Dermatology Associates Of West Michigan

CLIA Laboratory Citation Details

4
Total Citations
32
Total Deficiencyies
15
Unique D-Tags
CMS Certification Number 23D0687229
Address 1740 E Paris Avenue Se, Grand Rapids, MI, 49546
City Grand Rapids
State MI
Zip Code49546
Phone(616) 949-5600

Citation History (4 surveys)

Survey - April 8, 2024

Survey Type: Standard

Survey Event ID: F79R11

Deficiency Tags: D2000 D2000 D5209 D5209 D5415 D5415 D5417 D5417 D5475 D5475

Summary:

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 record review and interviews with Testing Personnel #17 and the Clinical Manager, the laboratory failed to enroll in a proficiency testing program for its gram stain testing for 2 (April 2022 to April 2024) of 2 years reviewed. Findings include: 1. A review of the laboratory's procedure manual revealed a procedure for performing gram stains to identify gram positive and gram negative organisms. 2. An interview on 4/8/24 at 3:45 pm with Testing Personnel #17 revealed the laboratory had not enrolled in proficiency testing for gram staining for 2022, 2023, and 2024. 3. An interview on 4/8/24 at 3:58 pm with the Clinical Manager revealed a total of 270 patient gram stains had been performed between April 8, 2022 and April 8, 2024. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. 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 -- This STANDARD is not met as evidenced by: . Based on record review and interview with the Clinical Manager, the laboratory failed to follow its competency assessment policies for 3 (Testing Personnel #3, #6, and #8) of 19 testing personnel listed on Form CMS-209. Findings include: 1. A review of the laboratory's "Quality Control/Quality Assurance Policy" revealed a section stating, "Quality assurance for the reading of KOH slides, Tzank Preps, and histopathology will be validated twice yearly via online with the Michigan Dermatology Society, by completing educational materials and/or by participating in peer review of slides." 2. A review of the laboratory's testing personnel competency assessments revealed a lack of documentation for the following personnel: a. Testing Personnel #3 completed Michigan Dermatological Society educational materials only once in 2023. b. Testing Personnel #6 completed Michigan Dermatological Society educational materials only once in 2022. c. Testing Personnel #8 completed Michigan Dermatological Society educational materials only once in 2023. 3. An interview on 4 /8/24 at 4:20 pm with the Clinical Manager confirmed documentation of twice annual performance of Michigan Dermatological Society educational materials, used to assess testing personnel competency, was not available for the testing personnel listed above. **This is a repeated deficiency from the 6/21/22 recertification survey.** D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on observation and interview with Testing Personnel #17, the laboratory failed to label its xylene and acetone containers to include the expiration dates for 2 jars observed. Findings include: 1. The surveyor observed two glass coplin jars labeled "xylene" and "acetone" without expiration dates. 2. An interview on 4/8/24 at 12:42 pm with Testing Personnel #17 confirmed the laboratory had not labeled the two glass coplin jars with the expiration dates. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation and interview with the Clinical Manager and Testing Personnel #17, the laboratory failed to ensure its Potassium Hydroxide preparation testing reagents were not used when they exceeded expiration dates for 2 (one Potassium Hydroxide 10% and one Chlorazol Black E) bottles observed. Findings include: 1. The surveyor observed two expired reagent bottles during a tour of the laboratory's testing areas on 4/8/24 at 1:02 pm: a. One Chlorazol Black E dropper -- 2 of 3 -- bottle lot 6505 with the expiration date of 3/23/24. b. One Potassium Hydroxide 10% dropper bottle lot 1342 with the expiration date of 12/8/23. 2. An interview on 4/8/24 at 4:20 pm with the Clinical Manager and Testing Personnel #17 confirmed the reagents were expired and had been used to test four patients since 12/8/23. D5475 CONTROL PROCEDURES CFR(s): 493.1256(e)(3)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (3) Check fluorescent and immunohistochemical stains for positive and negative reactivity each time of use. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with the Clinical Manager and Testing Personnel #17, the laboratory failed to perform and document immunohistochemical stain controls for positive and negative reactivity each time of use for 3 (Patients 9-11) of 3 patients reviewed. Findings include: 1. A review of 3 patient test reports for patients receiving testing using immunohistochemical stains revealed a lack of documentation of control positive and negative reactivity: a. Patient #9 received testing on 01/08/2024 for PRAME/MART1, SOX10 red, and p16. b. Patient #10 received testing on 06/19/2023 for BAP1, BRAF, Ki-67/MART1, PRAME/MART1, and p16. c. Patient #11 received testing on 07/21/2022 for BRAF, CD10, CD31, Ki- 67MART1, S100, p16, and p63. 2. The surveyor requested documentation of immunohistochemical stain controls for positive and negative reactivity on 4/8/24 at 3: 38 pm and it was not made available. 3. An interview on 4/8/24 at 4:20 pm with the Clinical Manager and Testing Personnel #17 confirmed documentation of immunohistochemical stain controls for positive and negative reactivity each time of use was not available. -- 3 of 3 --

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Survey - June 21, 2022

Survey Type: Standard

Survey Event ID: ZC4L11

Deficiency Tags: D5413 D5209 D5801 D5301 D5803 D5413 D5801 D5803

Summary:

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #16 (TP16), the laboratory failed to ensure a written policy was established and implemented that included the competency requirements from subpart M for the mycology, parasitology, and virology testing for 7 (TP9 to TP14, and TP18) of 15 testing personnel for the past 15 months reviewed. Findings include: 1. Record review revealed the laboratory did not establish and implement a competency assessment that contained the following six minimum regulatory requirements as follows: a. Direct observations of routine patient test performance, patient preparation, specimen handling, processing, and testing. b. Monitoring the recording and reporting of patient test results. c. Review of test results, worksheets, quality control records, proficiency testing results, and preventive maintenance. d. Direct observation of performance of instrument maintenance and function checks. e. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and f. Assessment of problem solving skills. 2. Record review revealed a lack of documentation of TP competency assessments for 7 (TP9 to TP14 and TP18) of 15 testing personnel performing mycology potassium hydroxide (KOH), parasitology scabies, and virology Tzanck smears for 15 months of testing. 3. An interview on 6/21/2022 at 12:02 pm, TP16 confirmed no policy had been established or implemented. . D5301 TEST REQUEST CFR(s): 493.1241(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 3 -- The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #16 (TP16), the laboratory failed to have a documented request for patient testing from an authorized person for 1 (#5) of 8 patient charts reviewed. Findings include: 1. A record review of the "KOH/Tzanck/Scabies Log" patient testing logs revealed for 1 (#5) of 8 patient charts reviewed there was no order in the patients electronic medical record (EMR) for the potassium hydroxide (KOH) performed on 5/25/2021. 2. An interview on 6/21 /2022 at 2:00 pm, TP16 confirmed their was no order in the EMR for patient #5 for KOH testing performed on 5/25/2022. 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 observation and interview with Testing Personnel #16 (TP16), the laboratory failed to calibrate and/or replace the expired thermometer in the GE refrigerator for 15 (March 2021 to June 2022) of 15 months of operation. Findings include: 1. During a tour of the laboratory on 6/21/2022 at 9:10 am, the surveyor observed a traceable min/max thermometer in the GE refrigerator had expired on 6/23 /2020. 2. When queried on 6/21/2022 at 9:10 am, TP16 was not aware the thermometer had expired. 3. An interview on 6/21/2022 at 9:10 am, TP16 confirmed the thermometer had expired and was not calibrated and/or replaced. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on document review and interview with Testing Personnel #16 (TP16), the laboratory failed to establish a system to 1) ensure the transcribed Mohs' surgery site -- 2 of 3 -- was accurately reported for 1 (G3123-21) of 11 Mohs' cases reviewed and 2) ensure the Mohs' case number is accurately transcribed throughout the Mohs' survey process for 1 (A-1155-21) of 11 Mohs' cases reviewed. Findings include: 1. Record review revealed for 2 of 11 Mohs' cases reviewed, the surgical site on the pre-op biopsy report, the Mohs' map, Mohs' log, and the final report in the electronic medical record (EMR) system are not consistent and the Mohs' case number was not transcribed properly throughout the Mohs' survey process as follows: Mohs' a. G-3123-21 performed on 7/21/2021 i. Pre-op biopsy report and the EMR report - right lower cutaneous lip ii. Mohs' map and Mohs' log - right lower lip b. A-1155-21 performed on 9/22/2021 i. Case number on the Mohs' log - A-1155-21 ii. Case number on the slides and the EMR report - A-1151-21 2. An interview on 6/21/2022 at 12:54 pm, TP16 confirmed the locations on the pre-op biopsy report, Mohs' map, Mohs' log, and the final EMR report were not consistent with the original biopsy site and the Mohs' case number was not transcribed properly throughout the survey process. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #16 (TP16), the laboratory failed to include the results of testing performed for 1 (Patient #5) of 8 patient test reports reviewed . Findings include: 1. A review of patient test reports revealed for 1 (Patient #5) of 8 patient charts reviewed, the final test report for the potassium hydroxide (KOH) testing was not in the patient's electronic medical record (EMR). 2. When queried on 6/21/2022 at 12:00 pm, TP16 was unable to provide the surveyor test results in the EMR system. 3. An interview on 6/21/2022 at 12:00 pm, TP16 confirmed the testing was performed and documented on the "KOH/Tzanck /Scabies Log" sheet and not entered into the patient's EMR. ***Repeat Deficiency from 4/14/2016 survey*** -- 3 of 3 --

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Survey - March 1, 2021

Survey Type: Standard

Survey Event ID: H7B011

Deficiency Tags: D5217 D5217 D5433 D5433 D6120 D6120 D6168 D6168 D6171 D6171

Summary:

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #16, the laboratory failed to verify the accuracy of its dermatopathology testing for 1 (2020) of 2 years reviewed. Findings include: 1. A review of the laboratory's "DAWM Quality Assurance for Pathology DAWM//Outside Lab (Slide Consults)" log revealed a lack of documentation of the performance of verification of accuracy for its dermatopathology testing at least twice annually for 2020. 2. A review of the laboratory's "Pathology Comparison Testing/Quality Assurance" policy revealed a section stating, "Twice a year, documentation from the past 6 month's reports will be collected. 5 difference reports will be chosen; showing the office visit date, slide number, patient initials, biopsy diagnosis, and the yes/no agreement of that diagnosis between the DAWM physician and the outside lab." 3. An interview on 3/1/21 at 9:30 am with Testing Personnel #16 confirmed the laboratory had not verified the accuracy of its dermatopathology testing at least twice annually in 2020. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities 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 -- specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #16, the laboratory failed to follow its established microscope maintenance procedures for 1 (Olympus CH-2) of 12 microscopes observed. Findings include: 1. The surveyor observed an Olympus CH-2 microscope with a calibration and maintenance sticker with the date of 9/30/19 during a tour of the facility on 3/1/21 at 9:00 am. 2. A review of the laboratory's "Quality Control/Quality Assurance Policy" revealed a section stating, "Microscope maintenance will be done annually by Toby's Instrument Shop and recorded." 3. An interview on 3/1/21 at 9:39 am with Testing Personnel #16 confirmed the microscope had not been serviced annually for 2020. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #16, the Technical Supervisor failed to assess employee competency for 8 (Testing Personnel 3, 4, 6, 9, 10, 11, 12, and 13) of 16 testing personnel listed on the CMS-209 form. Findings include: 1. A review of the laboratory's competency records revealed a lack of documentation of competency assessments for the following testing personnel: a. Testing Personnel #3 had a lack of documentation for 2020 b. Testing Personnel #4 had a lack of documentation for 2020 c. Testing Personnel #6 had a lack of documentation for 2020 d. Testing Personnel #9 had a lack of documentation for 2019 and 2020 e. Testing Personnel #10 had a lack of documentation for 2019 and 2020 f. Testing Personnel #11 had a lack of documentation for 2019 and 2020 g. Testing Personnel #12 had a lack of documentation for 2019 and 2020 i. Testing Personnel #13 had a lack of documentation for 2019 and 2020 2. A review of the laboratory's "Quality Control/Quality Assurance Policy" revealed a section stating, "All testing personnel in the office will complete and document competency through CME or training twice a year. All certificates will be kept on file in the Q. A. manual." 3. An interview on 3/1/21 at 11:36 am with Testing Personnel #16 and the Clinical Manager confirmed competency assessments were not available for the staff listed above. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: -- 2 of 4 -- . Based on record review and interview with Testing Personnel #16, the laboratory failed to ensure testing personnel performing highly complex testing met the qualification requirements of 493.1489. Findings include: 1. The laboratory failed to ensure testing personnel were qualified to perform high complexity testing. Refer to D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals -- 3 of 4 -- qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #16, the laboratory failed to ensure testing personnel performing highly complex testing met the qualification requirements of 493.1489 for 1 (Testing Personnel #16) of 16 testing personnel listed on the CMS 209 form. Findings include: 1. The surveyor reviewed the qualification documentation for personnel listed on the laboratory's CMS-209 form and the laboratory did not have qualification documentation for Testing Personnel #16 to qualify as high complexity testing personnel. 2. An interview on 3/1 /21 at 10:11 am with Testing Personnel #16 revealed they are performing tissue specimen gross examinations. 3. The laboratory was provided an additional 7 days to provide qualification documentation for Testing Personnel #16 and it was not available. -- 4 of 4 --

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Survey - June 20, 2018

Survey Type: Standard

Survey Event ID: I04D11

Deficiency Tags: D5429 D5429 D5433 D5433

Summary:

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to perform and document the room temperature and humidity readings for the mycology, parasitology, virology, dermatopathology, and Mohs' instrumentation in use for two (May 2016 to May 2018) of two years of operation. Findings include: 1. On June 20, 2018 record review revealed the laboratory did not perform and document room temperature and humidity readings for the microscopes, the dermatopathology tissue processing instrumentation, and the microscopic examination of the processed tissue slides for two (May 2016 to May 2018) of two years as follows: a. mycology, parasitology, and virology microscope examination 1. garden level - two microscopes 2. central level - five microscopes b. dermatopathology tissue processing instruments and microscope c. Mohs' tissue processing instruments and microscope 2. During the interview on June 20, 2018 at approximately 2:50 PM, the office manager confirmed the room temperature and humidity readings were not performed and documented in the laboratories. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system 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 -- performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: . Based on observation, lack of records, and interview, the laboratory failed to establish, perform, and document thermometer calibrations for two (May 2016 to May 2018) of two years to ensure proper operation of the GE refrigerator that stored the Periodic Schiff stain. Findings include: 1. On June 20, 2018 at 11:30 AM during a tour of the laboratory, the surveyor observed a GE refrigerator used to store the Periodic Schiff stain with a min/max thermometer in use with a sticker on the back side labeled with "RC 10/2015". 2. On June 20, 2018 at 11:40 AM, lack of records revealed the laboratory did not establish, perform, and document thermometer calibrations for two (May 2017 to May 2018) of two years of operation. 3. During the interview on June 20, 2018 at 2:50 PM, testing personnel #7 as listed on the CMS-209 confirmed the laboratory did not establish, perform, and document thermometer calibrations for the min/max thermometer. -- 2 of 2 --

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