Molalla Urgent Care

Summary Statement of Deficiencies 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 review of Quality Control (QC) records and discussion with staff during survey 11/02/2020, the laboratory failed to follow manufacturer's instruction for performing QC on urine dipsticks. Findings include: 1. Upon request for QC records for urinalysis during survey 11/02/2020, none could be produced. 2. During interview with staff at approximately 1200, staff confirmed that the laboratory does not perform QC on the urine dipsticks. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of patient reports with Hematology and Urinalysis results on them and discussion with the Office Manager, the laboratory failed to ensure appropriate units of measure for normal ranges and patient results were included on the report. Findings include: 1. There were no units of measure on the patient report for any 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 -- analyte in Hematology. 2. There were no units of measure on the patient report for any analyte in Urinalysis. 3. The Office Manager confirmed that they do not include units of measure for either of these specialties on patient reports during interview 11 /02/2020 at approximately 1:00 pm. -- 2 of 2 --

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: Review of the American Academy of Family Physicians (AAFP) proficiency testing (PT) shows the laboratory had unsuccessful participation for the 1st and 3rd event of 2017 for Hematology: Refer to D2130 and D2131. D2130 HEMATOLOGY 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. 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 -- This STANDARD is not met as evidenced by: Review of the American Academy of Family Physicians (AAFP) proficiency testing (PT) shows unsuccessful PT for the following analytes: Findings include: 1st event 2017 , 0775 RBC - 60% 1st event 2017, 0785 HCT - 40% 1st event 2017, 0795 HGB - 60% 3rd event 2017, 0775 RBC - 40% 3rd event 2017, 0785 HCT - 60% 3rd event 2017, 0795 HGB - 80% D2131 HEMATOLOGY CFR(s): 493.851(g) 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: Record review of proficiency testing from the American Academy of Family Practice (AAFP) reveals that your laboratory has unsuccessful proficiency testing for the specialty of Hematology. Findings include: 1st Event 2017 Hematology Specialty - 73% 3rd Event 2017 Hematology Specialty -78% -- 2 of 2 --