Khair Family Practice

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 25, 2025. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: A review of the current Procedure Manual confirmed that the Procedure Manual failed to contain written procedures. THE FINDINGS INCLUDE: 1. A review of the current Procedure Manual confirmed that there were no SOPs for the Waived Testing Procedures: Glucose Testing, Hemoccult Testing, HCG Urine Pregnancy Testing, Urinalysis Dipstick Testing, Rapid COVID-19 Testing, Rapid Influenza A/B Testing, and Rapid Strep Testing, 2. An interview with the Testing Personnel confirmed that package inserts were not used in lieu of written procedures for the Waived Testing Procedures: Glucose Testing, Hemoccult Testing, HCG Urine Pregnancy Testing, Urinalysis Dipstick Testing, Rapid COVID-19 Testing, Rapid Influenza A/B Testing, and Rapid Strep Testing, 3. An exit interview, with the Laboratory Director and Testing Personnel, in the conference room, on March 25, 2025, at 1:30pm, confirmed these findings to be accurate. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) (b)(2) The laboratory must test samples the same number of times that it routinely 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 -- tests patient samples. This STANDARD is not met as evidenced by: A review of 2023 - 2024 WSLH Proficiency Testing Records confirmed that Testing Personnel (TP) failed to process proficiency specimens in the same manner as routinely tested patient samples. THE FINDINGS INCLUDE: 1. A review of the WSLH Proficiency Testing Records confirmed that the proficiency testing challenges included three (3) Hematology events per year for a biannual total of six (6) testing events in 2023 - 2024. Five (5) specimens were received per event evaluated six (6) indices per proficiency specimen that included: Cell ID, RBC, HCT, HGB, WBC COUNT, and PLATELETS. A biannual total of thirty (30) Proficiency specimens are evaluated, which included the evaluation of one hundred and eighty (180) indices. 2. A review of the raw testing data of the proficiency samples revealed that all testing personnel (listed on CMS 209 - TP#1, TP#2, TP#3, TP#4, and TP#5) performed testing for all five (5) proficiency specimens for the six (6) testing events in the 2023 - 2024 Hematology Proficiency Testing Events. 3. An interview with the TP staff confirmed that routine patient specimens are processed once (1X) by a single TP, unless confirmatory testing is indicated by the initial test results. 4. An exit interview with the LD and TPs, in the conference room, on March 25, 2025, at 1:30pm, confirmed that Testing Personnel (TP) failed to process proficiency samples in the manner as routinely tested patient samples. 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: A review of the Procedure Manual confirmed that the Procedure Manual failed to contain any written procedures for the patient testing currently performed at the laboratory. THE FINDINGS INCLUDE: 1. A review of the Procedure Manual confirmed that there were no SOPs for the following procedures: CBC Testing , Quality Control, Quality Assurance, or Downtime. 2. An exit interview, with the Laboratory Director and Testing Personnel, in the conference room, on March 25, 2025, at 1:30p, confirmed these findings to be accurate. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. -- 2 of 4 -- This STANDARD is not met as evidenced by: A review of two (2) randomly presented patient reports for in-house testing (1 in- house CBC Report and 1 in-house COVID/ Influenza Report), confirmed that the patient test results report failed to contain reference ranges and/ or to identify where the testing was performed. THE FINDINGS INCLUDE: 1. A review of the in-house CBC test results confirmed that the reports did not identify the facility taht performed the testing. 2. A review of the in-house COVID and Influenza A/B confirmed that the test results reports did not contain reference ranges or identify the facility that performed the testing. 3. An exit interview with the Labortory Director and Testing Personnel, in the conference room, on March 25, 2025, at 1:30pm, confirmed that the in-house patient testing reports did not contain reference ranges or the identification of the testing facility. D6011 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(2) (e)(2) provide a safe environment in which employees are protected from physical, chemical, and biological hazards; This STANDARD is not met as evidenced by: A tour of the Laboratory testing areas confirmed that the Laboratory Director (LD) failed to provide the required safety protections against accidental exposure to hazardous chemicals. THE FINDINGS INCLUDE: 1. A tour of the Hematology testing area revealed that the area did not contain a clean sink or eyewash station. 2. An exit interview with the Laboratory Director and Testing Personnel, on March 25, 2025, at 1:30pm, confirmed that the LD failed to provide the required safety protections against accidental exposure to hazardous chemicals. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: A review of 2023 - 2025 Personnel Competency Records, confirmed that the Laboratory Director (LD) failed to assure the competency of laboratory Testing Personnel (TP). THE FINDINGS INCLUDE: 1. The review of the 2023 - 2025 Personnel Competency Records confirmed that the LD did not perform the required personnel training and competencies on TP#1, TP#2, TP#3, TP#4, and TP#5 ( as dentified on 2025- CMS 209 Personnel Form). Records indicate that TP conducted training and competencies on each other for the 2023, 2024, and 2025. 2. An exit interview, with the LD and TPs, on March 25, 2025, at 1:30pm, confirmed that the LD failed to assure the competency of laboratory Testing Personnel (TP). D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 -- 3 of 4 -- failures in quality as they occur; This STANDARD is not met as evidenced by: A review of 2023 - 2025 Quality Assurance (QA) Records confirmed that the Laboratory Director failed to provide appropriate oversight to assure the quality of laboratory services provided. THE FINDINGS INCLUDE: 1. A review of the 2023 - 2025 QA Records confirmed that the LD did not perform QA reviews. QA documentation revealed that QA reviews were conducted by unqualified Testing Personnel (TP) - TP#1, TP#2, TP#3, TP#4, and TP#5 as identified on the 2025- CMS 209 Personnel Form. 2. A review of the 2023 - 2025 Refrigerator Temperature Logs confirmed that Refrigerator Temperature Logs for January 2024 - December 2024 were not reviewed by the LD until February 10, 2025. 3. A review of the 2023 - 2025 Levy Jennings QC charts from the Sysmex Hematology Analyzer revealed erratic patterns for testing parameters with no documented review, investigation, or

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on November 20, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of the laboratory personnel files and staff interviews, the laboratory director (LD) failed to ensure that prior to testing patients' specimens, all testing personnel receive the appropriate training. Findings include: 1. Personnel file reviews revealed the LD failed to ensure proper documentation of initial training for staff #7 (CMS 209 form). 2. An interview with Staff #2 (CMS 209) and the office manager in the conference room on 11/20/18 at approximately 4 p.m. confirmed the personnel file did not contain initial training of staff #7 (CMS 209 form). 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 D0000 A Clinical Laboratory Improvement Amendments (CLIA) complaint survey was completed on October 16, 2018. The laboratory was found not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on surveyor review of laboratory records and an interview with the Laboratory Director (LD), the laboratory failed to enroll in a CMS-approved proficiency test (PT) program or peer review as required by Clinical Laboratory Improvement Amendments (CLIA) for the specialty of Hematology from January 2018 through October 2018. The findings include: 1. Review of laboratory PT records revealed the laboratory was not enrolled in a PT program or peer review for the specialty of Hematology from January 2018 through October 2018. 2. The Laboratory Director confirmed on 10/16 /18 at 10:30 AM in the office, that the facility was not enrolled in a CMS- approved PT program or peer review for the specialty of Hematology. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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 -- 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and an interview with the Laboratory Director (LD), the laboratory director failed to ensure the laboratory was enrolled in a CMS-approved proficiency testing (PT) program for the specialty of Hematology for 2018. The findings include: 1. A review of laboratory records revealed that the facility was not performing PT or enrolled in a PT program for the specialty of Hematology for 2018. 2. The Laboratory Director confirmed on 10/16/18 at 10:30 AM in the office, that the facility was not enrolled in a CMS- approved PT program or peer review for the specialty of Hematology. -- 2 of 2 --