Crumay Parnes Associates Inc

Summary Statement of Deficiencies 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 review of laboratory records, lack of documentation, and interview with the Clinical Supervisor (CS), the laboratory failed to document the Quality Control (QC) for human chronic gonadotropin (hcG) performed 02/23/2023 to 11/05/2024, using the Consult Diagnostics hCG Urine Tests Cassette. Findings include: 1. The laboratory Quality Control Program policy states," Per package insert, internal controls are included in the test and external controls should be completed with each new lot, each new shipment, monthly as a check on storage, as well as with each new untrained operator." 2. On day of survey 11/05/2024 at 9:20 am, the laboratory could not provide documentation of QC performed for new lot, new shipment, monthly or for new untrained operators when urine hcG examinations were performed from 02/23 /2023 to 11/05/2024. 3. The CS confirmed the findings above on, 11/05/2024 at 9:50 am. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations 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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the Clinical Supervisor (CS), the laboratory failed to document the positive and negative control each day of patient testing for KOH and Mineral Oil (Scabies) examinations performed from January 2024 until day of survey. Findings include: 1. The laboratory Quality Control (QC) Program policy states," Control examples are readily available at the microscope for reference. Use of the control should be noted with each read of a specimen." 2. On day of survey 11/05/2024 at 9:20 am review of microbiology logs revealed the laboratory failed to document a positive and negative control each day of patient testing for the following from January 2024 to the date of the survey: - 6 out of 25 days KOH examinations were performed: - 01/1/2024 - 02/06/2024 - 04/03/2024 - 06 /17/2024 - 07/10/2024 - 10/21/2024 -2 out of 3 days Mineral Oil (Scabies) examinations were performed: - 03/13/2024 - 06/13/2024 3. The CS confirmed the findings above on, 11/05/2024 at 9:50 am. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on records, lack of documentation and interview with the Clinical Supervisor (CS), the laboratory director (LD) failed to ensure quality assessment (QA) programs were maintained to assure the quality of laboratory services and to identify failures in quality as they occur from January 2024 to November 2024. Findings include: 1. The laboratory's Quality Assessment Policy stated," The clinical supervisor will review the laboratory records monthly for the following: Patient Test Management, Quality control, Proficiency Testing, Maintenance: Microscope and autoclave, inventory, communications, complaints. The quality factors will be rated as either satisfactory or unsatisfactory on the Quality Assessment form on a monthly basis." 2. On the day of survey 11/5/2024 at 9:10 am, the laboratory failed to provide documentation of the monthly QA Assurance performed for the following: - February 2024 - March 2024 - April 2024 - May 2024 - June 2024 - July 2024 - August 2024 - October 2024 3. The CS confirmed the findings above on, 11/05/2024 at 9:50 am. -- 2 of 2 --

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (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 review of the competency assessment (CA) records and interview with the office manager (OM), the TC failed to assess the competency of 5 of 6 testing personnel (TP) for each assay of mycology, virology, and parasitology microscopic examinations performed in 2021 and 2022. Findings Include: 1. On the day of survey, 02/23/2022 at 09:04 am, review of the competency assessment records revealed, the forms used to document competency did not separate the microscopic examinations for potassium hydroxide (KOH) mycology, tzanck smears (virology) and wet mount (scabies) parasitology for 5 of 6 TP (CMS personnel #2, #3, #4, #5, and #6) in 2021 and 2022. 2. The OM confirmed the finding above on 02/23/2022 around 10:15 am. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment 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 the lack of quality assurance (QA) documentation and an interview with the office manager (OM), the laboratory director (LD) failed to ensure a QA program was established and maintained to ensure the quality of services provided by the laboratory 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 -- from 02/04/2021 to the date of the survey. Findings include: 1. On the date of the survey, 02/23/2023 at 09:40 am, the laboratory could not provide a complete procedure or documentation for the periodic QA evaluation performed to assess the laboratory's pre-analytical, analytical, and post-analytical processes from 02/04/2021 to 02/23/2023. 2. The laboratory performed 198 microbiology examinations in 2022 (the annual volume listed on the CMS-116 form). 3. The OM confirmed the finding above on 02/23/2023 around 10:15 am. -- 2 of 2 --

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 laboratory personnel interview with Office Manager & the Laboratory Director and review of the personnel records, the Technical Consultant failed to establish written policies and procedures to assess Testing Personnel competency for 5 of 6 Testing Personnel. from 07/12/2018 through the date of the survey. Findings: 1. The laboratory could not produce written policies and procedures to assess Testing Personnel competency for KOH, Scabies, and Tzanck Smears, from 07/12/2018 through the date of the survey 02/03/2021. 2. The Laboratory Director acted as Technical Consultant#1 from 08/31/2018, through the date of the survey. 3. Review of the personnel records revealed no documentation of Testing Personnel competency for 5 of 6 Testing Personnel from 07/12/2018, through the date of the survey. 4. During the survey (11:30 02/03/2021), the Laboratory Supervisor 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 --