Monty Nicholas Heinen, Md

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Monty Nicholas Heinen, MD, CLIA # 19D0976385 on November 20, 2024. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the laboratory's CMS-209 (Laboratory Personnel Report) form, policies, and proficiency testing records; as well as interview with personnel, the laboratory failed to ensure proficiency testing samples were rotated among all testing personnel performing provider performed microscopy (PPM) testing for five (5) of five (5) events reviewed. Findings: 1. Review of the laboratory's CMS-209 form revealed the following two (2) personnel performed provider performed microscopy (PPM) testing to include KOH, wet prep, and fern testing: a) Personnel 1 b) Personnel 3 2. Review of the laboratory's policy "Laboratory Quality Management Plan" section "Proficiency testing" revealed "The laboratory must introduce proficiency testing test specimens into its routine workflow and process them using pre-examination and examination protocols generally applied to the processing of patient specimens, including repeat analysis." 3. Review of proficiency testing records for KOH, wet prep, and fern testing in 2023 and 2024 revealed Personnel 1 performed all testing for the following events and Personnel 3 did not participate in any events: a) 2023 Hematology/Coagulation - 1st Event b) 2023 Hematology/Coagulation - 2nd Event c) 2023 Hematology/Coagulation - 3rd Event d) 2024 Hematology/Coagulation - 1st Event b) 2024 Hematology/Coagulation - 2nd Event 4. In interview on November 20, 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 -- 2024 at 10:31 a.m., the Technical Consultant confirmed Personnel 1 was the only testing personnel that participated in the proficiency testing events identified above. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, review of the laboratory's temperature records, and interview with personnel, the laboratory failed to define acceptable room temperature limits within the manufacturer's required range for laboratory supplies stored in one (1) of one (1) rooms. Findings: 1. Observation by surveyor during the laboratory tour on November 20, 2024 at 9:40 a.m. revealed the following testing supplies stored in the laboratory: a) GeneXpert Xpert CT/NG - Lot 1001448217, Expiration date: 08/30 /2026 - Manufacturer's storage requirements 2 - 28 degrees Celsius 2. Review of the laboratory's room temperature logs for June 2024 through November 2024 revealed the laboratory defined the acceptable temperature limits as 15 - 30 degrees Celsius which exceeded the manufacturer's upper temperature limit. 3. In interview on November 20, 2024 at 1 p.m., the Technical Consultant confirmed the acceptable temperature limits defined by the laboratory exceeded the manufacturer's temperature limits. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: **Repeat deficiency from previous survey January 27, 2023** I. Based on observation, review of laboratory maintenance logs, and interview with personnel, the laboratory failed to ensure weekly maintenance was performed on the Cepheid GeneXpert as required by the manufacturer for two (2) of twenty-six (26) weeks reviewed. Findings: 1. Observation by surveyor during the laboratory tour on November 20, 2024 at 9:40 a.m. revealed the laboratory utilized a Cepheid GeneXpert analyzer for chlamydia and gonorrhea testing. 2. Review of the laboratory's "GeneXpert Maintenance Log" revealed the following required weekly tasks: a) Weekly Maintenance: - Power down the GeneXpert Instrument - Power down the GeneXpert Computer 3. Further review of the laboratory's Cepheid maintenance logs from June 2024 through November 2024 revealed the laboratory failed to perform weekly maintenance for the following weeks: - September 2 - September 6, 2024 - October 7 - October 11, 2024 4. In interview on November 20, 2024 at 1:53 p.m., the Technical Consultant confirmed the weekly maintenance was not performed as -- 2 of 5 -- identified above. II. Based on observation, review of laboratory maintenance logs, and interview with personnel, the laboratory failed to ensure monthly maintenance was performed on the Cepheid GeneXpert as required by the manufacturer for two (2) of five (5) months reviewed. Findings: 1. Observation by surveyor during the laboratory tour on November 20, 2024 at 9:40 a.m. revealed the laboratory utilized a Cepheid GeneXpert analyzer for chlamydia and gonorrhea testing. 2. Review of the laboratory's "GeneXpert Maintenance Log" revealed the following required monthly tasks: a) Monthly Maintenance: - Archive Tests - Purge tests - Replace fan filters 3. Further review of the laboratory's Cepheid maintenance logs from June 2024 through October 2024 revealed the laboratory failed to perform monthly maintenance for the following months: - September 2024 - October 2024 4. In interview on November 20, 2024 at 1:53 p.m., the Technical Consultant confirmed the monthly maintenance was not performed as identified above. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5413. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure proficiency samples are tested as required. Refer to D2007. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) 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)(6) Ensure the establishment and maintenance of acceptable levels -- 3 of 5 -- of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on observation, review of laboratory policies and records, as well as interview with personnel, the Laboratory Director failed to ensure that the laboratory performed required maintenance. Findings: 1. The laboratory failed to ensure weekly maintenance was performed on the Cepheid GeneXpert as required by the manufacturer for two (2) of twenty-six (26) weeks reviewed. Refer to D5429 I. 2. The laboratory failed to ensure monthly maintenance was performed on the Cepheid GeneXpert as required by the manufacturer for two (2) of five (5) months reviewed. Refer to D5429 II. 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 observation, record review, and interview with personnel, the Technical Consultant failed to provide technical and scientific oversight to the laboratory. Findings: 1. The laboratory failed to ensure proficiency testing samples were rotated among all testing personnel performing provider performed microscopy (PPM) testing for five (5) of five (5) events reviewed. Refer to D2007. 2. The laboratory failed to define acceptable room temperature limits within the manufacturer's required range for laboratory supplies stored in one (1) of one (1) rooms. Refer to D5413. 3. The laboratory failed to ensure weekly maintenance was performed on the Cepheid GeneXpert as required by the manufacturer for two (2) of twenty-six (26) weeks reviewed. Refer to D5429 I. 4. The laboratory failed to ensure monthly maintenance was performed on the Cepheid GeneXpert as required by the manufacturer for two (2) of five (5) months reviewed. Refer to D5429 II. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of the CMS-209 (Laboratory Personnel Report) form and personnel records as well as interview with laboratory personnel, the Technical Consultant failed to ensure all testing personnel were assessed through testing previously analyzed specimens, internal blind samples, or external proficiency samples for one (1) of four (4) testing personnel reviewed. Findings: 1. Review of the laboratory's CMS-209 form revealed the following testing personnel: Personnel 1 Personnel 3 Personnel 4 Personnel 5 2. Review of the laboratory's 2024 personnel records for Personnel 5 revealed a six (6) month competency assessment and an annual competency assessment performed, but the laboratory did not have documentation to support the performance of blind sample testing. 3. In interview on November 20, 2024 at 11:19 a. -- 4 of 5 -- m., the Technical Consultant stated Testing Personnel 5 did perform blind sample testing by performing a split sample analysis with other testing personnel, but he did not have documentation as identified above. -- 5 of 5 --

Summary Statement of Deficiencies D0000 A Certification survey was performed at Monty Nicholas Heinen, MD, CLIA # 19D0976385, on January 27, 2023. Monty Nicholas Heinen was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1201 CONDITION: Bacteriology 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories performing moderate complexity testing; Technical Consultant D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation by surveyor, record review, and interview with personnel, the laboratory failed to ensure quality laboratory services for the subspecialty of Bacteriology. Findings: 1. The laboratory failed to establish complete quality control (QC) procedures that included frequency of performance for Bacteriology testing. Refer to D5403. 2. The laboratory failed to ensure supplies, test kits, and controls did not exceed their expiration dates. Refer to D5417 I. 3. The laboratory failed to ensure quality controls utilized for Bacteriology testing were not expired. Refer to D5417 II. 4. The laboratory failed to perform maintenance for the Cepheid GeneXpert system as required for Bacteriology testing for one (1) of three (3) dates in June 2022. Refer to D5429. 5. The laboratory failed to follow their established procedure of testing quality control material following instrument repair for one (1) of three (3) service dates reviewed. Refer to D5433. 6. The laboratory failed to perform quality control (QC) for the Cepheid GeneXpert analyzer weekly per policy. Refer to D5445. 7. The laboratory failed to document

Summary Statement of Deficiencies D0000 A Recertification survey was performed on October 27, 2021 at Monty Nicholas Heinen, CLIA ID # 19D0672917. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual, personnel records and interview with personnel, the laboratory failed to establish competency policy for two (2) of six (6) personnel performing microscopic procedures. Findings: 1. Review of the Laboratory Personnel Report (209) provided at the time of the survey revealed two (2) providers performing microscopic procedures. 2. Review of the laboratory's personnel records revealed no evaluation of competency performed for two (2) of six (6) personnel listed as testing personnel performing direct wet prep. 3. Further review of laboratory policy and procedure revealed the laboratory had no policy addressing competency assessment of providers performing microscopic procedures to include, but not limited to: frequency of competency assessment, process for competency evaluation, who is responsible for competency assessment. 4. Interview with technical consultant on October 27, 2021 at 10:42am confirmed the laboratory did not have a policy for competency evaluation of providers performing microscopic procedures. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 A CERTIFICATION SURVEY was performed at Monty Nicholas Heinen, MD - 19D0976385 on September 10, 2018. Monty Nicholas Heinen, MD was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic Systems 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing, Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories performing moderate complexity testing, Technical Consultant D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: I. Based on observation, record review, and interview with personnel, the laboratory failed to report Urine Drug Screen (UDS) test results as preliminary results and failed to confirm all UDS test results as required by the manufacturer. Findings: 1. Observation by the surveyor on September 10, 2018 revealed the laboratory utilized the UScreen Drugs of Abuse Cup System for Urine Drug Screen (UDS) testing and reporting of Amphetamine (AMP), Barbiturates (BAR), Benzodiazepines (BZO), Cocaine (COC), Methylenedioxymethamphetamine (MDMA), Methamphetamine (MET), Methadone (MTD), Morphine (MOP), Morphine 200 (OPI), Marijuana (THC), Oxycodone (OXY), Phencyclidine (PCP), Tri-cyclic Antidepressants (TCA), and Buprenorphine (BUP) in patient urine samples. 2. Review of the UScreen Drugs of Abuse Cup System package insert revealed "This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- confirmatory method. Clinical consideration and professional judgement should be applied to any drug test result, particularly when preliminary positive results are indicated. " 3. Review of a random selection of Patient UDS Final Reports from April 31, 2018 through September 4, 2018 revealed the following patients failed to be reported as preliminary test results for UDS testing and failed to be confirmed by GC /MS as required by the manufacturer: Patient 188 on April 31, 2018; all results negative. Patient 189 on May 1, 2018; all results negative. Patient 190 on June 12, 2018; all results negative. Patient 191 on July 2, 2018; all results negative. Patient 192 on August 6, 2018; all results negative. Patient 193 on September 4, 2018; all results negative. Review of the Task 1 and 3 Forms submitted to the surveyor on September 10, 2018 revealed the laboratory performs 1000 UDS tests annually. 4. Interview with Personnel 2 on September 10, 2018 confirmed that patient urine drug screen test results were not reported as preliminary results and confirmed the laboratory does not confirm results as required by the manufacturer. II. Based on observation, record review, and interview with personnel, the laboratory failed to document the internal control for Urine Drug Screen (UDS) testing for each patient. Findings: 1. Observation by the surveyor on September 10, 2018 revealed the laboratory utilized the UScreen Drugs of Abuse Cup System for Urine Drug Screen (UDS) testing and reporting of Amphetamine (AMP), Barbiturates (BAR), Benzodiazepines (BZO), Cocaine (COC), Methylenedioxymethamphetamine (MDMA), Methamphetamine (MET), Methadone (MTD), Morphine (MOP), Morphine 200 (OPI), Marijuana (THC), Oxycodone (OXY), Phencyclidine (PCP), Tri-cyclic Antidepressants (TCA), and Buprenorphine (BUP) in patient urine samples. 2. Review of the UScreen Drugs of Abuse Cup System package insert revealed under "Reading the Results" for "Invalid" results states "If a color band is not visible in the control "C" region or a color band is only visible in the test "T" region, the test is invalid." The package insert goes on to state that another test is to be performed and if the same results are obtained then the laboratory is to contact the distributor from whom they purchased the product. 3. Review of a random selection of Patient UDS Test Records from April 31, 2018 through September 4, 2018 revealed the laboratory failed to document the internal control for each patient to ensure accurate and reliable UDS test results: Patient 188 on April 31, 2018; all results negative. Patient 189 on May 1, 2018; all results negative. Patient 190 on June 12, 2018; all results negative. Patient 191 on July 2, 2018; all results negative. Patient 192 on August 6, 2018; all results negative. Patient 193 on September 4, 2018; all results negative. Review of the Task 1 and 3 Forms submitted to the surveyor on September 10, 2018 revealed the laboratory performs 1000 UDS tests annually. 4. Interview with Personnel 2 on September 10, 2018 confirmed the laboratory failed to document internal controls for any of the patients tested. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, record review and interview with personnel, the laboratory -- 2 of 8 -- failed to ensure the quality of testing within the analytic systems. Findings: 1. The laboratory failed to ensure that "all reagents and PACs must be at 22 to 28 degrees Celsius prior to use" for the BD Affirm VPIII Microbial Identification Test System for twenty one (21) of fifty seven (57) patient test days . Refer to D5413. 2. The laboratory failed to have complete Individualized Quality Control Plan (IQCP) to support the reduction of quality control material testing for the BD Affirm VPIII Microbial Identification and Cepheid Xpert patient testing. Refer to D5445. 3. The laboratory's Quality Assurance monitors failed to identify and correct quality issues in Bacteriology, Mycology and Parasitology. Refer to D5793. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, record review and interview with personnel, the laboratory failed to ensure that all reagents and PACs must be at 22 to 28 degrees Celsius prior to use for the BD Affirm VPIII Microbial Identification Test System as required by the manufacturer for twenty one (21) of fifty seven (57) patient test days . Findings: 1. Observation by the surveyor on September 10, 2018 during the laboratory tour revealed the laboratory utilized the BD Affirm VPIII Microbial Identification Test System for the identification of Trichomonas vaginalis (T.vag), Garderella vaginalis (Gard vag), and Candida. 2. Review of BD Affirm VPIII Microbial Identification Test System Package insert revealed "all reagents and PACs must be at 22 to 28 degrees Celsius prior to use" . Further review of the package insert revealed the temperature requirements are needed for accurate and reliable test results. 3. Review of Temperature Records and Patient Test Records for BD Affirm VPIII Microbial Identification Test System from May 1, 2018 through August 22, 2018 revealed the laboratory documented temperatures outside the 22 to 28 degrees Celsius for the following days affecting the following patient test results: May 7, 2018 documented 21 degrees Celsius; patients 17 - 20 were tested and reported May 8 2018 documented 21 degrees Celsius; patients 21 - 26 were tested and reported May 10, 2018 documented 21 degrees Celsius; patients 27 - 32 were tested and reported May 14, 2018 documented 21 degrees Celsius; patients 33 - 37 were tested and reported May 15, 2018 documented 21 degrees Celsius; patients 38 - 49 were tested and reported May 17, 2018 documented 21 degrees Celsius; patients 50 - 54 were tested and reported May 18, 2018 documented 21 degrees Celsius; patients 55 - 70 were tested and reported May 21, 2018 documented 21 degrees Celsius; patients 71 - 80 were tested and reported May 22, 2018 documented 21 degrees Celsius; patients 81 - 82 were tested and reported May 25, 2018 documented 21 degrees Celsius; patients 83 - 88 were tested and reported May 29, 2018 documented 21 degrees Celsius; patients 89 - 101 were tested and reported July 6, 2018 documented 21 degrees Celsius; patients 102 - 108 were tested and reported July 23, 2018 documented 21 degrees Celsius; patients 109 - 118 were tested and reported July 26, 2018 documented 21 degrees Celsius; patients 119 - 124 were tested and reported July 30, 2018 documented 21 -- 3 of 8 -- degrees Celsius; patient 125 was tested and reported July 31, 2018 documented 21 degrees Celsius; patients 126 - 143 were tested and reported August 2, 2018 documented 21 degrees Celsius; patients 144 - 161 were tested and reported August 6, 2018 documented 21 degrees Celsius; patients 162 - 169 were tested and reported August 7, 2018 documented 21 degrees Celsius; patients 170 - 174 were tested and reported August 20, 2018 documented 21 degrees Celsius; patients 175 - 181 were tested and reported August 21, 2018 documented 21 degrees Celsius; patients 182 - 187 were tested and reported 4. Interview with personnel 2 on September 10, 2018 confirmed that patients are to be ran when all the reagents and PACs are between 22 to 28 degrees Celsius. Personnel 2 also confirmed that patients were tested and reported when the laboratory documented temperatures outside of 22 to 28 degrees Celsius. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to have complete Individualized Quality Control Plan (IQCP) to support the reduction of quality control material testing for the BD Affirm VPIII Microbial Identification and Cepheid Xpert patient testing. Findings: 1. Observation by the surveyor during the tour of the laboratory on September 10, 2018 revealed the laboratory maintained: a) BD Affirm VPIII Microbial Identification Test System for the identification of Trichomonas vaginalis (T.vag), Gardnerella vaginalis (Gard vag) and Candida testing. b) Cepheid Xpert testing for the identification of Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT). 2. Review of the Laboratory's IQCP for the BD Affirm VPIII and Cepheid Xpert test systems revealed the laboratory failed to maintain: a) A complete Risk Assessment that identifies and evaluates potential failures and sources of errors in all five components: Specimen, Test System, Reagents, Environment and Testing Personnel. b) Manufacturer Requirements: Operators Manual and package inserts c) In house quality control data to support the length of reduction in quality control frequency. d) Pertinent Literature to support the reduction of quality control. 3. Review of a random selection of patient records from October 10, 2017 through September 5, 2018 revealed the following sixteen (16) patient samples were tested and reported without establishing a complete Individualized Quality Control Plan that supports the reduction of quality control for the BD Affirm VPIII and Cepheid Xpert Test Systems. a) For the Cepheid Xpert Test System On October 10, 2017: Patient 1. On January 9, 2018: Patient 2 On April 3, 2018: Patient 3. On May 3, 2018: Patient 4. On June 7, 2018: Patient 5. On July 3, 2018: Patient 6. On August 7, 2018: Patient 7. On September 8, 2018: Patient 8. b) For the BD Affirm VPIII Test System On October 11, 2017: Patient 9. On January 8, 2018: Patient 10 On April 4, 2018: Patient 11. On May 2, 2018: Patient 12. On June 6, 2018: Patient 13. On July 2, 2018: Patient 14. On August 3, 2018: Patient 15. On -- 4 of 8 -- September 5, 2018: Patient 16. Review of the Task 1 and 3 form filled out by the laboratory and submitted to the surveyor on September 10, 2018 revealed the laboratory performs the following annual volumes: T.vag - 2400, Gard vag - 2400, Candida - 2400, NG - 2760, and CT 2760. 4. Interview with personnel 2 on September 10, 2018 confirmed the laboratory failed to have complete IQCP studies for the BD Affirm VPIII and Cepheid Xpert Test systems. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of