Allied Pediatrics & Family Medicine

Summary Statement of Deficiencies 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 review of Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D), American Proficiency Institute (API) enrollment report, Standard Operating Procedures (SOPs), lack of proficiency testing (PT) records as well as interview with Office Manager (OM), the laboratory failed to enroll in an approved PT program for the Bacteriology subspecialty and Hematology specialty. FINDINGS: 1. The laboratory performed on-site throat culture and Complete Blood Count (CBC) laboratory testing and result reporting. 2. There was no documentation of Hematology PT performance or results for the first event of 2024. 3. There was no documentation of Bacteriology PT performance or results for calendar year 2024. 4. The current, approved SOPs did not include instructions for performing such activity. 5. The OM confirmed the findings on January 10, 2025, at approximately 12:00 P.M. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a 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 -- 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 CMS PT CASPER 0155D summary reports, the laboratory failed to successfully participate in the CMS approved PT program for two of three consecutive testing events in the Bacteriology subspecialty in 2023 resulting in unsuccessful performance. Refer to D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) (e) 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 CMS PT CASPER 0155D summary reports from 2023, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events for the subspecialty Bacteriology. FINDINGS: a. A review of the CASPER 155 report revealed the following unsatisfactory scores: 1. Bacteriology Subspecialty: 2023 Second Event = 0% 2023 Third Event = 0% D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an -- 2 of 3 -- unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of calibration records, SOPs, as well as interview with OM, the laboratory failed to perform and document calibration every six months for calendar years 2023 and 2024. FINDINGS: 1. Calibration and documentation was performed for August 2023. 2. There was no documentation of calibration performance for 2024. 3. These are contrary to instructions indicated in the current, approved SOPs. 4. Approximately 2596 patient specimens were processed and results reported during the respective period. 5. The OM confirmed the findings on January 10, 2025, at approximately 11:30 A.M. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of CMS PT CASPER 0155D summary reports from 2023 and API enrollment report, the laboratory director (LD) failed to provide overall management and direction of the laboratory services. Refer to D5439 and D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of CMS PT CASPER 0155D 2023 summary reports and API enrollment report, the LD failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2028. -- 3 of 3 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on the review of temperature logs, the laboratory failed to monitor humidity since implementation 4/19/2019 through survey date as required by Horiba 60 Micros. The manufacturer has humidity requirement of 20-80%. Confirmed on an interview with practice manager on 10/12/2022 about 11:30am. 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 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) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports and PT records from the American Academy of Family Physicians (AAFP) PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Cell Identification (Cell I.D.)/White Blood Cell Differential(WBC Diff.). The following scores were assigned: 2020 second event =67% 2020 third event = 60% This is considered unsuccessful PT performance. Refer to D2130. D2130 HEMATOLOGY 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 -- CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on PT desk review of the CMS PT data reports and PT records from the AAFP PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Cell I.D.)/WBC Diff. The following scores were assigned: 2020 second event = 67% 2020 third event = 60% This is considered unsuccessful PT performance. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on PT desk review of the CMS PT and AAFP PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the test analyte Cell I.D./WBC Diff. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on PT desk review of the PT CMS data reports and AAFP PT reports, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, for the test analyte Cell I.D./WBC Diff. The following scores were assigned: Cell I.D./WBC Diff. 2020 second event = 67% 2020 third event = 60% This is considered unsuccessful PT performance. -- 2 of 2 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 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: Based on surveyor's review of the manufacturer's package inserts for the UriSpec Plus analyzer, UriSpec Multistix and interview with the practice manager and the testing personnel, the laboratory failed to follow the manufacturer's requirements for performing external positive and negative controls with each new vial opened for the UriSpec Plus Multistix from January 2018 to survey date. FINDINGS: 1. On August 7, 2019 at approximately 3:00 PM, the practice manager and the testing personnel confirmed that the required external positive and negative quality controls were not performed for urine Dip Sticks from January 2018 through the survey date. 2. Approximately 500 patients specimens were tested and reported for urinalysis from January 2018 through the survey date. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on a surveyor's review of proficiency testing records and an interview and confirmed with the practice manager and the testing personnel, the laboratory routinely tests patient Hematology samples once, but tested proficiency testing 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 -- samples in triplicates for all three events in 2018 and the first and second events in 2019. 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: Based on a surveyor's review of American Academy of Family Physicians (AAFP) Proficiency Testing ( PT) reports and interview with the practice manager and the testing personnel, the laboratory failed to evaluate, perform and document remedial action for the PT scores less than 100%. Findings: 2018 third event: Red Blood Cells (RBC) = 80% 2019 first event Platelets = 60% D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the surveyor's review of laboratory's Quality Control (QC) records and an interview with the practice manager and the testing personnel, the laboratory failed to check each new batch, lot number and/or shipment of 0.04 bacitracin disk for positive and negative reactivity from January 2018 through the survey date. FINDINGS: 1. The practice manager and the testing personnel confirmed on August 7, 2019 at approximately 3:00 PM, that the laboratory failed to check each new batch, lot number and/or shipment of 0.04 bacitracin disks for positive and negative reactivity from January 2018 through the survey date. 2. The laboratory failed to document the lot number and the expiration dates of the bacitacin disks used from January 2018 through the survey date. 3. Approximately 1500 patient specimens were tested and reported for throat culture during the above time period. 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 of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a surveyor's review of bacteriology Quality Control (QC) documentation and an interview with the practice manager and the testing personnel, the laboratory failed to perform QC as required from January 2018 through survey date. The laboratory failed to: 1. Perform and document the sterility for the SSA Media lot; 2. Document the physical characteristics of the SSA Media for any deterioration; 3. Approximately 1500 specimens were tested and reported for throat culture during the above time period. -- 3 of 3 --