East Liberty Family Health Care Center

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 lack of documentation and interview with the Technical Consultant (TC), the laboratory failed to establish and follow procedures to assess the competency of 1 of 1 TC for their supervisory responsibilities performed from 01/22/2025 to the date of the survey. Findings Include: 1. On the day of survey, 09/11/2025 at 10:24 am, the laboratory could not provide a procedure for assessing the competency of the laboratory's personnel for their supervisory responsibilities when overseeing potassium hydroxide (KOH) prep and wet mount microscopic examinations performed from 01/22/2025 to 09/11/2025. 2. The laboratory could not provide competency assessment records for 1 of 1 TC (CMS 209 personnel #6, dated 09/10 /2025) for their supervisory responsibilities performed from 01/22/2025 to 09/11 /2025. 3. The TC confirmed the findings above on 09/11/2025 at 11:03 am. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: 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 -- Based on review of the laboratory's procedure manual, proficiency testing records, lack of documentation and interview with the Technical Consultant (TC), the laboratory failed to provide 1 of 1 written procedure for testing personnel to follow when performing proficiency testing for Potassium Hydroxide (KOH) prep and wet mount microscopic examinations from 01/22/2025 to the day of survey. Findings include: 1. On the day of survey, 09/11/2025 at 10:24 am, review of the laboratory procedure manual and proficiency testing records revealed the laboratory did not establish a written procedure for testing personnel to follow when performing proficiency testing from 01/22/2025 to 09/11/2025 for KOH prep and wet mount microscopic examinations. 2. The laboratory reported 74 KOH prep and wet mount microscopic examinations performed in 2025 (CMS 116 estimated annual volume, dated 09/10/25). 3. The TC confirmed the findings above on 09/11/2025 at 11:03 am. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and 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 review of the laboratory's quality assessment (QA) policy, lack of documentation and interview with the Technical Consultant (TC), the Laboratory Director (LD) failed to ensure established QA programs were maintained and documented to assure the quality of laboratory services provided for 8 of 8 months from 01/22/2025 to the day of survey. Findings Include: 1. The laboratory's Quality Improvement/QA Plan states, "The Risk Manager will maintain a log of QI/QA activities. Risk Assessments will be conducted quarterly. Review and analysis of incident/injury reports, patient complaints, infection control data, and lab quality control will contribute to the assessment of Risk Prevention activities." 2. On the day of survey 09/11/2025 at 10:24 am, the laboratory could not provide site specific QA documentation of the periodic evaluation used to assess its pre-analytical, analytical, and post-analytical processes to assure the quality of laboratory services provided for 8 of 8 months from 01/22/2025 to 09/11/2025. 3. The TC confirmed the findings above on 09/11/2025 at 11:03 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 a lack of the laboratory ' s competency assessment records and interview with the Technical Consultant (TC) #2 (CMS 209), the laboratory failed to establish a competency assessment procedure to assess the competency of 1 of 2 technical consultant (TC) and 18 of 19 Testing Personnel (TP) for their supervisory and testing responsibilities performed in mycology, parasitology, and urinalysis in 2022 and 2023. Findings include: 1. On the day of the survey, 12/06/2023 at 10:12 am, the laboratory could not provide a competency assessment procedure to assess TC and TP for their supervisory and testing responsibilities. 2. The laboratory failed to provide competency assessment records for 1 of 2 TC #2 (CMS 209) for their supervisory responsibilities performed in 2022 and 2023. 3. The laboratory failed to provide competency assessments records for 18 of 19 TP (CMS 209 TP #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #16, #17, #18, and #19) who performed Potassium Hydroxide (KOH), wet mount, and urinalysis testing in 2022 and 2023. 4. The TC #2 confirmed the findings above on 12/06/2023 at 02:00 pm. 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: 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 -- Based on review of the American Academy of Family Physicians (AAFP) proficiency testing (PT) records, and interview with Technical Consultant (TC) #2 (CMS 209), the laboratory failed to document the evaluation and verification activities for PT testing performed in chemistry, hematology, and urinalysis in 2022. Findings include: 1. On the day of survey, 12/07/2023, review of laboratory's AAFP PT records revealed that the laboratory did not document the review and

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory policies and interview with the Director of Nursing, the laboratory failed to follow their quality assurance (QA) policy for 3 of 12 months in 2020 and 9 of 12 months in 2021. Findings Include: 1. The Quality Assurance Program Management and implementation states, " The QA committee shall convene monthly or more often if need to assess urgent concern". 2. On the day of survey, 10 /08/2021 at 03:30 p.m. , review of QA documentation revealed, the laboratory did not documented QA activities for the following: - 2020: January, February and March. - 2021: March, April, May, June, July, August, September, October, and November. 3. The Director of nursing confirmed the findings above on 10/08/2021 around 04:50 p. m.. 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 microscopes during the laboratory tour, review of 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 -- maintenance records, and interview with the Director of Nursing, the laboratory failed to document maintenance for the microscope from September 7, 2019 to the date of survey. Findings include: 1. The Laboratory could not provide microscope maintenance records for the microscope used for microscopic urinalysis, wet mounts, and potassium hydroxide (KOH) microscopic examinations. 2. The maintenance sticker observed at the time of survey, indicated that the microscope was last maintenance on 09/07/2019 and was due 09/07/2020. 2. The Director of Nursing confirmed the findings above on 12/08/2021 around 03:30 p.m. * Repeated Deficiency 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. This STANDARD is not met as evidenced by: Based on lack of Quality Control (QC) records and interview with the Director of Nursing, the laboratory failed to performed quality control (QC) each day of patient testing for potassium hydroxide (KOH), wet mount, and urine microscopic examinations performed in 2020 and 2021 Findings include: 1. On the day of survey, 12/08/2021, the Director of Nursing could not provide QC records for KOH, wet mount, and urine microscopic examination in 2020 and 2021. 2. The following microscopic examinations were performed: - 2020: KOH: 10 Wet mount: 22 Urine Microscopic: 3 -2021: KOH: 48 Wet Mount: 52 Urine Microscopic: 6 3. the Director of Nursing confirmed the finding above on 12/08/2021 at 03:30 pm. * Repeated deficiency. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

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 America Academy of Family Physicians (AAFP), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analyte: urine cultures which is in the specialty of Bacteriology. The laboratory had unsatisfactory scores for the 2nd event of 2020 and the 1st event of 2021. See: D2028 D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 an overall testing event score of satisfactory performance for 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 Report 155 report and performance evaluations from the proficiency testing organization America Academy of Family Physicians (AAFP), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analyte: urine cultures which is in the specialty of Bacteriology. The laboratory had unsatisfactory scores for the 2nd event of 2020 and the 1st event of 2021. Finding Include: 1. AAFP Bacteriology 2020 Event #2 urine culture score was 0%. 2. AAFP Bacteriology 2021 Event #1 urine culture score was 20%. -- 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 review of laboratory procedure manuals and interview with the director of nursing, the laboratory failed to establish a procedure to assess the competency of 9 of 10 TP who performed Fern, KOH and wet mount microscopic examinations in 2017 and 2018, and 2019. Findings include: 1. On the day of survey, 08/05/2019, the laboratory failed to provide a written policy on how to assess the competency of 9 of 10 TP who performed Fern, KOH and wet mount microscopic examinations from 01 /01/2017 to 08/05/2019. 2. The laboratory failed to assess the competency of 9 of 10 TP who performed KOH, fern and wet mount microscopic examinations in 2017 and 2018, and 2019. 3. The director of nursing confirmed the findings above on 08/05 /2019 around 1:30 pm. *** KOH= Potassium Hydroxide D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) 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 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 --