM revealed this medication should be in the refrigerator until opened.
One vial of Promethazine 25 ml/ml with the expiration date of 01/11; these findings were confirmed with the medication nurse at approximately 2:38PM and she discarded the medication.
The medication cart for rooms 200, 204-217 revealed:
One opened bottle ofNasacort AQ Nasal Spray revealed the bottle with no indication of an open date or a discard date. Interview with the medication nurse at 2:46 PM revealed that the staff are to mark the medication with an open date so they may discard the medication in 28 days and stated this medication did not contain the appropriate noted open date.
One opened bottle of Combigan eye drops and one opened bottle of Dorzolamide HCL 2% eye Drops without an indication of an open date. Interview with the medication nurse at 2:49 PM revealed that the staff are to mark the medication with an open date so they may discard the medication in 28 days and stated this medication did
not contain the appropriate noted open date.
One opened inhaler of Advair 250-50 Diskus with a label on the
packaging that indicates the package should be marked as to the open date and is not and do not use 30 days after the open date. Interview with the medication nurse at 2:51 PM confirmed these findings of no open date and it should be documented on the package.
One opened bottle of Ergocalciferol Oral Solution which does not indicate an open date. Interview with the medication nurse at approximately 2:53PM revealed that the medication should be marked by the staff with an open date.
On 07/20/2011 beginning at approximately 3:05PM the medication carts for the I 00 hall were inspected in the presence of the staff/medication nurses assigned to each medication cart. Three of the three medication carts inspected revealed the following:
The medication cart for rooms 125-136 revealed:
Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution with an open date of 06/13/2011, interview with the medication nurse at approximately 3:15PM this medication should have been discarded by 07/13/2011 and should not be on the medication cart.
The medication cart for rooms I 00-103 and 150-152 revealed:
Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution without an indication of an open date. Interview with medication nurse at this time revealed the staff are to notate the open date and the medication is to be discarded after 30 days of opening the medication.
One opened inhaler of Advair 250-50 Diskus with a label to indicate the opened date and there is no open date indicated on the label. Interview with the
medication nurse at 3:24PM revealed that the medication should contain the open date so the medication can be discarded appropriately.
The medication cart for rooms 153-156 and 255-256 revealed:
4 vials of Promethazine 25 mg/ml with an expiration date of I 0/10, these findings were confirmed with the medication nurse.
An inspection was done on 07/21/2011 at 8:41AM of the treatment cart located in the medication room, with a staff LPN. The nurse stated they do obtain supplies from this cart regularly. Inspection of this treatment cart revealed:
One opened bottle ofNystop 100,000 units/gm powder with the expiration date of 03/2011 this findings were confirmed with the nurse at this time.
One tube ofhemorrhoidal ointment with the expiration date of05/1 l this finding was confinned with the nurse at this time.
An inspection of the main treatment cart for the facility was done on 0712112011
at 9:04AM with a staff LPN. The inspection revealed:
One op'ened bottle ofVashe wound therapy with an opened date of 12/17/10 and according to the manufacturers label on the bottle reveals Vashe has a shelf life of 30 days at room temperature if not opened and once opened, solution must be used within 5 days; these findings were confirmed with the nurse at the time of the inspection.
An inspect.ion was done on 07/21/2011 at approximately 9:25AM of the treatment cart on Unit 300 with the Unit manager. Inspection revealed:
One opened container of Glycerin laxative suppositories with the expiration date of 05/11, these finding were confirmed with the nurse at the time of the inspection.
Two opened tubes of "Muscle Rub" with the expiration date of 12/ 10, these findings were confirmed with the nurse at the time of the inspection.
On 07/19/2011 at approximately 5:20PM an interview with the Director of Nurses (DON) revealed that the facility's policy and procedure and her expectations is that staff will
store all unopened insulins, including the insulin pen syringes, in the refrigerator. Once the insulins are opened they may be stored in the medication carts. She also stated once the insulin is opened the medication nurses are to label the insulin with an"open date" so that the insulin may be discarded after 28 days. Interview with the DON on 07/2/12011 at approximately 10:30AM revealed that it is the facility's policy and procedure and her expections that medications such as eye drops, inhalers and nasal sprays are marked with an open date and disposed of on the 28th day.
The facility's policy entitled "5.3 Storage and Expiration Dating of Medications, Biologicals, Syringes and Needles," reveals "5. Once any medication or biological package is opened, Facility should follow manufacturer/supplier guidelines with respect to expiration dates for opened medications. Facility staff should record the date opened on the medication container whenthe medication has a shortened expiration date once opened." "11. Facility should ensure that medications and biologicals are stored at their appropriate temperatures according to the United States Pharmacopeia guidelines for temperature range." The facility failed to follow their own policy and procedure.
An observation on 07/21/2011 at approximately 9:55AM revealed a medication cart for rooms 104-115 sitting in the hallway, not under the direct observation of the medication nurse. The surveyor observed a white capsule lying on top of the medication cart next to the medication administration record book.
Two different residents were observed to pass the medication cart. The medication nurse returned to the medication cart at approximately 10:00AM.
Ari interview with the medication nurse at this time revealed that she must have dropped the capsule during medication preparation for a resident and she believed that the white capsule was Glucosamine. She stated she would make sure that the appropriate resident
received the medication after her investigation to determine the identity of the capsule.
On 7/20/2011 at approximately 9:13 AM the 300 hall clean utility storage closet located across from room 305 was observed unlocked in the presence of 2 other surveyors. The door had a numeric code panel; however the surveyor was able to push the door open without entering a numeric code.
A lower level drawer in the clean utility storage closet contained 1 package of 30 prefilled single use syringes of Heparin lock flush solution 10 units/milliliter, 1 package of 30 prefilled single use syringes of Heparin lock flush solution 100 units/milliliter and 24- 10 milliliter prefilled syringes of n01mal saline.
The Director of Nursing (DON) was present and confirmed these findings. The DON stated the maintenance staff had ordered a part to repair the door and the part would be overnighted to the facility. The DON then instructed the 300 hall unit manager to post a sign on the clean utility closet door instructing staff to close the door and test the lock to ensure it was secure until the door was repaired.
On 7/20/2011 at approximately 9:35 AM the DON stated the maintenance staff were planning to place a different lock on the door until the ordered part arrived.
An interview was conducted with the maintenance supervisor on 7/20/2011 at approximately I 0:50 AM. The maintenance supervisor stated he was not aware the 300 hall clean utility closet door lock was malfunctioning until the surveyors observed this on 7/19/2011.
A Class III deficiency is a deficiency that the agency determines will result in no more than minimal physical, mental, or psychosocial discomfo11 to the resident or has the potential to compromise the resident's ability to maintain or reach his or her highest practical physical, mental, or psychosocial well-being, as defined by an accurate and comprehensive resident assessment, plan of care, and provision of services. A class III deficiency is subject to a civil penalty of $1,000 for an isolated deficiency, $2,000 for a patterned deficiency, and $3,000 for a widespread deficiency. The fine amount shall be doubled for each deficiency if the facility was previously cited for one or more class I or class II deficiencies during the last licensure inspection or any inspection or complaint investigation since the last licensure inspection. A citation for a class III deficiency must specify the time within which the deficiency is required to be corrected. If a class III deficiency is conected within the time specified, a civil penalty may not be imposed. § 400.23(8)(b), Fla. Stat. (2011).
The Respondent was cited with a Class III deficiency.
That from August 29, 2011 through August 31, 2011, the Agency conducted a follow-up to the unannounced licensure survey of Respondent's facility.
That based on observation, interview and policy review the facility failed to
follow their procedures for stornge and/or removal of expired and administered medications for 2 of 6 medication carts and 1 of 3 unit refrigerators observed.
An observation of the 200 hall medication cart B was conducted in the presence of the Licensed Practical Nurse (LPN) on 8/29/2011 at approximately 11:20 AM.
The top drawer of this medication cart contained 2 plastic med cups, one containing crushed medications with a resident name on the cup and one containing 7 pills (medications) with no name on the cup.
At this time the LPN stated both of these residents were sleeping and she planned to give them when they woke.
An observation of the 300 hall medication storage refrigerator was conducted in the presence of the unit manager on 8/30/201 I at approximately 11:32 AM. The refrigerator contained 2 Phenadoz 25mg suppositories expired on 5/2011. The unit manager confirmed the medications were expired.
An observation of the 300 hall medication cart #3 was conducted on 8/30/2011 at approximately 11:35 AM in the presence of the unit manager. The stock medication drawer of the cart contained 1 partial, opened bottle of vitamin B-6 25mg expired on 7/2011. The medication was confirmed to be expired by the unit manager.
The facility policy for storage and expiration dating of drugs (policy 5.3) was reviewed on 8/30/2011. The policy states #7 the facility should ensure that drugs and biologicals for each resident are stored in their originally received containers and #3 ensure drugs that have an expired date on the label are stored separately from other medications until destroyed.
The facility policy (6.0) for medication administration was reviewed on 8/31/2011. 5.1.2 of the policy states the facility staff should dispose of unused medication portions in accordance with the facility policy.
On 8/31/2011 at approximately 12:00 noon the Director of Nursing stated the facility does not have any other policy regarding disposal of unused medication portions, but the portions should be disposed of and not stored.
The Respondent was cited for an uncorrected Class III deficiency.
·The Respondent was previously cited for Class II deficiencies.
The Respondent was cited for one Class II deficiency (N216) on February 1, 2011 and for two Class II deficiencies (N072 and N216) on April 7, 2011.
A class II deficiency is subject to a civil penalty of $2,500 for an isolated deficiency, $5,000 for a patterned deficiency, and $7,500 for a widespread deficiency. The fine amount shall be doubled for each deficiency if the facility was previously cited for one or more class I or class II deficiencies during the last licensure inspection or any inspection or complaint investigation since the last licensure inspection. A fine shall be levied notwithstanding the correction of the deficiency. § 400.23(8)(b), Fla. Stat. (2011).
In this instance, the Agency is seeking a fine in the amount of four thousand dollars ($4,000), as a pattern Class Ill deficiency.
COUNT II
The Agency re-alleges and incorporates by reference Count I and Count II.
Based upon the above cited state deficiency, the Respondent was not m substantial compliance with criteria established under Chapter 400, Part II, Florida Statutes, or the rules adopted by the Agency, subjecting the Respondent to assignment of a conditional licensure status under Section 400.23(7)(b), Florida Statutes.
II
CLAIM FOR RELIEF
WHEREFORE, the State of Florida, Agency for Health Care Administration, respectfully seeks a final order that:
l. Makes factual and legal findings in favor of the Agency.
2. Imposes the relief set forth above.
Respectfully submitted on this 31st
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D. Carlton Enfinger, Es i e, Fl. Bar No. 793450 Office of the General oun el
Agency for Health C e A inistration 2727 Mahan Drive, Mai Stop #3
Tallahassee, Florida 32308-5407
Telephone: 850-412-3640
NOTICE
CERTIFICATE OF SERVICE
I HEREBY CERTIFY that a true and correct copy of the foregoing has been served by
U.S. Certified Mail, Return Receipt No. 7010 1670 0000 1044 3893 to Anthony J. Pileggi,
Administrator, Heritage Health Care Center, 3101 Ginger Drive, Tallahassee, Florida 32308, and via email to Anna Gay Small, Esquire, LaVie Care Centers, 10210 Highland Manor Drive, Suite 250, Tampa, FL33610 on this 3 ]st day ofJanuary, 2012:
D. Carlton Enfinger, Florida Bar No. 793
Office of the General C un el
Agency for Health Car A inistration 2727 Mahan Drive, Mail top #3
Tallahassee, Florida 32308-5407
Telephone:· 850-412-3640
Copy:
Donah Heiberg, FOM
| Issue Date | Proceedings |
|---|---|
| Jun. 11, 2012 | Order Closing File and Relinquishing Jurisdiction. CASE CLOSED. |
| Jun. 06, 2012 | Motion to Relinquish Jurisdiction filed. |
| May 04, 2012 | Order Granting Continuance and Re-scheduling Hearing (hearing set for June 12, 2012; 9:30 a.m.; Tallahassee, FL). |
| Apr. 25, 2012 | Motion for Continuance filed. |
| Mar. 14, 2012 | Order of Pre-hearing Instructions. |
| Mar. 14, 2012 | Notice of Hearing (hearing set for May 9, 2012; 9:30 a.m.; Tallahassee, FL). |
| Mar. 06, 2012 | Initial Order. |
| Mar. 05, 2012 | Standard License filed. |
| Mar. 05, 2012 | Conditional License filed. |
| Mar. 05, 2012 | Administrative Complaint filed. |
| Mar. 05, 2012 | Notice (of Agency referral) filed. |
| Mar. 05, 2012 | Request for Administrative Hearing filed. |
