Umpqua Medical Pc

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 American Proficiency Institute (API) proficiency testing results, review of the Casper Report 0155D , and phone interview with the front office manager revealed the laboratory had unsuccessful participation for two consecutive testing event for the specialty hematology. Refer to D2127 and D2130. D2127 HEMATOLOGY CFR(s): 493.851(d) 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 -- (d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) reports, and Casper Report 0155D, and phone interview with the front office manager, the laboratory failed to run and submit proficiency testing (PT) that resulted to a zero score for the 2nd event of 2024 in hematology. Findings include: 1. API 2nd event 2024. a) Platelet = 0% 2. Casper Report 0155D. a) Platelet = 0% 3. Phone interview with the front office manager on 01/08/2024 @ 12:36 PM confirmed that the laboratory failed to run PT samples and unable to submit the PT results to the PT provider. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 Proficiency Testing (PT) desk review of the American Proficiency Institute (API) results, review of the Casper report 0155D, and phone interview with the front office manager, the laboratory had unsuccessful performance in two (2) consecutive testing events for the following analyte in hematology in 2024. Findings include. 1. API 2nd event 2024 a) Platelet = 0% 2. API 3rd event 2024 a) Platelet = 60% 3. Casper Report 1055D 2nd event 2024 a) Platelet = 0% 4. Casper Report 0155D 3rd event 2024 a) Platelet = 60% 5. Phone interview with the front office manager on 01 /08/2024 @ 12:36 PM confirmed that the laboratory failed to run PT samples and unable to submit the PT results to the PT provider. 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 proficiency testing (PT) desk review of the American Proficiency Institute (API) proficiency testing results, review of the Casper Report 0155D, and phone interview with the front office manager revealed the laboratory director (LD) failed to provide overall management and direction to the laboratory. Refer to D6017 & D6018. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) (e)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing reports, and Casper Report 0155D, and phone interview with the front office manager, the laboratory director failed to ensure that PT results were run and submitted on time to the PT providers. Findings includes: 1. API 2nd event 2024. a) Platelet = 0%. 2. Casper Report 0155D 2nd event 2024. a) Platelet = 0% 3. Phone interview with the front office manager on 01/08/2024 @ 12:36 PM confirmed that the laboratory director failed ensure that PT samples were run and results were submitted on time to the PT provider. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

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 interview with the Office Manager, the Laboratory Director (LD) and review of written laboratory records made available for my review during survey 10 /24/2023, the laboratory failed to enroll in a CMS approved Proficiency Testing (PT) program for moderate complexity hematology testing performed at this laboratory in 2022 and 2023 to date. Findings include: 1. Upon review of the laboratory documents supplied for review during survey, no written or digital documentation of performance or evidence of enrollment in a CMS approved PT program could be produced. 2. Interview with the Office Manager and LD at 1:30 pm confirmed that there was no documentation of PT enrollment or performance for 2022 and 2023 to date to her knowledge. 3. The laboratory reports performing 2400 Hematology Complete Blood Counts (CBC's) on their patients annually. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems 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 -- identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of written laboratory documents made available for review during survey 10/24/2023 and interview with the Office Manager, the laboratory failed to ensure a written procedure for the ongoing mechanism to monitor and correct issues identified as quality indicators in a practice wide quality assessment (QA) plan / program was in place and being followed. Findings include: 1. Review of written laboratory documents made available for review during survey revealed the laboratory failed to ensure any QA program / plan was in place and being followed during 2022 and 2023 to date. 2. The Office Manager confirmed during interview at 1:30 pm that no written procedure for a QA plan / program was in place and had been approved by the LD for 2022 and 2023 to date. 3.The Office Manager confirmed during interview at 1:30 pm that the practice did not have an active and Laboratory Director (LD) approved QA plan or active QA monitors in place for this laboratory for 2022 and 2023 to date. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of