Pediatric Healthcare

Summary Statement of Deficiencies D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on reviews of the personnel records, the College of American Pathologists (CAP) Proficiency Testing (PT) records and an interview with Laboratory Supervisor (LS), the Laboratory Director (LD) who is also the Technical Supervisor (TS) failed to evaluate annual competencies for Testing Personnel (TP) listed on the CMS-209 (Laboratory Personnel Report). The surveyor noted three of the four TP previously qualified to perform high complexity testing had no documentation of annual evaluation since the date of the last survey, 6-9-2023 to the date of the current survey, 10-29-2025. The findings include: 1. A review of the personnel records revealed no evidence of evaluation for TP1, TP2 and TP10 by the LD/TS for annual competency assessments in the Throat and Fungal culture testing. 2. A review of the CAP PT records revealed the three TP had no documentation of performing the CAP PT events for the Throat and Fungal culture testing. 3. During the exit conference on 10-29-2025 at 1:30 PM, the LS confirmed the above findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of Policies and Procedures and in interview with Testing Personnel #2, the Laboratory Director failed to review and approve all policies and procedures prior to patient testing. This was noted from September 2023 to the date of the current survey, 10/5/2023. The findings include: 1. A review of the Policy and Procedure manual revealed no evidence of approval by the current Laboratory Director. 2. During an interview on 10/5/2023 at 1:30 PM, Testing Personnel #2 explained the Laboratory Director has recently moved into the role and had not yet approved the Policies and Procedures. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of Personnel records and an interview with Testing Personnel #2, the Technical Consultant failed to assess competency at least semi annually in the first year of patient testing. This was noted for one out of three Testing Personnel previously qualified from the date of the last survey, January 26, 2022, to the date of the current survey, October 5, 2023. The findings include: 1. A review of Personnel 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 -- records revealed Testing Personnel #3 to have an intial training date of 11/18/21 and an annual competency date of 11/30/2022. No evidence of a six month competency assessment was available for review. 2. During an interview on 10/5/2023 at 11:00 AM, Testing Personnel #2 confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of temperature logs, a review of the manufacturer's storage requirements for Horiba Minotrol Quality Controls (QC), and an interview with Testing Personnel #1, the laboratory failed to ensure the refrigerator maintained temperatures required for the storage of items therein, as per manufacturer's specifications for 92 days from December 2019 through January 2022. The findings include: 1. A review of the refrigerator temperature logs revealed acceptable ranges of 35-45 degree Fahrenheit (F), however temperatures were below this range 5 days in December 2019, 53 days in 2020, 30 days in 2021, and 4 days in January 2022 (for a total of 92 days out of acceptable ranges in the review period). 2. On 1/26/2022 at 3: 37 PM, the surveyor reviewed and confirmed the above noted findings with Testing Personnel #1. Contents of the refrigerator included the Horiba Minotrol Hematology QC, with storage requirements of 2-8 degrees Celsius (or 35-45 degrees F). Testing Personnel #1 confirmed the QC was stored at temperatures below the manufacturer's requirements. . D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) 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 -- (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of Bacteriology records and an interview with Testing Personnel #1, the laboratory failed to perform and document quality control (QC) checks on each lot number of urine culture media to ensure the media supported growth of Gram Positive and Gram Negative organisms. The laboratory failed to document media QC on eight lot numbers of Urine Culture Bi-plates used in 2021. The findings include: 1. A review of the Bacteriology records revealed the laboratory performed visual inspections of all culture media, including Blood, Mueller-Hinton and Bi-plate (Blood /MacConkey) agar. The laboratory also performed QC checks on the bi-plates using Staph aureus (a Gram Positive organism) and Escherichia coli (or E. coli, a Gram Negative organism) to document the media's ability to support growth. However, when reviewing the records, the surveyor noted eight lot numbers of bi-plates with visual inspection between 7/13/2021 and 12/10/2021 with no documentation of media QC. 2. During an interview on 1/26/2022 at 3:40 PM, the surveyor reviewed the Bacteriology records with Testing Personnel #1 who confirmed the bi-plate media QC was performed, but the laboratory had failed to document the results for each lot number. . D5781

Summary Statement of Deficiencies D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on a review of personnel listed on Form CMS-209, a review of the personnel files, and an interview with the Testing Personnel (TP) #1, the surveyor determined the laboratory failed to ensure two of two new testing personnel had documentation of training for moderate complexity testing completed before performing patient testing. The findings include: 1. A review of Form CMS-209 revealed two of the seven testing personnel listed had been hired since the previous survey on 3/28/2017. A review of the test menu for this laboratory revealed moderate-complexity testing personnel performed CBC's (Complete Blood Counts) and waived testing, and set up Bacteriology cultures for the Laboratory Director and other physicians to read and interpret. 2. A review of the personnel files revealed TP #2 was hired with an initial evaluation on 3/25/2019. TP #3 was hired 7/10/2017, with a semi-annual competency evaluation in February 2018, and an annual assessment on 7/10/2018. There was no documentation of training in the files for TP #2 or #3. 3. During an interview on 6/19 /2019 at 10:55 to 11:00 AM, the surveyor asked TP #1 about the training for TP #2 and #3. TP #1 stated she had the new personnel with her for a week in the laboratory for training. The surveyor then asked if the training was documented, reviewed and approved by the Laboratory Director (also Technical Consultant #1); TP #1 stated she had not realized this was required, and had not documented training staff on the operation of the Horiba Micros 60 Hematology analyzer, or Bacteriology culturing procedures. Thus the above noted findings were confirmed. . D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) 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 laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a review of Bacteriology Quality Control (QC) records, a review of the manufacturer's package insert for BD BBL Taxo A discs, and an interview with Testing Personnel (TP) #1, the Laboratory Director failed to ensure QC results were reported correctly and were acceptable from 2015 - 2018. Findings include: 1. A review of Bacteriology QC records revealed the reactivity of BD BBL Taxo A discs were checked when new lot numbers of discs were received once or twice each year. 2. A review of the QC logs revealed Group A Strep (Streptococcus pyogenes) with "Expected" results of "Growth", and "Actual" results documented as "Growth" on 3/17 /2015, 9/10/15, 1/13/2016, September 2017, 5/8/2018 and 9/26/18. [Group B- Streptococcus agalactia was documented with "Expected" and "Actual" results of "Negative" on the same dates.] 3. During an interview on 6/19/2019 at 3:40 PM, page 2 of the package insert for BD BBL Taxo A discs was reviewed with TP #1, as follows: "... User Quality Control ... RESULTS: A zone of inhibition is formed around the BD BBL Taxo A disc if the organism is a group A streptococcus. ... No zone of inhibition (growth up to the edge of the disc) is reported as "beta-hemolytic Streptococcus, presumptively not group A by bacitracin". ..." 4. As the interview continued, the surveyor explained their records had documented "Growth" for the positive Group A Strep QC since 2015, and as per the manufacturer's instructions, these QC results were unacceptable. Also following the manufacturer's instructions, the laboratory should specify the "Expected" results as "Positive" for zone of inhibition for the Group A Strep (Streptococcus pyogenes). The surveyor then asked who performed the testing; TP #1 explained the Medical Assistants inoculate the media cultures and place the Taxo A disc on the plates for the QC and patient cultures. Only the Laboratory Director or other physicians read and interpret the cultures. TP #1 stated she believed she had misunderstood what the physicians had reported to her, and had documented the QC incorrectly 2015-2018. The surveyor then stated in the specialty of Microbiology in this lab, the physicians are technically the high-complexity "Testing Personnel", and thus should document their own interpretations for QC and patients to ensure the results are transcribed correctly. Thus the above noted findings were confirmed. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 2 of 2 --