Wildwood Family Clinic

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 surveyor review of laboratory records and procedures and interview with Testing Personnel (Staff A), the laboratory did not define the acceptable humidity requirements and did not document the room temperature or humidity to ensure appropriate storage of reagents and reliable operation of the analyzers in the laboratory for the last two of two years. Findings include: 1. Review of laboratory records showed no documentation of the room temperature or humidity in the laboratory. 2. Review of the procedure, "Daily Laboratory Quality Control", showed the procedure required daily documentation of the room temperature between 20 - 26 degrees C (Celsius). Further review showed no evidence the laboratory evaluated the humidity requirements for the test systems in the laboratory. 3. Interview with Staff A on September 5, 2024, at 11:50 AM confirmed staff did not monitor or document the room temperature and humidity in the laboratory. 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 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 -- with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on surveyor review of laboratory records and interview with testing personnel, the laboratory director, who is also the technical consultant, did not provide overall management and direction in accordance with 493.1407 of this subpart. Findings include: 1. The laboratory director did not ensure the quality control program was established and maintained for the Pentra C400 analyzer to identify issues with the test system when they occurred in December 2023. See D 6020. 2. The laboratory director did not ensure testing personnel did not report patient test results when the Pentra C400 test system was not functioning properly. See D 6025. D6020 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 the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on surveyor review of quality control (QC) records from the Pentra C400 analyzer and procedures and interview with Testing Personnel (Staff A), the director did not ensure the quality control program for the Pentra C400 was established and maintained to allow testing personnel to identify issues with the test system as they occurred on six of six days in December 2023. Findings include: 1. Review of the 'Monthly QC results December 2023' and the 'Current Worklist QC Results' records for December 18 through 22 and 26, 2023, showed testing personnel performed multiple repeated testing runs over several days for each the following six analytes. The number of runs on each day with each control is shown below. The report identified the two external controls as 'N Multicontrol' and 'P Multicontrol'. Glucose: Level N Multicontrol December 18, 2 runs December 19, 3 runs December 20, 5 runs Level P Multicontrol December 20, 2 runs Potassium: Level N Multicontrol December 18, 5 runs, no acceptable result December 19, 3 runs Level P Multicontrol December 18, 5 runs, no acceptable result December 19, 2 runs December 21, 2 runs Chloride: Level N Multicontrol December 18, 5 runs, no acceptable result Level P Multicontrol December 18, 5 runs, no acceptable result December 21, 2 runs Sodium: Level P Multicontrol December 18, 5 runs, no acceptable result December 21, 2 runs High Density Lipoprotein (HDL) Level N Multicontrol December 21, 3 runs December 22, 2 runs December 26, 5 runs Low Density Lipoprotein (LDL) Level N Multicontrol December 22, 4 runs, no acceptable result December 26, 9 runs Level P Multicontrol December 26, 6 runs The 'Current Worklist QC Results' Daily control report showed the following

Summary Statement of Deficiencies D5781

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on surveyor comparison of survey forms, review of competence evaluations, and interview with testing personnel, the technical consultant did not evaluate and document performance semiannually for one of one new testing personnel performing moderate complexity testing in 2019. Findings include: 1. Comparison of the Laboratory Personnel Reports (Centers for Medicare and Medicaid Services (CMS) Form 209) from this and the previous survey, showed one testing personnel, staff B, was performing only waived testing on October 10, 2018, and was also performing moderate complexity testing on January 28, 2021. 2. Review of competence evaluations for staff B showed one documented competence evaluation in 2019 and one evaluation in 2020. 3. Interview with testing personnel, staff A, on January 28, 2021 at 9:50 AM confirmed staff B started performing moderate complexity testing after the last compliance survey. Further interview confirmed the technical consultant did not evaluate competence of staff B semiannually during the first year of moderate complexity 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 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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory failed to successfully participate in PT for the Cholesterol analyte in the Subspecialty of Routine Chemistry for events 2018-3 and 2019-2. See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 satisfactory performance for the same analyte or test in 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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) and American Proficiency Institute (API) PT records, the laboratory failed to have successful performance in PT for the Cholesterol analyte in the Subspecialty of Routine Chemistry for events 2018-3 and 2019-2. Findings include: 1. Review of PT records in the federal CASPER reporting system shows that the laboratory failed two out of three consecutive PT events for Cholesterol in the Subspecialty of Routine Chemistry - Event 2018-3, score 0% and Event 2019-2, score 20%. 2. Surveyor review of the API PT evaluation reports on August 21, 2019 confirmed the failed PT scores. This results in a failure to achieve an overall testing event score of satisfactory performance for two out of three consecutive testing events which is unsuccessful PT performance. -- 2 of 2 --

Summary Statement of Deficiencies 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) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)