Vista Medical Center North Arlington

Summary Statement of Deficiencies D0000 An off-site CLIA proficiency testing (PT) desk review was conducted for Vista Medical Center-North Arlington on September 18, 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 include the following condition under 42 CFR part 493 CLIA Regulation: D2016 - 42 CFR. 493.803 Condition: Successful Participation. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing (PT) desk review of the laboratory's Certification and Survey Provider Enhanced Reporting (CASPER)-0155 report, American Proficiency 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 -- Institute (API) evaluations for 2023 (Event three) and 2024 (Events one, and two), the laboratory failed to successfully participate in a proficiency testing program approved by Health and Human Services (HHS) for the specialty of Hematology for two of three events reviewed. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) off-site desk review of the laboratory's Certification and Survey Provider Enhanced Reporting (CASPER)-0155 report, American Proficiency Institute (API) evaluation reports for 2023 Event three) and 2024 (Events one and two) and interview, the laboratory failed to participate in PT for White Blood Cell count (WBC), Red Blood Cell count (RBC), Hemoglobin (HGB) Hematocrit (HCT), Platelet count (PLT) and WBC Differential (WBC Diff) for two (2) of three (3) hematology testing events resulting in initial unsuccessful PT participation. The findings include: 1. Review of the CASPER-0155 report revealed the following unsatisfactory scores: 2023 Event 3 - WBC, RBC, HGB, HCT, PLT, and Cell ID=0%, 2024 Event 2 - WBC, RBC, HGB, HCT, PLT, and Cell ID=0%, 2. A review of the laboratory's 2023 and 2024 API PT scores for the analytes WBC, RBC, HGB, HCT, PLT, and WBC diff revealed the following unsatisfactory scores: 2023 Event 3 - WBC, RBC, HGB, HCT, PLT, and WBC diff=0%, Unsuccessful, Failure to Participate. 2024 Event 2 - WBC, RBC, HGB, HCT, PLT and WBC diff=0%, Unsuccessful, Failure to Participate. The above findings resulted in initial unsuccessful participation for the analytes listed above. 3. In a telephone interview with the Technical Consultant on September 18, 2024, at approximately 10:10 AM, the findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced CLIA Proficiency Testing (PT) desk review survey was conducted for Vista Medical Center North Arlington on August 21, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as follows and includes the Condition under 42 CFR part 493 CLIA Regulation: D2000- 42 CFR. 493.801 Enrollment and Testing of Samples. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of the CASPER Report 0164S Proficiency Testing (PT) Failure to Re-Enroll Report and CASPER Report 0155, lack of documentation and email, the laboratory failed to enroll in a proficiency testing (PT) program for the Virology /SARS CoV-2 module from January 2023 until August 21, 2023. The findings include: 1. Review of the laboratory's CASPER Report 0164S PT Failure to Re-Enroll Report revealed a lack of documentation of the re-enrollment in a PT program for the specialty of Virology. 2. Review of the laboratory's CASPER Report 0155D Individual Laboratory Profile revealed a lack of documentation of scores for the first and second events in 2023 for Virology. 3. In an email correspondence with the laboratory on August 21, 2023 at 3:07 PM, the laboratory manager confirmed the 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 -- findings. The laboratory manager stated in the email that when they tried to enroll in PT for SARS CoV-2 for 2023, the PT program told the laboratory that they could not enroll for the same assay on the same instrument. After receiving the surveyor's email on August 21, 2023, the laboratory manager stated they contacted American Proficiency Institute and were told they could enroll for the SARS CoV-2 module. The laboratory provided a 2023 Order Confirmation with a order date of August 21, 2023 with shipment of samples on 09/18/2023. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Vista Medical Center-North Arlington on February 21, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The inspector noted the laboratory performs SARS-CoV-2 (COVID-19) testing and is in compliance with the applicable COVID-19 reporting requirements. Specific deficiencies cited are as follows and include the following Condition under 42 CFR part 493 CLIA Regulation: D6063 - 42 C.F.R. 493.1421 Condition: Testing Personnel. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a tour of the laboratory, review of the laboratory's policy and procedures, reagent records, quality control (QC) records, lack of documentation, patient test records and interview, the laboratory failed to follow their established policy to perform external QC materials with each shipment/lot number of each assay or, at minimum, monthly for two (2) of five (5) months reviewed from October 11, 2022 until the date of the survey on February 21, 2023. The findings include: 1. A tour of the lab on February 21, 2023 at approximately 9:30 AM revealed the laboratory performs SARS CoV-2 (COVID-19), Influenza A and B, Respiratory Syncitial Virus testing utilizing the Xpert Xpress CoV-2/Flu/RSV plus cartridges on the Cepheid GeneXpert Xpress System. 2. Review of the laboratory's policies and procedures revealed an Individualized Quality Control Plan (IQCP) approved by the laboratory director on June 18, 2022. The IQCP stated, "Quality Control for Cepheid GeneXpert 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 -- assays will consist of documenting acceptable results for 2 levels of external controls for each shipment/lot of each assay or, at minimum, monthly." 3. Review of reagent records from October 11, 2022 until the date of the survey on February 21, 2023 revealed the laboratory received a shipment of the Xpert Xpress CoV-2/Flu/RSV plus cartridges (reagent lot number 01908 exp 06/25/2023) on October 11, 2022. The laboratory received no additional shipments as of the date of the survey. External QC was performed for the shipment of Xpert Xpress CoV-2/Flu/RSV plus cartridges on October 11, 2022. 4. Review of QC and patient records for the GeneXpert Xpress system from October 11, 2022 until the date of the survey on February 21, 2023 revealed a lack of documentation of external QC materials for the Xpert Xpress CoV-2 /Flu/RSV plus cartridges for November 2022 and December 2022. Review of patient test records revealed one patient was tested on 11/27/2022 utilizing the Xpert Xpress CoV-2/Flu/RSV plus cartridges. The surveyor requested to review documentation of the external QC for the Xpress CoV-2/Flu/RSV plus cartridges for November 2022 and December 2022. The laboratory provided no documentation for review. 5. In an exit interview with the technical consultant on February 21, 2023, at approximately 1: 00 PM, the above findings were confirmed. 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: A. Based on a laboratory tour, review of the laboratory's maintenance logs, policies and procedures, manufacturer's operator guide, lack of documentation and interviews, the laboratory failed to provide documentation of the daily and monthly maintenance performed on the Horiba ABX Micros 60 hematology analyzer for six months from September 1, 2022 until the date of the survey on February 21, 2023. The findings include: 1. During a tour of the laboratory on February 21, 2023 at approximately 9:30 AM, the surveyor noted the laboratory utilizes the Horiba ABX Micros 60 Hematology analyzer (serial number 111CS99917) to perform Complete Blood Counts (CBC). 2. Review of the laboratory's maintenance logs from September 1, 2022 until the date of the survey on February 21, 2023 revealed a lack of documentation of the completed maintenance logs from September 1, 2022 until February 21, 2023. The surveyor requested to review the monthly maintenance logs for September 2002 to February 2023. The laboratory provided no documentation for review. 3. Review of the laboratory's policies and procedures revealed the following statement: "Horiba Micros 60: Maintenance: Daily-Check Reagent levels; Check Waste level-empty if needed; Perform Start-up Cycle and verify acceptable; Run control and verify acceptable; Perform Shut-down Cycle at end of day; Document with initials on Maintenance Chart for Horiba Micros 60; Weekly-to help insure reliability of analyzer and results generated; Perform concentrated cleaning; Perform Backflush of system; and Document with initials on Maintenance Chart for Horiba Micros 60." 4. Review of the manufacturer operator's guide revealed maintenance procedures to include performing daily start-up and shutdown, check reagent levels, check waste level and monthly performance of concentrated cleaning procedures. 5. In an exit interview with the technical consultant on February 21, 2023, at approximately 1:00 PM, the above findings were confirmed. B. Based on a laboratory tour, review of the laboratory's maintenance logs, policies and procedures, -- 2 of 4 -- manufacturer's operator guide, lack of documentation and interviews, the laboratory failed to provide documentation of the weekly and quarterly maintenance performed on the Cepheid GeneXpert Xpress System from from September 1, 2022 until the date of the survey on February 21, 2023. The findings include: 1. During a tour of the laboratory on February 21, 2023 at approximately 9:30 AM, the surveyor noted the laboratory utilizes the Cepheid GeneXpert Xpress System (serial number (845270) to perform SARS CoV-2 (COVID-19), Influenza A and B, and Respiratory Syncitial Virus testing. 2. Review of the Cepheid GeneXpert manufacturer's operator guide revealed the following maintenance procedures: Weekly-power down the GeneXpert instrument and computer; Quarterly-Clean plunger rod, cartridge bays, and instrument surfaces. 3. Review of the Cepheid GeneXpert's maintenance logs from September 1, 2022 until the date of the survey on February 21, 2023 revealed the following weeks lacked documentation of the weekly maintenance: November 2022 - 2 of 4 weeks; December 2022 - 2 of 4 weeks; January 2023 - 2 of 4 weeks; February 2023 - 2 of 3 weeks. The surveyor requested to review documentation of the weekly maintenance for the above listed months. The laboratory provided no documentation for review. 4. Review of the Cepheid GeneXpert's maintenance logs from September 1, 2022 until the date of the survey on February 21, 2023 revealed quarterly maintenance was performed during installation on July 20, 2022 and again on January 30, 2023. The surveyor requested to review additional documentation of the quarterly maintenance. The laboratory provided no documentation for review. 5. In an exit interview with the technical consultant on February 21, 2023, at approximately 1:00 PM, the above findings were confirmed. 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 review of the Center for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS 209), available testing personnel records, lack of documentation, and interview, the laboratory failed to provide documentation of education qualifications for two of five laboratory testing personnel performing non- waived testing on the Horiba ABX Micros 60 Hematology analyzer and the Cepheid GeneXpert Xpress analyzer from September 1, 2022 to the date of the survey on February 21, 2023. Refer to 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 -- 3 of 4 -- 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: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), personnel records, lack of documentation, and interview, the laboratory failed to retain documentation of education qualifications for two of five testing personnel (TP) from September 1, 2023 to the date of the inspection on February 21, 2023. Findings include: 1. Review of the CMS 209 Laboratory Personnel Report revealed that the Lab Director (LD) identified five TP as qualified to perform moderate complexity Complete Blood Count (CBC) and Food and Drug Administration (FDA) Emergency Use Authorized (EUA) Cepheid GenExpert Express Real-Time Polymerase Chain Reaction (RT-PCR) COVID-19 patient testing. 2. Review of the available laboratory personnel records of TP A and TP B for evaluation of education documentation revealed a lack of documentation of TP A and TP B's education. TP A and TP B's personnel record indicated initial training and patient testing began September 2022. The surveyor requested to review education documentation for TP A and TP B. The laboratory provided no education documentation to review. (See attached Personnel Code Sheet.) 3. In an exit interview with the technical consultant on February 21, 2023 at approximately 1:00 PM, the above findings were confirmed. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at Urgent Care Center of Arlington on March 12, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies are as follows: 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 Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), the laboratory's proficiency testing (PT) records and an interview with Testing Personnel (TP) A, the laboratory failed to rotate PT among testing personnel performing patient testing for nine (9) of nine (9) PT events during calendar years 2017 and 2018. Findings include: 1. Review of the CMS Form 209 revealed five (5) testing personnel performing patient testing in 2017 and 2018. 2. Review of the laboratory's 2017 and 2018 American Proficiency Institute (API) PT documentation (a total of 9 events) revealed TP A performed the following PT Events: 2017 API Core Chemistry Event 2; 2017 API Hematology/Coagulation Event 1; 2017 API Hematology/Coagulation Event 2; 2017 API Hematology/Coagulation Event 3; 2018 API Virology Event 3; 2018 API Core Chemistry Event 1; 2018 API Hematology/Coagulation Event 1; 2018 API Hematology/Coagulation Event 2 and 2018 API Hematology/Coagulation Event 3. 9 of 9 PT events were performed by TP A. (See Personnel Code Sheet.) 3. In an exit interview at approximately 1:45 PM, TP A confirmed the above findings. D2009 TESTING OF PROFICIENCY TESTING SAMPLES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) records and an interview with Testing Personnel (TP) A, the Laboratory Director (LD) and testing personnel failed to sign five (5) of nine (9) PT attestation statements during calendar years 2017 and 2018. Findings include: 1. Review of the American Proficiency Institute (API) records for 2017 and 2018 revealed the following: 2017 API Core Chemistry Event 2 attestation signed by LD and TP A; 2017 API Hematology /Coagulation Event 1 attestation signed by LD and TP A; 2017 API Hematology /Coagulation Event 2 attestation signed by LD and TP A; 2017 API Hematology /Coagulation Event 3 attestation not signed by Laboratory Director and TP A; 2018 API Virology Event 3 attestation not signed by Laboratory Director and TP A; 2018 API Core Chemistry Event 1 attestation signed by LD and TP A; 2018 API Hematology/Coagulation Event 1 attestation not signed by Laboratory Director and TP A; 2018 API Hematology/Coagulation Event 2 attestation not signed by Laboratory Directore and TP A; and 2018 API Hematology/Coagulation Event 3 attestation not signed by Laboratory Director and TP A. Five (5) of the 9 attestation statements were not signed by Laboratory Director and TP A. 2. In an exit interview at approximately 1:45 PM, TP A confirmed the above findings. 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 the review of the laboratory's proficiency testing (PT) records and interview with Testing Personnel (TP) A, the Laboratory Director (LD) failed to review and sign one (1) of nine (9) PT events during calendar years 2017 and 2018. Findings include: 1. Review of the American Proficiency Institute (API) PT records for four (4) events in 2017 and five (5) events in 2018 revealed that the LD failed to review and sign API 2018 Hematology/Coagulation Event 3 PT results. 2. In an exit interview at approximately 1:45 PM, TP A confirmed the above findings. 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. -- 2 of 11 -- This CONDITION is not met as evidenced by: Based on a review of the policy and procedure manual, instrument package inserts and operators guide, Quality Control records, Quality Assessment records, temperature records, instrument maintenance records, calibration records, and interviews, the laboratory failed: to document temperatures (Cross Reference D5413); perform and document instrument maintenance (Cross Reference D5429); perform calibration every 6 months for Horiba Micros 60+ (Cross Reference D5437); perform a positive and negative control each day of patient testing on the Cepheid GeneXpert (Cross Reference D5449); verify new lots of quality control for the Horiba Micros 60+ (Cross Reference D5469); and address analytic failures in the quality assessment system (Cross Reference D5791). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the policy and procedure manual, Cepheid GeneXpert validation records and interview with Testing Personnel (TP) A, the laboratory failed to have a written procedure for the Cepheid GeneXpert prior to reporting patients from June 20, 2018 until February 8, 2019. Findings include: 1. Review of the policy and procedure manual revealed a procedure for the Cepheid GeneXpert signed by the Laboratory Director on February 9, 2019. In an interview, TP A stated they did not have a procedure for the Cepheid GeneXpert prior to testing patients. He/she stated they did not have a procedure until February 9, 2019. 2. Review of the Cepheid GeneXpert validation records revealed the instrument was installed on June 8 2018 and patient testing began on June 20, 2018. 3. In an exit interview at approximately 1:45 PM, TP A confirmed the above findings. 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 the review of manufacturer's quality control package inserts, Horiba Micros 60+ operator's guide, temperature records, and interview with Testing Personnel (TP) A, the laboratory failed to monitor and document room temperature, relative humidity, and refrigerator temperatures according to manufacturer's specifications for six (6) of thirty (30) days in November 2017 and four (4) of thirty-one (31) days in December 2018. Findings include: 1. Review of the package insert for the Horiba Minotrol 16 -- 3 of 11 -- quality control material revealed the following statement, "Minoitrol and Minocal vials should be tightly covered and stored at 2-8 degrees Celsius." 2. Review of the Horiba Micros 60+ operator's guide revealed the following statement, "Operating ambient room temperature 16-34 degrees Celsius (61-93 degrees Fahrenheit), relative humidity less than 80%." 3. Review of the temperature records for November 2017 revealed the lack of documentation of room temperature, relative humidity and refrigerator temperature for 11/1/17, 11/2/17, 11/3/17, 11/12/17, 11/14/17 and 11/23 /17 (a total of 6 days). Review of the temperature records for December 2018 revealed the lack of documentation of room temperature, relative humidity and refrigerator temperature for 12/2/19, 12/9/19, 12/29/19 and 12/30/19 (a total of 4 days). 4. In an exit interview at approximately 1:45 PM, TP A 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 the review of the Horiba Micros 60+ procedure, available maintenance documentation, and an interview, the laboratory failed to follow the laboratory's Horiba Micros 60+ procedure for performing and documenting instrument maintenance procedures from July 1, 2018 to March 12, 2019. 1. Review of the Horiba Micros 60+ procedure revealed the following statements: "Daily-Check reagent levels; Check Waste level-empty if needed; Perform Start-up Cycle and verify acceptable; Run Control and verify acceptable; Perform Shut-down Cycle at end of day; Document with initials on Chart for Horiba Micros 60. Weekly-to help ensure reliability of analyzer and results generated-Perform Concentrated Cleaning; Perform Backflush of system; Document with initials on Maintenance Chart for Horiba Micros 60. As Needed-Annually-Preventative Maintenance via Service Rep." The surveyor requested maintenance documentation from the laboratory. At approximately 1:00 PM, TP A stated: "We perform maintenance on the Horiba but have not been recording it." 2. Review of the available maintenance documentation revealed a lack of documentation of the daily, weekly and monthly maintenance performed by testing personnel on the Horiba Micros 60+ from July 1, 2018 to March 12, 2019. 3. In an exit interview at approximately 1:45 PM, TP A 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 acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. -- 4 of 11 -- This STANDARD is not met as evidenced by: Based on review of policy and procedure manual, Horiba Micros 60+ calibration records, and an interview with Testing Personnel (TP) A, the laboratory failed to document calibration procedures every six (6) months for Complete Blood Count (CBC) testing according to their policy from 11/18/16 until 2/8/19. Findings include: 1. Review of the laboratory's procedure manual revealed a Horiba Micros 60+ policy that stated: "Calibration must be done every 6 months (or more often if conditions dictate, or major maintenance is performed). Document lot #s and Dates of calibration." 2. Review of the laboratory's 2016, 2017 and 2018 calibration records revealed calibrations were performed on the Horiba Micros 60+ on 11/18/16, 6/28/17, 3/5/18, 6/1/18 and 2/8/19. The surveyor requested additional documentation records for calendar year 2017, 2018 and 2019 demonstrating calibration for the Horiba Micros every 6 months. No additional calibration documentation was available between 6/28/17 to 3/5/18 and 6/1/18 and 2/8/19. 3. In an exit interview at approximately 1:45 PM, TP A confirmed the above findings. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: A. Based on review of the package insert for the Cepheid GeneXpert Chlamydia trachomatis and Neisseria gonorrhea (CT/NG) assay kit, Cepheid GeneXpert quality control records, instrument data file and interview with Testing Personnel (TP) A, the laboratory failed to perform external positive and negative quality control (QC) materials each day of patient testing for CT/NG from August 19, 2018 until February 8, 2019, while reporting thirty-seven (37) patients. Findings include: 1. Review of the package insert for the Cepheid GeneXpert Chlamydia trachomatis and Neisseria gonorrhea (CT/NG) assay kits revealed no manufacturer recommendations were given for external QC and the statement: "External controls may be used in accordance with local, state, and federal accrediting organizations, as applicable." was noted. 2. Review of the Cepheid GeneXpert quality control records for CT/NG from June 20, 2018 until February 8, 2019 revealed QC was performed on the following days: 10/3 /18, 11/14/18 and 1/22/19. The surveyor requested further documentation of QC. At approximately 12:30 PM, TP A stated: "We had an IQCP that we used from 8/18/18 to 2/8/19, that stated QC was to be performed every month, new shipment or lot of assay kits". The surveyor requested to review the IQCP. The laboratory provided an IQCP dated 2/8/19. No other IQCP was available for review. 3. Review of the GeneXpert's data file revealed CT/NG patient testing was performed on the following days: 08/20/18 1 patient #21598; 08/21/18 1 patient #30036; 08/22/18 1 patient #26145; 08/29/18 1 patient #20643; 09/08/18 1 patient #27215; 09/12/18 1 patient #21598; 09/29/18 1 patient #24545; 10/04/18 2 patients #30315 and 29337; 10/11/18 2 patients #30333 and 30395; 10/14/18 1 patient #30419; 10/23/18 1 patient #30491; 10/30/18 1 patient #27778; 10/31/18 1 patient #30545; 11/16/18 2 patients #30662 and 30636; 11/20/18 1 patient #30690; 11/23/18 1 patient #27215; 11/27/18 1 patient #20643; 12/04/18 1 patient #30791; 12/19/18 5 patients #30378, 30872, 30946, -- 5 of 11 -- 29376, and 30978; 12/21/18 2 patients #22562 and 30945; 12/24/18 1 patient #30945; 12/26/18 1 patient #31037; 12/27/18 1 patient #31053; 12/28/18 1 patient #27780; 01 /03/19 1 patient #31125; 01/06/19 1 patient #31160; 01/07/19 1 patent #23519; 02/01 /19 1 patient #31239; 02/02/19 1 patient #23573; A total of 37 patients. The surveyor requested to review the documentation of the laboratory performing positive and negative external quality control materials each day of patient testing listed above. No documentation was not available for review. 3. In an exit interview at approximately 1: 45 PM, TP A confirmed the above findings. B. Based on review of the package insert for the Cepheid GeneXpert Trichomonas Vaginalis (TV) assay kit, Cepheid GeneXpert quality control records, instrument data file and interview with Testing Personnel (TP) A, the laboratory failed to perform external positive and negative quality control (QC) materials each day of patient testing for TV from August 19, 2018 until February 8, 2019, while reporting sixteen (16) patients. Findings include: 1. Review of the package insert Cepheid GeneXpert Trichomonas Vaginalis (TV) assay kit revealed no manufacturer recommendations were given for external QC and the statement, "External controls may be used in accordance with local, state, and federal accrediting organizations, as applicable." was noted. 2. Review of the Cepheid GeneXpert quality control records for TV from June 20, 2018 until February 8, 2019 revealed QC was performed on the following days: 10/3/18, 11/14/18 and 1/22/19; The surveyor requested further documentation of QC. At approximately 12:30 PM, TP A stated: "We had an IQCP that we used from 8/18/18 to 2/8/19, that stated QC was to be performed every month, new shipment or lot of assay kits". The surveyor requested to review the IQCP. The laboratory provided an IQCP dated 2/8/19. No other IQCP was available for review. 3. Review of the GeneXpert's data file revealed patient testing was performed on the following days: 08/20/18 1 patient #21598; 08/21 /18 1 patient #30036; 09/12/18 1 patient #21598; 09/29/18 1 patient #24545; 10/23/18 1 patient #30491; 10/30/18 1 patient #27778; 11/12/18 1 patient #30635; 11/13/18 1 patient #19978; 11/16/18 1 patient #30662; 11/20/18 1 patient #30690; 12/04/18 1 patient #30791; 12/19/18 1 patient #30946; 12/26/18 1 patient #31037; 12/27/18 1 patient #31053; 01/07/19 1 patent #23519; 01/28/19 1 patient #31299. The surveyor requested to review the documentation of the laboratory performing positive and negative external quality control materials each day of patient testing listed above. No documentation was not available for review. 3. In an exit interview at approximately 1: 45 PM, TP A confirmed the above findings. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: -- 6 of 11 -- Based on the review of policy and procedure manual, Horiba Micros 60+ quality control (QC) data and interview with the Testing Personnel (TP) A, the laboratory failed to follow the established policy for performing verification of each new lot number of QC material prior to use for seven (7) of seven (7) lot numbers received in the calendar years 2018 and 2019. Findings include: 1. Review of the policy and procedure manual revealed a policy, "Quality Control", which stated: "Parallel testing of new lot numbers of QC should be performed for preferably 5 days to confirm the validity of new controls before putting into use. This should be documented accordingly." 2. Review of the Micros 60+ hematology analyzer's QC records revealed the following lot numbers of Horiba Minotrol 16 tri-level QC material were received in 2018 and 2019: MX410 expiration date 6/5/18; MX411 expiration date 8/6 /18; MX412 expiration date 10/6/18; MX413 expiration date 12/5/18; MX414 expiration date 2/5/18; MX415 expiration date 4/5/19; and MX416 expiration date 6/5 /19. The surveyor requested to review documentation of the verification of the new lot numbers of QC prior to use. No documentation was available for review. 3. In an exit interview at approximately 1:45 PM, TP A confirmed the above findings. 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 the review of the Quality Assurance (QA) plan, manufacturer's operating guide, package inserts, calibration records, Quality Control (QC) records, instrument data files, and interviews, the laboratory's established QA plan failed to identify and address analytic issues in the specialties of hematology, and bacteriology (Cross Reference D5413, D5429, D5437, and D5449). Findings include: 1. Review of the manufacturer's operating guide, package inserts, calibration records, quality control (QC) records, instrument patient data files revealed the following analytic issues: - No documentation of the laboratory monitoring or documenting temperatures for six (6) days in November 2017 and four (4) days in December 2018. - No documentation of the laboratory performing and documenting maintenance on the Horiba Micros 60+ from July 1, 2018 until March 12, 2019. - No documentation of the laboratory performing calibration on the Horiba Micros 60+ according to their policy in 2017 and 2018. - No documentation of the laboratory performing positive and negative quality controls each day of patient testing for the Cepheid GeneXpert from August 19, 2018 until February 2019. 2. Review of the QA plan revealed a schedule/checklist used by the laboratory for quality assessment monitoring The schedule/checklist listed the following monitors: "Environmental, Maintenance, QC/Levy Jennings, Log Reviews, QA Policy Review, Patient Test Management, Competency/Personal Training, Calibration/Calibration Verification, Lab Safety/OSHA review, Proficiency Testing Reviews, and Procedure Manual Review." The checklist was not completed from October 2017 until the date of the survey. The surveyor requested to review documentation of the completed checklist. No documentation was provided by the laboratory. 3. In an exit interview at approximately 1:45 PM, TP A confirmed the findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR -- 7 of 11 -- 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 policy and procedure manuals, Quality Control (QC) records, Quality Assessment (QA) records, personnel records, temperature records, maintenance records, and interviews, the laboratory director failed: to ensure the staff followed the established QC policy to print out monthly the Hematology Levy-Jennings graphs for the Horiba Micros 60+ (Cross Reference D6020 A) ; to ensure external quality control was performed each day of patient testing on the Cepheid GeneXpert (Cross Reference D6020 B and C); to ensure the QA Plan was maintained (Cross Reference D6021); to ensure the established competency policy was followed for new testing personnel (Cross Reference D6029); to ensure a step- wise procedure was available for the Cepheid GeneXpert analyzer used for patient testing (Cross Reference D6031). D6020 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 program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: A. Based on the review of the policy and procedure manual, Horiba Micros 60+ Quality Control (QC) records, and interviews with Testing Personnel (TP) A, the laboratory director failed to ensure the staff followed the established QC policy to print out monthly the Hematology Levy Jennings graphs for the eight (8) months reviewed between July 2018 and the date of the survey on 3/12/19. Findings: 1. Review of the policy and procedure manual revealed a policy, "Quality Control", which stated: "Levy Jennings graphs will be printed and reviewed for shifts and trends and