Center For Emergency Medicine Of Western Pa, Inc

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) evaluation reports, the laboratory director failed to ensure PT data was released by the PT program (CAP) to the state agency, Pennsylvania Deparment of Health (PA SA) in 2024. Findings include: 1. On the day of the PT desk review survey, 08/20/2024, review of the laboratory's CAP PT evaluation reports revealed the laboratory director failed to ensure PT data was released by CAP to the appropriate state agency (PA SA) in 2024. 2. Further review of the CAP PT evaluation reports revealed the PT results were only copied to CMS in 2024. 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 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 -- 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 155 Report and graded results from the proficiency testing (PT) organization, College of American Pathologists (CAP), the laboratory failed to successfully participate in proficiency testing for the routine chemistry analyte: PCO2 Blood Gas. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 155 Report and graded results from the proficiency testing (PT) 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 2nd event of 2024. Findings include: Subspecialty Year Event Score PCO2: Blood gas 2024 1 60% PCO2: Blood gas 2024 2 60% -- 2 of 2 --

Summary Statement of Deficiencies 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: Based on observation of the laboratory, lack of documentation, and interview with the laboratory director (LD) and compliance manager (CM), the laboratory failed to perform and document the maintenance/ function checks for 1 of 1 thermometer used to monitor refrigerator temperatures used for storage of chemistry reagents from 06/08 /2022 to the day of survey. Findings Include: 1. On the day of survey, 03/06/2024 at 12:30 pm, the laboratory could not provide maintenance/function check records for the following 1 of 1 thermometer used to monitor refrigerator temperatures used for storage of chemistry reagents from 06/08/2022 to 03/06/2024: - Stanley S/N 000CCC1EE23F 2. The following Chemistry Blood Gas reagents were found to be stored in the laboratory. - 20 of 20 I stat CG4++ Cartridge (Manufacturer's storage requirements - 2 - 8 Celsius). 3. The LD and CM confirmed the findings above on 03 /06/2024 at 1:45 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 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 competency policy and interview with the Laboratory Director (LD), the laboratory failed to establish a procedure to assess the competency of 1 of 1 Clinical consultant (on the CMS 209 form, listed as personnel #2) for their responsibilities in 2020 and 2021. Findings include: 1. On the day of survey, 06/08 /2021 at 08:50 am, the LD, could not provide a policy that reviews how to assess the competency for 1 of 1 Clinical Consultant for their responsibilities in 2020 and 2021. 2. The laboratory could not provide documentation for competency assessment for 1 of 1 CC. 3. The LD confirmed the finding above on 06/08/2021 around 10:30 am. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) 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 review of competency assessment records, College of Pathology (CAP) proficiency testing (PT) records and interview with Laboratory Director (LD), the Technical Consultant (TC) failed to evaluate the test performance of 164 of 164 testing personnel (TP) through internal blind testing samples or external PT samples 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 -- for blood gases assay examinations in 2020 and 2021. . Findings Include: 1. At the time of survey, 06/08/2022 at 09:30 am, the competency assessment records revealed the laboratory did not assess test performance of 164 of 164 TP through internal blind testing samples or external PT samples in 2020 and 2021 who performed blood gasses assay examinations on the ISTAT analyzer. 2. The LD confirmed the findings above on 06/08/2022 around 9:30 am. -- 2 of 2 --