Tidewater Family Practice Pc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Tidewater Family Practice on February 7, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows and includes the Condition under 42 CFR part 493 CLIA Regulation: D6033 -42 CFR. 493.1409 Technical Consultant Moderate Complexity. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on tour observation, review of procedures, lack of documentation, and interviews, the laboratory failed to follow their protocol for laboratory eye wash safety /maintenance for twenty-one (21) of 21 months reviewed (May 2022 to the time of the survey on February 7, 2024). Findings include: 1. During a tour of the laboratory on 2 /7/24 at 10:00 AM, the inspector noted no eye wash in view. 2. Review of the laboratory's procedures revealed a protocol titled "General Laboratory Safety Program" with subheading "Eye Wash Safety and Maintenance" that stated: "The eyewash station must be properly labeled and capable of flushing both eyes for a minimum of 15 minutes with cool or tepid water. All testing personnel must know the location of the eyewash station and trained in its use and maintenance. A saline solution bottle is not an appropriate method and cannot be used in place of an eyewash station being installed." 3. The inspector inquired regarding the observed lack of eye wash in the laboratory with records of eye wash maintenance documentation per the protocol outlined above. The primary testing personnel stated on 2/7/24 at 11:00 AM: "We have bottled saline eye wash that is stored in the next Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- room". The inspector was guided to an adjacent room and noted one four (4) ounce bottle of Bausch + Lomb Eye Relief Wash (Lot Number 6319814 ingredients- Purified Water, Boric Acid, and Sodium Chloride) stored inside an upper cabinet. The inspector noted that the eye irrigating solution had an expiration date of February 2020 (4 years expired). 4. An interview with the primary testing personnel and office manager on 2/7/24 at 12:30 PM confirmed the above findings D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) CLIA Laboratory Certification form, Food and Drug Administration's Emergency Use Authorizations extension, manufacturer's instructions for use, tour, package insert instructions, patient/quality control (QC) logs, lack of documentation, procedures, CMS Laboratory Personnel Report form, laboratory personnel files, and interviews, the Technical Consultant failed to: 1. ensure acceptable real-time PCR QC for SARS- CoV-2, Influenza A, Influenza B, and Respiratory Syncytial Virus testing was verified /documented for twenty-three of twenty-five Cepheid reagent cartridge lot numbers during the timeframe of May 2022 through December 2023. Cross Reference D6042. 2. to document Abbott Emerald hematology competency assessments for nine of ten testing personnel in calendar year 2023 per established procedure. Cross Reference D6046. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services CLIA Laboratory Certification form (CMS 116), Food and Drug Administration's (FDA) Emergency Use Authorizations (EUA) extension, manufacturer's instructions for use (IFU), tour, package insert instructions, patient/quality control (QC) logs, lack of documentation, procedures review, and interview, the Technical Consultant (TC) failed to ensure that the laboratory documented acceptable negative and positive QC for SARS-CoV-2 (COVID), Influenza A (FLU A), Influenza B (FLU B), and Respiratory Syncytial Virus (RSV) real-time RT PCR testing for twenty-three (23) of twenty-five (25) Cepheid reagent cartridge lot numbers while four hundred eighty-five (485) patient panels were reported from May 2022 to December 31, 2023. Findings include: 1. Review of the laboratory's CMS 116 form revealed that the laboratory director (LD) identified COVID, FLU A, FLU B, and RSV patient testing utilizing RT PCR reagent cartridges by Cepheid for the GeneXpert Xpress System for the timeframe of May -- 2 of 4 -- 2022 to the date of the inspection, 2/7/24. 2. Review of the FDA's EUA extension (dated 07/18/23) for Cepheid GeneXpert Xpress SARS-CoV-2/Flu/RSV Plus testing revealed IFU External Controls Instructions as: "Testing with the Xpert Xpress SARS- CoV-2/Flu/RSV Plus test is intended for use by trained operators who are proficient in performing tests using either GeneXpert Dx, GeneXpert Infinity and/or GeneXpert Xpress systems. External controls should be used in accordance with local, state, and federal accrediting organizations as applicable and following package instructions". 3. During a tour of the laboratory on 02/7/24 at 10:00 AM the inspector noted one (1) Cepheid GeneXpert Xpress analyzer (Serial Number 1100085555) in use for real-time RT-PCR testing with SARS-CoV-2/Flu/RSV Plus Cartridges. 4. Review of the laboratory's procedures revealed the Cepheid GeneXpert Xpress SARS-CoV-2/Flu /RSV Plus package insert that stated: "External controls are to be tested at the frequency noted below: a. Each time a new lot of Xpert Xpress CoV-2/Flu/RSV plus kits is received; b. Each time a new shipment of Xpert Xpress CoV-2/Flu/RSV plus kits is received even if it is the same lot previously received; c. Each time a new operator is performing the test (i.e., operator who has not performed the test recently); d. When problems (storage, operator, instrument, or other) are suspected or identified; e. If otherwise more frequently required by your institution's standard Quality Control (QC) procedures." 5. Review of the Cepheid analyzer's onboard patient and QC logs from 5/5/22 to 2/7/24 revealed acceptable SARS CoV-2 Positive QC (Target RNA detected), SARS CoV-2 Negative QC (Target RNA not detected), FLU A Positive QC (Target RNA detected), FLU A Negative QC (Target RNA not detected), FLU B Positive QC (Target RNA detected), FLU B Negative QC (Target RNA not detected), RSV Positive QC (Target RNA detected), RSV Negative QC (Target RNA not detected) results for two lot numbers: 09616 on 09/02/22 and 47203 on 02/02/24. The inspector noted there were no positive/negative target RNA controls verified/assayed for the following lot numbers utilized for reporting patient results: 05/05/22 to 12/31 /22: 21222, 09324, 08307, 06717, 07912, 07824, 05924 while reporting one hundred ninety one (191) patient panels; 01/02/23 to 12/31/23: 42304, 16707, 29509, 16404, 29302, 16204, 15908, 26809, 24916, 15501, 26809, 22506, 14206, 21210, 13513, 21222 while reporting two hundred ninety-four (294) patient panels; A total of 23 lot numbers were utilized for reporting 485 patient panels while not following manufacturer's QC guidelines. 6. The inspector requested to review additional QC records for the timeframe outlined above. No additional documentation was available for review. The inspector requested to review an approved Individualized Quality Control Plan (IQCP). No documentation was available for review. 7. Review of the laboratory's procedures revealed the following protocol: Technical Consultant Duties included statement: "The Technical Consultant is responsible for technical and scientific oversight including establishing a quality control program appropriate for the testing performed." 8. An interview with the primary TP and office manager on 2/7 /24 at 12:30 PM confirmed the above findings. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, procedures, lack of -- 3 of 4 -- documentation, and interviews, the technical consultant (TC) failed to document an evaluation of Abbott Emerald hematology competency assessments for nine (9) of ten (10) testing personnel (TP) in calendar year 2023 per established procedure. Findings include: 1. Review of the CMS 209 personnel form revealed that the laboratory director (LD) identified Personnel A as qualified/responsible to perform the duties of TC and 10 TP (TP # 1-10) as qualified/responsible for moderate complexity hematology testing utilizing Abbott Emerald instrument. (See Personnel Code Sheet.) 2. Review of the available personnel records revealed: Competency assessments for TP #1 were completed by the TC (Personnel A) in calendar years 2022 and 2023; Competency assessments for TP #2 - #10 were completed by TP #1. The inspector noted that TP #1 did not meet the qualification requirement to perform TC duties. 3. Review of the laboratory's procedures revealed the following two protocols: Technical Consultant Competency Form the LD outlined and identified Personnel A as TC and included statement: "The Technical Consultant is responsible for evaluating the competency of all testing personnel on an ongoing basis and evaluates and documents testing personnel's performance at six months and twelve months during the first year of employment and yearly thereafter." Staff Orientation -Training and Competency stated: "The Technical Consultant (TC) for moderate complexity testing is responsible for performing and documenting competency assessments. Peer testing personnel who do not meet the regulatory qualifications of a TC cannot be designated to perform competency assessments." The inspector inquired regarding the delegation of competency assessments for TP #2 - #10 to TP #1. The TC stated on 2/7/24 at approximately 11:30 AM, "I do come on site periodically but did not perform the competency assessments as noted. I did perform the assessment for the primary tech in the previous year. I can work with the staff to be directly involved going forward in the hematology competency assessments of all the TP." 4. An interview with the primary TP (TP #1) and office manager on 2/7/24 at 12:30 PM confirmed the above findings. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Tidewater Family Practice on May 4, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The inspector noted that the laboratory performs SARS-CoV-2 (COVID-19) testing and is in compliance with the applicable COVID-19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS 209), proficiency testing (PT) / accuracy verification records, lack of documentation, and an interview, the laboratory failed to verify the accuracy of Potassium Hydroxide (KOH) Wet Prep microscopy testing twice annually during the twenty-five (25) months reviewed (March 2020 to the date of the survey, May 4, 2022). Findings include: 1. Review of the laboratory's CMS 209 personnel form revealed that one (1) testing personnel (TP A) was identified by the lab director (LD) as responsible for performing patient KOH microscopy examinations during the review timeframe of March 2020 to 05/04/22. (See Testing Personnel Code Sheet.) 2. Review of the laboratory's American Proficiency Institute (API) PT documentation, a total of seven (7) events, revealed no KOH Wet Prep microscopy module results. The inspector requested to review twice annual accuracy verification for KOH Wet Prep in calendar years 2020 and 2021. No documentation was available for review. The technical consultant (TC) stated at approximately 12:30 PM, "I was not aware that the procedure was not being evaluated twice annually for accuracy but we will correct this as soon as possible. I plan to notify API to add it to our enrollment." 3. An exit 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 -- interview with the LD, TC, office manager, and lead testing personnel on 05/04/22 at approximately 1 PM confirmed the above findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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 An announced CLIA recertification survey was conducted at Tidewater Family Practice on February 18-19, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 a review of policies and procedures, manufacturer's operations manual, instrument maintenance records, quality control, patient test reports, lack of documentation, and interviews, the laboratory failed to: 1. document performance of required hematology analyzer maintenance twice annually in calendar year 2019 (see D5429); 2. document two levels of acceptable chemistry QC on 12/6/18 and 12/11/18 with fifteen (15) patients reported (see D5447 **REPEAT DEFICIENCY). 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of policies and procedures, manufacturer's operations manual, instrument maintenance records, lack of documentation, and an interview, the laboratory failed to document performance of required Abbott Emerald hematology analyzer maintenance twice in calendar year 2019. Findings include: 1. Review of the laboratory's procedure manual revealed a maintenance log that detailed Lubricating Syringe Pistons semi annually. 2. Review of the Abbott Emerald Operations Manual revealed manufacturer's instructions to "perform Lubricating Syringe Pistons maintenance procedure twice annually". 3. Review of the laboratory's Emerald hematology maintenance logs from April 2018 through January 2020, revealed that the semiannual piston syringe lubrication maintenance was recorded as performed once in calendar year 2019 (on 08/01/19). The inspector requested to review additional documentation of the piston syringe maintenance in calendar year 2019. No other records were available. The primary testing personnel stated on 2/19/20 at approximately 11:00 AM: "I do not have any other documentation about the maintenance. It appears that it was missed." 4. In an exit interview with the technical consultant and primary testing personnel on 2/19/20 at approximately 1:30 PM the above findings were confirmed. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the policies and procedures, Quality Control (QC) records, patient test reports and interviews, the laboratory failed to document two levels of acceptable Total Cholesterol QC on 12/06/18 and 12/11/18 with fifteen (15) patients reported . **REPEAT DEFICIENCY Findings include: 1. Review of the laboratory's policies and procedures revealed a QC policy that stated that QC is verified each day of patient testing. 2. Review of the laboratory's Total Cholesterol QC records (Abbott Architect analyzer) and LabDaq Laboratory Information System (LIS) patient logs for December 2018 revealed that the laboratory failed to document two levels of acceptable QC for the following dates and patient identification numbers tested: 12/06 /18 -54838, 54844, 54845, 54846, 54847, 54850, 12/11/18- 54885, 54886, 54887, 54888, 54889, 54890, 54891, 54892, 54893, for a total of two (2) days with 15 patients reported. The technical consultant (TC) stated on 2/18/20 at approximately 4: 30 PM, that the QC issue had been discussed in a quality assurance review but that it had not been noted that patients had been reported prior to