Clinic For Special Children,The

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at The Clinic for Special Children Inc. on 06/27/2024 by the Pennsylvania Department of Health. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D3009, D5209, D5213, D5429, D5775, D6093, D6095, D6107 and P5200. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory director (LD), the laboratory failed to ensure that the State of Pennsylvania (PA) regulations were met regarding reporting the presumptive presence of any disease required to to be reported by the provisions set forth in PA 27.22 relating to reporting of cases by clinical laboratories. Findings include: 1. The PA regulation 5.49. "Reportable diseases. The director of a clinical laboratory shall report to the Department all laboratory findings which indicate the presumptive presence of any disease required to be reported by the provisions set forth in 27.22 (relating to reporting of cases by clinical laboratories), or as required by other statutes or regulations of the Commonwealth or by Federal statutes." 2. On the day of the survey, 06/27/2024, the laboratory failed to provide a procedure for reporting presumptive diseases to the PA Department Health through PA NEDS or through other means of communication. 3. The laboratory failed to provide documentation of reporting positive influenza results to the PA Department of Health via PA NEDs from 11/17/2022 to the day of survey. 4. The LD confirmed the findings above on 06/27/2024 at 02:00 pm. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES 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 -- CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Laboratory Director (LD), the laboratory failed to establish and maintain a procedure to assess the competency of the laboratory's General Supervisor (GS), and Clinical Consultant (CC) for supervisory responsibilities 2023. Findings include: 1. On the day of survey, 06/27/2024, the laboratory failed to provide a written policy that reviews how to assess the competency of the laboratory supervisors for their regulatory responsibilities from 11 /17/2022 to the day of the survey. 2. The laboratory failed to provide competency assessment records for the following laboratory personnel for their supervisory responsibilities performed in 2023: - 1 of 1 CC (CMS 209 personnel #2) - 1 of 2 GS (CMS 209 personnel #3). 3. The LD confirmed the findings above on 06/27/2024 at 10:54 am. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologist (CAP) proficiency testing (PT) records and interview with the Laboratory Director (LD), the laboratory failed to document the evaluation and verification activities for PT testing performed in chemistry from 11/17/2022 to the date of the survey. Findings Include: 1. The CAP provided procedure Actions Laboratories Should Take when a PT Result is Not Graded states the following: "Code 26: Educational Challenge "Review participant summary for comparative results and document performance accordingly." 2. On the day of the survey, 06/27/2024, a review of CAP PT events the laboratory could not provide documentation of the verification of accuracy for the following CAP PT events that were not graded by the PT testing agency with code 26: - CAP BGL-B 2023 Biochemical Genetics: Amino Acid, quant Arginine HPLC/UPLC BGL-06 (Code 26). - CAP BGL-A 2024 Biochemical Genetics: EDU BGL-05 result Methionine (Code 26), EDU Quant Methionine HPLC/UPLC (Code 26), and EDU diagnosis BGL-05 (Code 26). 3. The LD confirmed the findings above on 06/27/2024 around 11:30 am. 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. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of documentation and interview with the Laboratory Director (LD), the laboratory failed to perform and document maintenance for 1 of 1 thermometer used to monitor refrigerator temperatures in the laboratory from 11/17/2022 to the date of the survey. Findings Include: 1. On the day of survey 06/27/2024, observation of the laboratory revealed 1 of 1 thermometer used to monitor refigerator temperatures used for the storage of reagents expired in 2018. 2. The laboratory could not provide maintenance or function checks records for 1 of 1 thermometer. 3. The LD confirmed the above findings 6/27/2024 at 2:35 pm. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Laboratory Director (LD), the laboratory failed to evaluate twice a year the relationship between test results using different methodologies and instrumentation in chemistry from 11/17/2022 to the date of the survey. Findings included: 1. On the date of the survey, 06/27/2024, the laboratory failed to provide documentation of the biannual comparison studies for the following 2 of 2 tests performed from 11/17/2022 to the day of survey: - DNA Sequencing (Plain Insight) vs. DNA Sequencing (Seq studio) - Amino Acid identification and quantitative (Agilent 1100) v. Amino Acid identification and quantitative (Agilent 1260 Infinity) 2. The laboratory performed 4442 chemistry examinations in 2023 (CMS 116, annual volume). 3. The LD confirmed the findings above on 06/27/2024 at approximately 1:00 pm. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) 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 review of the quality control (QC) records, lack of documentation, and interview with the laboratory director (LD), the laboratory director (LD) failed to ensure that a QC program was established and maintained to ensure the quality of services provided for 2 of 2 tests performed in chemistry from 11/17/2022 to the date of the survey. Findings Include: 1. On the day of the survey, 06/27/2024, the laboratory failed to provide documentation of the QC performed for the following 2 of 2 tests performed in chemistry from 11/17/2022 to day of survey: - DNA sequencing. - Amino Acid identification and quantitiation. 2. The laboratory performed 4442 chemistry tests in 2023 (CMS 116 annual volume). 3. The LD confirmed the findings above on 06/27/2024 around 12:00 pm. -- 3 of 4 -- D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) The laboratory director must ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. This STANDARD is not met as evidenced by: Based on review of the High Performance Liquid Chromatography (HPLC) maintenance records, laboratory procedures, and interview with the laboratory director (LD), the laboratory failed to ensure all laboratory established maintenance procedures for the HPLC analyzer were documented each time they were performed in 2023 and 2024. Findings include: 1. The laboratory's HPLC procedures states, "monthly: change OPA, Buffer, and H20." 2. On the date of the survey, 06/27/2024, review of the laboratory's HPLC maintenance records revealed the laboratory failed to document the following maintenance procedures performed in 2023 and 2024: Monthly: change OPA, Buffer, and H20: 2 of 2 months reviewed in 2024: January 2024 and February 2024. 11 of 11 months reviewed in 2023: January 2023 through November 2023. 3. The LD confirmed the findings above on 06/27/2024 at 01:30 pm. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, lack of documentation, and interview with the Laboratory Director (LD), the LD failed to specify, in writing, the duties and responsibilities of the clinical consultant (CC) involved in the preanalytic, analytic, and postanalytic phases of patient testing from 11/17/2022 to the date of the survey. Findings include: 1. On the date of the survey, 06/27/2024, the laboratory failed to provide written job responsibilities and duties for the following laboratory personal involved in the preanalytic, analytic, and postanalytic phases of patient testing from 11 /17/2022 to 06/27/2024: - 1 of 1 CC (CMS 209 personnel #2). 2. The LD confirmed the findings above on 06/27/2024 at 10:54 am. -- 4 of 4 --

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on direct observation and interview with the Laboratory Director (LD), the laboratory failed to establish a maintenance protocol for the Ergo One and Bio Hit pipettes used for High-performance liquid chromatography (HPLC) and ABI 3130 Genetic Analyzer. Findings include: 1. On the day of survey, 04/25/2018, during the tour of the Laboratory, the surveyor observed 10 Ergo One and 2 Bio Hit Pipettes each labeled with a calibration performed date of 12/14/2016 and Due 06/2017. a. Ergo One Pipettes: (# of Pipettes) Volume of Pipette (3) 2-20 ul (2) 0.1-2.5 ul (2) 200 ul (2) 30-300 ul Multi-Channel (1) 100-1000 ul b. Bio Hit Pipettes: (# of Pipettes) Volume of Pipette (1) 0.5-10 ul Multi-channel (1) 100-1000 ul 2. The LD stated "pipettes were normality calibrated every 6 months", but could not provide a procedure stating the maintenance protocol or evidence of recent calibration. 3. The LD confirmed the findings above on 04/25/2018 around 15:45 PM. Note: ul = microliter D6126 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(vi) The procedures for evaluation of the competency of the staff must include, but are not 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 -- limted to assessment of problem solving skills. This STANDARD is not met as evidenced by: Based on the review of Testing Personnel (TP) competency assessment records and interview with the laboratory director (LD), the laboratory failed to include the assessment of problem solving skills for 3 of 3 TP Competency assessments in 2017. Findings: 1) On the date of survey 04/25/2018, the surveyor reviewed competency assessment records of 3 of 3 TP. The competency assessment did not cover the assessment of problem solving skills which is one of the six requirements for CLIA competency assessment. 2) The LD confirmed the findings above on 04/25/2018 around 13:45 PM. -- 2 of 2 --