SC Administrative Law Court Decisions

STATEMENT OF THE CASE

This matter is before me pursuant to Petitioner's request for a contested case hearing challenging Respondent's decision to decertify Columbia Analytical Laboratories ("CAL" or "Petitioner"), Laboratory ID # 40001, for four parameters pursuant to Respondent's Laboratory Certification Program. The four parameters of concern were: Total Coliform Bacteria- SM 9223B, Fecal Coliform Bacteria- SM 9222D, Heterotrophic Bacteria- SM 9215B, and Volatile Organics By GC/MS: Capillary Column- EPA 8260B/ EPA 5035. After notice to the parties, a contested case hearing was held on July 26, 2002. At the hearing, counsel for the Petitioner notified the Court that his client no longer wished to contest the decertification for the Volatile Organics parameter; therefore this issue was removed from consideration.

Based upon the evidence presented, I make the following findings of fact, taking into consideration the burden on the parties to establish their respective cases by a preponderance of the evidence and taking into account the credibility of the witnesses:

1. This Division has personal and subject matter jurisdiction of this case.

2. Notice of the date, time, place and nature of the hearing was timely given to all parties.

3. Petitioner, Columbia Analytical Laboratories, Inc. is certified by the Department to analyze numerous drinking water contaminants monitored under the State Safe Drinking Water Act and the Clean Water Act, including Total Coliform Bacteria- SM 9223B, Fecal Coliform Bacteria- SM 9222D, and Heterotrophic Bacteria- SM 9215B. Heterotrophic Bacteria is also commonly referred to as "Heterotrophic Plate Count" or HPC.

4. On April 18, 2002, Department staff performed an on-site evaluation of CAL for all parameters for which the laboratory was certified.

5. As a result of the evaluation, Department staff noted several deficiencies that needed to be addressed by the laboratory. Department staff discussed their findings with the staff of the laboratory at the conclusion of the evaluation in an "exit interview."

6. On April 19, 2002, R. Wayne Davis, the program manager for the Department's Office of Environmental Laboratory Certification, sent CAL a letter decertifying the laboratory for Total Coliform Bacteria- SM 9223B, Fecal Coliform Bacteria- SM 9222D, and Heterotrophic Bacteria- SM 9215B. These parameters are collectively referred to as "biological parameters."

7. In a report dated June 4,2002, Department staff sent the laboratory a detailed final report of the April 18, 2002, evaluation. Because of the large number of facilities the Department must regulate and because of the large number of parameters held by commercial laboratories such as CAL, such a delay in preparing a final report is not unusual. The portions of the June 4, 2002, report relating to the biological parameters (pages 25-30) were received into evidence.

8. Petitioner timely requested a contested case hearing regarding the rescinding of its certification.

9. Leigh Plummer, an Environmental Health Manager II with the Department's Office of Environmental Laboratory Certification, conducted the portion of the evaluation for the biological parameters. Ms. Plummer has a B.S. in Biology from Appalachian State University. She has worked in environmental laboratory settings for over ten years. She has performed analyses for all three biological parameters. She has worked for the Department since 2001, in a position where she performs her current duties. Ms. Plummer performs approximately forty-eight on-site evaluations in a year. She was qualified as an expert witness in the areas of water microbiology and laboratory certification. The Petitioner stipulated to the applicability of the requirements of the EPA regulations.

10. The primary reason the Department initiated the decertification action for the three biological parameters was the issue of temperature control.

11. The three biological parameters all have a similar method of analysis: samples of drinking water are incubated in a sterile prepared media at a specific temperature and analyzed for the growth of bacteria. The appropriate testing methods are set out by federal regulation. These regulations require that the testing method adhere to standards set out in published compilation of Standard Methods for the Examination of Water and Wastewater.

• Under the State Safe Drinking Water Act, public drinking water systems are required to demonstrate that the water they supply is not contaminated by sampling their water and analyzing these samples for, inter alia, the three biological parameters involved in this action. For a test result to be scientifically and legally defensible, the analysis must be performed by a laboratory that is certified by the Department to conduct such tests.
• All three parameters require that the laboratory incubate test samples at a precise temperature of 35 degrees celsius, with an allowed variation of plus or minus .5 degrees. If a sample is incubated at too high or too low a temperature, bacterial growth may be inhibited, or the growth of other organisms might be induced, resulting in incorrect results. In any event, a sample that is incubated at a temperature lower than 34.5 degrees or higher than 35.5 degrees celsius is legally invalid.
• If a test result includes a "false positive," defined as a result incorrectly indicating the presence of certain bacterial pathogens, a public water service could be forced to unnecessarily take such actions as issuing boil water notices, and taking unneeded and expensive corrective action. If a test result includes a "false negative," defined as a result that incorrectly indicates that bacterial contamination is absent, the health of the public is put at risk.
• When Ms. Plummer inspected the laboratory, the incubator used for the biological parameters was set to 36 degrees celsius and the laboratory's standard operating procedure (SOP) called for a temperature setting of 36 degrees celsius, with an allowed variation of plus or minus 1.5 degrees. Because of this, Ms. Plummer cited the laboratory for this deficiency. The existence of this problem played a key role in her recommendation that the decertification action be instituted.
• During the evaluation and exit interview, Ms. Plummer discussed the temperature issues with Sandra Riley, a laboratory technician for Columbia Analytical, and Mark Gilbert, owner and operator of the laboratory. Ms. Plummer asked why the temperature setting for the incubator was set at 36 degrees instead of 35, and why the laboratory's SOP called for an incorrect temperature as well as an incorrect allowable temperature variation. Mr. Gilbert informed Ms. Plummer, and later Mr. Davis, that these settings must have reflected the value called for in the instructions provided by IDEXX, the manufacturer of the Colilert test kits used to perform Total Coliform analysis under EPA SM 9223B.
• Colilert was introduced in 1990. When it first came out, Colilert was not approved by EPA for the analysis of Total Coliform under EPA SM 9223B. IDEXX first marketed Colilert in 1990 and at that time recommended that the test be incubated at a temperature of 36 degrees celsius, with an allowed variation of plus or minus 1.5 degrees. EPA later approved Colilert for the analysis of Total Coliform under EPA SM 9223B after DEXX changed its instructions to call for a temperature of 35 degrees celsius, with an allowed variation of plus or minus .5 degrees. Based upon this information, Ms. Plummer concluded that the laboratory was relying on obsolete documentation if its SOP and temperature settings relied on old IDEXX documentation.
• When Petitioner filed its appeal of the Department's decision, it stated that its defense with regard to the temperature issue was that it was using the temperature recommended by the manufacturer of Colilert.
• It was the laboratory's practice to measure the actual ambient temperature of the incubator using a thermometer that was inserted into a hole in the top of the incubator so that the bulb of the thermometer was submerged in a beaker of water inside the incubator. According to applicable regulations, such a thermometer must have gradations displaying temperature variations in .5 degrees celsius or less.
• Each thermometer used at the laboratory must be certified annually by comparing its reading to a thermometer that is certified by the National Institute of Standards and Technology (NIST). The error of a thermometer (if any is present) is thereby taken into account in determining the actual temperature being taken.
• At trial, Sandra Riley and Mark Gilbert offered a different explanation for the temperature issue than that offered in the laboratory's request for a contested case hearing. According to Mr. Gilbert, the temperature setting for the incubator was set on 36 degrees celsius because the incubator's thermometer had a recorded correction factor of +.9 degrees. This means that when this thermometer recorded a temperature of 36 degrees, the true temperature inside the incubator was actually 35.1, which is within the parameters specified for the biological parameters. Mr. Gilbert testified that he discovered this fact during a file review the day before the hearing.
• According to the testimony of Mr. Gilbert and Ms. Riley, when the laboratory revised its SOP in 2000, the SOP must have called for a setting of 36 degrees on the incubator to take this correction factor into account, rounding up the .9 degree correction factor to 1 degree. Ms. Riley also testified that when she recorded the temperature readings for the incubator, she recorded the temperature the thermometer was showing instead of the corrected temperature, which would have been calculated by subtracting .9 degrees from the indicated temperature. However, according to Ms. Plummer, the appropriate practice is to record the corrected temperature instead.
• Ms. Riley certified the thermometer the laboratory was using in 2000 against the NIST thermometer, and the Petitioner placed a copy of the laboratory's 2000 NIST certification of the thermometer into evidence. The certification indicated that the thermometer used in the incubator in 2000 did in fact read .9 degrees too high.
• However, on cross-examination, Ms. Riley admitted that the laboratory had replaced the thermometer it was using in the incubator in 2001. Therefore, the 2000 certification placed into evidence by the Petitioners was not for the same thermometer that was used by the laboratory in 2002. The old thermometer was replaced because it only displayed gradations displaying temperature variations in 1 degree celsius, which did not give a sufficiently accurate reading. Ms. Riley testified that the old thermometer was replaced by a new thermometer with .1 degree gradations, but that the new thermometer must also have the same + .9 degree correction as the old thermometer; therefore, the SOP was correct. Ms. Riley assumed that the 2001 NIST certification for the incubator thermometer must be back in the lab. Ms. Riley did not know whether she or Mr. Gilbert had certified the incubator thermometer in 2001.
• On cross-examination, counsel for the Department asked Mr. Gilbert why the laboratory's SOP still called for an allowed temperature variation of plus or minus 1.5 degrees, instead of the .5 degree temperature variation called for under EPA SM 9223B. Mr. Gilbert testified that the laboratory staff must have mistakenly also included the .9 degree correction factor (rounded up to 1 degree) in calculating the allowed temperature variation. However, the Court must note that there is no rational explanation for adding a .9 degree correction factor into an allowable temperature variation. While it might make sense to have a SOP calling for a 36 degree incubator temperature setting when the laboratory staff knows the thermometer gives a reading that is approximately 1 degree too high, it is inappropriate to also add that correction factor into the allowable plus or minus temperature variation. The alternative explanation offered by the Department was that the laboratory simply failed to update its SOP following the 2000 evaluation, although Mr. Gilbert denied this allegation.
• Another problem related to incubator temperature control was noted by the Department. There are two basic types of thermometers: a thermometer where the level of mercury rises and falls with temperature, and a maximum temperature thermometer, which rises with an increase in temperature, and continues to record that maximum temperature until the user shakes the mercury back down. Laboratories measure incubator temperatures using this first type of thermometer. During her inspection, Ms. Plummer discovered that the thermometer the laboratory was using in the incubator was too short for the operator to read, and had to be lifted out of the beaker of water in the incubator to get a reading. When Ms. Plummer attempted to get a reading on the thermometer, the bulb of the thermometer lifted out of the water and the temperature fell rapidly. Ms. Plummer could not obtain an accurate temperature reading and she did not believe the staff of the laboratory could accurately read this thermometer either. Ms. Plummer asked Ms. Riley how she obtained accurate temperature readings under these circumstances. Ms. Plummer testified that Ms. Riley replied, "I read it real fast." However, Ms. Riley testified that she stated that reading the temperature on the thermometer was not a problem as her practice was only to lift the thermometer up enough to obtain a reading, and that she did not have to lift the bulb of the thermometer out of the water to obtain a reading.
• These two temperature control problems applied equally to Total Coliform Bacteria- SM 9223B, Fecal Coliform Bacteria- SM 9222D, and Heterotrophic Bacteria- SM 9215B.
• The Department noted an entirely separate temperature control issue applicable only to the Fecal Coliform Bacteria- SM 9222D parameter. Part of the SM 9222D parameter involves performing a "verification" test. Instead of using prepackaged media, the laboratory was preparing the culture medium at the laboratory, which it then must sterilize using an autoclave.
• The verification media must be autoclaved at a temperature of 121 degrees celsius for 12 to 15 minutes. If the media is autoclaved at a temperature that is too low, or for too short a time, the media may not be sterile. If the media is autoclaved at a temperature that is too high, or for too long a time, the proteins, carbohydrates, and other compounds in the media may become broken down, or denatured. In any event, if culture media is improperly sterilized, the results of the verification test will be rendered scientifically invalid and legally indefensible.
• The autoclave used by the laboratory was controlled by a timer. In addition, the autoclave had a temperature gauge on it. This temperature gauge is designed to ensure not only that the autoclave reaches the appropriate temperature, but also that the autoclave stays at the correct temperature throughout the sterilizing procedure. The timer is designed to shut the autoclave off when the sterilization procedure is finished. The temperature gauge on the autoclave was broken. Consequently, the laboratory was using a maximum temperature thermometer located inside of the autoclave. The problem with the laboratory's use of this thermometer to monitor autoclave temperature was that while the operator would be able to tell that the autoclave had reached the appropriate temperature, there would be no way to ensure that the autoclave remained at that temperature throughout the entire sterilization procedure. Because the maximum temperature thermometer will not record a falling temperature, (as the user must shake down the mercury to reset it) there is no way for the operator to know whether the autoclave temperature had fallen during the sterilization procedure.
• Mr. Gilbert testified that he did not share the Department's concern about the issue of the autoclave thermometer as the laboratory had other quality control processes in place. According to Mr. Gilbert, other quality control measures would show the presence of any problems with improperly sterilized media, and that no such problem had presented itself.
• Ms. Plummer testified concerning another alleged problem with the autoclave. In her discussions with Ms. Riley concerning the autoclave, Ms. Riley had informed Ms. Plummer that the timer on the autoclave would sometimes "stick" and fail to turn off at the appropriate time. Ms. Plummer noted this on paragraph 3, page 26 of her report. Ms. Plummer did not herself confirm whether the timer failed to function or not. Ms. Plummer did, however, ask Ms. Riley about the procedure the laboratory used to time the autoclave. In response, Ms. Riley told her that the laboratory used a kitchen timer instead.
• Ms. Riley's testimony on this issue directly contradicts Ms. Plummer's testimony. Ms. Riley testified that she never made such a statement to Ms. Plummer regarding the timer. She further testified that the timer on the autoclave worked properly, and that she used the kitchen timer as she moved throughout the laboratory to keep track of when the incubator was about to finish its cycle.
• Ms. Plummer noted another problem relating to the Fecal Coliform Bacteria- SM 9222D parameter. Fecal Coliform parameter requires the laboratory to perform a pre-and-post analysis "blank" to prove that the presence of Fecal Coliform, if found, is present in the water sample, and not a result of contamination in the testing apparatus. Before and immediately after each analysis, the lab prepares and analyzes a "control" sample containing only sterile buffered water. If a water sample tests positive for Fecal Coliform, and if the pre-and-post analysis blanks both test negative for Fecal Coliform, then the laboratory and its client can then positively conclude that the Fecal Coliform contamination came from the drinking water sample, and not from contamination in the testing apparatus. On at least six occasions, the laboratory had not been analyzing post-analysis "blanks" as required by SM 9222D. The Petitioner presented no testimony or other evidence to refute this allegation. Since the hearing, however, Petitioner has objected to testimony regarding "blanks" on the basis that it had no notice that the blanks were a factor in the decertification. However, Petitioner failed to voice its concerns during the hearing. Petitioner cannot sit silently during a hearing, raising no objections, and then raise issues such as these for the first time here.
• Ms. Plummer noted a final problem relating to the Fecal Coliform Bacteria- SM 9222D parameter. She noted that the laboratory was not performing verifications of typical and atypical colonies. She noted that the laboratory was only performing verifications of typical colonies. The Petitioners presented no testimony or other evidence to refute this allegation. In addition, Petitioner failed to raise any challenge to the testimony during the hearing.
• Mr. R. Wayne Davis testified generally concerning the Department's discharge of its duties under the certification regulations and the provisions of those regulations. The regulations contain no provision for any sort of sanction for a laboratory that is in violation- no provision for a suspension of a license for a definite period of time, and no provision for civil penalties. The sole legal recourse for the Department, if it finds a laboratory to be in violation, is to decertify the laboratory for the noncompliant parameter(s). If a laboratory loses parameter certification, its certification is to be immediately restored as soon as it satisfactorily completes the recertification process.
• The decertification/recertification procedure is not intended to be viewed as a sanction; that its use is intended as a mechanism to ensure compliance with the regulations. Once a noncompliant laboratory is decertified, it is entitled to immediately apply for a new certification. As soon as the laboratory has again demonstrated that it is in compliance, it is granted a new certification, and it is allowed to resume operation. Mr. Davis' Office used this procedure to force noncompliant laboratories to correct their deficiencies when, in the opinion of the Department, the health of the public could be compromised while the laboratory is taking the steps necessary to restore the scientific validity and defensibility of their data.
• I find that Petitioner failed to provide adequate temperature control in accordance with the applicable standard methods.

Based on the foregoing Findings of Fact, I conclude the following as a matter of law:

• The Administrative Law Judge Division is authorized to hear this case pursuant to S.C. Code Ann. §§44-55-40(I) (2002); 1-23-600(B) (Supp. 2001), and 1-23-310 et seq. (Supp. 2001).
• With regard to the issue of decertification, the Department has the burden of proof. ALJD Rule 29 (B).
• S.C. Code Ann. §44-55-40(J) authorizes the Department to "...conduct studies, investigations, surveillance of laboratories, including certification programs, and maintenance of any public water supply, waterworks system and water treatment facility; . . . ." S.C. Code Ann. § 44-55-40(J) (2002).
• S.C. Code Ann. Regs. 61-81 (1989) sets forth the State Environmental Laboratory Certification Program. This regulation was adopted on April 11, 1980. Laboratory certifications for the analysis of drinking water are acquired through the application of this regulation by the Department. Specifically, the regulation sets forth criteria for the Department's certification of laboratories performing analyses of drinking water samples to assure compliance with the Federal Clean Water Act, 33 U.S.C.A. §§1251, et seq. and the State Safe Drinking Water Act.
• Section H (2) of R. 61-81 states:

(2) Parameter Certification

Once certified, a laboratory will have its certification for a parameter withdrawn by failure to:

(a) Obtain acceptable results on a performance audit sample and a repeat audit sample.

(b) Comply with any part of Section F of this Regulation.

(emphasis added)

S.C. Code Ann. Regs. 61-81 H(2) (1989).

• Section F of R. 61-81 refers to Certification Criteria including "requirements in acceptable procedures, methodology, techniques, facilities, quality control, records keeping, and equipment, including any changes in those requirements." S.C. Code Ann. Regs. 61-81 F (1989).
• Under R. 61-81 H (2), the Department may decertify a laboratory's certification for any parameter where the laboratory fails to comply with any applicable state or federal regulatory requirement regarding acceptable procedures, methodology, techniques, facilities, quality control, records keeping, and equipment. S.C. Code Ann. Regs. 61-81 H (2) (1989).
• Under the regulation, the Department's sole legal recourse when it discovers a noncompliant laboratory is to institute a decertification action. This fact, coupled with the Department's practice allowing immediate recertification as soon as a laboratory demonstrates it has returned to compliance, indicates that this action is not punitive in nature. I conclude that the Department did not undertake this action with the primary objective of taking punitive action against CAL, but instead with the goal of ensuring its compliance with regulatory requirements.
• The Administrative Law Judge must judge the credibility of witnesses and may afford more weight to the testimony of one witness over another based on credibility. The presence or absence of a witness's interest in the outcome of a case can affect the weight of that witness's testimony. "Given the vested interest of one witness versus the lack of such in another, the testimony of one can be given greater weight." See Looper v. South Carolina Department of Health And Environmental Control, 98-ALJ-07-0436-CC, January 6, 1999, 1999 WL 26946. See also Jackson v. Jackson, 234 S.C. 291, 108 S.E.2d 86 (1959) (In passing upon the credibility of a witness , the trier of fact may "take into consideration her interest in the result . . . and all of the circumstances . . . tending to impeach her as a witness or throw discredit on her statements.")

The nature of the case is such that the resolution of this matter turns largely on the credibility of the parties' witnesses. During the conduct of the hearing, the testimony of the witnesses for the Department and the testimony of the Petitioner's witnesses directly contradicted each other in several key respects. If this tribunal accepts the testimony of the Department's staff as true, then the preponderance of the evidence shows that the laboratory staff was unclear as to the appropriate temperature settings pertaining to all three biological parameters. Even if the laboratory staff did have a temperature setting that was appropriate, it was only by sheer luck. Moreover, the preponderance of the evidence indicates a state of affairs in which the laboratory's staff was using equipment that was in such a condition that it was difficult, if not impossible, to obtain accurate and scientifically verifiable results.

The testimony of the Petitioner's witnesses is diametrically opposed to that of the Department's. If this tribunal were to accept their version of events, then the preponderance of the evidence shows that the laboratory was using the appropriate temperature settings for the incubator and had an accurate SOP despite the fact that laboratory staff was only able to determine the rationale for its practices after an extensive document review on the eve of trial. The Petitioner's witnesses testified that the equipment complained of by the Department had always worked properly, can be relied on to give accurate results, and that other quality control measures are in place to ensure proper Fecal Coliform verification results. There are two contentions for which Petitioner has offered no rebuttal, however; the laboratory's failure to analyze post-test "blanks" as required by SM 9222D, and the laboratory's failure to perform verification analyses of atypical Fecal Coliform colonies. For that reason, I must conclude that the Department acted properly in decertifying the laboratory for the Fecal Coliform parameter.

The issue of the remaining two parameters turns on the credibility of the witnesses. To believe the testimony of CAL's witnesses regarding the incubator and SOP in question requires this tribunal to accept some unusual, not to mention fortuitous, coincidences. As such, I find that the Department's witnesses provided the more credible testimony regarding these issues. ⁽¹⁾ Accordingly, the Department's decision to decertify CAL for the remaining parameters is likewise affirmed.

ORDER

IT IS HEREBY ORDERED that the final decision of DHEC decertifying Columbia Analytical Laboratories for four parameters, to wit: Total Coliform Bacteria-SM 9223B; Fecal Coliform Bacteria-SM9222D; Heterotrophic Bacteria-SM 9215B; and Volatile Organics by GC/MS: Capillary Column-EPA 8260B/EPA 5035, is AFFIRMED;

AND IT IS SO ORDERED.

___________________________________

C. DUKES SCOTT

ADMINISTRATIVE LAW JUDGE

August 15, 2002

Columbia, South Carolina

1. However, it is not necessary to make a finding with respect to the alleged "stickiness" of the autoclave timer. The Department has offered ample evidence of other violations sufficient to support its decision to decertify CAL on these parameters.