Nowcare Medical Associates

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Nowcare Medical Associates on July 17, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and includes two Conditions under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems, D6063 -42 CFR. 493.1421 Condition Testing Personnel. D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of hematology proficiency testing (PT) documentation, and an interview, the laboratory failed to ensure Complete Blood Count (CBC) PT testing results were returned to American Proficiency Institute (API) for one (1) of five (5) events reviewed from October 26, 2022 to the date of the survey on July 17, 2024. Findings include: 1. Review of the laboratory's API hematology PT documentation (2022 Event 3, 2023 Events 1-3, 2024 Event 1), a total of 5 events, revealed that the laboratory failed to submit and received failure to participate scores for the following CBC module: API 2022 Hematology Event 3 - 0% scores for Cell Identification, Red Blood Cell, White Blood Cell, Platelet, Hemoglobin, and Hematocrit. 2. An interview with the quality director on 7/17/24 at 1:30 PM confirmed the above findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 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 -- 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 manufacturer's operations manual, hematology analyzer maintenance records, procedures, instrument calibration records, lack of documentation, and interviews, the laboratory failed to: 1. document performance of required twice annual instrument preventative maintenance during the twenty (20) months reviewed (review timeframe: October 26, 2022 - July 17, 2024) **REPEAT DEFICIENCY, See D5429; 2. perform instrument calibration procedures for Complete Blood Count according to their procedure during the 20 months reviewed (timeframe: 10/26/22 to 7/17/24). See D5437. 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: Based on a review of manufacturer's operations manual, hematology analyzer maintenance records, lack of documentation, and an interview, the laboratory failed to document performance of required twice annual instrument preventative maintenance during the twenty (20) months reviewed (review timeframe: November 2022 - July 17, 2024). **REPEAT DEFICIENCY Findings include: 1. Review of the Abbott Emerald Operations Manual revealed manufacturer's instructions to "perform Lubricating Syringe Pistons maintenance procedure twice annually" (under heading: Preventative Maintenance). 2. Review of the laboratory's available Emerald hematology maintenance logs from November 2022 to the date of the inspection on 7 /17/24 revealed no documentation of the required semi-annual maintenance outlined above. The inspector requested to review documentation of the piston syringe maintenance in calendar year 2023 and year to date 2024. No records were available. 3. An exit interview with the quality director on 7/17/24 at 1:30 PM confirmed the above findings. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as -- 2 of 4 -- acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of procedures, instrument calibration records, lack of documentation, and an interview, the laboratory failed to perform instrument calibration procedures for Complete Blood Count (CBC) according to their procedure during the twenty (20) months reviewed (timeframe: 10/26/22 to 7/17/24). Findings include: 1. Review of the laboratory's procedure manual revealed a Hematology Calibration policy that outlined to calibrate CBC testing at a frequency of every 6 months. The policy stated: "Calibration is a procedure that confirms the accuracy and precision of the Emerald equipment. Calibration of the Emerald machine is performed every six months or more frequently as needed." 2. Review of the laboratory's Abbott Emerald instrument calibration documentation from 10/26/22 to the date of the inspection on 7/17/24, a total of 20 months, revealed the following 2 calibration records: 4/4/23, 4/30/24. The inspector requested to review hematology calibration recorded in October 2023. No additional calibration documentation was available for review. 3. An exit interview with quality director on 7/17/24 at 1:30 PM confirmed the above findings. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form, testing personnel records, lack of documentation, and interview, the laboratory failed to retain documentation of education qualifications for one of three testing personnel responsible for reporting moderate complexity patient test results during the review timeframe of October 26, 2022 to the date of the inspection on July 17, 2024. See D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: -- 3 of 4 -- Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), personnel records, lack of documentation, and an interview, the laboratory failed to retain documentation of education qualifications for one (1) of three (3) testing personnel (TP) responsible for hematology and chemistry testing during the review timeframe of October 26, 2022 to the date of the inspection on July 17, 2024. Findings include: 1. Review of the CMS 209 form revealed that the laboratory director identified 3 personnel as responsible and qualified to perform moderate complexity hematology Completed Blood Count and chemistry iSTAT Chem8 patient testing. 2. Review of the available laboratory personnel records for evaluation of education documentation revealed no record of education for TP A. (See Personnel Code Sheet.) The inspector requested to review an official transcript or diploma documentation of education for TP A. No documentation was available for review. 3. An exit interview with the quality director on 7/17/24 at 1:30 PM confirmed the above findings -- 4 of 4 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Nowcare Medical Associates on October 25, 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 Regulations. Specific deficiencies cited are as follows and includes one Condition under 42 CFR part 493 CLIA Regulation: D6000 -42 CFR. 493.1403 Laboratory Director D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, lack of documentation, and an interview, the laboratory failed to document a review/evaluation of three (3) of 3 hematology PT modules in calendar year 2021. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) hematology 2021 PT records (Events A-C) revealed no API retained results or documentation of review/evaluation for: 2021 API Hematology Module Complete Blood Count and Auto Differential Events 1, 2, 3. 2. The inspector requested to review the API results and evaluation documentation for the 3 hematology module events outlined above. The clinical coordinator stated on 10/25/22 at approximately 11:30 AM, "I can print the results from API web site." No documentation of review/evaluation was available for review. 3. An exit interview with the clinical coordinator on 10/25/22 at approximately 12:00 PM confirmed the above findings. 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 -- D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 a laboratory tour, review of procedures, and interviews, the laboratory failed to ensure that five (5) of 5 Abbott iSTAT boxed control reagents stored in the laboratory for use was within the manufacturer's expiration dates as observed on October 25, 2022. Findings include: 1. During a laboratory tour at approximately 10: 00 AM, the inspector noted the following 5 boxes of Abbott iSTAT control reagents (labeled as received and opened 5/19/22) stored in the lab refrigerator: TriControl Level 1 Lot #301141 one (1) box, expiration date of 9/30/2022; TriControl Level 2 Lot #311141 two (2) boxes, expiration date of 9/30/2022; TriControl Level 3 Lot #321141 2 boxes, expiration date of 9/30/2022; a total of 5 boxes were expired, observed on 10/25/22. The laboratory inspector inquired regarding the storage and use of the expired control reagents stored above. The clinical coordinator indicated that the laboratory had used the controls for accuracy determination of iSTAT chemistry Chem8 testing but was unable to confirm when the observed controls were last utilized. The clinical coordinator stated on 10/25/22 at approximately 10:15 AM, "I am going to dispose of these right now." 2. Review of the laboratory's procedure manual revealed an iSTAT Chem8 Procedure (review date 10/8/22) that stated, "Reagent: follow reagent package instructions for storage and stability". 3. An exit interview with the clinical coordinator on 10/25/22 at approximately 12:00 PM confirmed the above findings. 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: Based on a review of manufacturer's operations manual, hematology analyzer maintenance records, lack of documentation, and an interview, the laboratory failed to document performance of required twice annual instrument preventative maintenance during the twenty-three (23) months reviewed (review timeframe: December 2020 - October 25, 2022). Findings include: 1. Review of the Abbott Emerald Operations Manual revealed manufacturer's instructions to "perform Lubricating Syringe Pistons maintenance procedure twice annually" (under heading: Preventative Maintenance). 2. Review of the laboratory's available Emerald hematology maintenance logs from December 2020 to the date of the inspection on 10/25/22, revealed no documentation of the required semi-annual maintenance outlined above. The inspector requested to review documentation of the piston syringe maintenance in calendar year 2021 and year to date 2022. No records were available. 3. An exit interview with the clinical coordinator on 10/25/22 at approximately 12:00 PM confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR -- 2 of 6 -- CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a review of the laboratory's policies, quality assessment (QA), proficiency testing (PT), analyzer maintenance, Centers for Medicare and Medicaid Services Laboratory Personnel Report form, laboratory personnel files, lack of documentation, and interviews, the laboratory director failed to: 1. ensure that the policy for monthly QA review was maintained during the twenty-three (23) month review timeframe (December 2020 through the date of the survey on October 25, 2022). Cross Reference D6021. 2. identify the QA failures for lack of retention of PT review /evaluation records in calendar year 2021, documentation of twice annual hematology instrument preventative maintenance, initial training/competency for four (4) of 4 new testing personnel (TP), semiannual competency assessment documentation for three (3) of 4 new TP, annual hematology competency evaluation documentation for (5) of 5 TP in the 23 months reviewed (December 2020 to date of inspection 10/25/22). Cross Reference D6022. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policy and procedure manual, quality assessment (QA) records, lack of documentation, and interviews, the laboratory director (LD) failed to ensure that the QA policies were maintained during the twenty- three (23) month review timeframe (December 2020 through the date of the survey on October 25, 2022). Findings include: 1. Review of the laboratory's policy and procedure manual revealed a QA policy that outlined a monthly QA meeting with the lab director to evaluate testing personnel, procedure manual updates, quality control, maintenance, proficiency testing documentation, communication, and remedial actions. 2. Review of the laboratory's available QA documentation from December 2020 through the date of the survey on 10/25/22 revealed no monthly QA documentation. The inspector requested to review the QA documentation for the 23 months of review. No records were available for review. The clinical coordinator stated on 10/25/22 at approximately 11:00 AM, "We have all of the QA checklists up through 2020. Our technical consultant laboratory technologist retired in 2021 and was very good to keep those QA records up to date. We have restarted our monthly QA meetings as of this month for all of our office laboratories." 3. An exit interview with the clinical coordinator on 10/25/22 at approximately 12:00 PM confirmed the above findings. -- 3 of 6 -- D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, manufacturer's operations manual, hematology analyzer maintenance records, Centers for Medicare and Medicaid Services Laboratory Personnel Report form, laboratory personnel files, procedures, lack of documentation, and interviews, the laboratory director failed to identify the following quality assessment (QA) failures as they occurred: 1. lack of retention of PT review/evaluation records for three (3) of 3 hematology PT modules in calendar year 2021. Cross Reference: D5211. 2. lack of documentation for required twice annual hematology instrument preventative maintenance during the twenty- three (23) months reviewed (review timeframe: December 2020 - October 25, 2022). Cross Reference: D5429. 3. lack of retention of initial training/competency for four (4) of 4 new testing personnel (TP) from March 9, 2021 to the date of the inspection on 10/25/22. Cross Reference: D6029. 4. lack of retention of semiannual competency assessment documentation for three (3) of 4 new TP from 03/09/21 to the date of the inspection 10/25/22. Cross Reference: D6053. 5. lack of retention of annual hematology competency evaluation documentation for five (5) of 5 TP in calendar year 2021. Cross Reference: D6054. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. 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, lack of documentation, policies/procedures, and an interview, the laboratory director (LD) failed to document initial training/competency for four (4) of 4 new testing personnel (TP) from March 9, 2021 to the date of the inspection on October 25, 2022. Findings include: 1. Review of the CMS 209 personnel form revealed that the LD identified nine (9) TP as responsible for performing non-waived hematology Abbott Emerald Complete Blood Count (CBC) and SARS-CoV-2 (COVID-19) patient testing under Food and Drug Administration's (FDA) Emergency Use Authorizations (EUA) during the review timeframe (December 2020 to 10/25/22). During the entrance interview on 10/25/22 -- 4 of 6 -- at approximately 9:00 AM, the clinical coordinator identified 4 of the 9 listed TP as new testing personnel. 2. Review of the personnel records revealed that the following TP files lacked hematology and Quidel Sofia COVID-19 initial training/competency assessments: TP #1 start date of 03/09/21; TP #2 start date of 11/29/21; TP #3 start date of 08/30/21; TP #4 start date of 09/12/22. (*See Personnel Code Sheet.) 3. The inspector requested to review the initial training/competency documentation for the 4 TP outlined above. No documentation was available. The clinical coordinator stated on 10/25/22 at approximately 11:00 AM: "Our former technical consultant used to complete the competencies but has since retired. We cannot locate the competency assessments for last year and the lab director is working to get them completed." 4. Review of the laboratory's procedure manual revealed: Policy (titled: Miscellaneous Laboratory Protocol) statement - "As part of the quality assessment program the following protocols have been developed. Records of qualifications, training, and continuing education will be maintained on all laboratory personnel. The laboratory personnel performance and knowledge will periodically be reviewed by the lab director or technical consultant through direct observation as part of initial and ongoing training and competency. The laboratory staff will be trained on new procedures and test kits and proof of training will be kept on file. A review and re- evaluation of competency will be performed six months after hire and annually thereafter." Procedure: Quidel Sofia COVID-19 manufacturer's package insert and FDA's issued EUA - "Conditions of Authorization for Laboratory and Patient Care Setting: All operators using the product must be trained in performing and interpreting the results of the product, use appropriate personal protective equipment when handling this kit, and use the product in accordance with the authorized labeling." 5. An exit interview with the clinical coordinator on 10/25/22 at approximately 12:00 PM confirmed the above findings. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. 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, lack of documentation, policies/procedures, and interview, the technical consultant (TC) failed to document semiannual competency assessments for three (3) of 4 new testing personnel (TP) from March 9, 2021 to the date of the inspection on October 25, 2022. Findings include: 1. Review of the CMS 209 personnel form revealed that the laboratory director (LD) also serves in the role of TC. The LD identified nine (9) TP as responsible for performing non-waived hematology Abbott Emerald Complete Blood Count (CBC) during the review timeframe (December 2020 to 10/25/22). 2. Review of the personnel records revealed that the following 3 TP files lacked semiannual hematology competency assessments as of the date of the inspection on 10/25/22: TP #1 start date of 03/09/21; TP #2 start date of 11/29/21; TP #3 start date of 08/30/21. (*See Personnel Code Sheet) 3. The inspector requested to review semiannual competency documentation for the 3 TP outlined above. No documentation was available. 4. Review of the laboratory's procedure manual revealed the following protocol: Miscellaneous Laboratory Protocol that stated: "As part of the quality assessment program the following protocols have been developed. Records of -- 5 of 6 -- qualifications, training, and continuing education will be maintained on all laboratory personnel. The laboratory personnel performance and knowledge will periodically be reviewed by the lab director or technical consultant through direct observation as part of initial and ongoing training and competency. The laboratory staff will be trained on new procedures and test kits and proof of training will be kept on file. A review and re-evaluation of competency will be performed six months after hire and annually thereafter." 5. An exit interview with the clinical coordinator on 10/25/22 at approximately 12:00 PM confirmed the above findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. 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, lack of documentation, policies/procedures, and interviews, the technical consultant (TC) failed to document annual competency assessments for (5) of 5 testing personnel (TP) in calendar year 2021. Findings include: 1. Review of the CMS 209 personnel form revealed that the laboratory director (LD) also serves in the role of TC. The LD identified nine (9) TP as responsible for performing non-waived patient hematology Abbott Emerald Complete Blood Count (CBC). 2. Review of the personnel records revealed that the files of TP #5 - #9 lacked hematology competency assessments for calendar year 2021. (*See Personnel Code Sheet) 3. The inspector requested to review the 2021 annual competency documentation for the 5 TP outlined above. No documentation was available. The clinical coordinator stated on 10/25/22 at approximately 11:00 AM: "Our former technical consultant used to complete the competencies but has since retired. We cannot locate the competency assessments for last year and the director is working to get them completed." 4. Review of the laboratory's procedure manual revealed the following policies: Miscellaneous Laboratory Protocol: that stated: "As part of the quality assessment program the following protocols have been developed. Records of qualifications, training, and continuing education will be maintained on all laboratory personnel. The laboratory personnel performance and knowledge will periodically be reviewed by the lab director or technical consultant through direct observation as part of initial and ongoing training and competency. The laboratory staff will be trained on new procedures and test kits and proof of training will be kept on file. A review and re-evaluation of competency will be performed six months after hire and annually thereafter." 5. An exit interview with the clinical coordinator on 10/25/22 at approximately 12:00 PM confirmed the above findings. -- 6 of 6 --

Summary Statement of Deficiencies D0000 An announced on-site CLIA recertification survey was conducted at Nowcare Medical Associates on November 17, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on 11/2/2020 and virtual record review conducted on 11/13/2020. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. 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), laboratory personnel files, and an interview, the technical consultant (TC) failed to document annual competency assessments that included direct observation of Complete Blood Count (CBC) patient test performance for two (2) of three (3) testing personnel (TP) in the twenty-nine (29) months reviewed. Findings include: 1. During an entrance interview with the laboratory's office manager and technical consultant (TC) on 11/2/20, a review of the CMS 209 form revealed 3 TP responsible for moderate complexity CBC patient testing. 2. Review of the Abbott Emerald hematology competency assessment documentation from July 2018 to the date of the virtual record review on 11/13/20, a total of twenty- nine (29) months, revealed the laboratory's annual CBC competency assessments lacked required competency procedural element of direct observation of routine patient test performance (patient preparation, specimen handling, and analyzer testing) for TP A and TP B. The inspector noted that the competency assessment for TP A and TP B consisted of a check mark on a column header labeled "Competent" with no 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 -- evaluation criteria described. (See Personnel Code Sheet.) 3. During the onsite tour on 11/17/20, the inspector requested to review additional competency documentation. The TC stated at approximately 3:00 PM: "The competency assessment check list for my role as TC and as the primary testing personnel does include six elements. We have not updated the competency records for other two staff members who run the Emerald instrument". 4. In an exit interview with the TC at approximately 3:30 PM, the above findings were confirmed. D6048 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(ii) The procedures for evaluation of the competency of the staff must include, but are not limited to monitoring the recording and reporting of test results. 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), laboratory personnel files, and an interview, the technical consultant (TC) failed to document annual competency assessments that included monitoring of the recording/reporting of Complete Blood Count (CBC) patient test results for two (2) of three (3) testing personnel (TP) in the twenty-nine (29) months reviewed. Findings include: 1. During an entrance interview with the laboratory's office manager and technical consultant (TC) on 11/2/20, a review of the CMS 209 form revealed 3 TP responsible for moderate complexity CBC patient testing. 2. Review of the Abbott Emerald hematology competency assessment documentation from July 2018 to the date of the virtual record review on 11/13/20, a total of twenty-nine (29) months, revealed the laboratory's annual assessments lacked required competency procedural element of monitoring of the recording/reporting of CBC test results for TP A and TP B. The inspector noted that the competency assessment for TP A and TP B consisted of a check mark on a column header labeled "Competent" with no evaluation criteria described. (See Personnel Code Sheet.) 3. During the onsite tour on 11/17/20, the inspector requested to review additional competency documentation. The TC stated at approximately 3:00 PM: "The competency assessment check list for my role as TC and as the primary testing personnel does include six elements. We have not updated the competency records for other two staff members who run the Emerald instrument". 4. In an exit interview with the TC at approximately 3:30 PM, the above findings were confirmed. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. 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), laboratory personnel files, and an interview, the technical consultant (TC) failed to document annual competency assessments that included review of test results/worksheets, quality control (QC) records, or preventative maintenance for Complete Blood Count (CBC) patient test results for two (2) of three (3) testing personnel (TP) in the twenty-nine (29) months reviewed. -- 2 of 3 -- Findings include: 1. During an entrance interview with the laboratory's office manager and technical consultant (TC) on 11/13/20, a review of the CMS 209 form revealed 3 TP responsible for moderate complexity CBC patient testing. 2. Review of the Abbott Emerald hematology competency assessment documentation from July 2018 to the date of the virtual record review on 11/13/20, a total of twenty-nine (29) months, revealed the laboratory's annual CBC assessments lacked required competency procedural elements of review of test results/worksheets, quality control (QC) records, or preventative maintenance monitoring for TP A and TP B. The inspector noted that the competency assessment for TP A and TP B consisted of a check mark on a column header labeled "Competent" with no evaluation criteria described. (See Personnel Code Sheet.) 3. During the onsite tour on 11/17/20, the inspector requested to review additional competency documentation. The TC stated at approximately 3:00 PM: "The competency assessment check list for my role as TC and as the primary testing personnel does include six elements. We have not updated the competency records for other two staff members who run the Emerald instrument". 4. In an exit interview with the TC at approximately 3:30 PM, the above findings were confirmed. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Nowcare Medical Associates on June 14, 2018 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: D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's hematology proficiency testing (PT) documentation, and interviews, the laboratory failed to retain attestation statements signed by the laboratory director (LD) for six (6) of six (6) events reviewed. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) hematology PT documentation, a total of six (6) events, revealed no LD signed attestation statements for: 2016 Event 3, 2017 Event 1, 2017 Event 2, 2017 Event 3, 2018 Event 1, 2018 Event 2. The inspector noted that a stamp pad signature was utilized for the PT reports and inquired if the LD was responsible for stamping to document his attestation that proficiency testing samples were tested in the same 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 -- manner as patient specimens. The primary testing personnel stated: "No, the lab testing personnel can use the stamp in the lab and the lab director is to follow behind to initial and date the stamping. No documentation of the LD's written signature or initials with a date was available for review. 2. In an interview with the LD and technical consultant on 6/14/18 at approximately 4:30 PM , it was confirmed that the laboratory failed to retain copies of API attestation statements signed by the LD for six (6) of six (6) events reviewed. 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 the laboratory's hematology quality control (QC) Levey Jennings records from June 2016 through May 2018, and an interview, the laboratory failed to document lab director and technical consultant assessment and monitoring of the instrument's Complete Blood Count (CBC) testing according to their written quality assurance policy for sixteen (16) of twenty-four (24) months reviewed. See D5791 (**REPEAT DEFICIENCY) D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a laboratory tour, review of policies and procedures, instrument validation records, manufacturer's Users Guide, and an interview, the laboratory director (LD) failed to document approval of a hematology Complete Blood Count (CBC) procedure in September 2017 when the laboratory installed a new Abbott Emerald analyzer. Findings include: 1. During a tour of the laboratory at approximately 2:00 PM on 6/14/18, the inspector noted an Abbott Emerald hematology analyzer in use for CBC patient testing. 2. Review of the laboratory's Protocols and Package Inserts Manual revealed a hematology procedure for the Cell Dyn 1800. Review of the Quality Assurance Manual revealed a calibration protocol for the Cell Dyn 1800. 3. Review of the Abbott Emerald instrument installation and validation documentation revealed that the laboratory replaced a Cell Dyn 1800 with the Emerald (Serial Number 030617-007156) on 9/6/17. The inspector requested to review the CBC testing and calibration procedures for the Emerald analyzer. The primary testing personnel stated "we have not updated the procedure manual but we do have a User's Guide in the lab cabinet". The inspector reviewed the User's Guide and noted that the procedures included in the guide had not been signed as approved by the LD. 4. In an -- 2 of 3 -- interview with the TC at approximately 4:30 PM on 6/14/18, it was confirmed that the LD failed to document approval of an Abbott Emerald hematology CBC procedure after the analyzer's installation for patient testing in September 2017. 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: Based on a review of the policies and procedures, Quality Control (QC) monthly reports, and an interview, the laboratory failed to document, according to their written policy, review of monthly hematology Complete Blood Count (CBC) QC statistics for sixteen (16) of twenty-four (24) months reviewed. Findings include: 1. Review of the laboratory's policies and procedures revealed a quality assurance (QA) plan that outlined that the lab director (LD) and technical consultant (TC) are to review the hematology analyzer's Levey Jennings reports on a monthly basis in order to assess and correct problems. 2. In review of the laboratory's monthly QC from June 2016 through May 2018, the inspector noted that a stamp pad LD signature was utilized on sixteen (16) monthly QC cover pages to indicate review of the reports. The inspector inquired if the LD was responsible for stamping to document his review of the QC. The primary testing personnel stated: "No, we stamp the cover pages in the lab and the lab director will initial and date beside the stamped signature when he visits the lab". No documentation of the LD's written signature or initials with a date was available for review on the sixteen (16) monthly QC reports dated January 2017 to the date of survey on 6/14/18. The TC signature was also not documented on the monthly QC reports. 3. In an interview with the LD and TC at approximately 4:30 PM, it was confirmed that the laboratory failed to follow a written QA policy to document LD and TC review of the hematology analyzer's CBC Levey Jennings QC statistics for sixteen (16) of twenty-four (24) months reviewed. **REPEAT DEFICIENCY -- 3 of 3 --