Lakeside Pediatrics

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory (lab) failed to follow manufacturer's instructions for performing rapid antigen testing for Streptococcus Group A (Group A Step) in January and February 2024. Findings include: 1. Review on 2/8/2024 of the package insert for the lab's Group A Strep antigen tests revealed under intended use it was for the qualitative detection of Group A Strep using throat swab specimens. 2. Interview on 2/8/2024 at 11:30 p.m. with lab personnel revealed the lab ran out of bacitracin discs after 1/8/2024 and began using the rapid Group A Strep antigen test sourcing the specimen from growth obtained on culture plates. 3. Review of patient test logs from 1/9/2024 to 2/8/2024 revealed 5 patient throat cultures for presumptive identification of Group A Strep had been reported in the absence of bacitracin discs and using the rapid Group A Strep test. Further review of the 5 patient reports revealed 4 of the 5 had been reported as negative 1 of the 5 had been reported as positive for Group A Strep. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. 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 -- This CONDITION is not met as evidenced by: Based on record review and staff interview, the Laboratory Director (LD) failed to meet qualification requirements for high complexity testing in bacteriology in 2024. Refer to D6078. D6078 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1443 The laboratory director must be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R. (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) Be a doctor of medicine, a 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)(i) Have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(2)(ii) Have at least 2 years of experience directing or supervising high complexity testing; 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 and continue to be certified by a board approved by HHS; or (b)(3)(ii) Before February 24, 2003, must have served or be serving as director of a laboratory performing high complexity testing and must have at least-- (b)(3)(ii)(A) Two years of laboratory training or experience, or both; and (b)(3)(ii)(B) Two years of laboratory experience directing or supervising high complexity testing. (b)(4) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; or (b)(5) On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located; or (b)(6) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, the American Osteopathic Board of Pathology, or possess qualifications that are equivalent to those required for certification. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Laboratory Director (LD) failed to meet qualification requirements to director high complexity bacteriology testing in 2024. Findings include: 1. The laboratory failed to follow manufacturer's instructions for performing waived rapid antigen testing for Group A Streptococcus (Strep) resulting in the performance of high complexity testing in January and February 2024. 2. Review 2/8/2024 of the FDA test complexity database revealed the presumptive identification with a selective media, hemolysis, and bacitracin disk using a specimen director from throat swab specimen are categorized as moderate complexity. Use without bacitracin disks defaults to high complexity testing. 3. Interview with laboratory personnel on 2/8/2024 at 11:30 a.m. confirmed the off-label use of the waived rapid antigen testing for Group Strep and reporting of throat cultures for the -- 2 of 3 -- presumptive identification of Group A Strep without the use of bacitracin disks. 4. The LD did not have documentation at the time of survey of qualifications to director high complexity bacteriology testing. -- 3 of 3 --

Summary Statement of Deficiencies 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 record review and staff interview, the laboratory failed to perform bacteriology proficiency testing (PT) using the laboratory's routine methods in 6 of 6 events in 2018, 2019 and 2020. This is a repeat deficiency from the re-certification survey completed on 4/7/2016. Findings include: 1) Review on 9/23/2020 of patient records for the presumptive identification of group A Streptococcus (throat culture) from 2020 revealed that routine methods for each throat culture plate is read by one testing personnel. 2) Review on 9/23/2020 of Medical Laboratory Evaluation (MLE) PT records for throat cultures from 2018, 2019 and 2020 revealed five testing personnel read all 5 PT samples prior to the results due date in each of the following events: 2018 MLE-M3; 2019 MLE-M1, M2, and M3; 2020 MLE-M1 and M2. 3) Interview with Staff A (Medical Assistant) on 9/23/2020 at 10:30 a.m. confirmed the above findings. D2009 TESTING OF PROFICIENCY TESTING SAMPLES 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: 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 record review and staff interview, laboratory personnel performing bacteriology proficiency testing (PT) failed to sign the attestation form for 6 of 6 PT events in 2018, 2019, and 2020. Findings include: 1) Review on 9/23/2020 of Medical Laboratory Evaluation (MLE) PT records for presumptive identification of group A Streptococcus (throat cultures) and urine culture colony counts revealed 5 of 5 testing personnel failed to sign the attestation form for the following events: 2018 MLE-M3; 2019 MLE-M1, M2, and M3; 2020 MLE-M1 and M2. 2) Interview with Staff A (Medical Assistant) on 9/23/2020 at 10:30 a..m. confirmed the above finding. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: The laboratory director failed to ensure bacteriology proficiency testing (PT) samples were tested using routine methods in 2018, 2019, and 2020. Refer to tag D2007. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to check for positive and negative reactivity in 2016 and 2017, each lot number and shipment of bacitracin disks used for bacteriology testing. Findings include: 1) Review on 4/5/18 of quality control records from 2016 and 2017 revealed no documentation that the laboratory checked each lot number and shipment of "BD BBL Taxo A discs" (bacitracin disks) for positive and negative reactivity. The bacitracin disks were used in throat cultures for the presumptive identification of beta-hemolytic group A Streptococcus. 2) Review on 4/5/18 of the laboratory's "Throat Culture" procedure dated 6/2/2016 revealed no instruction to check each lot number and shipment of bacitracin disks for positive and negative reactivity. 3) Interview on 4/5/18 at 11:45 a.m. with a licensed practical nurse (LPN) who has administrative responsibilities for the laboratory confirmed the laboratory did not check each lot number and shipment of bacitracin disks for positive and negative reactivity. The LPN revealed the laboratory typically receives two shipments of bacitracin disks each year. 4) The laboratory performs approximately 850 throat cultures annually. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) 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 -- The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on record review and staff interview, the technical consultant failed to include assessment of bacteriology test performance in procedures for evaluation of competency in 2017. Findings include: 1) Review on 4/5/18 of proficiency testing (PT) records from 2017 revealed 3 of 6 testing personnel did not participate in PT for throat cultures and urine colony counts. 2) Interview on 4/5/18 with a licensed practical nurse (LPN) who has administrative responsibilities for the lab confirmed the above finding and revealed that no other methods were used in 2017 to assess the throat culture and urine colony count test performance for the 3 of 6 testing personnel who did not participate in PT. -- 2 of 2 --