B & W Stat Laboratory

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of the written procedure manual and interview with technical consultant (TC), the lab failed to document the lot numbers and expiration dates of all Toxicology reagents and controls. Findings: 1. The lab failed to document the lot numbers and expiration dates of the Toxicology calibrators when running patient samples on the Olympus AU640. 2. Review of quality control (QC) data performed during the year 2025. Showed on the day of the survey July 24, 2025, at 11:00 AM that lab testing personnel did not document the analyzer calibrator lot numbers and expiration dates to ensure accurate and reliable patient testing. 3. The TC confirmed on the day of the survey July 24, 2025, at 11:00 AM that lab testing personnel failed to document the analyzer calibrator lot numbers and expiration dates to ensure accurate and reliable patient testing. D5781

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation of the laboratory at 1:00 PM and interview with the testing person, the laboratory failed to report SARS-CoV-2 test results to the local health department as required by the Public Health Emergency for the detection of COVID- 19. Findings: 1. The laboratory has been performing COVID-19 testing since March 2020. 2. The laboratory has not reported positive nor negative test results as required by the Public Health Emergency. 3. The testing person stated that he tried to report the results to the Health Dept but the spreadsheet on the website did not work. 4. During the interview the testing person was asked did the lab try to submit test results by email, fax, or mail. The testing person stated no. 5. The testing person stated that the Health Dept did not want to receive COVID-19 test results submitted any other way than by spreadsheet. 6. During the interview the testing person was asked to confirm the Health Dept did not want to receive test results any other way than by spreadsheet. The testing person was unable to confirm. 7. The testing person confirmed that the lab failed to report SARS-CoV-2 test results to the local health department as required by the Public Health Emergency for the detection of COVID-19. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on review of patient test requisitions and interview with the testing person(TP), the laboratory failed to acquire a written nor a electronic test request from an authorized person prior to performing patient testing. Findings: 1. The laboratory performs COVID-19, Toxicology, RPR, and Pregnancy testing on a patient walk in basis and test samples received from area facilities needing patient testing. 2. The laboratory did not receive an authorized test request from an authorized provider prior to performing testing. 3. The laboratory has an inhouse test requisition and an off site test requisition for performing testing. 4. Review of ten off site test requisitions during the year 2020-2021 for Toxicology testing showed that the authorized physician ordering the test did not sign nor date the requisition prior to the test being performed in the section for "Authorizing Physician" 5. Review of the inhouse test request did not show that an authorized request was received by an authorized provider prior to performing patient testing. 6. The TP stated that the lab has never required an authorized test request prior to performing any patient testing and that it was not needed. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on record review and interview with Testing Person #1, the laboratory did not ensure that medications, or other substances used by the patient were reported on the requisition and available for review prior to reporting patient test results for urine toxicology. Findings: 1. A patient urine specimen for toxicology testing collected on 4 /20/21 and reported 4/21/21 was interpreted as abnormal for the presence of buprenorphine. The requisition for the patient did not include a list of medications or substances the patient is taking; 2. During interview in the afternoon of the day of survey, Testing person #1 stated that the clinic that the patient is seen uses a medication to treat addiction, but this medication was not given on the requisition; and 3. The clinical consultant would not have a list of medications/substances the patient -- 2 of 6 -- is taking to check for reactivity or cross reactivity in order to determine the result interpretation. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the written procedure manual and interview with the testing person and laboratory director, the laboratory failed to have written step by step procedures for all areas of the laboratory where patient testing was performed. Findings: I 1. The laboratory performs COVID-19, Toxicology, RPR, and Pregnancy testing on a patient walk in inhouse basis and test samples received from outside facilities needing patient testing. 2. The laboratory did not have a written procedure for collecting specimens and performing COVID-19 testing on the Centaur analyzer. 3. The laboratory did not have a written procedure for the review and release of Toxicology results. 4. The laboratory did not have a written procedure for how samples are distributed for testing after accessing was completed. 5. The laboratory did not have a written procedure for documenting the cooler temperature for samples that are transported and received from an outside facility. 6. The laboratory has a policy that the cooler temperature must be maintained within 2-8 Degree Celsius. 7. The laboratory did not have documentation that cooler temperatures were ever performed and documented. 8. The testing person confirmed that written step by step procedures for all areas of the laboratory where patient testing was performed was not available. II 1. The laboratory written procedure for RPR testing did not include instructions for performing titers and quality control for titers. The laboratory performed RPR titers for proficiency testing reported in 2019, and during interview with Testing Person #1 on the afternoon of the day of the survey, confirmed that there was no procedure for performing RPR titers. 2. The laboratory did not have a written procedure for performing serum HCG testing and did not have a written procedure for performing quality control for HCG testing each day a serum HCG test is performed. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on the review of the written procedure manual and interview with the testing person, the laboratory failed to provide all documents that were acquired during the COVID-19 antibody and antigen testing validation performed on the chemistry -- 3 of 6 -- analyzer. Findings: 1. The laboratory has been performing COVID-19 testing since March 2020 on the Centaur analyzer. 2. The testing person stated that a validation was performed for COVID-19 testing on the Centaur analyzer. 3. The SARS-CoV-2 IgG comparison study showed that two results (specimen CR095 and CR096 did not agree with the results obtained by the established analyzer. There was no written discussion of these two discordant results. 4. The laboratory did not have a written procedure stating how the Covid-19 validation was performed, and the parameters for acceptability 5. The laboratory did not have records showing the directors review and approval of the Covid-19 validation studies. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the written procedure manual and interview with the testing person, the laboratory failed to perform calibration verification procures on the chemistry analyzer. Findings: 1. The laboratory has been performing COVID-19 testing since March 2020 on the Centaur analyzer. 2. The lab did not perform calibration verification procedures on the chemistry analyzer. 3. The testing person stated that calibration verification procedures were performed on the chemistry analyzer. 4. The testing person failed to provide the calibration verification procedures during the time of the survey. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, -- 4 of 6 -- and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the written procedure manual and interview with the testing persons, the laboratory director (LD) failed to ensure that written duties and responsibilities were available for all persons involved in laboratory testing. Findings: 1. The laboratory performs Toxicology testing. 2. The LD failed to specify in the written the duties and responsibilities who is responsible for reviewing and releasing Toxicology test results to the provider. 3. Testing person 1 stated that he does the review of the Toxicology results prior to the release to the provider. 4. Observation of testing person 2 at 1:30 PM showed that this person can also review and release Toxicology results to the provider. 5. Testing person 1 stated that he is always beside testing person 2 when she reviews Toxicology results and release to the provider. 6. Testing person 1 confirmed that written duties and responsibilities were not available for all persons involved in laboratory testing. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on review of the written procedure manual and interview with the testing person, the technical consultant failed to have written step by step procedures for all areas of the laboratory where patient testing was performed. Findings: Refer to D5401 D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on the review of the written procedure manual and interview with the testing person, the technical consultant failed to ensure that all documents acquired during the COVID-19 antibody and antigen test validation performed on the chemistry analyzer were available during the time of the survey. Findings: Refer to D5421 1. The laboratory has been performing COVID-19 testing since March 2020 on the Centaur analyzer. 2. The testing person stated that a validation was performed for COVID-19 testing on the Centaur analyzer. 3. The SARS-CoV-2 IgG comparison study showed that two results (specimen CR095 and CR096 did not agree with the results obtained by the established analyzer. There was no written discussion of these two discordant results. 4. The laboratory did not have a written procedure stating how the Covid-19 -- 5 of 6 -- validation was performed, and the parameters for acceptability 5. The laboratory did not have records showing the directors review and approval of the Covid-19 validation studies. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on review of training and competency records and interview with the testing person, the technical consultant (TC) failed to provide training and competency checks when the lab started testing for COVID-19 antigens and antibodies. Findings: 1. The laboratory has been performing COVID-19 testing since March 2020 on the Centaur analyzer. 2. The TC failed to perform training and competency checks for lab personnel when the lab stated testing for COVID-19 antigens and antibodies. 3. The testing person confirmed that the TC failed to perform training and competency checks for lab personnel when the lab started testing for COVID-19 antigens and antibodies. -- 6 of 6 --

Summary Statement of Deficiencies D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on the review of test requisition slips and confirmation by interview with the Laboratory Director (LD) and the Technical Consultant (TC), the laboratory failed to ensure that each test requisition included the test to be performed for two (2) of the two (2) test requisition slips randomly selected for review (Accession number 439136 and 439137). The findings included: 1. Review of the test requisition slips for Accession numbers 439136 and 439137 revealed that the requisition slips did indicate what test is requested.The laboratory uses a manual test requisition slip that accompany each urine specimen. Note: The laboratory has a contractual agreement with a drug treatment center to perform urine drug screen that included (Amphetamine, Benzodiazepine, Cocaine, Methadone, Opiate, Phencyclidine, Marijuana, Buprenorphine, and 6 AM-heroin metabolite) for all specimens sent by the treatment center. 2. Interview with the LD and TC on December 14, 2018, at Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- approximately, 12:45 PM confirmed that the test requisition slips did not include what test is requested. Further interview revealed that although each slip did not include the test, based on the contractual agreement the laboratory tests all specimens for the aforementioned drugs. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on the review of test requisition slips, and the laboratory's monthly quality assessment, and interview with the Laboratory Director (LD) and the Technical Consultant (TC), it was determined that the laboratory's pre-analytic system quality assessment failed to identify that test requisition slips lacked the test to be performed. Two (2) of the two (2) test requisition slips randomly selected for review lacked the test to be performed (Accession number 439136 and 439137). Cross-reference D5305. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of records (the laboratory's policies and procedures manual, manufacturer's instructions, and quality control data and Levey-Jennings charts); and interview with the Laboratory Director (LD) and Technical Consultant (TC), the laboratory failed to establish criteria for quality control (QC) acceptability for each drug included in the qualitative urine drug screen. Three (3) of the three (3) months of QC records randomly selected for review failed to provide evidence that the laboratory established criteria for control acceptability (July, August and September 2018). The findings included: 1. Review of the laboratory's policies and procedures for urine drug screen entitled "QUALITY CONTROL AND ASSESSMENT" revealed instructions to evaluate daily control acceptability by evaluating the Standard Deviations (SD). However, there was no procedure for developing the control acceptable limits. 2. Review of the BIO-RAD, manufacturer's package insert for Liquicheck (the qualitative urine toxicology control) did not reveal control ranges for the qualitative assays performed on the laboratory's analyzer (AU640). Further review -- 2 of 5 -- of the insert revealed instructions for each laboratory to establish its own parameters. Note: The laboratory's drug screen profile included the following: Amphetamine, Benzodiazepine, Cocaine, Methadone, Opiate, Phencyclidine, Marijuana, Buprenorphine, and 6 AM-heroin metabolite. 3. The laboratory has programed the AU640 analyzer with QC acceptable ranges for the aforementioned drugs. However, there was no evidence that the ranges were established based on each lot of controls, for example, according to the review of Levey-Jennings (LJ) chart for Phencyclidine (PCP) and Amphetamine from July 1 through September 28, 2018, there was no evidence that the ranges were established for two different lots of the negative control. Lot Number (#) 70741 used in July 2018 and Lot #70751 used in August and September 2018. 4. Interview with the LD and the TC on December 14, 2018, at approximately, 12:00 Noon confirmed the lack of evidence for establishing control ranges. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: I. Based on the review of the laboratory's quality control (QC) log and Levey- Jennings (LJ) graph and the monthly analytic system quality assessment; and interview with the Laboratory Director (LD) and Technical Consultant (TC), the laboratory's post analytic system quality assessment failed to address QC values that were below Standard Deviations (SD) from July through September in 2018. Two (2) of the four (4) controls randomly selected for review were outside 2SD (positive QC for PCP and negative QC for Amphetamine). The findings included: A. Review of the laboratory's policies and procedures entitled "QUALITY CONTROL AND ASSESSMENT" revealed instructions to evaluate daily QC acceptability by evaluating the Standard Deviations. The policy further indicated that control value that exceeded the mean +/- 2SD but not +/-3SD is a warning sign that requires attention. B. Review of the LJ graph for Phencyclidine (PCP) and Amphetamine for July 1 through September 28, 2018 revealed that the positive QC for PCP and the negative QC for Amphetamine had readings outside 2SD for several days without any

Summary Statement of Deficiencies D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on the review of records (final laboratory results and reports labeled as duplicate) and face-to-face interview with the complainant on April 11, 2018 at 11:00 AM and with the Laboratory Director (LD) via telephone on April 27, 2018 at approximately 11:00 AM, the laboratory failed to establish a complaint investigation mechanism. There was no evidence that the complaint regarding wrong patient name on a report was investigated for one (1) of the one (1) patient's toxicology result that was reported with wrong patient name (Patient with laboratory number 8047178). The findings included: 1. Review of final report dated 2/16/18 (obtained from the complainant) revealed a wrong name for a Patient with laboratory number (#) 8047178. According to an interview with the complainant, the clinic notified the laboratory on 2/16/18 that the report the laboratory sent on 2/16/18 was for a patient that was last seen in the clinic in 2015. Further interview revealed that the laboratory then issued a report labeled duplicate on 2/20/18 for the correct patient. 2. On April 27, 2018, the laboratory staff were asked how the error occurred. According to the staff, the clinic had issued two different patients same medical record number. The laboratory test order dated 4/25/15 and 2/15/18 revealed that two different patients have the same medical record number. On 2/16/18, the laboratory staff generated a specimen label for the patient seen on 4/25/15 instead of 2/15/18 resulting with a report for the wrong patient. It should be noted that the staff were unaware of the aforementioned error until the surveyor brought it to their attention. 3. Interview with the LD confirmed the lack of investigation regarding a report being generated for the wrong patient on 2/16/18. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on the review of records (final laboratory results and reports labeled as duplicate) and face to face interview with the complainant on April 11, 2018 at 11:00 AM and with the Laboratory Director (LD) via telephone on April 27, 2018 at approximately 11:00 AM, the laboratory failed to establish a record keeping mechanism to retain a copy of the incorrect report for one (1) of the one (1) patient's result that was reported with wrong patient name (Patient with laboratory number 8047178). The findings included: 1. Review of final report dated 2/16/18 (obtained from the complainant) revealed a wrong name for a Patient with laboratory number (#) 8047178. According to an interview with the complainant, the clinic notified the laboratory on 2/16/18 that the report the laboratory sent on 2/16/18 was for a patient that was last seen in the clinic in 2015. However, the laboratory had no copy of the initial report with the wrong patient name. The record was updated to reflect the correct name and a duplicate report generated. The laboratory had no mechanism to retain original reports. 2. According to interview with the LD, the laboratory's information system is unable to retain a copy of the original report. Note: this is a repeat citation from 5/3/2017 re-certification survey. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on the review of records (final laboratory results and reports labeled as duplicate) and face to face interview with the complainant on April 11, 2018 at 11:00 AM and with the Laboratory Director (LD) via telephone on April 27, 2018 at approximately 11:00 AM, the laboratory failed to establish a quality assessment protocol for the post analytic phase of testing to retain a copy of the incorrect report for one (1) of the one (1) patient's toxicology result that was reported with wrong patient name (Patient with laboratory number 8047178). Cross reference D5821 NOTE: Repeat citation from 3/17/2009 and 5/3/2017 re-certification surveys. -- 2 of 2 --