vs. ) CASE NO. 81-2979
Respondent. )
Pursuant to notice, a formal hearing was held on August 11, 1982. This hearing was conducted in keeping with the provision Subsection 120.57(1), Florida Statutes. The hearing commenced at 9:35 A.M. in Room 602, Park Trammell Building, 1313 Tampa Street, Tampa Florida. This Recommended Order is being entered following review of the transcript of proceedings which was filed with the Division of Administrative Hearings on September 10, 1982, and consideration of those attachments to the Administrative Complaint which were filed with the Division of Administrative Hearings on October 8, 1982. 1/
de la PARTE & GILBERT, P.A.
The issues to be considered in this Recommended Order relate to an Administrative Complaint which the Petitioner filed against Respondent. In particular, the Administrative Complaint calls for the revocation of Respondent's certificate to conduct laboratory analyses for various microbiological parameters, select chemical tests and turbidity studies. This disciplinary action is in keeping with the State Public Water Laboratory Certification Program, Section 403.863, Florida Statutes, and Chapter 10D-41, Florida Administrative Code, which relates to that same subject. These alleged violations are set forth in the Administrative Complaint and those allegations are further refined through the attachments to the Administrative Complaint.
They deal with certain alleged failures on the part of the Respondent in performing tests, analyses, recording functions, provision of materials, tabulations, and retention of records. He is also accused of making false statements through documents dealing with certification. All of these acts are in violation of provisions of Chapter 10D-41, Florida Administrative Code, according to the complaint. (The details of the Administrative Complaint are discussed in the Conclusions of Law section of this Recommended Order.)
The list of witnesses, in order of their appearance, may be found in the index to transcript. The list of exhibits, page of their identification and receipt may be found in the index to transcript, with the exception of those exhibits upon which ruling on their admissibility was reserved. Those exhibits which were not admitted in the course of the hearing are discussed in the Conclusions of Law section of this Recommended Order.
In keeping with language in Section 403.863, Florida Statutes, and Chapter 10D-41, Florida Administrative Code, Petitioner licensed Kamran Kahjeh- Noori, who does business as as Kahjeh-Noori Laboratory. The licensing was through a process of certification to allow Kahjeh-Noori to conduct water testing. In particular, the laboratory was certified in microbiology (membrane filters); microbiology (most probable number); chemistry, and those materials, arsenic, barium, cadmium, chromium, lead, mercury, selenium and silver; chemistry (nitrates); chemistry (fluorides) and turbidity.
Water testing laboratories test drinking water from community and non- community water distribution systems.
At times relevant to this case, Respondent's laboratory performed microbiological and chemical tests of drinking water.
On October 13, 1981, Petitioner filed an Administrative Complaint against the Respondent charging various violations related to Respondent's certification. The Respondent requested a Subsection 120.57(1), Florida Statutes, hearing and that hearing was conducted on August 11, 1982.
In connection with the aforementioned certification in the various categories which Respondent had applied for and been granted, Petitioner, through its employees, conducted surveys of the Kahjeh-Noori Laboratory on December 12, 1979; December 8, 1980, February 10 and 11, 1981, and June 9, 1981, to insure compliance with rules related to Respondent's certification.
The inspection on December 12, 1979, revealed that the inhibitory residue test as specified in Rule 10D-41.55(6)(b)8., Florida Administrative Code, had not been performed to demonstrate that the washing/rinsing processes provide glass free of toxic materials. This relates to microbiology.
Respondent was made aware of this deficiency in writing and in responding to the statement of deficiencies, indicated that correction had been made or as Respondent stated that the correction had been "performed."
A survey conducted by the Petitioner on December 8, 1980, revealed the same problem with the inhibitory residue test as had been described in the matters related to the December 12, 1979, visit, in that that test had not been performed in accordance with Rule 10D-41.55(6)(b)8., Florida Administrative
Code. Respondent was again advised in writing of the deficiencies and in response to the deficiencies indicated that a correction had been "performed" on January 8, 1981. This response, as was the case in the December 12, 1979, incident, was a written response.
A further survey was conducted on February 10 and 11, 1981, in which the laboratory was inspected and the problem with the inhibitory residue test, in that it was not performed, was discovered in the course of this inspection, again related to Rule 10D-41.55(6)(b)8., Florida Administrative Code. This statement of deficiencies or violation was made known in writing and in his written response, Respondent indicated "media have been ordered from FIFFCO and will be completed by week of 4/20/81."
Finally, in an inspection on June 9, 1981, the problem with the inhibitory residue test, that is to say the fact that that test was not being performed to demonstrate that the washing/rinsing processes were providing glassware free of toxic material as specified in Rule 10D-41.55(6)(b)8., Florida Administrative Code, was still observed in the inspection.
The inhibitory residue test, which is designed to determine whether the washing of glassware is leaving residue on that container which might inhibit or enhance bacterial growth, was conducted subsequent to the last survey. In particular, it was conducted on June 17, 1981, and February 25, 1982, by an employee of the Respondent. The results of those tests may be found as Respondent's Exhibit Nos. 1 and 2.
In the inspection of December 12, 1979, it was discovered by Petitioner that laboratory pure water had not been analyzed annually by the test for bacteriological properties set forth in Rule 10D-41.55(6)(a)4., Florida Administrative Code (microbiology). Respondent was made aware of this shortcoming by written notification and in replying to this deficiency, indicated that the matter had been "performed."
Further inspection of the matter of laboratory pure water in the test for bacteriological properties set forth in Rule 10D-41.55(6)(a)4., Florida Administrative Code, was made during December 8, 1980, and a written notification was given to Respondent, indicating that this test had not been performed and requiring an explanation of that deficiency. In responding to the deficiency, Respondent indicated that it "had been analyzed only 2 parameters missing" and the date stated for the completion of that correction was January, 1981.
The inspection of February 10 and 11, 1981, discovered the same difficulty on the topic of laboratory pure water, in that the water was found not to have been analyzed on an annual basis by the test for bacteriological properties as required by Rule 10D-41.55(6)(a)4., Florida Administrative Code. This violation or problem was made known to the Respondent by written communication and replying to the deficiencies, in writing, Respondent indicated that "water will be analyzed by end of April."
The June 9, 1981, survey by the Petitioner of the Respondent's laboratory, established the same problem with testing related to laboratory pure water under the terms of Rule 10D-41.55(6)(a)4., Florida Administrative Code. Again written notification was made of this shortcoming.
Subsequent to the inspection of June 9, 1981, and specifically on June 17, 1981, an employee of Respondent made the test required by Rule 10D- 41.55(6)(a)4., Florida Administrative Code, and the results of that test may be found in Respondent's Exhibit No. 2. The water tested was that water which had been used in the Respondent's laboratory as far back as May, 1981, the date of the initial employment of the employee conducting this test. The conclusion reached was that the water did not contain toxic substances.
The survey of December 12, 1979, revealed that laboratory pure water had not been analyzed monthly for conductance, pH, chlorine residual and standard plate count as specified by Rule 10D-41.55(6)(a)5., Florida Administrative Code (microbiology). Surveys by the Petitioner of Respondent's laboratory conducted on December 8, 1980; February 10 and 11, 1981, and June 9, 1981, concerning Rule 10D-41.55(6)(a)5., Florida Administrative Code, revealed the same shortcomings on the matter of monthly analysis for conductance, pH, chlorine residual and standard plate count. The responses made to the written notification of the problems, which notification occurred following each survey, were the same as were related in the responses for violations of Rule 10D- 41.55(6)(a)4., Florida Administrative Code, discussed above.
The inspection of Respondent's laboratory, by Petitioner's employee, which occurred on December 8, 1980, revealed that sample bottles were not being tested with lauryl tryptose broth as required by Rule 10D-41.55(6)(b)9., Florida Administrative Code (microbiology). This problem was announced to Respondent in writing. By written response, the Respondent indicated that this matter was "performed" on January 8, 1981.
Further inspection of February 10 and 11, 1981, as conducted by Petitioner on Respondent's laboratory, revealed a lack of compliance with the rule related to testing of sample bottles with lauryl tryptose broth as specified in Rule 10D-41.55(6)(b)9., Florida Administrative Code. This deficiency was made known in writing from Petitioner to Respondent and in answering this shortcoming, Respondent indicated in writing that the matter was "completed," effective February 17, 1981.
In the period beginning late December, 1980, through late May, 1981, some tests related to sample bottles by the lauryl tryptose broth technique were carried out by one of Respondent's employees; however, no record was kept. In the absence of that record, it was reported in the evaluation report of the June 9, 1981, survey, which report was made by Petitioner's employee, that the matter related to testing sample bottles with lauryl tryptose broth, as specified in Rule 10D-41.55(6)(b)9., Florida Administrative Code, was still a problem.
Beginning June 13, 1981, written records were kept of bottles tested with lauryl tryptose broth, as may be seen through Respondent's Exhibit No. 4a, which is a record of those tests. That record reveals no growth of bacteria.
The February 10 and 11, 1981, survey conducted by Petitioner's employee, revealed that Respondent's laboratory was not recording the time of water sample arrivals as specified by Rule 10D-41.55(5)(a)7., Florida Administrative Code (microbiology). This violation was made known to the Respondent in writing and in his written reply, Respondent indicated that the matter was being "performed" effective February 12, 1981.
The inspection of June 9, 1981, conducted by Petitioner's employee found that Respondent and his laboratory personnel were still failing to record the time of sample arrival, as required by Rule 10D-41.55(5)(a)7., Florida Administrative Code.
Petitioner had contended that Respondent, in his equipment, i.e., sample bottles with screw caps, had liners to those caps that could not withstand repeated sterilizations as required by Rule 10D-41.55(5)(a)6., Florida Administrative Code (microbiology). This notice of violation was made in the course of the June 9, 1981, survey conducted by Petitioner at Respondent's laboratory. The facts when considered do not reveal such a violation or problem. Moreover, the Respondent's laboratory used "whirlpacks" for purposes of collecting drinking water samples and that had been its process beginning June, 1980.
During the June 9, 1981, survey, Petitioner discovered that the Respondent, in his laboratory operation, was not carrying out water sample incubations at 350 degrees Celsius +/- 0.5 degrees Celsius. This discovery in the June 9, 1951, survey is borne out by the record of temperature controls made by the Respondent in a period of April, May and June, 1981, prior to the inspection, and also following the inspection in June through December, 1981, Respondent's Exhibit Nos. 5a-c. This allegedly violates Standard Methods, 14th Edition, pages 916, 917, 918 and 931, and thereby contravenes Rule 10D- 41.55(4)(a), Florida Administrative Code (microbiology). Respondent admits that he had this text during pertinent times; however, this volume was not provided to the Hearing Officer.
The inspection of December 8, 1980, conducted by Petitioner's employee, revealed that the Respondent, in his laboratory operation, was not using quality control charts or a tabulation of mean and standard deviation to document data validity of silver and nitrate analyses as required by Rule 10D- 41.56(5)(1), Florida Administrative Code (chemistry). This problem was made known to the Respondent in writing and in answering the deficiencies Respondent indicated that the matter had been "performed" effective January 8, 1981.
During the course of the February 10 and 11, 1981, inspection, the same problem was observed with the quality control charts on the topic of tabulation of mean and standard deviation set forth in Rule 10D-41.56(5)(1), Florida Administrative Code. In response to this written notification of violation, Respondent replied in writing "corrected and copy was mailed 2/20/81" and indicated a completion date of 2/18/81.
Although certain charts had been received by the Petitioner prior to the June 9, 1981, survey (Petitioner's Exhibit No. 9c), that survey still revealed that quality control charts on silver and nitrate analyses as required by Rule 10D-41.56(5)(1), Florida Administrative Code, were missing.
Respondent ultimately submitted charts on silver and nitrate, Respondent's Exhibit Nos. 10 through 13. Those exhibits from the Respondent are flawed in that the measurements of precision and accuracy related to the chemical substances are identical and that degree of exactitude makes the results unreliable. (Accuracy describes whether an average of a group of identical samples represents a true value of those samples and precision describes whether the individual test results of several identical samples are similar.)
In the June 9, 1981, survey, it was discovered that the raw data and calculations related to quality control charts for the substances arsenic, barium, cadmium, chromium, lead, mercury, selenium and fluoride analyses had not been retained by Respondent's laboratory as specified by Rule 10D-41.59(1)(f)2., Florida Administrative Code.
Respondent has made statements in answering stated deficiencies found in paragraphs 5a through 5h of the Administrative Complaint which did not prove to be accurate. These circumstances are reported in the findings of fact related above.
Tests of sample bottles performed using lauryl tryptose broth during the period late December, 1980, through May, 1981, were not always recorded as specified by Rule 10D-41.59, Florida Administrative Code, in that on some occasions no record was made of the test.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the subject matter and the parties to this action. See Section 120.57, Florida Statutes; Section 403.863, Florida Statutes, and Rule 10D-41, Florida Administrative Code.
In the course of the hearing, ruling was reserved on the question of the recognition of Petitioner's witness James Wright as an expert in the purported fields of laboratory analysis and quality control. Having considered that question with due regard for the matters alleged in the Administrative Complaint and being of the opinion that this form of expertise as a prerequisite to giving ultimate fact testimony is not necessary for the trier of fact to resolve the matters in dispute, the qualification as expert in the aforementioned fields is denied.
Petitioner had offered Exhibit No. 5b at hearing. It is denied admission.
During the course of the hearing, argument was made on the subject of the significance of the attachments 1 through 9 to the Administrative Complaint. Having reviewed those attachments, together with the allegations found in the body of the Administrative Complaint, those aspects of the attachments which relate with particularity to the allegations found in the body of the Administrative Complaint are accepted as a part of the Administrative Complaint and the Respondent is deemed to have been noticed of those allegations constituted of the Administrative Complaint and the refinements found in the attachments. The remaining portions of the attachments to the Administrative Complaint are not deemed to be part of the Administrative Complaint process and may be only considered as aggravation in determining an appropriate penalty.
Those portions of the Petitioner's series of Exhibits 5 through 9, which comport with the Administrative Complaint's allegations and the refinements to those allegations as found in the attachments 1 through 9 to the Administrative Complaint, are admitted as proof of the allegations. Those portions of the Petitioner's Exhibit Nos. 5 through 9 not related to the Administrative Complaint as further refined by attachments 1 through 9 are limited to the role of proof of aggravation in assessing a penalty.
No other item of information, either by testimony or document, other than those allegations found in the Administrative Complaint and the select portions of the attachments to the Administrative Complaint is found to be part of the complaint process which the Respondent is noticed to defend against.
During the course of the hearing, certain testimony from Dr. Jack W. Frankel was proffered on the subject of his observations related to reagents found in the laboratory. Ruling was reserved on the question of the admissibility of that testimony. Having considered that testimony, it is now admitted as part of the record, particularly as proof of the accusation.
During the course of the hearing in this cause, ruling was reserved on the admissibility of Respondent's Exhibit No. 2, for purposes of defense to the accusations. Having considered that document in the context of the accusations, the Respondent's Exhibit No. 2 is admitted for purposes of defense against the accusations.
Subsequent to the date of the hearing, and in particular, by service dated September 20, 1982, Respondent moved to dismiss the Administrative Complaint, based upon the reputed failure of the Petitioner to comply with the terms and conditions of Subsections 403.863(1) and (4), Florida Statutes. On September 23, 1982, Petitioner filed its response in opposition to the motion. Having considered the motion to dismiss, the same is hereby denied.
On September 23, 1982, counsel for the Petitioner moved to establish liability for court reporter fees. This motion was responded to by the Respondent on October 1, 1982.
The Hearing Officer is without jurisdiction to consider this motion and no ruling is made. The motion and the response thereto are being transmitted with this Recommended Order for consideration by the agency head.
Petitioner's counsel has requested that official recognition or notice be made of Chapter 10D-41, Florida Administrative Code, and that request is granted and recognition is made of that chapter.
Following the presentation of the Petitioner's case in chief, Respondent's counsel moved to dismiss those accusations found in paragraphs 5d, 5g and 5h of the Administrative Complaint based upon sufficiency of proof. Having considered that motion, in keeping with the proof presented by Petitioner, the motion is denied.
Facts found in this case establish that the inhibitory residue test had not been performed to demonstrate that the washing/rinsing process provides glassware free of toxic material, as specified in Rule 10D-41.55(6)(b)8., Florida Administrative Code, in violation of that provision and Rule 10D-41.60, Florida Administrative Code, and thereby subjects Respondent to the penalties found in Rule 10D-41.60, Florida Administrative Code.
Facts found in this case establish that laboratory pure water had not been analyzed annually by the tests for bacteriological properties as specified in Rule 10D-41.55(6)(a)4., Florida Administrative Code, in violation of that provision and Rule 10D-41.60, Florida Administrative Code, and thereby subjects Respondent to the penalties found in Rule 10D-41.60, Florida Administrative Code.
Facts found in this case establish that laboratory pure water had not been analyzed monthly for conductance, pH, chlorine residual and standard plate count as specified in Rule 10D-41.55(6)(a)5., Florida Administrative Code, in violation of that provision and Rule 10D-41.60, Florida Administrative Code, and thereby subjects the Respondent to the penalties found in Rule 10D-41.60, Florida Administrative Code.
Facts found in this case establish that sample bottles were not tested with lauryl tryptose broth as specified in Rule 10D-41.55(6)(b)9., Florida Administrative Code, in violation of that provision and Rule 10D-41.60, Florida Administrative Code, and thereby subjects Respondent to the penalties found in Rule 10D-41.60, Florida Administrative Code.
Facts found in this case establish that the time of sample arrival was not recorded as specified in Rule 10D-4l.55(5)(a)7., Florida Administrative Code, in violation of that provision and Rule 10D-4l.60, Florida Administrative Code, and thereby subjects Respondent to the penalties found in Rule 10D-41.60, Florida Administrative Code.
There was insufficient showing on the part of Petitioner that sample bottles with screw caps did not have liners that could withstand repeated sterilizations as specified in Rule 10D-4l.55(5)(a)6., Florida Administrative Code, consequently no violations of that provision is found and no violation or penalty may be imposed according to Rule 10D-41.60, Florida Administrative Code.
Although facts established that incubations were not carried out at 35 degrees Celsius +/- 0.5 degrees Celsius, the Standard Methods, 14th Edition, was not provided to the Hearing Officer so no decision may be made about whether those changes in incubation temperatures are violative of the Standard Methods, 14th Edition, and as a result in violation of Rule 10D-41.55(4)(a), Florida Administrative Code. Therefore, no violation of Rule 10D-41.55(4)(a), Florida Administrative Code, has been shown and it has not been demonstrated that Respondent is in violation of Rule 10D-41.60, Florida Administrative Code, or subject to the penalties of that provision.
Facts found in this case establish that quality control charts or a tabulation of mean and standard deviation were not used to document data validity of silver and nitrate analyses as specified in Rule 10D-41.56(5)(1), Florida Administrative Code, in violation of that provision and Rule 10D-41.60, Florida Administrative Code, and thereby subjects Respondent to the penalties found in Rule 10D-41.60, Florida administrative Code.
Facts found in this case establish that raw data (record of analyses) used to create quality control charts for arsenic, barium, cadmium, chromium, lead, mercury, selenium and fluoride analyses had not been retained in the laboratory's records as specified in Rule 10D-41.59(1)(f)2., Florida Administrative Code, in violation of that provision and Rule 10D-41.60, Florida Administrative Code, and thereby subjects Respondent to the penalties found in Rule 10D-41.60, Florida Administrative Code.
There is an allegation to the effect that Respondent made false statements on documents associated with certification. Although Respondent had stated that he would make certain corrections within a specified period related to deficiencies, which did not occur, those failures on the part of Respondent do not rise to the level of "false statements" and the Respondent is not found to have violated Rule 10D-41.60(1), Florida Administrative Code, and should not be subjected to the penalties for violating that provision.
Facts found in this case establish test results of tests conducted on sample bottles using lauryl tryptose broth as specified in Rule 10D- 4l.55(6)(b)9., Florida Administrative Code, were not recorded on certain occasions as specified by Rule 10D-41.59, Florida Administrative Code, and are in violation of Rule 10D-41.59, Florida Administrative Code, and Rule 10D-41.60, Florida Administrative Code, and thereby subjects Respondent to the penalties found in Rule 10D-4l.60, Florida Administrative Code.
Those violations of rule provisions as set forth in these Conclusions of Law are violations that were found based upon the facts related in this Recommended Order, which facts were determined after receipt of evidence whose quality was competent and substantial enough to cause those factual findings and conclusions of law that followed.
Having considered the matters in the Administrative Complaint and its attachments, the transcript, the argument of counsel and proposals of counsel and those statements in mitigation and evidential items indicating violations outside he Administrative Complaint which were acknowledged by the Respondent in his replies to the stated deficiencies, it is
That a final order be entered which finds the Respondent to have violated rules as alleged in paragraphs 5a, 5b, 5c, 5d, 5e, 5h, 5i and 7 of the Administrative Complaint; dismisses Counts 5f, 5g and 6 of the Administrative Complaint, and by that final order limit the activities of Respondent's laboratory to activities other than testing water samples pursuant to Section 403.863, Florida Statutes, in the fields of microbiology and chemistry.
DONE and ENTERED this 15th day of October, 1982, in Tallahassee, Florida.
CHARLES C. ADAMS, Hearing Officer Division of Administrative Hearings The Oakland Building
Filed with the Clerk of the Division of Administrative Hearings this 15th day of October, 1982.
1/ Petitioner, in the person of counsel, has offered a memorandum in support of its position and Respondent's counsel has offered its proposed findings of fact, conclusions of law and a recommended order. Those materials have been considered prior to the entry of this Recommended Order and to the extent that they are consistent with the Recommended Order, they have been utilized. To the extent that those materials are not consistent with this Recommended Order, they are rejected.
Steven Huss, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard
de la PARTE & GILBERT, P.A.
David Pingree, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard
