Lakeview Pediatrics And Family Medicine

Summary Statement of Deficiencies D0000 An off-site CLIA proficiency testing (PT) desk review was conducted for Lakeview Pediatrics and Family Medicine by the Virginia Department of Health's Office of Licensure and Certification and was completed on September 30, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows and includes the Conditions under 42 CFR part 493 CLIA Regulation: D2016 - 42 CFR. 493.803 Condition: Successful Participation, D6000 - 42 CFR. 493.1403 Condition: Laboratories performing moderate complexity testing- Laboratory Director. 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: 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 -- Based on a review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0153 report, 2025 American Proficiency Institute (API) Proficiency test (PT) results, and interview, the laboratory failed to successfully participate in the platelet (PLT) anaylte in two (2) consecutive 2025 Hematology PT testing events (Event 1 and Event 2). Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0153 report, American Proficiency Institute (API) Proficiency test (PT) results for 2025 (events one and two), and interview, the laboratory failed to attain a score of at least eighty percent of acceptable responses for the platelet (PLT) anaylte in two (2) consecutive 2025 Hematology testing events resulting in an unsuccessful PT performance. Findings include: 1. Review of the CASPER 153 report revealed platelet PT scores of less than 80% for the following hematology events: 2025 Event 1 = 60%, 2025 Event 2 = 0%, resulting in unsuccessful PT performance. 2. Review of the two 2025 American Proficiency Institute (API) Proficiency test (PT) results confirmed the scores above and revealed that the lab failed to participate in the 2nd PT event resulting in a zero. 3. In a telephone interview with the lab director and clinical coordinator on 09/30/2025 at 2:20 PM, the results were confirmed. The lab director stated "We will work on it." D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR 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 proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 153 report, and the 2025 American Proficiency Institute proficiency testing records, the laboratory director (LD) failed to ensure the overall quality of the laboratory services provided by failing to ensure successful participation in a HHS approved Proficiency testing program. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of Certification and Survey Provider Enhanced Reporting (CASPER) 153 report, the laboratory's 2025 American -- 2 of 3 -- Proficiency Institute (API) Proficiency test records (events 1 and 2), and interview, the laboratory director (LD) failed to ensure successful participation in a HHS approved Proficiency testing program. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Lakeview Pediatrics and Family Medicine on June 6-7, 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 the two Conditions under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems, D6000 -42 CFR. 493.1403 Laboratory Director. 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 proficiency testing (PT) documentation, procedures, lack of documentation, and interviews, the laboratory failed to retain attestation statements signed by the laboratory director (LD) and testing personnel (TP) for six (6) of 6 Core Chemistry, and 6 of 6 Hematology module PT events during the review timeframe of September 2022 to the date of the inspection June 6, 2024. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) Core Chemistry and Hematology PT documentation, a total of twelve (12) module events (Chemistry 2022 Event 3, 2023 Events 1-3, 2024 Events 1-2, Hematology Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 2022 Event 3, 2023 Events 1-3, 2024 Events 1-2), revealed no signed attestation statements by the LD or performing TP. The inspector requested to review signed attestations for the 12 events outlined above. No documentation was available. The Quality Manager stated on 6/6/24 at 11 AM, "We made the assignments to ensure that the PT was rotated among the testing personnel but we failed to ensure that they signed the attestations". 2. The inspector noted API instructions on the PT records outlined above: "Signatures Required- For all PT results, an attestation statement must be signed by laboratory director and testing personnel and retained for minimum of two years." Review of the laboratory procedure manual revealed a Proficiency Testing Policy that stated, "the director and testing personnel will sign/date the attestation submission to the proficiency program." 3. An exit interview with the Quality Manager on 6/6/24 at 12:30 PM 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. This CONDITION is not met as evidenced by: Based on a review of manufacturer's operations manuals, instrument maintenance logs, policies and procedures, hematology calibration records, lack of documentation, and interview, the laboratory failed to: 1. document performance of semi-annual hematology instrument preventative maintenance per manufacturer's instructions in calendar year 2023 through the date of the inspection on June 6, 2024. *NOTE: THIS IS A REPEAT DEFICIENCY* Cross Reference- D5429A; 2. document performance of chemistry instrument preventative maintenance every six months per manufacturer's instructions in calendar year 2023 through the date of the inspection on 6/6/24. Cross Reference- D5429B; 3. document calibration procedures every six months for Complete Blood Count patient testing according to their written procedure in calendar year 2023. *NOTE: THIS IS A REPEAT DEFICIENCY* Cross Reference- 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: A. Based on a review of manufacturer's operations manual, instrument maintenance logs, lack of documentation, and an interview, the laboratory failed to document performance of semi-annual hematology instrument preventative maintenance per manufacturer's instructions in calendar year 2023 through the date of the inspection on June 6, 2024. **REPEAT DEFICIENCY Findings include: 1. Review of the Abbott Emerald Operation's Manual under Section 9 (titled: Preventative Maintenance -- 2 of 7 -- Schedule) revealed protocol instructions as, "Semi-Annual Maintenance- perform Lubricating Syringe Pistons procedure every six months per procedure below. Document the maintenance on the maintenance log". 2. Review of the laboratory's hematology maintenance logs for Abbott Emerald (Serial Number 030620-008346) for the timeframe of January 2023 to the date of the survey on 6/6/24, revealed that "Lubricating Syringe Pistons" maintenance was documented as performed once (dated 4/3/23). The inspector noted the maintenance was documented by an Abbott field service technician. 3. The inspector requested to review additional documentation of the semi-annual maintenance after 4/3/23. No additional documentation was available for review. 4. An exit interview with the Quality Manager on 6/6/24 at 12:30 PM confirmed the above findings. B. Based on a review of manufacturer's operations manual, instrument maintenance logs, lack of documentation, and an interview, the laboratory failed to document performance of chemistry instrument preventative maintenance every six months per manufacturer's instructions in calendar year 2023 through the date of the inspection on June 6, 2024. Findings include: 1. Review of the Abbott iSTAT Operation's Manual under section titled: Manufacturer's Quality System Instructions, revealed protocol instructions as: "Thermal Probe- ensure the thermal probe check is performed every six months on each iSTAT handheld analyzer. This verification check may be performed in conjunction with the analyzer software updates. Document in maintenance log." 2. Review of the laboratory's available chemistry maintenance logs for Abbott iSTAT (Serial Number 404261) for the timeframe of January 2023 to the date of the survey on 6/6/24, revealed no documentation of the thermal probe verification outlined above. 3. The inspector requested to review documentation of the every six month maintenance performed in calendar year 2023 and year to date 2024. No documentation was available for review. 4. An exit interview with the Quality Manager on 6/6/24 at 12:30 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 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 policies and procedures, hematology calibration records, lack of documentation, and an interview, the laboratory failed to document calibration procedures every six months for Complete Blood Count (CBC) patient testing according to their written procedure in calendar year 2023. *REPEAT DEFICIENCY* Findings include: 1. Review of the laboratory's procedure manual revealed a Quality Assurance protocol (CBC Calibration) that stated "calibration frequency for Abbott Emerald is at least once every six months". 2. Review of the Emerald hematology instrument (Serial Number 030620-008346) calibration documentation for calendar year 2023 up to the date of the inspection on 6/6/24, -- 3 of 7 -- revealed two documented calibration procedures (dated 4/03/23, 4/30/24). 3. The inspector requested to review additional calibration records for the Emerald analyzer during calendar year 2023. No additional calibration documentation was available for review. 4. An exit interview with the Quality Manager on 6/6/24 at 12:30 PM confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR 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 Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), CMS CLIA 116 Database, laboratory personnel files, proficiency testing (PT) records, policies, manufacturer's operations manuals, analyzer maintenance records, and interviews, the laboratory director failed to: 1. provide documentation of education credit hours in laboratory practice commensurate with the moderate complexity director responsibilities during the twenty-one months of review (September 2022 to June 6, 2024) - Cross Reference D6003; 2. to identify the quality assessment failures as they occurred for missed PT attestation documentation, missed twice annual hematology and chemistry instrument maintenance, and missed every six month hematology calibrations during the review timeframe outlined above - Cross Reference D 6021. D6003 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1405 AND 493.1406 The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of moderate complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R of this part. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the Laboratory is located; and (b)(2)(ii) Have had laboratory training or experience consisting of: (b)(2)(ii)(A) At least one year directing or supervising non- waived laboratory testing; or (b)(2)(ii)(B) Beginning September 1, 1993, have at least 20 continuing medical education credit hours in laboratory practice commensurate with the director responsibilities defined in 493.1407; or (b)(2)(ii)(C) Laboratory training equivalent to paragraph (b)(2)(ii)(B) of this section obtained during medical residency. (For example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution; and (b)(3)(i) Be certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the -- 4 of 7 -- American Board of Bioanalysis, or the American Board of Medical Laboratory Immunology; or (b)(3)(ii) Have had at least one year experience directing or supervising non-waived laboratory testing; (b)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; (b)(4)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing; and (b)(4)(iii) In addition, have at least one year of supervisory laboratory experience in non-waived testing; or (b)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; (b)(5)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing; and (b)(5)(iii) In addition, have at least 2 years of supervisory laboratory experience in non-waived testing; (b)(6) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under 493.1406; or (b)(7) On or before February 28, 1992, qualified under State law to direct a laboratory in the State in which the laboratory is located. Laboratory director qualifications on or before February 28, 1992 The laboratory director must be qualified to manage and direct the laboratory personnel and test performance. (a) The laboratory director must possess a current license as a laboratory director issued by the State, if such licensing exists; and (b) The laboratory director must: (b)(1) Be a physician certified in anatomical or clinical pathology (or both) by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (b)(2) Be a physician who: (b)(2)(i) Is certified by the American Board of Pathology or the American Osteopathic Board of Pathology in at least one of the laboratory specialties; or (b)(2)(ii) Is certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other national accrediting board in one of the laboratory specialties; or (b)(2)(iii) Is certified by the American Society of Cytology to practice cytopathology or possesses qualifications that are equivalent to those required for such certification; or (b)(2)(iv) Subsequent to graduation, has had 4 or more years of full-time general laboratory training and experience of which at least 2 years were spent acquiring proficiency in one of the laboratory specialties; (b)(3) For the subspecialty of oral pathology only, be certified by the American Board of Oral Pathology, American Board of Pathology or the American Osteopathic Board of Pathology or possesses qualifications that are equivalent to those required for certification; (b)(4) Hold an earned doctoral degree from an accredited institution with a chemical, physical, or biological science as a major subject and (b)(4)(i) Is certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other national accrediting board acceptable to HHS in one of the laboratory specialties; or (b)(4)(ii) Subsequent to graduation, has had 4 or more years of full-time general laboratory training and experience of which at least 2 years were spent acquiring proficiency in one of the laboratory specialties; (b)(5) With respect to individuals first qualifying before July 1, 1971, have been responsible for the direction of a laboratory for 12 months between July 1, 1961, and January 1, 1968, and, in addition, either: (b)(5)(i) Was a physician and subsequent to graduation had at least 4 years of pertinent full-time laboratory experience; (b)(5)(ii) Held a master's degree from an accredited institution with a chemical, physical, or biological science as a major subject and subsequent to graduation had at least 4 years of pertinent full- time laboratory experience; (b)(5)(iii) Held a bachelor's degree from an accredited institution with a chemical, physical, or biological science as a major subject and subsequent to graduation had at least 6 years of pertinent full-time laboratory experience; or (b)(5)(iv) Achieved a satisfactory grade through an examination conducted by or under the sponsorship of the U.S. Public Health Service on or before July 1, 1970; or (b)(6) Qualify under State law to direct the laboratory in the State in -- 5 of 7 -- which the laboratory is located. Note: The January 1, 1968 date for meeting the 12 months' laboratory direction requirement in paragraph (b)(5) of this section may be extended 1 year for each year of full-time laboratory experience obtained before January 1, 1958 required by State law for a laboratory director license. An exception to the July 1, 1971 qualifying date in paragraph (b)(5) of this section was made provided that the individual requested qualification approval by October 21, 1975 and had been employed in a laboratory for at least 3 years of the 5 years preceding the date of submission of his qualifications. 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), CMS CLIA 116 Database, laboratory personnel files, and an interview, the laboratory director (LD) failed to provide documentation of education credit hours in laboratory practice commensurate with the moderate complexity director responsibilities for the twenty one months of review (September 2022 to June 6, 2024). Findings include: 1. Review of the CMS Form 209 revealed that Personnel A was identified as LD and who also performs the duties of clinical consultant and technical consultant, and that nine testing personnel are responsible for moderate complexity Complete Blood Count (CBC) hematology and iSTAT Chemistry 8 panel patient testing during the review timeframe of September 2022 to 6 /6/24. *See Personnel Code Sheet. 2. Review of the CMS CLIA 116 database revealed Personnel B was identified as the laboratory director. The inspector inquired regarding the date of laboratory director change. The Quality Manager stated that Personnel B "left the position in late 2022". *See Personnel Code Sheet. 3. Review of the laboratory's employee files revealed that Personnel A's file contained current Medical Doctor license. The inspector requested to review documentation of laboratory training /experience or medical education for laboratory director responsibilities oversight of hematology and chemistry specialities. No documentation was available for review at the time of request. The Quality Manager stated during a follow up interview on 7/7 /24 at 2 PM, "I thought that since the LD was also listed as a director at one of our Certificate of Waiver locations, that would be sufficient to qualify as LD for Certificate of Compliance as well." 4. An exit interview with the Quality Manager on 6 /6/24 at 12:30 PM and follow up interview on 6/7/25 at 2 PM confirmed the above findings. 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 proficiency testing (PT) records, policies, manufacturer's operations manual, analyzer maintenance records, lack of documentation, and interviews, the laboratory laboratory director failed to identify the following quality assessment (QA) failures as they occurred: 1. lack of retention of PT attestation statements for twelve (12) of 12 hematology and chemistry PT modules during the -- 6 of 7 -- review timeframe of September 2022 to June 6, 2024; Cross Reference D2015. 2. lack of documentation for required twice annual hematology and chemistry instrument preventative maintenance during review timeframe outlined above; **REPEAT DEFICIENCY, Cross Reference D5429. 3. lack of documentation for required calibration procedures every six months for Complete Blood Count patient testing in calendar year 2023; *REPEAT DEFICIENCY* Cross Reference- D5437. -- 7 of 7 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Lakeview Pediatrics and Family Medicine on September 14, 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 was 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 two Conditions under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems D6000 -42 CFR. 493.1403 Laboratory Director D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) records, PT

Summary Statement of Deficiencies D0000 An announced on-site CLIA recertification survey was conducted at Lakeview Pediatrics and Family Medicine 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: D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) records and an interview, the laboratory failed to attain a score of at least eighty (80) percent (%) of acceptable responses for Group A Strep Antigen in one (1) out of three (3) Bacteriology testing events reviewed for calendar year 2019. Findings include: 1. Review of the laboratory's American Proficiency Institute PT records (2019 Events 1- 3) revealed Group A Strep Antigen scores of less than 80% for the following Bacteriology event: API 2019 2nd Event = 0% (challenges WST-03, WST-04 scored as unacceptable) 2. In an interview with the technical consultant, on 11/17/20 at approximately 1:30 PM, the above findings were confirmed. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as 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 -- determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of laboratory equipment, a tour, review of manufacturer's package insert instructions, and interviews, the laboratory failed to follow Abbott iSTAT chemistry reagent cartridge storage requirements for three (3) of twelve (12) cartridges on the date of the on-site inspection, November 17, 2020. Findings include: 1. During an entrance interview with the laboratory's office manager and technical consultant (TC) on 11/13/20, the inspector was informed of and noted that the laboratory utilized an Abbott iSTAT point of care chemistry analyzer (Serial Number SN 404261). 2. During a tour of the laboratory on 11/17/20 at approximately 12:30 PM, the inspector noted 12 iSTAT chem8 cartridges stored in the refrigerator (Lot Number H20191, expiration date 1/5/2021). The inspector noted 3 iSTAT cartridges (Lot Number H20191) stored at room temperature on the counter beside the iSTAT point of care instrument. The 3 packages had not been labeled with a room temperature storage expiration date. 3. Review of the iSTAT outer package revealed storage temperature instructions as 2-8 C. The manufacturer's package insert stated: "All iSTAT cartridges should be refrigerated at 2-8 C. Once removed from the refrigerator, cartridges may be stored at room temperature (18-30 C) for up to fourteen days. Once a cartridge has been warmed to room temperature, do not return it to the refrigerator. The manufacturer's labeled expiration date should be crossed out and the temperature expiration date should be written on the cartridge package." 4. The inspector inquired of the technical consultant (TC) regarding the laboratory's protocols for the iSTAT reagent cartridges stored at room temperature. The TC stated, at approximately 1:15 PM: "We store the cartridges in the refrigerator and pull out a few to keep at room temperature. The staff has been trained to write a new expiration date on the packages once they pull them out of the refrigerator. I will need to reiterate this with our staff". 5. In an interview with the TC, on 10/17/20 at approximately 1:30 PM, the above findings were confirmed D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of laboratory equipment, performance verification records, patient test logs, lack of documentation, and an interview, the laboratory director (LD) failed to evaluate and verify accuracy, precision, and reportable range for Complete Blood Count (CBC) testing for a newly installed Abbott Emerald hematology instrument prior to reporting patient results from 10/22/20 to the date of the survey on 11/17/20. Findings include: 1. During an entrance interview with the laboratory's office manager and technical consultant (TC) on 11/13/20, the inspector was informed of and noted that an Abbott field service specialist installed a new Emerald analyzer (Serial Number SN 030620-008346) on 10/22/20. 2. Review of the hematology analyzer -- 2 of 4 -- installation documentation revealed no evaluation or verification by the lab director of accuracy, precision, or the CBC reportable range for the Abbott Emerald SN 030620- 008346. The inspector requested to review documentation that the laboratory director verified the Abbott Emerald instrument prior to patient testing. No documentation was available for review. 3. Review of the patient accessioning test log revealed that the lab had reported three (3) CBC reports from 10/22/20 to 11/13/20. 4. In an interview with the TC at approximately 1:30 PM, the above findings were confirmed. 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. This STANDARD is not met as evidenced by: Based on review of policies and procedures, hematology calibration records, and an interview, the laboratory failed to document calibration procedures every six months for Complete Blood Count (CBC) patient testing according to their written procedure in calendar year 2020. Findings include: 1. Review of the laboratory's Quality Assurance (QA) procedures revealed a "CBC Calibration" policy that stated "calibration frequency for Abbott Emerald is at least once every six (6) months". 2. Review of the Emerald hematology instrument calibration documentation from January 2019 to the date of the virtual record review on 11/13/20, a total of twenty- three (23) months, revealed the following calibration records: 6/18/19, 8/5/19, 12/18 /19, 2/19/20. The inspector requested to review additional calibration records for the Emerald analyzer in calendar year 2020. No additional calibration documentation was available for review. The technical consultant (TC) stated at, approximately 11:00 AM, "The lab staff did miss the deadline for the calibration in that time period. We replaced that Emerald for a new one in October of 2020. They may have decided to postpone the calibration in August because they were planning to install a new machine". 3. In an interview with the TC on 11/17/20 at approximately 1:30 PM, the above findings were confirmed. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and -- 3 of 4 -- proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on a review of the Center for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS 209), personnel files, lack of documentation, and an interview, the laboratory director (LD) did not perform annual competency assessments for two (2) of two (2) technical consultants during the twenty-six (26) months reviewed. Findings: 1. Review of the laboratory's CMS 209 form revealed that the LD identified two technical consultants (TC). (See Personnel Code Sheet.) 2. Review of the laboratory's available personnel files revealed no competency assessment documentation for TC #1 or TC #2 in calendar year 2019 or 2020. The inspector requested to review competency assessment documentation for the duties of TC. No documentation was not available for review upon request. The office manager stated on 11/13/20 at approximately 10:00 AM, during the virtual record review, that "during the COVID-19 pandemic, we furloughed TC #1 and had to utilize TC #2 (from a different office location) to cover for most of calendar year 2020". We did complete competency assessments for them as testing personnel but not for their performance of consulting duties". 3. In an interview with the TC #1 on 11/17/20, at approximately 1:30 PM, the above findings were confirmed. -- 4 of 4 --