Premier Physicians Centers, Inc Lab

Summary Statement of Deficiencies D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on record review and interviews with the Office Manager (OM) and Technical Supervisor (TS) #2, the laboratory failed to meet the requirements for urine culture testing and reporting in the subspecialty of Bacteriology. All patient urine culture testing had the potential to be affected by this deficient practice. Findings Include: 1. The laboratory failed to follow the manufacturer's instructions for the incubation time of the Trypticase Soy Agar (TSA) and MacConkey Agar (Mac) and inoculated 32 out of 32 patient urine cultures on a Saturday, incubated the agar for more than 24 hours and read/reported the urine culture results on the following Monday from January 1, 2019 through April 17, 2019. (Refer to D5411) 2. The laboratory failed to follow the manufacturer's instructions for the incubation temperature of the Trypticase Soy Agar (TSA) and MacConkey Agar (Mac) and incubated patient urine cultures beyond the manufacturer's requirements in 2018 and 2019. (Refer to D5413) 3. The laboratory failed to check each batch (lot number and shipment) of Trypticase Soy Agar (TSA) and MacConkey Agar (Mac) for their ability to support growth, inhibit specific organisms and produce a biochemical response in 2017, 2018 and 2019. All patient urine culture testing and reporting had the potential to be affected by this deficient practice. (Refer to D5477) 4. The laboratory failed to review the effectiveness of their analytic systems' quality assessment program. All patients had the potential to be affected by this deficient practice. (Refer to D5793) D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 5 -- Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on record review and interviews with the Office Manager (OM) and Technical Supervisor (TS) #2, the laboratory failed to follow the manufacturer's instructions for the incubation time of the Trypticase Soy Agar (TSA) and MacConkey Agar (Mac) and inoculated 32 out of 32 patient urine cultures on a Saturday, incubated the agar for more than 24 hours and read/reported the urine culture results on the following Monday from January 1, 2019 through April 17, 2019. Findings Include: 1. Review of the manufacturer's package instructions found the following statements: BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) "Procedure... Incubate plates...for 18-24 h." BBL MacConkey II Agar "Procedure... Incubate plates...for 18-24 h." h; hour(s) 2. Review of the laboratory's "Microbiology Urine Culture" policy and procedure approved, signed and dated by the Laboratory Director on 03/25/2019 found the following statements: a. "...incubate for at least 24 hours." b. "After 24 hours of incubation observe the plates for any growth." 3. Review of the laboratory's 2019 urine culture log sheet found 32 out of 32 patient specimens read beyond the manufacturer's instructions of 24 hours in which the specimens were inoculated on a Saturday and read/reported on the following Monday as listed below: Patient Inoculated Read/Reported 1-XXXX98 01/05/2019 01/07/2019 1-XXXX43 01/19 /2019 01/21/2019 1-XXXX10 01/19/2019 01/21/2019 1-XXXX84 01/26/2019 01/28 /2019 1-XXXX03 02/02/2019 02/04/2019 1-XXXX71 02/09/2019 02/11/2019 1- XXXX51 02/09/2019 02/11/2019 1-XXXX57 02/16/2019 02/18/2019 1-XXXX43 02 /16/2019 02/18/2019 1-XXXX88 02/16/2019 02/18/2019 1-XXXX93 02/16/2019 02 /18/2019 2-XXXX25 02/16/2019 02/18/2019 2-XXXX77 02/16/2019 02/18/2019 1- XXXX33 02/16/2019 02/18/2019 2-XXXX99 02/23/2019 02/25/2019 1-XXXX06 02 /23/2019 02/25/2019 1-XXXX18 02/23/2019 02/25/2019 1-XXXX92 03/02/2019 03 /04/2019 1-XXXX57 03/02/2019 03/04/2019 1-XXXX88 03/02/2019 03/04/2019 1- XXXX83 03/02/2019 03/04/2019 1-XXXX25 03/16/2019 03/18/2019 1-XXXX58 03 /16/2019 03/18/2019 1-XXXX74 03/16/2019 03/18/2019 1-XXXX39 03/30/2019 04 /01/2019 1-XXXX40 03/30/2019 04/01/2019 1-XXXX01 03/30/2019 04/01/2019 1- XXXX68 03/30/2019 04/01/2019 1-XXXX37 03/30/2019 04/01/2019 1-XXXX85 04 /06/2019 04/08/2019 1-XXXX90 04/06/2019 04/08/2019 2-XXXX88 04/06/2019 04 /08/2019 4. The OM and TS#2 confirmed that the laboratory did not follow the manufacturer's instructions and read/reported inoculated urine culture TSA and Mac plates after more than 24 hours of incubation. The interviews occurred on 04/17/2019 at 12:22 PM. 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. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on record review and interviews with the Office Manager (OM) and Technical Supervisor (TS) #2, the laboratory failed to follow the manufacturer's instructions for the incubation temperature of the Trypticase Soy Agar (TSA) and MacConkey Agar (Mac) and incubated patient urine cultures beyond the manufacturer's requirements in 2018 and 2019. All patient urine culture testing had the potential to be affected by this deficient practice. Findings Include: 1. Review of the manufacturer's package instructions found the following statements: BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) "Procedure... Incubate plates...at 35 +/- 2 C..." BBL MacConkey II Agar "Procedure... Incubate plates...at 35 +/- 2 C..." C; degrees Celsius 2. Review of the laboratory's "Microbiology Urine Culture" policy and procedure approved, signed and dated by the Laboratory Director on 03/25/2019 found the following statements: a. "...incubating in the microbiology incubator at 36 C..." b. "...incubated at 35-38 deg..." c. "Temps monitored/recorded daily (35-38 C)." deg; degrees Celsius 3. Review of the laboratory's 2018 and 2019 urine culture incubator temperature log sheet found the following number of days in each month when the incubator temperature was not within the manufacturer's instructions: Month/Year number of days incubator temp was not within the manufacturer's instructions 01/2018 21 out of 26 days 02/2018 13 out of 24 days 03/2018 12 out of 27 days 04/2018 15 out of 25 days 05/2018 6 out of 25 days 06/2018 11 out of 26 days 07/2018 15 out of 25 days 08 /2018 7 out of 27 days 09/2018 6 out of 23 days 10/2018 11 out of 27 days 11/2018 12 out of 23 days 12/2018 10 out of 25 days 01/2019 12 out of 26 days 02/2019 9 out of 24 days 03/2019 12 out of 26 days 04/2019 9 out of 15 days 4. The OM and TS#2 confirmed that the laboratory did not follow the manufacturer's instructions and incubated the TSA and Mac urine culture plates higher than 37 C. The interviews occurred on 04/17/2019 at 12:22 PM. 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. This STANDARD is not met as evidenced by: Based on record review and interviews with the Office Manager (OM) and Technical Supervisor (TS) #2, the laboratory failed to check each batch (lot number and shipment) of Trypticase Soy Agar (TSA) and MacConkey Agar (Mac) for their ability to support growth, inhibit specific organisms and produce a biochemical response in 2017, 2018 and 2019. All patient urine culture testing and reporting had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's "Microbiology Urine Culture" policy and procedure, approved, signed and dated by the Laboratory Director on 03/28/2019 and provided on the date of the inspection found a section titled "VII. Quality Control-IQCP" consisting of the bulleted sub-sections; "Risk Assessment" and "QC Plan". The "QC Plan" sub-section did not indicate any onsite QC activities other than visual inspections, sterility checks -- 3 of 5 -- and printing of the BD Quality Certificate of Analysis from the BD website. IQCP; Individualized Quality Control Plan QC; quality control 2. Further review of the laboratory's IQCP documentation did not find any historical or current QC activity recorded for the TSA and Mac urine culture plates consisting of testing specific organisms to show the agar supported growth, inhibited specific organisms and produced a biochemical response, as applicable, for each batch (lot number and shipment) received. Additionally, there was no mention of incorporating the IQCP into the quality assessment program. 3. The OM and TS#2 confirmed via an email and a phone conversation on 04/29/2019 at 2:30 PM that the laboratory had not conducted any TSA and Mac QC activities to include testing specific organisms to show the agar supported growth, inhibited specific organisms and produced a biochemical response, as applicable, for each batch (lot number and shipment) received. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of