Pediatric Assoc Of Western Ct Llc

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 record review and staff interview, the laboratory failed to establish policies and procedures to assess competency for the regulatory responsibilities of the clinical consultant (CC) and the technical consultant (TC) in the specialty of hematology and subspecialty of bacteriology. Findings include: 1. Record review on 10/06/2025 of the laboratory's personnel competency files revealed the lack of competency assessment documentation for the regulatory positions of CC and TC. 2. Staff interview on 10/06 /2025 at 9:30 AM with the TC confirmed the above finding. The TC further commented that he/she was unaware of the regulatory requirement for competency assessment for the CC and TC positions. 3. The laboratory performs 16,205 complete blood counts annually in the specialty of hematology and 2,501 throat cultures annually in the subspecialty of bacteriology. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, 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 -- and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to investigate or take remedial action when unacceptable proficiency testing (PT) scores are received. Findings include: 1. Record review on 12/16/21 of the PT evaluation report from College of American Pathologists revealed the following: a. Unacceptable PT score was obtained for Red Blood Cells and Hematocrit for sample# HE-06 for Event B of 2021. b. Unacceptable PT score was obtained for Red Blood Cells, Hemoglobin and Hematocrit for sample# HE-12 for Event C of 2021. c. Documentation for investigation and/or

Summary Statement of Deficiencies D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to investigate or take remedial action when unacceptable proficiency testing (PT) scores are received. Findings include: 1. Record review on 6/13/19 of the PT evaluation report from the College of American Pathologists revealed: a. Unacceptable test result was obtained for hemoglobin sample # HE-11 for PT event HE-C 2017. b. Investigation or remedial action was not documented for the above unacceptable results. 2. Staff interview with nurse manager on 6/13/19 at 12:00 PM confirmed the laboratory did not investigate the above unacceptable PT result. 3. The laboratory performs 3,000 complete blood count (CBC) tests annually. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (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 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 -- 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 record review and staff interview, the laboratory failed to check each lot number and shipment of media for its ability to support growth and, as appropriate, select or inhibit specific organisms in the specialty of microbiology. Findings include: 1. Record review on 6/13/19 of the laboratory's quality control (QC) log for Hardy Diagnostics Strep Select Agar (SSA) revealed the laboratory failed to document the ability of the media to select or inhibit specific organisms for each lot number and shipment. Specifically, 71 of 71 shipments between 6/28/17 through 6/3/19. 2. Review of the above QC log further revealed that the laboratory was using two Streptococcus species (S. pyogenes and S. agalactiae) as positive and negative QC organisms to meet the above stated CLIA QC requirement. Documentation of positive and negative QC indicted as "pass" for both QC organisms in the log. 3. Record review on 6/13/19 of the Hardy Diagnostics SSA package insert revealed the laboratory must use a Streptococcus species as positive QC which will support the growth in SSA and to use either Escherichia Coli or Staphylococcus species as negative QC which will inhibit the growth in SSA. 4. Staff interview with the nurse manager (NM) on 6/13/19 at 10:45 AM confirmed the above findings. The NM stated he/she was unaware the laboratory need to use two organisms; one to support the growth and another one to inhibit the growth for SSA. 5. The laboratory performs 3,046 cultures annually in the specialty of microbiology. D5781

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 proficiency testing (PT) record desk review, the laboratory failed to successfully achieve a score of 80 percent (%) in two of three testing events for 2017 for the subspecialty of bacteriology, specifically Event 1: 77% and Event 3: 77%. Refer to citation D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record desk review, the laboratory failed to successfully achieve a score of 80 percent (%) in two of three testing events for 2017 for the subspecialty of bacteriology. Findings include: 1. Record review of the Center for Medicare & Medicaid Services (CMS) CASPER 0155D Report on 3/5/18 revealed the laboratory obtained unsatisfactory scores for two of three PT events for analyte # 0005 Bacteriology as follows: Year/Event # PT Score 2017 - Event - 1 77% 2017 - Event - 2 100% 2017 - Event - 3 77% 2. Record review of the College of American Pathologists PT program results for survey MC2 Microbiology Combination survey on 3/5/18 revealed the laboratory obtained unsatisfactory scores in two of three PT events as evidenced below. Year/Event # PT Score 2017 - Event -1 78% 2017 - Event -2 100% 2017 - Event-3 78% 3. The laboratory performs 3,388 cultures annually in the subspecialty of bacteriology. -- 2 of 2 --