Children's Home Of Pittsburgh, The

Summary Statement of Deficiencies D0000 A desk review for proficiency testing results was conducted by the Pennsylvania State Agency for The Children's Home of Pittsburgh on 01/07/2026. The laboratory was found out of compliance with the following conditions: 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 review of the CASPER 0155 report and graded results from the proficiency testing (PT) organization, College of American Pathologists (CAP), the laboratory failed to successfully participate in PT for PCO2, Blood Gas. The laboratory had unsatisfactory scores for the 1st and 3rd Events of 2025. Refer to D2096. 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CASPER 0155D Report and graded results from the proficiency testing organization, College of American Pathologists (CAP), the laboratory failed to achieve an overall testing score of satisfactory performance for the routine chemistry analyte: PCO2, Blood Gas . The laboratory had unsatisfactory scores for the 1st and 3rd events of 2025. Findings include: 1. Review of the CASPER 0155D report revealed the following unsatisfactory scores: - 2025 Event 1 PCO2, Blood Gas: 60% - 2025 Event 3 PCO2, Blood Gas: 60% 2. Further review of the laboratory's 2025 CAP PT agency's graded results confirmed the above findings resulting in unsatisfactory performance for the routine chemistry analyte: PCO2, Blood Gas. -- 2 of 2 --

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's Proficiency Testing (PT) Procedure, College of American Pathologists (CAP) PT records, lack of documentation, and interview with Technical Consultant (TC) #5, the laboratory failed to document the evaluation and verification activities performed for 1 of 2 CAP PT chemistry testing events in 2025. Findings include: 1. The laboratory's PT procedure states, "All results outside of the acceptable range will be investigated and documented on proficiency testing investigation and unacceptable result form." 2. On the day of the survey, 10/08/2025 at 10:55 am, review of the laboratory's CAP PT records revealed the laboratory failed to document the

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES 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 review of the laboratory's competency assessment records and interview with the Clinical Supervisor (CS), Chief Nursing Officer (CNO), and Technical Consultant (TC) #5 (CMS 209), the laboratory failed to follow a competency assessment procedure to assess the competency of 10 of 11 technical consultants (TC) for their supervisory responsibilities performed in 2022 and 2023. Findings include: 1. On the day of the survey, 12/07/2023 at 10:50 am, a review of laboratory's competency records revealed that the laboratory director (LD) failed to perform a competency assessment for 10 of 11 TCs for their supervisory responsibilities performed in 2022 and 2023. 2. The CS, CNO, and TC #5 confirmed the findings above on 12/07/2023 at 12:30 pm. 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 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 review of competency assessment records and interview with the Technical Consultant (TC), the Technical Consultant failed to evaluate and document the performance of 1 of 48 testing personnel (TP) responsible for the IStat chemistry test for the semi-annually competency during the first year. Findings Include: 1. At the time of survey, 12/08/2021 at 09:00 a.m. the laboratory was unable to produce the semi-annually competency assessment records for TP#33 2. The TC confirmed the finding above on 12/08/2021 at 11:25 a.m. 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 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES 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 review of laboratory procedure manuals and interview with the administrative director of lab services, quality and compliance manager, nursing manager, clinical nurse educator, laboratory director (LD) and technical consultant (TC), the laboratory failed to establish a complete competency assessment procedure to assess the competency of 1 of 1 consultant and 5 of 79 TP who performed chemistry and hematology testing from 12/11/2017 to the date of survey. Findings Include: 1. On the day of survey, 07/17/2019, the laboratory could not provide a written procedure to assess the competency of 1 of 1 consultants from 12/11/2019 to 07/17/2019. 2. The laboratory could not provide the annual competency assessment for 1 of 1 TC (Personnel #3 on the CMS 209 form, Laboratory Personnel Report). 3. The laboratory could not provide annual competency assessments for the following personnel not listed on the CMS 209 form for signing off on testing personnel competencies annually: - TP #24 on page 3 of 6 - TP #41 on page 4 of 6 - TP #62 on page 5 of 6 - TP #66 on page 6 of 6 - TP #68 on page 6 of 6 4. The administrative director of lab services, quality and compliance manager, nursing manager, clinical nurse educator, LD and TC confirmed the findings above on 07/17/2019 around 09:15 am. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations 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 -- 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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control records and interview administrative director of lab services, quality and compliance manager, nursing manager, clinical nurse educator, laboratory director (LD) and technical consultant (TC), the laboratory failed to perform external liquid quality controls (QC) of different concentration, each day of patient testing for blood gases and Hemoglobin tests performed on the Abbott I-Stat, EG7+ and EC8+ cartridges from 2018 to the day of survey. Findings include: 1. On the days of survey, 07/17/2019, review of I-Stat quality control records revealed, the laboratory performed external quality control for the Abbott I-Stat analyzer, and EC8+ cartridges on a weekly bases. 2. In 2018, 946 I-stat, EG7+ cartridge tests were performed. 3. In 2018, 178 I-stat, EC8+ cartridge tests were performed. 4. In 2019 (01 /01/2019 to 07/17/2019), 503 I-stat, EG7+ cartridge tests were performed. 5. In 2019 (01/01/2019 to 07/17/2019), 49 I-stat, EC8+ cartridge tests were performed. 6. The administrative director of lab services, quality and compliance manager, nursing manager, clinical nurse educator, LD and TC confirmed the findings above on 07/17 /2019 around 9:55 am. 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 review of Abbott I-Stat analyzer, EG7+ and EC8+ cartridge comparison records and interview with the administrative director of lab services, quality and compliance manager, nursing manager, clinical nurse educator, laboratory director (LD) and technical consultant (TC), the laboratory failed to evaluate the relationship between the 1 of 3 Abbott I-stat analyzer at least twice annually in 2018. Findings Include: 1. On the day of survey, 07/17/2019, review of the Abbott I-Stat analyzer, EG7+ and EC8+ cartridges comparison logs revealed, the laboratory did not perform comparisons on 2 of 3 I- stat's in use at least twice annually. - On 7/13/2018, comparison studies were performed on the pink and green I-stat's for the EG7+ and EC8+ cartridges, but not for the red I-stat. - On 3/18/2018, comparison studies were performed on the red and green I-stat's for the EG7+ and EC8+ cartridges, but not for the pink I-stat. 2. The 2018 comparisons were performed on the green I-stat twice a year, while the pink and red I-stat's were performed only once. 3. In 2018, 946 I-stat, EG7+ cartridge tests were performed. 4. In 2018, 178 I-stat, EC8+ cartridge tests were performed. 5. In 2019 (01/01/2019 to 07/17/2019), 503 I-stat, EG7+ cartridge tests were performed. 6. In 2019 (01/01/2019 to 07/17/2019), 49 I-stat, EC8+ cartridge tests were performed. 7. The administrative director of lab services, quality and compliance manager, nursing manager, clinical nurse educator and TC confirmed the findings above on 07/17/2019 around 10:45 am. -- 2 of 3 -- 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 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 review of the CASPER Report 155 report and performance evaluations from the proficiency testing organization College of American Pathologists (CAP), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analyte: Glucose (non waived), which is of the specialty Routine Chemistry. The laboratory had unsatisfactory scores for the 2nd event of 2017 and the 1st event of 2018. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing 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 CASPER 155 report and performance evaluations from the proficiency testing organization College of American Pathologists (CAP), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analyte: Glucose (non waived) which is in the specialty of Routine Chemistry in which the laboratory is certified under CLIA. The laboratory had unsatisfactory scores for the 2nd event of 2017 and the 1st event of 2018. Findings include: 1. CAP 2017 Event 2 for Glucose (non waived), the score was 0%. 2. CAP 2018 Event 1 for Glucose (non waived), the score was 0%. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --