Independence Park Medical Services Inc

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 an off-site desk review of American Proficiency Institute (API) proficiency testing (PT) records and an email with the technical consultant (TC) on 9/22/25, the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the subspecialty of parasitology in two (2) out of three (3) testing events resulting in unsuccessful PT performance. Refer to D2055. D2055 PARASITOLOGY CFR(s): 493.829(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 -- (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 an off-site desk review of American Proficiency Institute (API) proficiency testing (PT) records and an email with the technical consultant (TC) on 9/22/25, the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the subspecialty of parasitology in two (2) out of three (3) testing events resulting in unsuccessful PT performance. Findings include: 1. A desk review of the laboratory's proficiency testing results revealed parasitology scores of less than eighty percent. 2. The laboratory obtained an unsatisfactory score of 60 percent for parasitology in the first testing event of 2025. 3. The laboratory obtained an unsatisfactory score of 0 percent for parasitology in the second testing event of 2025. 4. An email conversation with the TC on 09/22/25 confirmed the laboratory failed to achieve satisfactory performance for parasitology. -- 2 of 2 --

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 surveyor review of proficiency testing records and an interview with the laboratory director, the laboratory failed to enroll in an approved proficiency testing program for the specialty Microbiology, subspecialty Virology for the Xpert Xpress CoV-2, Influenza A and B, and Respiratory Syncytial Virus assays. Findings include: 1. The laboratory began using the cartridges for patient testing on 12/16/2020. 2. The laboratory reports performing approximately 430 CoV-2/Flu/RSV per year. 3. The laboratory director stated she was unaware the cartridges were non-waived and required proficiency testing when used with the laboratory's Cepheid Xpert Xpress analyzer. 4. The laboratory director confirmed these findings by interview on 8/29/22 at 16:00 pm. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 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 -- examining specimens. This STANDARD is not met as evidenced by: Based on review of patient records, the Manual Urine Microscopic Examination Procedure, and interview with the laboratory director, the laboratory failed to include all the required elements for reporting urine microscopic test results in five (5) of five (5) urine microscopic results reviewed (#25223, 10317, 28814, 29792, 29763). Findings include: 1. The Manual Urine Microscopic Examination Procedure dated 12 /21/2020, lists six required elements (WBC, RBC, Epithelial Cells, Bacteria, Mucus /Yeast, and Casts/Crystals) for inclusion on the patient report. 2. Five of five urine microscopy reports reviewed lacked all six elements: a. #25223: missing WBC, Epithelial Cells, Bacteria, Mucus/Yeast, and Casts/Crystals b. #10317: missing Mucus /Yeast, and Casts/Crystals c. #28814: missing Mucus/Yeast, and Casts/Crystals d. #29792: missing WBC, Epithelial Cells, Bacteria, Mucus/Yeast, and Casts/Crystals e. #29463: missing WBC, Epithelial Cells, Bacteria, Mucus/Yeast, and Casts/Crystals 3. The laboratory reports performing 87 urine microscopic examinations annually. 4. The laboratory director confirmed these findings by interview on 8/29/22 at 16:00 pm. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on surveyor record review and an interview with the laboratory director, the laboratory failed to verify the performance specifications of the Cepheid CoV-2/Flu /RSV assay cartridges prior to reporting patient test results. Findings include: 1. The laboratory's verification records did not include data for the Cepheid CoV-2/Flu/RSV assay cartridges. 2. The laboratory began using the cartridges for patient testing on 12 /16/2020. 3. The laboratory reports performing approximately 430 CoV-2/Flu/RSV tests per year. 4. The laboratory director stated she was unaware the cartridges were non-waived and required verification of performance when used with the laboratory's Cepheid Xpert Xpress analyzer. 5. The laboratory director confirmed these findings by interview on 8/29/22 at 16:00 pm. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The -- 2 of 3 -- laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor record review and interview with the laboratory director, the laboratory failed to perform control procedures each day patient specimens are tested for the Cepheid CoV-2/Flu/RSV assay. Findings include: 1. The laboratory began using the cartridges for patient testing on 12/16/2020. 2. The laboratory reports performing approximately 430 CoV-2/Flu/RSV per year. 3. The laboratory director stated she was unaware the cartridges were non-waived and required daily control procedures when used with the laboratory's Cepheid Xpert Xpress analyzer. 4. The laboratory director confirmed these findings by interview on 8/29/22 at 16:00 pm. -- 3 of 3 --